"It didn't hurt me": patients' and providers' perspectives on unsupervised take-home doses, drug diversion, and overdose risks in the provision of medication for opioid use disorder during COVID-19 in San Juan, Puerto Rico.

BACKGROUND: During the COVID-19 pandemic, clinics offering medication for opioid use disorder (MOUD) needed to rapidly introduce unsupervised take-home dosing, while relapsing patients and patients unable to enter treatment faced increased risks of fentanyl-related overdose deaths and other drug-related harms. Based on a qualitative study of people who inject drugs (PWID) receiving MOUD treatment and MOUD staff in Puerto Rico, this paper documents the lived experiences of patients and providers during this period and the risk perceptions and management strategies to address substance misuse and drug diversion attributable to unsupervised take-home-dose delivery. METHODS: In-depth qualitative interviews were conducted with patients (N = 25) and staff (N = 25) in two clinics providing MOUD in San Juan, Puerto Rico, during 2022. Patients and staff were receiving or providing treatment during the pandemic, and patients reported injection drug use during the past thirty days. RESULTS: Patients were overwhelmingly male (84%), unmarried (72%), and unemployed (52%), with almost half (44%) injecting one to three times a day. Mean time in treatment was 7 years. Staff had a mean age of 46 years with more than half of the sample (63%) female. The majority of patients believed that unsupervised take-home dosing had no significant effect on their treatment adherence or engagement. In contrast, providers expressed concerns over the potential for drug diversion and possible increased risks of patient attrition, overdose episodes, and poor treatment outcomes. CONCLUSION: This study underscores the importance of insider perspectives on harm-reduction changes in policy implemented during a health crisis. Of note is the finding that staff disagreed among themselves regarding the potential harms of diversion and changes in drug testing protocols. These different perspectives are important to address so that future pandemic policies are successfully designed and implemented. Our study also illuminates disagreement in risk assessments between patients and providers. This suggests that preparation for emergency treatment plans requires enhanced communication with patients to match treatments to the context of lived experience.

Prescription Opioid Diversion Sources Among African Americans: Implications for Overdose Prevention.

Recent data show that African Americans (AAs) experienced a greater increase in overdose deaths involving prescription opioids relative to other racial/ethnic groups. One possible mechanism through which elevated risk for overdose is conferred to AAs could be due to greater exposure to contaminated counterfeit pills. Unfortunately, prescription opioid diversion is understudied among AAs and less is known regarding which sources AAs use to access pharmaceutical opioids. The objective of this study, therefore, was to identify and describe the most commonly used diversion sources for prescription opioids among AAs. Qualitative interview data are also presented to contextualize the most prevalent sources. This study used data from the Florida Minority Health Study, a mixed-methods project that included online surveys (n = 303) and qualitative in-depth interviews (n = 30) of AAs. Data collection was conducted from August 2021 to February 2022 throughout Southwest Florida. Analyses revealed that the most widely used sources for prescription opioids were dealers (33.0%) and friends/relatives (34.7%). Additionally, interview data indicated that dealers are the access point where larger volume acquisitions are made and high potency formulations are accessed. These findings suggest that AAs may utilize nonhealthcare related sources at higher rates than healthcare related sources to acquire prescription opioids. This is concerning because opioid pills acquired through nonhealthcare related sources are especially susceptible to fentanyl adulteration. These findings invite further study using nationally representative data to determine if AAs disproportionately use nonhealthcare related sources compared to persons from other racial/ethnic groups.

Preventing controlled substance diversion in perioperative settings: a narrative review.

