Dáil Éireann Debate, Tuesday - 21 March 2023
1326. Deputy Colm Burke asked the Minister for Health the steps he will take to enable community pharmacists to be facilitated in managing therapeutic substitution more effectively, that is, without in all cases the necessity of reverting to a GP for a prescription; and if he will make a statement on the matter. [12939/23]
View answerIn the case of medicines used most often in Ireland, there are typically multiple forms, strengths, brands, and generic medicines available from various sources. Where some individual medicines are in short supply, alternative options such as alternative strengths, brands, and generic medicines remain available to ensure continuity of treatment.
In other jurisdictions shortages protocols 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.
This framework proposal will need very careful consideration to ensure it is underpinned and supported by minimum criteria, which will support the safe and effective working of the process. Legislative amendments will also 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.
