All Party Parliamentary Group on Medicines and Medical Devices

Last month the PDA attended a round table meeting to discuss concerns related to Serious Shortage Protocols. The meeting took place on Tuesday 30 April 2019 at Portcullis House, Westminster.

Tue 28th May 2019 The PDA

The PDA was invited by Anne Marie Morris MP to send a representative to a round table meeting to discuss Serious Shortage Protocols (SSPs) which were passed into legislation at the beginning of April.

Whilst no protocols have yet been developed, during a parliamentary debate in March this year, a good deal of concern was raised about whether they were safe or not, so it was felt that a round table group would be useful to discuss concerns and how to address them.

Attendees at the meeting included representatives from several patient groups, the Royal Pharmaceutical Society, pharmacy contractors, clinicians, the pharmaceutical industry and NHS England.

The key objectives were to look at:

  1. What constitutes a ‘serious’ shortage?
  2. How should SSPs be developed?
  3. Next steps.

Discussions covered a number of areas including:

  • Causes of shortages and whether actions were required to address the causes in addition to the development of SSPs to mitigate potential impact.
  • Whether some drug groups or patient groups should be excluded from SSPs for reasons of safety. Several attendees noted that imprudent substitution in their field of practice could result in patient harm. Particular concern was expressed by:
    • clinicians involved with organ transplantation
    • clinicians caring for patients with epilepsy
    • clinicians dealing with patients using inhaled therapies
  • Pharmacists’ skills and commitment to promoting and ensuring patient safety.
  • It was felt that a clearer definition of ‘serious’ shortage was required since mechanisms were already in place to deal with shortages meaning that SSPs should really be for exceptional cases. Concern was also expressed about Ministers being allowed to decide what did or did not constitute a ‘serious shortage’. It was suggested by the chair that SSPs should perhaps be restricted to exceptional events such as Brexit, total (or near total) loss of manufacturing capacity or similar.
  • That there was more work involved in implementing and managing an SSP than initially suggested in the consultation and that the need for increased staffing levels and other resources to maintain patient safety when implementing a therapeutic change needed to be recognised (changing a patient’s medication requires meaningful discussion with and support for the patient and effective lines of communication between all healthcare professional providing care to the patient).

Following discussions, it was agreed that a note would be drafted on behalf of the group and sent to the government asking for:

  1. Clarity on what would constitute a serious shortage, preferably with examples.
  2. Clarity on who should be consulted during the production of an SSP and reassurance that relevant groups would be involved.
  3. Clarity on how SSP content would be agreed and on how inclusion and exclusion criteria for a given drug would be decided.
  4. Clarity on the communications strategy and guidance material which would be produced to support all relevant stakeholders including patients, pharmacists and other clinicians.

The PDA looks forward to the government response.

Though not entirely BREXIT related, these changes have been accelerated because of BREXIT and the PDA is also an attendee at the government’s pharmacy BREXIT forum where we continue to ensure the voice of individual pharmacists is heard.

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