research drug tests

• Subscribe to journal Subscribe
• Get new issue alerts Get alerts

Secondary Logo

Journal logo.

Colleague's E-mail is Invalid

Your message has been successfully sent to your colleague.

Save my selection

Appropriate Use of Drug Testing in Clinical Addiction Medicine

Jarvis, Margaret MD, DFASAM; Williams, Jessica MPH; Hurford, Matthew MD; Lindsay, Dawn PhD; Lincoln, Piper MS; Giles, Leila BS; Luongo, Peter PhD; Safarian, Taleen BA

American Society of Addiction Medicine, Rockville, MD (MJ, TS); Institute for Research, Education and Training in Addiction (JW, DL, P Lincoln, LG, P Luongo); and Community Care Behavioral Health Organization, Pittsburgh, PA (MH).

Send correspondence and reprint requests to American Society of Addiction Medicine (ASAM), 11400 Rockville Pike Suite 200, Rockville, MD 20852. E-mail: [email protected]

Received 14 February, 2017

Accepted 16 April, 2017

The authors report no conflicts of interest.

Supplemental digital content is available for this article. Direct URL citation appears in the printed text and is provided in the HTML and PDF versions of this article on the journal's Web site ( www.journaladdictionmedicine.com ).

This article is the summary of a supplement to this issue titled The Appropriate Use of Drug Testing in Clinical Addiction Medicine .

Biological drug testing is a tool that provides information about an individual's recent substance use. Like any tool, its value depends on using it correctly; that is, on selecting the right test for the right person at the right time. This document is intended to clarify appropriate clinical use of drug testing in addiction medicine and aid providers in their decisions about drug testing for the identification, diagnosis, treatment, and recovery of patients with, or at risk for, addiction. The RAND Corporation (RAND)/University of California, Los Angeles (UCLA) Appropriateness Method (RAM) process for combining scientific evidence with the collective judgment of experts was used to identify appropriate clinical practices and highlight areas where research is needed. Although consensus panels and expert groups have offered guidance on the use of drug testing for patients with addiction, very few addressed considerations for patients across settings and in different levels of care. This document will focus primarily on patients in addiction treatment and recovery, where drug testing is used to assess patients for a substance use disorder, monitor the effectiveness of a treatment plan, and support recovery. Inasmuch as the scope includes the recognition of addiction, which often occurs in general healthcare settings, selected special populations at risk for addiction visiting these settings are briefly included.

The purpose of the American Society of Addiction Medicine (ASAM) document Appropriate Use of Drug Testing in Clinical Addiction Medicine is to provide guidance about the effective use of drug testing in the identification, diagnosis, treatment, and promotion of recovery for patients with, or at risk for, addiction. This document draws on existing empirical evidence and clinical judgment on drug testing with the goal of improving the quality of care that people with addiction receive.

Drug testing uses a biological sample to detect the presence of a specific drug (or drugs) as well as drug metabolites that remain in the body following use for a window of time. No universal standards exist today in clinical drug testing for addiction identification, treatment, medication monitoring, or recovery. Relatedly, there is very limited empirical evidence about whether the use of drug testing in addiction treatment settings leads to improved clinical outcomes.

DOCUMENT FOCUS

This document focuses on when, where and how often it is appropriate to perform drug testing in the identification, treatment and recovery of patients with, or at risk for, addiction. These recommendations are not meant to be clinical practice guidelines, which typically focus on either more generalized or disease-specific recommendations. ASAM recognizes that drug testing is used in other contexts (eg, criminal justice, workplace and pain management settings). ASAM's intent with this document, however, is to focus primarily on patients in addiction treatment and recovery, where drug testing is used to assess the patient for a substance use disorder (SUD), monitor the effectiveness of their treatment plan and support recovery, and to also focus on selected special populations at risk for addiction in general healthcare settings. Although ASAM acknowledges that these recommendations may be applied to other settings where drug testing is utilized, note that the materials reviewed and methodology used were restricted to the populations and settings described.

TARGET POPULATION

This appropriateness document is intended for addiction specialists and for all providers utilizing drug testing in the context of the identification, treatment and monitoring of patients with, or at risk for, addiction. This document will also be useful for physicians and other providers concerned about the possibility of addiction in their patient population.

RECOMMENDATION DEVELOPMENT PROCESS

The RAND Corporation (RAND)/University of California, Los Angeles (UCLA) Appropriateness Method (RAM) provides a specific process for combining the best available scientific evidence with the collective clinical judgment of field experts to arrive at recommended practices ( Fitch et al., 2001 ). The RAM is ideal for the identification of underuse or overuse of specific clinical procedures or tests, as well as in situations where rigorous clinical trials are lacking. The use of the RAM produced a set of appropriateness statements regarding the use of drug testing in the identification, diagnosis, treatment, and promotion of recovery for patients with, or at risk for, addiction.

ASAM's Quality Improvement Council (QIC) was the oversight committee for the development of the appropriateness document. The QIC appointed a 10-member expert panel to participate throughout the development process, rate treatment scenarios, and review the draft document. In selecting the panel members, the QIC made every effort to avoid actual, potential, or perceived conflicts of interest that may arise as a result of relationships with industry and other entities among members of the expert panel. All QIC members, expert panel members, and external reviewers of the document were required to disclose all current related relationships, which are presented in the Supplemental Digital Content, https://links.lww.com/JAM/A56 .

The expert panel was comprised experts and researchers from multiple disciplines, medical specialties, and subspecialties, including academic research, internal medicine, adolescent medicine, pain medicine, emergency medicine, medical toxicology, anesthesiology, psychiatry, and obstetrics/gynecology. Physicians with both allopathic and osteopathic training were represented. Furthermore, the panel members represented a range of practice settings including opioid treatment programs (OTPs), physician health programs, private practice, and academic medical centers. The expert panel was assisted by a technical team from the Institute for Research, Education and Training in Addictions (IRETA). The expert panel moderator and medical advisor was selected by the IRETA project team and approved by the QIC.

EVIDENCE REVIEW AND GRADING

Existing clinical guidelines offering guidance on the use of drug testing for patients with, or at risk for, addiction were located and reviewed. Overall, the review of existing guidelines revealed that numerous consensus panels and expert groups have offered guidance on the use drug testing for patients with addiction. However, with the notable exceptions of the Substance Abuse and Mental Health Services Administration's (SAMHSA) Treatment Improvement Protocols (TIP) 40 and 43 ( CSAT, 2007; CSAT, 2012 ), very few of these guidelines address drug testing in the context of patient levels of care. Publications by authoritative professional societies, including the American Society of Addiction Medicine (ASAM), the American Academy of Pediatrics (AAP), and the American College of Obstetrics and Gynecologists (ACOG) were also consulted. Although not typically evidence-based, a representative sample of payer policies was also consulted for information about the patient populations and types and frequency of drug testing that are currently reimbursed in clinical care. See the Supplemental Digital Content, https://links.lww.com/JAM/A56 for a complete list of clinical guidelines reviewed.

A review of empirical evidence regarding the use of drug testing in the identification, treatment, and monitoring of patients with, or at risk for, addiction was conducted. Relevant research was identified via a PubMed MeSH term search for Substance-related Disorders and Substance Abuse Detection articles published in the previous 10 years, capturing the most up-to-date findings for a field defined by rapidly advancing technological innovations. Important earlier articles were identified through reverse citation search. Given the relative paucity of research directly examining drug testing in SUD populations and settings, the review was not limited to randomized controlled trials or similarly rigorous methodologies; it included cohort studies and case studies. Of the 866 articles identified, 113 were retained following a title and abstract review for relevance to the topic of biological detection of addictive substances in an appropriate population or setting. See the Supplemental Digital Content, https://links.lww.com/JAM/A56 for a complete list of articles reviewed.

Overall, the literature review revealed that drug testing has rarely been examined for its value as a clinical intervention or as a differential source of information. Many research studies include drug testing as an outcome measure of treatment adherence or progress, but few examined whether and how drug testing itself works to improve outcomes for patients with, or at risk for, addiction.

RAND/UCLA Appropriateness Method

Statements pertaining to the appropriate use of drug testing in the identification, treatment, and monitoring of patients with, or at risk for, addiction were derived from the review of existing guideline publications, payer policies, and literature. There were some clinical areas identified by the project team and medical advisor relevant to addiction treatment settings where existing clinical recommendations or adequate empirical evidence were not found (eg, certain levels of care). In these situations, appropriateness statements were generated in conjunction with the medical advisor and the lack of the existing evidence was clearly documented.

Each appropriateness statement was rated by the project team on degree of clinical consensus from previous guidelines and quality of empirical evidence. A high clinical consensus rating was reserved for statements supported by multiple sources. A high empirical evidence rating was reserved for statements emerging from multiple studies using rigorous study methodology (eg, randomized controlled trials). The statements and supporting evidence ratings were organized into a table, which served as the foundation for rating by the expert panel. A background article discussing each appropriateness statement and relevant clinical or empirical evidence was also developed and provided to the expert panel members.

Each panel member rated the appropriateness of each statement on a 9-point scale where 1 = extremely inappropriate and 9 = extremely appropriate. Appropriateness refers to whether the expected benefit of following the guidance offered by a statement outweighs any anticipated risks, irrespective of cost. The experts were asked to use their own best clinical judgment (rather than perception of what other experts might say) of appropriateness for an average patient presenting to an average provider who performs drug testing in an average setting that provides care for patients with addiction.

Statements with median scores in the 1 to 3 range were classified as inappropriate, those in the 4 to 6 range as uncertain, and those in the 7 to 9 range as appropriate. Consensus was defined as a statement that received no more than 2 ratings outside of the median score range. This cutoff for disagreement is commonly used for panel sizes of 8 to 10 members.

Expert Panel Meeting

The 10-member expert panel came together for a 2-day meeting to discuss their ratings, focusing on statements that were rated uncertain or about which they disagreed. The goal of the discussion was to discern whether uncertain and divergent ratings were due to real clinical disagreement or “artefactual” disagreement, such as fatigue while completing the rating instrument or misunderstanding of the statements. The expert panel was encouraged to modify statements for clarity and suggest additional statements during the discussion.

After the meeting, each expert rated the appropriateness of the subset of previously uncertain and disagreed upon statements, as well as the new statements that were constructed, on a 9-point scale, where 1 = extremely inappropriate and 9 = extremely appropriate. A table of the statements, their final ratings and associated evidence ratings is included in the Supplemental Digital Content, https://links.lww.com/JAM/A56 .

COMMENTS AND MODIFICATION

The first draft of the appropriateness document was created and sent to the expert panel and ASAM staff. During a subsequent teleconference held in January 2017, ASAM shared feedback with the project team regarding the document's organization, and a revised version was provided. ASAM directed an external review of the appropriateness document, which consisted of input from ASAM members and stakeholders including experts from the addiction treatment community, professional societies, and the public. The external review period was conducted from February 3, 2017, to February 28, 2017. Further edits to the appropriateness document were made on the basis of this feedback.

CLINICAL RECOMMENDATIONS

The clinical recommendations generated by the RAM and external review process are listed below. Additional discussion and references are included in the Supplemental Digital Content, https://links.lww.com/JAM/A56 .

PART 1: PRINCIPLES OF DRUG TESTING IN ADDICTION TREATMENT

Clinical value of drug testing, principles of biological detection of substance use.

Providers should understand that drug tests are designed to measure whether a substance has been used within a particular window of time.

Drug Testing and Self-Reported Substance Use

Drug testing should be used in combination with a patient's self-reported information about substance use.

Drug testing is an important supplement to self-report because patients may be unaware of the composition of the substances(s) they have used.

Drug testing is particularly appropriate for patients facing negative consequences if substance use is detected, who are therefore less likely to provide accurate self-reported substance use information.

Discrepancy between self-report and drug tests results can be a point of engagement for the provider.

Drug Testing and Patient Outcomes

Because evidence suggests that drug testing assists with monitoring adherence and abstinence in treatment and can improve patient outcomes, drug testing should be used widely in addiction treatment settings.

Drug Testing and Evidence-Based Therapy

Contingency management is the most extensively researched behavioral therapy used in conjunction with drug testing. When utilizing contingency management therapy to encourage abstinence, providers should consider incorporating drug testing.

Clinical Use of Drug Testing

Therapeutic tool.

Drug testing is recommended as a therapeutic tool as part of evidence-based addiction treatment.

Providers should utilize drug testing to explore denial, motivation, and actual substance use behaviors with patients.

If drug-testing results contradict self-reports of use, therapeutic discussions should take place.

Providers should present drug testing to patients as a way of providing motivation and reinforcement for abstinence.

Providers should educate patients as to the therapeutic purpose of drug testing. To the extent possible, persuade patients that drug testing is therapeutic rather than punitive to avoid an “us versus them” mentality.

If a patient refuses a drug test, the refusal itself should be an area of focus in the patient's treatment plan.

Treatment providers should include drug testing at intake to assist in a patient's initial assessment and treatment planning.

Results of a medical and psychosocial assessment should guide the process of choosing the type of drug test and matrix to use for assessment purposes.

Drug test results should not be used as the sole determinant in assessment for SUD. They should always be combined with patient history, psychosocial assessment, and a physical examination.

Drug testing may be used to help determine optimal placement in a level of care.

Drug testing can serve as an objective means of verifying a patient's substance use history.

Drug testing can demonstrate a discrepancy between a patient's self-report of substance use and the substances detected in testing.

For a patient presenting with altered mental status, a negative drug test result may support differentiation between intoxication and presence of an underlying psychiatric and/or medical condition that should be addressed in treatment planning.

Drug testing can be helpful if a provider is required to document a patient's current substance use.

Drug testing should be used to monitor recent substance use in all addiction treatment settings.

Drug testing should be only 1 of several methods of detecting substance use or monitoring treatment; test results should be interpreted in the context of collateral and self-report and other indicators.

PART 2: PROCESS OF DRUG TESTING IN ADDICTION TREATMENT

Choosing a test, clinical necessity and value.

Before choosing the type of test and matrix, providers should determine the questions they are seeking to answer and familiarize themselves with the benefits and limitations of each test and matrix.

Test selections should be individualized based on specific patients and clinical scenarios.

Patients’ self-reported substance use can help guide test selection.

Identifying Substance(s) of Interest

Drug testing panels should be based on the patient's drug(s) of choice and prescribed medications, and drugs commonly used in the patient's geographic location and peer group.

Addiction treatment programs/providers should establish a routine immunoassay panel.

Providers should not rely on the National Institute on Drug Abuse 5 (also known as the SAMHSA 5) as a routine drug panel.

Test panels should be regularly updated based on changes in local and national substance use trends. Providers should collaborate with the testing laboratory when determining the preferred test selections to obtain information about local and demographic trends in substance use.

Matrix Advantages and Disadvantages

Providers should understand the advantages and disadvantages of each matrix before considering rotational strategies.

If a particular specimen cannot be collected (eg, due to baldness, dry mouth, shy bladder), providers should consider collecting an alternative specimen.

If a given sample is likely to be prone to confounds, providers should choose an alternative matrix. For example, heavily chemically treated hair is not appropriate for drug testing.

Presumptive and Definitive Tests

Presumptive testing should be a routine part of initial and ongoing patient assessment.

Presumptive testing should be used when it is a priority to have more immediate (although less accurate) results.

Providers should know the cutoff threshold concentrations that their laboratory uses when interpreting a report of “no drug present.”

Federal cutoff threshold concentrations used for occupational testing are not appropriate for clinical use because they are calibrated for workplace testing.

Definitive testing techniques should be used whenever a provider wants to detect specific substances not identified by presumptive methods, quantify levels of the substance present, and refine the accuracy of the results.

Definitive testing should be used when the results inform clinical decisions with major clinical or non-clinical implications for the patient (eg, treatment transition, changes in medication therapies, changes in legal status).

If a patient disputes the findings of a presumptive test, a definitive test should be done.

When ordering a definitive test, providers should advise the testing laboratory if the presence of any particular substance or group of substances is suspected or expected.

Because not all laboratories automatically perform a definitive test of positive presumptive results (the common term for this is “reflex” testing), providers should be aware that laboratories may require a specific order for definitive testing.

Providers should always consider cost both to patients and insurers when utilizing drug testing.

Responding to Test Results

Providers should attach a meaningful therapeutic response to test results, both positive and negative, and deliver it to patients as quickly as possible.

Providers should not take a confrontational approach to discussing positive test results with patients.

Providers should be aware that immediate abstinence may not be a realistic goal for patients early in treatment.

When making patient care decisions, providers should consider all relevant factors surrounding a case rather than make a decision based solely on the results of a drug test.

Considering all relevant factors is particularly important when using drug test results to help make irreversible patient care decisions.

Unclear Test Results

Providers should contact the testing laboratory if they have any questions about interpreting a test result or to request information about the laboratory procedures that were used.

Providers may consult with a medical toxicologist or a certified Medical Review Officer (MRO) for assistance in interpreting drug test results.

If the provider suspects the test results are inaccurate, he or she should consider repeating the test, changing the test method, changing/adding to the test panel, adding specimen validity testing, or using a different matrix.

If tampering is suspected, samples should not be discarded. Rather, further testing should be performed to help identify whether and how tampering occurred.

Providers should consider samples that have been tampered with to be presumptive positive.

Presumptive Test Results

Positive presumptive test results should be viewed as “presumptive positive” results until confirmed by an independent chemical technique such as Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS).

An appropriate response to positive presumptive test results includes speaking with the patient.

Providers should review all medications, herbal products, foods, and other potential causes of positive results with the patient.

An appropriate response to positive presumptive test results may include speaking with the laboratory for assistance in interpreting the test results.

Because presumptive tests may use cutoff values, a negative presumptive test result should not be over-interpreted. It does not rule out substance use or SUD, as the latter is a clinical diagnosis.

It is appropriate to consider ordering a definitive test if presumptive test results are negative, but the patient exhibits signs of relapse.

Definitive Test Results

In the event of a positive definitive test result, consider intensifying treatment or adding adjunctive treatments.

An appropriate response to positive definitive test results may include speaking with the laboratory for assistance in interpretation.

Providers should use caution when using drug test results to interpret a patient's amount or frequency of substance use. Individual metabolism and variability in absorption should be considered.

Providers should not over-interpret a negative definitive test result. It does not rule out substance use or SUD, as the latter is a clinical diagnosis.

Test Scheduling

Test frequency.

For people in addiction treatment, frequency of testing should be dictated by patient acuity and level of care.

Providers should look to tests’ detection capabilities and windows of detection to determine the frequency of testing.

Providers should understand that increasing the frequency of testing increases the likelihood of detection of substance use, but there is insufficient evidence that increasing the frequency of drug testing has an effect on substance use itself.

Drug testing should be scheduled more frequently at the beginning of treatment; test frequency should be decreased as recovery progresses.

During the initial phase of treatment, drug testing should be done at least weekly. When possible, testing should occur on a random schedule.

When a patient is stable in treatment, drug testing should be done at least monthly. Individual consideration may be given for less frequent testing if a patient is in stable recovery. When possible, testing should occur on a random schedule.

Random Testing

Random unannounced drug tests are preferred to scheduled drug tests.

A random-interval schedule is preferable to a fixed-interval schedule because it eliminates known non-testing periods (eg, if Monday is randomly selected from a week interval, the patient knows they will not be tested Tuesday-Saturday) and it is preferable to a truly random schedule because it limits the maximum number of days between tests.

PART 3: ADDITIONAL KEY ELEMENTS OF A TESTING PROGRAM

Documentation and confidentiality.

Addiction treatment programs should provide written drug testing procedures to patients. Procedures should be reviewed with the patient at the start of his or her treatment.

Providers should document the rationale for the drug tests they order and the clinical decisions that are based upon drug test results.

Providers should ask patients about and document potential sources of cross-reactivity, including various foods and current medications.

Particular characteristics of a sample with the potential to lead to problems with interpretation (eg, hair that has been chemically treated) should be documented at the time of collection.

Test results should be documented.

Test results should be kept confidential to the extent permitted by law. Providers should thoroughly explain to patients all rules regarding confidentiality, consent, and sharing test results with outside entities.

In general, providers should use caution when sharing test results with outside entities such as justice settings or employers. When sharing test results with outside entities, it is optimal that positive results be verified with a definitive test.

Practitioner Education and Expertise

Knowledge and proficiency.

Providers responsible for ordering tests should be familiar with the limitations of presumptive and definitive testing.

Providers responsible for ordering tests should be familiar with the potential for cross-reactivity in drug testing.

Providers responsible for ordering tests should consider the possible impact of tampering on test results. Providers should note that tampering is more likely in settings where consequences for substance use are severe, such as discharge from treatment.

Providers responsible for ordering tests should understand the potential benefits of alternative matrices to urine (eg, oral fluid, hair, etc).

Providers responsible for ordering tests should be aware of the costs of different test methods.

If the provider responsible for making clinical decisions based on test results does not have training in toxicology, he or she should collaborate with a medical toxicologist, a toxicologist from the testing laboratory, or an individual with MRO certification, as needed.

Language and Attitude

Providers should communicate with patients about drug testing using non-stigmatizing language. For example, results should be discussed as “positive” or “negative” as opposed to “clean” or “dirty.”

Providers should exhibit a consistent and positive attitude toward drug testing. Ambivalent attitudes toward drug testing among staff can be a barrier to its effective use.

Test Facilities and Devices

Point of care tests.

Staff training and demonstrated proficiency is particularly important for organizations that use point of care tests (POCTs).

Providers performing POCTs should be evaluated for their proficiency. POCTs should be performed only by providers who demonstrate adequate proficiency with the drug test in question. Facilities using POCTs should periodically evaluate the accuracy of their system in comparison to a qualified laboratory.

