The Human Medicines (Amendment) Regulations 2019 order – which came into force on February 9 – includes provisions to allow pharmacists to dispense an alternative in accordance with a “serious shortage protocol” that could be announced by the government – rather than the prescription and without contacting the GP – in the event of a national medicines shortage.

Having the power to dispense alternatives without contacting a GP puts pharmacists in an “invidious position”, Norman Lamb, Liberal Democrat MP for North Norfolk, argued in a parliamentary debate on revoking the powers yesterday (March 18).

“They may well be having to make decisions ​that may impact adversely on a patient’s health and wellbeing when they are not necessarily skilled to make those judgements,” he said.

Ivan Lewis, Independent MP for Bury South, agreed, stressing that “pharmacists are skilled professionals in medicines and medicines management, but they are not specialist prescribers”.

Helen Goodman, Labour MP for Bishop Auckland, questioned why doctors undergo “all this training if anybody without it is suddenly able to dole out prescriptions”.

She also questioned whether pharmacists would be appropriately insured if a patient suffers an adverse effect as a result of the pharmacist dispensing under a government protocol – a concern raised by pharmacy bodies during the Department of Health and Social Care’s (DH) informal consultation on the shortages powers.

“Contentious regulations”

Shadow health secretary Jonathan Ashworth – who tabled the parliamentary motion to revoke the shortages powers – said the regulatory changes are “perhaps one of the most far-reaching and contentious of the government’s changes to medicines regulation in recent times”, and “could cause real problems for people with long-term conditions”.

He argued that doctors know a patient’s medical history better than a pharmacist, and claimed that “many community pharmacists do not necessarily want [the] responsibility” of dispensing alternatives without contacting a GP.

The government should have consulted patients, patient groups and health stakeholders before “rushing through these changes”, Mr Ashworth stressed, and called for “extensive communication and training” to “manage expectations and any dissatisfaction”.

“Considerable misinformation”

Defending the shortages powers, health minister Jackie Doyle-Price stressed that a protocol would be implemented only in “exceptional circumstances”, to “allow highly trained pharmacists” to dispense within the “narrow confines” of government instructions.

There has been “considerable misinformation” around the shortages powers and it is “not about pharmacists acquiring prescribing rights by the back door”, she stressed.

“It is entirely about ensuring that patients have access to the medicine they need, by making the best possible use of highly qualified pharmacists and freeing up GP time for patients who need to see their GP.”

The parliamentary motion to revoke the shortages powers was defeated by 292 to 240.

Read yesterday’s debate in full.

Legal challenge

Not-for-profit organisation the Good Law Project launched legal proceedings against the DH last month for pushing through the regulatory changes “without proper consultation with patient and clinical groups”. Ms Doyle-Price said the High Court rejected the judicial review request last week.