buprenorphine--naloxone-drug-combination and Substance-Related-Disorders

The effects of steady-state faldaprevir on the safety, pharmacokinetics, and pharmacodynamics of steady-state methadone and buprenorphine-naloxone were assessed in 34 healthy male and female subjects receiving stable addiction management therapy. Subjects continued receiving a stable oral dose of either methadone (up to a maximum dose of 180 mg per day) or buprenorphine-naloxone (up to a maximum dose of 24 mg-6 mg per day) and also received oral faldaprevir (240 mg) once daily (QD) for 8 days following a 480-mg loading dose. Serial blood samples were taken for pharmacokinetic analysis. The pharmacodynamics of the opioid maintenance regimens were evaluated by the objective and subjective opioid withdrawal scales. Coadministration of faldaprevir with methadone or buprenorphine-naloxone resulted in geometric mean ratios for the steady-state area under the concentration-time curve from 0 to 24 h (AUC(0-24,ss)), the steady-state maximum concentration of the drug in plasma (C(max,ss)), and the steady-state concentration of the drug in plasma at 24 h (C(24,ss)) of 0.92 to 1.18 for (R)-methadone, (S)-methadone, buprenorphine, norbuprenorphine, and naloxone, with 90% confidence intervals including, or very close to including, 1.00 (no effect), suggesting a limited overall effect of faldaprevir. Although individual data showed moderate variability in the exposures between subjects and treatments, there was no evidence of symptoms of opiate overdose or withdrawal either during the coadministration of faldaprevir with methadone or buprenorphine-naloxone or after faldaprevir dosing was stopped. Similar faldaprevir exposures were observed in the methadone- and buprenorphine-naloxone-treated subjects. In conclusion, faldaprevir at 240 mg QD can be coadministered with methadone or buprenorphine-naloxone without dose adjustment, although given the relatively narrow therapeutic windows of these agents, monitoring for opiate overdose and withdrawal may still be appropriate. (This study has been registered at ClinicalTrials.gov under registration no. NCT01637922.).

Topics: Administration, Oral; Adult; Aminoisobutyric Acids; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Drug Interactions; Female; Humans; Leucine; Male; Methadone; Middle Aged; Oligopeptides; Proline; Quinolines; Substance Withdrawal Syndrome; Substance-Related Disorders; Thiazoles; Young Adult

As the baby boomers age, the number of older adults with comorbid substance use and mental disorders is projected to grow. Little research has examined the potential impact of substance use on older adults' mental health treatment use and unmet treatment need. This study examined these associations among the rapidly growing population of baby boomers and their older counterparts.. Data are from the 2008 to 2012 National Survey on Drug Use and Health (NSDUH) (N = 18,443 respondents aged 50-64 and 11,191 aged 65 +). Age-combined and age-stratified logistic regression analyses were used to examine relationships between alcohol, illicit drug, and tobacco use and mental health problems, treatment use, and perceived unmet treatment need, with sociodemographic characteristics and health status as covariates.. Heavy alcohol, illicit drug, and tobacco use increased the odds of having a mental health problem in both age groups. Compared to those who used alcohol on 1-99 days during the preceding year, lifetime abstainers had significantly lower odds of having received mental health treatment in both age groups. Poorer self-rated health and past-year mental health treatment use increased the odds of perceived unmet treatment need in both age groups, while lifetime abstention in the boomers decreased the odds.. This study's key finding is the lower likelihood of mental health treatment use among lifetime abstainers in both age groups. Further research may identify barriers to treatment use and ways to promote use among both age groups.

