Unsafe Drug Use Research Articles

Behavioral patterns of people who use synthetic psychostimulants: Results of a qualitative study in St. Petersburg, Russia.

Russia, like many other places, is currently experiencing a proliferation of new psychoactive substances, many of which are psychostimulants. In St. Petersburg, these appear to be mostly congeners of cathinone. We sought to obtain qualitative data to better understand the impact on the health and behaviors of people who use drugs (PWUD) by recruiting individuals who reported recent use of psychostimulants. In-depth qualitative data on current drug use and its effects were collected through thirty interviews (n=30) and two focus groups (n=10: five male, five female). The interviews and focus groups also provided data on the social contexts of drug use including sexual behaviors and associated medical issues. Secondary data about online drug purchases were obtained from a source that accesses and analyzes darknet purchases. Qualitative data were initially coded using a priori codes developed on the basis of the interview guide, and then data were coded again inductively based on emergent findings from the data. Thematic analysis was carried out using OpenCode 4.0 qualitative data analysis software. Thematic analysis of the interviews and focus groups identified distinct differences in behavior patterns between older, more experienced PWUD and a "new generation" of PWUD. Routes of initiation of drug use and sexual behaviors associated with drug use differed, but both groups reported high levels of unsafe injection and sexual behaviors. In interpreting the texts and purchasing data, we have attempted to anticipate how the drug use patterns can influence HIV transmission. The emergence of a new class of psychostimulant drugs presents new threats to the health of drug users and new opportunities to intervene to reduce those risks. The information obtained may assist HIV/AIDS prevention specialists and drug user support groups in their efforts to decrease unsafe drug use and sexual behaviors.

Disability-adjusted life years and mortality rate attributed to unsafe sex and drug use for AIDS in the Middle East and North Africa countries

BackgroundThe Middle East and North Africa, is one of few regions where the number of new human immunodeficiency virus infections is increasing. The present study aimed to estimate the attributable burden of unsafe sex and drug use in Acquired immunodeficiency syndrome in the Middle East and North Africa countries.MethodsWe used the Global Burden of Disease data 2017 to estimate the attributable mortality and disability-adjusted life-years to unsafe sex and drug use in Acquired immunodeficiency syndrome in the Middle East and North Africa countries (21 countries) from 1990 to 2017 by region, sex and age. The percent change was calculated at three time points by country and sex.ResultsThe rate of Disability-adjusted life years/100,000 attributed to drug use for Acquired immunodeficiency syndrome increased 1.10 (95% CI: 0.75–1.71) to 13.39 (95% CI: 9.98–18.17) in women of Middle East and North Africa countries from 1990 to 2017, and there is an increasing trend in Disability-adjusted life years attributable to drug use for Acquired immunodeficiency syndrome in men. The rate of Disability-adjusted life years/100,000 attributed to unsafe sex for Acquired immunodeficiency syndrome increased in women of Middle East and North Africa countries, 5.15 (95% CI: 3.34–8.07) to 53.44 (95% CI: 38.79–75.89); and 10.06 (95% CI: 6.61–16.18) to 46.16 (95% CI: 31.30–72.66) in men. Age-standardized mortality rate attributed to drug use and unsafe sex for Acquired immunodeficiency syndrome increased from 1990 to 2017 in both sex in Middle East and North Africa countries.ConclusionThe rate of Disability-adjusted life years /100,000 and age-standardized mortality rate attributed to unsafe sex and drug use increased in Middle East and North Africa from 1990 to 2017. While most of such countries have traditional cultures with religious believes, such increase need to be addressed in more depth by all policy makers.