They need to understand the statistical and analytical sensitivity of the device.

They need to understand the spectrum of analytes (drugs and metabolites) detected by the device.

They need to understand any known interferences from drugs or metabolites that could affect interpretation of results.

They need to understand the nomenclature of the device.

Users of POCTs should refer to the POCT package insert and/or the manufacturer to determine the device's capabilities.

Cost issues should be considered when deciding to initiate a POCT protocol. These include costs associated with additional staff time and training, space to perform testing, quality assurance procedures, and documentation of POCT results.

Choosing a Laboratory

Providers should seek to work with a laboratory that has expertise in drug testing in addiction treatment settings.

When selecting a laboratory, providers should investigate whether state law requires a specific certification.

It is important to work with a laboratory qualified to perform accurate tests and assist in the interpretation of results.

Providers should work to create a collaborative relationship with the laboratory; important areas for collaboration are test panel selection, detecting sample tampering, interpreting test results, and identifying regional drug use trends.

When selecting a laboratory, providers should contact the toxicology director or a medical toxicologist at the laboratory to discuss panels, types of drug tests, testing procedures, and technical assistance.

Because drug testing should be individualized, laboratories should allow providers to order specific tests for each patient.

PART 4: BIOLOGICAL MATRICES

Use of urine drug testing in addiction treatment.

Urine should be considered the most well-established and well-supported biological matrix for presumptive detection of substance use in a clinical setting.

Urine should be considered the best established matrix for POCTs.

If tampering is of high concern or appropriate measures to reduce the likelihood of tampering cannot be taken, providers should consider using an alternative specimen type.

Urine Sample Integrity

Urine should be considered the matrix most prone to sample tampering through dilution, adulteration and substitution.

Providers should choose collection methods that protect patients’ dignity and privacy while minimizing opportunities for tampering.

Observed sample collection can deter urine sample tampering; if there are concerns about tampering, collection should be observed by a same-gender staff member.

Observed urine sample collection does not completely prevent sample tampering; providers should consider other strategies to mitigate urine sample tampering.

Providers should consider the use of an unobtrusive sample collection method for patients with a history of psychological trauma, especially sexual trauma.

• Ensure that potential adulterants, such as soap, ammonia, or bleach are not readily available in the collection area.
• Consider placing blue dye in the toilet and turn off the water source to the collection area during collection.

If a provider suspects that a patient has engaged in substance use but continues to produce negative urine test results, sample collection should be observed and specimen validity testing should be conducted.

If a sample is suspected of having been tampered with, it should be tested for specimen validity including creatinine concentration, pH level, specific gravity, and adulterants.

All samples undergoing definitive testing should be tested for creatinine concentration, pH level, and specific gravity (if creatinine is low).

Signs of Urine Sample Tampering

Temperature outside expected range of 90 to 100 degrees within 4 minutes of production (This can be checked using a heat sensitive strip).

Unusual color or smell, soapy appearance, cloudiness or particles floating in the liquid.

If a urine sample exhibits unusual specimen characteristics, the sample should undergo specimen validity testing to help identify whether and how tampering occurred.

Responding to Specimen Validity Test Results

For patients with past incidences of dilute urine samples, it is advisable to collect samples in the morning or request that patients decrease water intake prior to sample collection.

For patients with past incidences of dilute urine samples, use creative solutions, such as collecting before work, on days off, or use an alternative matrix.

Urine Testing for Specific Substances

Ethanol-containing products, including hand sanitizers and mouthwash, should be avoided before an ethyl glucuronide test.

Urine testing is helpful when assessing amphetamine use. Particular caution should be paid to the interpretation of amphetamine immunoassays due to known limitations in specificity.

Particular caution should be paid to the interpretation of benzodiazepine immunoassays due to known limitations in specificity.

Immunoassay results should be used cautiously when monitoring a patient's adherence to prescribed benzodiazepines. If a patient reports that he or she is taking the drug but a urine drug screen is negative, further analysis using definitive testing should be considered.

Particular caution should be paid to the interpretation of opiate immunoassays due to known limitations in specificity.

Patients should be instructed to avoid the consumption of food items that contain poppy seeds because they can result in a positive opiate test.

Urine testing is helpful when assessing cannabis use, although it is difficult to determine the timing or cessation of consumption in chronic users due to extended windows of detection for tetrahydrocannabinol.

The relevance of blood testing in addiction treatment is limited mostly to emergency situations where there is a need to assess intoxication or impairment.

No statements about the appropriateness of breath testing were endorsed by the expert panel.

Oral fluid testing is appropriate for presumptive detection of substance use in addiction treatment settings.

Oral fluid collection with a device that facilitates saliva collection is preferable to expectoration.

The creation of a sample for oral fluid testing should be observed.

It is recommended that patients abstain from eating for 15 to 60 minutes prior to oral fluid sample collection.

If a patient recently took a drug by mouth (ingestion or inhalation), it is recommended to wait at least 2 hours before collecting an oral fluid sample.

There is insufficient evidence to support the use of sweat testing in addiction treatment. More research is needed before sweat testing can be recommended over urine testing in clinical settings.

Hair testing in addiction treatment can detect long-term patterns of use. Routine use of hair testing is not appropriate for addiction treatment.

PART 5: SETTINGS

Outpatient services (level of care 1.0) and intensive outpatient/partial hospitalization services (2.0).

Because the opportunity for substance use is greater in outpatient treatment than in more intensive levels of care, drug testing has a particularly important role in monitoring substance use.

Providers should implement a random unannounced schedule of testing in outpatient services whenever possible, because the patient's opportunity for substance use is greater relative to residential treatment.

Drug testing should be scheduled on days following weekends, holidays, and paydays when feasible. Providers should communicate with patients about plans for additional drug tests around events/special occasions.

Additional drug testing should be considered if a patient is experiencing stressful psychological events.

Residential/Inpatient Services (3.0) and Medically Managed Intensive Inpatient Services (4.0)

Drug testing plays an important role in maintaining a drug-free therapeutic environment in residential treatment.

When residents leave the treatment program on passes, they should be asked to provide a sample for drug testing shortly after their return. Providers should communicate with patients about plans for additional drug testing following their return.

Opioid Treatment Services

The primary purposes of drug testing in the context of opioid treatment services (OTS) are (a) detecting substance use that could complicate treatment response and patient management, (b) monitoring adherence with the prescribed medication, and (c) monitoring possible diversion.

Drug testing can be an important tool for detecting the use of substances that can be lethal in combination with a prescribed opioid agonist medication (eg, benzodiazepines).

Drug testing has potential application across all stages of OTS including pre-induction assessment and treatment planning, active treatment, and during maintenance and recovery. Providers should utilize drug testing during the assessment phase and throughout treatment.

Providers should utilize drug testing as an aspect of contingency management in OTS.

Provider education should include knowledge of the metabolic pathways of commonly prescribed opioids.

Testing Schedule

Drug testing frequency is determined by stage of treatment as well as other patient factors and should be individualized.

Testing should be more frequent during the stabilization period and less frequent during the maintenance period.

Drug testing during and after tapering from methadone or buprenorphine continues to be an important way to support a patient's recovery; providers may want to consider increasing drug testing frequency during tapering and in the period after tapering.

Expected drug test results (ie, positive for prescribed medication and negative for unexpected substances) should be praised and responded to with tangible contingencies such as take-home doses of medication.

High concentration of a parent drug in the absence of its metabolites is consistent with sample tampering in the form of post-collection addition of the drug to the sample and potential diversion. In this case, a follow-up assessment should be conducted with the patient.

A test that is negative for the prescribed medication (eg, negative for buprenorphine in a patient prescribed buprenorphine) should not be used on its own to determine that diversion is occurring.

Unexpected drug test results could indicate the need for 1 or more of the following responses: (a) a higher level of care; (b) a higher dose of medication; (c) a different schedule of testing, such as random rather than scheduled and/or more frequent; and/or (d) increased education for the patient.

Considerations for Opioid Treatment Service Settings

For patients in OTP settings, the federally mandated 8 tests per year should be seen as a minimum, and it is often appropriate to perform testing more frequently than 8 times per year; determinations about testing frequency and duration should be made with consideration of individual patients, as noted above.

For patients in OTP settings, provider responses to unexpected test results can include discontinuation or reduction of take home doses of medication, more frequent or random schedule of drug testing, and increased counseling and peer group sessions.

Considerations for Office-Based Opioid Treatment Settings

For patients in office-based opioid treatment settings, the drug test panel should include the therapeutic drug and/or its metabolites.

In addition to drug testing, diversion can be reduced or prevented by frequent office visits, Prescription Monitoring Programs, observed dosing, and medication counts.

In order to provide buprenorphine or naltrexone treatment, providers must have access to drug testing laboratories.

Frequency of drug testing in buprenorphine treatment should be at least monthly, unless otherwise clinically indicated (eg, patients who have become stable in recovery may require less frequent testing).

Drug testing (and a negative test result for opioids) is indicated before starting treatment of opioid use disorder using naltrexone. Drug testing also is indicated throughout treatment using naltrexone.

Frequency of drug testing in treatment of opioid use disorder using naltrexone should be at least monthly, unless otherwise clinically indicated.

Recovery Residences

Weekly random drug testing is appropriate in a recovery residence.

Any patient expelled from a recovery residence should be able to continue an ongoing therapeutic relationship with his or her outpatient addiction treatment provider.

PART 6: SPECIAL POPULATIONS

Adolescents.

Use drug testing to assist in early identification of substance use in high-risk populations of adolescents including but not limited to those with known past substance use and those in treatment for mental health disorders.

Drug testing to monitor adolescents in addiction treatment or recovery from an SUD can be performed by providers in primary care.

When an adult observes symptoms characteristic of substance use in an adolescent, providers should use drug testing as part of an assessment for a possible addiction.

Adolescents and Self-Reported Substance Use

Even if an adolescent reports substance use, providers should consider drug testing for additional information because adolescents are less likely to self-report accurately.

Adolescents and Home Testing Kits

Because of a variety of limitations with home drug testing process and interpretation, providers should not encourage the use of home drug testing for adolescents.

Adolescent Consent

Before beginning the drug testing process with an adolescent, providers should explain drug testing protocols in full.

Drug testing an adolescent without his or her consent is not appropriate, except in emergency situations (eg, accidents, suicide attempts, and seizures).

Providers should acquire consent before drug testing an adolescent with symptoms such as school failure, fatigue, or excessive moodiness. Because these are not emergency situations, they are not hazardous enough to warrant skipping this step.

If an adolescent refuses to consent to a drug test, the provider should clearly document refusal and continue to evaluate the possibility of SUD through other methods and refer the patient to a specialist with additional mental health or substance use expertise.

Adolescent Confidentiality

Before beginning the drug testing process, providers should ask the adolescent for permission to share the results with parents/guardians and discuss confidentiality with parents/guardians in order to encourage parental involvement.

If an adolescent declines to share drug test results, the provider should not share them unless there is an acute risk of harm to the patient or others.

Test Choice

Drug test panels for adolescents should include the substances most used by the demographic.

Responding to Positive Test Results

If a positive definitive drug test result indicates that an adolescent is engaging in high-risk substance use, the provider should assist the patient and his or her parent or guardian in developing a plan for monitoring and treatment.

Pregnant Patients

Consequences and confidentiality.

Providers should be aware of the adverse legal and social consequences of detecting substance use among pregnant women. They should familiarize themselves with local and state reporting requirements before conducting a drug test and relay this information to each patient before conducting a drug test.

Screening, Assessment, and Monitoring

Comprehensive substance use assessment, which may include drug testing, is part of obstetrical best practices. Providers working with this population should learn about and appropriately use clinical laboratory tests.

For a pregnant patient with a history of addiction, providers should be aware that the postpartum period is a time of increased vulnerability. Therefore, assessment for relapse, which may include drug testing, should be part of the postpartum visit.

Providers should keep drug test results and associated diagnoses confidential to the extent permitted by law.

Patient-Provider Relationship

When speaking with patients, providers should emphasize the therapeutic reasons for drug testing to avoid stigmatization.

Test Considerations

In a prenatal care setting, routine Screening and Brief Intervention for alcohol use should be conducted, but laboratory testing is not recommended except in cases of suspected or known risk factors for Alcohol Use Disorder.

As pregnant women who use substances are less willing to disclose the use of opioids and benzodiazepines than other substances, testing for opioids and benzodiazepines helps identify an often underreported behavior.

Urine is an appropriate matrix for drug testing women who are pregnant.

Test Results

As a follow up to a presumptive positive test result, providers should use definitive tests to clearly identify individual drugs.

Responses to positive drug test results can include: patient education, referral to treatment, and the creation of a treatment plan.

Providers should be familiar with local treatment resources and programs for pregnant women.

People in Recovery

It is appropriate to conduct drug testing for a minimum of 5 years in healthcare settings for most patients in stable recovery. The frequency of drug testing for patients in stable recovery should depend on the severity and chronicity of the patient's addiction.

It is appropriate for patients in stable recovery to receive periodic Recovery Management Checkups that include a drug testing component.

Immediate evaluation for treatment or treatment intensification as a response to a positive drug test result is appropriate for most patients in stable recovery.

Health and Other Professionals

Drug testing is especially useful in supporting recovery of individuals who have increased access to psychoactive substances, including healthcare professionals and professionals in safety sensitive positions. Additional testing should be considered for those in recovery who have significant occupational exposure to addictive substances.

RESEARCH RECOMMENDATIONS

This document is intended to provide guidance about the effective use of drug testing in the identification, diagnosis, treatment, and promotion of recovery for patients with, or at risk for, addiction. There were areas with insufficient evidence to make a recommendation, and/or a recommendation was not rated with agreement by the expert panel members. These areas were translated into the research recommendations below.

• Further research is needed on whether and how drug testing can be used to determine efficacy of and adjustments to treatment plans.
• Additional research is needed on the relationship between drug testing and functional status and other addiction treatment outcomes. Further research should include mediators and moderators of the relationship.
• More research is needed on the utility of clinical drug testing in populations where SUD is often identified, including primary care, emergency room, and pain management patients.
• Significantly more research is needed on optimal testing frequency as well as the relationship between specific frequency and duration of drug testing and treatment monitoring and outcomes.
• Additional research is needed on how to utilize drug testing to detect novel and synthetic drugs (eg, cannabinoids, cathinones).
• Although evidence suggests that random testing schedules are more effective than testing on a predictable timeline, further study is needed to determine whether there are situations where non-random testing is sufficient.
• Further and ongoing research is needed on which drugs should be included in drug test panels.
• Further research is needed on determinations of when a definitive test as follow-up or in place of a presumptive test should occur.
• Additionally, more research is needed on the benefits of forgoing presumptive testing and beginning with definitive testing, and on discerning the roles of different kinds of definitive testing.

PART 3: ADDITIONAL CONSIDERATIONS FOR DRUG TESTING IN ADDICTION TREATMENT

• More research on effective personnel training to increase the reliability of drug testing conducted at the point of care is needed.
• The development of appropriate cutoffs for POCT needs more research. Though manufacturer recommended cutoffs are generally more appropriate for workplace rather than clinical drug testing, producing guidelines for a clinical setting requires more information.
• Further research is needed on the effects of conducting onsite testing and interpretation versus routinely sending tests to a laboratory for results.
• Further research on the impact of insurer regulations and restrictions on drug testing, addiction treatment, and overall healthcare costs would be useful.
• Further research is needed to develop a protocol for evaluating sample tampering in urine drug testing. Further research is also needed to clarify what methods should be employed to verify specimen validity in alternative matrices.
• Additional study is required to determine the detectability of cannabis use in multiple matrices, namely oral fluid and hair.
• Research is lacking on which substances’ metabolites can be helpfully detected through hair testing. More information on false positives, environmental adulterants, and detection windows would be beneficial.
• More research is needed on whether hair and nail testing is clinically useful in ascertaining substance use patterns and history.
• More research is needed on the utility of sweat testing in addiction treatment settings.
• Additional research is needed on oral fluid, including which specific drugs/metabolites oral fluid testing might best detect.
• Further research on tobacco testing in the context of addiction treatment would be useful.
• Further research is needed on the role of drug testing for identification of potential issues in primary care or other settings outside of addiction treatment such as mental health settings.
• Before making any specific recommendations of frequency or duration specific to level of care, further research should occur.
• Further research will be required to offer complete information regarding appropriate drug testing panels in OTS. The same applies to the role of drug testing in determining optimal dosing in the context of OTS.
• In the context of OTS, further research is needed on frequency of drug testing and on response to drug testing results.
• Further research is needed to determine whether testing frequency should vary between full agonists, partial agonists, and antagonists when treating addiction involving opioid use.
• Although it is agreed that instances exist where an adolescent ought to be drug tested regardless of their own desires, the exact circumstances would benefit from further refinement.
• Further research is needed to determine what, if any, clinical benefit there is to routinely utilizing drug testing with pregnant women.
• Additional research is needed on what methods might be utilized to test for identification of alcohol use during pregnancy.
• Further research is needed on how widely the drug testing standards developed for Primary Health Providers could be applied to other addiction treatment programs.

APPLICABILITY AND IMPLEMENTATION ISSUES

This document is intended to aid providers in their clinical decision-making and patient management. The document strives to identify and define clinical decision-making junctures that meet the needs of most patients in most circumstances. Clinical decision-making should involve consideration of the quality and availability of expertise and services in the community wherein care is provided. In circumstances in which the document is being used as the basis for regulatory or payer decisions, improvement in quality of care should be the goal. Because lack of patient understanding and adherence may adversely affect outcomes, providers should make every effort to promote the patient's understanding of, and adherence to, prescribed and recommended pharmacological and psychosocial treatments and any associated testing. Patients should be informed of the risks, benefits, and alternatives to a particular treatment or test, and should be an active party to shared decision-making whenever feasible. Recommendations in this document do not supersede any federal or state regulation.

CONCLUSIONS

Drug testing should be a routine part of initial and ongoing patient assessment of recent substance use in all addiction treatment settings. Drug test results should be not be used as the sole determinant when making patient care decisions; instead, they should be used in conjunction with patients’ substance use self-reports, treatment history, psychosocial assessment, and physical examination. Drug testing should be included at intake to assist in a patient's initial assessment and treatment planning and as a routine part of ongoing assessment for substance use that could complicate treatment response and patient management. Test selections should be individualized based a patient's drug of choice, prescribed medications, and drugs commonly used in the patient's geographic location and peer group. Treatment setting factors such as opportunity for substance use, the need to maintain a drug-free therapeutic environment, ensuring adherence with prescribed medications and monitoring for possible diversion also play a role in test selection. Frequency of testing should be dictated by patient acuity and level of care and tests’ detection capabilities and windows of detection.

APPROPRIATENESS DOCUMENT GROUP MEMBERS

Louis Baxter, MD, DFASAM

Lawrence Brown, MD, MPH, DFASAM

Matthew Hurford, MD, Expert Panel Moderator

William Jacobs, MD

Kurt Kleinschmidt, MD

Marla Kushner, DO, FASAM

Lewis Nelson, MD

Michael Sprintz, DO, FASAM

Mishka Terplan, MD, MPH, FASAM

Elizabeth Warner, MD

Timothy Wiegand, MD, FACMT, FAACT

John Femino, MD, DFASAM

Kenneth Freedman, MD, MSA, MBA, DFASAM

Barbara Herbert, MD, DFASAM

Margaret A. Jarvis, MD, DFASAM, Chair

Margaret Kotz, DO, DFASAM

David Pating, MD, FASAM

Sandrine Pirard, MD, PhD, MPH, FAPA, FASAM

Robert Roose, MD, MPH, FASAM

Brendan McEntee, ASAM Staff

Taleen Safarian, ASAM Staff

Penny S. Mills, MBA, e Executive Vice President

Peter Cohen, MD, Medical Advisor

Leila Giles, BS

Piper Lincoln, MS

Dawn Lindsay, PhD

Peter Luongo, PhD

Jessica Williams, MPH

addiction identification; addiction treatment; American Society of Addiction Medicine; drug testing; medication monitoring; opioid treatment services; substance use disorder

Supplemental Digital Content

• Supplement document; [PDF] (616 KB)
• + Favorites
• View in Gallery

Readers Of this Article Also Read

Opioid settlements: the role for addiction medicine in guiding effective..., asam clinical considerations: buprenorphine treatment of opioid use disorder..., utility of urine drug testing in outpatient addiction evaluations, the asam national practice guideline for the treatment of opioid use disorder:..., the asam/aaap clinical practice guideline on the management of stimulant use....

An official website of the United States government

Here’s how you know

Official websites use .gov A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS A lock ( Lock Locked padlock icon ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

Drug Checking

• Potentially harmful substances like fentanyl and xylazine can be mixed into a variety of drugs without people knowing it, raising the risks of overdose and other harms. Drug checking (not to be confused with drug testing ) is a harm reduction practice in which people check to see if drugs contain certain substances. Some drug checking methods (such as fentanyl test strips ) can be used anywhere people use drugs, while other methods (like infrared spectrometry) are performed on-site at facilities like syringe services programs and overdose prevention centers . 1, 2
• NIDA-funded research 3, 4 shows that some people change their drug use behavior when their drugs test positive for fentanyl. This includes not using alone 3 and using smaller amounts of the drug more slowly. 4 NIDA funds research to determine whether drug checking helps reduce harms associated with drug use, such as overdose.
• NIDA also supports research to better understand if and how drug checking technologies can become more accurate, accessible, and effective. This includes developing and testing smartphone- and internet-based drug checking services, mobile drug checking facilities, and programs that integrate access to fentanyl test strips into overdose response and education.

