Pharmaceutical product safety recalls: A retrospective pattern analysis in a tertiary care public hospital (2003 – 2009)

Abstract

Pharmaceutical product recalls (PRs) have become rampant and increased dramatically in recent years. Decision for PR is made if there is or may be risk to the user of the product due to faulty production or medical reasons. This retrospective study was to evaluate the pattern and trend of PR incidence and to identify the major manufacturing and clinical root causes of reported pharmaceutical product (i.e. drug) recalls in one of the big and busy tertiary care public hospitals located in Klang Valley, Malaysia. Data in PR forms between January 2003 and December 2009 were recorded and analysed descriptively. Overall in 7 consecutive years, the study hospital received 74 general nation PR notices (2003: n = 17 (23.0%); 2004: 14 (18.9%); 2005: 12 (16.2%); 2006: 3 (4.1%); 2007: 5 (6.8%); 2008: 16 (21.6%); 2009: 7 (9.4%)). About 27 (36.5%) of direct PR notices involved this hospital merely. National Pharmaceutical Control Bureau issued 6.8% PR notices, pharmaceutical companies voluntary 91.9% and 1.3% unstated. Pharmaniaga Manufacturing requested PR the highest (16.2%), followed by Safire Pharmaceuticals (13.5%), Duopharma (12.2%) and SM Pharmaceuticals (12.2%). Degree III was the commonest action level of nation PR (97.3%) compared to degree I (2.7%). Among the reasons of PR include pharmaceutical physical appearance (40.5%), physicochemical parameter (28.4%), adverse drug reaction (4.1%), microbial test (4.1%), packaging (4.1%), contamination of foreign particles (2.7%), mixed up with other ingredients (2.7%) and sterility (1.3%). The highest pharmacological class of PR was antibiotic (14.9%), followed by non-steroidal anti-inflammatory drugs (NSAIDs) (9.5%), vitamins (8.1%) as well as antifungal (8.1%). The most respective frequent dosage form was tablet (51.4%), followed by injection (14.9%) and suspension (12.2%). The response periods toward PR were 39.2% < 7 days, 37.8% > 7 days – 1 month and 16.2% > 1 month. Essential actions taken by all respective parties in dealing with the specification of the pharmaceutical products to ensure drug safety and harmless drug use hence avert possible health risks to patients.