PIPELINE_66

December 22 The Journal of the Pharmaceutical & Pharmacovigilance Association

ABPI Code of Practice Report Summary

MHRA PV Inspection Metrics Trials and Triumphs

Introducing an AI-powered Medical Information Chatbot

£12.00 or Free for Members 771478 327005 65

Issue 66

News and Trends

9

PIPELINE

Issue 65

CONTENTS 03 04 19 23 30 32 39 41 44 46 48 49

Letter from the editors

By Dora Amene, PIPELINE Co-Editor

Read

PIPELINE

PIPA Salary Survey 2022 Analysis

By Chris Isaacs, PIPA Vice President

Online: pipaonline.org/ pipa-journal/

MI audit inspection readiness checklist

Making Medicines Information meaningful: Revisiting the SmPC

By Nat Knight, Datapharm

ABPI Code of Practice news and trends

By Jayne Packham, Jayne Packham Consultancy Limited

Reimaging patient safety

By Sharmila Sabaratnam, Veeva Systems

Ensuring medical information is accessible to all

By Dan Wills, Patient Information Forum

MHRA PV Inspection Metrics Report Summary

By Kamei Au, Drive Phase PV Why Scientific Literature and Copyright Compliance Are Essential to Medical Affairs

By Heather Desmarais, HJD Consulting LLC on behalf of CCC (Copyright Clearance Center) Chatbot successes and challenges

By Julie Boothe, Orion Pharma (UK) Ltd Presidents Report

By Pooja Patel, PIPA President

Meet the PIPA Committee 2023

Copyright for any article accepted for publication in PIPELINE is transferred to PIPA once the article is submitted. Copyright covers the exclusive rights to reproduce & distribute the article in any form (such as photocopies or electronic copies) and applies to the complete article and any part within. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form without written permission from PIPA. PIPA will, wherever possible, grant permission to authors to subsequently use their articles, or to others to take limited numbers of copies, provided permission is obtained from the editors in advance. PIPA members are permitted to print a copy of PIPELINE and / or save a single copy of the electronic file for their personal use.While all reasonable efforts are made to ensure the accuracy of the information presented in this journal, the editors do not accept any liability for loss arising from reliance on the information presented.The opinions expressed in the journal are not necessarily those of PIPA, its Committee or companies to which members belong - unless otherwise stated.

PIPELINE Editor: Dora Amene

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LETTER FROM THE EDITORS Welcome to the second and final edition of PIPELINE for 2022, the publication of which was delayed due to a struggle in getting enough articles for this edition. There is no PIPELINE without articles, and we encourage more volunteers from the membership to contribute to PIPELINE on any topic of interest as we do our best to deliver new editions throughout the year.

This post-conference edition of PIPELINE feels like a breath of fresh air as we have decided to steer away from Brexit and COVID-19 talks, both of which clearly had a significant impact on the way we work and operate in PIPA and within the industry.

In sport, England topped their group in the 2022 World Cup and made it to the quarter finals where they met with France for an epic match. At the time of this publication, the World Cup in Qatar would have ended. Did France win their second World Cup title in a row?

Back to normality after COVID meant that we were able to return to an in-person event for our 2022 PIPA Annual Conference which was held at the Hogs Back Hotel on 28th and 29th September.

The traditional 2-day format of conference was graced by some very experienced speakers who delivered an interesting and topical programme of sessions; there were joint pharmacovigilance and medical information plenary sessions followed by PV, MI and Code Compliance presentations and workshops running in parallel. Suzie Lavington gave an excellent presentation on ‘Rising Stronger from Mental Health to Mental Wealth' which was a great start to the day and really set the tone for the whole conference. As always, we had our exhibitors in person with lots of interactions with the delegates.

The overall feedback from conference was very positive with delegates happy to have met in person. The focus for next year’s conference is to include more global content in the agenda topics.

We want to take this opportunity to congratulate Pooja Shah and Chris Isaacs who were announced as the new President and Vice President of the Association, and we wish them the very best in their roles as we operate under their leadership. We are also delighted to announce that Jessica Morris from PrimeVigilance won the prize draw for completing the conference feedback questionnaire.

Going back to this edition of PIPELINE, we are delighted to present the first president’s report from our new lead, Pooja Shah. We have topical articles relevant to medical information, Code Compliance and Pharmacovigilance.

