David Cullinane
Question:370. Deputy David Cullinane asked the Minister for Health if he is considering the introduction of a serious shortage protocol regarding medicine supply; and if he will make a statement on the matter. [30386/23]
View answerThursday, 22 June 2023
Questions (370)
Written answers
In other jurisdictions outside of Ireland Serious Shortages Protocols (SSP) are used to facilitate community pharmacists to supply either an alternative quantity, strength, pharmaceutical form, or medicine. Legislation in Ireland already allows for generic substitution (alterative strengths, quantity and forms) but does not allow for therapeutic substitution.
Shortages protocols are product specific and are only used in very limited situations. For example, in the UK every draft SSP is reviewed by NHS England’s National Medical Director and Chief Pharmaceutical Officer, who can suggest amendments and raise any potential safety concerns, and Ministerial authorisation is necessary to give effect to the protocol. Each SSP is time limited.
The Department of Health is scoping the introduction of a similar framework, a limited stock supply framework (LSS) in Ireland which will only be used in certain emergency situations such as shortages. This is the case in all other countries that have a protocol in place. Legislative amendments will be required.
There are risks associated for both the pharmacist and patient with substituting prescriptions and the Department will need to be satisfied that these risks are addressed which will impact the timeframe for implementation. An initial proposal on implementation of this policy option is complete and work to develop the governance, legal, training and patient safety aspects of this proposal will be completed this year. The Department will engage with key stakeholders as this policy is developed.
Question No. 371 answered with Question No. 293.