Naloxone DrugFacts

Naloxone can quickly restore normal breathing to a person during an opioid overdose.

Latest from NIDA

What do drug tests really tell us?

NIH and FDA leaders call for more research, lower barriers to improve and implement drug- checking tools amid overdose epidemic

NIH launches harm reduction research network to prevent overdose fatalities

Find more resources on drug checking.

• Learn more about fentanyl test strips from the Centers for Disease Control and Prevention (CDC).
• Read more about how drug checking and other harm reduction practices contribute to the U.S. Department of Health and Human Services Overdose Prevention Strategy .
• Learn more about drug checking and its role in harm reduction from the U.S. Department of Justice. 
• Carroll JJ, Mackin S, Schmidt C, McKenzie M, Green TC. The Bronze Age of drug checking: barriers and facilitators to implementing advanced drug checking amidst police violence and COVID-19 . Harm Reduct J. 2022;19(1):9. Published 2022 Feb 4. doi:10.1186/s12954-022-00590-z
• Russell E, Sisco E, Thomson A, et al. Rapid analysis of drugs: A pilot surveillance system to detect changes in the illicit drug supply to guide timely harm reduction responses - eight syringe services programs, Maryland, November 2021-August 2022 . MMWR Morb Mortal Wkly Rep . 2023;72(17):458-462. Published 2023 Apr 28. doi:10.15585/mmwr.mm7217a2
• Goldman JE, Waye KM, Periera KA, Krieger MS, Yedinak JL, Marshall BDL. Perspectives on rapid fentanyl test strips as a harm reduction practice among young adults who use drugs: a qualitative study . Harm Reduct J . 2019;16(1):3. Published 2019 Jan 8. doi:10.1186/s12954-018-0276-0
• Peiper NC, Clarke SD, Vincent LB, Ciccarone D, Kral AH, Zibbell JE. Fentanyl test strips as an opioid overdose prevention strategy: Findings froßm a syringe services program in the Southeastern United States . Int J Drug Policy . 2019;63:122-128. doi:10.1016/j.drugpo.2018.08.007

An official website of the United States government

Here’s how you know

Official websites use .gov A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS A lock ( Lock Locked padlock icon ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

In Crisis? Call or Text 988

Your browser is not supported

Switch to Chrome, Edge, Firefox or Safari

Drug Testing Resources

Find resources on Workplace drug-testing programs, which are designed to detect the presence of alcohol, illicit drugs, or certain prescription drugs. 

Frequently Asked Questions About Federal Workplace Drug Testing

FAQ's About Federal Workplace Drug Testing

Drug testing is a prevention and deterrent method that is often part of a comprehensive drug-free workplace program. Any workplace drug-testing program, Federal and non-federal, should comply with applicable local, state, and federal laws.

Laboratory Resources

• Current HHS Certified Laboratory Lists
• Electronic Custody and Control Approved Laboratory List
• Drug Testing Index from Quest Diagnostics
• Authorized Drug Testing Panels – Urine and Oral Fluid
• 2019 Suppliers of Blind Quality Control Urine Samples (PDF | 132 KB)
• 2011 Anomalous Results for 6-Acetylmorphine (PDF | 33 KB)
• National Laboratory Certification Program (NLCP)
• 2024 National Laboratory Certification Program (NLCP) (PDF | 52 KB)
• 2019 NLCP Revised Fee Schedule Notice (PDF | 505 KB)
• 2019 NLCP Certification Payment Schedule (PDF | 25 KB)

Cannabimimetics Testing: For the current list of HHS-certified laboratories that offer cannabimimetics testing for federal agency specimens, please contact the National Laboratory Certification Program (NLCP) at (919) 541-7242 or email [email protected] .

Specimen Collection Resources

• 2024 Oral Fluid Collection Handbook (PDF | 1.7 MB)
• 2024 Oral Fluid Collection Site Manual (PDF | 540 KB)
• 2024 Oral Fluid Collection Site Checklist (PDF | 290 KB)
• 2024 Urine Specimen Collection Handbook (PDF | 2 MB)
• 2024 Urine Specimen Collection Site Manual (PDF | 616 KB)
• 2024 Urine Specimen Collection Site Checklist (PDF | 272 KB)
• 2020 Oral Fluid Collection Handbook (PDF | 1.5 MB)
• 2022 Oral Fluid Collection Site Manual (PDF | 496 KB)
• 2022 Oral Fluid Collection Site Checklist (PDF | 511 KB)
• 2022 Urine Specimen Collection Handbook (PDF | 2 MB)
• 2022 Urine Specimen Collection Site Manual (PDF | 532 KB)
• 2022 Urine Specimen Collection Site Checklist (PDF | 605 KB)
• Access archived specimen collection resources

Conducting Drug Tests

Testing must be conducted by an HHS-certified test facility . HHS-certified urine laboratories and oral fluid laboratories conduct all tests and report all specimen results. For urine only, instrumented initial test facilities (IITFs) conduct the initial drug and first specimen validity tests for urine specimens and report only the negative and negative-dilute results. IITFs forward specimens requiring further testing to an HHS-certified urine laboratory.

Before beginning drug testing, ask the following questions addressed in your drug-free workplace policy and consider how they will affect your testing program.

• Who receives testing?
• When are the drug tests given?
• Who conducts the testing?
• What substances are tested for?
• Who pays for the drug testing?
• What steps are taken to ensure the accuracy of the drug tests?
• What are the legal rights of employees who receive a positive test result?

Develop a system to protect the confidentiality of employee drug-testing records. Select a person within your organization who will be responsible for receiving employee drug test results, and make sure that the person is aware of confidentiality protocols. Explain the relationship of the drug testing program to your organization’s employee assistance plan (EAP) , if one is offered. Let employees know how drug-testing results can be used to inform their treatment, rehabilitation, and re-integration into the workplace.

Find more information on determining whether to conduct workplace drug testing .

Types of Drug Tests

Drug tests vary, depending on what types of drugs are being tested for and what types of specimens are being collected. Blood (plasma, serum, whole blood), breath, hair, meconium, saliva (oral fluid), sweat, body tissues, and urine are some of the specimen types that can be used for drug testing.

Under the authority of Section 503 of Public Law 100-71, 5 U.S.C. Section 7301, and Executive Order No. 12564, the Department of Health and Human Services (HHS) establishes the scientific and technical guidelines for Federal workplace drug testing programs and established standards for certification of laboratories engaged in drug testing Federal agencies. The Substance Abuse and Mental Health Services Administration (SAMHSA) has published mandatory guidelines for drug testing for urine (UrMG) and for oral fluid (OFMG).

Federal agency drug tests include five categories of drugs, along with required specimen validity tests (for urine) and provisions for analysis of specimen biomarkers. Drug categories and drugs include: amphetamines (amphetamine, methamphetamine, methylenedioxyamphetamine [MDA], methylenedioxymethamphetamine [MDMA]); cocaine; marijuana; opiates/opioids (heroin, codeine, hydrocodone, hydromorphone, morphine, oxycodone, oxymorphone); and phencyclidine (PCP). On a case-by-case basis, specimens may be tested for any of the Schedule I or II drugs of the federal Controlled Substances Act. Urine specimen validity tests are used to determine if a specimen exhibits abnormal physical characteristics, causes reactions or responses characteristic of an adulterant during initial or confirmatory drug tests, or contains an unidentified substance that interferes with the confirmatory analysis. Biomarker tests are used to identify specimens that are not consistent with a human specimen (i.e., based on the absence or abnormal concentration of the biomarker).

Drug testing may be used in the following set times or circumstances:

• Pre-employment: You can make passing a drug test a condition of employment. With this approach, all job candidates will receive drug testing prior to being hired.
• Annual Physical Tests: You can drug test your employees as part of an annual physical examination. Be sure to inform employees that drug testing will be part of the exam. Failure to provide prior notification is a violation of the employee's constitutional rights.
• For-cause and Reasonable Suspicion Tests: You may decide to test employees who show discernible signs of being unfit for duty (for-cause testing), or who have a documented pattern of unsafe work behavior (reasonable suspicion testing.) These kinds of tests help to protect the safety and wellbeing of the employee and other coworkers.
• Post-accident Tests: Testing employees who were involved in a workplace accident or unsafe practices can help determine whether alcohol or other drug use was a contributing factor to the incident.
• Post-treatment Tests: Testing employees who return to work after completing a rehabilitation program can encourage them to remain drug-free.
• Random Tests: Tests using an unpredictable selection process are the most effective for deterring illicit drug use.
• Return-to-duty Tests and Follow-up Tests: Regulated employees that return to duty may be subject to follow-up testing. These kind of tests follow the employee to subsequent employers or through breaks in service.

Test Results

Ensuring the accuracy of drug-testing results is critical. Using an HHS certified laboratory to test the specimens and a Medical Review Officer (MRO) to interpret federally-regulated test results are required and help prevent inaccurate testing. MROs are licensed physicians who receive laboratory results and have knowledge of drug testing, substance use disorders and federal drug testing regulations.

MROs are trained to verify test reports by interpreting and evaluating test results together with the employee’s medical history, employee interview, and other relevant information. A negative test result does not indicate that an employee or job applicant has never used illicit drugs (or alcohol), nor is it a guarantee against future use. Note that a laboratory-confirmed positive test result does not automatically identify an employee or job applicant as having misused drugs, nor does a laboratory biomarker result of invalid, adulterated, or substituted automatically identify a person as having tampered with a specimen.

Federal agency specimen collections are split into containers A and B. Container A is tested by the HHS-certified laboratory. Container B is retained for additional testing (if needed). Federal employees or employees in safety and security-sensitive industries that receive a MRO-verified positive drug test report have the right to have the split specimen (container B) tested by a second HHS-certified laboratory. Although a second test is not required, all employers should include this right in their employee drug-testing programs.

Depending on the federal agency, the workplace, and the circumstances, employees who drug test positive may be referred to Employee Assistance Programs ( EAPs ), into treatment, or for disciplinary action.

Medical Review Officer (MRO) Resources

• MRO Certification Entity Application Request: The Department of Health and Human Services (HHS) Requirements for Approval of Medical Review Officer (MRO) Certification (PDF | 97 KB)
• 2024 MRO Guidance Manual (PDF | 7.2 MB)
• 2024 MRO Case Studies Oral Fluid (PDF | 452 KB)
• 2024 MRO Case Studies Urine (PDF | 502 KB)
• 2020 MRO Guidance Manual (PDF | 7.7 MB)
• 2022 MRO Case Studies Oral Fluid (PDF | 486 KB)
• 2022 MRO Case Studies Urine (PDF | 560 KB)
• 2022 Approval of Entities that Certify MROs
• Access archived MRO Resources

An official website of the United States government, Department of Justice.

Here's how you know

Official websites use .gov A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS A lock ( Lock A locked padlock ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

Fast and Portable Drug Testing: Dual-Method Prototype Shows Promise for Court-Admissible Drug Testing

Forensic laboratory backlogs can slow down analysis of seized drugs. [1] Field-based techniques, like colorimetric tests, are quick and easy to use but can produce false positives and unclear results. [2] Now, a National Institute of Justice-supported research team from Illinois State University has developed and tested a portable dual-method testing platform that could allow law enforcement officers to rapidly and accurately analyze seized drugs on site. The platform consists of a Raman spectroscopy module added to a commercially available mass spectrometry device. In a blind test of 500 samples, a prototype of the platform produced 99.8% accurate results. [3]

“This technology has the potential to assess the probative value of chemical evidence at the crime scene, requiring only pertinent samples to be sent to off-site laboratories for confirmation, easing the burden of casework and therefore reducing the magnitude of backlogged evidence,” said Christopher C. Mulligan, the project’s lead researcher. “By screening physical evidence at the crime scene, law enforcement personnel could rapidly determine whether a criminal investigation is needed.”

Two Tests on One Portable Device

Mass spectrometry and Raman spectroscopy are classified as Category A detection techniques by the Scientific Working Group for the Analysis of Seized Drugs. [4] Mass spectrometry is capable of discriminating individual drugs and other substances in a mixture, while Raman spectroscopy can be used to identify designer drug isomers (molecules with the same formula but a different shape). Both techniques are highly selective, require little to no sample preparation, and are easy to administer. The integration of two independent, validated techniques onto a single platform would, if the device becomes commercially available, meet the Scientific Working Group for the Analysis of Seized Drugs’ two-tiered identification guidelines for court-admissible evidence.

For their platform, the researchers chose two specific methods of mass spectrometry and Raman spectroscopy that are suitable for analyzing very small amounts of seized evidence: Paper spray ionization mass spectrometry and surface-enhanced Raman spectroscopy.

View an infographic showing how the dual method works

Prototype Design

A portable mass spectrometry platform, FLIR System AI-MS 1.2, outfitted with a paper spray ionization mass spectrometry module and a surface-enhanced Raman spectroscopy module served as the base for the dual-method prototype. (In a previously National Institute of Justice-funded study, the Illinois State team showed that the paper spray ionization mass spectrometry system accurately identified trace amounts of common and emerging drug types from unprepared samples. The testing was completed by recent police academy graduates and high school students.)

Next, the researchers designed and tested a paper substrate that could be used for both analysis methods. They obtained the best results from a strip of Whatman filter paper coated with gold nanoparticles for surface-enhanced Raman spectroscopy placed in a 3-D printed plastic cartridge with an embedded copper wire for paper spray ionization mass spectrometry.

To analyze a drug sample, the researchers placed a small amount of the substance directly on the paper strip and loaded it into the plastic cartridge mounted on a movable stage beneath the paper spray ionization mass spectrometry and surface-enhanced Raman spectroscopy modules. First, an electrical current applied to the copper wire created an ionic spray of the sample for mass spectrometry measurement. Next, the cartridge would slide under the Raman spectroscopy laser for sample analysis.

Assessing Platform Performance

The researchers performed a blinded experiment to test the reliability of their dual-method platform. Five hundred paper strips with trace amounts (less than 200 nanograms) for positive drug controls and blank paper strips for negative controls were randomly assigned to be tested by student members of Mulligan’s research group over 25 days.

The team reported no false positives and a marginal false negative rate of 0.17% for the blinded experiment. At first, testers took an average of 6.84 minutes to test each sample, but eventually decreased their sample throughput time to 4.87 minutes after gaining more experience with the platform.

The researchers also performed isomer tests on authentic drug seizures, like crystal methamphetamine, in collaboration with local law enforcement practitioners. Results demonstrated that the platform was able to differentiate isomers of novel psychoactive substances.

What’s Next?

According to the researchers, results from prototype testing showed that their dual-method platform has the potential to modernize policing of drug-related crime and traffic violations. And if the platform’s test results prove to be admissible in court, the researchers say its use could lead to expedited criminal investigations, casework, judicial proceedings, and potential plea bargaining. The platform’s portability could also prove useful at correctional facilities and in rural communities as a rotating or shared resource for law enforcement.

The research team is investigating collaborations with industry for future commercialization. “Financial constraints will most likely be the determiner for successful commercialization and implementation,” said Mulligan. “With budgetary concerns affecting law enforcement and forensic agencies, this technology will have to be shown as financially viable.”

About this Article

The research described in this article was funded by NIJ grant 2017-R2-CX-0022 , awarded to Illinois State University. This article is based on the grantee final report “ Coupling Raman Spectroscopy with Ambient Sampling, Portable Mass Spectrometry for On-site, High-Throughput Evidence Confirmation on a Single Instrumental Platform ” (March 2020) by Christopher C. Mulligan.

Researchers from Illinois State University have received two other NIJ grants related to research focused on analyzing evidence at the crime scene:  

• Analytical Validation and Impact Assessment of On-Site Evidence Screening via Ambient Sampling, Portable Mass Spectrometry
• Accessing the Probative Value of Physical Evidence at Crimes Scenes with Ambient Mass Spectrometry and Portable Instrumentation

[note 1] Matthew R. Durose, Kelly A. Walsh, and Andrea M. Burch. Census of Publicly Funded Forensic Crime Laboratories: 2009 , Washington, DC: U.S. Department of Justice, Bureau of Justice Statistics, Office of Justice Programs, National Institute of Justice, August 2012, NCJ 238252.

[note 2] Yukari Tsumura, Toshiaki Mitome, and Shigeru Kimoto, “ False Positives and False Negatives with a Cocaine-Specific Field Test and Modification of Test Protocol to Reduce False Decision ,” Forensic Science International 155 (2005): 158 – 164.

[note 3] Daniel S. Burr, et al., “ Integrating SERS and PSI-MS with Dual Purpose Plasmonic Paper Substrates for On-Site Illicit Drug Confirmation ,” Analytical Chemistry 92 (2020): 6676 – 6683.

[note 4] Zachary E. Lawton, et al., “ Analytical Validation of a Portable Mass Spectrometer Featuring Interchangeable, Ambient Ionization Sources for High Throughput Forensic Evidence Screening ,” Journal of The American Society for Mass Spectrometry 28 (2016): 1048 – 1059.

Cite this Article

Read more about:, related publications.

• Coupling Raman Spectroscopy With Ambient Sampling, Portable Mass Spectrometry for On-site, High-Throughput Evidence Confirmation on a Single Instrumental Platform

Related Awards

• Coupling Raman Spectroscopy with Ambient Sampling, Portable Mass Spectrometry for On-site, High-Throughput Evidence Confirmation on a Single Instrumental Platform

• Clinical trials and evidence

Getty Images

Effectively incorporating AI into drug research, development

A recent report from accenture analyzes the value and impact ai can have on drug research and development..

• Veronica Salib, Assistant Editor

Last month, Accenture published a report titled “Reinventing R&D in the age of AI,” outlining how biopharmaceutical companies have been and can continue to leverage artificial intelligence (AI) and other intelligent technologies in the drug and therapeutic research and development pipeline.

Kailash Swarna, a managing director and Accenture Life Sciences Global Research and Clinical lead, sat down with PharmaNewsIntelligence to discuss various facets of the report and explain how companies can effectively incorporate AI to address ongoing challenges in research and development and get a return on their technological investments .

“Data and analytics are going to play a vital role in advancing drug development across the board from early research through late-stage clinical development,” said Swarna. “The key challenges for the industry that we are all aware of is that it still takes too long and costs too much to bring a medicine to market and patients. As a premier technology firm, we believe it is incumbent on us to bring the best of what data analytics and technology can do for drug discovery and development across the board.”

Accenture conducted a series of in-depth interviews with leaders at biopharma companies to better understand the role of AI and its potential in drug development and discovery. During the CEO forum, which occurs the day before the JP Morgan conference, Accenture conducts closed-door interviews with these leaders.

“For the first time, we saw technology rise to the top as a key area of opportunity and concern for biopharma,” noted Swarna, as he revealed that was how Accenture’s report started.

Key Challenges in Research and Development

Acknowledging the ongoing challenges in this field is important to understanding the opportunities for AI to improve research and development. The drug research and development landscape presents many difficulties. Although the complexity and magnitude of these challenges change based on the company and environment, Swarna offered some insight into the significant challenges faced by this industry.

Scientific Growth

“The biggest challenge is both an opportunity and a challenge. We see that there've been tremendous advances in biology and basic disease biology. We understand human disease biology better than we've ever done as a global scientific community working to address unmet needs in disease areas,” he stated, suggesting that one challenge is keeping up with scientific growth.

“Science has grown dramatically in terms of its impact on patients and the benefit for patients, but we've not been able to keep pace with the growth in science in terms of executing on that scientific progress and being able to shorten the time and the cost associated with bringing therapeutics and devices to patients.”

Swarna referred to the mechanics of clinical trials as “fraught,” meaning data management challenges and other complexities littered throughout the trial process. For example, clinical trials often take a long time to execute. While significant resources across the industry have been allocated to shorten the time it takes to get a drug to market, it can still take over a decade and billions of dollars.

Macroeconomics

In addition to keeping up with advancing science, drug research and development firms are also challenged by macroeconomic conditions, including reimbursement challenges and the Inflation Reduction Act in the US.

“It's changing how companies think about their portfolios and the molecules as well as the disease areas they will focus on,” Swarna emphasized. “There's a whole retooling of the industry in terms of thinking about the impact of the macroeconomic conditions, reimbursement, and the economics of bringing drugs to market. That's a second driver.”

Technology Optimization

The final challenge is optimizing technology in research and development. Many companies have invested in various technologies across the industry.

“Technology investments that companies have made have been very important and very useful investments in individual areas, but bringing them all together and systematically utilizing data from early research through to late stage development and regulatory submission [is a challenge], he explained. “There's a lot that can be done. There's a lot of opportunity to unify all of that.”

Reinventing Research and Development with AI

The report focuses on the idea that technological intervention can reinvent and improve the research and development pipeline.

“Unlike other previous technology movements, this is not about an individual technology. Generative AI and analytics are not just about one technology implementation. It is about a systematic rethinking of the processes and the data flow and the investments that companies make in technology to really go end-to-end early research, early discovery through to late-stage development and beyond,” he said.

He reiterated that technology reinvention is about enterprise-wide strategy and implementation.

Responsible AI

However, reinvention requires companies to consider the potential challenges that AI may present. “We have a very robust framework at Accenture that we call our responsible AI framework,” noted Swarna.

Responsible AI is an industry-wide term that considers how AI can be used effectively and how certain challenges that are inevitable with AI , like bias and security, can be addressed.

Accenture considers multiple factors regarding bias, which means choosing the right patient populations to study and understanding how bias might have impacted existing data that inform ongoing research.

In addition, the company considers security issues, including intellectual property protection and patient privacy, in its responsible AI framework.

