MPs were embroiled in a fierce parliamentary debate this week (18 March) about whether pharmacists are skilled enough to take on new powers under the Serious Shortage Protocols (SSPs).
The protocols, passed under the Human Medicines (Amendment) Regulations 2019, will give community pharmacists the power to provide appropriate alternatives to patients in the event of serious medicine shortages without having to go back to the patient’s GP.
Health minister Jackie Doyle-Price defended the shortages powers against the attacks of MPs, saying there was ‘considerable misinformation’ surrounding the regulations.
Here’s our pick of the biggest misconceptions highlighted in the debate and what the legislation really entails.
Myth one: The SPPs are ‘an extraordinary power grab’
During the debate, shadow health secretary Jonathan Ashworth called the protocols ‘an extraordinary power grab’ on the part of Conservative ministers, claiming the reforms had not undergone proper scrutiny in Parliament or by the sector.
However, the legislation was laid before Parliament following consultation between the Department of Health and Social Care (DHSC) and stakeholders including the Pharmaceutical Services Negotiating Committee (PSNC) and other pharmacy representative bodies in December 2018.
At the time, PSNC said it ‘welcomed’ the speed with which DHSC consulted on the legislation and was ‘pleased to see that [its] comments and observations had been taken on board’.
It added that it ‘supports the introduction of the SSPs’ and is continuing to ‘work closely’ with the DHSC to ‘ensure that they are implemented safely and effectively’.
Myth two: Pharmacists are ‘acquiring prescribing rights by the back door’
Helen Goodman, Labour MP for Bishop Auckland, asked: ‘What is the point of doctors having all this training if anybody without it is suddenly able to dole out prescriptions?’
However, the protocols do not give pharmacists unbridled powers to write or change prescriptions if they have not already trained as independent prescribers.
Instead, they give pharmacists the ability to dispense different doses, strengths or forms of a medicine, for example as a tablet rather than a capsule, if there is a severe shortage of a particular medicine.
Pharmacists may also be able to provide a generic alternative or in ‘extremely rare’ cases a ‘clinically appropriate’ therapeutic alternative following appropriate discussions with the patient.
As Ms Doyle-Price pointed out, currently pharmacists ‘must supply exactly what is on the prescription and cannot deviate from that’, even if supply issues mean the specific strength and quantity of that medicine are unavailable.
She added that pharmacists currently have ‘no flexibility’ and must send patients back to their GP if the exact prescription cannot be supplied, which is she pointed out is ‘not an efficient use of GPs’ time’.
While supply to the patient will formally be against the SSP, linking to their prescription, Ms Doyle-Price stressed that the news powers are 'not about pharmacists acquiring prescribing rights by the back door’.
Myth three: Pharmacists are ‘not skilled’ enough to have these powers
Norman Lamb, Liberal Democrat MP for North Norfolk, argued that pharmacists are put in an ‘invidious position’ and may have to make ‘decisions that may impact adversely on a patient’s health and wellbeing when they are not necessarily skilled to make those judgments’.
While he acknowledged that certain pharmacists have undertaken further training, Mr Ashworth agreed that the changes had been ‘rushed through without any resource put into education, explanation or wider training that may be needed’.
However, all protocols will be developed with the involvement of clinicians, according to PSNC.
Ms Doyle-Price said: ‘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.’
She added that pharmacists would be ‘limited’ by the ‘very tightly drafted’ protocols and ‘would only be able to prescribe outside the terms of the prescription within the narrow confines of the protocol’.
Pharmacists ‘in any doubt about what they are prescribing’ can and should refer patients back to their GPs, while patients can return to their prescriber if they do not want the protocol alternative, she said.
PSNC says that pharmacists will only have to ‘consider whether supply against the SSP is both reasonable and appropriate, subject to the SSP protocol conditions’.
Myth four: The protocols are ‘one size fits all’
Responding to concerns from MPs, Ms Doyle-Price stressed that the legislation is ‘by no means… one size fits all’ but represents ‘strict protocols for specific prescription-only medicines’.
She said: ‘The shortage protocols will be very tightly defined, within given circumstances, as to what drug will be an appropriate alternative treatment.
‘All those issues would be dealt with from protocol to protocol, having been considered by a pharmacy panel who can properly and rigorously challenge what an appropriate substitute would be in the event of a shortage of any medicine’.
When ‘serious shortages’ occur, each medicine will have its own SSP that has been carefully developed by senior clinicians, ‘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 SSP is designed only to address an ‘immediate shortage’ which is not expected to continue indefinitely and therefore will only have been issued in ‘exceptional circumstances’.
Myth five: The powers ‘put patients at risk’
Anne Marie Morris, Conservative MP for Newton Abbot, agreed with Mr Lamb that the SSPs ‘put patients at risk’ and ‘it is not appropriate’ for pharmacists to make these decisions.
Ms Doyle-Price said: ‘The regulations on how pharmacists will be able to apply this protocol are designed to minimise not only the demand on GPs but the risk to patients, because pharmacists will only be able to use their powers under these regulations according to very clear criteria, and we will still encourage them to speak to prescribers where there is any element of doubt.’
Mr Lamb also raised a concern about who would be held liable if there were to be ‘adverse effects’ as a result of a medicine change made under the protocols.
Ms Doyle-Price allayed fears, explaining that advice would be taken ‘from a pharmacy panel, in conjunction with those most affected, to make sure that we put in place appropriate risk management on those occasions’.
Myth six: Prescriptions can be changed by pharmacists even when ‘unsuitable’
Mr Ashworth raised concerns about the suitability of the protocols for patients with conditions such as epilepsy.
He said: ‘After facing pressure from those [patient] groups, the Government accepted that replacement drugs were unsuitable for epilepsy patients, but they have left it open to pharmacists to reduce the strength of dosage for epilepsy medication.’
Ms Doyle-Price stressed that the Government had considered the protocols for ‘complex’ cases carefully.
She said: ‘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.’
She added that these drugs may not be exempt from the protocols, however, explaining that reduced quantities may still be issued during shortages to ensure available stock is ‘spread out across all patients’ rather than some ‘leaving the pharmacy empty-handed’.
Myth seven: These are Brexit regulations
Ms Doyle-Price pointed out that the regulation will not just apply in the case of a no-deal Brexit but ‘will apply in any case’ due to the current ‘challenge in managing medicines’.
According to the PSNC, ‘while introduced due to the possibility of a no-deal exit from the EU’, the introduction of the SSPs ‘is not dependent on it’.
Myth eight: The SSP is a terrible idea and should be revoked
Facing a barrage of ‘misinformed’ criticism from MPs, Ms Doyle-Price said: ‘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.’
She added: ‘This ensures a co-ordinated response to a shortage and timely access to medicines.’
The attempt to revoke the SSPs was quashed with 292 votes to 240.