Several pharmacy bodies have said the serious shortage protocol (SSP) does not go far enough to meet the demands of medicine shortages, and more solutions should be considered.
The policy, which came into force in July 2019 in England, enables community pharmacists to supply a specified medicine in the place of another which is experiencing shortages, without needing to seek authorisation.
The Department of Health and Social Care (DHSC) published its one-year review of the policy on 27 May, which suggested there were ‘no concerns’ about the policy.
The consultation, which ran from 3-24 November, asked 16 organisations whether they had any concerns over the impact of the policy on the prescription-only medicines market and patient safety.
After eight responses were received, the review concluded that the policy had been ‘beneficial’ for managing medicine shortages.
It said: ‘In the 12 months that the SSP policy has been in effect, DHSC is not aware of any concerns being raised about the effect on the medicines market or on patient safety for any of the SSPs that have been issued to date. None of the responses to the stakeholder consultation held as part of this review indicated any concerns about the policy.
‘Engagement with stakeholders has, rather, shown that SSPs have received a largely positive reception and are viewed as being beneficial, both in managing medicines shortages and in saving time.’
However, the Company Chemists’ Association told the Pharmacist: ‘Whilst the CCA welcomes the fact that the department has honoured its obligation as set out in the regulations to review the SSPs we are still concerned about the effectiveness of the SSPs as they have not delivered flexibility at the point of supply, as was originally intended.
‘We continue to call for further measures to be explored as more permanent alternatives to SSPs, including elevating the clinical aspect of pharmacists’ practice through allowing generic substitution of strength and quality in appropriate circumstances, without the SSP process.’
In its consultation response, the National Pharmacy Association (NPA) also called for further measures to be taken.
It said: ‘The NPA suggests that the serious shortage protocols have not gone far enough to be able to meet the demands of medicine shortages.’
The NPA suggested that pharmacies should be able to share medicines with each other in order to meet patient demand in the event that one or more pharmacies in an area are running short, and that pharmacists should be empowered to use their professional judgement to make any simple, non-clinical substitutions when a medicine is out of stock.
The Royal Pharmaceutical Society’s (RPS) consultation response also criticised the policy, saying SSPs had ‘been rarely used’ and were often ‘bureaucratic and professionally frustrating’.
It said: ‘Pharmacists and GPs are having to spend more time dealing with medicines shortages, with community pharmacists legally obliged to contact prescribers or refer people back to prescribers to amend original prescriptions, even for minor adjustments. This is frustrating for the patient, pharmacist and prescriber.
‘The process can cause delays in access to medicines and takes up health professionals’ time, which could be used elsewhere to support patient care. We believe that legislation should be amended to allow pharmacists to make minor amendments to a prescription, without a protocol, when a medicine is out of stock.’
However, chief executive of the Association of Independent Multiple Pharmacies, Leyla Hannbeck said that they welcome the conclusion that community pharmacists have been ‘operating the SSP effectively since it was introduced’. Since the policy was enacted, 12 SSPs have been issued. Seven of those have been for antidepressant fluoxetine in 10mg, 30mg and 40mg doses.