“Protecting patient privacy and being compliant with all the regulations around patient privacy around the world is really important for us to think about [to use] technology in the right way inside an organization because this is a very powerful technology, and [without] guardrails around how it's used, we could run into data loss or data breaches.”

Measuring ROI

Swarna explained how companies can ensure that the technologies they deploy effectively and positively impact their research and development life cycle.

“We've developed a rubric for being able to do that,” he noted. “The one thing that is potentially different in our industry from other industries is that we are a long cycle industry.”

“We've tried to come up with an objective measure in terms of the impact and the return on investment on these technologies in terms of changing or bending the curve in terms of both cost and time. So we have a framework that we use internally and with our clients.”

Additionally, companies have developed quantitative measures to act as interim milestones. For example, companies can assess their recruitment cost per patient, recruitment velocity, and other factors.

“Those are all measures that we can observe in smaller chunks of time as opposed to waiting to see the impact across the entire value chain from end to end. So those are some of the measures we can take,” he noted. “The one key thing would be it'll vary by company and the stage in which they are implementing. Some companies have decided to lead with this in terms of making this part of the core strategy. Others are taking a more conservative view based on where they are in their own internal business cycle.”

Benefits of Using AI in Clinical Trials

Theoretically, incorporating AI into clinical trials can help reduce research times and spending. While Swarna and Accenture cannot speak to the greater implications of policy on drug pricing, he offered a theoretical outcome that underscores the benefits of using AI in clinical research.

“An individual drug can become more profitable for a company because the actual development costs, in theory, could be lower.”

Swarna explained that, theoretically, a cost reduction achieved through optimizing the right technologies could result in lower development costs, which could trickle down to make medicine more affordable and accessible globally.

He also explained that reducing research and development spending could provide more effective drugs to broader populations without excessively costing the overall healthcare system.

• Navigating the black box AI debate in healthcare
• Responsible AI Deployment in Healthcare Requires Collaboration

How to Effectively Integrate AI into Clinical Trials

Dig deeper on clinical trials and evidence.

Manufacturing complex pharmaceutical products with new technologies

AWS partners look to GenAI, competencies, marketplace sales

Analyzing 2023 Technology Trends in the Life Sciences Industry

Related q&a from veronica salib, could roche’s malaria test help address the national blood shortage.

Strategies for ending the national blood shortage may include expanding the donor pool, rationing, and diagnostic tests.   Continue Reading

Accurately diagnosing T1D, identifying biomarkers

The ACCESS-T1D study works to improve T1D diagnoses among at-risk groups and identify biomarkers for more straightforward disease diagnosis.   Continue Reading

Are compounded “DIY” peptides the answer to the GLP-1 shortage?

The short answer is no, according to Lydia Alexander, MD, president of the Obesity Medicine Association.   Continue Reading

A national survey revealed that while many Americans are comfortable with artificial intelligence in healthcare, some have ...

AI revealed insights into the relationship between lung cancer therapy and heart complications, which could help minimize cardiac...

Houston Methodist has successfully piloted ambient clinical intelligence and AI tools to bolster efficiency and cost savings ...

Understanding the quality bonus payment program is critical to appreciating Medicare Advantage and discussing the calls for ...

Only 45% of individuals who received a surprise bill challenged it and only 43% of those who were denied coverage appealed the ...

Medicare includes four different segments that each insure a wide variety of services and supplies for enrollees.

Ambient AI technology is helping Ochsner Health improve patient-provider relationships by allowing clinicians to spend ...

Epic's goal to bring customers live on TEFCA by the end of 2025 complements Carequality's plan to align with TEFCA as the ...

Key considerations for selecting an EHR vendor include assessing practice needs, conducting a thorough market scan and evaluating...

NIST encouraged organizations to implement its three post-quantum cryptography standards to prepare for the emergence of powerful...

A healthcare data breach at Alabama Cardiovascular Group affected upwards of 280,000 individuals after an unauthorized party ...

Lawsuits often follow a healthcare data breach, but understanding what drives litigation trends can help healthcare organizations...

• Fierce Pharma
• Fierce Biotech
• Fierce Healthcare
• Fierce Life Sciences Events
• Cell & Gene Therapy
• Clinical Data
• Venture Capital
• Diagnostics
• AI and Machine Learning
• Special Reports
• Clinical Development
• Special Report
• Awards Gala
• Fierce Events
• Industry Events
• Whitepapers

The Evolving Alzheimer’s Disease Landscape

Alzheimer’s disease research and drug development is evolving at a rapid pace. Decades of research has led to the approval of the first disease-modifying drugs and new pathological discoveries. The first blood-based biomarker tests will bring equitable access to screening and diagnosis while accelerating clinical research. These major breakthroughs in the last few years alone represent a pivotal time in the Alzheimer’s disease landscape. “This is an unprecedented time for Alzheimer’s research. Significant advances have been made in understanding pathological factors affecting disease, long-awaited disease-modifying treatments have been approved and more convenient diagnostic tools are becoming available - all major steps in changing the course and impact of this once-elusive disease,” stated Dr. David Morgan, Director of the Alzheimer’s Alliance and Professor of Translational Neuroscience at Michigan State University. A new era of Alzheimer’s disease therapies There are now ten treatments approved for Alzheimer’s disease, including two recently-approved disease-modifying drugs – the most recent approved in July 2024 . The disease-modifying treatments are a class of monoclonal antibodies that target the removal of amyloid-beta plaque build-up in those with mild cognitive impairment or early Alzheimer’s disease. Researchers convening at the recent Alzheimer’s Association International Conference acknowledged that the community can build upon the latest advances. “We need new therapies, many more targets, better drugs, more convenient drugs, but it is important that we have changed the landscape by having disease-modifying therapies.” Next wave of Alzheimer’s disease testing - plasma-based biomarker tests One of the major advances in the Alzheimer’s disease landscape is the emerging blood-based biomarkers tests that are expected to improve diagnosis in primary care, reduce wait times for treatment initiation, accelerate clinical trial recruitment and greatly lower the cost of diagnosing Alzheimer’s. Only 10 years ago, Alzheimer’s disease diagnosis relied on symptom observations. Since then, the gold standard has moved to a PET scan or lumbar puncture. These diagnostic options are costly, invasive and inaccessible in many communities. One of the challenges to accessing the new monoclonal antibody treatments is the availability of PET scans to screen for qualified patients. The convenience of blood-based biomarker tests would relieve this bottleneck.  A panel has been assigned by the Alzheimer’s Association to conduct a systematic review of the plasma-based biomarker tests and expects to provide a clinical practice guideline in early to mid 2025. Emerging biological pathways as drug development targets Most of the recent drug development efforts have been focused on mechanisms that aim to remove amyloid plaque build-up or tau tangles, main hallmarks of the disease. Researchers are now turning their attention to the role of inflammation in Alzheimer’s disease development and progression. Most recently, a study of a GLP-1 agonist , part of a class of drugs used for diabetes, weight loss and heart disease, demonstrated neuroprotective effects that may help to protect the brains of people with Alzheimer’s disease. Previous studies have shown how GLP-1 agonists can reduce neuroinflammation. The GLP-1 agonists did not alter amyloid-β and tau biomarkers nor show improvements in cognition, but the anti-inflammatory and neuroprotective effects of GLP-1 agonists warrant further studies and opens new biological pathways in the potential treatment of Alzheimer’s. The study showed the potential of repurposing diabetes drugs in the treatment of Alzheimer’s and exploring drug candidates that target similar biological pathways to diabetes treatments. Identifying a combination of therapies or a multi-factorial Approach To treat a complex disease such as Alzheimer’s will likely require a combination of therapies or a multi-factorial approach. The Alzheimer’s Association has identified modifiable risk factors associated with the development and progression of Alzheimer’s disease including untreated visual loss, LDL cholesterol, hearing loss, depression, Type 2 diabetes, exercise and cognitive stimulation. While these preventative lifestyle measures may delay the onset and progression of Alzheimer’s disease, lifestyle habits alone are unlikely to prevent disease development. Clinicians believe that a multi-factorial approach will be required that includes lifestyle habits and a combination of disease-modifying and symptomatic treatments that target multiple biological pathways. InMed’s INM-901 demonstrates a novel, multi-factorial approach to treating Alzheimer’s Among the drug candidates in preclinical development is InMed’s INM-901, a promising small molecule that has demonstrated disease-modifying effects and appears to target multiple biological pathways , including the peroxisome proliferator-activated receptor (PPAR), which is associated with diabetes development and plays an important role in cell metabolism and immune response. Preclinical studies of INM-901 in well-characterized Alzheimer’s disease models indicate that INM-901 reduces neuroinflammation and cell death and promotes the growth of neurites in the brain – which enables cell-to-cell communication and is essential for brain processing. The growth of neurites, which is diminished in patients with Alzheimer’s, signifies enhanced neuronal function and may indicate the potential to restore the damage caused by Alzheimer’s disease. InMed’s INM-901 is among the several promising treatments in development that may be able to change the course of Alzheimer’s disease.

The LiFFT Study

Description, eligibility and criteria, what to expect.

• Receive lurbinectedin (study drug) infusions
• Complete frequent clinic visits at CHOP Philadelphia
• Have frequent blood tests, including research blood tests to measure lurbinectedin levels 
• Have periodic imaging performed to evaluate your response to treatment
• Have research tumor biopsies with anesthetic agent or general anesthesia (required if you are 18 years or older and your tumor is accessible (optional if you are under 18)
• Have research genetic tests (if not previously done clinically)
• Get optional research PET scans with a radioactive tracer

Related specialties

We need families like you

Your time and participation make a difference in supporting the work of the Research Institute and children in our community. Learn more about opportunities to participate in our research.

• Today's news
• Reviews and deals
• Climate change
• 2024 election
• Fall allergies
• Health news
• Mental health
• Sexual health
• Family health
• So mini ways
• Unapologetically
• Buying guides

Entertainment

• How to Watch
• My Portfolio
• Latest News
• Stock Market
• Biden Economy
• Stocks: Most Actives
• Stocks: Gainers
• Stocks: Losers
• Trending Tickers
• World Indices
• US Treasury Bonds Rates
• Top Mutual Funds
• Options: Highest Open Interest
• Options: Highest Implied Volatility
• Basic Materials
• Communication Services
• Consumer Cyclical
• Consumer Defensive
• Financial Services
• Industrials
• Real Estate
• Stock Comparison
• Advanced Chart
• Currency Converter
• Credit Cards
• Balance Transfer Cards
• Cash-back Cards
• Rewards Cards
• Travel Cards
• Credit Card Offers
• Best Free Checking
• Student Loans
• Personal Loans
• Car insurance
• Mortgage Refinancing
• Mortgage Calculator
• Morning Brief
• Market Domination
• Market Domination Overtime
• Asking for a Trend
• Opening Bid
• Stocks in Translation
• Lead This Way
• Good Buy or Goodbye?
• Financial Freestyle
• Capitol Gains
• Fantasy football
• Pro Pick 'Em
• College Pick 'Em
• Fantasy baseball
• Fantasy hockey
• Fantasy basketball
• Download the app
• Daily fantasy
• Scores and schedules
• GameChannel
• World Baseball Classic
• Premier League
• CONCACAF League
• Champions League
• Motorsports
• Horse racing
• Newsletters

New on Yahoo

• Privacy Dashboard

Yahoo Finance

Drug abuse testing market report by drug type, product & services, sample type, end users countries and company analysis - global forecast to 2032.

Drug Abuse Testing Market

Dublin, Aug. 13, 2024 (GLOBE NEWSWIRE) -- The "Drug Abuse Testing Market Report By Drug Type, Product & Services, Sample Type, End Users Countries and Company Analysis 2024-2032" report has been added to ResearchAndMarkets.com's offering. Global Drug Abuse Testing Market Analysis Drug Abuse Testing Market will attain US$ 11.87 billion by 2032, up from US$ 6.17 billion in 2023, with a CAGR of 7.53% between 2024 and 2032.

Strict rules and guidelines pruned at work places, educational institutions and sports activities organizations are the key factors for the growth of the drug abuse testing market. Various industries require the implementation of drug testing in order to maintain a safe as well as an environmentally sustainable workplace. Schools alongside other institutions such as faculties and faculties on the similar method hire drug testing as a strategy of discouraging learners from taking drugs.

Besides, it will be important for the corporations related to sports to look into furthering fair competition and safeguarding the health of the athletes. Any regulation tends to always cover drug testing offerings, to ensure both adherence to the standards specified as well as safety of the delivery to different categories of consumers. Increasing concern for the effects of drugs on fitness and the value of the early identification of the issue to encourage to recover stimulates the drug abuse test market. It is important to stress that tasks within the sphere of public health activity and popularization of awareness campaigns disregard complete programs of substance abuse prevention and cure and include regular drug testing.

This facility proposes the use of drug testing to track patient improvement and adherence to the prescription regimens offered by healthcare sellers and rehabilitation facilities. Such endeavors, backed by governmental and non-governmental bodies, cultivate a preventive strategy to managing as well as minimizing the consequences of substance dependence, essentially popularizing the market for drug testing services. The versatility in drug testing technologies has a lot to do with the boost of growth the market has undergone through. They have relations to the refinement of various facets of the drug testing process be it precision, efficiency, or user-friendliness. For instance, the development in such drug testing products as the rapid testing kits has escalated by providing speedy and accurate results. Moreover, the development of the non-invasive tests, which include saliva and hair checks, has provided other options concerning people that are subjected to drug testing. Moreover, the incorporation of strategies in virtual health systems for effects tracking and reporting has enhanced the full drug testing procedure's ease and feasibility. Such advancements have helped to decrease the time taken in getting the look at effects and increase the users' compliance with the testing procedures. Furthermore, those advancements have rendered it possible to increase the options of the drug testing packages in various facility types, ranging from scientific facilities or chemistry-based testing to home testing services. These improvements have dramatically transformed the drug testing further that makes it more efficient and flexible in any healthcare and non-healthcare organizations. Asia Pacific Drug Abuse Testing Market The drug abuse testing market in the Asia Pacific is steadily rising on account of the enhancing cost of substance related issues and more emphasis on early diagnose and prevent techniques. Countries like China, India, and Japan have witnessed an increase in the cases of the abuse of drugs hence leading the governments and the companies to adopt strict drug testing measures in workplaces, colleges, and rehabilitation centers. New testing techniques that are faster than urine testing and the new drug testing kits also drive this market by offering accurate and quick results. Asian drug abuse testing market is emerging because of advancement in health care facilities, rising position in public health tasks pertaining to funding, complicity between government agencies and private companies and the implementation of drug testing in regulation enforcement and forensic programs. Drug Abuse Testing Company Analysis Some of the giant companies that have made a mark in the drug abuse testing industry include Danaher Corporation, LabCorp, Abbott Laboratories, Quest Diagnostics, Thermo Fisher Scientific Inc, F. Hoffmann-La Roche Ltd., Bio-Rad Laboratories Ltd. and Medtronic Plc. These groups provide a wide range of drug testing products such as testing kits, laboratories, and new electronics and chemical for drug identification and analysis. These contributions facilitate maintaining safe places of work, policing duties, and health risk assessment processes. Drug Abuse Testing Company News

In February 2024, OraSure Technologies Inc. (OSUR) highlighted solid financial performance during its profit call, with increased operating income, expanded gross margins, and a robust cash balance.

In February 2024, Veriteque (US) and OraSure Technologies (US) agreed to a distribution deal for SwabTek test kit products. OraSure's oral fluid screening solutions will complement Veriteque's SwabTek brand presumptive field test kits.

In December 2023, Quest Diagnostics (US) launched a new confirmatory testing service for novel psychoactive substances (NPS). The panel tests cover 88 different compounds from various drug classes, including synthetic cannabinoids, designer stimulants, opioids, benzodiazepines, fentanyl analogs, and other additives found in illicit drugs.

Key Attributes:

Key Players Analysis: Business Overview, Product Portfolio, Recent Development & Strategies, Revenue Analysis

Danaher Corporation

Abbott Laboratories

Quest Diagnostics

Thermo Fisher Scientific Inc.

F. Hoffmann-La Roche Ltd.

Bio-Rad Laboratories Ltd.

Medtronic Plc.

Product & Services - Market breakup in 4 viewpoints

Rapid Testing Devices

Consumables

Laboratory Services

Sample Type - Market breakup in 5 viewpoints

Drug Type - Market breakup in 7 viewpoints

Cannabis/Marijauna

Amphetamine & Methaphetamine

Country - Market breakup of 25 Countries

North America

United States

United Kingdom

Asia Pacific

South Korea

New Zealand

Latin America

Middle East & Africa

Saudi Arabia

South Africa

For more information about this report visit https://www.researchandmarkets.com/r/kvk0v2

About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

Information

• Author Services

Initiatives

You are accessing a machine-readable page. In order to be human-readable, please install an RSS reader.

All articles published by MDPI are made immediately available worldwide under an open access license. No special permission is required to reuse all or part of the article published by MDPI, including figures and tables. For articles published under an open access Creative Common CC BY license, any part of the article may be reused without permission provided that the original article is clearly cited. For more information, please refer to https://www.mdpi.com/openaccess .

Feature papers represent the most advanced research with significant potential for high impact in the field. A Feature Paper should be a substantial original Article that involves several techniques or approaches, provides an outlook for future research directions and describes possible research applications.

Feature papers are submitted upon individual invitation or recommendation by the scientific editors and must receive positive feedback from the reviewers.

Editor’s Choice articles are based on recommendations by the scientific editors of MDPI journals from around the world. Editors select a small number of articles recently published in the journal that they believe will be particularly interesting to readers, or important in the respective research area. The aim is to provide a snapshot of some of the most exciting work published in the various research areas of the journal.

Original Submission Date Received: .

• Active Journals
• Find a Journal
• Proceedings Series
• For Authors
• For Reviewers
• For Editors
• For Librarians
• For Publishers
• For Societies
• For Conference Organizers
• Open Access Policy
• Institutional Open Access Program
• Special Issues Guidelines
• Editorial Process
• Research and Publication Ethics
• Article Processing Charges
• Testimonials
• Preprints.org
• SciProfiles
• Encyclopedia

Article Menu

• Subscribe SciFeed
• Recommended Articles
• Google Scholar
• on Google Scholar
• Table of Contents

Find support for a specific problem in the support section of our website.

Please let us know what you think of our products and services.

Visit our dedicated information section to learn more about MDPI.

JSmol Viewer

Matrixing designs for shelf-life determination of parenteral drug product: a comparative analysis of full and reduced stability testing design.

1. Introduction

2. materials and methods, 2.1. products, 2.2. stability study design, 2.3. tested parameters and analytical methods, 2.4. matrixing designs, 2.5. data analysis, 3.1. evaluation of the least stable filling volume and batch-to-batch variability, 3.2. regression analysis, 3.3. shelf-life calculation, 4. discussion, 4.1. regression analysis, 4.2. shelf-life determination, 4.3. adequacy of matrixing designs, 5. conclusions, supplementary materials, author contributions, institutional review board statement, informed consent statement, data availability statement, conflicts of interest.

