Objective:
After the alert of European Medicines Agency on 5th of July 2018 and update on July 17, 2018 for possible contamination with N-nitrosodiumethylamine /NDMA/ of active substance Valsartan manufactured in Huahae Pharmaceuticals in China the Bulgarian Drug Agency made an official announcement in the Information Media - TV and newspapers. After the statement a real panic emerged among the patients and many of them stopped all antihypertensive drug.
Design and method:
The antihypertensive therapy of group of 400 patients referred to Specialized Cardiology Practice for an annual consultation was analyzed. The group consisted of 288 women and 112 men. Age between 18 and 90 years 302.30% of them were over 60 years old.
Results:
30 % of the patients / 74 men and 46 women / stopped their therapy for almost a month. 28 % of the patients were prescribed by GP‘s other trade formulas of Valsartan. 42 % of the patients were switched to other ARB‘s – predominantly Irbersartan. The analysis shows that the patients that stopped their treatment in 77% were over 65 years old. No cases of possible damage due to the use of these drugs have been reported yet.
Conclusions:
1. As far as Medicine is art, but Healthcare is business, this event played the role of “Stress Test” for the whole system.
2. It is needed to overview all the responsibilities and obligations of the main Institutions that organize and control the process of registration of medications and treatment of people.Their united and coordinated actions are needed in cases like the one we discuss. Moreover fake news may appear too as far as pharma companies are in constant competition.
3. The doctors must pass a specific vocational training for treatment of vulnerable groups like elderly, or well informed patients who are very sensitive for any changes in their treatment or any information concerning the safety of the pharmaceutical products.