Concomitant drugs with buprenorphine user deaths

BackgroundBuprenorphine is abused in several countries notwithstanding its benefits as an analgesic and as an opioid agonist treatment medication. Benzodiazepines and alcohol have previously been associated with buprenorphine toxicity. This study elucidates the role of emerging concomitant drugs in different groups of buprenorphine user deaths. MethodsAll cases in the Finnish national post-mortem toxicology database from 2016–2019 in which buprenorphine or norbuprenorphine was a laboratory finding in any post-mortem specimen and age at death of 15–64 years were investigated for cause and manner of death, concurrent drug and alcohol findings, age, and gender. ResultsThere were 792 deaths with a buprenorphine finding, of which buprenorphine was implicated in poisoning without other opioids in 271 cases (34 %). In this group of buprenorphine poisoning deaths, concomitant benzodiazepines were found in 94 % (clonazepam 53 %), illicit drugs in 63 %, gabapentinoids in 50 % (pregabalin 41 %), alcohol in 41 %, antidepressants in 32 %, and antipsychotics in 28 % of cases; only three deaths showed no benzodiazepines, alcohol, or gabapentinoids. Polydrug use was common regardless of the cause of death. In the age group 15 to 24 years, concomitant use of benzodiazepines and illicit drugs, and buprenorphine poisoning were more prevalent than in the age group 25–64 years. ConclusionsThe unprecedentedly high concomitant use of benzodiazepines in buprenorphine user deaths obscures other possible pharmacological risk factors for buprenorphine poisoning that could be relevant for prevention. Higher mortality in the younger age group suggests particularly unsafe drug use patterns that should be addressed.

Women who inject drugs in Russia: stigma as a barrier in access to HIV and drug treatment services

Abstract Background There are over one million people living with HIV in Russia. People who inject drugs experience major disparities in their susceptibility to the virus and in their access to HIV services. Women who inject drugs (WWID) have been shown to be at heightened susceptibility to HIV, through both unsafe drug use and unprotected sex. Less is known about the social determinants of engagement in care specifically among WWID. Methods We conducted a qualitative research study in St. Petersburg in order to assess what factors influence engagement in HIV-related and drug rehabilitation services. We conducted in-depth interviews with 20 service providers and 30 WWID from June-November 2018. We recruited providers to represent a range of services, including government clinics, non-governmental organizations, and family services. We recruited WWID through community outreach services. We used thematic analysis and a team-based approach to coding data. Results A major theme across our data was the stigma and discrimination that WWID experience in their everyday lives and in their interactions with the healthcare system. WWID are subjected to stigmatization related to gender norms about drug use, the capacity to fulfill their roles as mothers, (for some) engagement in sex work, and (for some) HIV-positive serostatus. WWID are often reluctant to seek HIV-related services, including testing and treatment, out of fear of being treated poorly because of their drug use. The omnipresent societal stigma manifests into self-stigmatization and many WWID questioned their deserving of and abilities to seek healthcare services, including drug rehabilitation and HIV-related care. Conclusions Interventions are needed to address the stigma and discrimination that WWID in Russia experience in families, communities, and health institutions. Additionally, psychosocial interventions may help to address the self-stigmatization that sometimes influences WWID's self-efficacy to seek services.

Exposure to HIV risks among young people who use drugs (YPUD) in three cities in Vietnam: time to develop targeted interventions

IntroductionThe aim of this study is to identify the profiles of young people who use drugs (YPUD) and their exposure to HIV risks in the 3 main cities of Vietnam, Haiphong, Hanoi, and Ho Chi Minh City (HCMC), in order to design a community-based intervention to prevent HIV.MethodsA survey using respondent-driven sampling (RDS) was conducted among YPUD aged 16–24. Participants were eligible if they reported drug use, confirmed by a urine test. After obtaining informed consent, they were screened for HIV/HCV and assessed using face-to-face questionnaires and self-report. A cluster analysis was conducted, taking into account risk behaviors and confirmed HIV-positive status.ResultsSeven hundred and three YPUD aged 16–24 were recruited between October 2016 and February 2017, 584 of whom were included in the final analysis. Median age was 21 (17.7, 23.0); 79% were male, 18% female, and 2% transgender. Methamphetamines use was reported by 77%, followed by cannabis (51%) and heroin (17%); polydrug use was common; 15% had “ever” injected drugs. HIV prevalence was 7%. Among all participants, 48% reported non-consistent condom use and 1% reported needle/syringe sharing during the previous month. Four distinct profiles of HIV risk behaviors were identified: The high multiple-risk group mixed unsafe drug use with unsafe sexual practices and had higher prevalence of HIV; the second group practiced high-risk sex with non-consistent condom combined with methamphetamine use; the third group was a moderate-risk group with limited unsafe sexual practices; and the fourth was considered at “low-risk” as reportedly, most never had sex and never injected. The highest risk group included more female YPUD, living in HCMC, who used heroin and had unsafe sex with their regular partners. The second high-risk group included most of the MSM and all transgender people and frequently reported mental health disorders.ConclusionsThe profiles of YPUD who are at risk of HIV vary according to age, location, and population group. Injecting YPUD are the most exposed to risk and need immediate attention. Sexual exposure to HIV is very common. Mental health is a major concern. Interventions need to be integrated in a differentiated but holistic approach.