• Aulton, M.E.; Taylor, K.M. Aulton’s Pharmaceutics: The Design and Manufacture of Medicines , 6th ed.; Elsevier Health Sciences: Amsterdam, The Netherlands, 2021. [ Google Scholar ]
• Dongare, S.D.; Mali, S.S.; Patrekar, P.V. Sterile parenteral products: A narrative approach. J. Drug Deliv. Ther. 2015 , 5 , 41–48. [ Google Scholar ] [ CrossRef ]
• Akers, M.J. Sterile Drug Products: Formulation, Packaging, Manufacturing and Quality , 1st ed.; CRC Press: Boca Raton, FL, USA, 2010. [ Google Scholar ]
• ICH Steering Committee. Stability Testing of New DRUGS substances and Products Q1A(R2), ICH Harmonized Tripartite Guideline, Current Step 4 Version Dated 6 February 2003 ; ICH Steering Committee: Minneapolis, MN, USA, 2003. [ Google Scholar ]
• U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research. Guidance for Industry Q3B(R2) Impurities in New Drug Products ; U.S. Department of Health and Human Services: Washington, DC, 2006.
• Lin, T.-Y.D.; Chen, C.W. Overview of Stability study Designs. J. Biopharm. Stat. 2003 , 13 , 337–354. [ Google Scholar ] [ CrossRef ] [ PubMed ]
• ICH Steering Committee. Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products Q1D, ICH Harmonized Tripartite Guideline, Current Step 4 Version Dated 7 February 2002 ; ICH Steering Committee: Minneapolis, MN, USA, 2002. [ Google Scholar ]
• Nordbrock, E. Statistical comparison of stability study designs. J. Biopharm. Stat. 1992 , 2 , 91–113. [ Google Scholar ] [ CrossRef ] [ PubMed ]
• Chow, S.-C. Statistical Design and Analysis of Stability Studies , 1st ed.; Chapman and Hall/CRC: Boca Raton, FL, USA, 2007. [ Google Scholar ]
• Natarajan, J.; Altan, S.; Raghavarao, D. Expiration Dating of Pharmaceutical Compounds in Relation to Analytical Variation, Degradation Rate, and Matrix Designs. Drug Inf. J. 1997 , 31 , 589–595. [ Google Scholar ] [ CrossRef ]
• DeWoody, K.; Raghavarao, D. Some optimal matrix designs in stability studies. J. Biopharm. Stat. 1997 , 7 , 205–213, Erratum in J. Biopharm. Stat. 1997 , 7 , 667. [ Google Scholar ] [ CrossRef ] [ PubMed ]
• Oliva, A.; Fariña, J.; Llabrés, M. Comparison of Shelf-Life Estimates for a Human Insulin Pharmaceutical Preparation Using the Matrix and Full-Testing Approaches. Drug Dev. Ind. Pharm. 2003 , 29 , 513–521. [ Google Scholar ] [ CrossRef ] [ PubMed ]
• European Medicines Agency (EMA). ICH Q1E. Evaluation of Stabiliy Data. CPMP/ICH/420/02 ; European Medicines Agency (EMA): Amsterdam, The Netherlands, 2003. [ Google Scholar ]
• European Medicines Agency (EMA). ICH Q3B. Impurities in New Drug Products. CPMP/ICH/2738/99 ; European Medicines Agency (EMA): Amsterdam, The Netherlands, 2006. [ Google Scholar ]
• Burdick, R.K.; LeBlond, D.J.; Pfahler, L.B.; Quiroz, J.; Sidor, L.; Vukovinsky, K.; Zhang, L. Stability. In Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry. Statistics for Biology and Health ; Springer: Cham, Switzerland, 2017. [ Google Scholar ]
• Gabrielsson, J.; Lindberg, N.O.; Pålsson, M.; Nicklasson, F.; Sjöström, M.; Lundstedt, T. Multivariate methods in the Development of a New Tablet Formulation. Drug Dev. Ind. Pharm. 2003 , 29 , 1053–1075. [ Google Scholar ] [ CrossRef ] [ PubMed ]
• Carstensen, J.T. Stability and Dating of Solid Dosage Forms. Pharmaceutics of Solids and Solid Dosage Forms ; Wiley-Interscience: Hoboken, NJ, USA, 1977; pp. 182–185. [ Google Scholar ]

Click here to enlarge figure

Share and Cite

Pavčnik, L.; Locatelli, I.; Trdan Lušin, T.; Roškar, R. Matrixing Designs for Shelf-Life Determination of Parenteral Drug Product: A Comparative Analysis of Full and Reduced Stability Testing Design. Pharmaceutics 2024 , 16 , 1117. https://doi.org/10.3390/pharmaceutics16091117

Pavčnik L, Locatelli I, Trdan Lušin T, Roškar R. Matrixing Designs for Shelf-Life Determination of Parenteral Drug Product: A Comparative Analysis of Full and Reduced Stability Testing Design. Pharmaceutics . 2024; 16(9):1117. https://doi.org/10.3390/pharmaceutics16091117

Pavčnik, Lara, Igor Locatelli, Tina Trdan Lušin, and Robert Roškar. 2024. "Matrixing Designs for Shelf-Life Determination of Parenteral Drug Product: A Comparative Analysis of Full and Reduced Stability Testing Design" Pharmaceutics 16, no. 9: 1117. https://doi.org/10.3390/pharmaceutics16091117

Article Metrics

Article access statistics, supplementary material.

ZIP-Document (ZIP, 384 KiB)

Further Information

Mdpi initiatives, follow mdpi.

Subscribe to receive issue release notifications and newsletters from MDPI journals

Warning: The NCBI web site requires JavaScript to function. more...

An official website of the United States government

The .gov means it's official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

• Publications
• Account settings
• Browse Titles

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.

National Research Council (US) and Institute of Medicine (US) Committee on Drug Use in the Workplace; Normand J, Lempert RO, O'Brien CP, editors. Under the Influence? Drugs and the American Work Force. Washington (DC): National Academies Press (US); 1994.

Under the Influence? Drugs and the American Work Force.

• Hardcopy Version at National Academies Press

7 Impact of Drug-Testing Programs on Productivity

Many employers in the United States have attempted to address the problems they perceive to be related to alcohol and other drug use by establishing drug-testing programs, as described in Chapter 6 . What effects do drug-testing policies and programs have on people's productivity at work? Unfortunately, there have been few systematic studies relating these drug-testing programs to workers' productivity, and those that have been done are often flawed in significant ways. This chapter critically reviews the literature that does exist and discusses how the effects of such programs may best be evaluated. It also reviews the literature on the attitudes of workers and job applicants toward such programs and the potential effects of these attitudes on productivity.

We reiterate here an important point that was mentioned in Chapters 1 and 6 . It is related to the methods and measures used by the studies reviewed here: most drug-testing programs do not include alcohol among the drugs to be tested. Executive Order #12564 signed by President Reagan in 1986 mandated testing for illicit drugs; subsequently, in 1988 the HHS ''Mandatory Guidelines for Federal Workplace Drug Testing Programs" limited the number of drugs to be tested to the following commonly used illicit drug classes: (1) marijuana, (2) opiates (heroin, morphine), (3) cocaine, (4) amphetamine and methamphetamine, and (5) phencyclidine. These guidelines have served as a model for most drug testing programs that have been implemented to date. The only exception to this omission of alcohol is the recent Omnibus Transportation Act of 1991, which requires the Department of Transportation to include alcohol as a target drug in their testing program. To date no evaluation of adding alcohol to the list of drugs to be tested for has been carried out.

• Types And Uses Of Drug-Testing Programs

Workplace drug-testing programs are of three distinct types: (1) preemployment testing of job applicants; (2) incident-driven or for-cause testing of employees (e.g., post-accident, fitness for duty); and (3) postemployment testing without specific cause, often selected at random from a pool of targeted (usually sensitive) positions (Walsh et al., 1992). In 1988, 3 percent of the employers surveyed by the U.S. Department of Labor (1989) had some type of drug-testing program; by 1990, this figure had risen to 4 percent (Employee Assistance Professional Association, 1991). The majority of this testing has been undertaken by major corporations. Among the largest employers (with more than 1,000 employees) surveyed by the Department of Labor, 43 percent had some type of drug-testing program, whereas only 2 percent of the smallest establishments (with fewer than 50 workers) had such programs. More recent surveys of workplace drug testing indicate that between 50 and 75 percent of medium and large organizations now test current or prospective employees for drugs (American Management Association, 1992; Axel, 1990; Hayghe, 1991).

Preemployment drug testing is the most prevalent form of drug testing: 85 percent of those companies the Department of Labor surveyed with a testing program tested job applicants. Findings from the Monitoring the Future project (Patrick O'Malley, personal communication, 1992) show that increasing proportions of the work force have undergone testing for drug use in recent years: in 1987, 15 percent of men and 6 percent of women surveyed by the follow-up study reported having had a drug test; the corresponding figures in 1991 were 33 and 16 percent. In other words, by 1991, one in three young adult men and one in six women report having been tested. Most of these tests were preemployment drug tests.

Although the surveys reveal that corporate executives and human resources managers believe that drug-testing programs are effective tools for improving workplace safety, health, and productivity, there is little empirical evidence pertaining to their efficacy. To date, most evaluation attempts have consisted of simply monitoring and interpreting trends in laboratory tests results.

The main impetus for the rapid diffusion of these programs appears to have evolved from the preeminence given by the Reagan and Bush administrations to their "war on drugs" policies, from which the concept of a "drug-free workplace" first emerged, the substantial amount of publicity given to recent tragic accidents, and numerous government regulations and directives. Favorable court rulings have also substantially contributed to making drug testing common in corporate America.

Over the past decade, incumbent presidents and Congress have not only authorized drug testing by public and private employers, but also have required or encouraged it in some workplaces. Their actions provide legal authority for drug testing that overrides all contrary authority except the U.S. Constitution. The scope of workplace drug testing is limited by certain state and federal constitutional restrictions, particularly in the public sector and in postemployment settings; these limits, however, are generous and allow a broad range of employees to be tested using a wide range of reliable methodologies. A detailed treatment of the legal issues surrounding drug testing is provided in Appendix B . The argument here is that the policies of previous administrations, the legislature, and the judicial systems have all contributed to establishing drug testing as a major component of the nation's "war on drugs."

Unfortunately, to date, little consideration if any, has been given to assessing the impact of such programs on public health. Although this chapter is concerned with the effectiveness of workplace drug-testing programs on productivity, the reviewed literature still provides valuable information to policy makers. The emphasis on workplace productivity rather than public health or social welfare affects the evaluation method and criteria used in this chapter. In evaluating the efficacy of drug-testing programs, the researcher's perspective will influence what are regarded as acceptable program objectives, which in turn will determine the proper criteria for evaluating program effectiveness. Walsh et al. (1992) point out that, from a public health perspective, the primary question is whether drug intervention programs prevent or postpone any death, disease, disability, or dysfunction associated with the use or abuse of drugs.

From business or human resource management perspectives, the prevailing question is different from that of the public health perspective. In a business context, the primary concern is whether such programs allow the corporation to function more efficiently in a competitive market. Acceptable evaluation criteria are whatever business decision makers consider relevant productivity indices (e.g., absenteeism, work output, safety and health).

Job-site drug-testing programs have some promise in this respect. About three-fourths of adult men (16 years and older) and over half of adult women are in the labor force (Bureau of the Census, 1989). A sizable proportion of a worker's waking hours are spent at work, and a common sense of identity often exists within the work setting, where coworkers share norms and values. Workers are also subject to powerful influences that encourage conformity that can be used constructively to tackle problem behaviors such as alcohol and drug abuse. Formal and informal channels for communicating messages about drug abuse and treatment abound. Workplace drug programs thus have the potential for extensive social benefits. At the same time, such programs may have social costs. Some have argued, for example, that business drug intervention programs such as preemployment testing may aggravate society's drug problem by making those in need of assistance (e.g., applicants testing positive who are denied a job) unemployable.

• Impact Of Drug-Testing Programs

Preemployment Drug Testing

Preemployment testing is not only the most common form of drug-testing currently in place in organizations, but it has also received the largest amount of attention from the research community. One of the earliest evaluation studies attempting to assess the efficacy of preemployment drug testing that appeared in the published literature was carried out by Lewy (1983), who reported that 13 of 500 hospital job applicants tested positive for one or more of 5 drug classes (benzodiazapine, barbiturates, amphetamines, phencyclidine, and opiates). Based on this limited descriptive information and the cost of testing, the author concluded that preemployment drug testing is not a financially viable selection procedure. A significant limitation of the study is that the investigator did not test for the most prevalent illicit drugs (marijuana and cocaine) and made no attempt to assess the relationship between test results and performance.

Parish (1989) also attempted to evaluate the effectiveness of an applicant drug-testing program at a large hospital. This study focused on the important question, which had not yet been addressed in the literature, of whether preemployment drug test results were associated with job performance indicators. All employees hired over a 6-month period were tested for illicit drug use. The drug test results were kept confidential and, after 1 year of employment, job performance measures were extracted from personnel files. The 22 employees who had tested positive were found to have had a 28 percent higher turnover rate and a 64 percent higher rate of receiving disciplinary warnings. Twenty-five percent of the identified drug users received poor performance evaluations from their supervisors, compared with 5 percent of those who tested negative. Despite these observed disparities, no statistically significant relationship was detected between drug test results and job performance characteristics. The author commented that the null results were probably due, at least in part, to the small number of cases in the drug-positive group, an observation that has since been confirmed by other reviewers (Normand et al., 1990; Zwerling et al., 1990). These cautions are well taken. Given the low power of the statistical tests used, the brief tenure of the employees, and the complete absence of hired applicants testing positive for cocaine, the study's failure to reject the null hypothesis provides little reason to believe that preemployment drug use cannot predict some employment behavior.

Blank and Fenton (1989) carried out a similar predictive study with U.S. Navy recruits who were screened for illicit drugs before being sent to recruit training. Only those who tested positive for marijuana alone or negative for all drugs were retained. The 500 recruits who tested positive for marijuana were compared with a matched group of approximately 500 recruits who tested negative for all drugs. The results showed that 43 percent of the marijuana positives but only 19 percent of the negatives had been discharged from the Navy after 2.5 years. Despite this dramatic difference, the study should not be read as establishing the efficacy of drug testing as a selection procedure, even in the naval context. When evaluating the predictive value of an employee selection procedure, it is essential that the research sample include applicants who are typical of the population to which the results will be generalized and that the procedure be assessed in a way that is consistent with its operational use (Society for Industrial and Organizational Psychology, 1987). In the Blank and Fenton study, the use of a matched control group of 500 recruits resulted in a prevalence rate of 50 percent in the studied sample, which is substantially higher than what would be expected in the population of interest (i.e., Navy recruit applicants). The inflation of the prevalence rate upwardly biases the estimated predictive validity coefficient (i.e., the correlation between test results and turnover). Furthermore, the drug-positive group consisted only of identified marijuana users, whereas most organizations with a preemployment drug-testing program screen applicants on a wide variety of illicit substances. More importantly, recruits who tested positive for marijuana at selection, though retained by the Navy, were subject to follow-up and occasional random testing. Failing a subsequent drug test was grounds for dismissal. Thus, at least some of the turnover was probably a direct result of ongoing efforts to detect and discharge drug-using sailors and was not necessarily based on actual performance decrements or behavioral problems that might have resulted from the use of drugs. Moreover, since recruits who had tested positive for marijuana before induction were more likely to be tested subsequently then controls, a higher rate of dismissal for subsequent drug use would not show that they were more likely than the control group members to have used drugs after induction.

A large-scale attempt to assess the predictive efficacy of preemployment drug testing was conducted at the Boston general mail facility (Zwerling et al., 1990). The authors of this prospective study tested 4,964 job applicants in the Boston division of the U.S. Postal Service at the time of their preemployment medical examinations. Data from the urinalysis were collected for research purposes only and had no bearing (with the exception of positive opiates) on hiring or other employment decisions. Outcome measures were later obtained from personnel files (subjects were followed up, on average, for 406 calendar days). Of those tested, 2,537 applicants accepted the postal job offer. A proportional hazards model was used to analyze the data and to statistically control for age, sex, smoking, exercise status, race, and job classification. Identified marijuana users showed increased risks (relative risk ratio) of termination (1.56) (i.e., positive marijuana employees were 1.56 times more likely than negatives to turnover), accidents (1.55), injuries (1.85), disciplinary actions (1.55), and absenteeism (1.56) when compared with employees who tested negative. Cocaine positives showed an increased risk of absenteeism (2.37) and injuries (1.85).

One problem with this study is that the representativeness of the study sample (and therefore the generalizability of the results) was compromised by arbitrarily deleting whole applicant subgroups from the analyses (e.g., Hispanics, Native Americans, employees in professional or technical positions). If these individuals belong to the population of job applicants, then excluding them from the study sample limits the generalizability of the results and biases the parameter estimates. Furthermore, the authors elected to operationalize drug test results into discrete categories (e.g., marijuana, cocaine) rather than defining it as it is typically operationalized (positive on any drug versus negative on all drugs). Also, the use of statistical control techniques for potential confounding factors is questionable (Lord, 1967; Cochran and Rubin, 1973; Reichardt, 1979) when the predictive value of a selection device is being assessed.

Normand and Salyards (1989) reported the results of a large-scale longitudinal study that assessed the contribution of preemployment drug testing to the prediction of future job success. In this study, 5,465 U.S. Postal Service job applicants at 21 sites across the country were tested for use of illicit drugs as part of their preemployment medical examination. Test results were kept confidential and had no bearing on any subsequent personnel actions. Job outcome measures for 4,396 applicants who were hired were extracted from personnel records at four different time points (see Figures 7.1 and 7.2 ). After having been on the job for an average of 8.2 months, employees who tested positive were found to be absent at a rate 45 percent higher than those who tested negative (4 percent of scheduled work hours versus 3 percent). The drug-positive group also showed a 40 percent higher dismissal rate compared with the group testing negative for drugs (13 compared with 10 percent). A follow-up study indicated that, after an average of 1.3 years on the job, the observed absence and turnover differences between the two groups had increased substantially (Normand et al., 1990). The positive group showed a 59 percent higher rate of absenteeism (7 compared with 4 percent) and a 47 percent higher rate of firing (15 compared with 11 percent) compared with those testing negative. Despite a high level of statistical power in this study (the probability of detecting even weak effects exceeded 0.95 in this study), no significant associations were detected between drug test results and accidents and injuries.

Absence rates at four time points. NOTE: employee tenure: 8.2 months, 1.3 years, 2.4 years, and 3.3 years.

Firing rates at four time points. NOTE: employee tenure: 8.2 months, 1.3 years, 2.4 years, and 3.3 years.

In July 1990, after having been on the job for an average of 2.4 years, both the absenteeism and turnover disparities across the two groups had further increased: the positive group's absenteeism and firing rates were found to be 66 and 69 percent higher, respectively, than those of the negative group (Normand and Salyards, 1991). Finally, after 3.3 years on the job, the disparity in absenteeism rates plateaued at 66 percent, whereas the disparity in firing rates had increased to 77 percent (Normand and Salyards, 1992). As part of this latest follow-up, the investigator examined more specific indicators of job absence. A notable finding was that the observed disparities in absenteeism rates across the two groups were mirrored when annual absence frequencies were examined (30.61 compared with 18.75). Furthermore, more specific analyses by type of leave (sick leave, leave without pay, and absent without official leave—AWOL) showed that the disparities across groups were greatest for AWOLs, the most dysfunctional leave type. This latest update also extracted information pertaining to disciplinary infractions ( Figure 7.3 ) and employee assistance program referrals ( Figure 7.4 ). Results indicated that the employees who tested positive for drugs at preemployment were much more likely to be formally disciplined (a risk ratio of 2.44) and to experience problems requiring the intervention of an employee assistance program (EAP) (a risk ratio of 2.67). Further analyses revealed that the most common disciplinary action was due to attendance infractions and that the most commonly diagnosed EAP assessment problem at induction was alcohol-related. Employees who tested positive were 3.47 times more likely to be referred to an EAP for drinking problems and 5.69 times more likely to be referred for drug abuse problems as those who tested negative. A similar pattern was observed when medical claims data were examined (see Figure 7.5 ). The drug-positive employees were 3.42 times more likely as drug-negative employees to file medical claims having alcohol or drug-related diagnosis. Accident and injury rates continued to show no difference.

Disciplinary actions: drug-test results by infraction.

EAP referrals: drug-test results by problem identification.

Drug-test results by medical claims information: number, dollar amount, and drug-related claims.

The generalizability of the results of this study may be limited by the peculiarities of the work setting. That is, the positive rates and outcome measures distributions may not necessarily be reflective of other organizational settings. Until more empirical studies of this kind are carried out, one will not be able to determine with a high degree of accuracy to what extent these results can be generalized to other organizations. One factor that further complicates the generalizability issue is the change in prevalence rates of illicit drug use over time. The proportion of people in the general population who use illicit drugs has been declining relatively quickly since 1980. Such fluctuations in the prevalence of drug use are bound to affect the rate of positive preemployment drug-test results and consequently the effectiveness of preemployment drug-testing programs.

This study also highlights the importance of the perspective in which statistics are presented. For example, a 77 percent higher rate of firing after 3 years may suggest great benefits to preemployment drug screening and the policy of not hiring positive testers. However, as depicted in Figure 7.2 , 76 percent of those who tested positive at preemployment had not been fired after 3 years, compared with 86 percent of those testing negative. This represents a 10 percent absolute difference between groups in retention rates, which appears to be less drastic than the reported 77 percent higher rate of firing.

For-Cause Testing

Only two published studies are available that attempt to evaluate the effectiveness of for-cause drug-testing programs (Crouch et al., 1989; Sheridan and Winkler, 1989). Each of these studies appeared in a nonrefereed publication.

Crouch et al. (1989) compared employees (N = 12) who tested positive in a for-cause drug-testing program to a control group (N = 47) selected from the total employee pool who had similar demographic characteristics at the Utah Power and Light Company. Retrospective employment information was collected over a 2-year period. The mean number of sick hours accumulated by the drug-positive group was 75.3 compared with the control mean of 55.8. Employees testing positive used an average of 63.8 hours of unexcused leave compared with 18.7 hours for the control group. An analysis of vehicle accidents revealed that the identified drug users were significantly more likely to be involved in an accident compared with the matched control group. These differences were all found to be statistically significant. Surprisingly, a comparison of the medical expenditures used by each group indicated that the control group's use of medical benefits ($719) actually exceeded that of the drug-positive group ($504).

Findings from a similar study conducted at Georgia Power Company (Sheridan and Winkler, 1989; Winkler and Sheridan, 1989) compared employees who tested positive in a for-cause drug-testing program to a control group on the use of medical benefits, absenteeism, and accidents. Drugpositive and control groups were matched on sex, age, ethnicity, job category, and length of service in an attempt to control for nonrandom selection of subjects. When compared with their controls, individuals testing positive used significantly more medical benefits ($1,377 compared with $163), showed greater absenteeism (165 compared with 47 hours of yearly absenteeism), and had a higher rates of vehicular accidents (23 compared with 11 percent).

These two studies, however, are fraught with both conceptual and methodological difficulties. From a conceptual view point, it is not clear whether the objective of these studies was to evaluate the impact of a for-cause drug-testing program or the impact of individual drug use on productivity indices. Because both studies attempted to isolate, through matching techniques, the effect of testing positive from potential individual confounding factors, the intent appears to be to assess the impact of drug use on outcome measures, rather than to isolate the effect of the for-cause drug-testing programs on outcome measures.

Methodologically, however, the matching technique used is inadequate to this task. Matching has serious, well-recognized methodological weaknesses (Campbell and Erlebacher, 1975; Campbell and Stanley, 1966; Cochran and Rubin, 1973; Craig and Metze, 1979; Kerlinger, 1986; Reichardt, 1979) that are exacerbated in these studies for two reasons. First, the drug-tested group may have been selected in part by behaviors related to the dependent variables and, second, drug use, which was a basis for separating the groups, is no doubt correlated with a number of variables on which the subjects are not matched and that are plausibly related to the dependent variables. Thus, these two studies cannot tell us whether for-cause drug testing deters drug use or affects an organization's productivity, and they provide no reliable information on the effects of drug use on job-related performance measures.

