Human Medicines (Amendment) Regulations — House of Commons, 2019-03-18
Topic: Health
Jacqueline Doyle-Price (Conservative, Centre-right): As I explained, it was the issues regarding EpiPens that brought home to us the need to have a suitable protocol in place Hon. Members have expressed concern about the role of pharmacists in the system. At the moment, where the prescriber has prescribed a specific medicine, including a specific strength and quantity, the retail pharmacist must supply exactly what is on the prescription and cannot deviate from that. The pharmacist has no flexibility if the exact order cannot be supplied, for example, because of supply issues. The pharmacist has to send the patient back to their GP. Clearly that would not be an efficient use of GPs’ time if we could put in place a protocol that would enable the application of alternative medicines. The serious shortage protocol enables retail pharmacists to supply in accordance with a strict protocol for a specific prescription-only medicine, rather than against a prescription, without going back to the prescriber. That will be done only in exceptional circumstances, in the event of a serious shortage of a medicine, when all other mitigation measures have been exhausted or would be likely to be ineffective, and all the clinical community think it is appropriate to issue such a protocol. The protocol may prescribe one of the following options: an alternative quantity, an alternative pharmaceutical form, an alternative strength, a therapeutic equivalent or a generic equivalent. However, as I said, each case will be considered on its merits, and of course the risk of various health conditions. We believe that therapeutic substitution will be extremely rare. It would need to be clinically appropriate, and a sufficient stock of any alternative would be required As I have said, any serious shortage protocol will be developed with clinician input. Which clinicians are involved will depend on the expertise required, but we would involve, for example, the relevant royal colleges and societies. We would also work closely with patient representative groups, as we did in the EpiPen shortage. Each protocol would clearly set out what action can be taken by the retail pharmacy, in what circumstances, for which patients, and during which period. I re-emphasise that this is not about pharmacists acquiring prescribing rights by the back door. It is entirely about ensuring that patients have access to the medicine they need by making the best possible use of highly qualified pharmacists and freeing up GP time for patients who need to see their GP. If a pharmacist is in any doubt about what they are prescribing, they can always exercise their professional judgment to refer an individual patient back to the GP, and if patients do not want the alternative under the protocol, they can always go back to their prescriber Let me be very clear: patients will not be given alternative medicines where this is not medically appropriate. This includes patients with complex medication regimes or conditions such as epilepsy or HIV. However, that does not mean that they are exempt from the protocols. For example, a protocol for a reduced quantity of anti-epilepsy medication could be issued, as we did for EpiPen. That would have to be considered against a backdrop of all the available stock being spread out across all patients, and there being time for patients to see their prescriber if the supply issues become long term. Without the protocol, some patients would receive the medicines prescribed to them, but some would leave the pharmacy empty-handed. Clearly, we need to make sure that all patients have timely access to their medicines In the event of a serious shortage of any medicine, it is vital that patients continue to receive the treatment they need. The introduction of strict protocols, developed with specialist doctors, is a sensible step that will, in exceptional circumstances, allow highly trained pharmacists to provide an appropriate alternative or quantity, as set out in the protocol, to reduce the impact on patients. This ensures a co-ordinated response to a shortage and timely access to medicines Of course, I hope that we never have to introduce a serious shortage protocol, but there may be times when we have no other options, because all other measures have been exhausted or are likely to be ineffective. Not implementing the statutory instrument would put patients’ timely access to medicines at risk, first, by not enabling drug treatment services to supply all dosage forms of naloxone hydrochloride; secondly, by imposing much more burdensome implementation of safety features of packs of medicines with flexibilities to accommodate the specific characteristics of the UK supply chain; and thirdly, by denying the Government an important tool to manage shortages of medicines and to ensure that patients continue to get the right medicines in a timely manner. I hope that the motion is defeated.