PURPOSE: Diversion of controlled substances in the perioperative setting is an ongoing challenge, with consequences for patients, anesthesiologists, perioperative staff, and health care facilities alike. Perioperative environments are at high risk for diversion, since controlled substances are frequently handled in these settings, with varying levels of oversight. In this narrative review, we summarize strategies for preventing diversion of controlled substances in perioperative settings (i.e., operating rooms, endoscopy suites, and postanesthesia recovery units). SOURCE: We performed a targeted literature search in PubMed MEDLINE, Embase, Scopus, Web of Science, the Cochrane Register of Controlled trials, and the Cochrane Database of Systematic Reviews, as well as a manual search for additional references. We used terminology related to drug diversion, drug abuse, anesthesiologists, pharmacists, physicians, operating room personnel, and controlled substances. PRINCIPAL FINDINGS: Many strategies have been described for preventing diversion in perioperative settings, and these are broadly categorized into: education, distribution, auditing, or provider screening. Some of these approaches may be time- and resource-intensive. There is limited evidence to inform anesthesia departments' choice of which strategies to adopt. CONCLUSION: Although awareness of perioperative controlled substance diversion has been improving, there are too few data to suggest an optimal approach. Anesthesia departments will need to work collaboratively with hospital pharmacies and actively select strategies that are reasonable given local resources.

RéSUMé: OBJECTIF: Le détournement des substances contrôlées en milieu périopératoire constitue un défi permanent qui a des conséquences pour la patientèle, les anesthésiologistes, le personnel périopératoire et les établissements de soins de santé. Les environnements périopératoires courent un risque élevé de détournement, car les substances contrôlées sont fréquemment manipulées dans ces milieux, avec divers niveaux de surveillance. Dans ce compte rendu narratif, nous résumons les stratégies de prévention du détournement des substances contrôlées dans les milieux périopératoires (c.-à-d. salles d'opération, salles d'endoscopie et salles de réveil). SOURCES: Nous avons réalisé une recherche documentaire ciblée dans les bases de données PubMed, MEDLINE, Embase, Scopus, Web of Science, le registre Cochrane des essais contrôlés et la base de données Cochrane des revues systématiques, ainsi qu'une recherche manuelle de références supplémentaires. Nous avons utilisé une terminologie liée au détournement de médicaments, à l'abus de substances, aux anesthésiologistes, aux pharmacien·nes, aux médecins, au personnel de salle d'opération et aux substances contrôlées. CONSTATATIONS PRINCIPALES: De nombreuses stratégies ont été décrites pour prévenir le détournement dans les milieux périopératoires, et celles-ci sont généralement classées en éducation, distribution, audit ou dépistage des fournisseurs et fournisseuses de soin. Certaines de ces approches peuvent exiger beaucoup de temps et de ressources. Il existe peu de données probantes pour éclairer le choix des départements d'anesthésie quant aux stratégies à adopter. CONCLUSION: Bien que la sensibilisation au détournement périopératoire de substances contrôlées se soit améliorée, il y a trop peu de données pour suggérer une approche optimale. Les départements d'anesthésie devront travailler en collaboration avec les pharmacies hospitalières et choisir activement des stratégies raisonnables qui tiennent compte des ressources locales.

Primary prevention of prescription opioid diversion: a systematic review of medication disposal interventions.

Background: In the U.S., 50-75% of nonmedical users of prescription opioids obtain their pills through diversion by friends or relatives. Increasing disposal of unused opioid prescriptions is a fundamental primary prevention strategy in combatting the opioid epidemic.Objectives: To identify interventions for disposal of unused opioid pills and assess the evidence of their effectiveness on disposal-related outcomes.Methods: A search of four electronic databases was conducted (October 2019). We included all empirical studies, systematic literature reviews, and meta-analyses about study medication disposal interventions in the U.S. Studies of disposal interventions that did not include opioids were excluded. We abstracted data for the selected articles to describe the study design, and outcomes. Further, we assessed the quality of each study using the NIH Study Quality Assessment Tools.Results: We identified 25 articles that met our inclusion criteria. None of the 13 studies on drug take-back events or the two studies on donation boxes could draw conclusions about their effectiveness. Although studies on educational interventions found positive effects on knowledge acquisition, they did not find differences in disposal rates. Two randomized controlled trials on drug disposal bags found higher opioid disposal rates in their intervention arms compared to the control arms (57.1% vs 28.6% and 33.3%, p = .01; and 85.7% vs 64.9%, p = .03).Conclusions: Peer-reviewed publications on opioid disposal interventions are limited and either do not address effectiveness or have conflicting findings. Future research should address these limitations and further evaluate implementation and cost-effectiveness.

