Substitution of prescriptions by pharmacists has not adversely affected patient safety or the operation of the medicines market, the first annual review of serious shortage protocols (SSPs) has found.
Serious shortage protocols (SSPs) under the Human Medicines Regulations 2012 (HMRs) are an additional tool to manage and mitigate medicines shortages. An SSP enables community pharmacists to supply a specified medicine in accordance with a protocol rather than a prescription, without needing to seek authorisation from the prescriber, saving time for patients, pharmacists and prescribers.
They are only used during a serious shortage, where a medicine would be likely to be out of stock for some time, and if, in the opinion of ministers, it would help manage the supply situation. They are primarily used by pharmacists without ready access to a prescriber who can alter the prescription.
Over the past year 12 SSPs have been issued, seven of which were for fluoxetine.
According to ministers, SSPs have largely been positively received, both in managing medicines shortages and in saving time. To alleviate safety concerns, all SSPs detail which patients should be excluded from an SSP supply and pharmacists are asked to assess patients’ suitability, and gain their consent.
Other SSPs have covered
- haloperidol (Serenace)
- Competact 15mg/850mg tablets
- Estradot 75 microgram patches.
Prior to introducing SSPs, a consultation highlighted safety concerns about automatic therapeutic or generic substitution of medicines for high-risk patients, and the potential for adverse effect on the medicines market.