Topics: Adolescent; Adult; Age Factors; Alcoholism; Buprenorphine, Naloxone Drug Combination; Comorbidity; Female; Health Services Needs and Demand; Humans; Male; Mental Health Services; Middle Aged; Narcotics; Opioid-Related Disorders; Patient Satisfaction; Population Growth; Prescription Drug Misuse; Quality of Life; Substance-Related Disorders; United States; Utilization Review; Young Adult

HIV-infected prisoners fare poorly after release. Though rarely available, opioid agonist therapy (OAT) may be one way to improve HIV and substance abuse treatment outcomes after release. Of the 69 HIV-infected prisoners enrolled in a randomized controlled trial of directly administered antiretroviral therapy, 48 (70%) met DSM-IV criteria for opioid dependence. Of these, 30 (62.5%) selected OAT, either as methadone (N = 7, 14.5%) or buprenorphine/naloxone (BPN/NLX; N = 23, 48.0%). Twelve-week HIV and substance abuse treatment outcomes are reported as a sub-study for those selecting BPN/NLX. Retention was high: 21 (91%) completed BPN/NLX induction and 17 (74%) remained on BPN/NLX after 12 weeks. Compared with baseline, the proportion with a non-detectable viral load (61% vs 63% log(10) copies/mL) and mean CD4 count (367 vs 344 cells/mL) was unchanged at 12 weeks. Opiate-negative urine testing remained 83% for the 21 who completed induction. Using means from 10-point Likert scales, opioid craving was reduced from 6.0 to 1.8 within 3 days of BPN/NLX induction and satisfaction remained high at 9.5 throughout the 12 weeks. Adverse events were few and mild. BPN/NLX therapy was acceptable, safe and effective for both HIV and opioid treatment outcomes among released HIV-infected prisoners. Future randomized controlled trials are needed to affirm its benefit in this highly vulnerable population.

Topics: Anti-Retroviral Agents; Buprenorphine; Buprenorphine, Naloxone Drug Combination; CD4 Lymphocyte Count; Female; HIV Infections; Humans; Male; Mental Disorders; Methadone; Middle Aged; Naloxone; Narcotic Antagonists; Narcotics; Prisoners; Substance-Related Disorders

Despite increased public awareness and use of opioid agonist therapy (OAT), there is little published data on contraception among women on methadone or buprenorphine/naloxone. This study aimed to characterize patterns of contraception use among this population.. We conducted a cross-sectional survey between May 2014 and October 2015 at 6 medical clinics, pharmacies, and community organizations in British Columbia. Trained surveyors used the Canadian Sexual Health Survey (CSHS) to collect information on contraceptive practices and barriers to health care access. Descriptive analysis was performed on the subset of women on OAT who were at risk for unintended pregnancy.. Of the 133 survey respondents, 80 (60.2%) were at risk for unintended pregnancy. Among the 46 respondents with a recent pregnancy, 44 (95.7%) reported it as unintended. Of those at risk for unintended pregnancy, the most common contraceptive methods used were "no method," male condom, and depo-medroxyprogesterone at 28.8%, 16.3%, and 12.5%, respectively. Only 5% reported dual protection with a barrier and hormonal or intrauterine method. Barriers to contraception access included difficulty booking appointments with providers and cost, although 97% of all respondents reported feeling comfortable speaking with a physician about contraception.. We found that most respondents using OAT reported prior pregnancies that were unintended, and used less effective contraceptive methods. Health care professionals who provide addiction care are uniquely positioned to address their patients' concerns about contraception. Incorporating family planning discussions into OAT services may improve understanding and use of effective contraceptive methods. Addressing unmet contraceptive needs may enable women on OAT to achieve their reproductive goals.

Topics: Adult; British Columbia; Buprenorphine, Naloxone Drug Combination; Contraception; Contraception Behavior; Cross-Sectional Studies; Family Planning Services; Female; Health Services Accessibility; Humans; Male; Methadone; Middle Aged; Opiate Substitution Treatment; Opioid-Related Disorders; Pregnancy; Pregnancy, Unplanned; Substance-Related Disorders

Topics: Adult; Antidepressive Agents; Buprenorphine, Naloxone Drug Combination; Female; Humans; Male; Physicians; Practice Guidelines as Topic; Sertraline; Substance-Related Disorders; United States

Topics: Buprenorphine, Naloxone Drug Combination; Codeine; Drug Misuse; Female; Humans; Ireland; Male; Pain Management; Pregnancy; Self Medication; Substance-Related Disorders