Buyback Program of Unused Prescription Opioids in US Rural Communities, 2017-2018.

Objective. To implement an opioid buyback program after ambulatory surgery.Methods. We performed a prospective cohort study of 578 opioid-naïve patients prescribed opioids after ambulatory surgery at a rural US Veterans Affairs (VA) hospital from 2017 to 2018. We reimbursed $5 per unused opioid pill ($50 limit) returned to our VA for proper disposal. We tracked the number of participants, number of unused opioid pills returned, surgeon prescribing, and refill requests.Results. Out of 578 eligible patients, 171 (29.6%) returned 2136.5 unused opioid pills. Information shared with surgeons after 6 months led to a 27% decrease in opioid prescribing without an increase in refills.Conclusions. With this opioid buyback program, rural patients had a safe and convenient place to dispose of unused opioids. Surgeons used information about returns to adjust opioid prescribing after common ambulatory surgeries without an increase in refill requests.Public Health Implications. Although providers prescribe within state opioid guidelines, there will be variations in patient use after ambulatory surgery. An opioid buyback program helped our patients and surgeons decrease unused prescription opioids available for diversion in our rural communities.

Long-term medical cannabis use and risk factors for diversion: Report on physician's guidance and patients' behaviour.

OBJECTIVES: Various jurisdictions have legalized cannabis for medical purposes. As with all psychoactive medications, medical cannabis carries a risk of diversion and accidental ingestion. These risks may be particularly high among long-term medical cannabis patients as safety practices may become less salient to patients once the treatment becomes part of everyday life. The current study examines whether patients who have used medical cannabis for longer periods differ from those who have used for shorter periods in terms of sociodemographic background and other key aspects of medical cannabis use. Furthermore, the study examines the relationship between length of medical cannabis treatment and risk factors related to storage and diversion. Finally, the study examines the extent to which oncologists provide information to their patients about safe storage and disposal. METHODS: One hundred twenty-one medical cannabis oncology patients were interviewed face-to-face and 55 oncologists participated in a survey about safe storage and disposal practices related to medical cannabis. RESULTS: Length of medical cannabis treatment was related to administration by smoking and using higher monthly dosages. In terms of risk for unsafe storage and diversion, length of medical cannabis was positively associated with using cannabis outside the home and having been asked to give away medical cannabis. Physicians did not report providing information to patients regarding safe storage and disposal practices in a regular manner. SIGNIFICANCE OF RESULTS: Results suggest that there is an ongoing risk of unsafe storage and diversion over the course of medical cannabis treatment. Oncologists may need to give more consistent and continued training in safe storage and disposal practices, especially among long-term medical cannabis patients.

An Automated Software Application Reduces Controlled Substance Discrepancies in Perioperative Areas.

BACKGROUND: Perioperative controlled substance diversion and tracking have received increased regulatory focus throughout the United States. The authors' institution developed and implemented an automated web-based software application for perioperative controlled substance management. The authors hypothesized that implementation of such a system reduces errors as measured by missing controlled substance medications, missing controlled substance kits (a package of multiple controlled substance medications), and missing witness signatures during kit return. METHODS: From December 1, 2014 to March 31, 2017, the authors obtained missing controlled substance medication, controlled substance kit, and witness return signature data during the preimplementation, implementation, and study period of the controlled substance management application at a single university hospital. This before and after study was based on a QI project at the authors' institution. The authors included all cases requiring anesthesia services. The primary outcome of this study was the rate of missing controlled substance medications. Secondary outcomes included rates for kits not returned to pharmacy and missing kit return witness signatures. RESULTS: There were 54,302 cases during the preimplementation period, 57,670 cases during the implementation period, and 65,911 cases during the study period. The number of missing controlled substance medication (difference 0.7 per 1,000 cases; 95% CI, 0.38-1.02; P < 0.001) and kit return errors (difference 0.45 per 1,000 cases; 95% CI, 0.24-0.66, P < 0.001) declined after implementation of the application. There was no difference in the number of missing witness return signatures (difference 0.09 per 1,000 cases; 95% CI, -0.08 to 0.26, P = 0.350). A user survey with 206 of 485 (42%) response rate demonstrated that providers believed the new application managed controlled substances better than the previous system. CONCLUSIONS: A software application that tracks perioperative controlled substance kits with deep integration into the electronic health record and pharmacy systems is associated with a decrease in management errors.

