Drug shortages continue to represent a significant barrier to the ability of pharmacists and other health providers to deliver quality care to patients. It forces the substitution of safe and effective therapies with alternative therapy; compromising or delaying medical procedures; or causing medication errors. Drug shortages pose a serious public health issue and it won’t end soon. Are we ready to call it a crisis?
The 2015 International Drug Shortages Conference was held on the 5th and 6th of May in Taipei, Taiwan. The purpose of the conference was to assess in depth the economic, manufacturing and regulatory factors that cause and contribute to drug shortages and consider possible solutions. The conference was organized by the Taiwan Food and Drug Administration and the Taiwan Generic Pharmaceutical Association. The conference attendees included representatives from the U.S.A, Japan, Canada, Australia, Malaysia, India and Europe.
Over the course of two days, an update on drug shortages in different countries around the world such as Japan, U.S.A, Australia and Taiwan were presented. Participants discussed a number of possible contributing factors for drug shortages as well as prevention and mitigation strategies.
Taiwan, like the rest of the world, has been experiencing an increase in frequency of drug shortages. The National Medicines Shortages Reporting System this year listed 128 products in short supply. This number increased from just 12 items five years ago.
There are many causes of drug shortages in Taiwan. One main reason is good manufacturing process enforcement actions. As of this year, all pharmaceutical companies must comply with PIC/SGMP standards. Statistics from January show that of 149 pharmaceutical companies, 48 have stopped the production of over 3000 products as they did not comply with PIC/SGMP standards.
According to the National Medicines Shortages Reporting System, antibiotics, external preparations (e.g. topical ointments) and oncology drugs topped the list of drug shortages. Antibiotic injections are more vulnerable to shortages mainly because of high costs resulting from complicated manufacturing processes and high standards of quality control. There is presently only one pharmaceutical company that produces penicillin G injections. Clinical outcomes may be compromised if production problems occur as it is the only treatment available for syphilis.
In the face of a drug shortage, pharmacists must act rapidly both in drug procurement and in therapeutic decision-making to ensure that patients receive uninterrupted, therapeutically equivalent and safe drug therapy. The question is…are YOU ready to combat drug shortages?