Circumstances of overdose among street-involved, opioid-injecting women: Drug, set, and setting

IntroductionCurrent discourses about the causes of the overdose crisis largely focus on the harmful effects of drugs. Prior research, however, indicates that drug use experience is shaped by complex interactions of drugs with physiological and mental “sets” of people who use drugs and the wider social and physical “setting.” Zinberg's “drug, set, and setting” theoretical framework was applied to identify patterns in circumstances leading up to women's overdose. MethodsIn-depth semi-structured interviews were conducted with 29 opioid-injecting street-involved women, clients of a Philadelphia harm reduction program. Qualitative analysis with deductive and inductive coding was utilized to examine transcripts for theory-driven and emerging themes. ResultsTen out of 29 women attributed their overdose to “drugs,” reporting the unpredictable quality of street opioids, concurrent use of benzodiazepines, or chasing the “high.” Thirteen women reported “set” as a type of circumstance where their emotional states were affected by a “good” or “bad” day, leading them to unusual drug consumption practices. Six women described “setting” type of circumstances where their overdose was preceded by a recent change in context, such as release from prison, which prompted unsafe drug use to address physiological or psychological dependence on drugs. ConclusionWhile all overdoses result from the pharmacological action of drugs, some overdoses were triggered by circumstances occurring in women's set or setting. Overdose prevention policies should embrace not only individual-level behavioral interventions, but also structural measures to address stress, social isolation, and risky drug use contexts that plague the lives of street-involved women who inject opioids.

316. Hepatitis C and Engagement in Health Care Among Persons Who Inject Drugs and Persons Who Use Non-Injection Drugs, Philadelphia

BackgroundThe growing opioid epidemic is driving increasing rates of hepatitis C virus (HCV) infections in the United States. HCV transmission is most frequently attributed to unsafe injection behaviors, but can occur via other unsafe drug use and sexual behaviors. Differences in demographics, HCV rates and associated risk factors in non-injecting PWUD (NIPWUD), compared with people who inject drugs (PWID) must be understood in order to target elimination strategies.MethodsChange is Philadelphia’s program to eliminate HCV among PWUD and enrollment includes HCV testing, linkage services, and an interviewer-administered survey including risk behaviors and healthcare engagement. This interim analysis includes the first 835 enrollees that identified as PWUD. For this analysis, PWID are enrollees who indicated ever injecting drugs and those who had not are NIPWUD.ResultsAmong enrollees, 76% (N = 637) reported ever injecting drugs. PWIDs were younger and non-Hispanic (NH) white while NIPWUD were older and NH Black (age: P = 0.003; race/ethnicity: P < 0.0001). NIPWUDs had a high seropositivity rate though significantly lower than PWIDs (24% vs. 85%, respectively; P < 0.0001). Among PWID enrollees, 94% (N = 596) ever snorted. Of enrollees, 63% (N = 124) of NIPWUD and 56% (N = 356) of PWID identified having a PCP (P =0.07). PWIDs are more likely than NIPWUD to have overdosed (OD) (40% vs. 9%; P < 0.0001) though high rates of both groups ever witnessed an OD (84% vs. 67%, respectively). While 80% (N = 105) of NIPWUDs know how to use Narcan, 60% (N = 79) carry it, {94% (N = 503) and 71%(N = 381) in PWID, respectively}. NIPWUDs are more likely to be interested in drug treatment (P < 0.0001) and to have received it in the last 12 months (P = 0.0008).ConclusionNotable HCV infection exists among non-injecting PWUD reinforcing the need for harm reduction counseling and access to drug use equipment used for smoking and snorting. NIPWUD may be able to access drug and HCV treatment through PCPs and fatal ODs may be prevented by ensuring NIPWUDs have access to Narcan. In addition, PWID are likely to snort as well and should be counseled on non-injecting harm reduction methods. To succeed in micro elimination among PWUD, a focus on NIPWUDs as well as PWIDs is necessary to mitigate transmission of HCV.Disclosures All authors: No reported disclosures.

