NLEM drug shortages: There should be a centralized system for reporting drug shortages

The National List of Essential Medicines (NLEM) contains drugs that are considered to be most effective and safe to meet the most important needs in a health system. The drugs are selected on the basis of the disease burden in the country including what is of immediate concern. Medicines in NLEM are listed with reference to all levels of healthcare: Primary (P), Secondary (S) and Tertiary (T).

The list was last updated in 2015, which now contains a total of 376 medicines. In 2016, cardiac stents were added to the list.

Shortages of drugs, especially those in the NLEM, therefore are a cause of concern.

Few days back, there was a shortage of syrup furosemide, a life saving drug for children with heart failure. About two years back, there was a shortage of two drugs in the market, d-penicillamine (DPEN). D-penicillamine is used to treat patients with Wilson’s disease (copper overload) with liver, neurological and psychiatric manifestations. And, patients have to be on this drug lifelong.

Both furosemide and D-penicillamine are included in the National List of Essential Medicines (NLEM).

There can be several reasons for drugs running short in supply. These can include manufacturing and quality problems, delays and discontinuations, regulatory issues or problems in the supply chain. Patient care is affected as safe and effective drugs are then substituted with alternative drugs, which may be more expensive and may not be as effective as the first-line drugs.

In the United States, manufacturers provide the FDA with most drug shortage information. And, the agency works closely with them to prevent or reduce the impact of shortages.  All current and resolved drug shortages and discontinuations are reported to FDA at drugshortages@fda.hhs.gov, which are then compiled in a Drug Shortages Database.

But, unfortunately no such system exists in India to take care of drug shortages. There should be a centralized system, which informs doctors about the drugs that are running short in supply and, where drug shortages can also be reported.

Dr KK Aggarwal

Padma Shri Awardee

President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)

Group Editor-in-Chief IJCP Publications

President Heart Care Foundation of India

Past National President IMA