Changing an individual patient's prescribed medicine during a consultation is common practice but implementing a practice-wide change in a prescribed medicine, for all pat-ients who take it, is a little more controversial.
However, recent legal advice states that consent for this from patients is not usually required.
The typical scenario is for a primary care organisation (PCO) to organise a change in the medicine prescribed for patients to a more cost-effective product in the same therapeutic group.
Although this causes work for all practices, it presents particular difficulties for dispensing doctors.
Beyond the efforts of changing the repeat medicine items, there will be an increase in the number of face-to-face and telephone consultations generated by patients anxious about, or confused by, this switch. Without a pharmacist playing intermediary, dispensing doctors will need to deal with a higher percentage of these queries.
A medicines switch also creates extra work in the dispensary, involving changes in medicine ordering and stock levels; there is potential for loss of income through unused stock of the previous medicine.
Patient dissatisfaction is another side-effect of the process. Despite a switch being undertaken by the PCO, patients may assume that the practice is changing the medicines to save money, which will be kept by the partners.
Of course, some switches are initiated by the practice. Dispensing doctors may opt to switch patients from brands as these come off patent. This saves the NHS money, may reduce the number of wholesalers used by a practice and often increases profitability.
We have also made changes to patients' medicines due to supply problems or to pre-empt a potential supply difficulty.
In order to ascertain how switches should be implemented and to clarify issues around informed consent, we decided to seek advice from our ethics committee and from Beachcroft Solicitors in partnership with our PCT.
We needed to know when we switched patients' medicines whether consent needed to be explicit or implied: did patients have to agree to a change for it to be made, or could we assume consent had been given where patients were sent written confirmation of an imminent drug switch and did not object to this going ahead?
Lawyers advised that, under the NHS Act 2006, PCOs have a duty to provide a comprehensive health service; however, this does not give a patient the right to demand a partic- ular medication or health intervention.
Consequently, a PCO may operate a policy of switching medication to a cheaper version, but this must be within set protocols, in accordance with local decision-making and standard operating procedures. If these are not in place, then PCOs are not operating lawfully.
Most surprisingly, they adv-ised that although informing patients is good practice, a medicine switch does not require consent, as long as the cheaper drug is as clinically active as its more expensive counterpart, there are no medical contraindications nor problems with any of the new additives.
They concluded that a decision to switch to a cheaper version of the same treatment can be viewed as a purchasing decision and does not require informed consent.
The ethical committee broadly agreed with this, arguing that while it is preferable for patients to agree to any change, it is not a prerequisite.
What is vital is that the process of switching should be clearly defined, fulfilling certain criteria.
Decisions on switches must be rational and agreed by stakeholders including GPs and patient representatives. Patients should be informed of a change before they collect their prescription; posters in the waiting room are insufficient methods of informing patients.
We have been advised that any switch programme should be implemented consistently across a PCO and regularly reviewed.
A legal challenge is more likely to occur where these designated steps are not undertaken, so corners must not be cut.
Consent for a medicine switch to a lower cost alternative is not required if:
- Dr Phipps is a dispensing GP in Lincolnshire