Switching of H(2)-Receptor Antagonists to Over-the-Counter Status in Finland : Implications for Consumption and Adverse Effects.

OBJECTIVE

To evaluate the consumption and safety of H(2)-receptor antagonists after switching ranitidine and famotidine to over-the-counter (OTC) status.

METHODS

The Finnish drug consumption data, based on the sales of medicines, and the national register for adverse drug reactions (ADRs) from 1990 to 2003 were used. We studied the consumption of H(2)-receptor antagonists, proton pump inhibitors, sucralfate and antacids (A02BA, A02BC, A02BX02 and A02A, respectively, according to the Anatomical Therapeutic Chemical [ATC] classification). We compared the ADRs of H(2)-receptor antagonists with proton pump inhibitors.

RESULTS

The total consumption of medicines for the treatment of peptic ulcer disease and gastro-oesophageal reflux disease increased more than 2-fold from 1990 to 2003 (from 12.8 daily defined doses [DDD]/1000 inhabitants/day to 29.6 DDD/1000 inhabitants/day). Initially, switching ranitidine and famotidine to OTC status in 1996 increased their consumption. Since 1998, proton pump inhibitors have been the most commonly used drug group for the treatment of peptic ulcer and gastro-oesophageal reflux disease in Finland. In 2003, the consumption of proton pump inhibitors was 75% (22.2 DDD/1000 inhabitants/day) of the total consumption of drugs for the treatment of peptic ulcer and gastro-oesophageal reflux disease. Switching ranitidine and famotidine to OTC status did not affect the number of reported adverse reactions to these drugs.

CONCLUSIONS

According to information collected from the Finnish consumption and ADR databases, H(2)-receptor antagonists are very often used in self-medication and they do not have serious adverse effects. However, the total number of reports concerning these ATC groups in the national ADR database is not very high, and therefore patient-based surveys are needed to verify this finding.