The diversion of nonscheduled psychoactive prescription medications in the United States, 2002 to 2017.

PURPOSE: Systematic studies of the diversion of nonscheduled drugs, except for gabapentin, are not apparent. We searched diversion case reports of all other nonscheduled psychoactive prescription drugs in the Researched Abuse, Diversion, and Addiction-Related Surveillance (RADARS) System. METHODS: Case report data are drawn from a quarterly survey of prescription drug diversion completed by a national sample of law enforcement and regulatory agencies. Rates of diversion per 100 000 population were calculated for each year from 2002 to 2017 for prescription medications with greater than 400 reported cases during the period. RESULTS: Cyclobenzaprine, quetiapine, and trazodone met criteria for analysis. We found a significant and steady increase in the diversion of each drug over the period. The 2017 annual rates of diversion per 100 000 population for the three medications range from 0.0428 to 0.0726. Although these rates of diversion are much lower than the rate for total opioid analgesics, they are all more than five times higher in 2017 compared with 2002. While diversion rates for opioids have decreased in recent years, rates for cyclobenzaprine, quetiapine, and trazodone have continued to increase. CONCLUSIONS: A common attribute of the three nonscheduled drugs studied here is that all are used for the treatment and/or self-treatment of opioid withdrawal symptoms, and the increasing diversion of these drugs may be related to the ongoing opioid epidemic and to increasing levels of control over pharmaceutical opioid availability in the United States. Prescribers need to be aware of illicit markets for these medications and prescribe to their patients with appropriate caution.

Detecting the diverted use of psychoactive drugs by adolescents and young adults: A pilot study.

PURPOSE: The increasing trend of diversion of nonprescription drugs (NPDs) by adolescents or young adults is worrying. We implemented this pilot study before a national investigation to identify requests for suspected recreational use of psychoactive drugs made by young subjects to community pharmacies. METHODS: Thirty-eight French community pharmacies were asked to complete questionnaire (with age, gender of subjects; name, form, quantity of drugs) for each suspect request formulated by subjects under 26. Besides, pharmacists were asked about the regulatory measures they thought useful to decrease this diverted use by young people. Nineteen pharmacies participated. The study covered from December 12, 2016 to January 23, 2017. RESULTS: Forty-one requests mentioning 51 drugs were reported. They concerned males (85%) aged 20 years old on average, including 6 minors. The most frequent age class was that comprised between 18 and 20 years old. Codeine-containing drugs (29 reports) and promethazine (17 reports), the main components of the popular cocktail "Purple drank," were the most requested, followed by dextromethorphan (3 reports). Fifteen drugs were requested in syrup form. One request concerned the prescription drug ketamine. Pharmacists suggested to schedule the concerned NPDs to prescription-only drugs and to increase the education of students as well as the public. CONCLUSIONS: Codeine and promethazine, the main components of the popular cocktail Purple drank, were the most requested. Suspect requests of psychoactive drugs made by adolescents or young adults in community pharmacies should be carefully surveyed and combined to the monitoring of falsified prescriptions.

America's Opioid Epidemic: Supply and Demand Considerations.

America is in the midst of an opioid epidemic characterized by aggressive prescribing practices, highly prevalent opioid misuse, and rising rates of prescription and illicit opioid overdose-related deaths. Medical and lay public sentiment have become more cautious with respect to prescription opioid use in the past few years, but a comprehensive strategy to reduce our reliance on prescription opioids is lacking. Addressing this epidemic through reductions in unnecessary access to these drugs while implementing measures to reduce demand will be important components of any comprehensive solution. Key supply-side measures include avoiding overprescribing, reducing diversion, and discouraging misuse through changes in drug formulations. Important demand-side measures center around educating patients and clinicians regarding the pitfalls of opioid overuse and methods to avoid unnecessary exposure to these drugs. Anesthesiologists, by virtue of their expertise in the use of these drugs and their position in guiding opioid use around the time of surgery, have important roles to play in reducing patient exposure to opioids and providing education about appropriate use. Aside from the many immediate steps that can be taken, clinical and basic research directed at understanding the interaction between pain and opioid misuse is critical to identifying the optimal use of these powerful pain relievers in clinical practice.

