PIPELINE_72

Issue 72

The Journal of the Pharmaceutical Information & Pharmacovigilance Association

May 2024

µPIPELINE

In Memoria: Dr John Talbot Medical Information – The Unsung Heroes of the Pharmaceutical Industry?

Defining the Concept of Vigilance for Medical Devices What the Impending ABPI Code Update Means for QR Codes and Medicines Information

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CONTENTS 03 04 06 08

Medical Information – The Unsung Heroes of the Pharmaceutical Industry?

By Anne Turnbull

Defining the Concept of Vigilance for Medical Devices

By Belinda Dowsett

What the Impending ABPI Code Update Means for QR Codes and Medicines Information

By Simon Zedlewski

In Memoria: Dr John Talbot

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PIPELINE Editor: Dora Amene

MEDICAL INFORMATION – THE UNSUNG HEROES OF THE PHARMACEUTICAL INDUSTRY? Around twenty years ago, when starting a new role in an in-house medical information team, I was introduced to the marketing team. I distinctly remember them referring to me as one of the ‘ladies in cardigans’.

I confess to feeling a little offended (I thought I was quite sharply dressed)!

information available with no further context. If they then have a choice to use that company’s medicine again, or a competitor medicine manufactured by another company who have provided a better information service previously, who are they likely to go to?

In a world governed by directives, regulations and codes of practice, it is easy to lose sight of the human touch when ensuring compliance in responding to medical information enquiries.

But a good medical information response goes beyond simply providing data in a manner that checks all the boxes.

The best medical information teams will ensure HCPs and members of the public receive a five-star experience that will reinforce their positive experience of, and confidence in the medicines manufactured by, the pharmaceutical company they have contacted.

I would like to think that this rather dismissive take on the MI function has changed over the intervening two decades, but I fear that medical information often remains an underrated, undervalued and often overlooked resource.

THE FACE OF THE PHARMACEUTICAL COMPANY For many healthcare professionals, and members of the public, their one and only interaction with a pharmaceutical company will be through a member of the medical information team. Arguably, then, the reputation of the organisation can be laid at the door of the MI department: they should be championed as ambassadors for their employing companies and ensure that their customer service is second to none.

The days of ‘ladies in cardigans’ may be long past, but perhaps we should be wearing capes instead…as the unsung customerfacing heroes of the pharmaceutical industry!

Imagine going out for dinner and the food you receive is not what you ordered. Or that you wait an unacceptable length of time for your main course, only to be told that it’s not available with no explanation as to why not. Would you return to the restaurant, or go elsewhere next time?

The same principle can be applied to the service provided by a medical information team. Perhaps a busy hospital pharmacist emails the MI department with an enquiry, but the response provided doesn’t answer the question, or go beyond the information they already know from the Summary of Product Characteristics. Or they wait two weeks for a response to an extended stability data enquiry, only to be told there is no

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Anne Turnbull

www.mipharmaceuticals.com

DEFINING THE CONCEPT OF VIGILANCE FOR MEDICAL DEVICES The concept of ‘vigilance’, as it applies to medical devices, relates to the identification, reporting and trending of serious incidents as well as any corrective actions related to safety1.

It is distinct but related to the supporting post-market surveillance processes which focus on the monitoring of information to provide periodic confirmation that the benefit of a medical device outweighs the risk. These are not new concepts, however the requirements for vigilance and postmarket surveillance were not clearly delineated or articulated within the original Medical Device Directive (MDD) or In Vitro Diagnostics Directive (IVDD).

Establishment and definition of processes and workflows for post-market surveillance activities.

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Vigilance activities to detect emerging negative trends. For example, increases in frequency or severity of incidents.

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Requirement for Periodic Safety Update Reports (PSURs5).

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Upload of PSURs to a centralised database (EUDAMED6).

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Risk-based approach.

However, there are also some key differences. Of particular note is that for medical devices, the manufacturer is required to establish, within a degree of certainty, whether an adverse event or incident is related to, or is likely to be related to, the use of the device7.

This informs the decision of reportability. This is in contrast to pharmaceuticals, which do not require the establishment of the causal relationship to necessitate reportability8. In addition, the pathways and timelines for reporting of incidents and vigilance activities are also unique for pharmaceuticals and medical devices.

With the introduction of the European Medical Device Regulations (MDR 2017/745)2 and In Vitro Diagnostic Regulations (IVDR 2017/746)3, it appears that the regulator has taken inspiration from its pharmaceutical counterpart with regards to definitions. Now, both MDR and IVDR more clearly specify the requirements for both the post-market surveillance processes and outputs, as well as implementing stricter reporting requirements and increasing the visibility of manufacturers’ reports of device performance and safety4.

These differences are primarily a factor of the inherent differences in the mode of action between pharmaceuticals and devices (chemical/pharmacological versus physical), which can make it impossible to definitively confirm a causative relationship between a drug and an event8. Despite the differences, the aim of medical device vigilance and pharmacovigilance remain the same – to improve patient care and ensure the ongoing safety of pharmaceuticals and medical devices to end users.