Prevalence of Drug Prescriptions and Potential Safety in Patients with Cirrhosis: A Retrospective Real-World Study.

IntroductionPatients with cirrhosis are at risk for adverse drug reactions (ADRs) due to altered pharmacokinetics and pharmacodynamics. We aimed to determine the prevalence of drug prescriptions and the potential safety of these prescriptions in a real-world cohort of patients with cirrhosis.MethodsThis was a retrospective cohort study based on linked real-world data from the Out-patient Pharmacy Database and the Hospitalisation Database of the PHARMO Database Network. Patients with a diagnosis of cirrhosis between January 1998 and December 2015 were included. Follow-up ended when the patient underwent a liver transplant, died, transferred out of the database, or on 31 December 2015. Prescription data were derived from a community pharmacy database and were compared with our previously developed safety recommendations for 209 drugs.ResultsIn total, 5618 patients were included and followed for a median of 3 years (interquartile range [IQR] 1–7). In the first year after the diagnosis, patients used a median of nine drugs (IQR 5–14), with proton pump inhibitors (prevalence 53.9%), aldosterone antagonists (43.6%), and sulfonamide diuretics (41.3%) being the most commonly used drug groups. Almost half (48.3%) of 102,927 prescriptions consisted of drugs with a safety recommendation. The prevalence of potentially unsafe drug use was 60.0% during the total follow-up. Three nonsteroidal anti-inflammatory drugs (NSAIDs) were among the five most commonly used potentially unsafe drugs.ConclusionsPatients with cirrhosis use a large number of drugs. Almost two-thirds of patients in our cohort used potentially unsafe drugs. To prevent ADRs in these frail patients, personalised pharmacotherapy is necessary.Electronic supplementary materialThe online version of this article (10.1007/s40264-018-0744-1) contains supplementary material, which is available to authorized users.

Partner influences on young women\u2019s risky drug and sexual behavior

BackgroundAdolescent girls with a history of maltreatment are at heightened risk for health-risking behaviors, including unsafe sexual behaviors and drug use. However, few studies have examined the views of this population in regard to sexual partner choice, sexual behaviors, and decisions to use drugs with sexual partners.MethodsWe conducted 15 semistructured, open-ended qualitative interviews with young women ages 18–24 with a history of maltreatment and asked them to reflect on their experiences as adolescents. We used the constant comparison method to group the qualitative coded data into themes.ResultsAnalysis of the interviews suggested that adolescent girls with maltreatment histories often report that they chose partners who are promotive of risky drug and sexual behavior. The interviews also provided insight into why this population is likely to use drugs with their partner and why they might be hesitant to talk about or practice safe sex with their partner.ConclusionThe young women’s feedback highlighted five areas where adolescent girls with maltreatment histories could benefit: (a) provision of information about partner characteristics that are promotive of both risky behavior and those that are linked to healthy relationships, (b) provision of information about how one’s partner can influence one’s own drug use, (c) practice talking about safe sex with partners, (d) provision of information about safe sex practices and the risks associated with unsafe sex, and (e) provision of information about the risks associated with drug use and unsafe sexual behavior to adolescent boys.

Examining the Association Between Psychiatric Disorders and Cocaine Binges: Results From the COSMO Study.

