Can pharmacies exchange medicines when they have excess stock?
Managing pharmacy stock in a way that ensures uninterrupted supply to as many patients as possible, while also maintaining manageable stock levels, has always been challenging, but became even more so with the introduction of the 10-day return window on 1st February 2014.
This requirement was introduced in the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 to 2013 when the Title VII of Directive 2001/83/EC of the Community code relating to medicinal products for human use was transposed into Irish legislation.
HPRA guidelines clearly state that: “From 1 February 2014, products returned from a customer who does not hold a WDA [wholesale distribution authorisation] or an MIA [manufacturer’s authorisation covering manufacturing and/or importation activities] should only be considered for return to saleable stock if they have been received back into the wholesaler’s care within ten days of having been received by the customer. The returns of medicinal products are deemed to be appropriate where an incorrect order has occurred or in the instance of an incorrect or failed delivery.”
“There may be some exceptional circumstances whereby a medicinal product is returned outside this timeframe. This may occur, for example, where a small number of packs of a medicinal product has been ordered to meet the anticipated needs of an individual patient to ensure continuity of treatment but that patient’s medication is suddenly changed or is no longer required. Where such deviations to the 10-day timeframe occur, a risk assessment should be performed and a justification fully documented prior to considering the stock suitable to return to saleable stock.”
Source: Guide to Good Distribution Practice of Medicinal Products for Human Use (HPRA)
Additionally, we have special categories of medicines such as control drugs, fridge items and High-Tech medicines, which all come with their own specific storage and returns requirements.
It's not hard to see then that it can quite easily happen that a certain amount of medication will invariably end up gathering dust on the shelf or taking up precious space in the fridge/CD safe just waiting to go out of date.
Seeing the problem, some well-intentioned pharmacists have come up with an elegant solution, using a relatively newly acquired tool in their arsenal, social media groups and forums. Why not post a list of unused medicines, especially the very expensive ones such as High-Tech medicines, into the group to find a pharmacy that can make use of these medicines, which would otherwise go to waste, costing the pharmacy or the taxpayer thousands of euros in the process.
On the surface, this seems like a perfectly reasonable solution. After all, we do this on a regular basis between neighbouring pharmacies when they run out of medicines for a walk in patient who needs them for immediate use.
Unfortunately, there is one very fundamental problem with this solution. It's not legal. The reason we can exchange medicines locally is because there is a specific exception in the legislation for this exact case. It is covered by paragraph 4 of Article 6 of Regulation of Retail Pharmacy Businesses Regulations 2008 (SI 488 of 2008) as highlighted below.
Sourcing of medicinal products
6. (1) A person carrying on a retail pharmacy business shall obtain his or her supplies of medicinal products (including medicinal products on a general sales list) from persons —
(a) who are themselves the holders of a manufacturer’s authorisation or a wholesaler’s authorisation in respect of such products, or
(b) who are the holders of an authorisation granted by the competent authority of another EEA State authorising the manufacture of such products or their wholesale distribution.
(2) A person carrying on a retail pharmacy business shall obtain his or her supplies of veterinary medicinal products from persons —
(a) who are themselves the holders of a manufacturer’s licence granted under Regulation 20 of the animal remedies regulations, or an animal
remedies wholesaler’s licence granted under Regulation 30 of those Regulations, in respect of such products, or
(b) who are the holders of a licence granted by the competent authority of another EEA State authorising the manufacture of such products
or their wholesale distribution.
(3) Notwithstanding paragraphs (1) and (2), a person carrying on a retail pharmacy business may accept the return of a medicinal product, including a veterinary medicinal product, that had previously been dispensed or supplied, and such product shall be kept in a secure manner that is segregated from other medicinal products, including other such veterinary medicinal products, and shall be disposed of in a manner otherwise than for the purpose of use as a medicinal product or as a veterinary medicinal product.
(4) The provisions of paragraphs (1) and (2) shall not apply in the case of occasional transactions between retail pharmacy businesses involving the exchange of medicinal products with a view to meeting the immediate prescription needs of an individual patient.’
Source: Regulation of Retail Pharmacy Businesses Regulations 2008 (SI 488 of 2008)
Paragraphs one and two clearly state that in all other cases a person carrying on a retail pharmacy business shall obtain his or her supplies of medicinal products from holders of manufacturer’s authorisation or a wholesaler’s authorisation, i.e. not another pharmacy, unless such pharmacy is a holder of said authorisations.
