Current landscape of pharmacovigilance in Pakistan

Drug Regularity Authority of Pakistan came into being in 2012 after multiple casualties were reported due to dispensation of counterfeit & adulterated drugs. The primary purpose was to address any quality & efficacy issues related to medicines and encourage healthcare professionals to play their role in provision of safe medication therapy by practicing pharmacovigilance. Currently, a Medicine Surveillance portal for reporting is available for ADR reporting along with ADR and Drug & Device complaint forms. A new mobile app, MedSafety was recently launched to encourage public to report.

Assessment of Knowledge, Attitude, and Practice of Adverse Drug Reaction Reporting Among Community Pharmacy in Gondar Town, Ethiopia, 2021

Background: Drugs can treat diseases, reduce symptoms, and enhance patients’ health and quality of life. However, taking a drug is not always as easy as just swallowing a pill. This is because drugs have some unwanted effects. Adverse Drug Reactions (ADRs) are one of the leading causes of morbidity and mortality and contribute to excessive health care costs. Objectives: To assess knowledge, attitude, and practice of health care providers on adverse drug reporting among community pharmacists, Gondar, Ethiopia Methods: Community-based cross-sectional study designs were used from July - August 2021. The sampling method was a survey from community pharmacists. Self-administered questioner was used, and the collected data was entered into Epi-info Version 7.0 and exported to SPSS version 20 software for analysis. Result: The study included 215 community pharmacy professionals to assess the knowledge, attitudes, and practices of adverse drug reaction reporting. From a total of 215 community pharmacy professionals, 34 (15.8%) of the respondents were able to differentiate ADR from side effects and only 56(26%) respondents felt that they are adequately trained in ADR reporting. Out of 215 respondents, 78(36.3%) and 146(67.9%) knew the availability of the national reporting system and ADR reporting form in Ethiopia respectively. The study revealed that 21.4% [95% CI: 18.6-35.9] and 42.3% [95% CI: 38.2-65.9] of community pharmacists have poor knowledge and negative attitude towards ADR reporting respectively. Conclusion: Underreporting of ADR by community pharmacists was identified in this study. Training sessions to clarify the role of various community pharmacists in ADR reporting will hopefully fill the observed gap in knowledge and practices. The community pharmacy should formulate strategies to enhance the detection and reporting of ADRs.

Educational Intervention to Improve the Knowledge, Attitude, Practices of Health Care Professionals and Students Regarding the Pharmacovigilance in Tertiary Care Hospitals

Introduction: An adverse drug reaction (ADR) is any noxious, unintended, and undesired effect of a drug, which occurs at the doses which are used in humans for prophylaxis, diagnosis, or therapy, which is reported by ‘‘the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem” known as PV. ADRs are significantly underreported worldwide. A KAP survey usually conducted to collect information on the knowledge, attitudes, and practices about general and/or specific topics of a particular population. Aim and Objectives: To evaluate the KAP studies on the educational intervention to improve the knowledge, attitude, practice of health care professionals and students regarding the pharmacovigilance in tertiary care hospitals. To evaluate, assess and evaluate the measures the knowledge, attitude and practice of PV among students and Health Care Professionals in tertiary care hospital of India. Methods: Pharmacists and HCPs were asked to complete a paper-based 21 item questionnaire. Results: A total of 250 pharmacists received the questionnaire and 214 agreed to participate, giving a response rate of 85.6%. In knowledge, component of ADR were known by 71.2% and the term PV and ADR were answered correctly (97.3%). In practice 55.9% attended the PV workshop and 88.8% were willing to implement ADR reporting in practice. Conclusion: Most of the participants had relatively better knowledge and practice towards PV and ADR reporting. Majority of the health care professional felt ADR reporting to be important. The study also shows, after counseling to them we got better response and results than before. The finding of our study suggests that there is scope for improving the ongoing Pharmacovigilance activities in India. There is a need for continuing educational initiatives for pharmacist and other health care professionals.

Current Status of Adverse Drug Reaction Reporting by the Physicians in A Medical College Hospital

