Everything you need to know about serious shortage protocols

The number of medicines in short supply has been a persistent thorn in the side of the pharmacy profession for many years. This peaked in November 2017 when the list of medicines in short supply compiled by the Pharmaceutical Services Negotiating Committee (PSNC) grew to include 91 different drugs.

In that same month,
3,000 pharmacies requested concessionary prices from the PSNC
— a marked increase from less than 150 pharmacies per month before May 2017. The PSNC told the government in July 2018 that when these supply issues were at their worst, one in ten drugs dispensed by pharmacies were affected.

In an effort to mitigate the impact of shortages on patients, the government launched an “informal consultation” on proposals to amend the Human Medicines Regulations 2019 on 5 December 2018. The proposals would enable the government to issue “serious shortage protocols” (SSPs) allowing pharmacists to switch a patient to a different medication, if the one prescribed is in short supply, without having to refer the patient back to the prescriber.

The amendment passed through the consultation phase and came into force on 9 February 2019.

What will the protocols allow a pharmacist to do?

According to the Department of Health and Social Care (DHSC), if an SSP is issued, pharmacists will be asked to respond to a medicines shortage in one of four ways: dispensing a reduced quantity,  a therapeutic equivalent, a generic equivalent or an alternative dosage form of the drug.

Each protocol would set out precisely what action pharmacists can take, under what circumstances and for which patients. Each protocol is also expected to be time limited.

In its response to the consultation on the proposed use of these protocols, the DHSC said those enabling pharmacists to prescribe “either an alternative quantity, strength or pharmaceutical form are likely to be more common than protocols for a therapeutic or generic equivalent”. These, it said, would only be used in “very exceptional circumstances”.

When following the protocol, the pharmacist will be able to make the designated substitution without having to consult with the patient’s prescriber.

When will these protocols be issued?

The DHSC has said it will issue protocols to manage supply issues “in case of a serious shortage, if it would help manage the supply situation”. It has not given any kind of threshold for when one might be issued but said a protocol “would be developed with input from clinicians” and “after discussion with the manufacturer”.

However, the DHSC has specified that not all drugs will be eligible for certain types of protocols. For example, it has said that therapeutic or generic switching will not be suggested for treatments for epilepsy or those “requiring biosimilar products where the medicines that are prescribed need to be prescribed by brand for clinical reasons”.

“In these cases, patients would always be referred to the prescriber for any decision about their treatment before any therapeutic or generic alternative is supplied,” the government has said.

The ability to issue protocols is just one part of a larger move to temper price increases from pharmaceutical manufacturers. In 2017,
the DHSC was given special powers
enabling it to instruct manufacturers to reduce the price of a generic medicine or introduce other controls on their branded products in cases where it thinks drug companies are charging “unreasonable” prices for generics. 

Are these protocols being rushed through because of Brexit?

Not exactly. In answer to the responses from pharmacy bodies, the government clarified: “Whilst this proposal was prompted by the EU exit work it was not linked to a no deal EU exit.”

It added: “Regardless of whether a shortage of a medicine is caused by a no deal EU exit or something else, an SSP can be a useful tool for managing any shortage and mitigating any impact on patients.”

However, the consultation and subsequent legislative change has been extraordinarily quick, with an implementation date a month before the UK is due to leave the EU. With many predicting chronic medicines shortages in the event of a no-deal Brexit, its speed and timing is unlikely to be a coincidence.

Mark Koziol, chair of the Pharmacists’ Defence Association (PDA), said that while the Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board “made slow and incomplete progress on decriminalising inadvertent dispensing errors … this proposal expects a rushed discussion and implementation at an infinitely faster pace to make a significant change because of Brexit deadlines”.

What have the professional bodies said?

These types of drug switching protocols have been called for in the past by the PSNC and the Royal Pharmaceutical Society (RPS) so the amendment was welcomed by the professional bodies. In their respective responses to the government consultation, both bodies said they were generally “supportive” of the legislative changes and “welcomed” the use of SSPs.

Sibby Buckle, vice chair of the RPS English Pharmacy Board, had already called for therapeutic substitution powers to come into effect before the UK leaves the EU. The PSNC said on 28 November 2018 that pharmacists should be able to automatically substitute an alternative medicine if they cannot dispense the prescribed item, in an effort to help deal with possible drugs shortages after Brexit.

The PDA, however, warned that the ability to issue protocols would “open the door” to governmental interference in medicines supply and “pose a risk to patient safety”.

It added in its consultation response that the government “must ensure that safeguards are in place to prevent inappropriate use of SSPs for factors unrelated to EU withdrawal”.

What do doctors think?

The British Medical Association (BMA) has not published its full response to the government’s proposals, instead releasing a statement criticising the move towards dispensing therapeutic equivalents without consulting a GP.

The statement said the BMA leaders “do not agree” with dispensing a therapeutic equivalent “as a blanket approach”.

“Patients have idiosyncratic responses to drugs within the same class, and the pharmacist will not know what has already been used,” it explained. “This would, effectively, be a new prescription.”

Instead, the BMA said it would “accept a pharmacist amending the prescription only after discussion with the prescriber, including information about medicines availability”.

Andrew Green, GP committee clinical and prescribing lead at the BMA, said that while the legislation “is intended to minimise disruption to patients, GPs and pharmacists in the event of a serious shortage”, the BMA “[does] not believe that it is appropriate for pharmacists to change patients from one drug to a different one without authorisation from an independent prescriber”.

What happens next?

The legislation came into force on 9 February 2019 but, as the first protocol has yet to be issued, the impact of the legislation changes on pharmacists, GPs and patients remains to be seen.

However, the government has written into the new legislation that the SSP provision be reviewed one year after the first protocol is introduced and will look at “any adverse consequences for either the market in prescription-only medicines or patient safety”.

There is also the threat of a legal challenge. The Good Law Project has said it will start judicial review proceedings if the DHSC fails to remove the amendments in legislation by 25 February 2019, claiming that the government’s initial consultation — which lasted one week from 5–12 December 2018 — was “insufficient and unlawful”.