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Don Lavoie is alcohol programme manager at Public Health England and Gul Root is lead pharmacist, Health and Wellbeing Directorate, Public Health England
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gp complaintsMarch 30 2016

Draft proposals to amend legislation to allow pharmacies to supply medicines dispensed under a ‘hub and spoke’ system have been published.

The consultation also asks for views on legislative changes which will:

  • permit prices to be printed on medicines labels
  • clarify labelling requirements for monitored dosage systems (MDS) and for medicines dispensed under patient group directions (PGDs)
  • address an exemption for pharmacists regarding the preparation and assembly of medicines.

Details of the proposed changes are set out in a consultation document, along with a draft of the proposed necessary statutory instrument. The document has been issued jointly by the Department of Health and the medicines regulator, the MHRA.

Setting out the changes to allow ‘hub and spoke’ dispensing models by ‘spoke’ pharmacies that do not form part of the same retail pharmacy business as the ‘hub’ pharmacy, the proposed change will require amending eth 1968 Medicines Act.
Currently, this only allows ‘hub and spoke’ dispensing between pharmacies within the same retail business.
The consultation document says that ‘hub and spoke’ is “gaining popularity due to its potential to make the dispensing process more efficient, lower operating costs and free up pharmacists to spend more time with patients. The model allows for cost advantages to be exploited by expanding the scale of assembly and preparation which makes automation more viable.

“Automation in dispensing, implemented alongside a robust quality assurance system, is linked to safer dispensing with fewer dispensing errors. Large scale ‘hub’ pharmacies have the capability to increase efficiency and lower operating costs significantly.” A full business impact assessment of any changes to ‘hub and spoke’ will be developed after the consultation.

Among the views sought are whether the Government should remove the current impediment preventing different pharmacy businesses being involved in dispensing a prescription. It is also asking whether there should be any restriction on preventing a dispensed medicine being supplied to the patient directly from a central ‘hub’, despite the prescription being presented at a ‘spoke’ pharmacy which would normally hand the medicine to the patient.

Other questions are whether a hub dispensary should still be required to be a registered pharmacy, and whether ‘hub and spoke’ dispensing raises issues in respect to the regulation of pharmacies.

With regards the prices of medicines appearing on medicines labels, the questions follow the Health Secretary Jeremy Hunt’s proposal in June 2015 that displaying the indicative price of the dispensed medicine on the label for any costing more than £20 could help reduce medicines waste.

The change, which has only been proposed for England so far, would require amending the Human Medicines regulations 2012. However: “The proposed amendments would not make it a requirement to include this information on the dispensing label but would merely pave the way for the price of a medicine to be put on the dispensing label should this be required under NHS terms of service for medicines dispensed as part of the NHS pharmaceutical services.”

Other changes to the Act would make it clear that labelling of MDS or PGD dispensed medicines should reflect the general labelling requirements, despite the medicines potentially having been handled for supply in a MDS unit.

There would be “as now, a minimum requirement for the information on the dispensing label to include the patient's name, the name and address of the pharmacy and the date of sale or supply, and, if specified by the prescriber or as judged appropriate by the pharmacist, the name of the medicine(s), directions for use of the product and precautions relating to the use of the product.

“For MDS, we would additionally enable prescribers and pharmacists to include a description of the medicinal product, if they consider this appropriate, to aid understanding of which medicine is which.”

The fourth area of consultation follows a judgement from the Court of Justice of the European Union over the exemption for pharmacists over producing unlicensed medicines that are not in a pharmacopoeia and the potential impact on ‘hub and spoke’ dispensing. The consultation wants to know if people think pharmacists should continue to be allowed to prepare ‘chemist’s nostrums’

The consultation closes on May 17.

Links:

DoH/MHRA consultation documents

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