Product information and national guidelines consistently recommend the estimation of serum alanine aminotranferase (ALT) before and after approximately 3 months as part of risk management following initiation of statin therapy. The aim of this study was to determine compliance to the recommendations for monitoring ALT in patients initiated on statin therapy. The prevalence of abnormal serum ALT levels was also evaluated and compared with current data. We performed a retrospective observational audit of the Medicine's Monitoring Unit (MEMO) prescribing record-linkage database, which includes evidence of prescribing and biochemistry results of all patients in Tayside, Scotland. We examined patients with first-time statin prescriptions and evaluated all laboratory liver function tests recorded before and after prescriptions from 1st January 2002 to 31st December 2002. Of the 5717 patients identified, 54% were male and the subjects had a mean age of 62 +/- 14 standard deviation (SD) years. The prescriptions yielded five types of statin and included the start date, dose, and number of tablets. In total, 1455 (25%) patients had no biochemistry data at all from the year 2002, and despite the 75% of patients who had an ALT measurement, over 90% of patients did not follow the current recommendations. The prevalence of elevated transaminases was consistent with published data in that significant elevation occurred in 1.9% of subjects. Adherence to the recommended laboratory monitoring for patients first prescribed with statin therapy is low in Tayside. Adverse drug reactions need to be more closely monitored by all healthcare professionals involved in prescribing. Monitoring can highlight abnormalities and therefore reduce potentially damaging effects.
|Number of pages||5|
|Publication status||Published - 2009|
- Adverse drug reactions
- Drug safety monitoring
- ADVERSE DRUG EVENTS