Journal of Pharmacovigilance and Drug Research

Pharmacovigilance in Nepal: Present Glance and Areas to Improve.

2023-12-01T04:16:01+00:00

As the global issues ponder upon the drug safety and Consumer pharmacovigilance, pharmacovigilance in Nepal started from year 2004, however is still at infancy stage. In this commentary we aimed to portray the past and present state of the PV in Nepal along with some of the international and resource limited countries situation along with the areas we can work upon for the effective adverse event reporting, assessment, monitoring and management which leads to the drug safety and quality medicine use in some context in the resource limited countries like Nepal.

Analysis of drug-induced pancreatitis reports within the United States Food and Drug Administration and Veterans Health Administration Drug Event Reporting Systems

2023-12-01T04:16:01+00:00

Introduction: A true case of drug-induced pancreatitis (DIP) can be difficult to define due to a lack of monitoring parameters and potential confounders to the diagnosis of pancreatitis. Adverse drug event (ADE) reporting systems may give insight into which medications and drug classes are most commonly associated with DIP.

Objectives: This study aimed to analyze two United States (US) ADE reporting systems to determine the most common drugs associated with a report of DIP and to compare what is reported to what is published about drugs that carry a high risk of DIP.

Methods: We conducted a retrospective, cross-sectional evaluation of ADE reports from the Food and Drug Administration (FDA) and the Veterans Health Administration (VHA) between 2007 – 2021.

Results: We identified 53,181 and 1,520 reports of suspected DIP from the FDA and VHA databases, respectively. Incretin-based therapies (GLP-1 RAs and DPP-4is) were the most common drugs with DIP reports in both databases.

Conclusions: Incretin-based therapies comprised approximately 1 in every 5 reports of suspected DIP submitted to two major US ADE databases from 2007 - 2021. These newer medication classes appear to be associated with pancreatitis more frequently than traditional culprit medications.

Knowledge, attitude, and practices regarding reporting of Adverse Events Following Immunization (AEFI) among healthcare professionals

2023-12-01T04:16:01+00:00

Background: Vaccines enhance immunity, yet Adverse Events Following Immunization (AEFI) challenge public trust and immunization coverage by impacting safety perceptions.

Materials and Methods: In Karnataka, India, this cross-sectional study employed self-administered questionnaires at sub-centers (SC) and primary health centers (PHC). Findings were tabulated and analyzed using chi-square (p<0.05).

Results: From 247 subjects, the study achieved a 95% response rate. Notably, 65% exhibited proficient AEFI knowledge, and 88% possessed a favorable attitude toward reporting practices. Age, gender, prior training, and service duration were significant factors for knowledge distinctions. Attitude variations correlated with age, AEFI knowledge, and previous training. Identified barriers impact knowledge, attitude, and reporting.

Conclusion: The majority of healthcare workers at PHC and SC had good knowledge and positive attitudes with good reporting practices of AEFI. A few factors that hinder the diagnosis and reporting must be addressed by routine in-service training. The use of e-media should be brought into practice.

Knowledge and practice of Iraqi community pharmacists on national adverse events reporting and review of the constraints of drug safety reporting

2023-12-01T04:16:02+00:00

Introduction: Pharmacovigilance aids in protecting patients from adverse drug effects. Community pharmacists can play a significant role in the reporting of adverse drug reactions (ADRs) due to their advantageous position in terms of direct contact with patients and medical specialization,

Objectives: To determine the pharmacists' awareness in Baghdad and attitude regarding the national adverse drug reactions (ADRs) system activities in Iraq and their knowledge about the spontaneous reporting system

Methods: In this study, a validated self-administered cross-sectional questionnaire was used. During the study period, the questionnaire was distributed to 278 community pharmacists who worked in Baghdad for 4 months.

Results: Out of 278 pharmacists who participated in this questionnaire, 250 pharmacists completed the questionnaire. About 57% of them were female with less than 10 years experience in retail pharmacies. The study showed that about 76% already had information about the term pharmacovigilance and the existence of a pharmacovigilance center in Iraq, but about half of them showed a low level of knowledge about the way of filling, reporting, and sending ADR reports. Furthermore, About 90% of them prefer new ways of filling the ADR reports like using special mobile apps, special QR codes, and more simplified adverse event forms.

Conclusion: The study revealed that the community pharmacists in Baghdad have a positive view on ADR and pharmacovigilance, but several barriers were revealed that could impede the Iraqi pharmacovigilance center activities regarding spontaneous reporting of health care professionals.

Methotrexate overdose induced acute kidney injury and pancytopenia: a case report

2023-12-01T04:16:02+00:00

Introduction: Methotrexate is a folic acid antagonist. Dose of methotrexate is ranging from 7.5 mg–30 mg per week. In rheumatoid arthritis (RA), a low dose of methotrexate is used.

Case presentation: A 48-year-old female patient suffering from RA, was admitted to a tertiary care hospital. The patient was taking methotrexate 15 mg daily instead of once weekly dosing schedule mistakenly (cumulative dose of 105 mg). The patient presented with a diffuse ecchymotic rash over both extremities with oral mucositis associated with dysphagia. Upon investigation, pancytopenia (TLC= 3400 /µL, RBC= 1.85 Lac/µL, Platelets= 6000/µL) with microcytic hypochromic anemia (Hb= 4.3 g/dl) with acute kidney injury (Urea= 78 mg/dl, Creatinine= 2.26 mg/dl) was found. Elevated C-reactive protein (9.8 mg/dl) and dyslipidemia (Triglyceride= 218 mg/dl) were also evident. The case was suspected to be methotrexate toxicity and reported in the suspected Adverse Drug Reaction (ADR) form(v1.4).

Management: The patient was advised to stop methotrexate and manage with injectable folinic acid (25 mg thrice Daily for 3 days) and clotrimazole mouth paint locally (thrice daily for two weeks). ADR was assessed as Probable/Likely (WHO-UMC scale), Probable (Naranjo scale), Severe (Modified Hartwig's Severity scale), and Preventable (Schumock and Thronton scale).

Conclusion: Such case report being the first line of evidence for recognizing unexperienced ADR, should be reported for 'signal detection' to improve patient care and safety. Prescription Audit Guidelines (under National Health Mission) should be followed for drug dispensing.