E‐pharmacovigilance: development and implementation of a computable knowledge base to identify adverse drug reactions

Abstract

AIMSComputer-assisted signal generation is an important issue for the prevention of adverse drug reactions (ADRs). However, due to poor standardization of patients' medical data and a lack of computable medical drug knowledge the specificity of computerized decision support systems for early ADR detection is too low and thus those systems are not yet implemented in daily clinical practice. We report on a method to formalize knowledge about ADRs based on the Summary of Product Characteristics (SmPCs) and linking them with structured patient data to generate safety signals automatically and with high sensitivity and specificity. METHODSA computable ADR knowledge base (ADR-KB) that inherently contains standardized concepts for ADRs (WHO-ART), drugs (ATC) and laboratory test results (LOINC) was built. The system was evaluated in study populations of paediatric and internal medicine inpatients. RESULTSA total of 262 different ADR concepts related to laboratory findings were linked to 212 LOINC terms. The ADR knowledge base was retrospectively applied to a study population of 970 admissions (474 internal and 496 paediatric patients), who underwent intensive ADR surveillance. The specificity increased from 7% without ADR-KB up to 73% in internal patients and from 19.6% up to 91% in paediatric inpatients, respectively. CONCLUSIONSThis study shows that contextual linkage of patients' medication data with laboratory test results is a useful and reasonable instrument for computer-assisted ADR detection and a valuable step towards a systematic drug safety process. The system enables automated detection of ADRs during clinical practice with a quality close to intensive chart review.

Predicting risk of adverse drug reactions in older adults

“…E-pharmacovigilance (where a computer links a patient's medications with their laboratory results) can inform prescribers of potential ADRs in the setting of abnormal laboratory values [Neubert et al 2013]. This represents an important step towards a systematic drug safety process but requires clinician engagement, intensive resources and regular updates.…”

Optimizing spontaneous adverse drug reaction reporting in public healthcare setting in Namibia

“…This may include ongoing training and education at pre-service and in-service levels, involvement of Therapeutic Committees at facility and regional levels and introduction, for example, of innovative electronic reporting to improve efficiency and boost the response rate among healthcare workers. [19][20][21][22] In conclusion, the study revealed a high level of knowledge of pharmacovigilance and ADR reporting system among the healthcare workers, though this has informed neither their attitude nor their practice of ADR reporting as seen in their reported attitude and practice. In other to optimize the current system, there is a need for effective communications between TIPC and the healthcare workers; this may be in the form of feedback, continuing professional development (CPD) lectures, advocacy within the health sector and community engagement.…”

“…Depending on the setting, centralized, national reporting systems may not always be the solution to pharmacovigilance but if they are adopted—as is the case in Namibia—there is a need to continually support their function and improvement. This may include ongoing training and education at pre‐service and in‐service levels, involvement of Therapeutic Committees at facility and regional levels and introduction, for example, of innovative electronic reporting to improve efficiency and boost the response rate among healthcare workers …”

“…The result is similar to other studies conducted in Nigeria and India which estimated the awareness of the Yellow Card ADR reporting scheme and/or had reported an ADR at 32% and 37%, respectively. 18,19 More reports were received from the nursing cadre, these are more in number within the health system and the pharmacy cadre which is more involved with pharmacovigilance activities, and this raises questions relating to representation of the sample. However, in general, the survey was inclusive and able to distinguish subtle differences between the professional groups, for example, knowledge levels.…”

Dramatyping: A generic algorithm for detecting reasonable temporal correlations between drug administration and lab value alterations

“…The general standard and still the most commonly used method of ADR detection is mandatory spontaneous reporting (Neubert et al, 2013). In the USA, the primary source of such reports is the FDA Adverse Event Reporting System (FAERS) database (FDA, 2014) of the U.S. Food and Drug Administration (FDA).…”