Pharmacovigilance and Adverse Drug Reactions (Adrs) Practice of Healthcare Professionals

Aim: To assess pharmacovigilance and adverse drug reactions practice of healthcare professionals in Ribat University Hospital, Khartoum, Sudan. Methods: This was a cross-sectional study to evaluate pharmacovigilance and ADRs practice among physicians, pharmacist and nurses working in the National Ribat University, Khartoum, Sudan. The sample size was calculated as 100. Data were collected by a pre-tested questionnaire after obtaining ethics approval. Data analysis was performed by SPSS software. Results: The HCPs who acquired good and poor pharmacovigilance practice were 16 (16%) and 84 (84%) respectively. Ninety-eight (98%) of the healthcare professionals have ever experienced ADR in their patients during professional practice. Ninety-four (94%) have ever seen ADR reporting form. Forty (40%) have ever reported ADR to the pharmacovigilance center. Pharmacists, Physicians and nurses with good practice were30.8%, 18.4% and 7.9% respectively. Conclusion: Most healthcare professionals acquire good pharmacovigilance practice. The pharmacist acquires higher level of pharmacovigilance practice followed by physicians and nurses. Healthcare professionals with shorter years of experience have significantly higher pharmacovigilance practice. Keywords: Pharmacovigilance, Adverse Drug Reactions, Healthcare Professionals

Gender Differences in Adverse Drug Reactions Among Adult Patients Reported to the Iraqi Pharmacovigilance Center

For many years it was argued that there may be a gender differences in adverse drug reactions (ADRs). This assumption was based on many possible factors such as hormonal or behavior differences, and it was not clearly identified since the female gender was not preferred to be enrolled in many clinical trials. The primary aim of this study was to assess the extent of possibly relevant gender differences in drug–ADRs regarding causality, severity, preventability, seriousness, expectedness and outcome. While the secondary aim was to assess for which group of drugs and for which ADRs gender differences are identified most often. The study was a retrospective one that depends on processing a specially selected group of data obtained from the Iraqi Pharmacovigilance Center database. The data included consisted of 3833 individual case safety reports sent during the period from 1st January 2017 to 31st December 2019. It was found that the reported adverse drug reactions for females (60.84 %) were much more than males (39.16 %). In addition, significant differences in age group distribution of adverse drug reactions were found in which females in their reproductive age had more adverse drug reactions while the older adult males were more likely to suffer adverse drug reactions if compared with the same age groups from the opposite gender. The highest type of adverse drug reactions for both genders were those that fall in the skin and subcutaneous tissue disorders (26.4 % in females) and (22.6 % in males) with statically significant difference between the two genders. While the highest group to cause adverse drug reactions was the systemic anti-infective agents with a greater chance ‘statistically significant’ in females to suffer a side effect from this group of medications (40.8 %) compared to male gender (35.5 %). The frequency of serious adverse drug reactions was significantly more prevalent in females (45.4 %) than for males (41.3 %) while the fatal outcome was significantly more observed in males (0.8 %) as compared with females (0.2 %). The expectedness analysis gave the finding that for each gender the expectedness of adverse drug reactions was nearly equal.

Perspectives of Pharmacovigilance of AYUSH Drugs among Teaching faculty, Post graduate students and Interns of three different Ayurvedic Teaching Institute in Amravati District of Maharashtra state – A cross sectional survey.

Pharmacovigilance helps to prove the system safe, more scientific in the terms of modern terminology. It is an absolute requirement to ensure public safety and to promote the AYUSH systems of medicine. Pharmacovigilance program launched in the India by Department of AYUSH, Ministry of health and family welfare, on 29/09/2008. Though it is helpful for development of system and government emphasized for implementation of it in root level, till date there is lack of awareness about this program among teaching faculties of AYUSH system. So to find out level of perspective of Pharmacovigilance in Teaching faculty, Post graduate students and Interns of Three different Ayurvedic Institutes in Amravati districts present study was carried out in November 2020. Method:A structured and validated questionnaire with some miner modification used3 and distributed in the form of Hard copy among Teaching faculty, Residential medical officer and Interns of Three Ayurvedic colleges in Amravati District of Maharashtra state. Total of 50 teaching faculties with 62% of Lecturer cadre, 32% are of Reader and 2.50% of Professor Cadre responded to the questionnaires, with this one medical officer also responded to the questionnaire. Total 12 PG (Post graduate students) of different department take participation in the study while 88 Interns recorded their response in this study, so total participants in this study are 150 (n=150).Result:52% (78) of participants aware of Pharmacovigilance program for Ayurvedic drugs in India and44% (66) of participants actually know exactly where the National Pharmacovigilance center for AYUSH Drugs is situated. Only 11.33% (17) of participants responded correct answer to question where the International Pharmacovigilance center for AYUSH drug is situated. In this study 58.66% (88) of participants accept that Ayurvedic drugs have adverse effect. Only 32.66% (49) participants responded that they are encountered with adverse event due to Ayurvedic drug in there clinical practice and out of which only 12% (18) of participants reported the adverse event. 18% of participant’s familiar with standardized format for reporting ADR.Only 3.33% of participants give the example of Ayurvedic drugs banned due to ADR. Only 5.33% of participants attended the CME or training program about Pharmacovigilance of Ayurvedic drugs.Conclusion: Over all result shows the lack of awareness towards Pharmacovigilance program of AYUSH drugs in faculty and students of all Ayurvedic colleges in Amravati. Also Bletonism to point out adverse drug reaction (ADR) caused due to Ayurvedic drug and report it to the authorized center in standardized format. So to increase awareness about PV it should be include in Syllabus and more CME, Seminar and workshop should organized for students, teaching faculty and private practioner.

