EXAGGERATED EXPIRATION DATES OF PHARMACEUTICALS- ENHANCING ECONOMIC BURDEN ON HEALTH CARE SYSTEM OF A COUNTRY
Author(s)
Kaushal N, Vaidya Y, Gulati M, Singh SK
Lovely Professional University, Phagwara, India
Presentation Documents
The expiry dates mentioned on the medicines are considered inviolable by the patients. Given by the manufacturer and approved by the highest regulatory agencies of a country, expiry date is considered as the ultimate safeguard to ensure the safety of the medicine being used by the patients. Exaggerated expiration dates pose economic burden on the healthcare system of a country, the effect being more significant in the underdeveloped and developing economies. In developed countries these issues have been addressed by using pharmacoeconomic tools like a. Cost- minimization analysis b. Cost- effective analysis c. Cost- utility analysis d. Cost- benefit analysis. The outcome of the studies conducted under the Shelf Life Extension Program by FDA clearly indicate that pre-occupation with the safety issues has resulted in all stake-holders being too conservative about the expiry dates. This results in the wasteful disposal of the drugs which are still therapeutically effective after their labelled expiry dates. This article discusses the general societal notions about the expiry dates of the drugs, the procedures being generally followed by pharmaceutical industries to give the expiration dates to the drugs, cases where the expiry dates have been extended by the regulatory agencies themselves and a testing program that started as an Air Force initiative in collaboration with FDA and saved American taxpayers millions of dollars. The article also recommends the scientific course that may be taken towards a more pragmatic approach towards the expiry date labelling.
Conference/Value in Health Info
2014-05, ISPOR 2014, Palais des Congres de Montreal
Value in Health, Vol. 17, No. 3 (May 2014)
Code
PHP139
Topic
Health Policy & Regulatory
Disease
Multiple Diseases