LAW: Balancing act of medicine supply

Do community pharmacies have to provide medicines in compliance aids, and can they charge for the service? Noel Wardle shares his take…

The Equality Act (which replaced the Disability Discrimination Act in 2010) is often cited as a reason for supplying medicines in a compliance aid. This is a complex piece of legislation, but, in essence, provides a statutory duty on businesses to make “reasonable adjustments” in relation to the service that they provide to take into account any relevant disability of a service-users.

This statutory obligation might include the provision of a compliance aid where a patient would be at a “substantial disadvantage” without. However, the need to provide medicines in a compliance aid under the Equality Act needs careful consideration and is a balancing exercise.

The NHS Terms of Service for community pharmacies in England state that medicines should be provided in original packs save in certain circumstances, which include because of patient needs.

GPhC guidance

The General Pharmaceutical Council (GPhC) has not published specific guidance in relation to the supply of medicines in compliance aids versus original packs. However, the GPhC Standards require “patient-centred care” and, in particular, state that a pharmacist must: “give the person all relevant information in a way they can understand, so they can make informed decisions and choices”.

There is, of course, a significant amount of information included on, and within, original medicine packs, some of which at least is lost when medicines are assembled into a compliance aid.

Additionally, the GPhC provides that pharmacists must ensure that “the way in which pharmacy services, including the management of medicines and medical devices, are delivered safeguards the health, safety and wellbeing of patients and the public”.

We have dealt with many fitness to practice investigations that have centred on the provision of medicines in compliance aids. Recent examples include:

• Supplying warfarin in MDS trays
• Dispensing errors which were not spotted during the final accuracy check, in part because the medicine had been removed from its original blister pack
• Dispensing from the previous MAR sheet/PMR rather than by reference to the repeat prescription due to delays in receiving repeat prescriptions from the surgery
• Changes in repeat medication not identified when the MDS tray was being prepared
• Inserting other prescribed items into the MDS tray outside of the patient’s regular GP prescription
• Frequency of prescriptions-in particular prescriptions being generated more often than required but being submitted for payment even though they were not dispensed.

NICE guidance

NICE has published guidance on medicines adherence: “Medicines adherence: involving patients in decisions about prescribed medicines and supporting adherence - January 2009.”

This is quite a lengthy document, but, in summary, it provides that:

• Non-adherence can arise in two sets of circumstances:
• beliefs and concerns or problems about the medicines (intentional non˗adherence), or
• because of practical problems (unintentional non˗adherence).
• no specific intervention can be recommended for all patients. Tailor any intervention
• Find out what form of support the patient would prefer to increase their adherence to medicines.
• Address any beliefs and concerns that patients have that result in reduced adherence.
• Side effects can be a problem for some patients. If this is the case you should discuss
• Ask patients if prescriptions charges are a problem for them.
• Because evidence supporting interventions to increase adherence is inconclusive, only use interventions to overcome practical problems associated with non˗adherence if a specific need is identified. Target the intervention to the need. Interventions might include:
• suggesting that patients record their medicine˗taking
• encouraging patients to monitor their condition
• simplifying the dosing regimen
• using alternative packaging for the medicine
• using a multi˗compartment medicines system.

It can be seen from the NICE guidance that the use of compliance aids (a “multi compartment medicines system”) is one of a number of interventions that may be considered, but comes towards the end of the list of suggested interventions. It is not the first line solution for non-adherence.

RPS guidance

The Royal Pharmaceutical Society has produced guidance – “Improving Patient Outcomes Through MCA – July 2013” and a toolkit.

In brief summary, the RPS guidance provides that:

• Although MCA may be of value to help some patients with problems managing their medicines and maintaining independent healthy living, they are not the best intervention for all patients and many alternative interventions are available. The evidence-base indicates that MCA should not automatically be the intervention of choice for all patients.
• Not all medicines are suitable for inclusion in MCA. Furthermore, all stakeholders should recognise that the re-packaging of medication from the manufacturer’s original packaging may often be unlicensed and involves risks and responsibility for the decisions made.
• With the limited evidence base currently indicating a lack of patient benefit outcomes with the use of MCA, it is a recommendation of the RPS that the use of original packs of medicines, supported by appropriate pharmaceutical care, should be the preferred intervention for the supply of medicines in the absence of a specific need for an MCA in all settings.

Pharmacy owners should therefore carefully consider whether to supply a compliance aid based on the individual needs of patients, but the use of a compliance aid to assist with non adherence requires a balancing exercise and is unlikely to be the first line of intervention to improve compliance.

Compliance aids must be provided free of charge if they are required in order to meet the statutory obligations contained within the Equality Act. In all other circumstances, pharmacy owners may charge for the provision of medicines in a compliance aid.

The above is a general overview and we recommend that independent legal advice is sought for your specific concerns. If you require further information in relation to the points raised in this article you should contact Noel Wardle a partner at Charles Russell Speechlys LLP and heads the Healthcare Regulation team. Noel can be contacted on Noel.Wardle@crsblaw.com.

This article also appeared in the May issue of Pharmacy Business.