We hope 2022 provided you with opportunities for career development and further training. Here at PIPA, the training working party work tirelessly to examine all our courses and identify a broader knowledge need for members to suit all career paths.

Talking about career paths and developments, the results from the 2022 PIPA Salary Survey carried out in May 2022 provided some interesting insights into the roles within the pharmaceutical industry held by our members. The survey was completed by 122 respondents of varying ages and years of experience within the industry, representing a good mix when it came to comparing salary.

PIPA’s free webinars and discussion forums are a chance to reach the wider membership, exchange ideas and discuss questions/ topics of interest from other members. We encourage members to attend the webinars and contribute in some way or the other by interacting and making suggestions for future topics.

As always, feedback from the membership is welcomed and we encourage you to interact with us and the wider PIPA membership via our online platforms below: Official PIPA Website: https://www.pipaonline.org/ LinkedIn: https://www.linkedin.com/company/pipa-pharmaceutical-information-andpharmacovigilance-association/ We hope to see you online at one of our events in the near future.

If there is anything you would like to see PIPA get involved with or do, please do get in touch at pipa@pipaonine.org We encourage more members to contribute to PIPELINE and make suggestions on topics for articles. Please contact us at journaleditor@pipaonline.org if you would like to contribute or make suggestions for the next edition.

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Written by Dora Amene PIPELINE Co-Editor

PIPA SALARY SURVEY 2022 ANALYSIS

The 2022 PIPA Salary Survey was carried out in May 2022 and the results provided some interesting insights into the roles within the pharmaceutical industry held by our members. The analysis is to be read as a guide only. In addition, it should be noted that the results are based on the number of respondents to the survey and the higher the number of respondents the more accurate the data for analysis. Therefore, considerations will be raised where potential anomalies have been identified.

DEMOGRAPHICS The total number of respondents for this year’s salary survey was 122. It’s worth noting that not all questions were answered by every respondent and some questions were completed with multiple answers. The demographics covered in this section are as follows:

Gender Age • Experience in other sectors • Type of company • Basis of employment • Geographical location of responsibility • Expected place of work • •

The survey was completed by predominately female respondents with 96 verses 23 males.

96

100

80

60

40

20

0

23 Male

Female

0

Non-binary

GENDER 4

0

Other

3 Prefer not to say

The survey was completed by respondents of varying ages representing a good mix when it came to comparing salary,

25

for example against years’ experience within the industry.

23 23

20

16 16

16

15

12

11

10

5

3

2 0

<24

25-29

30-34

35-39

40-44

45-49

50-54

55-59

60+

AGE

NHS Medicine/pharmacy

HAVE YOU

56.67%

WORKED IN ANY OTHER SECTOR?

Ye

s

43.33% N o

The majority of respondents had gained experience working in other sectors (56.67%). These sectors included:

5

Veterinary Research Education

Respondents from a wide variety of backgrounds completed the survey with the majority being from Innovator companies.

Of note, some respondents were working in companies

operating in multiple areas with 30% of respondents selecting two or more answers for this question. The options for ‘Other’ are provided in the salary section.

“the majority being from Innovator companies” 60

54 50

40

30

23

20

29 13

10

0

15 13 11

9 2

Innovator

Generic

Biotech

Devices

OTC

Diagnostic

CRO

MI PV outsource outsource company company

WHICH BEST DESCRIBES YOUR COMPANY? 6

8 Other (please specify)

The survey was completed by associates who were mainly full-time permanent employees (85%), with a small number of permanent 100

part-time employees (12%) and a handful of contractors (3%). No respondent completed the survey who was on a fixed term contract.

99

80

60

40

20

0

14 Permanent full time

4

Permanent part time

0

Contractor

Fixed term contract

WHAT IS THE BASIS OF YOUR EMPLOYMENT? membership, however the wide variety of locations covered by the respondents allowed for a more comprehensive dataset when it came to comparing salary. Of note, 10% of respondents covered all areas.