Correctional psychopharmacology: pitfalls, challenges, and victories of prescribing in a correctional setting.

Mentally ill patients are entering the criminal justice system at alarming rates, representing a significant percentage of those incarcerated. Correctional facilities are mandated to provide mental health treatment to inmates. The increasing number of inmate patients has made psychiatry an important part of institutional operations. Psychiatrists are called to provide psychopharmacological interventions to aid in the safe operation of institutions and provide effective treatment to those with mental illness. This article discusses the uniqueness of prescribing within correctional settings and delineates important aspects of correctional psychiatry. It includes information on navigating the rigid structure of correctional environments, providing effective interventions for behaviourally disruptive and manipulative inmates, prescribing within the limits of formulary restrictions, considerations for dispensing medication, preventing medication diversion, involuntarily medication practices, and treatment of aggressive inmates. The article concludes with case illustrations that depict the pitfalls, challenges, and victories of working with inmate patients.

Schedules of Controlled Substances: Extension of Temporary Placement of THJ-2201, AB-PINACA and AB-CHMINACA in Schedule I of the Controlled Substances Act. Temporary order.

The Administrator of the Drug Enforcement Administration is issuing this temporary order to extend the temporary schedule I status of three synthetic cannabinoids pursuant to the temporary scheduling provisions of the Controlled Substances Act. The substances are: [1-(5-Fluoropentyl)-1H-indazol-3-yl](naphthalen-1-yl)methanone (THJ-2201); N-1-Amino-3-methyl-1-oxo-2-butanyl]-1-pentyl-1H-indazole-3-carboxamide (AB-PINACA); N-[1-Amino-3-methyl-1-oxo-2-butanyl]-1-(cyclohexylmethyl)-1H-indazole-3-carboxamide (AB-CHMINACA), including their optical, positional and geometric isomers, salts, and salts of isomers. The current final order temporarily placing THJ-2201, AB-PINACA and AB-CHMINACA into schedule I is in effect through January 29, 2017. This order will extend the temporary scheduling of THJ-2201, AB-PINACA and AB-CHMINACA for one year, or until the permanent scheduling action for these three substances is completed, whichever occurs first.

Impact of the Hydrocodone Schedule Change on Opioid Prescription Patterns in South Dakota.

INTRODUCTION: Prescription opioid use is becoming increasingly common; consequently, opioid overdose deaths are increasing at an alarming rate. Hydrocodone, one of the most commonly abused opioids, was changed from a schedule III controlled substance to the more stringent schedule II to decrease abuse and diversion, effective Oct. 6, 2014. The objective of this study was to examine the impact of the hydrocodone schedule change on opioid prescribing in South Dakota. METHODS: Opioid prescription patterns were examined in the following six-month phases: the baseline phase before the change, the transition phase when existing hydrocodone prescriptions could still be refilled, and the final phase. The South Dakota Board of Pharmacy Prescription Drug Monitoring Program provided aggregate monthly data for South Dakota opioid prescriptions (i.e., total number of prescriptions and days supplied), including urban and rural stratification. T-tests were performed on the monthly values for each phase to determine the significance of differences in prescription features between phases. RESULTS: The number of hydrocodone prescriptions significantly decreased 14 percent from baseline to final phase, while the days supplied per prescription significantly increased 7.4 percent. These changes were greater in rural areas than in urban areas. Conversely, the number of other opioid prescriptions significantly increased by 6.5 percent over this timeframe. CONCLUSIONS: The number of hydrocodone prescriptions decreased, while the days supplied per prescription increased. These changes were greater in rural areas than in urban areas. In addition, the number of other opioid prescriptions increased. These trends may reflect some unintended effects of the schedule change.

Opioid Overdose Deaths and Florida's Crackdown on Pill Mills.

