Every day millions of patients rely on medicines supplied by the pharmaceutical industry.
Manufacturers know that any medicine shortage is extremely worrying for the people affected by it. They do everything they can to prevent medicine supply problems occurring and to resolve them quickly if they do happen.
Companies work to prevent shortages happening in the first place in a number of ways:
- Each part of the manufacturing and distribution process is risk assessed and back-up plans are put in place
- Preventative maintenance work is done on production machinery
- Companies review usage levels to predict seasonal spikes in demand and query unusual order patterns
- Stock levels are monitored and managed and stock may be reallocated from one market to another if needed
Despite the best efforts of all concerned, supply problems can happen for unforeseen reasons such as:
- Manufacturing problems
- Availability of raw materials (active pharmaceutical ingredients), or other medicine or pack components
- Unexpected demand
Government reporting requirements for medicines shortages and discontinuations
If shortages arise, companies are required to notify the Department of Health and Social Care (DHSC) who will work with a range of stakeholders to resolve them quickly using tried and tested procedures.
The DHSC has now published guidance which outlines the obligations on companies to inform the department of any medicine discontinuations or anticipated supply shortages, to help manage supply issues and mitigate any potential impacts on patients.
Companies take their responsibilities very seriously and are accountable to UK regulators should supplies of their products become unavailable.