Managing medicine shortages

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.

HRT medicine shortages - May 22

The Government is working with the industry to improve supply of HRT products.

The ABPI has established a dedicated Project Team of our members to focus on supply chain issues that relate to HRT products. By volume, the HRT market is mainly generic, but we are in contact with Government and other trade associations on issues relating to supply.

We are also working closely with our members, the NHSE Menopause Programme and the DHSC Medicines Supply Team to support supplier engagement on HRT and wider Women’s Health Strategy.

You can see our last statement on HRT here.

Related content in this section:

• Medicine supply
• Managing medicine shortages
• Counterfeiting
• Falsified Medicines Directive (FMD)
• Medicines information access to patients