The geographical areas covered by respondents were mainly GB/UK (106), EEA (48) and EMEA (44). It is expected that most respondents would have chosen GB/UK given the location distribution of PIPA 120

100

106

“10% of respondents covered all areas”

80

60

48

44

40

15

20

0

28

GB / UK

EEA

14

Asia Pacific

EMEA

LATAM

North America

GEOGRAPHICAL LOCATION OF RESPONSIBILITY 7

Over three quarters of the respondents were expected to perform their responsibilities within a hybrid working environment with less than 5% working full-time in the office.

Of those 5% of respondents who were fully office based, 40% worked for a CRO, 60% covered generics and 100% worked

for a company that employed 50 people or less in the UK. No doubt the COVID-19 pandemic contributed to these results but interesting to know that post pandemic there is a shift towards a hybrid working model rather than a return to the office on a full-time basis.

100

89 80

60

“less than 5% working full-time in the office”

40

23

20

0

5 Fully in the office

Fully at home

Hybrid working

WHERE DOES YOUR COMPANY EXPECT YOU TO WORK?

SALARY DATA The salary comparisons covered in this section are as follows:

Interestingly, the average salary of the respondents with a smaller number of years’ experience in medical information was higher than the equivalent average salary in pharmacovigilance.

However, by 20+ years’ experience it was the average salary of the experienced pharmacovigilance respondents that was higher.

Time spent in industry Highest qualification • Type of company • Size of company • Most important job factors • Least important job factors • Job title • Gender • Fairness of salary & remuneration package • Legal responsibilities • •

The number of medical information respondents with 16-20 years’ worth of experience was very small and this may be the reason behind the apparent anomaly.

One further factor to consider is that some of the respondents had experience in both medical information and pharmacovigilance. When compared with the average salary for all those with pharmaceutical experience (£65,901), respondents with combined medical information and pharmacovigilance experience earned a higher average salary (£69,224).

8

100000

Pharmaceutical

Pharmacovigilance

Medical information

80000

60000

40000

1-5

6-10

11-15

16-20

20+

AVERAGE SALARY (£) PER TIME SPENT IN INDUSTRY Average salary per highest qualification ranged from £39,543 (GCSE or equivalent) to £105,750 (BPharm). A consideration here is that there were a very small number of respondents with a BPharm as their highest qualification and the average number of years’ experience was 15+. When compared with the average

Other (please specify) Post Graduate Diploma MBA PhD MSc BSc MPharm

number of years’ experience of the respondents with an MPharm as their highest qualification (4.3) the difference in average salary becomes clearer. Other qualifications provided included: • MD • B-Tec • MRCP • PharmD

85811

63369 77500 75948 57269 69987 55862

105750

BPharm A-level (or equivalent) GCSE (or equivalent)

0

20000

50300 39543 40000

60000

80000

100000

AVERAGE SALARY (£) PER HIGHEST QUALIFICATION 9

120000

Respondents from PV outsource companies averaged the highest salary with £71,792. However, when a couple of salaries significantly higher than the rest due to other factors were removed, the average for ‘PV outsource companies’ fell to £55,150. Other types of companies where respondents did not receive a car or car allowance included ‘CRO’ and ‘Other’.

‘Other’ included (but not limited to):

• Consultancy • Herbal medicines

The type of company with the lowest average salary as per the survey responses was diagnostic companies, but a contributing factor to this may have been that the number of respondents from a diagnostic company was very small in comparison to the other types of company.

Other PV Outsource Company

51863 48703

MI Outsource Company CRO

35000 44057 51562

Diagnostic OTC Devices Biotech Generic Innovator 0

10000

20000

30000

• Medical Communications • Contracting services

40000

50000

67583 71792

71363 64496 64301 60000

70000

80000

AVERAGE SALARY (£) PER TYPE OF COMPANY along with the size of the company. Companies with over 1000 employees paid the lowest average salary but provided the highest 8 number of benefits.

With the exception of companies with 26-50 employees, the average salary decreases as the size of the company increases.

90000 However, the number of benefits in general appears to increase 80000

81750

6.5

70000

63812

60000

6

69469 68471 4.85

50000

6.78

6.52

7.2

7

6

63119 62607 59941

5

4

40000

30000

3

3

2

20000

1

10000

0

Under 25

26-50

51-100

101-250

251-500

501-1000

1001+

0

AVERAGE SALARY (£) & NO. OF BENEFITS PER SIZE OF COMPANY 10

“most important job factor... work/life balance” Respondents considered the most important job factor to be ‘work/life balance’ with 34.4% of the total vote. This was followed by ‘job satisfaction’ and ‘money’ with 26.4% and 12.8% respectively. The remaining three factors of ‘intellectual challenge’, ‘respect’ and ‘making a difference’ combined made up just over a quarter of all respondents.

