The PDA has received a number of enquiries concerning guidance being issued by some PCTs regarding the dispensing of tablets/capsules where these are to be administered via crushing, dispersing or otherwise interfering with the integrity of the dosage unit. A concern of members is that the motivation for the guidance may be cost rather than patient care driven, in order to reduce the demand for unlicensed specials and the impact this may have on their insurance.
Regardless of individual viewpoints on this topic, it does raise certain ethical dilemmas for pharmacists.
Pharmacists have a clear duty of care towards patients in this area: should any problems arise members would need to demonstrate that any decisions taken had the patient’s best interests in mind. Citing PCT recommendations or the prescriber’s directions as a defence, would not absolve a pharmacist from their own personal professional responsibility towards patient care.
The PDA recognises that there will be times where pharmacists acting in their patients best interests, may need to consider supplying a medicine in a manner or form which interferes with the integrity of its license; such decisions should only be taken after following a considered professional cognitive process. In so doing and despite going through such a process, the pharmacist will be taking a personal risk and in the event that something goes wrong, they will be held to account for their actions.
The PDA would like to give reassurances to its members that where pharmacists act in a responsible and professional manner and decide to make such a supply, the underwriters will continue to provide cover should a problem arise. When approaching this issue however the PDA strongly advises its members to consider the following:
- Whether the supply of a licensed medicine with a recommendation or direction to administer it in an unlicensed way (by crushing or dispersing tablets or opening capsules) is preferable to an unlicensed special made by a specials manufacturer e.g. because of the urgent nature of the request or because of the innocuous effect of the crushing or dispersal, or even because of specific knowledge about the capabilities of the patient.
- Discussing treatment options with the prescriber and providing patients or carers with sufficient information about the merits and risks of the options in order to gain informed consent.
- Ensuring that cost must never be the primary driver for making such decisions.
- That any decisions made are with a sound evidence base and/or in line with good/accepted practice. The National Prescribing Centre is currently consulting on draft guidance for prescribing specials and this should provide additional guidance when published.
- Keeping a contemporaneous written record of their considerations in this regard.
Pharmacists who work for PCTs and have professional input into the production of local guidance on using medicines in an unlicensed way should be mindful that the act of producing such directions also exposes them to additional risk in the event that pharmacists or prescribers are subsequently implicated in an adverse event as a result of following the guidance. If members are involved in the production of such guidance we advise that any recommendations have a sound evidence base to enable pharmacists making the supply to come to an informed decision.
The PDA and its underwriters encourage and trust pharmacists to exercise their professional judgement in the best interests of patients thereby minimising their own exposure and the risk of harm to patients.