OBJECTIVES: We examined the effect on opioid overdose mortality of Florida state laws and law enforcement operations targeting "pill mills." METHODS: We collected 2003 to 2012 mortality data from the Florida Department of Health and the North Carolina State Center for Health Statistics (the comparison state) to estimate changes in the rates of death from prescription opioid, heroin, or any opioid overdose. RESULTS: Florida's actions were associated with an estimated 1029 lives saved from prescription opioid overdose over a 34-month period. Estimated reductions in deaths grew over the intervention period, with rates per 100,000 population that were 0.6 lower in 2010, 1.8 lower in 2011, and 3.0 lower in 2012 than what would have been expected had the changes in mortality rate trends in Florida been the same as changes in trends in North Carolina. Florida's mortality rates from heroin and total opioid overdose were also lower than anticipated relative to changes in trends in North Carolina. CONCLUSIONS: Findings from this study indicate that laws regulating pain clinics and enforcement of these laws may, in combination, reduce opioid overdose deaths.

Addressing misuse and diversion of opioid substitution medication: guidance based on systematic evidence review and real-world experience.

BACKGROUND: Opioid dependence treatment, comprising opioid substitution treatment (OST) and psychosocial intervention, is accepted to improve outcomes in opioid addiction for both the individual and public health. OST medication such as methadone or buprenorphine may be misused or diverted. This results in failure to recover from addiction, increased crime and the spread of blood-borne viruses. Worldwide, attempts to address misuse and diversion have been proposed and implemented with varying impact. METHODS: A structured, expert-led process recommended the most impact. As an initial step, a broad range of strategies were defined, and a systematic review of published literature identified 37 highly relevant sources of evidence. Experts reviewed this evidence and ranked the list of strategies for effectiveness and ease of implementation, based on their clinical experience. RESULTS/CONCLUSIONS: Three groups of strategies to address misuse or diversion are defined, depending on impact (effectiveness and ease of implementation). Preferred strategies include the promotion of access to treatment and the use of product formulations less likely to be misused. However, additional data and innovative approaches to address this complex problem are needed.

Dental opioid prescribing practices and risk mitigation strategy implementation: Identification of potential targets for provider-level intervention.

BACKGROUND: Given the regular use of immediate-release opioids for dental pain management, as well as documented opioid misuse among dental patients, the dental visit may provide a viable point of intervention to screen, identify, and educate patients regarding the risks associated with prescription opioid misuse and diversion. The aims of this statewide survey of dental practitioners were to assess (a) awareness of the scope of prescription opioid misuse and diversion; (b) current opioid prescribing practices; (c) use of and opinions regarding risk mitigation strategies; and (d) use and perceived utility of drug monitoring programs. METHODS: This cross-sectional study surveyed dentists (N = 87) participating in statewide professional and alumni organizations. Dentists were invited via e-mail and listserv announcement to participate in a one-time, online, 59-item, self-administered survey. RESULTS: A majority of respondents reported prescribing opioids (n = 66; 75.8%). A minority of respondents (n = 38; 44%) reported regularly screening for current prescription drug abuse. Dentists reported low rates of requesting prior medical records (n = 5; 5.8%). Only 38% (n = 33) of respondents had ever accessed a prescription drug monitoring program (PDMP), and only 4 (4.7%) consistently used a PDMP. Dentists reporting prior training in drug diversion were significantly more likely to have accessed their PDMP, P < .01. Interest in continuing education regarding assessment of prescription drug abuse/diversion and use of drug monitoring programs was high. CONCLUSIONS: Although most dentists received training related to prescribing opioids, findings identified a gap in existing dental training in the assessment/identification of prescription opioid misuse and diversion. Findings also identified gaps in the implementation of recommended risk mitigation strategies, including screening for prescription drug abuse, consistent provision of patient education, and use of a PDMP prior to prescribing opioids.

Medication Assisted Treatment for Opioid Use Disorders Reporting Requirements. Final rule.

This final rule outlines annual reporting requirements for practitioners who are authorized to treat up to 275 patients with covered medications in an office-based setting. This final rule will require practitioners to provide information on their annual caseload of patients by month, the number of patients provided behavioral health services and referred to behavioral health services, and the features of the practitioner's diversion control plan. These reporting requirements will help the Department of Health and Human Services (HHS) ensure compliance with the requirements of the final rule, "Medication Assisted Treatment for Opioid Use Disorders," published in the Federal Register on July 8, 2016.