Random Drug Testing

The committee was not able to locate any published studies that examine the effects of random drug testing on the productivity of the work force. The published literature on the effects of random drug testing consists mostly of descriptive reports of trends. Deterrence effects of random testing programs are often inferred from observed decreases in positive drug test rates, which frequently follow the implementation of such programs (Osborn and Sokolov, 1989; Taggart, 1989). However, the evaluation of random drug-testing programs is complicated by the fact that very few, if any, corporations have implemented such programs in isolation. Most corporations with random drug-testing programs have also implemented applicant and/or for-cause drug-testing programs. This makes it difficult to isolate the effect of random drug testing on productivity. The trend studies done to date have not overcome these difficulties, for they lack the kinds of controls that would allow one to confidently attribute observed changes in drug-use patterns to the implementation of random drug-testing programs. Furthermore, even if a reduction in drug use could be attributed to the implementation of a random drug-testing program, this would not in itself be evidence that the program has affected productivity. More research and more sophisticated research is clearly needed. Information on the relative effectiveness of the various components of a universal drug-testing program (i.e., applicant, forcause, and random drug-testing programs) would be useful to business and could have substantial policy relevance.

Workplace Drug Testing and Productivity

What can we conclude from the extant research on the efficacy of drugtesting programs? Contrary to what certain popular publications or newsletters may indicate, there are few empirically based conclusions that may be reached concerning the effectiveness of drug-testing programs in improving workplace productivity. The two for-cause drug-testing evaluation studies published to date suffer from serious methodological problems that preclude any scientific assessment of the impact of for-cause testing on work force productivity, and no evidence evaluating the effects of random drug testing on worker productivity has yet appeared in the published literature. Enough studies of preemployment drug-testing programs have been published with sufficiently consistent results that we can conclude that preemployment drug-test results are, in at least some job settings, valid predictors of some job-related behaviors. Those who test positive for drugs before employment are, as a group, likely to have higher rates of absenteeism, turnover, and disciplinary actions than those who test negative (Blank and Fenton, 1989; Normand et al., 1990; Zwerling et al., 1990).

In addition, it appears that preemployment drug-test results are also predictive of subsequent alcohol and drug problems. Salyards (1993) reported that job applicants who tested positive were 3.47 times more likely to be referred to an EAP for drinking problems and 5.69 times more likely to be referred for drug abuse problems as those testing negative at preemployment. Furthermore, drug-positive individuals were 3.42 times more likely as other employees to file medical claims involving an alcohol-or drugrelated diagnosis. Blank and Fenton (1989) found that 14 percent of marijuana-positive Navy recruits were discharged for drug-or alcohol-related problems compared with 1 percent of those who tested negative.

These figures do not necessarily mean, however, that preemployment drug testing is a cost-effective selection program. Finding that job applicants' drug-test results are predictive of critical job behaviors means that employers can select, on average, more productive workers if they attend to drug test information than if that information is not used to make hiring decisions. However, as with any other type of selection program, the predictive efficacy of drug test results depends on a few critical selection parameters. In particular, the prevalence of drug use among potential job applicants has to be sufficiently large to yield meaningful measures of association between test results and the outcome measure and to justify the cost of testing (see Chapter 6 for discussion on low base rate). Thus a test that is cost-effective and predictively valid at one point in time may cease to be or, conversely, may become even more useful, if the pattern of drug use in the larger population changes.

Another important characteristic of most of the preemployment drug studies we have reviewed is that they have used analytical drug-testing procedures that conform with the guidelines of the National Institute on Drug Abuse. Many private organizations (especially smaller employers) that test today use less stringent testing procedures and methods that introduce sources of error that can be expected to make their programs less efficacious than the programs that have been studied to date (Murphy and Thornton, 1992a).

It is also possible for employers to overweight preemployment drug-test results. In the best studies done to date, employers chose applicants using the cues they ordinarily apply without reference to evidence of drug use. The research shows that, among this group, those who tested positive performed worse by certain job-related criteria than those who showed no evidence of recent drug use. The studies do not show that positive testers performed worse than those who would have replaced them had they been rejected on the basis of drug-test information. In particular, there is a danger that, if drug-test results trump other signs that warn of job difficulties, negative drug testers will be preferred to positive testers who exceed them on job-related criteria. A major gap in the extant research is its failure to examine the interaction of recent drug usage and other job-related applicant characteristics. Although the studies show preemployment drug testing to be predictively valid, they also indicate that many applicants who test positive could be hired without producing any job-related difficulties.

• Conceptual Incongruities In Research Methods

Conceptual Issues

As stated at the beginning of this chapter, considerable confusion surrounds the basic evaluation research issue of how to assess the efficacy of drug-testing intervention programs. Most studies we reviewed claim to be investigating the same basic issue (i.e., the efficacy of drug-testing programs on productivity), and many employ similar designs. In many instances, however, the methods used to compare the work outcomes of drugpositive employees with those found to be drug-negative (or a matched drug-negative control group) are conceptually distinct from one another and reflect divergent research purposes. This state of affairs can be attributed to a lack of clarity in defining the research purpose.

Central to any scientific investigation is an analysis of the problem situation and a clear-cut formulation of the research purpose. Broadly speaking, a research study may be designed primarily for the purpose of explaining or predicting phenomena (e.g., see Cook and Campbell, 1979). In explanatory research, the emphasis is on identifying variables and understanding the processes by which they influence the phenomenon of interest. Establishing that covariation among variables exists is not sufficient. What is sought is an explanation as to why variables covary (Blalock, 1968). The hope is that by understanding the conditions that influence these phenomena, researchers and policy makers will be in a better position to recommend courses of action that will help to alleviate individual, organizational, and social woes. The task is difficult to accomplish. Most problems in the social and behavioral sciences have multiple and entangled causes that are often difficult to identify, isolate, and measure. Because the number of possible causal patterns among variables is virtually infinite, it is necessary to rely on theory to provide guidance and direction (James et al., 1982) in attempts to explain why observed differences exist. Theory confirmed by data can provide powerful explanations.

In predictive research, the emphasis is on studying the degree of covariation among variables and using this information to make predictions about subjects' future behavior or performance. Predictive research does not require a theoretical framework to proceed, even though theory may play a role in the initial development or selection of predictor variables and may be useful in generating finer predictions. Prediction is particularly important in practical applications, for example, the selection of applicants for employment, college entrance, and training programs. Prediction studies are descriptive by nature—they describe differences and examine their potential impact on aggregate outcomes.

The appropriateness of the methods used to assess the efficacy of an intervention program depends on the goals or purpose of the programs and the evaluation. If the primary objective for implementing drug-testing programs is to enhance work force productivity, what is crucial to the evaluation of preemployment testing is the predictive validity of drug test results (Society for Industrial and Organizational Psychology, 1987). If the drug test results are found to be valid predictors of critical job outcome measures, the average quality of new employees is likely to improve by implementing a selection program that takes drug test results into account. Evidence that such a program is predictively valid (i.e., that it enhances the average quality of the selected workers) means that the program has an effect on aggregate measures (e.g., mean value) of the outcome variables—not that drug use has an effect on the outcome variables. This is equally true of assessments of postemployment, for-cause, and random drug-testing programs. To evaluate their efficacy is to assess the impact of implementing the programs on productivity measures and not the impact of individual drug use on productivity measures. Within this framework, controlling for potential individual confounding variables (e.g., Crouch et al., 1989; Sheridan and Winkler, 1989; Winkler and Sheridan, 1989; Zwerling et al., 1990, 1992) is irrelevant and potentially erroneous.

There seems to be an implicit notion in the evaluation literature on drug intervention that negative employment behaviors or outcomes must be shown to be due to the effects of drug use, separate from other ''extraneous" influences, in order to establish the efficiency of a drug intervention program. This might possibly explain why so many drug intervention evaluation studies employ matching or statistical control procedures. The notion that drug use must be causally linked to critical employment criteria (otherwise why control for the effects of other influences?) goes well beyond the requirements for establishing the efficacy of drug intervention programs on productivity. As we note elsewhere in this report (see Chapter 5 ), it may be that drug use is more of a symptom of problematic job behavior than a cause, at least for the early stages of drug involvement.

These comments are not intended to detract from the importance of carrying out studies that attempt to untangle the complex causal relationship between drug use and problem behavior at work or elsewhere. Indeed, even though program evaluation and understanding human behaviors are different research issues, there is an important practical intersection. The better we understand the relationship between drug use and problem behavior, the more likely we are to be able to design an efficacious intervention program. In doing so, we can limit the unfairness that results from false negative predictions that have negative consequences for individuals. Moreover, in certain situations, it may be wrong or even illegal to employ valid selection programs. Thus there are reasons for research on drug-testing programs to control for individual variables. The reasons, however, are not to ascertain whether drug-testing programs have predictive validity but rather to further specify the conditions under which individual drug use influences individual performance. Because of conceptual confusion, statistical and matching techniques tend to be used for the former purpose.

The type or nature of drug-testing programs (preemployment, for-cause, or random) is another factor that is critical to the selection of an adequate evaluation strategy, because different types of drug-testing programs have different objectives. Program objectives determine the research purpose, which in turn dictate the choice of the study design and methods (e.g., variables to be measured, their operationalization, and statistical models) to be used. Unfortunately, most organizations that implement such testing programs do not articulate their program objectives clearly. This complicates matters for a researcher charged with evaluating the effectiveness of these programs. The lack of congruency between research purpose and method is an underlying source of much of the current conceptual and interpretational confusion regarding acceptable strategies for assessing the efficacy of drug intervention programs. To deal with this problem, researchers must secure clear statements of the program goals before designing their studies, and they must specify the goals that have motivated their evaluations in writing their research reports.

Cost-Effectiveness of Drug-Testing Programs

Two distinct audiences use the results of cost-effectiveness evaluations of intervention programs: policy makers and program administrators (or organizational decision makers). These groups need different types of information in order to make informed decisions. Policy makers, for example, are particularly concerned with the costs and benefits associated with various drug intervention programs (e.g., treatment modalities, testing) for society as a whole, while organizational decision makers need program-specific information pertaining to the costs and benefits of programs in their organizations or organizations like theirs.

Business decision makers want to know whether drug intervention programs enhance productivity, and if so, whether the consequent financial benefits justify program expenditures (relative to the costs of not intervening or to implementing another intervention). Unlike the cost of illness studies that are reviewed in Chapter 5 , cost factors such as criminal activities, social welfare, incarceration, and early death were not typically included in utility models implemented by business. It is not that these factors are unimportant, but, from a business perspective, the interest is on relatively short-term return on investment at the organizational level. This is in contrast to policy decision makers, who are more interested in the long-term economic impact of broad policy change on society's welfare.

Only two peer-reviewed studies (Normand et al., 1990; Zwerling et al., 1992) have reported empirical estimates of the costs and benefits associated with implementing a drug-testing program. Both of these were carried out within the U.S. Postal Service and dealt with preemployment drug testing. In both instances the findings revealed that preemployment drug testing was a cost-efficient selection program. However, both studies neglected to include some important parameters into their models (e.g., variable cost, corporate taxes). Since there have been almost no empirical studies of the cost-effectiveness of drug-testing programs, it appears that decisions by organizations to adopt such programs have often been made without a well-grounded consideration of the likely benefits associated with their implementation. To the extent that governmental pressure has induced such programs, this is particularly likely to be the case.

There is a substantial body of literature that deals with the difficult issue of translating the statistical impact of organizational intervention programs into financial productivity indicators (i.e., dollars). Researchers in human resource management and related fields have applied the methods of utility analysis to estimate the probable benefits of programs ranging from ability testing to improved performance appraisal and feedback (see Boudreau, 1991; Jones and Wright, 1992; and Judiesch et al., 1992 for recent reviews of utility estimation techniques).

Both the utility and fairness of preemployment drug testing as a selection device depend in part on the type of employment errors that result from implementing such programs. Two types of errors are of concern. First, as discussed in Chapter 6 , false positive classification error (mislabeling an individual as a drug user when in reality he or she is not a user) not only is disconcerting but also reduces the efficacy of the selection process. In the case of drug testing, it is well established that, when performed by a competent (NIDA-certified) laboratory, the rate of false-positive classification is virtually zero. But the superficial screening tests used by some businesses without confirmation increase the probability of false-positive classification error substantially. Second, and numerically more important, are what can be thought of as false-negative prediction errors. There will always be a number of applicants who test positive who would have been successful in their jobs had they been hired; to judge by the findings reported in the studies reviewed in this chapter, these falsely negative prediction errors will constitute the majority of drug-positive job applicants. False negative prediction errors also affect the efficacy of drug-testing programs, and minimizing them will increase a program's benefit-cost ratio.

This discussion of false-positive and false-negative errors should not obscure a central fact: the use of a valid selection program increases the proportion of successful new hires over what would be obtained had the selection program not been implemented. The prevalence of errors does affect the magnitude of the gains from a cost-benefit standpoint, so totally apart from fairness there are reasons to work to minimize them.

• Effects Of Drug Testing On Attitudes And Morale

Another issue that merits discussion is the impact of drug-testing programs on the attitudes and morale of applicants and employees. Despite its increasing frequency, employee drug testing is still controversial. Several authors (e.g., Crant and Bateman, 1989; Murphy et al., 1990, 1991; Stone and Kotch, 1988) have suggested that workers and job applicants may react negatively to drug testing. Although different studies yield different estimates of the frequency of negative reactions, it is common for 40 to 50 percent of those surveyed to express reservations about employee drug testing (Hanson, 1990; Konovsky and Cropanzano, 1993; Murphy et al., 1990).

Attitudes toward drug testing may affect the behavior of applicants and incumbents, especially if drug testing involves policies or procedures that are objectionable to large numbers of individuals (Chadwick-Jones et al., 1982; Goodman and Friedman, 1971). In particular, attitudes toward practices such as drug testing may affect an individual's job search and job choice and his or her subsequent satisfaction with the job and the organization (Murphy and Thornton, 1992b; Schwab et al., 1987).

Murphy and Thornton (1992b) present evidence that individuals with negative attitudes toward drug testing are less likely to apply to, and may be less likely to accept, jobs in organizations that test for drugs. Their study suggests that attitudes toward drug testing and the probability that attitudes would affect subsequent job search behavior were largely unrelated to grades and academic qualifications, which implies that highly qualified applicants are as likely as less qualified applicants to be influenced in their job choices by their attitudes toward testing. Given the frequency of negative reactions to drug testing and the possible consequences of those attitudes, it is important to examine the ways in which specific characteristics of drug-testing programs affect attitudes and to explore ways in which negative reactions to drug testing might be minimized. The apparent efficacy of preemployment drug testing could be illusory if testing programs bias applicant pools so as to overrepresent those with few job options.

Influence of Job Characteristics

Reactions to employee drug testing vary substantially, depending on the job in question (Murphy and Thornton, 1992b; Murphy et al., 1991). In general, the higher the likelihood that impaired job performance could pose a danger to an individual, his or her coworkers, and the public, the higher the level of approval for drug testing. Thus, drug testing is likely to be seen as more acceptable for airline pilots than for accountants. Murphy et al. suggest that drug testing will also meet with higher levels of approval if the job involves activities or functions that are believed to be substantially impaired by drug use. Finally, there is evidence that drug testing is more common and more likely to be accepted in lower-level jobs than in managerial and executive jobs (Murphy and Thornton, 1992a).

Influence of Program Characteristics

There is considerable evidence that the policies and practices that define employee drug-testing programs can substantially affect reactions to drug testing. First, employee drug testing may be seen as an invasion of privacy, which is likely to lead to negative reactions (Stone and Stone, 1990). Urine testing is an especially sensitive procedure; the need to provide urine samples strikes many people as offensive, and the need to do so in front of witnesses or under tightly monitored conditions may seem particularly offensive. Privacy-related concerns might also be more salient in situations in which drug tests provide information about behavior outside the workplace. For example, it is well known that an individual who is a chronic user of marijuana can test positive for days or even weeks after having stopped using the drug, and that marijuana use that is completely divorced from the work setting can nevertheless lead to a positive drug test.

Research on attitudes toward drug testing and on perceptions of justice and equity in organizations (e.g., Konovsky and Cropanzano, 1993; Murphy et al., 1990) suggests that there are three factors that substantially affect the likelihood of negative reactions. First, drug-testing programs vary in the extent to which they are seen as reasonable. Testing programs that are restricted to high-risk occupations, or that are clearly and convincingly justified by management, are not likely to be a significant source of controversy. Second, drug-testing programs vary in the extent to which their overall orientation is seen as punitive. Testing programs that result in severe or irrevocable sanctions (e.g., dismissal) are more likely to be seen in a negative light than programs that are designed to help people deal constructively with substance abuse (e.g., by recommending counseling). Finally, drug-testing programs that involve consultation between labor and management are less likely to be seen in a negative light than those that are unilaterally imposed by management.

Limitations of Research on Reactions to Drug Testing

In evaluating research on attitudes toward drug testing, there are two reasons for caution in making broad generalizations. First, the majority of the studies in this area have employed convenience samples, usually college students. The attitudes of college students might differ in a number of ways from those of a general work force population (Murphy et al., 1991). Second, these studies often employ simulation methods (e.g., asking students to go through a simulated job interview) whose external validity is unclear (for an exception, see Murphy and Thornton, 1992b). The fact that an individual is willing to turn down a job offer in an experimental simulation does not necessarily predict behavior in real job interviews.

One of the few studies that has investigated the reactions of work force members is the High School Senior follow-up surveys (Patrick O'Malley, personal communication, 1992). These follow-up surveys show that, in general, most young adults are supportive of both preemployment and postemployment drug testing. In 1991, 65 percent "approved" or "strongly approved" of urine tests as a condition for getting a job like their own job, and 60 percent approved of urine tests as a condition for keeping a job such as their own. These figures reflect increases of about 15 percent in approval since 1987; for getting a job, the 1987 figure was 49 percent, and for keeping a job, the 1987 figure was 46 percent.

Approval rates have consistently been slightly higher among those who had actually been required to take a urine test. In 1991, among those who had been tested, either pre-or postemployment, 78 percent approved of preemployment testing compared with 61 percent of those who had not been tested. Postemployment testing was approved by 70 percent of those who had been tested, compared with 57 percent of those who had not been tested. These differences may reflect the types of people who get tested, positive experience with drug testing, or cognitive dissonance resulting from consent to a previously disapproved procedure.

On the basis of the research literature reviewed in this chapter, the committee provides the following conclusions and recommendations.

• Conclusions And Recommendations
• The empirical evidence pertaining to the efficacy of preemployment drug testing indicates that such programs may be useful to employers in choosing wisely among job applicants. However, regardless of the magnitude of the correlations between drug use and dysfunctional job behavior measures, the practical effectiveness of any drug-testing program depends on other parameters such as the prevalence of drug use in the population tested. The presence of significant relationships between drug use and workplace performance measures does not necessarily mean that an effective drug-testing program will substantially improve work force performance, and a program that substantially improves performance with some employees or in some job settings may do little to improve performance with other employees or in other job settings.
• Despite beliefs to the contrary, the preventive effects of drug-testing programs have never been adequately demonstrated. Although, there are some suggestive data (e.g., see the military data in Chapter 3 ) that allude to the deterrent effect of employment drug-testing programs, there is as yet no conclusive scientific evidence from properly controlled studies that employment drug-testing programs widely discourage drug use or encourage rehabilitation.

Recommendation: Longitudinal research should be conducted to determine whether drug-testing programs have deterrent effects.

• Many studies of alcohol and other drug use by the work force have been flawed in their design and implementation. Organizations that conduct their own drug studies can, by encouraging their researchers to publish in professional journals, enhance quality control and contribute to a knowledge base that will enable them to deal more effectively with future alcohol and other drug problems.
• Different objectives have been suggested for work site drug-testing and diverse alcohol and other drug intervention programs. These include improving workers' performance, preventing accidents, saving on health costs, and working toward a drug-free society by deterring drug use. The effectiveness of alcohol and other drug intervention programs cannot be adequately evaluated unless the goals of such programs are clear.

Recommendation: Organizations should clearly articulate their objectives prior to initiating alcohol and other drug intervention programs and should regularly evaluate their programs in light of these objectives.

Among job applicants and workers, testing for drugs other than alcohol is already common and generally accepted. Of young men in a 1991 general population survey of high school graduates, 33 percent reported that they had been tested, 61 percent reported that they approved of preemployment testing, and 60 percent reported that they approved of postemployment testing. Approval rates were even higher among those who had been tested.

• Very little is known about what happens to job applicants who are not hired or to employees who are fired as a consequence of a positive drug test.

Recommendation: Research should be conducted on the impact of drug-testing programs with attention not only to those who remain within the organization as well as to those who are not hired or are dismissed. In particular, more information is needed about the impact of drug-testing programs on the health and productivity of the work force.

Recommendation: In light of the relatively low rates of alcohol and other drug abuse among the work force (see Chapter 3 ), the moderate predictive validity of testing programs (see Chapter 7 ), and the fact that many factors other than drug use may cause performance deficiencies seen in drug users (see Chapter 5 ), drug-testing programs should not be viewed as a panacea for curing workplace performance problems. Nonetheless, drug-testing for safety-sensitive positions may still be justified in the interest of public safety.

