Safety Profile Of Medicines Research Articles

Assessment of self-medication practices and safety profile of medicines utilisation among pregnant women attending antenatal clinics in Freetown, Sierra Leone: a multicentre cross-sectional study.

Despite the potential foetal and maternal risks of self-medication, studies on self-medication practice and the safety profile of medicines used during pregnancy are scarce in our setting. This study determined the self-medication practice and safety profile of medicines used among pregnant women. This cross-sectional study was conducted in face-to-face interviews among 345 pregnant women at three hospitals in Sierra Leone. Data were analysed using descriptive statistics and binary logistic regression to determine the prevalence and associated factors of self-medication. A total of 345 pregnant women participated in the study. The prevalence of self-medication prevalence among pregnant women with conventional and/or herbal medicine was 132 (38.3%). Also, 93 (75%) of the conventional medicines (CMs) were categorised as probably safe, of which paracetamol 36 (29.0%) was commonly used, followed by amoxicillin 23 (18.5%) and antimalarials 22 (17.7%) for common illnesses such as headache 30 (25.4%), urinary tract infection 23 (19.4%) and malaria 22 (18.6%). The most common reason for self-medication was previous experience with the disease 24 (27.3%). Luffa acutangula 19 (30.2%) was the most used herbal medicine (HM), and Oedema 30 (47.6%) was the most reported ailment. Among the HM users, 34 (54.0%) believe they are more effective than CMs. Secondary school education (AOR = 2.128, 95%CI = 1.191-3.804, p = 0.011), tertiary education (AOR = 2.915, 95%CI = 1.104-7.693, p = 0.031), monthly income of greater than NLe 1,000 (AOR = 4.084, 95% CI = 1.269-13.144, p = 0.018), and perceived maternal illness (AOR = 0.367, CI = 0.213-0.632, p = <0.001) were predictors of self-medication. Self-medication practice was highly prevalent and was associated with educational status, monthly income, and perceived maternal illness during pregnancy. Therefore, intervention programmes should be designed and implemented to minimise the practice and risk associated with self-medication among pregnant women.

Safety Profile of Medicines Used for the Treatment of Drug-Resistant Tuberculosis: A Descriptive Study Based on the WHO Database (VigiBase®).

The introduction of new drugs that increase the usage of repurposed medicines for managing drug-resistant tuberculosis (DR-TB) comes with challenges of understanding, properly managing, and predicting adverse drug reactions (ADRs). In addition to the health consequences of ADRs for the individual, ADRs can reduce treatment adherence, thus contributing to resistance. This study aimed to describe the magnitude and characteristics of DR-TB-related ADRs through an analysis of ADRs reported to the WHO database (VigiBase) in the period from January 2018 to December 2020. A descriptive analysis was performed on selected reports from VigiBase on the basis of medicine-potential ADR pairs. The ADRs were stratified by sex, age group, reporting country, seriousness, outcome of the reaction, and dechallenge and rechallenge. In total, 25 medicines reported to be suspected individual medicines or as a fixed-dose combination in the study period were included the study. Pyrazinamide (n = 836; 11.2%) was the most commonly reported medicine associated with ADRs, followed by ethionamide (n = 783; 10.5%) and cycloserine (n = 696; 9.3%). From the report included in this analysis, 2334 (31.2%) required complete withdrawal of the suspected medicine(s), followed by reduction of the dose (77; 1.0%) and an increased dose (4; 0.1%). Almost half of the reports were serious ADRs mainly caused by bedaquiline, delamanid, clofazimine, linezolid, and cycloserine that are the backbone of the DR-TB treatment currently in use. A third of the reports required medication withdrawal, which impacts treatment adherence and ultimately leads to drug resistance. Additionally, more than 40% of the reports indicated that ADRs appeared two months after the commencement of treatment, thus it's important to remain alert for the potential ADRs for the entire duration of the treatment.

Characteristics of paediatric adverse drug reaction reports in Malaysia

During clinical trials, special populations such as children, pregnant women and elderly are excluded, creating lack of information on safety profile of medicines in these population. The lack of reliable efficacy and safety data often leads to under- or over-dosing in paediatric age groups which make them susceptible to adverse drug reactions (ADRs). This study was aimed to investigate the characteristics of ADR reports and serious ADRs among paediatric population in Malaysia. Descriptive analyses were undertaken for demographic characteristics and severity of the ADRs. Binary logistic regression was performed to identify association between selected variables and ADRs. A total of 3410 paediatric case reports for 6769 ADRs were reported within the 5-year period. Children aged one to 12 years old were the most frequently reported to experience ADRs (n=5488, 81%). Male gender exceeds more than half of the ADR reports (n=3812, 56.3%) and Malay race has the highest ADR reports (n=4780, 72%). Majority of the ADR reports were not serious (n=6285, 93%). Anti-infective medicines contributed most of the ADR reports (n=6024, 75%). The most common ADRs were from general disorders and administration site conditions (n=2879, 43%). A binary logistic regression showed male gender were more likely to experience nervous and respiratory system disorder ADRs (p &lt; 0.05). Surveillance of medicines marketed for use in children must be strengthened to prevent severe life-threatening ADRs. Effective support decision tool for prescribing in paediatric population with an integrated pharmacovigilance monitoring will support continuous safety monitoring for all marketed medicines.

Effectiveness of the Med Safety mobile application in improving adverse drug reaction reporting by healthcare professionals in Uganda: a protocol for a pragmatic cluster-randomised controlled trial

IntroductionCombination antiretroviral therapy (cART) has massively reduced HIV mortality. However, long-term cART increases the risk of adverse drug reactions (ADRs), which can lead to higher morbidity, mortality and healthcare costs...