Although cocaine binges and mental health problems have both been identified as significant risk factors for different health hazards, little is known about the relationship between mental health and cocaine binging. Hence, the aim of this study is to examine the association between psychiatric disorders and cocaine binge. Participants were part of a prospective cohort study of individuals who either smoke or inject cocaine. The dependent variable, namely a cocaine binge within the past month, was defined as the repetitive use of large quantities of cocaine until the individual was unable to access more of the drug or was physically unable to keep using. Psychiatric disorders were assessed using the Composite International Diagnostic Interview and the Diagnostic Interview Schedule questionnaires. Logistic regression models were performed to examine the association between cocaine binging and psychiatric disorders, adjusting for potential confounders. Of the 492 participants, 24.4% reported at least 1 cocaine binging episode during the prior month. Among the study population, 48.0% met the criteria for antisocial personality disorder (ASPD), 45.5% for anxiety disorders, and 28.2% for mood disorders. Participants with ASPD were more likely to binge (adjusted odds ratio 1.73, 95% confidence interval 1.10-2.73), whereas those with a mood disorder were not. The association between anxiety disorders and cocaine binging was significant only in univariate analyses. ASPD increased the odds of reporting cocaine binge in our study population. These results highlight the need for a better understanding of the specific dimensions of ASPD that contribute to the increased risk of unsafe drug use behaviors.

Unsafe Drug Use and Arrhythmic Events in Brugada Patients with ICD: Results of a Long-Term Follow-Up.

Brugada syndrome is a hereditary disease linked with an increased risk of sudden death that may require an implantable cardioverter-defibrillator (ICD) in order to halt the arrhythmic events. The aim of this study was to identify possible triggers for appropriate ICD therapies in patients with Brugada syndrome, focusing on their past and current therapeutic profiles. Thirty patients with high-risk Brugada syndrome, with ICD implanted at the Coimbra Hospital and University Center, were enrolled. Patients were questioned about their Brugada syndrome history, previous cardiac events, comorbidities, present and past medications, and physical activity. Patients were followed up during 5.8 ± 5.3years. The ICD was interrogated, and arrhythmic events and device therapies were recorded. The cohort who received appropriate ICD therapies was compared with the remaining patients to determine the potential link between clinical variables and potentially fatal arrhythmic events. More than half of the patients (53.3%) took at least one non-recommended drug, and 16.7% received appropriate ICD therapies, with a long-term rate of 4.0%/year. There was a tendency for more appropriate ICD therapies in patients who took unsafe drugs (85.7 versus 45.5%, p = 0.062), and the mean time between unsafe drug intake and appropriate ICD therapies was 3.8 ± 7.5days. This study revealed that the medical community is still unaware of the pharmacological restrictions imposed by Brugada syndrome. Patients who took non-recommended drugs seem to have a higher risk of ventricular arrhythmic events.

Public Health and Public Order Outcomes Associated with Supervised Drug Consumption Facilities: a Systematic Review.

Supervised drug consumption facilities (SCFs) have increasingly been implemented in response to public health and public order concerns associated with illicit drug use. We systematically reviewed the literature investigating the health and community impacts of SCFs. Consistent evidence demonstrates that SCFs mitigate overdose-related harms and unsafe drug use behaviours, as well as facilitate uptake of addiction treatment and other health services among people who use drugs (PWUD). Further, SCFs have been associated with improvements in public order without increasing drug-related crime. SCFs have also been shown to be cost-effective. This systematic review suggests that SCFs are effectively meeting their primary public health and order objectives and therefore supports their role within a continuum of services for PWUD. Additional studies are needed to better understand the potential long-term health impacts of SCFs and how innovations in SCF programming may help to optimize the effectiveness of this intervention.

The association between symptoms of mental disorders and health risk behaviours in Vietnamese HIV positive outpatients: a cross-sectional study