Background: In order to improve the spontaneous Adverse Drug Reaction (ADR) reporting practice by the physicians, there is an obligatory need to investigate the current situation of ADR reporting by them. The study was conducted to observe the ADR reporting pattern among physicians in a tertiary medical college hospital. Materials and methods: This was a descriptive cross sectional study carried out in a tertiary medical college hospital during the study period of March 2020 to October 2020. Data were collected from 100 physicians working on different departments using self designed pretested questionnaire by convenient sampling technique. Results: Among the 100 respondents 70 provided response to questionnaire giving a response rate 70%. Most of the respondents (61.43%) had adequate knowledge on ADR reporting. A good number of respondents showed positive attitude but there is no practice of ADR reporting though most of the respondents (84.3%) had experienced it in last 1 year. Most of the respondents experienced ADR with antibiotic (81.35%), NSAIDs (33.89%) & anticonvulsants (15.25%) and maximum (44.06%) experienced ADR was with skin, 30.50% with GIT and 23.03% with respiratory system involvement. The cause of under reporting was mainly due to inaccessible ADR form, busy schedule, unaware of how and whom to report and lack of motivation to report. The respondents would be encouraged to report ADR if they were provided with simple & available reporting form, regular guideline & bulletin. Conclusion: There is an urgent need for educational training & seminar regarding our national online reporting system to emphasizing ADR reporting. Chatt Maa Shi Hosp Med Coll J; Vol.20 (2); July 2021; Page 8-13

A questionnaire-based knowledge, attitude and practice study to determine the awareness of pharmacovigilance among the health care professionals in a tertiary care hospital of West Bengal

Background: Pharmacovigilance programs have been introduced to keep an eye on adverse drug reactions and safe use of drugs. All Healthcare professionals (HCPs) should report each and every adverse events which they come across. Pharmacovigilance programme of India is running actively since 2010 but India contributes only 2% of Adverse drug reactions (ADR’s) reported worldwide. There is need to monitor awareness of HCP’s about pharmacovigilance to achieve the goals. Such studies from peripheries of Eastern India are lacking. The aim of the study was to assess the knowledge, attitude and practice and overall awareness among HCP’s about pharmacovigilance and to understand actual barriers of ADR reporting.Methods: A cross-sectional questionnaire-based study was done in Burdwan Medical College and Hospital. Ninety-nine HCP’s completed the pre-designed questionnaire. There were 15 questions to assess the awareness and cause(s) of underreporting. Data were analysed using appropriate statistical software.Results: We analysed data of 67 doctors and 32 nurses. We found, 67.2% doctors and 59.4% nurses knew definition of pharmacovigilance. About half HCP’s had knowledge about existing pharmacovigilance committee in our hospital. Almost all HCP’s felt ADR reporting is necessary. Surprisingly 88.1% doctors and 46.9% nurses experienced ADR at least once but 25.4% and 3.1% reported them respectively. For knowledge and practice related questions, correct responses were significantly higher for doctors. Most common discouraging factors regarding ADR reporting were, didn’t know how to report (52.5%) where to report (41.4%).Conclusions: Attitude of HCP’s towards pharmacovigilance activities was appreciable and combining it with periodic sensitizing programs, and training sessions will increase the knowledge, clear doubts about ADR reporting and improve the awareness about pharmacovigilance.

Surveillance of adverse drug reactions at an adverse drug reaction monitoring centre in Central India: a 7-year surveillance study

ObjectivesTo analyse and present the occurrence and severity of spontaneous adverse drug reaction (ADR) reports prospectively registered at an ADR monitoring centre (AMC) in Central India.Setting and dataThe survey was conducted between 2013 and 2019 at an ADR Monitoring Centre in Central India. ADRs were recorded using the standard ‘Suspected ADR Reporting form’.Outcome measuresThe causality of the ADRs were categorised using the WHO causality assessment scale to assess the relationship between a drug and the occurrence of an ADR.ResultsTotally 1980 spontaneous ADRs were reported involving 960 patients and 1316 drugs prescriptions. The occurrence of ADRs was common among male patients (64%) and patients of age between 19 and 65 years (81%). Antimicrobials caused 29% ADRs, followed by drugs of antiretroviral therapy (19%). Zidovudine caused most ADRs (88%) followed by ethambutol and ciprofloxacin. The ADRs of skin and subcutaneous tissue disorders (28%) were most common among all system organ classes followed by gastrointestinal systems (18%). Four per cent of all reported ADRs were severe. A peak of ADR reports was attained in 2016 with 224 reports, which decreased to 127 in 2019.ConclusionA high number of ADRs caused by antimicrobials is an alarming situation, which adds up to antimicrobial resistance. Judicious use of antimicrobials is yet again proven as need of the hour. Under-reporting of ADRs is evident in our study and is a major factor for the delay in the withdrawal of drugs responsible for causing ADRs. Interventions in terms of training and feedback are suggested to encourage and improve ADR reporting.