• American Management Association 1992. 1992. AMA Survey on Workplace Drug Testing and Drug Abuse Policies . New York: American Management Association.
• Axel, H. 1990. Corporate Experiences with Drug Testing Programs . New York: The Conference Board.
• Blalock, H.M. 1968. Theory building and causal inferences . In H.M. Blalock, editor; and A.B. Blalock, editor. , eds., Methodology in Social Research . New York: McGraw-Hill.
• Blank, D.L., and J.W. Fenton 1989. Early employment testing for marijuana: demographic and employee retention patterns . Pp. 139-150 in S.W. Gust, editor; and J.M. Walsh, editor. , eds., Drugs in the Workplace: Research and Evaluation Data . Rockville, Md.: National Institute on Drug Abuse. [ PubMed : 2554140 ]
• Boudreau, J.W. 1991. Utility analysis for decisions in human resource management . Pp. 621-746 in M. Dunnette, editor; and L. Hough, editor. , eds., Handbook of Industrial and Organizational Psychology , Vol. 2. Palo Alto, Calif.: Consulting Psychologists Press.
• Bureau of the Census 1989. Statistical Abstract of the United States, 1988 . Washington, D.C.: U.S. Department of Commerce.
• Campbell, D.T., and A. Erlebacher 1975. How regression artifacts in quasi-experimental evaluations can mistakenly make compensatory education look harmful . Pp. 597-617 in E.L. Struening, editor; and M. Guttentag, editor. , eds., Handbook of Evaluation Research . Beverly Hills, Calif.: Sage Publications.
• Campbell, D.T., and J.C. Stanley 1966. Experimental and Quasi-Experimental Designs for Research . Chicago: Rand McNally.
• Chadwick-Jones, J.K., N. Nicholson, and C. Brown 1982. The Social Psychology of Absenteeism . New York: Praeger.
• Cochran, W.G., and D.B. Rubin 1973. Controlling bias in observational studies: a review . Sankhya, The Indian Journal of Statistics 35:417-446.
• Cook, T.D., and D.T. Campbell 1979. Quasi-Experimentation: Design and Analysis Issues for Field Settings . Chicago: Rand McNally.
• Craig, J.R., and L.P. Metze 1979. Methods of Psychological Research . Philadelphia, Pa.: W.B. Saunders.
• Crant, J.M., and T.S. Bateman 1989. A model of employee responses to drug-testing programs . Employee Responsibilities and Rights Journal 2:173-190.
• Crouch, D.J., D.O. Webb, L.V. Peterson, P.F. Buller, and D.E. Rollins 1989. A critical evaluation of the Utah Power and Light Company's substance abuse program: absenteeism, accidents, and costs . Pp. 169-193 in S.W. Gust, editor; and J.M. Walsh, editor. , eds., Drugs in the Workplace: Research and Evaluation Data . Rockville, Md.: National Institute on Drug Abuse. [ PubMed : 2509923 ]
• Employee Assistance Professional Association 1991. EAPA Exchange October :23-25. Employee Assistance Professional Association, Alexandria, Va.
• Goodman, P., and A. Friedman 1971. An examination of Adams' theory of inequity . Administrative Science Quarterly 16:271-288.
• Hanson, A. 1990. What employees say about drug testing . Personnel July:32-36.
• Hayghe, H.V. 1991. Anti-drug programs in the workplace: are they here to stay? Monthly Labor Review 114:26-29.
• James, L.R., S.A. Mulaik, and J.M. Brett 1982. Casual Analysis: Assumptions, Models, and Data . Beverly Hills, Calif.: Sage Publications.
• Jones, G.R., and Wright, P.M. 1992. An economic approach to conceptualizing the utility of human resource management practices . Pp. 271-300 in G. Ferris, editor; and K. Rowland, editor. , eds., Research in Personnel and Human Resources Management , Vol. 10. Greenwich, Conn.: JAI Press.
• Judiesch, M.K., F.L. Schmidt, and M.K. Mount 1992. Estimates of the dollar value of employee output in utility analysis: an empirical test of two theories . Journal of Applied Psychology 77:234-250.
• Kerlinger, F.N. 1986. Foundations of Behavioral Research , 3rd ed. New York: Holt, Rinehart, and Winston.
• Konovsky, M.A., and R. Cropanzano 1993. Justice considerations in employee drug testing . In R. Cropanzano, editor. , ed., Justice in the Workplace: Approaching Fairness in Human Resource Management . Hillsdale, N.J.: Erlbaum. (In press.)
• Lewy, R. 1983. Preemployment qualitative urine toxicology screening . Journal of Occupational Medicine 25:579-580. [ PubMed : 6886865 ]
• Lord, F.M. 1967. A paradox in the interpretation of group comparisons . Psychological Bulletin 68:304-305. [ PubMed : 6062585 ]
• Murphy, K.R., and G.C. Thornton, III 1992. a Characteristics of employee drug testing programs . Journal of Business and Psychology 6:295-309. 1992. b Development and validation of a measure of attitudes toward employee drug testing . Educational and Psychological Measurement 52: 189-201.
• Murphy, K.R., G.C. Thornton, III, and D.H. Reynolds 1990. College students' attitudes toward employee drug testing programs . Personnel Psychology 43:615-631.
• Murphy, K.R., G.C. Thornton, III, and K. Prue 1991. The influence of job characteristics on the acceptability of employee drug testing . Journal of Applied Psychology 76:447-453. [ PubMed : 1864814 ]
• Normand, J., and S.D. Salyards 1989. An empirical evaluation of preemployment drug testing in the United States Postal Service: interim report of findings . Pp. 111-138 in S.W. Gust, editor; and J.M. Walsh, editor. , eds., Drugs in the Workplace: Research and Evaluation Data . Rockville, Md.: National Institute on Drug Abuse. 1991. Applicant Drug Testing: Update of a Longitudinal Study . Paper presented at the 1991 Annual Convention of the IPMA Assessment Council, Chicago, Illinois. 1992 Applicant Drug Testing: An Update of the Empirical Validation Evidence . Paper presented at the 7th annual conference of the Society for Industrial and Organizational Psychology, Montreal.
• Normand, J., S.D. Salyards, and J.J. Mahoney 1990. An evaluation of preemployment drug testing . Journal of Applied Psychology 75:629-639. [ PubMed : 2286599 ]
• Osborn, C.E., and J.J. Sokolov 1989. Drug use trends in a nuclear power company: cumulative data from an ongoing testing program . In S.W. Gust, editor; and J.M. Walsh, editor. , eds., Drugs in the Workplace: Research and Evaluation Data . NIDA Research Monograph 91. Rockville, Md.: National Institute on Drug Abuse. [ PubMed : 2509935 ]
• Parish, D.C. 1989. Relation of the pre-employment drug testing result to employment status: a one-year follow-up . Journal of General Internal Medicine 4:44-47. [ PubMed : 2915272 ]
• Reichardt, C.S. 1979. The statistical analysis of data from nonequivalent group designs . Pp. 147-205 in T.D. Cook, editor; and D.T. Campbell, editor. , eds., Quasi-Experimentation: Design and Analysis Issues for Field Settings . Chicago: Rand NcNally.
• Salyards, S.D. 1993. Preemployment drug testing: associations with EAP, disciplinary, and medical claims information . PharmChem Newsletter 21(1):1-4.
• Schwab, D.P., S.L. Rynes, and R.J. Aldag 1987. Theories and research on job choice . In K. Rowland, editor; and G. Ferris, editor. , eds., Research in Personnel and Human Resource Management , Vol. 5. Greenwich, Conn.: JAI Press.
• Sheridan, J.R., and H. Winkler 1989. An evaluation of drug testing in the workplace . In S.W. Gust, editor; and J.M. Walsh, editor. , eds., Drugs in the Workplace: Research and Evaluation Data . NIDA Research Monograph 91. Rockville, Md.: National Institute on Drug Abuse.
• Society for Industrial and Organizational Psychology 1987. Principles for the Validation and Use of Personnel Selection Procedures , 3rd ed. College Park, Md.: Division of Industrial-Organizational Psychology, American Psychological Association.
• Stone, D.L., and D.A. Kotch 1988. Individuals' attitudes toward organizational drug testing policies and practices . Journal of Applied Psychology 74:518-521. [ PubMed : 2737995 ]
• Stone, E.F, and D.L. Stone 1990. Privacy in organizations: theoretical issues, research findings, and protection mechanisms . In G. Ferris, editor; and K. Rowland, editor. , eds., Research in Personnel and Human Resource Management , Vol. 8. Greenwich, Conn.: JAI Press.
• Taggart, R.W. 1989. Results of the drug testing program at Southern Pacific Railroad . In S.W. Gust, editor; and J.M. Walsh, editor. , eds., Drugs in the Workplace: Research and Evaluation Data . NIDA Research Monograph 91. Rockville, Md.: National Institute on Drug Abuse.
• U.S. Department of Labor 1989. Survey of Employer Anti-Drug Programs . Washington, D.C.: U.S. Department of Labor.
• Walsh, D.C., L. Elinson, and L. Gostin 1992. Worksite drug testing . Annual Review of Public Health 13:197-221. [ PubMed : 1599585 ]
• Winkler, H., and J. Sheridan 1989. An Analysis of Workplace Behaviors of Substance Abusers . Paper presented at the National Institute on Drug Abuse conference on Drugs in the Workplace: Research and Evaluation Data, Bethesda, Md.
• Zwerling, C., J. Ryan, and E.J. Orav 1990. The efficacy of preemployment drug screening for marijuana and cocaine in predicting employment outcome . Journal of the American Medical Association 264:2639-2643. 1992 Costs and benefits of preemployment drug screening . Journal of the American Medical Association 267: 91-93. [ PubMed : 2232039 ]
• Cite this Page National Research Council (US) and Institute of Medicine (US) Committee on Drug Use in the Workplace; Normand J, Lempert RO, O'Brien CP, editors. Under the Influence? Drugs and the American Work Force. Washington (DC): National Academies Press (US); 1994. 7, Impact of Drug-Testing Programs on Productivity.
• PDF version of this title (2.6M)

In this Page

Related information.

• PubMed Links to PubMed

Recent Activity

• Impact of Drug-Testing Programs on Productivity - Under the Influence? Impact of Drug-Testing Programs on Productivity - Under the Influence?

Your browsing activity is empty.

Activity recording is turned off.

Turn recording back on

Connect with NLM

National Library of Medicine 8600 Rockville Pike Bethesda, MD 20894

Web Policies FOIA HHS Vulnerability Disclosure

Help Accessibility Careers

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

• View all journals
• Explore content
• About the journal
• Publish with us
• Sign up for alerts
• Research Briefing
• Published: 22 August 2024

AI-recognized mitochondrial phenotype enables identification of drug targets

Nature Computational Science ( 2024 ) Cite this article

2 Altmetric

Metrics details

• Computational biology and bioinformatics
• Drug screening

Revealing a drug’s mechanism of action (MOA) is costly and time-consuming. In this study, we used deep learning to extract temporal mitochondrial phenotypic features after exposure to drugs with known MOAs using re-identification algorithms. The trained model could then predict the MOAs of unidentified substances, facilitating phenotypic screening-based drug discovery and repurposing.

This is a preview of subscription content, access via your institution

Access options

Access Nature and 54 other Nature Portfolio journals

Get Nature+, our best-value online-access subscription

24,99 € / 30 days

cancel any time

Subscribe to this journal

Receive 12 digital issues and online access to articles

92,52 € per year

only 7,71 € per issue

Buy this article

• Purchase on SpringerLink
• Instant access to full article PDF

Prices may be subject to local taxes which are calculated during checkout

Chandrasekaran, S. N. et al. Image-based profiling for drug discovery: due for a machine-learning upgrade? Nat. Rev. Drug Discov. 20 , 145–159 (2021). A review article that describes in detail the application of image-based profiling to the field of drug discovery through machine learning methods.

Article   Google Scholar  

Way, G. P. et al. Morphology and gene expression profiling provide complementary information for mapping cell state. Cell Syst. 13 , 911–923.e9 (2022). This paper reports that morphology and gene expression are complementary profiling assays, each with its own advantages and disadvantages.

Spinelli, H. M. The multifaceted contributions of mitochondria to cellular metabolism. Nat. Cell Biol. 20 , 745–754 (2018). A review article that presents multifaceted roles of mitochondria in cell metabolism.

Eisner, P. M. et al. Mitochondrial dynamics in adaptive and maladaptive cellular stress responses. Nat. Cell Biol. 20 , 755–765 (2018). A review article that presents the role of mitochondrial dynamics in adaptive and non-adaptive cellular stress responses.

Download references

Additional information

Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

This is a summary of: Yu, M. et al. Deep learning large-scale drug discovery and repurposing. Nat. Comput. Sci . https://doi.org/10.1038/s43588-024-00679-4 (2024).

Rights and permissions

Reprints and permissions

About this article

Cite this article.

AI-recognized mitochondrial phenotype enables identification of drug targets. Nat Comput Sci (2024). https://doi.org/10.1038/s43588-024-00682-9

Download citation

Published : 22 August 2024

DOI : https://doi.org/10.1038/s43588-024-00682-9

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

Quick links

• Explore articles by subject
• Guide to authors
• Editorial policies

Sign up for the Nature Briefing: Translational Research newsletter — top stories in biotechnology, drug discovery and pharma.

Efficient photocatalytic degradation of diclofenac drug using the Zn 1-x-y Pr x Al y O photocatalyst under UV light irradiation

• Research Article
• Published: 22 August 2024

Cite this article

• Emanoel Martins 1 ,
• Pollyana Trigueiro 2 ,
• Aimée G. Jerônimo 2 ,
• Ricardo Barbosa 2 ,
• Luan Neves 2 ,
• Débora A. Sales 1 ,
• Luciano C. Almeida 3 ,
• Bartolomeu C. Viana 1 ,
• Adriano S. Soares 1 &
• Ramón R. Peña-Garcia   ORCID: orcid.org/0000-0002-4945-1297 1 , 2  

Explore all metrics

Herein, we report the efficient photocatalytic degradation of the diclofenac drug using the Zn 1-x-y Pr x Al y O photocatalyst [x, y] = (0.00, 0.00), (0.03, 0.01), (0.03,0.03) under UV light irradiation. The analysis of the structure reveals that the Pr 3+ and Al 3+ cations insertion into the ZnO lattice leads to a decrease in the lattice constant ( a and c ), Zn–O bond length, strain lattice, and crystallite size. These alterations are linked to the high degree of atomic disorder triggered by the dopants, which produce stress and strain in the ZnO structure. The Raman measurements confirmed the structural phase and showed changes in the position and intensity of the E 2 High mode, associated with oxygen vibrations and material crystallinity. The presence of the dopants reduces the concentration of V Zn and V O ++ type defects while increasing the levels of V O , V O + , and O i defects, as observed from the fitting of the Photoluminescence spectra. Furthermore, it was noted that de Pr 3+ and Al 3+ cations insertion into ZnO increases the optical band gap, which is associated with the Moss-Burstein effect. The micrograph images show that dopants transform the morphology from quasi-spherical particles to irregular cluster structures. The textural analysis indicated that an increase in the concentration of Al 3+ in the ZnO lattice led to a higher surface area, likely enhancing photocatalytic activity. The sample containing 3% Pr 3+ and 3% Al 3+ showed the highest photocatalytic activity and degraded up to 71.42% of diclofenac. In addition, experiments with scavengers revealed that hydroxyl radicals are the main species involved in the drug’s photodegradation mechanism. Finally, the Zn 1-x-y Pr x Al y O compound is highly recyclable and stable.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Subscribe and save.

• Get 10 units per month
• Download Article/Chapter or eBook
• 1 Unit = 1 Article or 1 Chapter
• Cancel anytime

Price includes VAT (Russian Federation)

Instant access to the full article PDF.

Rent this article via DeepDyve

Institutional subscriptions

Similar content being viewed by others

Visible light-embedded CuO/ZnO twofold execution for photocatalysis and photoluminescence

Photocatalytic degradation of diclofenac sodium in aqueous solution using N, S, and C-doped ZnO

Fabrication of an organic-based PI/ZnO composite with high visible photocatalytic properties toward tetracycline

Explore related subjects.

• Environmental Chemistry

Data availability

All data generated or analyzed during this study are included in this published article.

Achouri F, Corbel S, Balan L et al (2016) Porous Mn-doped ZnO nanoparticles for enhanced solar and visible light photocatalysis. Mater Des 101:309–316. https://doi.org/10.1016/j.matdes.2016.04.015

Article   CAS   Google Scholar  

Ahmad I, Shoaib Akhtar M, Ahmed E et al (2020) Rare earth co-doped ZnO photocatalysts: solution combustion synthesis and environmental applications. Sep Purif Technol 237:116328. https://doi.org/10.1016/j.seppur.2019.116328

Alaveh Y, Samadi M (2024) A comparative study on tetracycline photodegradation over ZnO/BiOBr and ZnO/BiOI nanoarchitectures: the relationships between synthesis parameters and photocatalytic activity. Mater Sci Semicond Process 179:108534. https://doi.org/10.1016/j.mssp.2024.108534

Alprol AE, Mansour AT, El-Beltagi HS, Ashour M (2023) Algal extracts for green synthesis of zinc oxide nanoparticles: promising approach for algae bioremediation. Materials (basel) 16:1–23. https://doi.org/10.3390/ma16072819

Amaranatha Reddy D, Ma R, Kim TK (2015) Efficient photocatalytic degradation of methylene blue by heterostructured ZnO-RGO/RuO2 nanocomposite under the simulated sunlight irradiation. Ceram Int 41:6999–7009. https://doi.org/10.1016/j.ceramint.2015.01.155

Anas M, Han DS, Mahmoud K et al (2015) Photocatalytic degradation of organic dye using titanium dioxide modified with metal and non-metal deposition. Mater Sci Semicond Process 41:209–218. https://doi.org/10.1016/j.mssp.2015.08.041

Araujo FP, Honorio LMC, Lima IS et al (2020a) New composite TiO2/naturals gums for high efficiency in photodiscoloration process. Ceram Int. https://doi.org/10.1016/j.ceramint.2020.03.100

Article   Google Scholar  

Araujo FP, Trigueiro P, Honório LMC et al (2020b) A novel green approach based on ZnO nanoparticles and polysaccharides for photocatalytic performance. Dalt Trans 49:16394–16403. https://doi.org/10.1039/d0dt01128b

Araujo FP, Trigueiro P, Honório LMC et al (2020c) Eco-friendly synthesis and photocatalytic application of flowers-like ZnO structures using Arabic and Karaya Gums. Int J Biol Macromol. https://doi.org/10.1016/j.ijbiomac.2020.10.132

Balakrishnan A, Chinthala M, Polagani RK (2024) 3D kaolinite/g-C3N4-alginate beads as an affordable and sustainable photocatalyst for wastewater remediation. Carbohydr Polym 323:121420. https://doi.org/10.1016/j.carbpol.2023.121420

Bhakar K, Rajpurohit NA, Sillanpää ME, Kumar D (2024) Design and synthesis of Z-scheme heterojunction-based ZnO-MnWO4@g-C3N4 ternary nanocomposite for efficient methylene blue degradation. Inorg Chem Commun 160:111884. https://doi.org/10.1016/j.inoche.2023.111884

Bouarroudj T, Aoudjit L, Nessaibia I et al (2023) Enhanced photocatalytic activity of Ce and Ag Co-doped ZnO nanorods of paracetamol and metronidazole antibiotics co-degradation in wastewater promoted by solar light. Russ J Phys Chem A 97:1074–1087. https://doi.org/10.1134/S0036024423050278

Cabrera-Baez M, Padrón-Hernández E, Soares JM et al (2021) Effect of yttrium substitution in Fe-doped ZnO nanoparticles: an EPR study. J Magn Magn Mater 538:168317. https://doi.org/10.1016/j.jmmm.2021.168317

Castro-Lopes S, Guerra Y, Silva-Sousa A et al (2020) Influence of pH on the structural and magnetic properties of Fe-doped ZnO nanoparticles synthesized by sol gel method. Solid State Sci 109:106438. https://doi.org/10.1016/j.solidstatesciences.2020.106438

Chang C-J, Lin C-Y, Hsu M-H (2014) Enhanced photocatalytic activity of Ce-doped ZnO nanorods under UV and visible light. J Taiwan Inst Chem Eng 45:1954–1963. https://doi.org/10.1016/j.jtice.2014.03.008

Conte F, Tommasi M, Degerli SN et al (2023) Comparison of different advanced oxidation processes (AOPs) and photocatalysts for the degradation of diclofenac. ChemPhotoChem 202300177. https://doi.org/10.1002/cptc.202300177

Costa-Silva M, Araujo FP, Guerra Y et al (2022) Photocatalytic, structural and optical properties of Ce–Ni co-doped ZnO nanodisks-like self-assembled structures. Mater Chem Phys 292. https://doi.org/10.1016/j.matchemphys.2022.126814

de Sá IGF, Araújo FP, Paz dos Santos FE et al (2024) Synthesis of ZnO co-doped with Er and Co: effect of the dopants on the structural, optical properties and yellow eosin photocatalytic response. Solid State Sci 147:107400. https://doi.org/10.1016/j.solidstatesciences.2023.107400

Divya NK, Pradyumnan PP (2016) Solid state synthesis of erbium doped ZnO with excellent photocatalytic activity and enhanced visible light emission. Mater Sci Semicond Process 41:428–435. https://doi.org/10.1016/j.mssp.2015.10.004

Elangovan M, Bharathaiyengar SM, PonnanEttiyappan J (2021) Photocatalytic degradation of diclofenac using TiO2-CdS heterojunction catalysts under visible light irradiation. Environ Sci Pollut Res 28:18186–18200. https://doi.org/10.1007/s11356-020-11538-w

França DB, Trigueiro P, Silva Filho EC et al (2020) Monitoring diclofenac adsorption by organophilic alkylpyridinium bentonites. Chemosphere 242:125109. https://doi.org/10.1016/j.chemosphere.2019.125109

