5PSQ-026 Impact of a safety alert with valsartan in a health management area

Background Valsartan is an angiotensin II receptor antagonists (ARAII), used to treat high blood pressure and heart failure. In July 2018, a safety alert about the presence in certain drugs with valsartan of an impurity (N-nitrosodimethylamine (NDMA)), potentially cancer-causing, was released by all health agencies. In our country, the local agency informed about all brands contaminated, encouraging patients affected to change it for another one in their pharmacies. Purpose To describe the impact of a safety alert in the consumption of valsartan. Material and methods A retrospective observational study of all patients in treatment with valsartan was conducted. First, after the safety alert, we obtained a list of patients in treatment with valsartan, selecting those with the impure drug. Second, in October we reviewed if those patients continued with valsartan or changed to another ARAII. The variables were age, sex, drug before and after the alert, time between the alert and the measure taken, if one was made (change of ARAII, suspension of treatment, maintained the same ARAII but changed to an original brand or another generic). Results Two-hundred and twenty-six patients were included (131 females), with an average age of 72.32 years (44–96). From all patients, 73 (32%) did not go to the doctor and when they had to pick up the next box was when the pharmacist gave them a non-contaminated drug. The rest of the 153 patients (68%) visited the doctor after the safety alert. In these patients: 105 changed to losartan, three to telmisartan and three to candesartan; 37 changed the label of valsartan (35 to an original brand and two to generic); and six suspended the ARAII drug. The average time between the alert and the doctor’s visit was 12.7 days. Conclusion Many physicians preferred to change medications than to continue with valsartan, so we will have to check if this trend remains in time and the consumption of valsartan is reduced. In addition, 32% of patients did not go to the doctor and did not change the drug until it had finished, without being aware of the safety alert, so the method of communicating health alerts to patients will have to be improved. References and/or acknowledgements No conflict of interest.