Storage of Pharmacy Only Non-Prescription Medicines
The PSI recently announced that they would be expecting pharmacy's to demonstrate compliance with the 2016 legislation on the storage of pharmacy only medicines by April 2018: PSI Regulatory Notice 1/2017: Storage of Pharmacy Only Medicines in a Retail Pharmacy Business. This blog aims to help pharmacists carry out a review of the storage of these medicines.
The PSI notice follows an update to the legislation in 2016. The Regulation of Retail Pharmacy Businesses Regulations 2008 (S.I. No. 488 of 2008) was amended by S.I. No. 80 of 2016 and Regulation 5(1)(ea) was inserted. Under this regulation the pharmacy owner and the superintendent pharmacist is required to ensure that pharmacy-only medicines “are stored in a part of the premises to which the public does not have access”. In practical terms this means pharmacists should review the shelves in the public pharmacy area and any pharmacy only medicines should be relocated behind the medicines counter or to another appropriate area of the pharmacy that the public don’t have access to. To ensure a thorough review, any medicines located beside or adjacent to the medicines counter should also be included. Essentially if pharmacy only medicines are stored in any area of the pharmacy where a member of the public could pick them off the shelf they should be moved to an area the public don’t have direct/physical access to.
If you are not sure of the classification of a medicine, it can be checked via the ‘Find a Medicine’ section of the HPRA website www.hpra.ie. As the regulator of medicines their information takes precedence over information on the status of medicines from other sources. If the listing for a medicine on the HPRA website states it is a ‘product not subject to medical prescription’ and is ‘supplied through pharmacies only’ the product is a pharmacy only medicine and is required to be stored in a part of the premises to which the public does not have access.
To generate a list of pharmacy only medicines from the HPRA website a ‘Find a Medicine’ advanced search can be undertaken. When undertaking the search ensure you tick the dispensing status as ‘product not subject to medical prescription’ and supply status as ‘supply through pharmacies only’. This will generate webpages listing pharmacy only medicines.
What medicines could you be missing? Examples of the more common pharmacy only medicines found on front of pharmacy shelves during PharmaConsult audits include Nizoral shampoo, Daktarin cream and powder, various NSAID gels, Difflam products and Pharmaton products.
If you would like assistance or further information on this or any other regulatory issue don’t hesitate to contact us at email@example.com or firstname.lastname@example.org.
Management of Pharmacy Only Medicines
The PSI recently issued draft guidelines on the management of non-prescription medicines, which are currently undergoing a public consultation process. PSI Draft Guidelines on the Sale and Supply of Non-Prescription Medicinal Products from a Retail Pharmacy Business. Details of the consultation process are available on their website www.psi.ie.
The guideline addresses the legislative basis for supervision of the sale and supply of non-prescription medicines and the associated counselling of patients. The guidance has sections outlining the expectations in relation to pharmacist involvement in supplies, patient consultations in general and specific circumstances, the policy, procedure and staff training requirements and the management of internet supply.
Controlled Drugs Guidance
In October the PSI and Medical Council issued joint guidance entitled ‘Safe Prescribing and Dispensing of Controlled Drugs’. The guidance outlines the changes brought about by the Misuse of Drugs Regulations 2017, which came into effect in May this year. It sets out the legal provisions and requirements relating to prescribing and dispensing controlled drugs. The practical information on controlled drug classifications, prescription requirements and sample prescriptions are useful, particularly where they refer to the new requirements for benzodiazepine (schedule 4 part 1) prescriptions.
From this month PharmaConsult will be offering a pharmacy regulatory and practice update and advice subscription service. The annual service will include six written updates on regulatory and practice issues a year exclusively for signed up members (similar to the above) and three half hour consultations (advice/ information via a combination of phone and/or email) on topics and at a time decided by the subscriber. Subscribers will also have access to the service within defined short timelines. Modifications to this service are available on request. Pricing is competitive for this new service, particularly if you sign up before the end of the year. Members can also avail of our other services at more competitive rates. If you want to sign up or think you might be interested in this service, please contact us for further information: email@example.com, firstname.lastname@example.org or 087 4198376.
Further information on this service will be included on our website and circulated to contacts in the coming weeks.
Please also note that PharmaConsult onsite services are offered from bases in Dublin, Tipperary or Sligo.
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Caroline Hogg MPSI, Owner and Lead Consultant PharmaConsult