New penalties concerning drug shortages welcomed by compounding pharmacists

penalties not reporting drug shortages

With the incidence of drug shortages increasing worldwide, one made-to-order medication specialist has welcomed a proposal to introduce substantial fines for drug manufacturers and marketers who don’t report upcoming disruptions to supply.

Matthew Bellgrove from National Custom Compounding on the Gold Coast said failure to notify authorities of a shortage in some essential medications could result in serious adverse health events for vulnerable people.

“When doctors, pharmacists and hospital administrators are warned of an upcoming shortage of an important drug they can plan for it, keeping whatever limited supplies they have for those most in need and arranging for alternative or compounded medication – medication that’s made from scratch in a local laboratory –  to make up the shortfall.”

“However if a shortage strikes with little or no warning, there’s a very real danger of patients experiencing significant set-backs in their health care, leading to a potentially serious complications.”

The proposal to fine drug manufacturers who fail to notify health authorities of looming drug shortages has come from the Therapeutic Goods Administration (TGA) after a period of consultation with stakeholders in the health care sector.

In a summary of their consultation the TGA said health care professionals supported, “…the proposal that all information on a critical shortage be reported within a 2 day timeframe.” The definition of a ‘medicines shortage’ was also agreed upon as well as which essential medicines should be included in the scope of mandatory reporting.

Health professionals involved in TGA’s consultation also advocated for stricter penalties for sponsors (drug marketers) in breach of mandatory reporting requirements, up to and including criminal prosecution.

Individuals found in breach of the new legislation could be fined up to $21,000 while companies would face fines of up to $210,000. This amount is significantly down from the figure of $6.3 million originally proposed by the TGA at the beginning of the consultation period. Those in breach would also be ‘named and shamed’ by the TGA.

Participants in the consultation also agreed on the implementation of a Medicines Watch List. This list will reflect the current and longer-term (up to 6 months) availability in Australia of medicines ‘deemed to be of critical importance’.  As described by a the TGA: “Medicines will be included (on the Medicines Watch List) on the basis that if there was any shortage of, or permanent discontinuation of the supply of, the medicine in Australia, that this could result in:

  • significant morbidity in relation to patients in Australia or
  • the death of one or more patients in Australia.”

The changes will also cover the reporting of medications for which the manufacturer is planning to cease production. For medications considered ‘of critical impact’, 12 months notice will be required while medications not considered of ‘critical impact’ will require 6 months notification.

“Drug manufacturers often cease production on certain medications for a number of reasons,” Matthew said, “Sometimes it’s an older medication that the drug company believes has been superseded by a newer, improved alternative, and sometimes demand has dropped off, making production no longer as profitable for the manufacturer.”

“Whatever the reason discontinued medication can be very problematic for some patients on long term treatment plans who’ve been using a medication for many years. They’re forced to find an alternative that may not be as effective for their particular condition or may react adversely with other medication they’re taking.”

“Compounding pharmacies can again help in this situation by stepping in and making medications when the commercial manufacturer ceases production.”

For more information on the important contribution compounding pharmacies make to the health care sector during drug shortages contact Matthew Bellgrove at National Custom Compounding on 1300 731 755 or [email protected].