Spontaneous reporting of adverse drug reactions: who reports and what?

A survey among Bordeaux pharmacovigilance centre 'users' and 'non-users' was conducted in Aquitaine, France. Two hundred physicians having reported to the centre at least one adverse drug reaction (ADR) during the past 3 years were matched to a randomly selected sample of 400 physicians who did not report. They were asked to anonymously fill out a postal questionnaire collecting data on their individual characteristics, including their practice mode, and on ADRs that they observed and reported during the past 12 months. The number of questionnaires returned was 151 (25%), of which 76 were from users (38%) and 75 from non-users (19%). The two groups had very close individual characteristics. All but three responders had observed at least one ADR during the past 12 months. For the different types of ADRs defined in terms of seriousness and labelling, more users had seen ADRs than non-users but among those who observed them, the numbers of ADRs seen were similar in both groups. In any case, the more recent the drug, the more prone to report were the physicians.     

Data mining spontaneous adverse drug event reports for safety signals in Singapore – a comparison of three different disproportionality measures

ABSTRACT

Objectives: Quantitative data mining methods can be used to identify potential signals of unexpected relationships between drug and adverse event (AE). This study aims to compare and explore the use of three data mining methods in our small spontaneous AE database.

Methods: We consider reporting odds ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN) and Gamma Poisson Shrinker (GPS) assuming two different sets of criteria: (1) ROR–1.96SE>1, IC–1.96SD>0, EB05>1 (2) ROR–1.96SE>2, IC–1.96SD>1, EB05 >2. Count of drug-AE pairs ≥3 was considered for ROR and GPS.

Results: The Health Sciences Authority, Singapore received 151,180 AE reports between 1993 and 2013. ROR, BCPNN and GPS identified 2,835, 2,311 and 2,374 significant drug-AE pairs using Criterion 1, and 1,899, 1,101 and 1,358 respectively using Criterion 2. The performance of the three methods with respect to specificity, positive predictive value and negative predictive value were similar, although ROR yielded a higher sensitivity and larger area under the receiver operating characteristic curve. ROR and GPS picked up some potential signals which BCPNN missed.

Conclusions: The defined threshold used for ROR (Criterion 1) is a useful screening tool for our small database. It may be used in conjunction with GPS to avoid missed signals.     

How much for a dime bag? An exploration of youth drug markets

Relatively little is known about how youth obtain marijuana and other drugs. The Drugs, Alcohol and Violence International (DAVI) study explored youthful drug markets among samples of school students, detained youth, and school dropouts (ages 14-17 years) in the greater metropolitan areas of Philadelphia, Toronto, Montreal, and Amsterdam. Students frequently reported sharing drugs, either getting them from others or giving them to others for free. Sharing was less common among the more drug-involved detainees and dropouts. Marijuana was typically obtained either outdoors or in a house or apartment. Few youth reported getting marijuana at school. In Amsterdam, where marijuana can be purchased in small quantities in coffeeshops, this was the most common place to get marijuana, even though 18 is the legal age for purchase. Alcohol was also most likely to be obtained in stores or restaurants across all the sites, even though none were of legal age except those in Amsterdam age 16 or older. Youth most often reported purchasing marijuana in nickel, dime or other small bags, which are not standardized units. The exception again was Amsterdam, where youth most often reported quantities in grams or joints, which is how it is sold in coffeeshops. The lack of standardization of units makes economic cost estimates suspect. Even standardized units such as alcohol present problems since youth report a wide range of 'typical purchases.' Survey data can, however, more aptly describe drug market characteristics such as general location of purchase, and relationship with the seller.     

How do treatment repeaters use the drug treatment system? An analysis of injection drug users in Massachusetts

This study explored common drug treatment utilization patterns in the first four types of treatments entered by injection drug users (IDUs) with multiple admissions. A Massachusetts longitudinal database with all entries to all licensed drug treatment programs was used. Treatment repeaters' admission patterns varied considerably. For the years 1997-2001, there were 2,500-3,000 IDUs new to the system each year who became treatment repeaters and who had more than 250 utilization patterns. Only approximately half of these repeaters followed the 10 most common utilization patterns. The most common pattern (for 30% of the population each year) was only entering detoxification two to four times; the only other common pattern (involving 4-8% of the population) was having entered methadone maintenance twice or having entered detoxification then methadone maintenance. Studies are needed to identify the extent to which the absence of a systematic pattern is caused by client, payment, or treatment setting and systems issues. A key implication is the need to develop policies that provide support for states to develop continuum-of-care models for their drug treatment systems.     

Future of toxicology--mechanisms of toxicity and drug safety: where do we go from here?