8.8

Interestingly, ‘money’ was also in the top three least important factors with 21.3% of the vote being topped only by ‘intellectual challenge’ with 24.6%. ‘Respect’ and ‘making a difference’ were joint third with 19.1% and the remaining two factors of work/life balance and job satisfaction making up 15.9% of the surveyed respondents when combined.

5.3

6.4

10.6

24.6

34.4

11.2

19.1

12.8

21.3 19.1

26.4

LEAST IMPORTANT JOB FACTOR (%)

MOST IMPORTANT JOB FACTOR (%) Work / life balance

Job satisfaction

Money

Making a difference

Intellectual challenge

Respect 11

(£36,968). It was surprising to see that the team leader average salary was lower than the average salary for the entry level role (£41,536) given that a team leader has some managerial or authoritative responsibilities. However, as an apparent anomaly, it is difficult to interpret further as there were a low number of respondents identifying as team leaders (3.42%) and the title of ‘Team Leader’ is subjective.

The highest average salary when compared with job title was the regional or global head which was understandable given the extent of responsibilities. For the most part the sliding decline from regional or global head to entry level role was expected with the exception of the principal role (£65,356) being slightly higher than the manager role (£62,190) and the lowest average salary per job title being the team leader

103861

Regional or Global Head (supervisory responsibility over more than one department, region or country)

80305

Head of Department (supervisory responsibility over an entire team within department)

62190

Manager (managerial responsibility over an entire team within department) Team Leader (limited managerial and greater supervisory responsibility within department)

36898 65356

Principal (no managerial responsibility but greater supervisory responsibility or expert role within department) Senior (no managerial but some supervisory responsibility or expert role within department) Entry level (no managerial or supervisory responsibility within department)

0

20000

45549 41536

40000

60000

80000

AVERAGE SALARY (£) PER JOB TITLE AVERAGE SALARY (£) PER GENDER It was welcoming to see the average salary between males and females virtually equal with £64,859 and £66,467, respectively. The average salary for those respondents who preferred not to provide a gender is lower at £55,784 and this may have been due to the very low number of respondents in this category.

Male

Female

Prefer not to say 12

100000

120000

24.76

25

0

1.94

0.95

Extremely unfair

2

3

7

8

6.67 9

FAIRNESS OF REMUNERATION PACKAGE

Other

No special legal responsibilities

Appropriately Qualified Person

Notified Signatory for Promotional Certification

Responsible Person for Devices

National Contact Person

40000

Deputy QPPV

Extremely generous

The Notified Signatory for Promotional Certification came out with the highest average salary per legal responsibilities at £92,751 followed by the QPPV with £82,544. As one might expect, there was a rolling decrease in average salary from QPPV (£82,544) to Deputy QPPV (£76,200) to National Contact Person for PV (£74,872) most likely due to the level of responsibilities associated with those roles. It is worth mentioning that there was a very small number of respondents who performed the role of Responsible Person for Devices and the salary range varied significantly. Interestingly, the average salary for those with no legal responsibilities (£61,141) was not the lowest salary, with the appropriately qualified person at £54,323. ‘Others’, with an average salary of £74,362, included but not limited to:

60000

20000

8.74

9.71 6

80000

QPPV

19.42 7.62

Average

100000

0

13.59

14.29

12.62

17.48

5.83 4

Package as a whole (%)

4.76

5

2.91

3.81

7.62

10

8.57

15

Although nearly a quarter of all respondents felt their salary was ‘average’, the overall majority of respondents rated their salary (54.29%) and package as a whole (64.08%) above average. The most chosen score for the package as a whole was ‘8’ with 19.42%. At the other end of the scale, of the 19 respondents who rated their overall package below average, 53% were looking to either leave their role or company in the next year.

