Government proposals that would enable pharmacists to switch patients’ prescriptions during a medicines shortage without consulting their doctor are set to be reviewed after one year.
In response to a consultation on amendments to the Human Medicines Regulations 2012 legislation, which would introduce the use of “strict shortage protocols”, the government has added a “review clause” that will legally require the Department of Health and Social Care (DHSC) to review the amendments one year after the first protocol is issued.
The protocols will allow pharmacists to dispense an alternative medicine if the prescribed drug is unavailable, without having to contact the patient’s GP. Pharmacists would be able to respond to a shortage in four ways, including dispensing a reduced quantity, a therapeutic equivalent, a generic equivalent or an alternative dosage form.
According to the DHSC, respondents to a consultation on the use of such protocols “were broadly supportive of the proposal”, but concerns were raised “about the lack of public consultation”.
Additionally, the Pharmacists’ Defence Association (PDA) said in its response published on 10 January 2019 that the use of protocols could “pose a risk to patient safety”.
The DHSC said in its response to the consultation that it had “amended the regulation post-consultation to include a review clause”.
This means that the DHSC “will be required by law to review the serious shortage protocol provision as soon as is reasonably practical after the end of one year after the first protocol starts to have effect”.
The response continued: “The review will look at, specifically, any adverse consequences for either the market in prescription-only medicines or patient safety.”
In an explanatory memorandum attached to the draft amendment laid before parliament on 18 January 2019, the government admitted that the protocols may pose “some risks to patients”.
The memorandum said: “The main benefits of the protocol would be the NHS cost savings associated with GP time.
“There may be some risks to patients, and therefore costs associated with this, but clinicians setting out the guidance will consider and minimise these risks when setting out the guidance.”
It adds that the impact on community pharmacies will be “neutral” as pharmacists will need “to inform the GP when they dispense against a protocol and they may also be required to do some further checks that they would not do when dispensing against a prescription”.
Sandra Gidley, chair of the Royal Pharmaceutical Society’s English Pharmacy Board, told The Pharmaceutical Journal that the protocols need “to be relatively fleet of foot”.
She said: “For example, community pharmacists are often aware that stock is in short supply before the situation is officially recognised.
“It would be useful if we could have reassurances around timescales for kickstarting the process and how quickly a decision can be made. By the same token, thought needs to be given to how and when patients are switched back.”
According to the draft legislation, the regulations clarified that “a serious shortage is a serious shortage in the opinion of ministers … and if clinicians think it is appropriate, after discussion with the manufacturer and/or marketing authorisation holder”.
The amendments allowing the use of “serious shortage protocols” are expected to come into force on 9 February 2019 and are not linked with a no-deal Brexit.