With a rise in overdoses and medical emergencies related to opioids, buprenorphine-naloxone (bup-nx) is seen as a preferred treatment for opioid dependence. However, the research examining experiences with bup-nx among polysubstance users who may or may not be opioid dependent has been limited.. The purpose of the study was to examine use, characteristics of users, and experiences of bup-nx use among polysubstance users entering drug-free recovery programs.. This study examined secondary data on 896 opioid or opiate user individuals (53.4% male) collected by drug-free, self-help-based residential recovery centers during intake.. One-quarter of users said bup-nx helped them with their substance use while 75% of bup-nx users reported that bup-nx either had no effect or a negative effect on their drug problems. Of the very few (4%-7%) obtaining bup-nx solely through a prescription, over 90% reported relief from withdrawal. However, over 80% of those who obtained bup-nx through illicit means reported using bup-nx until their preferred drug could be obtained and used it for its euphoriant effect. Three groups of opioid users were created including one group with no bup-nx use, one with lifetime but not recent bup-nx use, and one with recent (past 6 month) use. There were differences in substance use patterns and characteristics of bup-nx experiences between the different groups.. Results suggest that the views of bup-nx by individuals in drug-free recovery centers are varied, with many seeing bup-nx as not unlike other opioids while others report bup-nx as self-medication.

Topics: Adult; Buprenorphine, Naloxone Drug Combination; Drug Users; Female; Humans; Male; Middle Aged; Opiate Substitution Treatment; Substance-Related Disorders

Kratom use in the West has increased recently, yet the prevalence and motives for use among individuals with a history of substance use disorder (SUD) have not been fully examined. Kratom has been documented as a means of treating chronic pain, mitigating drug dependence, and easing withdrawal symptoms, yet it is unclear if substance users are utilizing kratom as a self-medication. Abuse liability, side effects, and overall appeal of kratom remain uncertain.. In April 2017, an anonymous survey regarding kratom use and motivations was completed by clients enrolled in a 12-Step-oriented residential program. 500 respondents with a self-reported history of SUD completed the survey.. 20.8% of respondents endorsed lifetime kratom use and 10.2% reported past-12-month use. Kratom-users were younger (=32.1 vs. 35.9, p<0.001) and were more versatile substance users. A majority (68.9%) of kratom-users reported having used the drug as a means of reducing or abstaining from non-prescription opioids (NPO) and/or heroin, and 64.1% reported using kratom as a substitute for NPO/heroin. 18.4% of kratom-users reported using the drug due to a disability or chronic pain. One-third of kratom-users stated that kratom was a helpful substance and that they would try it again. However, kratom was not preferred and was indicated as having less appeal than NPO, heroin, amphetamines, and Suboxone.. Among substance users, kratom use may be initiated for a variety of reasons, including as a novel form of harm-reduction or drug substitution, particularly in the context of dependence and withdrawal from other substances.

Topics: Amphetamines; Analgesics, Opioid; Buprenorphine, Naloxone Drug Combination; Chronic Pain; Heroin; Humans; Motivation; Prevalence; Residential Treatment; Self Medication; Self Report; Substance Withdrawal Syndrome; Substance-Related Disorders; Surveys and Questionnaires

Opioid use disorder among young adults is rising sharply with an increase in morbidity and mortality. This study examined differences in treatment response to a fixed dose of buprenorphine-naloxone between heroin (HU) and prescriptions opioids (POU) users.. Eighty opioid dependent young adults (M = 22 years) were treated with buprenorphine-naloxone 16-4 mg/day for 8 weeks. Differences between HU (N = 17) and POU (N = 63) on changes in weekly opioid use, opioid craving, withdrawal, and depression symptoms were analyzed with mixed-effects regression models.. The HU had an overall mean proportion of weekly opioid use of .32 (SD = .14) compared to POU's weekly mean of .24 (SD = .15) showing a significant main effect (Z = 2.21, p = .02). Depressive symptoms (CES-D scores) were elevated at baseline for both groups (HU: M = 23.1, SD = 11.9; PO: M = 22.2, SD = 9.4), but only POU improved significantly to a score of 9.88 (SD = 7.4) compared to HU's score of 18.58 (SD = 10.3) at week 8 (Z = 2.24, p = .02). There were no significant differences in treatment retention, craving, or withdrawal symptoms.. Treatment response to 16-4 mg/day of buprenorphine-naloxone was significantly diminished for heroin users relative to opioid prescription users in weekly opioid use. Heroin users also had persistent depressive symptoms suggesting the need for close monitoring.. These data suggest that young heroin users might require higher doses of buprenorphine. (Am J Addict 2017;26:838-844).