Recent high-profile drug withdrawals increase the pressure on regulators and the pharmaceutical industry to improve preclinical safety testing. Understanding mechanisms of drug toxicity is an essential step toward improving drug safety testing by providing the basis for mechanism-based risk assessments. Nonetheless, despite several decades of research on mechanisms of drug-induced toxicity and the application of various new technologies to preclinical safety assessment, the overall impact on preclinical safety testing has been modest. Assessing the risk of exposing humans to new drug candidates still depends on preclinical testing in animals, which in many, but not all cases, predicts outcomes in humans accurately. The following offers a perspective on the challenges and opportunities facing efforts to improve preclinical safety testing and outlines gaps and needs that must be addressed. A case is built for focusing solutions on defined problems within the current safety testing paradigm rather than imposing wholesale change. Targets for application of new technologies, including in silico screening, biomarkers, surrogate assays and 'omic technologies, are outlined. Improving drug safety testing will depend on improving the application of mechanism-based risk assessment but will also require improving public and private collaborations in order to focus research regarding the mechanism of drug-induced toxicity on the most important problems.     

Community pharmacists’ knowledge and perspectives of reporting adverse drug reactions in Australia: a cross-sectional survey

International Journal of Clinical Pharmacy - Background Under-reporting of adverse drug reactions (ADRs) by healthcare professionals is prevalent worldwide. Community pharmacists are the most...     

“How do online and offline sampling compare in a multinational study of drug use and nightlife behaviour?”

BackgroundOnline sampling is widely used to recruit hard to reach samples such as drug users at nightlife events. We conducted the first study comparing differences in demographics, drug use and nightlife behaviour between an online sample of young adults engaging with the European nightlife scene, and an offline sample recruited at nightclubs and festivals in Europe.MethodsOnline participants who attended at least six nightlife events in the past 12 months were recruited using social media advertising (May-November 2017). Offline participants were recruited at nightclubs and festivals using a random intercept method (May-November 2017). Samples were compared with respect to age, gender, past year use of alcohol, cannabis, cocaine, ecstasy/MDMA and amphetamines, and past year attendance at nightclubs, licensed festivals, illegal festivals, pubs and house-parties.Results6153 online and 3529 offline participants were recruited. When adjusting for differences in age and gender, online participants were less likely to have used each drug and to have attended illegal festivals, pubs and house-parties in the past 12 months. The online sample also used each drug and attended each venue, with the exception of nightclubs, less frequently on average than offline participants. Adjusted odds ratios (range 0.37 to 1.39) and regression coefficients (range -0.84 to 0.07) indicate that the majority of observed differences between the samples were of a small effect size.ConclusionsEstimates of drug use and nightlife engagement are more conservative when using online sampling compared to venue based sampling. Observed differences were generally small in effect, indicating good overall representativeness when using online sampling in the European nightlife scene.     

Incidence of lethal adverse drug reactions in the comprehensive hospital drug monitoring, a 20-year survey, 1974–1993, based on the data of Berne/St. Gallen

Objectives: Realising the limitations of spontaneous drug monitoring systems concerning the epidemiological aspects, a comprehensive program was founded. It was based on previous publications from the US, Canada and Northern Ireland, mainly those of the BCDSP (Boston Collaborative Drug Surveillance Programme). Methods: Drug monitoring was carried out by a group of physicians which included the medical head of each of the divisions of internal medicine, a statistician and an informatician. Only probable or definite drug event relationships were included. A probable event is defined as one in which the drug interaction was more likely to be the cause than any non-drug-related cause. The same criteria were valid for the lethal reactions. Results: In the present evaluation, we found 26 probable lethal adverse drug reactions out of a total of 48,005 patients consecutively admitted to the divisions of internal medicine of three Swiss teaching hospitals during the years 1974–1993, an incidence of 0.054%. The median age of the cohort was 68 years (range 11–103 years), of which 49% were women. The median hospital stay was 14 days and the median number of drugs was eight per patient. Conclusion: The patients with a lethal outcome were presented under the eight pharmacologic–therapeutic classes of drugs and the classification proposed by NS Irey. This is based on long histopathologic experience and helps to identify preventable risks. Received: 30 June 1999 / Accepted in revised form: 10 April 2000     

How do general practitioners manage alcohol-misusing patients? Results from a national survey of GPs in England and Wales

The appropriateness of the primary care setting to undertake health promotional activities has been emphasized, but little is known about the clinical work of GPs with patients misusing alcohol. This study examines how GPs managed alcohol-misusing patients. A 20% random sample of all general practitioners in England and Wales were surveyed using a postal questionnaire. A 44% response rate was achieved. GPs reported managing different levels of severity of drinking problems differently. Basic interventions, such as reporting the alcohol misuse diagnosis and the provision of advice and information, were routine. Health promotion leaflets were not used uniformly, even with the less severe problem drinkers. Detoxification, prescribing of drugs and the management of medical complications were undertaken mainly with dependent patients. Dependent drinkers were the most likely group to be referred to specialist services, while internal practice referrals occurred with all drinking status categories. Anti-depressants were the drugs most usually prescribed to alcohol-misusing patients. The data point to a need for basic guidelines, not only on how to manage and refer dependent drinkers, but also on how to detect and manage those who are not yet manifesting problems but are drinking above recommended guidelines. One of the most evident areas in which there appears to be a need for guidelines is that of prescribing within primary care.     

