Written Question · S5W-29509 · Session 5
What its position is on introducing a system that will allow people to report adverse reactions to therapies, similar to the Yellow Card sc…
The question
To ask the Scottish Government what its position is on introducing a system that will allow people to report adverse reactions to therapies, similar to the Yellow Card scheme that the Medicines and Healthcare products Regulatory Agency (MHRA) operates for adverse reactions to medicines and medical products.
The answer
There are existing organisations, systems and processes in place in Scotland to identify and manage any concerns patients have with respect to their treatment.
Patients who have experienced an adverse reaction to a therapy or treatment are advised to, first of all, seek medical assistance from their family doctor and/or the relevant clinic where they are being treated. It would then be for the healthcare professional managing their care to determine if an adverse event has occurred and, if so, to report it on the local adverse event reporting and learning system.
Patients who, having spoken to the relevant healthcare professional, remain concerned may then raise a complaint with the appropriate NHS Board. If they are unhappy with the final decision of the NHS Board, they could then pass their complaint to the Scottish Public Service Ombudsman for review.
If the treatment is a medicine or a medical device, there are existing systems in place for adverse events to be notified by healthcare professionals – the Yellow Card Scheme (Scheme) for medicines and Incident Reporting and Investigation Centre (IRIC) for medical devices. Alternatively, public and patients in Scotland can, if they wish, report both medicines and medical device incidents directly through the Scheme, which is used UK-wide.
If the treatment causing concern was bought at a retail outlet, such as a pharmacy, the patient or member of the public should return to the outlet where the product was purchased. Members of the public can also raise concerns with their local trading standards office, in addition to using the Scheme.
If a patient has an issue with a specific therapy or therapist
- particularly for services provided in the private sector
- they can contact the regulator for that particular profession, such as the General Chiropractic Council; Health and Care Professions Council, who regulate physiotherapists; or Healthcare Improvement Scotland (HIS), who regulate independent healthcare, including independent hospitals, private psychiatric hospitals, independent hospices, and independent clinics, for instance.
Patients who have experienced an adverse reaction to a therapy or treatment are advised to, first of all, seek medical assistance from their family doctor and/or the relevant clinic where they are being treated. It would then be for the healthcare professional managing their care to determine if an adverse event has occurred and, if so, to report it on the local adverse event reporting and learning system.
Patients who, having spoken to the relevant healthcare professional, remain concerned may then raise a complaint with the appropriate NHS Board. If they are unhappy with the final decision of the NHS Board, they could then pass their complaint to the Scottish Public Service Ombudsman for review.
If the treatment is a medicine or a medical device, there are existing systems in place for adverse events to be notified by healthcare professionals – the Yellow Card Scheme (Scheme) for medicines and Incident Reporting and Investigation Centre (IRIC) for medical devices. Alternatively, public and patients in Scotland can, if they wish, report both medicines and medical device incidents directly through the Scheme, which is used UK-wide.
If the treatment causing concern was bought at a retail outlet, such as a pharmacy, the patient or member of the public should return to the outlet where the product was purchased. Members of the public can also raise concerns with their local trading standards office, in addition to using the Scheme.
If a patient has an issue with a specific therapy or therapist
- particularly for services provided in the private sector
- they can contact the regulator for that particular profession, such as the General Chiropractic Council; Health and Care Professions Council, who regulate physiotherapists; or Healthcare Improvement Scotland (HIS), who regulate independent healthcare, including independent hospitals, private psychiatric hospitals, independent hospices, and independent clinics, for instance.
In the Official Report
No contribution in the Official Report cites S5W-29509 by reference.