BackgroundA high prevalence of symptoms of mental disorders (SOMD) has been found among people living with HIV/AIDS (PLHIV). Additionally, SOMD may impact on the prevalence of high-risk health behaviours (HRB). This study investigates the relationship between SOMD and HRB in a large sample of Vietnamese HIV positive outpatients.MethodsA cross-sectional study was conducted with 400 outpatients at two HIV/AIDS clinics in Ho Chi Minh City, Vietnam, selected using a systematic sampling technique. Validated scales were used to measure SOMD, specifically symptoms of depression, anxiety, alcohol use disorder (AUD), substance use disorder (SUD) and HIV associated dementia (HAD). Participants completed a self-report questionnaire assessing HRB during the preceding 12 months including unsafe sexual practices and illicit drug use. Multivariable logistic regression models were used to evaluate associations between SOMD and HRB.ResultsThe majority of participants (63.5%) were male and the median age was 34.0 years. Unsafe sexual practices and illicit drug use were reported by 13.8 and 5.5% of participants. The prevalences of HAD, depression, AUD, anxiety and SUD symptoms were 39.8, 36.5, 13.3 10.5, 3.3% respectively. There was no association between SOMD and HRB either with or without adjusting for correlates of HRB, except between symptoms of SUD and illicit drug use. PLHIV who had symptoms of SUD were more likely to use illicit drugs (adjusted Odds Ratio 81.14, 95% CI 12.55–524.47).ConclusionsWhile the prevalence of SOMD among HIV positive outpatients was high, most SOMD were not associated with increased HRB. Only illicit drug use was predicted by symptoms of SUD. Screening PLHIV for symptoms of SUD may be useful for detecting people likely to be engaging in illicit drug use to reduce the risk of secondary disease transmission.

Correlates of Double Risk of HIV Acquisition and Transmission Among Women who Inject Drugs in St. Petersburg, Russia.

Russia continues to experience a growing HIV epidemic, and women account for an increasing proportion of new HIV diagnoses in the country. This study aims to provide up-to-date information on factors associated with unsafe sex and drug use behaviors among women who inject drugs in St. Petersburg, Russia. In this community-based sample of 500 women who inject drugs, 64% tested positive for HIV. Women reported the following: 21% reported injection risk, 22% reported sexual risk, and 18% reported double risk. Multivariable analyses using logistic multinomial regression showed that older age is associated with increased risk behaviors. Involvement in transactional sex is associated with injection risk [aOR=1.59 (1.02, 2.48)] but protective against sexual risk [aOR=0.11 (0.06, 0.19)]. Exposure to sexual violence is associated with increased injection risk [aOR=1.78 (1.01, 3.14)] and double risk [aOR=3.38 (1.50, 7.63)]. These findings indicate the need to address both the unsafe injection and sexual risks among women who inject drugs in Russia.

Area restrictions, risk, harm, and health care access among people who use drugs in Vancouver, Canada: A spatially oriented qualitative study

Area restrictions prohibiting people from entering drug scenes or areas where they were arrested are a common socio-legal mechanism employed to regulate the spatial practices of people who use drugs (PWUD). To explore how socio-spatial patterns stemming from area restrictions shape risk, harm, and health care access, qualitative interviews and mapping exercises were conducted with 24 PWUD with area restrictions in Vancouver, Canada. Area restrictions disrupted access to health and social resources (e.g., HIV care) concentrated in drug scenes, while territorial stigma prevented PWUD from accessing supports in other neighborhoods. Rather than preventing involvement in drug-related activities, area restrictions displaced these activities to other locations and increased vulnerability to diverse risks and harms (e.g., unsafe drug use practices, violence). Given the harms stemming from area restrictions there is an urgent need to reconsider this socio-legal strategy.

Substance Use and HIV Among Female Sex Workers and Female Prisoners: Risk Environments and Implications for Prevention, Treatment, and Policies.

Female sex workers (FSWs) and female prisoners experience elevated HIV prevalence relative to the general population because of unprotected sex and unsafe drug use practices, but the antecedents of these behaviors are often structural in nature. We review the literature on HIV risk environments for FSWs and female prisoners, highlighting similarities and differences in the physical, social, economic, and policy/legal environments that need to be understood to optimize HIV prevention, treatment, and policy responses. Sex work venues, mobility, gender norms, stigma, debt, and the laws and policies governing sex work are important influences in the HIV risk environment among FSWs, affecting their exposure to violence and ability to practice safer sex and safer drug use behaviors. Female prisoners are much more likely to have a drug problem than do male prisoners and have higher HIV prevalence, yet are much less likely to have access to HIV prevention and treatment and access to drug treatment in prison. Women who trade sex or are imprisoned and engage in substance use should not be considered in separate silos because sex workers have high rates of incarceration and many female prisoners have a history of sex work. Repeated cycles of arrest, incarceration, and release can be socially and economically destabilizing for women, exacerbating their HIV risk. This dynamic interplay requires a multisectoral approach to HIV prevention and treatment that appreciates and respects that not all women are willing, able, or want to stop sex work or drug use. Women who engage in sex work, use drugs, or are imprisoned come from all communities and deserve sustained access to HIV prevention and treatment for substance use and HIV, helping them and their families to lead healthy and satisfying lives.

