Adverse drug reactions in a primary care population prescribed non-steroidal anti-inflammatory drugs

Abstract

Objective. To determine how often patients with musculoskeletal (MSK) complaints prescribed a non-steroidal anti-inflammatory drug (NSAID) subsequently consult their general practitioner (GP) with a non-serious adverse drug reaction (ADR). Design. Cohort study. Setting. A healthcare database containing the electronic GP medical records of over 1.5 million patients throughout the Netherlands. Patients. A total of 16 626 adult patients with MSK complaints prescribed an NSAID. Main outcome measures. The patients’ medical records were manually assessed for the duration of NSAID use for a maximum of two months, and consultations for complaints predefined as potential ADRs were identified. Subsequently, the likelihood of an association with the NSAID use was assessed and these potential ADRs were categorized as likely, possible, or unlikely ADRs. Results. In total, 961 patients (6%) consulted their GP with 1227 non-serious potential ADRs. In 174 patients (1%) at least one of these was categorized as a likely ADR, and in a further 408 patients (2.5%) at least one was categorized as a possible ADR. Dyspepsia was the most frequent likely ADR, followed by diarrhoea and dyspnoea (respectively 34%, 8%, and 8% of all likely ADRs). Conclusion. Of the patients with MSK complaints prescribed an NSAID, almost one in 30 patients re-consulted their GP with a complaint likely or possibly associated with the use of this drug. The burden of such consultations for non-serious ADRs should be taken into account by GPs when deciding whether treatment with an NSAID is appropriate.

Adverse and Hypersensitivity Reactions to Prescription Nonsteroidal Anti-Inflammatory Agents in a Large Health Care System

“…10,12 We found NSAID side effect reactions, including some potentially mild (i.e., gastrointestinal complaints, dizziness, headache) and some potentially severe (e.g., nephrotoxicity) that are similar to prior data. 1,12,25 Patients prescribed only COX-2 inhibitors had a lower overall one-year ADR incidence using the standard definition (1.3%), although using the expanded definition, incidence was similar (1.9%). For these patients, HSRs comprised a greater proportion of the ADRs (28.2% using the standard definition and 26.5% using the expanded definition).…”

“…10,12 However, these studies have included all “allergies” -- inclusive of both HSRs and side effects -- in their frequency estimates. Additionally, although electronic health records (EHRs) contain both coded and non-coded (i.e., free-text) data, prior incidence estimates of NSAID allergy from EHR data used only coded elements, which may have underestimated HSR burden.…”

Determinants of self-medication with NSAIDs in a Portuguese community pharmacy

“…This finding may have safety implications as it was suggested that among patients seeking NSAIDs following musculoskeletal complaints, 6% incur in adverse events. 27 …”

A Comprehensive Review of Non-Steroidal Anti-Inflammatory Drug Use in The Elderly

“…In the primary care setting, Koffeeman et al conducted a retrospective cohort study using a database of 1.5 million patients in the Netherlands who were prescribed NSAIDs due to musculoskeletal pain symptoms [ 66 ]. They found that 6% of all patients consulted their primary care provider due to non-serious potential adverse drug reactions and the most common symptom was dyspepsia (32%).…”