Topics: Adolescent; Age Factors; Analgesics, Opioid; Buprenorphine, Naloxone Drug Combination; Cognitive Behavioral Therapy; Combined Modality Therapy; Craving; Drug Therapy, Combination; Female; Heroin Dependence; Humans; Male; Memantine; Opiate Substitution Treatment; Opioid-Related Disorders; Psychotherapy, Group; Substance Withdrawal Syndrome; Substance-Related Disorders; Young Adult

At present, polydrug abuse comprises, besides traditional illicit drugs, new psychoactive substances (NPS) and non-prescribed psychotropic medicines (N-PPM). Polydrug abuse was comprehensively evaluated among opioid-dependent patients undergoing opioid maintenance treatment (OMT).. Two hundred consecutively collected urine samples from 82 OMT patients (52 male) treated with methadone or buprenorphine-naloxone medication were studied using a liquid chromatography/time-of-flight mass spectrometry screening method. The method enables simultaneous detection of hundreds of abused substances covering the traditional drugs of abuse and many NPS as well as N-PPM.. Ninety-two (45.8%) samples were positive for the abused substances. Benzodiazepines (29.0%), amphetamines (19.5%), cannabinoids (17.0%), NPS (13.0%), N-PPM (9.0%), and opioids (9.0%) were detected in different combinations. The simultaneous occurrence of up to three groups of abused substances was common (40.0%), and in one sample, all six groups were found. The stimulant NPS alpha-pyrrolidinovalerophenone was found in 10.0% and the sedative N-PPM pregabalin in 4.0% of the samples. The patients were seldom aware of what particular NPS they had abused.. A widespread occurrence of abused substances beyond the ordinary was revealed. Identifying these patients is essential as polydrug abuse is a safety risk to the patient and may cause attrition from OMT.

Topics: Adult; Buprenorphine, Naloxone Drug Combination; Chromatography, Liquid; Female; Humans; Illicit Drugs; Male; Mass Spectrometry; Methadone; Middle Aged; Opiate Substitution Treatment; Opioid-Related Disorders; Psychotropic Drugs; Retrospective Studies; Substance Abuse Detection; Substance-Related Disorders; Young Adult

To test if polysubstance use profiles and drug-related outcomes differ between those receiving and not receiving opioid substitution therapies (OST) among people who inject drugs (PWID).. An annual cross-sectional, sentinel sample of PWID across Australia.. Data came from 3 years (2011-13) of the Illicit Drug Reporting System (IDRS).. A total of 2673 participants who injected drugs from the combined national IDRS samples of 2011 (n = 868), 2012 (n = 922) and 2013 (n = 883).. Latent class analysis (LCA) was used to summarize participants' self-reported use of 18 types of substances, with the resulting polysubstance use profiles then associated with participant experience of a number of drug-related outcomes.. Polysubstance use profiles exhibiting a broad range of substance use were generally at increased risk of negative drug-related outcomes, whether or not participants were receiving OST, including thrombosis among OST receivers [odds ratio (OR) = 2.13, 95% confidence intervals (CI) = 1.09-4.17], injecting with used needles among OST receivers and non-receivers, respectively (OR = 2.78, 95% CI = 1.50-5.13; OR = 2.15, 95% CI = 1.34-3.45) and violent criminal offences among OST receivers and non-receivers, respectively (OR =2.30, 95% CI = 1.16-4.58; OR = 1.87, 95% CI = 1.14-3.07). An important exception was non-fatal overdose which was related specifically to a class of PWID who were not receiving OST and used morphine frequently (OR = 1.83, 95% CI = 1.06-3.17) CONCLUSION: Regardless of opioid substitution therapies usage, people who inject drugs who use a broad-range of substances experience greater levels of injecting-related injuries and poorer health outcomes and are more likely to engage in criminal activity than other groups of people who inject drugs.