PNS22 Real-World DATA of ADR Reports in Signal Detection - DME Perspective

The Designated Medical Event (DME) is a serious medical event that is often causally associated with medicines. This way, EMA has developed a list of DME, through Medical Dictionary for Regulatory Activities (MedDRA). The list is used by the EMA and Member States to focus on suspected adverse drug reaction(ADR) reports that deserve special attention, irrespective of statistical criteria used to prioritise safety reviews. DME search in ADR reports is one of the methods used to detect safety signals. The objective of our study is to identify and characterize the reports of ADR that contain the DME, in Portugal. A retrospective study was conducted to identify and characterize the spontaneous ADR reports with DME, occurred in Portugal, between 2014 to 2019. A descriptive analysis was performed for the following data: type of notifier (consumer or healthcare professional), medicines classified by the Anatomical Therapeutic Chemical Code, ADR coded with MedDRA and description of ADR in the summary of product characteristics (SmPC). During this 5-year period, the Portuguese Pharmacovigilance System received 15344 reports, of these 1335 correspond to reports with DME (1305 by healthcare professionals; 30 by consumers). The annual percentage of reports with DME has been increasing, with the exception of the last year. The most frequent ATC group with or without DME is “Antiinfectives For Systemic Use”. The most frequent System Organ Classes of the reports with the DME is “Skin and subcutaneous tissue disorders”. Of the 1335 reports with DME terms, 130 of these reports are not described in the SmPC. It is important to obtain real-word data, especially in the area of drug safety, because it is a way to prevent ADR. In this way, notifiers should be made aware of the importance of sharing data related to ADR, thus increasing knowledge about the safety profile of medicines.

Clinical trials with drugs in Brazil: an analysis of the main characteristics

Introdução: Os resultados de ensaios clínicos são utilizados pelas agências regulatórias de todo o mundo para fins de registro e comercialização de medicamentos. A Agência Nacional de Vigilância Sanitária (Anvisa) é a responsável pelos registros de tecnologias em saúde no Brasil e regras para análises técnicas de ensaios clínicos. A Anvisa vem atuando para atualizar seu arcabouço regulatório a respeito de ensaios clínicos com medicamentos no país, para reduzir tempo de análise e harmonizar conforme regras internacionais. Objetivo: Caracterizar os ensaios clínicos de fase III, com medicamentos, realizados no Brasil a partir da publicação da RDC n° 9, de 20 de fevereiro de 2015, da Anvisa. Método: Estudo exploratório e descritivo realizado em três etapas: (1) análise quantitativa pré e pós RDC n° 9/2015; (2) análise da população participante de ensaio clínico que embasou registros de medicamentos; (3) caracterização dos ensaios clínicos realizados no Brasil. Resultados: Houve redução em 20% de ensaios clínicos realizados no Brasil quando se compara o período anterior e posterior à publicação da RDC n° 9/2015 da Anvisa; apenas 33% dos ensaios clínicos que embasaram registros de medicamentos no país foram realizados com população brasileira; os medicamentos sintéticos e biológicos somam 96% da intervenção estudada nos ensaios clínicos; placebo ainda é muito utilizado como comparador (37%); a indústria farmacêutica é majoritariamente o patrocinador dos ensaios clínicos (86%). Conclusões: Diante deste cenário, é imperativo que se fortaleçam as ações de farmacovigilância no Brasil, a fim de conhecer os perfis de efetividade e segurança dos medicamentos após exposição da população brasileira.

Self-Medication and Safety Profile of Medicines Used among Pregnant Women in a Tertiary Teaching Hospital in Jimma, Ethiopia: A Cross-Sectional Study.

Background: Despite the potential foetal and maternal risks of self-medication, studies on self-medication and safety profile of medicines used during pregnancy are scarce. This study determined the prevalence, predictors and safety profile of medicines used for self-medication during pregnancy at Jimma University Medical Centre (JUMC) in Ethiopia. Methods: A hospital-based cross sectional study was conducted on 1117 hospitalized pregnant women or postpartum women in the maternity and gynaecology wards at JUMC between February and June 2017. Data were collected using an interviewer-administered structured questionnaire and by reviewing patient medical records. Data were analysed using descriptive statistics and logistic regression. Result: Nearly 3 out of 10 women reported taking at least one type of conventional medicine for self-medication, mainly analgesics 92.3%. Almost 75.0% of the self-medicated women used medicines classified as probably safe and 13.6% as potentially risky to use during pregnancy. Medicinal plant use, religion and access to a health facility near their residency were significantly associated with self-medication during pregnancy. Conclusions: Self-medication is common among pregnant women at JUMC. Most women used medicines classified as safe to use during pregnancy. There is need for enlightenment of pregnant women on the potential dangers of self-medication during pregnancy to prevent foetal and maternal risks.

Dried Blood Spots, Pharmacokinetic Studies and Better Medicines for Children

Determining circulating drug concentrations in children is an ongoing obstacle to the development of age-appropriate dosing regimens. The requirement for small blood sample volumes in children compared with adults is a significant barrier to obtaining age-specific pharmacokinetic-pharmacodynamic data for this population and hence optimizing the efficacy and safety profile of medicines used by this group. This article discusses the potential for dried blood spot sampling to offer a solution to this issue.

Submit a Yellow Card to report adverse drug reactions

The Yellow Card scheme involves the collection of voluntary reports of suspected adverse drug reactions by health professionals. It is operated jointly by the Committee on the Safety of Medicines (CSM) and the Medicines and Healthcare products Regulatory Agency (MHRA). The purpose of the scheme is to increase the understanding of the safety profile of medicines and to ensure that any unrecognized adverse effects of medicines are identified as quickly as possible.