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UK pharma's 'controversial' new pharmacist compliance rules

As the changes take effect CompliMed's Dr Rina Newton says they look to be a practical step forward
Pharmacy and the ABPI Code of Practice

For a few years now UK-registered pharmacists have been allowed to act as final medical signatories under the industry's self-regulatory rules, the ABPI Code of Practice. Initially this was within narrow confines and required supervision by a medic. More recently this requirement was dropped, but pharmacists could still only act as medical signatories in relation to some, and not all, areas ... until now.

Given the lack of any cases relating to this area for Code regulator the PMCPA to judge, a number of pharmacists wrote to the director of the PMCPA asking that the expansion to pharmacists' remit be considered under the new proposals to amend the Code. A new ABPI Code was published in January 2014 and this proposal has been included. The new Code will be enforced from this month, so companies should consider the consequences of this amendment. The 2014 Code now permits UK-registered pharmacists to certify all promotional and non-promotional material in the same manner as medically-qualified medical signatories.

The Code is regularly revised and changes result from various sources: amendments to International or European Codes; updates to UK legislation; routine review; significant case precedent and/or amendments requested by companies.

Certification is a mandatory requirement for all promotional and certain non-promotional material, which requires both medical and non-medical signatories to vouch that the final form complies with the Code and relevant advertising regulations.

The introduction of pharmacists as medical signatories took a step-wise approach:

  • In 2006, pharmacists could, under the direction of a medical signatory, certify certain promotional material (where the products were not new, the pharmacist had worked on them for at least a year and the campaigns were not new or novel)
  • In 2011, some limitations were removed and pharmacists were able to certify all promotional material (as well as meetings involving travel outside the UK)
  • In 2014, all limitations were removed, although pharmacists must be UK registered (medically-qualified medical signatories do not).

As pharmacists have, to a certain degree, certified promotional material for the past eight years, the concerns raised relate to pharmacists certifying non-promotional material (such as patient support programmes); and to the potential for pharmacists to replace medics in the certification process.

Views and impact
Unsurprisingly, opposition to the changes came from pharmaceutical physicians and their representative bodies, who raised concerns about pharmacists not being trained in non-pharmacological management and the change having “serious implications for patient care and safety” with an “impact on the reputation of the pharmaceutical industry”.

But in its consultation comments, the Royal Pharmaceutical Society considered this move “recognised the skills, experience and professional standing of pharmacists”. Pharmacists are trained in clinical therapeutics and complete pre-registration in a clinical setting; they discuss conditions and medicines with patients and, since 2006, those that undertake further training have been able to prescribe autonomously.

No-one disputes that the industry requires robust review of materials so that patient safety remains a priority. Given that some industry pharmacists are already non-medical signatories and others are trained and assessed alongside medics to be signatories, there should be no opportunity for standards to slip. The PMCPA will collect data on upheld complaints for future analysis. 

Anecdotal evidence from some companies suggests that medical signatories may spend up to 30-40 per cent of their time on approval and certification. So pharmacists will not be 'replacing' in-house medics but providing welcome extra resource to companies that want/need them.

Dr Paul Schofield, medical director at Napp, said: “A number of companies requested that the remit of pharmacists was extended and the ABPI Medical Expert Network agreed that this provided flexibility and an increased pool of signatories.” He added: “Companies are not obliged to change their arrangements.”

A practical step
The inevitable shift in supply and demand of medical signatories will affect their recruitment and retention in companies where copy approval constitutes a significant investment of time and effort. Although some consider the use of pharmacist medical signatories to be controversial, the indications so far are that this is a practical step that poses no threat to the standard of material and activities produced by pharmaceutical companies.

Article by
Dr Rina Newton

a qualified pharmacist and managing director of CompliMed

23rd May 2014

From: Marketing, Regulatory



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