A review on vaccine pharmacovigilance during covid-19

Pharmacovigilance is important for collecting, detecting, monitoring adverse events which is the main objective. The adverse events reported should be assessed in order to know the casual relationship and avoid unnecessary effects on the recipient. Many people are vaccinating in a short period, so it is becoming much burden to the pharmacovigilance centers. The international society of pharmacovigilance (ISOP), the French national agency for medicines and health products safety (ANSM), and many others were in continuous collaboration and taking many initiatives to identify the safety and efficacy of vaccines and to provide answers to the raised questions respectively. Through pharmacovigilance, signals were detected, and many adverse events were identified. Pharmacovigilance of BioNTech/Pfizer-m-RNA, Moderna-mRNA vaccine, Covishield, Johnson and Johnson, Vaxzevria, Sputnik V, Convidecia are addressed. With BioNTech/Pfizer-m-RNA 12,249 ADRs, with Moderna-mRNA vaccine 577 ADRs, with Covishield 447 ADRs, with Johnson and Johnson 653 ADRs, with Vaxzevria 743 ADRs were reported. These vaccines resulted in immune thrombocytopenic purpura, cerebrovascular events, thrombosis, thrombocytopenia, facial paralysis, deaths, and many other reactions which may be fatal. But the events reported were less compared to the safety of the patients. All these events were maintained by the Uppsala monitoring center.

An overview of the worldwide master key for pharmacovigilance and its role in India

Introduction: Pharmacovigilance (PV) is defined as the science and activities related to the detection, assessment, understanding, and prevention of Adverse Drug Reactions (ADRs) and related conditions. Methods: In the 1970s, several significant cases of ADR aided the advancement of the discipline. Between 1989 and 2004, several attempts were made to implement such a program in India, but the scheme was eventually launched in 2010 and is now operating successfully and producing positive results. Results: The pharmacovigilance Program of India (PvPI) contributed different data to the World Health Organization (WHO) Uppsala Monitoring Center (UMC) based on the data gathered from this process. Indian regulatory have sent several alerts to stakeholders and provided the Central Drugs Standard Control Organization (CDSCO) with several recommendations. CDSCO has since advised Marketing Authorisation Holders (MAHs) to follow the same guidelines and has amended the Drugs and Cosmetics Act and Regulations to reflect this. Conclusions: The time has come for Indian regulatory authorities to take the required action based on data generated in our country rather than data generated in several other countries.

A STUDY OF AGREEMENT BETWEEN WHO-UPPSALA MONITORING CENTRE CRITERIA, NARANJO ALGORITHM, AND LIVERPOOL ALGORITHM FOR CAUSALITY ASSESSMENT OF ADVERSE DRUG REACTIONS

Objective: A standard causality assessment tool of an adverse drug reaction (ADR) is essential to compute the risk-benefit assessment of the medication taken by the patient and categorize its relationship likelihood. It should be reproducible and should not differ with the background and experience of the evaluator. Though there are a large number of causality assessment tools, none is unanimously accepted worldwide. So, this study was done to assess the agreement between three frequently used methods of causality assessment, the World Health Organisation-Uppsala Monitoring Centre (WHO-UMC) system, the Naranjo’s algorithm, and the Liverpool algorithm. Methods: 172 ADR forms from the pharmacovigilance unit were randomly selected for the study. Causality assessment was done using three different methods, the WHO-UMC system, Naranjo’s algorithm, and the Liver pool algorithm. Cohen’s Kappa statistics was applied to look for agreement between the causality assessment methods. Results: The agreement between the WHO-UMC criteria and Naranjo’s algorithm was the highest (136), with a Kappa value of 0.511, suggesting a moderate level of agreement. A maximum number of disagreements were noted between the WHO-UMC system and the Liverpool algorithm method (110). Conclusion: A moderate agreement exists between the WHO-UMC system and the Naranjo algorithm. There is poor agreement between the Liverpool algorithm and the other two scales. Therefore, it is recommended that both the WHO-UMC system and the Naranjo algorithm be used for causality assessment of ADRs.

Analysis of the reports sent to an institutional patient safety program

Introduction: pharmacovigilance and patient safety programs have in common the monitoring of drugs, but despite sharing epidemiological method, language and legislation, there does not seem to be a clear relationship between them. Objectives: characterize and analyze the reports sent to the institutional patient safety program. Materials and methods: observational descriptive cross-sectional study of the reports database from an institutional patient safety program during 2016. Medication errors were classified according to the document WHO 2009. Adverse Drugs Reactions (ADR) were classified according to Uppsala Monitoring Center. Results: from the patient safety program it was detected that the omission of drugs or doses was the most frequent error (42.8%) followed by ADRs (20.9%). Harmful incidents were the most frequent (61.2%) followed by no harm incidents (38.8%). From the pharmacovigilance program 41 ADR and 15 therapeutic failures were identified, in which Phlebitis was the most frequently reported (23, 7%) followed by hypersensitivity reactions (18.4%) and excessive neuromuscular blockade (13.1%). Conclusions: a very important amount of incidents is not considered by any of the two programs, losing a valuable risk management opportunity. The program did not identify a clear distinction between harmful incident and ADR.