Pharmacists' interventions in the population of pregnant women and recomandations for pharmacy practice impoveme

Introduction. The use of drugs in pregnancy, despite to potential risks, is a very common and necessary. Pharmacists' interventions in the process of drug dispensing to pregnant women may be essential for the use of the safest drug for the foetus. The aim of the study was to explore Serbia pharmacists' interventions in the population of pregnant women and to suggest measures for interventions advancement. Methods. Internet-based study was performed during the period April 1st - May 31th, 2012. The questionnaire, specially designed according to aims of the study, was distributed to pharmacists via their e-mails. Participation in the study was anonymous and voluntarily. Data according to pharmacists' socio-demographics characteristics and their experiences in interventions during drug dispensing to pregnant women were gathered. SPSS software was used in data analysis. Results. The questionnaire was distributed to 2972 pharmacists, 4% accepted to participate. More than half of participants, 57.6%, had experience with dispensing of drug to pregnant women which is not safe for the foetus. In total 47.9% of all participants made a contact with prescriber and warned about potential risk of proscribed drug for the foetus. A less than a half of such interventions, 40.7 %, ended with the change in therapy. Conclusion. Pharmacists could give a significant contribution to prevention of unsafe drug use trough the interventions and consultation with physicians about drug safety for the fetus which is the fondation for development of pharmacy servises derectited to pregnant women.

Methadone maintenance treatment participant retention and behavioural effectiveness in China: a systematic review and meta-analysis.

BackgroundMethadone maintenance treatment (MMT) has been scaled up by the Chinese government alongside persistent compulsory drug user detention, but the extent to which detention interferes with MMT is unknown. The study systematically reviews Chinese MMT retention rates, reasons for drop out, and behavioural changes.MethodChinese and English databases of literature are searched for studies reporting retention rates, drug use and sexual behaviours among MMT participants in China between 2004 and 2013. The estimates are summarized through a systematic review and meta-analysis.ResultsA total of 74 studies representing 43,263 individuals are included in this analysis. About a third of MMT participants drop out during the first three months of treatment (retention rate 69.0% (95% CI 57.7-78.4%)). Police arrest and detention in compulsory rehabilitation was the most common cause of drop out, accounting for 22.2% of all those not retained. Among retained participants, changing unsafe drug use behaviours was more effective than changing unsafe sexual behaviours. At 12 months following MMT initiation, 24.6% (15.7-33.5%) of MMT participants had a positive urine test, 9.3% (4.7-17.8%) injected drugs and only 1.1% (0.4-3.0%) sold sex for drugs. These correspond to 0.002 (<0.001-0.011), 0.045 (0.004-0.114) and 0.209 (0.076-0.580) times lower odds than baseline. However, MMT participants did not have substantial changes in condom use rates.ConclusionMMT is effective in drug users in China but participant retention is poor, substantially related to compulsory detention. Reforming the compulsory drug user detention system may improve MMT retention and effectiveness.

Safe drug use in long QT syndrome and Brugada syndrome: comparison of website statistics