In particular, knowledge of the two industries finds that the postmarket practices for pharmaceuticals and medical devices share the following common features: •

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Requirement for receipt, triage and quality, clinical (medical) and/or regulatory assessment of complaints and incidents for reportability determination.

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The changes to post-market surveillance and vigilance processes for medical devices also addresses some of the concerns and limitations of the previous regulatory framework.

Under the medical device and IVD directives, the focus for notified bodies was on ensuring that manufacturers had available sufficient data to support the positive benefit to risk ratio for their devices, with little emphasis or definition as to how this was intended to be monitored and maintained over time.

The updated regulations aimed to specifically address this with the introduction of the post-market surveillance processes of postmarket clinical follow-up (PMCF) for medical devices and postmarket performance follow-up (PMPF) for IVDs, as well as periodic safety update reports (PSURs)9,10. These processes aim to ensure that products are made available to the end user in as timely a manner as possible, whilst still allowing the regulator to ensure the continued collection of data to support ongoing monitoring of the risk/benefit profile of the products. The overall objective is improved patient treatments and outcomes, as well as ensuring that users have access to the latest technology without compromising patient or user safety.

This article is intended to communicate PharmaLex’s capabilities which are backed by the author’s expertise.

However, PharmaLex Pty Ltd and its parent, Cencora, Inc., strongly encourage readers to review the references provided with this blog and all available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions related thereto as the blog may contain certain marketing statements and does not constitute legal advice.

Although Europe is taking a lead with medical device vigilance and post-market monitoring, post-market oversight of medical devices amongst other global regulators has intensified, with many adopting more stringent processes and requirements to provide assurance of the safety and effectiveness of medical devices11,12.

The definition and standardisation of the terms within vigilance and post-market surveillance processes across jurisdictions remains limited. However, the concept for ongoing monitoring and reporting of device incidents is largely the same.

The challenge now is for manufacturers to adopt and implement vigilance and post-market processes that address the variabilities between requirements, as well as staying on top of the everevolving global regulations.

Belinda Dowsett

Associate Director, Medical Devices / IVD PharmaLex

REFERENCES 1

https://iris.who.int/bitstream/handle/10665/337551/9789240015319-eng.pdf?sequence=1

2

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0745

3

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic devices. https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R0746

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Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices, Medical Device Coordination Group Document, European Commission, 2023. https://health.ec.europa.eu/system/files/2023-02/mdcg_2023-3_en_0.pdf

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Periodic safety update reports (PSURs), EMA. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/ pharmacovigilance-post-authorisation/periodic-safety-update-reports-psurs

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EUDAMED database, European Commission. https://ec.europa.eu/tools/eudamed/eudamed

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https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02017R0745-20170505

8

https://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/wc500232767_en.pdf

9

Post-market clinical follow-up (PMCF) Plan Template A guide for manufacturers and notified bodies, MDCG. 2020. https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_7_guidance_pmcf_plan_template_en_0.pdf

10

Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs), MDCG, 2022. https://health.ec.europa.eu/system/files/2022-01/mdcg_2022-2_en.pdf

11

https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom/ outcome/chapter-8-post-market-surveillance-vigilance-market-surveillance

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https://www.tga.gov.au/medical-devices-reforms-enhancements-post-market-monitoring

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What the impending ABPI Code update means for QR Codes and medicines information QR codes offer a bridge between offline and online interactions. Used well, they can be a highly effective and sustainable tool for Medical Information and Medical Affairs teams to share critical information with healthcare professionals.

Engagement insights

With the impending update to Clause 12 of the ABPI Code of Practice, use of QR Codes is under review and the pharmaceutical industry is being poised to harness this technology more fully.

Reducing print debt

Once printed information leaves the Pharma professional’s hands, finding out whether it has been engaged with is a nigh-on impossible task. QR Codes can incorporate tracked links so you are able to gain some insight on user engagement and preferences.

It should be noted that not all QR Codes are equal – how they are created can unlock additional benefits from use, such as the ability to track engagement. So bear in mind that how you create your QR code determines whether you can gather insight into how the reader landed on your linked information.

Within the current ABPI Code, there is no guidance around the use of QR codes. This has meant that printed materials tend to include the abbreviated PI.

So it seems an apt time to delve into the world of QR codes, exploring the benefits and some of the risks when considering adoption.

The abbreviated PI, however, can still occupy valuable real estate on the page. Moreover, HCPs have indicated in the past that they prefer to see the full PI due to the level of detail it provides.

UNDERSTANDING QR CODES

PI can also go out of date at any time. So a great headache for Pharma has been the constant possibility that their materials would have to be recalled, updated and printed all over again following an update to part of the PI.

QR codes, short for Quick Response codes, are two-dimensional barcodes that encode information. Unlike traditional barcodes, QR codes can store a wealth of data, including text, URLs, and contact details. When scanned using a smartphone camera or a dedicated scanning app, QR codes instantly link users to the associated content.