Revision of Import and Export Requirements for Controlled Substances, Listed Chemicals, and Tableting and Encapsulating Machines, Including Changes To Implement the International Trade Data System (ITDS); Revision of Reporting Requirements for Domestic Transactions in Listed Chemicals and Tableting and Encapsulating Machines; and Technical Amendments. Final rule.

The Drug Enforcement Administration is updating its regulations for the import and export of tableting and encapsulating machines, controlled substances, and listed chemicals, and its regulations relating to reports required for domestic transactions in listed chemicals, gamma-hydroxybutyric acid, and tableting and encapsulating machines. In accordance with Executive Order 13563, the Drug Enforcement Administration has reviewed its import and export regulations and reporting requirements for domestic transactions in listed chemicals (and gamma-hydroxybutyric acid) and tableting and encapsulating machines, and evaluated them for clarity, consistency, continued accuracy, and effectiveness. The amendments clarify certain policies and reflect current procedures and technological advancements. The amendments also allow for the implementation, as applicable to tableting and encapsulating machines, controlled substances, and listed chemicals, of the President's Executive Order 13659 on streamlining the export/import process and requiring the government-wide utilization of the International Trade Data System (ITDS). This rule additionally contains amendments that implement recent changes to the Controlled Substances Import and Export Act (CSIEA) for reexportation of controlled substances among members of the European Economic Area made by the Improving Regulatory Transparency for New Medical Therapies Act. The rule also includes additional substantive and technical and stylistic amendments.

The role of security in the prevention, detection and response to drug diversion by healthcare personnel.

Drug diversion by healthcare personnel poses substantial and growing risks to patients, staff, healthcare institutions and the community, the author reports. It is essential that clinical, pharmacy, and security personnel work together on diversion-related issues to reduce those risks, she says. In this article she spells out the critical roles of security personnel in the investigation of suspected diversion and the response to confirmed diversion.

Recognizing Potential Buprenorphine Medication Misuse: Product Packaging Does Not Degrade With Laundering.

BACKGROUND: Expanded office-based buprenorphine opioid dependence treatment is associated with medication misuse and diversion consequences. Recurrent early refill requests may indicate misuse or diversion, although further research is needed on how to effectively recognize and address the issue in clinical practice. In the current study, patient report of damaged medication from laundering prompted evaluation of laundering on degradation of buprenorphine-containing product packages and contents. METHODS: Four buprenorphine product packaging approaches were assessed: 3 buprenorphine/naloxone placebo demonstration products (Suboxone and Bunavail film in foil wrappers and Zubsolv tablet in a blister pack) and Rexam-manufactured Screw-Loc closure pill container filled with a chewable aspirin as a surrogate for generic buprenorphine and buprenorphine/naloxone products. Two experimental laundering conditions, wash machine alone (W) and washer/dryer (W+D), were compared with unlaundered control (C) condition. Standard laundering settings were based on patient presentation. Products from the 2 experimental conditions and the control condition were labeled A, B, or C with counterbalanced assignment prior to visual examination of packaging and contents by the investigator who was blinded to condition. RESULTS: Packaging and contents remained intact for all products across experimental conditions, with only minor cosmetic effects compared with control. The W+D Suboxone film had 1-2 mm curling of the wrapper corners. Zubsolv blister packs had slight paper label fading (W+D > W). Bunavail W+D foil had an indentation outlining the inner film. The W+D bottle tablet had a ˜1 mm nick on one edge. No other differences were noted. After implementing more structured treatment and reviewing the results with the patient, he endorsed fabricating the laundering story to get additional medication. CONCLUSIONS: Laundering is an unlikely cause of damaged buprenorphine-containing medication packaged in foil wrappers (Suboxone, Bunavail), blister pack (Zubsolv), or prescription pill bottle (generic buprenorphine or buprenorphine/naloxone products). Patient reports of such may indicate medication misuse or diversion.