The Department of Health plans to introduce new legislation, called the Regulation of Retail Pharmacy Businesses (Amendment) Regulations 2014, that will require pharmacists to store pharmacy only medicines in an area to which the public do not have access. Similar laws have been in place regarding prescription only products and controlled drugs for many years. Pharmacy only medicines are medicines which do not need to be supplied under prescription but can only be sold in a pharmacy under the supervision of a pharmacist. If these Regulations are introduced, pharmacies will be limited in the manner in which they can display pharmacy only products for sale and the current practice of displaying pharmacy only products on the pharmacy floor, which occurs in some pharmacies, will cease. For those pharmacies who currently display pharmacy only goods on the shop floor, expenditure may be required to comply with the Regulations.
Pharmacists will, of course, be familiar with the Pharmaceutical Society of Ireland Guidelines on the Sourcing, Storage and Disposal of Medicinal Products within a Retail Pharmacy Business dated May 2011, which recommend that pharmacy only medicines should be stored behind the pharmacy counter. The new Regulations, once enacted, will make this mandatory.
The new Regulations were recently considered by the European Commission during a three month standstill period which expired on 19 June 2014. This ‘standstill period’ is required under EU law prior to the introduction of technical regulations and allows for submissions to be made to the European Commission by interested parties on the proposed changes. The European Commission made some comments in relation to the proposed Regulations and these are currently being considered by the Department of Health prior to the Minister signing the Regulations into law.
A failure to comply with the new Regulations will be an offence under the Pharmacy Act 2007 which can carry hefty fines and / or terms of imprisonment. The new Regulations will also make it an offence to fail to comply with the laws already in place regarding the storage of prescription only and controlled drug products.
It remains to be seen whether the new Regulations will be enacted. However, pharmacists who do not currently follow the recommendations of the PSI to store pharmacy only medicines outside the reach of the public should carefully observe if the Regulations are passed and make appropriate changes in their pharmacies to avoid prosecution.