How do components of evidence-based psychological treatment cluster in practice? A survey and cluster analysis

Evidence-based psychological treatments (EBPTs) are clusters of interventions, but it is unclear how providers actually implement these clusters in practice. A disaggregated measure of EBPTs was developed to characterize clinicians' component-level evidence-based practices and to examine relationships among these practices. Survey items captured components of evidence-based treatments based on treatment integrity measures. The Web-based survey was conducted with 75 U.S. Department of Veterans Affairs (VA) substance use disorder (SUD) practitioners and 149 non-VA community-based SUD practitioners. Clinician's self-designated treatment orientations were positively related to their endorsement of those EBPT components; however, clinicians used components from a variety of EBPTs. Hierarchical cluster analysis indicated that clinicians combined and organized interventions from cognitive-behavioral therapy, the community reinforcement approach, motivational interviewing, structured family and couples therapy, 12-step facilitation, and contingency management into clusters including empathy and support, treatment engagement and activation, abstinence initiation, and recovery maintenance. Understanding how clinicians use EBPT components may lead to improved evidence-based practice dissemination and implementation.     

A prospective survey of knowledge and perceptions of ondansetron: what do health care workers know about this drug?

Ondansetron is a relatively new drug whose optimal use is dependent on an understanding of its characteristics and role relative to traditional antiemetics. To assess perceptions and knowledge regarding ondansetron, we conducted a prospective written survey involving 56 physicians, pharmacists, and nurses at this hospital. Pharmacists claimed to be exposed to ondansetron promotion by industry more than the other groups. Apart from industry, pharmacists were considered to be the most common source of drug information. Nurses were less aware of dosage form equivalence than the other groups (p = 0.042). Physicians were more aware of twice daily dosing efficacy than other respondents (p = 0.0006). Nurses were able to better identify the relative duration of antiemetic benefit over metoclopramide (p = 0.008); however, most participants tended to be misinformed on this issue. Pharmacists were more familiar with the side effect profile while physicians were more cognizant of oral (p = 0.001) and parenteral (p = 0.018) drug costs than other groups. Overall, survey scores for physicians and pharmacists were higher than those for nurses (p = 0.007). There is an apparent difference across health care profession disciplines in the perceptions and knowledge about ondansetron. Specific misconceptions could lead to suboptimal drug use and warrant efforts to ensure a good understanding of the attributes and relative role of this agent.     

How do drinking cultures change? – or do they?: A provisional model based on evidence of transitions in Denmark

Denmark, along with other industrialised nations, has experienced recent declines in alcohol consumption and other changes to its drinking culture. The point of departure for this study stems from growing evidence of changes in the Danish drinking culture. We have thus proposed a model to describe a society’s drinking culture and have then applied it to the Danish case. We examine trends for several components of the model and focus roughly on a 10-year period from 2003 to 2013. The components include longitudinal survey data on consumption and alcohol‐related harm, registry data on morbidity and mortality, alcohol taxes and prices, physical availability, consumer purchasing power, demographic and structural changes, drinking norms and attitudes, alcohol advertising, as well as health education and promotion efforts. Although unable to conduct formal tests of drinking culture change, a review of our assembled data points in the direction of declining or stagnating consumption and increasing restrictiveness in attitudes, policies and regulations, thus suggesting the start of a shift in drinking practises and perceptions in Denmark. Such changes may also apply to other industrialised countries. Future research should examine longer periods, refine the model and its components, and if possible, conduct formal tests of change.     

National and local guidance on services for drug misusers: do they influence current practice?— results of a survey of community pharmacists in South East England

Objective — To investigate levels of awareness of national and local guidance about services for drug misusers and their effect on pharmacy practice. Method — A postal survey in 1997 to collect data on current involvement in services for drug misusers, awareness of and receipt of key documents pertaining to drug misuse, effects of guidelines and protocols on practice, and influences on decisions to provide services. Setting — A random one in two sample (n=1,582) of community pharmacies in the South East of England (North and South Thames regions). Key findings — A 65.1 per cent response rate was achieved. Just over half (54.7 per cent) were dispensing Controlled Drugs for the management of dependence, 47.2 per cent were selling clean injecting equipment and 15.5 per cent were offering a needle exchange service. Most respondents were unaware of key government documents, with the exception of “Health of the nation,” and only a small minority had received copies. The most influential factors on current position on service provision were “personal experience,” “local need” and “Royal Pharmaceutical Society of Great Britain (RPSGB) policy.” New local guidelines and initiatives mainly related to supervised consumption of methadone in pharmacies and pharmacy needle exchange. Conclusion — Community pharmacies are substantially and increasingly involved in providing*** primary care services for drug misusers. However, there is a disturbing lack of awareness of key government initiatives, possibly due to the lack of dissemination of such documents. RPSGB policy as a key influencing factor points to an opportunity for the profession to take a more influential position.