França R, Araujo FP, Castro-Lopes S et al (2023a) Effect of Cr cations addition on the structural, morphological, optical, and photocatalytic properties of Er-doped ZnO structures. Mater Today Commun 37:107419. https://doi.org/10.1016/j.mtcomm.2023.107419

França R, Araujo FP, Neves L et al (2023b) Photoresponsive activity of the Zn0.94Er0.02Cr0.04O compound with hemisphere-like structure obtained by co-precipitation. Materials (Basel) 16. https://doi.org/10.3390/ma16041446

Freitas WA, Soares BECF, Rodrigues MS et al (2022) Facile synthesis of ZnO-clay minerals composites using an ultrasonic approach for photocatalytic performance. J Photochem Photobiol A Chem 429:113934. https://doi.org/10.1016/j.jphotochem.2022.113934

Gibbs ZM, Lalonde A, Snyder GJ (2013) Optical band gap and the Burstein-Moss effect in iodine doped PbTe using diffuse reflectance infrared Fourier transform spectroscopy. New J Phys 15. https://doi.org/10.1088/1367-2630/15/7/075020

Goodarzi N, Ashrafi-Peyman Z, Khani E, Moshfegh AZ (2023) Recent progress on semiconductor heterogeneous photocatalysts in clean energy production and environmental remediation. Catalysts 13. https://doi.org/10.3390/catal13071102

Güell F, Galdámez-Martínez A, Martínez-Alanis PR et al (2023) ZnO-based nanomaterials approach for photocatalytic and sensing applications: recent progress and trends. Mater Adv 4:3685–3707

Gurylev V, Perng TP (2021) Defect engineering of ZnO: review on oxygen and zinc vacancies. J Eur Ceram Soc 41:4977–4996. https://doi.org/10.1016/j.jeurceramsoc.2021.03.031

Hassan A, Jin Y, Irfan M, Jiang Y (2018) Acceptor-modulated optical enhancements and band-gap narrowing in ZnO thin films. AIP Adv 8. https://doi.org/10.1063/1.5020830

Honorio LMC, Trigueiro PA, Viana BC, Ribeiro AB, Osajima JA (2019) Nanostructured materials for the photocatalytic degradation of organic pollutants in water. In: Gonçalves G, Marques P (eds) Nanostructured materials for treating aquatic pollution. Eng Mater. Springer, Cham. https://doi.org/10.1007/978-3-030-33745-2_3

Jerônimo AG, Barbosa R, Neves L et al (2024b) Simultaneous La3+ and Cu2+ cations insertion in the ZnO crystal structure and its effect on the structural, optical, and photocatalytic properties. J Mater Sci 59:1280–1297. https://doi.org/10.1007/s10853-023-09308-3

Jiménez-Rosado M, Gomez-Zavaglia A, Guerrero A, Romero A (2022) Green synthesis of ZnO nanoparticles using polyphenol extracts from pepper waste (Capsicum annuum). J Clean Prod 350:131541. https://doi.org/10.1016/j.jclepro.2022.131541

Kadam AN, Kim TG, Shin DS et al (2017) Morphological evolution of Cu doped ZnO for enhancement of photocatalytic activity. J Alloys Compd 710:102–113. https://doi.org/10.1016/j.jallcom.2017.03.150

Khalid NR, Hammad A, Tahir MB et al (2019) Enhanced photocatalytic activity of Al and Fe co-doped ZnO nanorods for methylene blue degradation. Ceram Int 45:21430–21435. https://doi.org/10.1016/j.ceramint.2019.07.132

Khalid NR, Sabir M, Ali F et al (2023) Green synthesis and characterizations of bi-functional Mo-doped ZnO nanostructures for antimicrobial and photocatalytic applications. Mater Chem Phys 296:127306. https://doi.org/10.1016/j.matchemphys.2023.127306

Khanizadeh B, Khosravi M, Behnajady MA et al (2020) Mg and La Co-doped ZnO nanoparticles prepared by sol–gel method: synthesis, characterization and photocatalytic activity. Period Polytech Chem Eng 64:61–74. https://doi.org/10.3311/PPch.12959

Latif S, Liaqat A, Imran M et al (2023) Development of zinc ferrite nanoparticles with enhanced photocatalytic performance for remediation of environmentally toxic pharmaceutical waste diclofenac sodium from wastewater. Environ Res 216:114500. https://doi.org/10.1016/j.envres.2022.114500

Leng Q, Yang D, Yang Q et al (2015) Building novel Ag/CeO2 heterostructure for enhancing photocatalytic activity. Mater Res Bull 65:266–272. https://doi.org/10.1016/j.materresbull.2015.02.008

Lins A, Jerônimo AG, Barbosa R et al (2023) Facile synthesis of Ni-doped ZnO nanoparticles using cashew gum: investigation of the structural, optical, and photocatalytic properties. Molecules 28:7772. https://doi.org/10.3390/molecules28237772

Malik AQ, ul Mir TG, Amin O et al (2022) Synthesis, characterization, photocatalytic effect of CuS-ZnO nanocomposite on photodegradation of Congo red and phenol pollutant. Inorg Chem Commun 143:109797. https://doi.org/10.1016/j.inoche.2022.109797

Malik AQ, ul Mir TG, Kumar D et al (2023) A review on the green synthesis of nanoparticles, their biological applications, and photocatalytic efficiency against environmental toxins. Environ Sci Pollut Res 30:69796–69823. https://doi.org/10.1007/s11356-023-27437-9

Mancuso A, Sacco O, Mottola S et al (2023) Synthesis of Fe-doped ZnO by supercritical antisolvent precipitation for the degradation of azo dyes under visible light. Inorg Chim Acta 549:121407. https://doi.org/10.1016/j.ica.2023.121407

Manikanika, Chopra L (2022) Photocatalytic activity of zinc oxide for dye and drug degradation: a review. Mater Today Proc 52:1653–1656. https://doi.org/10.1016/j.matpr.2021.11.283

Martins E, Jerônimo AG, Barbosa R et al (2024) Influence of Al cations insertion on the structural, morphological, optical properties, and methyl orange photocatalytic remotion of Pr-doped ZnO system. Mater Chem Phys 318:129300. https://doi.org/10.1016/j.matchemphys.2024.129300

Matar GH, Andac M (2024) Highly efficient degradation of basic dyes using gold-coated nature-based supermagnetic iron oxide nanoparticles as eco-friendly nanocatalysts. Environ Sci Pollut Res. https://doi.org/10.1007/s11356-024-32775-3

Mohammedi A, Meglali O, Ibrir M et al (2024) Effect of ZnO doping co-carried out by Co–Cu on nonlinear optical properties prepared by the spin coating method. Opt Quantum Electron 56:1–16. https://doi.org/10.1007/s11082-023-05577-z

Mondal S, Jamal M, Ayon SA et al (2024) Synergistic enhancement of photocatalytic and antimicrobial efficacy of nitrogen and erbium co-doped ZnO nanoparticles. J Rare Earths 42:859–868. https://doi.org/10.1016/j.jre.2023.10.002

Montero-Muñoz M, Ramos-Ibarra JE, Rodríguez-Páez JE et al (2018) Role of defects on the enhancement of the photocatalytic response of ZnO nanostructures. Appl Surf Sci 448:646–654. https://doi.org/10.1016/j.apsusc.2018.04.105

Mugunthan E, Saidutta MB, Jagadeeshbabu PE (2019) Photocatalytic activity of ZnO-WO3 for diclofenac degradation under visible light irradiation. J Photochem Photobiol A Chem 383:111993. https://doi.org/10.1016/j.jphotochem.2019.111993

Nadeem MS, Munawar T, Mukhtar F et al (2023) Facile synthesis of PANI and rGO supported Y/Pr co-doped ZnO: boosted solar light-driven photocatalysis. Appl Phys A Mater Sci Process 129. https://doi.org/10.1007/s00339-023-06701-2

Narayanan N, Kannoth DN (2017) Exploring p type conductivity in ZnO thin films by In–N codoping for homo-junction devices. J Mater Sci Mater Electron 28:5962–5970. https://doi.org/10.1007/s10854-016-6270-y

Padmavathy V, Sankar S (2020) Influence of rare earth (La and Y) codoping on optical properties of ZnO: Ag nanograins. Optik (stuttg) 220:165133. https://doi.org/10.1016/j.ijleo.2020.165133

Peña-Garcia R, Guerra Y, Milani R et al (2019) Influence of Ni and Sr on the structural, morphological and optical properties of ZnO synthesized by sol gel. Opt Mater (amst) 98:109427. https://doi.org/10.1016/j.optmat.2019.109427

Peña-Garcia R, Guerra Y, Castro-Lopes S et al (2021) Morphological, magnetic and EPR studies of ZnO nanostructures doped and co-doped with Ni and Sr. Ceram Int 47:28714–28722. https://doi.org/10.1016/j.ceramint.2021.07.030

Punia K, Lal G, Alvi PA et al (2019) A comparative study on the influence of monovalent, divalent and trivalent doping on the structural, optical and photoluminescence properties of Zn0.96T0.04O (T: Li+, Ca2+& Gd3+) nanoparticles. Ceram Int 45:13472–13483. https://doi.org/10.1016/j.ceramint.2019.04.048

Punia K, Lal G, Barbar SK et al (2021a) Oxygen vacancies mediated cooperative magnetism in ZnO nanocrystals: a d0 ferromagnetic case study. Vacuum 184:109921. https://doi.org/10.1016/j.vacuum.2020.109921

Punia K, Lal G, Dalela S et al (2021b) A comprehensive study on the impact of Gd substitution on structural, optical and magnetic properties of ZnO nanocrystals. J Alloys Compd 868:159142. https://doi.org/10.1016/j.jallcom.2021.159142

Rajpurohit NA, Bhakar K, Nemiwal M, Kumar D (2022) Design and synthesis of hybrid nanostructures for sustainable energy and environmental remediation. Arab J Geosci 15. https://doi.org/10.1007/s12517-022-09456-x

Raskar ND, Dake DV, Mane VA et al (2019) One step synthesis of vertically grown Mn-doped ZnO nanorods for photocatalytic application. J Mater Sci Mater Electron 30:10886–10899. https://doi.org/10.1007/s10854-019-01433-7

Rasool M, Baig MM, Kaleem M et al (2024) Photocatalytic and adsorption behavior of a new efficient LaxNiyMn3–(x+y)O4/SiO2 composite for environmental remediation application. Ceram Int 50:4790–4809. https://doi.org/10.1016/j.ceramint.2023.11.223

Rocha M, Araujo FP, Castro-Lopes S et al (2023) Synthesis of Fe–Pr co-doped ZnO nanoparticles: structural, optical and antibacterial properties. Ceram Int 49:2282–2295. https://doi.org/10.1016/j.ceramint.2022.09.196

Rueda-Salaya L, Hernández-Ramírez A, Hinojosa-Reyes L et al (2020) Solar photocatalytic degradation of diclofenac aqueous solution using fluorine doped zinc oxide as catalyst. J Photochem Photobiol A Chem 391:112364. https://doi.org/10.1016/j.jphotochem.2020.112364

Sá AS, Feitosa RP, Honório L et al (2021) A brief photocatalytic study of zno containing cerium towards ibuprofen degradation. Materials (Basel) 14. https://doi.org/10.3390/ma14195891

Schneider JT, Firak DS, Ribeiro RR, Peralta-Zamora P (2020) Use of scavenger agents in heterogeneous photocatalysis: truths, half-truths, and misinterpretations. Phys Chem Chem Phys 22:15723–15733. https://doi.org/10.1039/d0cp02411b

Shanmugaraj K, Campos CH, Mangalaraja RV et al (2023) Gold nanoparticle–decorated earth-abundant clay nanotubes as catalyst for the degradation of phenothiazine dyes and reduction of 4-(4-nitrophenyl)morpholine. Environ Sci Pollut Res 30:124447–124458. https://doi.org/10.1007/s11356-022-19523-1

Silva M, Trigueiro P, Jerônimo A et al (2024) Eco-friendly synthesis of Zn0.97La0.03O compound with natural polysaccharide and its application in methylene blue and eosin dyes discoloration. Mater Lett 363:136256. https://doi.org/10.1016/j.matlet.2024.136256

Silva MCR, Castro-Lopes S, Jerônimo AG et al (2024b) Green synthesis of Er-doped ZnO nanoparticles: an investigation on the methylene blue, eosin, and ibuprofen removal by photodegradation. Molecules 29. https://doi.org/10.3390/molecules29020391

Soares AS, Araujo FP, França R et al (2023) Effect of pH on the growth and ibuprofen photocatalytic response of Zn1 − xCoxO compound synthesized by the co-precipitation method. J Mater Res 38:2439–2452. https://doi.org/10.1557/s43578-023-00980-4

Soares AS, Araujo FP, Osajima JA et al (2024) Nanotubes/nanorods-like structures of La-doped ZnO for degradation of methylene blue and ciprofloxacin. J Photochem Photobiol A Chem 447:115235. https://doi.org/10.1016/j.jphotochem.2023.115235

Soni R, Thakur A, Ghotekar S et al (2024) Sparkling jewels of innovation: revolutionizing environmental solutions with spinel-infused advanced nanomaterials, unveiling today’s insights, and illuminating tomorrow’s frontiers. J Alloys Compd 993:174542. https://doi.org/10.1016/j.jallcom.2024.174542

Sridhar A, Sakthivel P, Saravanakumar K, Sankaranarayanan RK (2023) Dual doping effect of Ag+ & Al3+ on the structural, optical, photocatalytic properties of ZnO nanoparticles. Appl Surf Sci Adv 13:100382. https://doi.org/10.1016/j.apsadv.2023.100382

Tabib A, Bouslama W, Sieber B et al (2017) Structural and optical properties of Na doped ZnO nanocrystals: application to solar photocatalysis. Appl Surf Sci 396:1528–1538. https://doi.org/10.1016/j.apsusc.2016.11.204

Teixeira ARFA, de Meireles NA, Longo E et al (2019) SrSnO3 perovskite obtained by the modified Pechini method—insights about its photocatalytic activity. J Photochem Photobiol A Chem 369:181–188. https://doi.org/10.1016/j.jphotochem.2018.10.028

Umar A, Akbar S, Kumar R et al (2024) Ce-doped ZnO nanostructures: a promising platform for NO2 gas sensing. Chemosphere 349:140838. https://doi.org/10.1016/j.chemosphere.2023.140838

Vitiello G, Iervolino G, Imparato C et al (2021) F-doped ZnO nano- and meso-crystals with enhanced photocatalytic activity in diclofenac degradation. Sci Total Environ 762:143066. https://doi.org/10.1016/j.scitotenv.2020.143066

Waghadkar YB, Umarji G, Kekade SS et al (2024) Synthesis and characterization of indium-doped ZnO nanoparticles by coprecipitation method for highly photo-responsive UV light sensors. Sensors Int 5:100271. https://doi.org/10.1016/j.sintl.2023.100271

Wang H, Li X, Zhao X et al (2022) A review on heterogeneous photocatalysis for environmental remediation: from semiconductors to modification strategies. Chin J Catal 43:178–214. https://doi.org/10.1016/S1872-2067(21)63910-4

Zaid EHA, Sin JC, Lam SM, Mohamed AR (2023) Fabrication of La, Ce co-doped ZnO nanorods for improving photodegradation of methylene blue. J Rare Earths. https://doi.org/10.1016/j.jre.2023.02.001

Zheng ALT, Abdullah CAC, Chung ELT, Andou Y (2023) Recent progress in visible light-doped ZnO photocatalyst for pollution control. Int J Environ Sci Technol 20:5753–5772

Download references

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES); Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), (CNPq N 4/2021—Bolsa de Produtividade em Pesquisa – PQ, 307659/2021–6), (Chamada CNPq/MCTI/FNDCT Nº 18/2021—Faixa A, 407796/2021–5); Financiadora de Estudos e Projetos (FINEP) and Fundação de Amparo à Ciência e Tecnologia de Pernambuco (FACEPE) (APQ-0635–3.03/21-Jovens Pesquisadores).

Author information

Authors and affiliations.

Programa de Pós-Graduação Em Ciências E Engenharia Dos Materiais, Universidade Federal de Piauí, Teresina, PI, Brazil

Emanoel Martins, Débora A. Sales, Bartolomeu C. Viana, Adriano S. Soares & Ramón R. Peña-Garcia

Programa de Pós-Graduação Em Engenharia Física, Universidade Federal Rural de Pernambuco, Unidade Acadêmica Do Cabo de Santo Agostinho, Cabo de Santo Agostinho, PE, Brazil

Pollyana Trigueiro, Aimée G. Jerônimo, Ricardo Barbosa, Luan Neves & Ramón R. Peña-Garcia

Departamento de Engenharia Química, Universidade Federal de Pernambuco, Recife, PE, Brazil

Luciano C. Almeida

You can also search for this author in PubMed   Google Scholar

Contributions

Emanoel Martins, Aimée G. Jerônimo, Ricardo Barbosa, Luan Neves, and Débora A. Sales contributed to conceptualization, data curation, investigation, methodology, visualization, and writing of the original draft. Bartolomeu C. Viana, Pollyana Trigueiro, and Luciano C. Almeida contributed to formal analysis, validation, visualization, writing of original draft, writing review and editing. Adriano S. Soares and R. Peña-Garcia contributed to conceptualization, formal analysis, funding acquisition, investigation, methodology, project administration, resources, supervision, validation, visualization, writing original draft, writing review and editing.

Corresponding author

Correspondence to Ramón R. Peña-Garcia .

Ethics declarations

Ethical approval.

Not applicable.

Consent to participate

Not applicable

Consent for publication

All authors consent to publish.

Competing interests

The authors declare no competing interests.

Additional information

Responsible Editor: Sami Rtimi

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.

Reprints and permissions

About this article

Martins, E., Trigueiro, P., Jerônimo, A.G. et al. Efficient photocatalytic degradation of diclofenac drug using the Zn 1-x-y Pr x Al y O photocatalyst under UV light irradiation. Environ Sci Pollut Res (2024). https://doi.org/10.1007/s11356-024-34768-8

Download citation

Received : 19 March 2024

Accepted : 16 August 2024

Published : 22 August 2024

DOI : https://doi.org/10.1007/s11356-024-34768-8

Share this article

Anyone you share the following link with will be able to read this content:

Sorry, a shareable link is not currently available for this article.

Provided by the Springer Nature SharedIt content-sharing initiative

• Co-precipitation
• UV light irradiation
• Photocatalysis
• Diclofenac drug
• Find a journal
• Publish with us
• Track your research

• Skip to main content
• Skip to FDA Search
• Skip to in this section menu
• Skip to footer links

The .gov means it’s official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

U.S. Food and Drug Administration

•   Search
•   Menu
• Resources | Drugs
• Information for Consumers and Patients | Drugs
• Buying & Using Medicine Safely
• Generic Drugs

FY 2023 GDUFA Science and Research Report

FY 2023 GDUFA Science and Research Report  (PDF - 19 MB)

FDA’s generic drug Science and Research Program created under the Generic Drug User Fee Amendments (GDUFA) is an essential component of FDA’s mission to protect and promote public health. The Science and Research Program is implemented through extensive research collaborations among FDA scientists and through multiple collaborations with research institutions worldwide.

GDUFA-funded research aims to improve the efficiency with which generic drugs can be developed and assessed, and benefits public health in two critical ways:

• making it more feasible for manufacturers to develop generic drugs, which can reduce the risk of drug shortages and facilitates competition; and
• enhancing patient access to treatment by helping make these products more available, allowing patients in the United States to obtain the medicines they need.

Each year, multiple sources of public input help FDA identify specific generic drug science and research priorities that can help expand and accelerate patient access to generic drugs. FDA then advances research in those scientific areas and publishes reports that correspond to these activities and their outcomes. In FY 2023 eight scientific areas were identified as GDUFA Science and Research Priority Initiatives. Accordingly, this FY 2023 GDUFA Science and Research report describes active research projects and outcomes organized into eight chapters corresponding to the eight priority areas with a ninth chapter reporting on additional generic drug  

Table of Contents

(Each link below will open a 19 MB PDF)

• Introduction
• Joint Directors' Message
• Chapter 1: Impurities
• Chapter 2: Complex APIs
• Chapter 3: Complex Dosage Forms & Formulations
• Chapter 4: Complex Routes of Delivery
• Chapter 5: Drug-Device Combination Products
• Chapter 6: Oral and Parenteral Products
• Chapter 7: Quantitative Methods & Models
• Chapter 8: Data Analytics & Artificial Intelligence
• Chapter 9: Other Generic Product Science & Research
• Acknowledgments

Joint Directors’ Message 

The GDUFA science and research program facilitates patient access to high-quality, safe, and effective generic drugs. It does this by advancing research in areas where generic product development has been limited due to scientific knowledge gaps. For example, an insufficient scientific understanding can create uncertainty about how to develop a complex generic product, or how to demonstrate that it is bioequivalent to its brand name reference listed drug product. Each fiscal year, experts across the generic drug industry collaborate with FDA to establish research priorities for the most pressing scientific challenges they face with generic product development. Scientists and clinicians from industry, academia, and the FDA then strategically design research projects and studies so that the research outcomes enable FDA to build scientific bridges across the knowledge gaps. The outcomes of this research help FDA establish efficient new approaches for pharmaceutical manufacturers to develop generic drugs that were previously challenging or unfeasible to develop, thus making these generic medicines available for patients.

Read the full FY 2023 GDUFA Science and Research Report  Joint Directors' Message .