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Quality check of spontaneous adverse drug reaction reporting forms of different countries

Bandekar MS, Anwikar SR, Kshirsagar NA

Pharmacoepidemiol Drug Saf, 2010 Nov;19(11):1181-5.
PMID: 20845409 DOI: 10.1002/pds.2004

Adverse drug reactions (ADRs) are considered as one of the leading causes of death among hospitalized patients. Thus reporting of adverse drug reactions become an important phenomenon. Spontaneous adverse drug reaction reporting form is an essential component and a major tool of the pharmacovigilance system of any country. This form is a tool to collect information of ADRs which helps in establishing the causal relationship between the suspected drug and the reaction. As different countries have different forms, our aim was to study, analyze the suspected adverse drug reaction reporting form of different countries, and assess if these forms can capture all the data regarding the adverse drug reaction. For this analysis we identified 18 points which are essential to make a good adverse drug reaction report, enabling proper causality assessment of adverse reaction to generate a safety signal. Adverse drug reaction reporting forms of 10 different countries were collected from the internet and compared for 18 points like patient information, information about dechallenge-rechallenge, adequacy of space and columns to capture necessary information required for its causality assessment, etc. Of the ADR forms that we analyzed, Malaysia was the highest scorer with 16 out of 18 points. This study reveals that there is a need to harmonize the ADR reporting forms of all the countries because there is a lot of discrepancy in data captured by the existing ADR reporting forms as the design of these forms is different for different countries. These incomplete data obtained result in inappropriate causality assessment.

Matched MeSH terms: Adverse Drug Reaction Reporting Systems/standards*
Community pharmacists' views on adverse drug reactions reporting in Malaysia: a pilot study

Ting KN, Stratton-Powell DM, Anderson C

Pharm World Sci, 2010 Jun;32(3):339-42.
PMID: 20336371 DOI: 10.1007/s11096-010-9382-0

OBJECTIVES: To investigate community pharmacists' knowledge, attitudes and views on adverse drug reaction (ADR) reporting. Setting Seven community pharmacies in Malaysia.
METHOD: Structured interviews with community pharmacists. Informed consent was obtained and interviews were audio-recorded and transcribed verbatim.
MAIN OUTCOME MEASURES: Content analysis of themes on awareness of ADR reporting, reporting activities, attitudes and views on patient reporting.
RESULTS: All pharmacists claimed to have some knowledge of a reporting system but only one had submitted a report directly to the regulatory authority. Despite the low level of reporting activities, all participants agreed that it was part of their professional obligation to report an ADR. Most participants were not aware of the direct patient reporting scheme and were skeptical about its success. Lack of awareness and patients' limited knowledge about their medications were viewed as barriers to patient reporting. Local attitudinal issues including pharmacists' attitude towards ADR reporting were described as possible contributing factors.
CONCLUSION: Community pharmacists have an important role in reporting ADRs. Many Malaysian patients are still perceived to be ill-informed of their medications, an important determinant to the success of patient reporting. There is a need for further training about ADRs and ADR reporting for health professionals and further education for patients.

Matched MeSH terms: Adverse Drug Reaction Reporting Systems/standards*
Fulltext Quality of adverse event reporting in clinical trials of remdesivir in patients with COVID-19

Kow CS, Aldeyab M, Hasan SS

Eur J Clin Pharmacol, 2021 Mar;77(3):435-437.
PMID: 33011825 DOI: 10.1007/s00228-020-03008-6
Matched MeSH terms: Adverse Drug Reaction Reporting Systems/standards*
Predicting the Risk of Adverse Drug Reactions in Older Inpatients: External Validation of the GerontoNet ADR Risk Score Using the CRIME Cohort

Petrovic M, Tangiisuran B, Rajkumar C, van der Cammen T, Onder G

Drugs Aging, 2017 02;34(2):135-142.
PMID: 28000156 DOI: 10.1007/s40266-016-0428-4

BACKGROUND: Adverse drug reactions (ADRs) in older people are often preventable, indicating that screening and prevention programs aimed at reducing their rate are needed in this population.
OBJECTIVE: The aim of this study was to externally validate the GerontoNet ADR risk score and to assess its validity in specific subpopulations of older inpatients.
METHODS: Data from the prospective CRIteria to assess appropriate Medication use among Elderly complex patients (CRIME) cohort were used. Dose-dependent and predictable ADRs were classified as type A, probable or definite ADRs were defined according to the Naranjo algorithm, and diagnostic accuracy was tested using receiver operating characteristic (ROC) analyses. Sensitivity and specificity were calculated for a cut-off point of 4.
RESULTS: The mean age of the 1075 patients was 81.4 years (standard deviation 7.4) and the median number of drugs was 10 (range 7-13). At least one ADR was observed in 70 patients (6.5%); ADRs were classified as type A in 50 patients (4.7%) and defined as probable or definite in 41 patients (3.8%). Fair diagnostic accuracy to predict both type A and probable or definite ADRs was found in subpopulations aged <70 or ≥80 years with heart failure, diabetes, or a previous ADR. Good accuracy to predict type A ADRs was found in patients with a low body mass index (BMI; >18.5 kg/m2) and a Mini-Mental State Examination (MMSE) score of >24/30 points, as well as in patients with osteoarthritis. The cut-off point of 4 points yielded very good sensitivity but poor specificity results in these subpopulations.
CONCLUSION: This study suggests that the GerontoNet ADR risk score might represent a pragmatic approach to identifying specific subpopulations of older inpatients at increased risk of an ADR with a fair to good diagnostic accuracy.

Matched MeSH terms: Adverse Drug Reaction Reporting Systems/standards*