What about the code of conduct
Some colleagues have defended the practice of inter-pharmacy exchange of unused medicines via private online forums as being in line with the Code of Conduct for pharmacists.
The Code of Conduct is a six-principle Code which serves as a public declaration of ethical standards which govern the practice of pharmacy and which the public, patients and other healthcare professionals require and expect of pharmacists.
The primary principle of the Code requires that the practice by a pharmacist of his/her profession must be directed to maintaining and improving the health, wellbeing, care and safety of the patient.
There is nothing in this Code that would in any way justify inter-pharmacy exchange of excess medicines as it does not in any way benefit the “health, wellbeing, care or safety of the patient”.
The PSI view of inter-pharmacy exchange of medicinal products
In their GUIDELINES ON THE SOURCING, STORAGE AND DISPOSAL OF MEDICINAL PRODUCTS, the PSI clearly state that “inter-pharmacy exchange of medicinal products is only permitted, by the regulations, when it is necessary to meet the immediate prescription needs of an individual patient.” (Chapter 3.1.3, Page 4)
Source: GUIDELINES ON THE SOURCING, STORAGE AND DISPOSAL OF MEDICINAL PRODUCTS (PSI)
The High-Tech problem
Besides some expensive fridge medicines, the biggest issue for most pharmacies has been the difficulty of returning most High-Tech medicines. Unfortunately, the process has been made unreasonably difficult and has left many pharmacies holding thousands of euro of essential lifesaving medicines without any patients to dispense them to.
While it's indisputable that the High-Tech medicines returns policy is certainly a significant factor here, there is another very big issue, which many pharmacists don't want to admit to and that is poor stock management practices by many pharmacies.
In their Good Dispensing Practice – High Tech Scheme part of the Pharmacy Practice Guidance folder, the PSI explain that “The management of the supply of medicinal products under the High Tech Scheme by a pharmacist from a retail pharmacy business requires specific and particular care”.
In section 3.1 the PSI state that: “The operation of the scheme is under the auspices of the HSE and any pharmacist participating and delivering care to any patient under this service must ensure that they adhere fully to the operational requirements published by the HSE.
This scheme operates as a patient-specific pharmaceutical care and treatment programme with a nominated pharmacy responsible for a specific patient and their complete and complex medication and health needs.”
“Patient-specific dispensing occurs with a particular product obtained for a particular individual patient. Patient-specific monitoring is required on an ongoing basis and the pharmacist monitors overall medicines therapy notwithstanding that a High Tech medicinal product may not be required at a particular patient visit.”
In section 3.2 the PSI state that “Medicinal products, where possible, should be dispensed in the manufacturer’s original pack. As such products are not routinely dispensed, or stocked, in a retail pharmacy business; care must be taken to ensure patients understand the necessity to allow adequate notice for ordering their own patient specific product.
Source: Pharmacy Practice Guidance - High Tech Scheme (PSI)
As we can see the PSI continually stress that the High-Tech scheme is a patient-specific scheme and that it requires extra care and attention as it involves novel and potentially toxic medication. They go on to say that “Patient-specific monitoring is required on an ongoing basis” and that “product may not be required at a particular patient visit”. They even state that “care must be taken to ensure patients understand the necessity to allow adequate notice for ordering their own patient specific product”.
From what is written above it's quite obvious that if pharmacies are being left with a significant number of unused High-Tech medicines, they are not adhering to the PSI guidelines when it comes to ordering of these medicines. In fact, some pharmacists have openly admitted to stockpiling these medicines in advance of patients presenting as they don't want the patient to have to return for them or in any way concern themselves with accessing their specific medication.
While that is certainly desirable in many other situations, it's absolutely not appropriate when it comes to very expensive and potentially toxic High-Tech medicines. As the PSI state in their guidelines, these are usually patients with “complex medical and health needs” and they should not be treated in the same way as patients with high cholesterol or high blood pressure might be.
These patients are often not stable and their condition and their medication can change quickly and unexpectedly. Stockpiling these expensive medicines for the sake of convenience is not appropriate and should not be practised.
So to answer the original question of this article, can pharmacies exchange medicines when they have excess stock? No, they can't. There are very specific conditions under which they can do so in the case of immediate need for a specific patient but outside of that they really need to focus on better stock management, particularly when it comes to High-Tech medicines. At the end of the day, the HSE don't pay us €62.03 per month when a High-Tech medicine is dispensed and €31.02 when it is not, compared to just €5 to €3.50 per item on the GMS scheme, for providing essentially the same service.