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.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.