Benzodiazepine poisoning in Morocco: epidemiological study.

Objective: This study aims to describe the main epidemiological characteristics of benzodiazepine intoxication in Morocco. Methods: This is a retrospective study of cases of benzodiazepine poisoning reported at the Poison Control and Pharmacovigilance Center of Morocco between 2012 and 2016. Results: During the period 2012-2016, 1,544 cases of benzodiazepine poisoning were recorded in Morocco. The average age of the addicts is 21.68 ± 14.41 years. According to the data of the study, 70% are Female, with a sex ratio of 2.25.The suicidal act represents a significant percentage with 31.5% of cases. Almost all patients were orally intoxicated with 97.1%.The signs presented are various according to the quantity ingested and the time elapsed before the treatment in particular the psychiatric, neurological, digestive and cardiovascular disorders. Unfortunately, three cases died. The other cases survived with or without sequelae. Conclusion: benzodiazepines are drugs used in the treatment of several disorders such as anxiety, insomnia and psychomotor agitation. Unfortunately, many people do not know how to use this type of medicine.which exposes them to poisoning, for this reason it is necessary to carry out sensitization campaigns for the good use of benzodiazepines at the national level. Bangladesh Journal of Medical Science Vol.20(2) 2021 p.396-400

Minireview of drug safety and pharmacovigilance

Pharmacovigilance or drug safety is defined as science and actions related to diagnosis, evaluation, understanding and avoidance of harmful effects or any other problems related to drugs. Adverse drug reaction (ADR) may be caused by intrinsic factors, extrinsic factors, underlying medical conditions, interactions and wrong usage. Adverse drug reaction (ADR) may be caused by intrinsic factors, extrinsic factors, underlying medical conditions, interactions and wrong usage. ADR causing intrinsic factors include the active ingredients in the drug itself. In Saudi Arabia, the National Pharmacovigilance Center (NPC) was established in March, 2009 as a semi-autonomous department of Saudi Food and Drug Authority (SFDA). The purpose of NPC was to perform early detection of ADR and safe use of drugs. We need pharmacovigilance because animal experiments and clinical trials performed before marketing are insufficient evidence of drug safety.

Risk management of adverse effects of antimalarial drugs: Knowledge of Physicians and Pharmacists in KAYES, MALI

In order to improve therapeutic compliance and prevent antimalarial drug resistance, we conducted this study to evaluate the knowledge of physicians and pharmacists in Kayes on the management of adverse effects of antimalarial drugs. Methods: A cross-sectional study was conducted from July to November 2017 among physicians and pharmacists selected by simple random sampling and practicing in the Kayes region for more than one year. The survey was based on a questionnaire proposed by the national pharmacovigilance center. In addition to a descriptive analysis of the results, a logistic regression analysis was performed to assess potential factors that could be associated with knowledge. Results: Among 151 physicians and pharmacists participated in the study, less than 40% had better knowledge about the management of antimalarial drug adverse events. Physicians and pharmacists working in government facilities were more likely to have better knowledge compared with those working in other facilities (OR=8.38; 95% CI: 2.48-28.30). In addition, pharmacists were more likely to have better knowledge than physicians (OR=3.48; 95% CI: 1.21-12.19). Conclusions: The frequency of good knowledge of the management of adverse drug reactions to antimalarials is insufficient, although membership in government structures and profession seem likely to improve it.