Topics: Abscess; Adolescent; Adult; Alcoholism; Amphetamine-Related Disorders; Analgesics, Opioid; Australia; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Cocaine-Related Disorders; Cross-Sectional Studies; Drug Overdose; Female; Heroin Dependence; Humans; Male; Marijuana Abuse; Methadone; Middle Aged; Needle Sharing; Odds Ratio; Opiate Substitution Treatment; Opioid-Related Disorders; Substance Abuse, Intravenous; Substance-Related Disorders; Thrombosis; Violence; Young Adult

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.. 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.. 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.. 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.

Topics: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Humans; Laundering; Narcotic Antagonists; Prescription Drug Diversion; Product Packaging; Substance-Related Disorders

Topics: Animals; Behavior, Addictive; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Clinical Trials as Topic; Cocaine-Related Disorders; Counseling; Dopamine; Drug Discovery; Drug Industry; Humans; Ibogaine; Lobeline; Molecular Targeted Therapy; Naloxone; Naltrexone; Oligopeptides; Opioid-Related Disorders; Pleasure; Rats; Receptors, Nicotinic; Reward; Substance-Related Disorders; Tobacco Use Disorder; Vaccines; Vesicular Monoamine Transport Proteins

We present a 1-year program evaluation of the Medical Withdrawal Support Service (MWSS) provided at the Sioux Lookout Meno Ya Win Health Centre. The centre's service area includes 4 rural municipalities and 28 First Nations communities. The program involves inpatient detoxification for opioid dependence with the use of buprenorphine-naloxone.. Data were collected from preadmission interviews (i.e., medical history, substance use history, previous counselling, social history, previous addiction treatment and screening tools used during the interview); discharge forms (i.e., length of stay, maximum dose of prescribed buprenorphine-naloxone and client goals); and postdischarge interviews.. Overall, 81% of the clients successfully completed the program. Two weeks after discharge, 48% of clients reported continued abstinence. At 3-month follow-up, 32% were abstinent, and at 6 months, 30% were abstinent.. The MWSS shows positive outcomes for many clients, their families and communities. Clients returned to work and school, became more engaged in healthy meal preparation and exercise, spent more time with family and were more involved as leaders in their communities.. Nous présentons l’évaluation d’un programme d’un an offert par les Medical Withdrawal Support Services (MWSS) au Centre de santé Sioux Lookout Meno Ya Win. La zone desservie par le Centre englobe 4 municipalités rurales et 28 communautés des Premières Nations. Il s’agit d’un programme de désintoxication au moyen de buprénorphine–naloxone offert en établissement à des patients qui souffrent d’une dépendance aux opiacés.. Des données ont été recueillies à partir d’entrevues précédant l’admission (incluant antécédents médicaux, antécédents de toxicomanie, thérapies antérieures, histoire sociale, traitements antérieurs contre les dépendances et outils de dépistage appliqués en cours d’entrevue), des sommaires d’hospitalisation (c.-à-d., durée du séjour, dose maximum de buprénorphine–naloxone prescrite et objectifs du client) et d’entrevues consécutives au congé.. Dans l’ensemble, 81 % des clients ont terminé le programme avec succès. Deux semaines après leur congé, 48 % des clients disaient être demeurés abstinents. Au suivi de 3 mois, 32 % étaient encore abstinents et après 6 mois, 30 % l’étaient toujours.. Les MWSS donnent des résultats positifs pour de nombreux clients, leurs familles et les communautés. Les clients sont retournés au travail ou à l’école, ont adopté de meilleures habitudes en ce qui concerne la préparation de repas santé et la pratique d’exercice, ont passé plus de temps en famille et ont davantage agi comme leaders dans leur communauté.

