Monitoring Drug Safety Information - Recommendations of Foreign Regulatory Authorities

Analysis of administrative decisions of foreign regulatory authorities on the recoil of medicines and/or the need for changes in the instructions for their medical use due to changes in the safety profi le, conducted by experts of the Scientifi c Centre for Expert Evaluation of Medicinal Products revealed 16 administrative decisions. These decisions contained information on the following medicines registered in Russia: norepinephrine, xylometazoline, mometason, liraglutide recombinant, exenatide, insulin recombinant human, insulin degludec, teriparatide, progesterone, gestodene, desogestrel, dienogest, drospirenone, norgestrel, lynestrenol, levonorgestrel, medroxyprogesterone, mestranol, nomegestrol, norethisterone, norgestimate, chlormadinone, cyproterone, estradiol, ethinylestradiol, etonogestrel, ethinylestradiol, fi nasteride, abiraterone, thiamazole, omega-3-acid ethyl esters, pitavastatin.

Monitoring of Foreign Drug Safety Information

Analysis of administrative decisions of foreign regulatory authorities on the recoil of medicines and/or the need for changes in the instructions for their medical use due to changes in the safety profile, conducted by experts of the Scientific Centre for Expert Evaluation of Medicinal Products revealed 23 administrative decisions. These decisions contained information on the following medicines registered in Russia: аmitriptyline, duloxetine, quetiapine, lamotrigine, topiramate, phenytoin, articaine, epinephrine, bupivacaine, oxybutynin, dexlansoprazole, pantoprazole, esomeprazole, famotidine, ketoconazole, minocycline, quinolone and fluoroquinolone (cinoxacin, ciprofloxacin, flumequine, levofloxacin, lomefloxacin, moxifloxacin, nalidixic acid, norfloxacin, ofloxacin, pefloxacin, pipemidic acid, prulifloxacin and rufloxacin), antiretrovirals (abacavir, abacavir, dolutegravir, lamivudine, zidovudine, atazanavir, cobicistat, emtricitabine, tenofovir, darunavir, didanosine, rilpivirine, efavirenz, enfuvirtide, etravirine, fosamprenavir, indinavir, lopinavir, ritonavir, maraviroc, raltegravir, rilpivirine, nevirapine, saquinavir, tipranavir), direct-acting antiviral drugs (daclatasvir, dasabuvir, elbasvir, grazoprevir, glecaprevir, pibrentasvir, sofosbuvir, ombitasvir, ritonavir).

Patients' Knowledge of Key Messaging in Drug Safety Communications for Zolpidem and Eszopiclone: A National Survey

Drug Safety Communications (DSCs) are used by the Food and Drug Administration (FDA) to inform health care providers, patients, caregivers, and the general public about safety issues related to FDA-approved drugs. To assess patient knowledge of the messaging contained in DSCs related to the sleep aids zolpidem and eszopiclone, we conducted a large, cross-sectional patient survey of 1,982 commercially insured patients selected by stratified random sampling from the Optum Research Database who had filled at least two prescriptions for either zolpidem or eszopiclone between July 1, 2012 and June 30, 2013. Among the 594 respondents (32.7% response rate), two-thirds reported hearing generally about drug safety information prior to starting a new drug, with the remaining one-third “rarely” or “never” hearing such information. Providers and pharmacists were primary sources of drug safety information. Two-thirds of zolpidem users and half of eszopiclone users reported having heard about the related DSC messages, ability to accurately identify the major factual messages was limited (overall median 2 correct out of 5, with men and those reporting higher educational level scoring higher [2/5 vs. 1/5, p=0.001]). Respondents reacted to new drug safety information about their sleep aids by reporting that they would want to learn about alternative ways to help them sleep (70%) and seek out more information about the safety of their specific sleeping pill (59-78%). Opportunities may exist for the FDA to work with providers and pharmacies to help ensure the DSC information is more widely received and is more fully understood by those taking the affected medications.

Adverse drug reactions in hospitalized paediatric patients in a tertiary care center in Kerala, India

Background: Drug safety information about children is scarcely available. This study aims to describe the ADRs in hospitalized paediatric patients under 12 years of age in paediatrics wards of DM WIMS Hospital, Wayanad, Kerala, a tertiary care center in southern part of India.Methods: A retrospective study based on data collected as per the ongoing pharmacovigilance program of India (PvPI) was conducted for twelve months period in order to study the ADRs in hospitalized paediatric patients under 12 years of age with at least one medication prescribed. The study was conducted in paediatrics wards of DM WIMS Hospital, Wayanad. WHO-UMC scale and Naranjo´s Algorithm was used to evaluate causality, the modified Hartwig and Siegel assessment scale was used to establish severity and the Schumock and Thornton criteria was used to determine preventability.Results: Forty-two children (42) who experienced 55 ADRs were included in the study. The frequency was higher in children under 1 year of age (47.62%). Emergence of ADRs was higher in male patients (59.52%), in those used three or more medicines together (71.43%) and in those with systemic antibiotics (58.18%).Conclusions: Being the first study from Kerala in paediatric patients, it is an important contribution to drug safety profile in children from this region of India. ADRs frequency and other descriptive characteristics are provided for the enrolled children under 12 years of age. ADRs are an additional burden of morbidity and risk, particularly in those who used several medicines, including antibiotics.

A quantitative approach to segmentation for prescription drug safety programs

Purpose The aim of this paper is to enhance the effectiveness of pharmacovigilance programs that provide information about medical products to benefit consumers, aid health care professional’s decision-making and improve community health. This research sought to determine whether distinct segments of consumers can be identified for prescription drug safety social marketing and communication activities and if these segments would respond differently to information about prescription drug products. Design/methodology/approach Theories of risk information-seeking behavior were used to develop questions for respondents in an online survey panel. Latent class analyses identified clusters that were similar in their ability to accurately interpret risks and benefits, preferred sources of health information, medication use and other related factors. Multinomial logistic regression models identified demographic and psychographic differences across the segments. Logistic and linear regression models were then used to compare each segment’s responses to a specific drug safety information product. Findings The 1,244 respondents were clustered into four segments: not engaged (12 per cent), low-involvement users (29 per cent), careful users (50 per cent) and social information seekers (9 per cent). These segments were distinguished by perceived seeking control, self-appraisal of skill, information insufficiency, self-efficacy, information competency and health literacy. Sources of health information and health-seeking behaviors were also different across the four segments. Significant differences were found among the segments in their comprehension and perceived utility of the content and their intentions to take relevant actions. Practical implications From an array of potential behavioral influences, adults can be segmented by risk information-seeking constructs and related behaviors. These segments respond differently to drug safety information. Use of the personas developed in this work can help pharmacovigilance programs around the world develop more relevant and tailored social marketing products, services and content. Originality/value A social marketing approach using empirically tested theoretical constructs can be useful for drug safety or pharmacovigilance programs. The results were used to create personas that quickly convey relevant information to drug safety program managers and staff.