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UPDATED - 'Get a grip': HSCC calls for rapid change to drug substitution rules

The health and social care committee’s (HSCC) pharmacy inquiry report has demanded drastic changes to sector funding and pharmacist substitution powers.

The health and social care committee (HSCC) today (May 29) urged the government to update regulations on “dose and formulation” substitutions within three months to address medicines shortages in a new report from its pharmacy inquiry.

Community pharmacists should be able to “dispense what they have available” when they encounter stock shortages, according to the HSCC.

Read more: Whooping cough: DH reactivates two SSPs for antibiotic clarithromycin

It said that the government must “get a grip” on shortages, condemning the existing policy regime as “clearly insufficient”. 

And the HSCC added that generic substitution should be introduced after a government consultation to account for concerns around “patient safety” and “unintended impacts on the supply chain”. 

It also recommended that the government:

  • Reviews the effectiveness of serious shortage protocols (SSPs), “with a focus on their timing and their administrative burden”
  • Commissions an independent review of the medicines supply chain “as soon as possible”, to be “completed within six months of starting”
  • Outlines “what impact it believes national patient safety alerts have on private prescribing and what scrutiny and enforcement measures are in place to ensure private prescribers adhere to these alerts”


Funding “overhaul”


The committee also said that the community pharmacy contractual framework (CPCF) needs to be “completely overhauled”. 

It added that the government must “close the gap” in the funding arrangement that has seen “an annual shortfall of at least £67,000 per pharmacy”. 

Read more: General election: CPE ‘deeply concerned’ over prospect of further contract delays

The HSCC proposed making reimbursement less complex and suggested measures like “de-risking the purchasing price of medicine” so that cash flows can be more easily predicted. 

Community pharmacy must have “mechanisms to fund both dispensing and clinical service delivery, avoiding a situation where one pays for another”, the committee said.


“Powerful endorsement”


Community Pharmacy England’s (CPE) chief executive Janet Morrison said that the report is “another powerful endorsement” of the community pharmacy sector. 

She praised the balance of the report - from its warnings about “the perilous state of pharmacy businesses” to its showcase of “the untapped potential that community pharmacies have to offer”.

Morrison added that CPE is “urging all political parties to commit to supporting community pharmacies” ahead of the general election

Read more: ‘Thriving market’: Minister upbeat about community pharmacy despite closures

The Royal Pharmaceutical Society’s (RPS) England board chair Tase Oputu meanwhile said that the report offers “clear priorities” for the government’s approach to pharmacy “whoever wins the general election”.

“The next government must act on today’s recommendations and put improving patient care at the heart of its agenda,” she added.


“Wide-ranging and robust”



And the Company Chemists’ Association’s (CCA) head of public affairs Neeraj Shah said that the report’s “wide-ranging and robust” recommendations align with those offered by CCA chief executive Malcolm Harrison in his appearance at the inquiry.

Shah added that the CCA supports the report’s calls for a funding uplift and a “long overdue” independent review of the medicines supply chain. 

“We hope that the next government will provide the investment the sector needs,” Shah said.

Read more: HSCC: ‘Nonsensical’ that pharmacists lack generic substitution powers

Numark chair Professor Harry McQuillan added that the report is “absolutely correct” in its assessment of community pharmacy funding.

“With Pharmacy First we need a [contract] that represents modern day realities and patient requirements aligned with a strategy for professional development for our sector,” he said.


The pharmacy inquiry so far


The HSCC held the final session of its pharmacy inquiry in March, when pharmacy minister Dame Andrea Leadsom told the committee that the community pharmacy sector “continues to be a thriving market”.

The inquiry was launched in June last year to “examine the readiness of pharmacy services to capitalise on future opportunities”.

Dame Andrea’s comments drew the ire of CPE, which wrote to HSCC chair Steve Brine to say that its own analysis “tells a story of declining performance, loss-making and negative net assets”.

Read more: Pharmacists altering prescriptions could ‘exacerbate’ shortages, says minister

In February, Brine told the 2024 Sigma Pharmaceuticals conference that medicines shortages are “an infection that runs the risk of spreading across the body of primary care, not just pharmacy”, as he called for more substitution powers for pharmacists.

But in January, Dame Andrea claimed in response to a parliamentary question on substitution that pharmacists could “exacerbate” medicine supply issues if allowed to switch, according, she said, to an “assessment” made by the government. 

A C+D freedom of information (FOI) request subsequently revealed that the Department of Health and Social Care (DH) did not have a published assessment on substitution.

Read more: ‘No published assessment’ on pharmacist drug substitution, DH reveals

Meanwhile, in a January sitting of the inquiry, Pharmacists’ Defence Association (PDA) chair Mark Koziol told the HSCC that regulation could be changed to allow pharmacists to better focus on “medicines management issues”.

The pharmacist should be the patient's medicines champion,” he said.

And in November, chief executive of the Independent Pharmacies Association (IPA, then known as the Association of Independent Multiple Pharmacies or AIMp) Dr Leyla Hannbeck told the HSCC that the system used to reimburse NHS work was “not fair” and “not fit for purpose”.

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