Top 10 regulatory issues affecting pharmacy industry

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With 2019 almost over and 2020 rapidly approaching, Susan Hunneyball offers her top 10 regulatory issues affecting the pharmacy sector.

  1. The Five-Year Community Pharmacy Contractual Framework. In at number one, this five-year funding arrangement is, of course, going to shape the development of pharmacy and pharmacy regulation for the next five years and possibly longer.
  2. Serious Shortage Protocols. After comments in the House of Commons on SSPs, which demonstrated what could be seen as a hurtful lack of faith in pharmacy professionals, SSPs have been implemented smoothly in the case of fluoxetine.
  3. Community Pharmacy Consultation Service (CPCS). Although there are some regulatory issues in the service specification, the CPCS seems to be reinforcing pharmacy’s role in the front line of urgent primary care.
  4. Medicinal Cannabis. After much excitement at the beginning of the year following the introduction of “Medicinal Cannabis” we seem to be seeing a period of consolidation. The National Pharmacy Association has called for clearer guidance from the Home Office – will this be issued?
  5. E-cigarettes. It turns out that ‘vaping’ could be more harmful than anyone had thought – there are a number of scientific studies being carried out at the moment and regulatory action must be on the horizon.
  6. Homeopathy. Criticism of the Professional Standards Authority for Health and Social Care’s (PSA) decision to re-accredit the Society of Homeopaths is another blow for homeopaths. The main criticism is the endorsement by some practitioners of a therapy that links vaccination and allopathic medicine to autism.
  7. Falsified Medicines Directive (FMD). The legislation is in force and pharmacies are scanning items but the future for FMD is uncertain. Let’s see what will come out of the EU negotiations.
  8. Consolidation. We are coming closer to the next round of PNA consultations and as we do so the protections offered by consolidation under the 2013 regulations become less tempting.
  9. Hub & Spoke. Lots of talk about Hub and Spoke at the Pharmacy Show in October with detailed scrutiny of the risks and benefits from a number of big hitters. The law will need to be changed to allow small independents a shot at Hub & Spoke, but questions were being asked about whether it would be worth it for them as they will not have the economies of scale enjoyed by the multiples.
  10. Inspections. With premises inspections posted on the GPhC website since summer of 2019 this is a developing area. Where will the GPhC be going with their themed inspections and will they be a useful tool? The new style GPhC inspection clearly draws much from the CQC and Ofsted formats, and having experience of all three, I can say the GPhC is looking quite good by comparison.