Drug shortages have been in the headlines for years but getting them under control has proved to be a complex, multifaceted problem. Reports of critical shortages for chemotherapeutic agents, saline solutions, other injectables, and oral medications have lead healthcare providers oft times to seek other options for therapy. There has even been one firm created expressly to aid hospitals to avoid or resolve drug shortages.
A report just released and titled “Drug Shortages: Root Causes and Potential Solutions” offers a look into the current thinking on the issue. The report can be found here by clicking on the link in the first line of this FDA web page.
The report identifies the following causes for drug shortages:
- Lack of incentives for manufacturers to produce less profitable drugs;
- The market does not recognize and reward manufacturers for “mature quality systems” that focus on continuous improvement and early detection of supply chain issues; and
- Logistical and regulatory challenges make it difficult for the market to recover from a disruption
and provides the following solutions:
- Creating a shared understanding of the impact of drug shortages on patients and the contracting practices that may contribute to shortages;
- Developing a rating system to incentivize drug manufacturers to invest in quality management maturity for their facilities; and
- Promoting sustainable private sector contracts (e.g., with payers, purchasers, and group purchasing organizations) to make sure there is a reliable supply of medically important drugs.
The causes and recommendations seem to fly in the face of the demand for cheaper generic and brand‑name drug products. You can’t continue cutting prices and insurance payments and expect firms to be able to develop, manufacture, and continue to sell unprofitable drugs. Nor can you expect firms to be able to invest in the infrastructure to meet the type of long-term quality initiatives that are also implied in feeding the problem.
The report was generated by the Drug Product Task Force and chaired by the FDA. Eight other federal organizations participated in the study and development of the report. It contains the term “enduring solutions” in its text, and this is what we are all after as correcting each individual shortage as it occurs without looking towards the long-term objective of preventing shortages in the future by having redundant systems and options is clearly not working. Perhaps it is time to pony up before the race is lost.