Drug category ‘Pharmacy Plus’ considered in NHS England review of high-dose statins

The creation of a new class of Pharmacy (P) Plus drugs was discussed as part of a review of how high-dose statins might be available without a prescription from community pharmacies.

Minutes of two meetings, obtained via an access to information request by Pharmaceutical journal on June 30, 2021, detailed discussions on the future of high dose statins between NHS England and Improvement (NHSE & I) with the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Pharmacy Association (NPA), including the suggestion of the creation of a P plus category.

In the minutes of one of the meetings, which took place on August 26, 2020, a representative of the MHRA said that the introduction of the additional category would require a “new classification of drugs”.

“We would need to consider what we think are the requirements for it to be classified as P Plus,” they said. “Diagnosis involving clinical measurements, ongoing treatment, record keeping and provisioning personally by the pharmacist … many of these issues relate to the procurement model.”

The minutes continued to say that, if discussed further, the new classification was an area in which stakeholders should be “heavily involved”.

“It will take time and will require consultation. “

At a subsequent meeting held between the NPA and the NHSE & I on September 10, 2020, a similar discussion around a P plus category took place. However, the NPA representative said he was “unclear” as to the value of the new category.

“Access to files and infrastructure … would still be required [whether] the high-intensity statin was a ‘P’ or ‘P +’ status item, “the record read, adding: the patient.”

Commenting on the NHSE & I’s review of access to high-dose statins and discussions around a potential P Plus category, Michelle Riddalls, CEO of the Proprietary Association of Great Britain (PAGB), said she had also met with representatives of NHSE & I in 2020 for a “high level discussion”.

“No conclusions were drawn at this meeting,” she said.

“PAGB supports the reclassification of drugs to the extent possible, once their safety and efficacy profile has been established, as a means of improving access to drugs and supporting self-management. .

“We are also promoting an enhancement of the role played by pharmacists within the health system, in recognition of their training and expertise,” she added.

An NHS England spokesperson said Pharmaceutical journal that his review of high-dose statins was underway and had been delayed due to the COVID-19 pandemic.

Speaking at the NHS England Health and Care Innovation Exhibition in Manchester in September 2019, Simon Stevens, Managing Director of NHS England, said he had asked NHS officials to work with the Medicines and Health Products Regulatory Agency “to determine if we can move our high-dose statin and other appropriate drugstore treatments.”

A study presented at the Congress of the European Society of Cardiology in Paris and published in the Journal of the American Medical Association (September 2, 2019) found that a long-term reduction of 1 mmol / L in low-density lipoprotein cholesterol with a 10 mmHg reduction in blood pressure was linked to an 80% reduction in the lifetime risk of developing heart disease and circulatory disease.

As a result of the research, Stevens told the conference that Keith Ridge, pharmaceutical director for England, and Nikki Kanani, director of primary care at NHS England, would lead a review with the MHRA on how high statins dose could be manufactured. available at community pharmacies.

READ MORE: NHS England is considering three models to make high-dose statins available in community pharmacies

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