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5PSQ-147 The valsartan saga: pharmacists’ competence to resolve the therapeutic challenge
  1. C Muscat1,2,
  2. A Attard1,2,
  3. L Azzopardi1,
  4. A Serracino Inglott1,2
  1. 1University of Malta, Faculty of Medicine and Surgery- Department of Pharmacy, Msida, Malta
  2. 2Malta, Medicines Authority, San Gwann, Malta


Background A safety alert by the European Medicines Agency notified that some valsartan products were contaminated with the genotoxic impurity, N-nitrosodimethylamine (NDMA). This triggered a voluntary recall of potentially impacted valsartan medicines.

Purpose To investigate the competence of the pharmacist in assessing and addressing the risk-benefit associated with the safety concern of NDMA in valsartan medicines.

Material and methods A symposium was organised to evaluate the competence of the pharmacists in the application of scientific knowledge to the therapeutic challenges in the valsartan saga. A 32-slide presentation and nine questions were prepared and presented to the pharmacists (n=26, 16 females, 10 males; age 22 to 45; 10 hospital, 12 community, four industrial pharmacists) The responses given in the interactive discussion were recorded interactively by the Mentimeter and the results were related to the competence through an arbitrary evaluation.

Results Eighteen pharmacists (68%) stated that NDMA is a probable human carcinogen found to cause cancer in animals. Twenty-two (84%) stated that not all sartans contain a tetrazole ring and 20 (77%) responded that the formation of NDMA occured during the synthesis of valsartan. Twenty (77%) stated that NDMA is unlikely to bioaccumulate and seven (27%) stated that the half-life of valsartan is 6 hours. Six pharmacists (24%) correctly stated that 1.5 mcg/day was the tolerated limit for daily exposure to NDMA and 24 (88%) stated that drinking water, ham, bacon and cigarettes were contaminated with NDMA. Twenty (77%) pharmacists advised that valsartan should not be stopped abruptly until alternative treatment was available and 24 (92%) stated that they would recommend switching patients to another sartan as early as possible.

Conclusion The findings show that pharmacists have the necessary competence to deal with the valsartan saga. However, the symposium shows that pharmacists can benefit from an added value to their scientific knowledge such as in the pharmacokinetics and the clinical relevance of angiotensin-receptor antagonists and the threshold for toxicological concern of NDMA impurites.

References and/or acknowledgements Pottegard A, Kristensen KB, Ernst MT, et al. Use of N-nitrosodimethylamine (NDMA) contaminated valsartan products and the risk of cancer: Danish nationwide cohort study. BMJ 2018;362:k3851.

No conflict of interest.

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