Topics: Adolescent; Adult; Aged; Buprenorphine, Naloxone Drug Combination; Female; Humans; Inpatients; Male; Middle Aged; Ontario; Prospective Studies; Substance-Related Disorders

conduct needs assessments and treatment compliance evaluations in MMT and Suboxone Substitution State Programs in Georgia (Republic of). 506 patients (2 females) were surveyed (92% on Methadone, 8% on Suboxone) from 6 Tbilisi and 4 regional State Programs in 2011 November. Mean age - 40±8,56 (22-65) year; 254 (51.4%) were in treatment for 1-3 year. Evaluation was carried out on the base of structured self-questionnaire that covers demographics, drug use history, general drug use trends, psychotherapeutic sessions' acceptance and open label question regarding treatment challenges and satisfaction. 305 (60.3%) attended individual and 57 (11.3%) group psychotherapy sessions with 50.79% attending once/month or rare. The main reason given for therapy non-attendance - no needs for it (29.48%); the main drugs before admission - heroin (80.04%), buprenorphine (53.49%); Main drugs used in Georgia nowadays - desomorphine ("crocodile"), alcohol and marihuana. Commonly used drugs by program patients (136 positive answers) - alcohol-13.62%, marihuana-10.39%, pregabalin - 8.17%, opioids- 6.62% (mostly-"crocodile"), home-made stimulants-6.23%, sedatives -5.45%. 55.4% are extremely satisfied with treatment, 82.4% - with program staff. Patients' main wishes- free of charge programs (46.4%) and provide take-home doses (22.07%). Methadone and Suboxone ST are being well accepted in Georgia and appear to be reducing illegal opioid use. However, the psychotherapeutic sessions' attendance is very low.

Topics: Adult; Aged; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Female; Georgia (Republic); Government Programs; Heroin Dependence; Humans; Hypnotics and Sedatives; Male; Marijuana Abuse; Methadone; Middle Aged; Naloxone; Needs Assessment; Opiate Substitution Treatment; Patient Compliance; Patient Satisfaction; Psychotherapy; Substance-Related Disorders; Surveys and Questionnaires; Young Adult

Although many in the addiction treatment field use the term "medication-assisted treatment" to describe a combination of pharmacotherapy and counseling to address substance dependence, research has demonstrated that opioid agonist treatment alone is effective in patients with opioid dependence, regardless of whether they receive counseling. The time has come to call pharmacotherapy for such patients just "treatment". An explicit acknowledgment that medication is an essential first-line component in the successful management of opioid dependence.

Topics: Behavior, Addictive; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Counseling; Humans; Methadone; Naloxone; Narcotic Antagonists; Opiate Substitution Treatment; Opioid-Related Disorders; Substance-Related Disorders

The development and implementation of programs in the U.S. to minimize risks and assess unintended consequences of new medications has been increasingly required by the Food and Drug Administration (FDA) since the mid 1990s. This paper provides four case histories of risk management and post-marketing surveillance programs utilized recently to address problems associated with possible abuse, dependence and diversion. The pharmaceutical sponsors of each of these drugs were invited to present their programs and followed a similar template for their summaries that are included in this article. The drugs and presenting companies were OxyContin, an analgesic marketed by Purdue Pharma L.P., Daytrana and Vyvanse, ADHD medications marketed by Shire Pharmaceuticals, Xyrem for narcolepsy marketed by Jazz Pharmaceuticals, and Subutex and Suboxone for opioid dependence marketed by Reckitt Benckiser Pharmaceuticals Inc. These case histories and subsequent discussions provide invaluable real-world examples and illustrate both the promise of risk management programs in providing a path to market and/or for keeping on the market drugs with serious potential risks. They also illustrate the limitations of such programs in actually controlling unintended consequences, as well as the challenge of finding the right balance of reducing risks without posing undue barriers to patient access. These experiences are highly relevant as the FDA increasingly requires pharmaceutical sponsors to develop and implement the more formalized and enforceable versions of the risk management term Risk Evaluation and Mitigation Strategies (REMS).

Topics: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Dextroamphetamine; Drug and Narcotic Control; Drug Industry; History, 20th Century; History, 21st Century; Humans; Lisdexamfetamine Dimesylate; Methylphenidate; Naloxone; Oxycodone; Product Surveillance, Postmarketing; Risk Management; Sodium Oxybate; Substance-Related Disorders

Topics: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Curriculum; Diffusion of Innovation; Evidence-Based Medicine; Harm Reduction; Health Services Needs and Demand; Humans; Naloxone; Nurse's Role; Nursing Assessment; Patient Care Planning; Psychiatric Nursing; Substance-Related Disorders; United States