International Journal of Risk & Safety in Medicine - Volume Pre-press, issue Pre-press

Authors: Gøtzsche, Peter C.

Article Type: Research Article

Abstract: BACKGROUND: The widespread use of psychiatric drugs does not appear to be evidence-based but seems to be driven mainly by commercial pressures. I studied whether two widely differing drug classes, antipsychotics and antidepressants, showed similar patterns in long-term usage. METHODS: I constructed usage curves over a ten-year period, from 2006 to 2016, based on data from Statistics Denmark. RESULTS: In 2006, a total of 110,235 patients deemed a prescription for an antipsychotic and 395,018 for an antidepressant, corresponding to 2.0% and 7.3% of the Danish population. Only 21,846 vs. 79,030 of these were first-time users (19.8% …vs. 20.0% ). The percentage of current users who redeemed a prescription for the same or a similar drug in each of the following years was remarkably similar for the two classes of drugs, and after ten years, it was 35% vs. 33%. Using the requirement that the patients identified in 2006 needed to redeem the prescription only once during the next ten years, 42% vs. 43% were taking a drug in 2016. This suggests that most patients identified at any given point in time as drug users continue taking such drugs for many years, with little or no interruption in drug intake. For first-time users, the drop in usage was much quicker. The percentage of first-time users who redeemed a prescription for the same or a similar drug in each of the following years fell to about one-third (29% vs. 36% ) already after two years. Using 2011 as the starting year yielded similar results. CONCLUSIONS: If we accept the evidence-based premises that antipsychotics and antidepressants do not have clinically relevant effects and that the patients dislike them, the data suggest massive overuse of the drugs, to a remarkably similar degree. We need to focus on helping patients withdraw slowly and safely from the drugs they are on instead of telling them that they need to stay on them. Show more

Keywords: Antipsychotics, antidepressants, usage

DOI: 10.3233/JRS-195060

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-6, 2019

Authors: Katyal, Jatinder | Arora, Ekta | Gupta, Yogendra Kumar

Article Type: Research Article

Abstract: BACKGROUND: Recent years have seen a surge in pharmacovigilance (PV) related activities in India. In the present study the impact of these initiatives on medical students from across the country was evaluated to identify their effectiveness, lacunae and arrive at remedial measures. METHODS: A cross-sectional, questionnaire based study was conducted. The survey questionnaire consisted of 28 multiple response items. The areas covered included subject knowledge (theoretical and practical), attitude and awareness towards pharmacovigilance. RESULTS: The survey participants (n  = 253) were from 71 medical colleges and 17 states across India. While 60% of the participants were familiar …with the term ‘Pharmacovigilance’, many could not distinguish side effect and adverse drug reaction. The majority was unaware that ‘Periodic Safety Update Report’ (PSURs) is a mandatory pharmacovigilance activity by the industry. 91% felt reporting is a useful practice and causes for under-reporting are a lack of awareness followed by attitude, misconceptions about what to report, fear of litigation and interestingly the least important is lack of time. However, most were reluctant to have reporting as mandatory tool; they would rather use it voluntary. CONCLUSION: In spite of collaborative and synchronized efforts by various agencies there is a need to further improve the PV milieu in India by confidence building exercises, imparting training on PV programme, updating of the current knowledge on PV and also sustaining motivation. Show more

Keywords: Pharmacovigilance, medicine safety, adverse drug reaction, medical students, India

DOI: 10.3233/JRS-195012

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-10, 2019

Authors: Ivashchenko, D.V. | Buromskaya, N.I. | Savchenko, L.M. | Shevchenko, Yu.S. | Sychev, D.A.

Article Type: Research Article

Abstract: OBJECTIVE: To analyse the frequency, structure and risk factors of adverse drug effects in adolescents with acute psychotic episode by the methods of global triggers - Paediatric All-Cause Harm Measurement Tool (PACHMT) and Global Assessment of Paediatric Patient Safety Tool (GAPPS). PATIENTS AND METHODS: We used 151 completed case histories of patients who were admitted to a psychiatric hospital with acute psychotic episode. We applied Global Trigger Tool algorithm to each case retrospectively: we developed a special trigger list for psychiatric patients based on PACHMT, GAPPS and general Global Trigger Tool. We also calculated the Medical Appropriateness Index …(MAI) for each case. We applied trigger tool analysis for calculation of treatment safety parameters. Statistical analyses included Pearson’s Chi-square, Mann-Whitney U, and Kruskal-Walles tests. RESULTS: We identified a total of 261 triggers among 151 analysed cases, 51 of which were accompanied by adverse drug effects (ADEs) (overall positive prediction value = 19.54% ). The value of ADEs per 1000 bed days was 4.73, ADEs per 100 admissions was 33.77%. Extrapyramidal reactions to antipsychotics (58.8% ) were the most common ADEs, followed by an abrupt medication stop of one or more drugs due to ADEs (25.5% ). Significant predictors of antipsychotic-induced extrapyramidal symptoms were age, MAI score and total number of hospital admissions. CONCLUSION: We recommend three triggers, “Abrupt medication stop”, “Prescribing of extrapyramidal symptoms corrector”, and “Hospital readmission within 30 days”, with reasonable positive predictive value for incorporation into routine systems for patient safety monitoring in adolescents with an acute psychotic episode. Antipsychotic-induced extrapyramidal symptoms were more prevalent in older adolescents and patients with fewer lifetime hospital admissions. These patients need to be carefully monitored to ensure patient safety. Show more

Keywords: Drug safety, psychiatry, Global Trigger Tool, antipsychotics, safety, adolescents, GAPPS

DOI: 10.3233/JRS-195030

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-11, 2019

Authors: Harasani, Klejda | Xhafaj, Delina | Qipo, Orgesa

Article Type: Research Article

Abstract: BACKGROUND: Prevalence of potentially inappropriate prescriptions (PIP) varies among community-dwelling patients and this difference partly depends on the methods used to evaluate improper use. OBJECTIVE: The aim of our study was to assess the prevalence and type of PIP among community-dwelling elderly as well as among middle-aged people by applying three different explicit tools – Ghent Older People’s Prescriptions community Pharmacy Screening (GheOP3 S) tool, The European Union Potentially Inappropriate Medications EU(7)-PIM list and PRescribing Optimally in Middle-aged People’s Treatments (PROMPT). METHODS: Cross-sectional study among community-dwelling patients in Tirana (Albania) from 1 March to 1 June …2018. Two community pharmacists reviewed the prescriptions independently. The PIP index and the mean number of PIP / patient was calculated. RESULTS: In total, 241 participants were included in the study. Among 142 elderly patients, 55.6 % and 54.2 % of them were prescribed at least one PIP, respectively according to the GheOP3 S tool and the EU7 PIM list. After applying PROMPT criteria, we found at least one PIP in 33.3 % of the middle-aged patients. The most commonly represented PIP drugs groups were cardiovascular drugs among older people and non-steroidal anti-inflammatory drugs among middle-aged people. Reminding and proposing the patient to undergo yearly influenza vaccination was the most common potentially prescribing omission. CONCLUSIONS: Prevalence of PIP is higher in elderly patients and slightly different according to the tool used for detection. However, PIP are also common in the middle-aged population. Show more

Keywords: Potentially inappropriate prescriptions, community-dwelling patients, prevalence, Albania ORCID 0000-0002-1877-6662

DOI: 10.3233/JRS-195052

Citation: International Journal of Risk & Safety in Medicine, vol. Pre-press, no. Pre-press, pp. 1-9, 2019