Quality Risk Management ICH Q9 – Revision published for public comments
Medicine Shortages Framework established for effective management of medicinal product shortages
Ensuring continuity of supply of medicinal products and managing medicines shortages when they do occur is a key component of patient care. The Health Products Regulatory Authority (HPRA) launched a new national initiative (The Medicine Shortages Framework) to better manage human medicinal products shortages and their impact on Irish patients. In addition, the HPRA also published a guidance document on 14 Sep 2018 on Medicinal Product Shortages.
The Medicine Shortages Framework was developed in collaboration with a wide range of stakeholders, including other state health sector bodies, healthcare professionals, patient groups, and industry. A new function has been created within the HPRA who will be responsible for coordinating the management of medicine shortages on the Irish market and it will work closely with various stakeholders to manage and respond to shortages when they occur and reduce the impact of shortages on patients. In addition, the HPRA has also created a dedicated section on its website to provide information on the medicines which are in short supply, and their anticipated return to the market.
While the framework document focuses on the management of shortages that occur, it is critical that key stakeholders have proactive strategies in place to prevent shortages occurring.
All stakeholders involved in the medicine supply chain have a role in ensuring that patients have continued access to the medicines they need and also in the prevention and management of stock out situations. The Marketing Authorization Holder (MAH), Manufacturer and the Wholesale distributors have a legal obligation to ensure, within the limits of their responsibility to ensure the appropriate and continued supply of products to meet he needs of the patient.
The MAH has oversight of the supply of their medicines and are responsible for:
- ensuring that supply and demand are aligned
- developing strategies to prevent shortages
- understanding the impact of a shortage
- preparing the appropriate response to the shortage
- notifying the HPRA.
Manufacturers are responsible for:
- ensuring that they have capacity to manage reasonable supply fluctuations
- developing risk based strategies to prevent shortages due to the manufacturing process
- reporting general issues that could result in potential or actual shortages to the HPRA.
Wholesale Distributors are responsible for:
- sourcing alternative medicines during a shortage
- monitoring and communicating stock levels
- managing equitable distribution of medicine that is in stock shortage
- reporting any general issues that could result in potential or actual shortages to the HPRA.
There are a variety of reasons why a shortage occurs, but based on the current shortages listed for the Irish market on the dedicated section of the HPRA website:
(www.hpra.ie/homepage/medicines/medicines-information/medicines-shortages)
The main drivers are Manufacturing Delays, API impurity issues and increased demand, with the former two categories making up >90% of the shortages that may have a medium or high impact on patients. Therefore, it is important the MAH have a supply continuity plan in place and that both the MAH and the Manufacturer completes a risk assessment of their supply chain to ensure that it is robust.
In addition to the HPRA’s initiative, The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), together with key stakeholders, has set up an EU-wide task force to develop and coordinate actions for better prevention, identification, management of and communication on issues that can affect the availability of medicines, in order to improve continuity of supply of human and veterinary medicines across Europe. Over the next 2 years, the task force will be:
- looking at ways to minimise supply disruptions and avoid shortages by facilitating approval and marketing of medicines using the existing regulatory framework (e.g. using work sharing and reduced timetables when possible)
- developing strategies to improve prevention and management of shortages caused by disruptions in the supply chain (e.g. developing guidance for companies on reporting of shortages)
- encouraging best practices within industry to prevent shortages;
- improving sharing of information and best practices among EU regulatory authorities to better coordinate actions across the EU;
- fostering collaboration with stakeholders and enhancing communication of supply problems to EU citizens.
The task force will organise a multi-stakeholder workshop on 8-9 November 2018 to gather stakeholders’ perspectives on how to address availability issues and to include their input into the deliverables of the task force.
http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2018/08/WC500254243.pdf
If you would like further information or wish to discuss how we can tailor our services to meet to help you to develop your supply continuity plans or risk assessments please connect with us to discuss +353 1 846 4742 or contactirl@pharmalex.com
Related posts