We sought to obtain insights into the efficacy of two websites, www.QTdrugs.org and www.BrugadaDrugs.org, that have the intention to prevent fatal arrhythmias due to unsafe drug use in Long QT syndrome and Brugada syndrome. Prospective web-use statistical analysis combined with online surveys were employed. Our main outcome measure was the percentage of Long QT syndrome patients and Brugada syndrome patients reporting refraining or discontinuation of possible unsafe drugs. QTdrugs.org has received >3 100 000 visitors from 180 countries. Most visitors originated from the Americas (87%), as compared with Europe (7%), Asia (3%), Oceania (2%), and Africa (1%). The QTdrugs.org survey yielded 340 respondents: 34% were patients and 50% medical professionals. Of the patients, 79% reported that they refrained from, and 61% reported discontinuing drugs due to the website. The website was very much appreciated by 65% of the respondents and 30% found it rather helpful. The BrugadaDrugs.org received >48 000 visitors from 154 countries. Most visitors originated from Europe (46%) and the Americas (39%), but less from Asia (10%), Oceania (4%), and Africa (<1%). The BrugadaDrugs.org survey yielded 178 respondents: 68% were patients and 21% medical professionals. Of the patients, 72% reported refraining from, and 48% discontinuing drugs due to the website. The website was very much appreciated by 72% of the respondents and 25% found it rather helpful. These websites are extensively used, they promote drug awareness, and they help patients to avoid possible pro-arrhythmic drugs. Visitors find the websites valuable but should note their limitations.

FDA Regulation of Off-label Drug Promotion Under Attack

IN 2005, ALFRED CARONIA WORKED AS A SALES REPRESENtative for the drugmaker Orphan Medical promoting the central nervous system depressant sodium oxybate (Xyrem), which had been approved by the US Food and Drug Administration (FDA) to treat narcolepsy. With the company’s knowledge and approval, Caronia promoted the drug to physicians for numerous unapproved (“off-label”) indications—including insomnia and fibromyalgia—and claimed the drug was safe in elderly and pediatric patients, despite warnings on the label that safety was not established in those populations. The Department of Justice investigated Caronia and Orphan Medical for violating the Food, Drug, and Cosmetic Act (FDCA). The manufacturer pleaded guilty, but Caronia did not. At trial, the government claimed that his representations to physicians effectively misbranded sodium oxybate because it was not FDA approved for the purposes he promoted. Caronia was convicted by a jury in 2008 and sentenced to probation, community service, and a $25 fine. Caronia appealed the conviction, arguing that he had been prosecuted for his speech, breaching his First Amendment rights. The government responded that it had merely used his speech as evidence of his intent to misbrand the drug— that is, Caronia’s statements showed he intended the drug to be used for purposes not described on the label. On December 3, 2012, the Second Circuit Court of Appeals sided with Caronia, overturning his conviction. In a 2-1 split decision, the court found that the prosecutors’ contention that Caronia’s promotional speech constituted misbranding and amounted to criminalizing speech. Such a restriction on speech, the court noted, would require the government to satisfy a set of rigorous conditions to justify it—a standard that many judges are now applying, even when the restriction concerns “commercial speech” like drug promotion. Citing a 2011 Supreme Court decision, the court held that heightened scrutiny was also appropriate because the FDA regulations targeted only statements with a particular content (off-label promotion) and only when disseminated by drugmakers. Under this requirement for heightened scrutiny, precedent held that if the commercial speech is “truthful and not misleading,” restricting it must serve a substantial government interest, directly and materially advance that interest, and be no broader than necessary. Focusing on the latter 2 requirements, the court found that restricting offlabel promotion does not directly advance the government’s interest in reducing unsafe drug use because it “paternalistically” blocks the “free flow of information” that could improve a physician’s off-label prescribing decisions, since it is the physician’s—not the government’s— role to determine which information is useful. Second, the court held that limiting off-label promotion is too broad an intervention, because the government could achieve its goal without inhibiting speech. Other options included educating physicians and patients “in differentiating between misleading and false promotion, exaggerations and embellishments, and truthful or non-misleading information,” affixing disclaimers to off-label uses, capping the number of off-label prescriptions a physician may write, and reminding physicians that they could be sued for malpractice if off-label prescriptions resulted in adverse outcomes. Although the 3-judge opinion is subject to review by the full Second Circuit (as well as the Supreme Court), United States v Caronia signals that courts’ evolving views of protecting corporations’ commercial speech may prove incompatible with regulating drug promotion. The nation has long put prescription drugs in a special category of commercial goods and regulated their promotion more than that of other products because unsubstantiated claims by manufacturers about their medications can result in tragic public health consequences. As a result, manufacturers cannot sell drugs without the FDA determining that their benefits outweigh their risks for their intended uses. As the dissenting judge pointed out, the United States v Caronia decision could be the first step in the judicial dismantling of the US system of drug regulation.