7.76

20

20.95

Salary (%)

• Company Director • Responsible Person (GDP/Clinical Trials) • Head of Quality & Compliance • Budget Signatory • SDEA Signatory

AVERAGE SALARY (£) PER LEGAL RESPONSIBILITIES 13

NON-SALARY DATA The Non-salary data covered in this included:

36.8

The average hours respondents were contracted to work per week was 36.8 but the average hours respondents actually worked was 39.9. The average number of additional hours worked of 3.1 was interesting to see considering more than a third of all respondents chose work/life balance as their most important job factor. When responses from those working part-time were analysed the results were very similar with average contracted hours at 27.6 and average actual hours worked at 30.2 with the difference being an additional 2.6 hours per week.

How many hours a week are you contracted to work?

39.9

• Hours of work • Out of hours service • Flexible working hours • Nights spent away from home on business • Basis of bonus awarded • Basis of car/car allowance awarded • Other benefits • Leave allocation taken

AVERAGE HOURS OF WORK

How many hours a week do you actually work on average?

for provided no out of hours service. This is a mixed bag and potentially down to factors such as whether the respondent worked in the department responsible for the provision of the out of hours service or if the company was a CRO or service provider who did not offer that specific service.

Nearly half of all respondents confirmed that the company they work at did provide an out of hours service, however they did not partake in its provision (45.69%). Around a fifth of all respondents did partake in the company’s out of hours service (18.97%) with the rest (35.34%) confirming that the company they worked

35.34%

No, the company has no out of hours service

45.69%

Yes, the company has an out of hours service but I do not partake in its provision

18.97% Yes, the company has an out of hours service and I do partake in its provision

0

10

20

30

40

DOES YOUR COMPANY / DEPARTMENT OFFER AN OUT OF HOURS SERVICE AND DO YOU PARTAKE IN THIS? 14

50

working within a hybrid working environment since of the 103 respondents who had some option of flexible working hours, 98% were either fully home based or worked in a hybrid working environment. In addition, 2.6% of respondents who had no option for flexible working hours were also fully office based.

An overwhelming majority of respondents (88.03%) received some sort of flexible working hours, whether it be core working times with flexi-time (42.74%), full flexi-time (15.38%) or flexible hours with no set system (29.91%). These results may 50 to the high percentage of respondents who are now be linked

42.74% 40

29.91%

30

20

15.38%

11.97%

10

0

Core working times with flexi-time

Full flexi-time

Flexible but no set system

No flexible option

DOES YOUR COMPANY PROVIDE FLEXIBLE WORKING HOURS? 15

Most respondents did not spend any nights away from home on business (69.23%). As the grouped number of nights spent away from home on business increased, the number of respondents decreased-with 23.08% spending 1-2 nights away, 5.13% spending

3-5 nights away and 2.56% spending 5 or more nights away on business. There were no significant trends in terms of time spent away on business and other variables other than 60% of those who spent 5 or more nights away worked for innovator biotech company.

23.08% 69.23% 5.13% 2.56%

0 1-2 3-5 5 or more

HOW MANY NIGHTS PER MONTH, ON AVERAGE, DO YOU SPEND AWAY FROM HOME ON BUSINESS? For 69.52% of respondents, their bonus was paid on the basis of both personal and business performance. A small number of respondents were paid a bonus solely on business performance (11.43%) and smaller still was the number of

respondents who received a bonus solely on their personal performance. Just over a tenth of all respondents received no bonus (10.48%) and a very small number of respondents were not aware of how their bonus was rewarded.

Personal performance

6.67% Business performance

11.43%

Both

69.52% No bonus

10.48% Unknown

1.90% 0

10

20

30

40

50

60

ON WHAT BASIS IS YOUR BONUS PAID? 16

70

80

(%)

60

55.77%

50

40

34.62%

Just over half of all respondents didn’t receive a car or car allowance but for those that did, 34.62% received their car or car allowance based on job grade and 2.88% on a needs basis. A small number of respondents did not know how the car or car allowance at their place of work was awarded (6.73%).

30

20

10

6.73%

2.88% 0

Need

0%

Grade

Both

No car

Unknown

ON WHAT BASIS IS YOUR COMPANY CAR / CAR ALLOWANCE AWARDED 100

93.40%

When it came to other benefits, pension schemes (93.4%) and private healthcare (85.71%) were by far the most common.