ALLOPURINOL-INDUCED STEVENS–JOHNSON SYNDROME AND TOXIC EPIDERMAL NECROLYSIS: A CASE REPORT

Allopurinol is used for the treatment of gout and related conditions; it is associated with various adverse drug reactions (ADRs) such as Stevens– Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). A 50-year-old female was presented to the emergency ward with chief complaints of reddish pinpoint lesions over the back, chest, abdomen, and lower limb-upper limb for the past 6 days. She was diagnosed with SJS. On medication interview, it was revealed that she was on allopurinol therapy, which she took 5 days back as a self-medication. The World Health Organization - Uppsala Monitoring Centre (WHO) scale was used to access the causality assessment, ADR was found to be probable. The drug was withdrawn from the therapeutic regimen of the patient. The patient was discharged after 25 days from the hospital. Allopurinol has the strongest association with SJS with TEN. There should be a screening of HLA-B 5801 antigens before commencing the allopurinol therapy to the patients.

Pharmacovigilance or patient safety: analysis from a patient safety program

Purposedrugs are the common point of pharmacovigilance and patient safety programs. Despite using a common language, the same epidemiological method and legislation that requires the operation of the two programs, there does not seem to be a clear relationship between them.Methodologyobservational descriptive cross sectional study of the reports database from an institutional patient safety program. Medication errors were classified according to the document The Conceptual Framework for the International Classification for Patient Safety (ICPS) WHO 2009. Adverse Reactions (ADR) were classified according to Uppsala Monitoring Center.Resultsthe omission of drugs or doses was the most frequent error with 42.8% followed by ADRs (20.9%). No harm incidents corresponded to 61.2% and the remaining 38.8% was represented in near missincidents and no harm incidents. There were included 41 ADR and 15 therapeutic failures corresponding to a point-prevalence of 57 ADR/10,000 patients-year and 28.6% (56/196) of reports related to drugs. Phlebitis is the most frequently reported with 23, 7% followed by hypersensitivity reactions with 18.4% and excessive neuromuscular blockade with 13.1%.Conclusionsconsidering time, level of care and number of bed, ADR prevalence seem low. A very important proportion of reports corresponding to near miss incidents or no harm incidents is not taken into account by the security managers, losing a valuable risk management opportunity in the patient safety programs.

Induziert Methylphenidat Leberschäden? – Analyse von Spontanmeldungen an das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM)

Zusammenfassung. Spontanmeldungen an das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) wurden bezüglich Leberschädigungen unter einer Therapie mit Methylphenidat (MPH) gesichtet. Unter Anwendung der Bewertungskriterien des Uppsala Monitoring Centre (UMC) der Weltgesundheitsorganisation (WHO) erfolgte eine Einschätzung der Verdachtsfälle hinsichtlich eines möglichen kausalen Zusammenhangs. Ermittelt wurden in der Nebenwirkungsdatenbank des BfArM Verdachtsfälle aus Deutschland über den Zeitraum vom 01.01.2006 bis einschließlich 23.05.2016. Mithilfe der Suchstrategie „Standardized MedDRA Queries“ (SMQ) wurde in der Datenbank nach dem Wirkstoff MPH und der potenziellen unerwünschten Arzneimittelwirkung (UAW) „Hepatic Disorder“ gesucht. Die Spontanmeldungen wurden auf Vollständigkeit geprüft und klinisch beurteilt. Insgesamt handelte es sich um 60 Verdachtsfälle von Leberschädigungen durch MPH. 15 Fälle waren aufgrund lückenhafter Dokumentation nicht beurteilbar. Bei 25 Verdachtsfällen wurde ein Zusammenhang zwischen der Einnahme von MPH und dem Auftreten von Leberschäden als „unwahrscheinlich“ eingestuft. Ein „möglicher“ kausaler Zusammenhang fand sich bei 11 Fällen, ein „wahrscheinlicher“ kausaler Zusammenhang bei 9 Fällen: Berichtet wurde von jeweils einem Patienten mit fulminanter Hepatitis und größenprogredientem benignen Lebertumor und 18 Fällen mit (reversibler) Leberenzymwerterhöhung. Gemäß unseren Auswertungen ist MPH in Bezug auf Leber- und Gallenerkrankungen gut verträglich.