Reducing the risk of non-compliance Which leads us to the next benefit - because printed PI can go out of date at any time, it can be a huge risk when your printed materials are left in circulation. QR Codes therefore offer a constant interface to information which is maintained and updated in the digital realm.

HOW CAN QR CODES BENEFIT PHARMA? You might have plenty of experience as a user of QR codes, whether it be from banners, flyers or event materials, but you would be forgiven for being unaware of how these work and the benefits they bring. Here are a few things to consider before adopting QR codes in your printed materials.

THE POTENTIAL RISKS AND LIMITATIONS Data Security and Privacy

Enhancing the experience with your brand

QR codes can lead to external websites or apps, potentially exposing users to malicious content, therefore it’s important for users to be safe in the knowledge that they are directed to a trusted and reputable source of information.

By offering a more interactive experience, this can create a bigger impact with the consumers of your information.

Furthermore, QR Codes can be great for engagement with medicines information - medical professionals can quickly retrieve the relevant drug details, dosages, and safety information during consultations through a mobile device. By allowing them to take your information into the palm of their hand, they can easily view up-to-date information wherever they are.

When incorporating QR Codes into your materials, it’s wise to be mindful of this and consider how you communicate to the user where they will be directed. Additionally, ensuring that the destinations of QR Codes are reviewed and kept updated is critical for compliance.

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User Familiarity Since the pandemic, QR Codes have seen something of a revival, but not all healthcare professionals may be familiar with them. Make sure you educate or guide users on how to scan QR codes and emphasise why they’ve become important in providing access to up-to-date information.

Lack of organisation If you’ve ever managed tracked links, you’ll know that it can quickly get messy. And for Pharma specifically, you need to ensure you are audit-ready, having good sight of who created what and when.

So it’s important to select a supplier who offers an easy-to-use management platform with good visibility and the facilitation of keeping links safe and organised.

Physical Constraints

QR codes are more than mere patterns; they’re gateways to knowledge. As Pharma begins to welcome this technology, Datapharm is keeping its customers ahead of the curve by implementing QR code functionality into its emc compliance solution.

LEARN MORE AT THE PIPA CONFERENCE 2024 Datapharm, the provider of emc (electronic medicines compendium) will be presenting at the annual PIPA Conference in September, where you can learn more about using QR Codes with digital prescribing information.

To learn more about this functionality, contact servicedesk@datapharm.com.

From a design perspective QR Codes can be a Godsend, freeing up more space on the page and being cosmetically more appealing than a long html link.

But there’s nothing worse than having your shiny new materials ready for an event or meeting only to discover that people are struggling to scan the code. The size and quality of print is important, and QR codes which are too small or too low in resolution might not be scanned accurately if printed on tiny labels or areas of a page.

Therefore, it’s advisable to opt for a clearer image where possible, with sufficient contrast for easy scanning. There’s little need to be elaborate with the design, so just keep it simple, large enough and usable as a priority.

THE ANTICIPATED ABPI CODE UPDATE: WHAT’S NEXT FOR PHARMA? As we await the ABPI Code update, there is anticipation that it will include the use of QR Codes to access PI from printed materials.

This follows the consultation process during December 2023 to February 2024. The proposals, of which this is one, are currently being reviewed.

Should that update happen, Medical Affairs, Brand and Medical Information teams can start actioning the incorporation of QR Codes into content such as training materials, collateral for events and marketing materials.

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Simon Zedlewski

Content Marketing Manager Datapharm Ltd

IN MEMORIA:

DR JOHN TALBOT

We are sad to say that Dr John Talbot, who was Co-editor of the 6th Edition of Stephens’ Detection and Evaluation of Adverse Drug Reactions, has recently passed away.

John was a lifelong pharmacovigilance professional who was one of the industry leaders in applying ICH guidelines especially about clinical safety. John had been the Director of Patient Safety at Astra-Zeneca R&D Charnwood in Loughborough until 2011, with a global role in patient safety processes. Prior to this he had been Head of the Spontaneous Reports Group in International Product Safety and Pharmacovigilance for GlaxoWellcome. Prior to his safety roles in the pharmaceutical industry, John had been a hospital pharmacist working in a number of UK teaching hospitals, and eventually obtained a joint appointment at Birmingham Medical School and the Queen Elizabeth Hospital, undertaking a PhD on adverse drug reaction monitoring.

Throughout his career, John was a regular speaker on drug safety issues at universities and international symposia. As an academic he helped create the Postgraduate Course in Pharmacovigilance at the University of Hertfordshire, bringing the core principles of drug safety to future generations of pharmacovigilance professionals. In addition to this significant academic contribution, John was invaluable to the university’s contribution to the European MSc Pharmacovigilance and Pharmacoepidemiology (Eu2P) programme. John successfully supervised many research students, several of whom went on to publish their work. Throughout his academic career, John was regularly invited to lecture on the Adverse Drug Reactions, Drug Interactions and Pharmacovigilance course at the University of Oxford.

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