PIPA UK Medical Information guidelines – what’s changed?

The revised PIPA ‘UK Guidelines for the Pharmaceutical Industry for Medical Information Departments’ have recently landed on my door mat.  So what are the guidelines, what is new and what are the implications?

What are the guidelines?

The guidelines come from PIPA – the UK based Pharmaceutical Information and Pharmacovigilance Association – and were originally written in 1995.  Having been in MI for 25+ years, yes I was proudly part of the original standards team!  The guidelines are specifically for PIPA members and so you need to be a PIPA member to access them.   The nine page document sets out practical guidelines indicative of a high quality MI service.  The guidelines are recommended for all pharmaceutical companies, but adherence is voluntary.

What has changed?

The 2018 guidelines have the usual text and format tidying, but go well beyond this with significant additions in requirements.  There is a considerable amount of new content with a mix of pragmatic suggestions to handle certain situations and more prescriptive guidelines.  PIPA members should definitely read the new guidelines to appreciate all the changes, but these are some of the major changes worth flagging.

• Emergency out of hours enquiries from healthcare professionals.  New guidance states it is good practice to respond within 1-2 hours.
• Using voicemail or answering machines in office hours should be minimised, but if a message is left, enquirers should be called back as soon as possible.  As good practice, enquirers should wait no more than 30 minutes for a call-back.
• The target deadlines for answering enquiries have been shortened, which reflects current industry practices.  The aim is to meet the customer’s deadline.  Before, in the absence of an agreed deadline, a reasonable standard was five to ten working days depending on the nature and complexity of the enquiry.  The new guidance states that enquiries should be answered immediately if the information is to hand.  If not, more urgent enquiries should be answered within two days and complex enquires answered within five days.  For very complex enquiries, or where other departments need to be contacted, a longer timeframe of 10 workings days may be more appropriate.
• When handling unsolicited off-label or unlicensed medicine enquiries from healthcare professionals, a sufficient audit trail should be available to ascertain they are unsolicited.  An audit trail could be an email from the enquirer or a signed MI request form.
• All MI responses sent to patients must be peer-reviewed by other members of the MI team.
• Guidance is given on how frequently standard response documents and frequently asked questions should be reviewed.
• If information is requested via a third party, such as a Sales rep, the Sales rep may be notified the response has been sent but may not be copied into the details of the response, especially if it contains off-label information.
• If a third party is used to provide MI responses, it is recommended that the service is audited regularly, ideally every two years or according to your audit SOP.

Implications?

If you are a UK pharmaceutical company that has adopted the PIPA guidelines into your SOPs and working practices, your practices will definitely need reviewing.  Make sure you work with your outsourcing partners to ensure they adopt the necessary points into their practices as well.

In my view, a lot of the changes give clarity to the guidelines and are already common practice.  But a few of the new points will be challenging for some companies to adopt.  Working with so many MI departments, I know that company practices vary widely and not every company will agree with every recommendation – the guidelines are voluntary, though.

There are two points that companies frequently debate in my MI up to date forum.  Firstly is the examination of patient responses – the ABPI Code does not specify how companies should perform the examination and many companies use a checklist to self-examine their work.  And secondly is the sending of healthcare responses asked via Sales – some companies choose to send on-label responses via their Sales staff.  Happy reading and debating over the next few months!

Written on 20 February 2018 (image updated 18 April 2018)

The information contained above is provided for information purposes only. The contents of this article are not intended to amount to advice and you should not rely on any of the contents of this article. Professional advice should be obtained before taking or refraining from taking any action as a result of the contents of this article. Jayne Packham Consultancy Ltd disclaims all liability and responsibility arising from any reliance placed on any of the contents of this article.