Background During the year 2013, the Spanish Agency for Medicines and Health Products (AEMPS) issued a series of alerts related to medicines containing tetrazepam: 1- Communication of start of the review process by the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) as a result of new data about a higher frequency of cutaneous adverse reactions to tetrazepam, without any specific recommendation (January). 2- Recommendation not to exceed seven days when starting new treatment and to review prolonged treatment (April). 3- Decision to suspend the marketing, to not allow initiation of new treatments and to look for alternative drugs (June).
Tetrazepam has been widely used in Spain since 1978. These alerts have forced a change in prescribing habits for indications of tetrazepam.
Purpose To analyse prescribing trends for tetrazepam and therapeutic alternatives in response to safety alerts issued by AEMPS.
Materials and methods Retrospective study of tetrazepam prescriptions and alternative treatment (AT) in the outpatients department of a 650-bed hospital that serves a population of 220,000 inhabitants. AT was defined as drugs in the tetrazepam therapeutic group (tizanidine, baclofen, cyclobenzaprine and methocarbamol) and benzodiazepines that shared indications (ketazolam and diazepam). We recorded the number of Defined Daily Doses (DDDs) of the drugs prescribed each month during two different periods: No Alerts Period (NAP), from January to August 2012, and Alerts Period (PA), from January to August 2013. To evaluate the influence of different alerts on prescribing, periods of a month either side of each notification were compared to 2012 (First period (FP): January, February and March, Second Period (SP): April and May and Third Period (TP): June, July and August). The global influence was analysed by comparing mean DDD/month between the NAP and the AP of each drug. Prescription data were obtained from the application for the registration and use of prescription-dispensing data of the Public Health System of Andalucía (Mycrostrategy). The Chi-squared test was applied to data.
Results In the FP DDD of tetrazepam decreased from an average of 2247 DDD/month in 2012 to 1607 DDD/month, the sum of DDD of AT increased from 4028 DDD/month to 6028 DDD/month. During the SP tetrazepam prescribing decreased from 2090 DDD/month to 725 DDD/month and AT increased from 3988 DDD/month to 8303 DDD/month. In the TP tetrazepam use fell from 2197 DDD/month to 67 DDD/month and the AT increased from 3999 DDD/month to 9655 DDD/month. Globally tetrazepam DDD decreased from 2189 month in NAP to 809 DDD/month in the PA, 63% reduction (p < 0.001). The AT increased from 4007 DDD/month in NAP to 7970 DDD/month in the PA, an increase of 99% (p < 0.001). Within the AT, the drugs that increased their prescription with respect to the previous year were: diazepam 3235 DDD/month (81% of AT), ketazolam 456 DDD/month (11%) and cyclobenzaprine 201 DDD/month (5%).
Conclusions The publication of alerts has reduced the use of tetrazepam by our doctors in a phased manner. Prescriptions were diverted to their AT, causing a significant increase in their use. Diazepam was the most used AT.
No conflict of interest.
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