ABPI CODE OF PRACTICE NEWS & TRENDS

Summary

The last 18 months have seen substantial changes at the PMCPA (the Prescription Medicines Code of Practice Authority) and to the ABPI Code of Practice itself. Of note, the 2021 Code came into force on 1st July 2021, Heather Simmons, Director of the PMCPA, retired and we

Code case trends

Alleged breaches of the Code continue to flow into the PMCPA. The latest 2020 PMCPA annual report (www.pmcpa.org.uk accessed 10 January 2023) cites they investigated 127 cases with 736 individual allegations. Shockingly there were 55 complaints from one individual – most likely from someone declaring themselves as an anonymous health professional. As you can imagine, this has started some lively discussions within the industry!

Cases are becoming more complex and 2020 saw an average time of 29.5 weeks to complete cases. This was slightly less than in 2019 (32.61 weeks) but we understand there is a considerable backlog of 2022 cases with the PMCPA. The next annual report will show if this is a continuing trend or not.

now wait to see what changes and direction the new Director, Alex Fell will bring.

So what is the latest Code news and case trends?

Social media

Social media continues to be a hot topic. Unlike in some countries, there is very little information in the UK Code about social media. We are keenly awaiting the PMCPA’s updated digital communication guidelines which were due to be published at the end of 2022. In the meantime, tracking Code cases is the only way to see the dos and don’ts that should be incorporated into your policies and procedures. In a nutshell:

• Make sure you have a UK specific social media policy.

• Make sure all staff have been trained on the policy and importantly, follow it.

• Make it clear which posts employees and third parties can interact with and what that interaction can be.

• Your personal social media accounts and activities can come in scope of the Code.

There are two notable social media risks. Firstly, if a company, their employees or third parties create or link to content which directly or indirectly mentions their medicines. This risks promoting a licenced or unlicensed medicine to the public and health professionals. And secondly, be careful about sharing, liking or interacting with posts. This is seen as proactive dissemination of information to your connections and again could inappropriately promote a medicine.

Companies can use social media, but all posts must be Code compliant and certified or examined before use, depending on the content.

AQP role

The 2021 Code introduced a new role called Appropriately Qualified Person (AQP). AQPs can examine materials which don’t need to be certified. This includes written responses from MI departments or similar to unsolicited enquiries from the public etc.

AQPs do not need to be medical practitioners or pharmacists but need to have appropriate skills to examine the specific materials. MI departments have examined responses for years but now some MI staff are embracing the AQP opportunity, developing their Code knowledge, honing their skills and being recognised formally in the compliance process.

Unsolicited enquiries

A couple of recent cases (3451 and 3497) give a stark reminder that a call to action, on company websites, to contact Medical Information about specific products is seen as soliciting an enquiry. The response would not take benefit from being outside the definition of promotion.

So, companies need to be mindful as to what is triggering an enquiry and making sure there is no prompt from the company.

Information quality

There is the inevitable flow of cases challenging the quality of data, whether it is robust enough and whether claims can be substantiated. Describing medicines as ‘excellent’ and ‘powerful’ have both seen breaches of the Code for being superlatives and unambiguous. Footnotes continue to be problematic.

There are only a few cases where Medical Information responses have breached the Code, but you still need to be mindful that clause 6 applies to any information, claims and comparisons, including MI responses. The challenge is providing sufficient information to enable the reader to form their own opinion of the therapeutic value of the medicine, but not bombarding them with so much detail that it is quicker for them to read the original clinical paper.

My final thoughts

I always say that reading the Code is the easy part. But really understanding the practical implications is harder and it takes time to become a Code practitioner. Remember that the Code learning journey never stops because new cases are published all the time and they set case precedence. Cases can subtly change our interpretation and help to form our policies, procedures and guidelines.

Jayne Packham is a Medical Information and Code of Practice trainer. For further information, please contact Jayne on jayne@jaynepackham.co.uk

Written by Jayne