Assessment of Knowledge, Attitude, and Practice in Adverse Drug Reaction Reporting of Healthcare Professionals in Vietnam: A Cross-Sectional Study

Background: Under-reporting is a major issue of ADR spontaneous reporting system. This study assesses the knowledge, attitude, and practice of healthcare professionals in Children’s Hospital in Vietnam and suggests solutions to enhance ADR reporting rate based on findings. Methods: A cross-sectional study was conducted and 397 self-administered structured questionnaires were distributed to all potential HCPs working in surveyed hospital within 2 weeks from June 03 to June 20, 2020. Results: Overall response rate was 97% with 384 responses. A majority answered correctly ADRs’ knowledge apart from form supplier (1.6%) and possible causes (2.6%). The need to focus on patient care (33.3%) and the trivia of reaction (31.5%) reduced HCPs’ attention. About 61.7% reported once in their career, 49.7% had training. Having trained group had numbers of practice significantly higher than their counterparts. Major reason for not reporting was lack of information and instruction. Preferred solutions were regularly training, updating, and collaboration of HCPs in reporting ADR. Conclusion: Healthcare professionals had adequate knowledge, positive attitude, and moderate practice. Training significantly raised the number of practices in reporting ADR. Preferred solutions were regular training, updating, and collaboration of healthcare professionals in ADR reporting.

An Exploration of Knowledge, Attitude, and Practices of Physicians toward Pharmacovigilance at Tertiary Care Hospitals in Khyber-Pakhtunkhwa Province, Pakistan

Drug safety assures the effectiveness, safety, and security of drugs, vaccines, and other biologicals to protect public health. Medication-related errors coupled with unjudicial medication practices often cause a catastrophic impact on the healthcare system globally. The present study aimed to assess the knowledge, attitude, and practice of physicians toward pharmacovigilance and barriers to adverse drug reaction (ADR) reporting at tertiary care hospitals in Khyber-Pakhtunkhwa (KP) province, Pakistan. A descriptive cross-sectional study was conducted among registered doctors working in seven tertiary care hospitals from seven administrative divisions of KP province of Pakistan from July 2019 to March 2020. During the study period, 358 physicians who fulfilled the inclusion criteria and agreed to participate completed and returned the validated structured questionnaires. Descriptive and inferential statistics were applied for data analysis. The majority of physicians had poor knowledge (81.3%) regarding pharmacovigilance along with poor reporting practices (94.9%), although (96.5%) had a positive attitude toward ADR reporting. A significant barrier identified was the unavailability of reporting forms (95.9%), whereas mandatory ADR reporting (96.2%) was the major factor to encourage ADR reporting. Physicians aged ≥ 41 and experience ≥ 11 years had significantly more knowledge than other categories (P < 0.001). Significant association (P < 0.001) of physicians’ knowledge and practice were found where 77.2% of the participants having poor knowledge reported poor practices. Physicians’ understanding of pharmacovigilance was suboptimal, although they have a positive attitude toward ADR reporting. Thus, there is a need for continuous education and training programs to support pharmacovigilance activities that could improve physicians’ understanding.

Assessment of knowledge, attitude and practice of pharmacovigilance and adverse drug reactions reporting among the community pharmacies in Dharan

<p class="abstract"><strong>Background:</strong> Community pharmacist’s (CPs) knowledge, attitude and practice (KAP) of pharmacovigilance and adverse drug reactions (ADR) play a vital role in preventing harmful effects of medicine. The objective was to assess the KAP of pharmacovigilance and ADR reporting among CP.</p><p class="abstract"><strong>Methods:</strong> A cross-sectional study was carried out among 132 CP in Dharan between February-March 2019 by using a self-administered 25-item semi-structured questionnaire. The KAP score was categorized as good (score 13-25) and poor (score 0-12). The descriptive statistics were calculated using Microsoft excel 2010.</p><p class="abstract"><strong>Results:</strong> Out of 132 pharmacies, only 77 responded giving a response rate of 58.3%. There were 45 (58.4%) male. Majority of the participants (45, 58.4%) had completed diploma in pharmacy course. Only 23 (29.9%) respondents gave the correct responses regarding the definition of pharmacovigilance and 23.4% were aware of the national pharmacovigilance centre. 50.9% agreed that reporting of ADRs is a part of pharmacist duty and it was important to report ADRs and was leading cause of hospitalization. Sixty three (81.8%) participants had never ever been trained on how to report ADR. Seventy (90.9%) participants were willing to report ADR, however, 51 (66.2%) had never seen the ADR reporting form. Only 3 (3.9%) participants had good KAP score (23.33±1.54).</p><p class="abstract"><strong>Conclusions:</strong> Despite of relatively better attitude towards pharmacovigilance and ADR reporting, they had a limited knowledge and practice with regard to ADR reporting and pharmacovigilance. The study findings highlights the need to strengthen the community pharmacovigilance program for safer medication use at the community level.</p>