Pharmacovigilance in Covid-19 vaccines

The ongoing pandemic coronavirus disease of 2019 (COVID-19), originated from Wuhan, China, has caused universal challenging and threatening with considerable health impact and economic losses. Therefore, vaccination, as preventive and protective medical countermeasure, remains an excellent issue for reducing morbidity and mortality of this emerging infectious disease. As of April 2021 and by Emergency Use Authorization (EUA) process, 16 vaccines were authorized by at least one national regulatory authority for public use: two Ribonucleic Acid (RNA) vaccines (Pfizer–BioNTech and Moderna), seven conventional inactivated vaccines (BBIBP-CorV manufactured by Siinopharm, CoronaVac, Covaxin, WIBP-CorV, CoviVac, Minhai-Kangtai and QazVac), five viral vector vaccines (Sputnik Light, Sputnik V, Oxford–AstraZeneca, Convidecia, and Johnson & Johnson) and two protein subunit vaccines (EpiVacCorona and RBD-Dimer). As other countries, Morocco has established an anti-COVID-19 vaccine strategy in order to effectively contribute to the monitoring of vaccine safety supported by the national platform health vigilance and regulated by the National Anti-Poison and Pharmacovigilance Center (CAPM). In this review, we recorded the main current developed COVID-19 vaccines and discussed pharmacovigilance strategies and tools related safety and tolerability of those therapies. In parallel, a review of the Moroccan experience in this field is also conducted.

Methods, tools, and techniques in toxicovigilance

Toxicovigilance is the active process of identifying and evaluating the toxic risks existing in a community, and evaluating the measures taken to reduce or eliminate them. The operation of toxicovigilance requires the use of methods, tools, and techniques. The objective of this article is to describe the organization of toxicovigilance, to identify their components, and to specify the methods, tools and techniques which are applied to them and are necessary for their operation. To achieve those goals, we based our study on a bibliographic synthesis, where some key references were selected, analysed, and summarised. The results of our study have shown that the performance of a toxicovigilance system requires the mastery and integration of methods, tools, and techniques by trained and experienced staff. Those methods, tools and techniques can be classified into six stages. The study also showed that the practice of toxicovigilance is one of the core tasks of a poison control centres. Our study has shown that Anti-poison and Pharmacovigilance center Morocco constitutes a real observatory in terms of toxicovigilance. It ensures a vigilance and alert function concerning different toxic groups.

Toxicological analysis of acute pesticides poisoning among Moroccan population

The aim of this study is to evaluate the importance of toxicological analysis in acute intoxications by pesticides through the experience of the laboratory of the Poison Control and Pharmacovigilance Center of Morocco (CAPM). This is a retrospective study from January 2014 to September 2020, concerning suspected pesticides poisoning cases. The cholinesterase activity was measured in whole blood and the chromatographic analyzes (GC-MS and LC-MS-MS) were conducted in blood, urine and gastric lavage fluid. In this study, 398 tests were involved. The median age of the patients was 14 with an interquartile range of [4-26 years]. The sex ratio (F / M) was 1.5. The requests were from the region of Rabat-Salé-Kénitra in 82.8% of cases (north-western Morocco). The cholinesterase activity measurement was performed for 295 patients with low values in 3.7% of cases. The toxicological screening by GC-MS and LC-MS-MS detected the pesticide responsible of poisoning in 62 cases as insecticides in 38% of cases, redenticides (33% of cases) and herbicides (5% of cases). Toxicological analysis plays an essential role in the diagnosis and the management of acute pesticides poisoning. Interpretation of results is carried over by analyst with close cooperation with clinical toxicologist.

Adverse drug reactions of anti-infective drugs for systemic use in Morocco: Pharmaco-Epidemiological study 2008-2016

Analyzing the spontaneous reports of adverse drug reactions (ADRs) of anti-infective drugs for systemic use is an essential pillar in creating valuable database in pharmacovigilance.Therefore, the main of this study is to describe the epidemiological and clinical properties, as well as, the frequency and profile of ADRs generated by anti-infective treatment, declared at the Moroccan Anti-Poison and Pharmacovigilance Center (MAPPC).A retrospective descriptive study was implemented from the notifications of ADRs generated between 2008 and 2016 and recorded on VIGIBASE. Over the research period, 1161 cases of ADRs reports were declared. The average age was 37.4 years ± 19.52, it’s been noticed that the adults were the most affected in 81.89% of the total cases, with the sex ratio (Female / Male) being 1.34. Antimycobacterials and antibacterials for systemic use were responsible for 68% and 28.3% of the adverse reactions, respectively. 29.76% of the cases showcased skin and subcutaneous tissue disorders and 23.23% of the cases displayed hepatobiliary and pancreatic system disorders. Serious cases represented 30% of all noted cases, including 2 fatalities. In the interest of preventing the risk of adverse reactions originating from the taking anti-infective drugs for systemic use, reporting to the ADRs to the pharmacovigilance system should be highly encouraged.