In addition to pension schemes and private healthcare, the majority of respondents also received the following benefits:

85.71% 80

69.57%

• Paid membership/subscriptions (69.57%) • Cycle to work scheme (61.70%) • Ability to buy or sell holidays (58.33%) The benefits received by the least number of respondents were profit share scheme and out of hours remuneration at 12.66% and 17.07%, respectively.

61.70%

60

58.33%

44.44% 40

Buy / sell holiday

Cycle to work scheme

Membership subscriptions paid

12.66%

Out of hours remuneration

17.07%

Profit share scheme

Stock / share option scheme

Share save / purchase scheme

Private healthcare

Pension scheme

20

Affiliate partners discount scheme

31.46%

31.40%

0

OTHER BENEFITS PROVIDED BY YOUR COMPANY 17

“the number of days

not taken ranged from 1 to 10 days”

21.90 %

For the respondents who did not take their full allocation of leave, the number of days not taken ranged from 1 to 10 days with the majority leaving 5 days. It is not uncommon for companies to allow employees to roll over several annual leave days and this may have been a factor in this response.

78.1 0%

Yes

No DO YOU TAKE YOUR FULL LEAVE ALLOCATION EACH YEAR? The final question on the salary survey was related to any further comments. A small number of comments were provided showing that some respondents were happy with their salaries and benefits whilst others believed improvements could be made with one respondent confirming that benefits were being improved.

One respondent felt that part-time positions made it hard to progress whilst another was looking to leave their company due to how the company they work for was run. Last, but not least, was a comment on how pension contribution becomes more important the older you get.

To conclude, this year’s salary survey was very insightful and many thanks to all those who participated.

Written by Chris Isaacs Vice President

18

AUDIT AND INSPECTION

READINESS CHECKLIST SUMMARY

This checklist is one of many resources available on the PIPA website. It was designed to help medical information departments identify key points to focus on during the preparation for an inspection, and has been recently updated. A downloadable version is available via https://pipaonline.org/medical-information/inspection-checklist/

MEDICAL INFORMATION (MI) INSPECTION/AUDIT READINESS ASSESSMENT TOOL DOCUMENT

YES/NO

PROCESS Do your MI processes align with global and regional documentation, and if there are any local variations are these documented? Can you describe each step? Can you clearly indicate the relationship with Pharmacovigilance and Quality Assurance to ensure adverse events (AEs) and product quality complaints (PQCs) are reported? Are you able to describe the process for handling MI requests on safety related topics?

Do you have a process in place for reconciliation of AEs/PQCs, reported by MI? If your medical information database is interfaced with the PV or the Quality database, are there regular checks to ensure the systems are exchanging the relevant information such as MI details needed for the AE report, and the AE report tracking number for MI to add to the case in the MI enquiry system?

Can you retrieve all up-to-date MI applicable standard operating procedures (SOPs)/working practices and any relevant documented local business processes? (e.g. SOPs/working practices describing company requirements and processes followed by MI staff to report AEs/PQCs, to comply with copyright, data protection etc).

PROCESS DETAILS Do you have a local policy / regulatory requirement for retaining hard copy source documents? If so, have you ensured that your archiving procedure is clear? If you are taking detailed paper notes prior to logging into your database, do you ensure that the notes are scanned and attached to the system?

19

Do you provide an out of hours service? If so, do you have a process flow chart or documentation to support this service? Is testing of the service performed and adequately documented? If you do not provide an out of hours service, do you have a process to ensure AEs and PQCs are handled/processed in the required timeframe (if reported) (e.g. left on voicemail after business hours, during a holiday shutdown, system outage)?

Do you have a current disaster recovery/business continuity plan that covers your processes, as appropriate?

What type of back up do you have for your department to show continuous daily business hour coverage? (i.e. to ensure AEs and PQCs are handled/processed in the required timeframe).

PROCESS ROLES Job descriptions - does a job description exist for all positions in MI (contract or permanent)? (The job description should describe all key activities of the current role).

TRAINING Can you provide the role based curriculum for MI in your country/location if asked?

Are training records for MI staff complete?

Do you have an onboarding/training program for new MI staff? Is this documented?

Are the onboarding/training materials (slide decks etc.) for MI staff easily retrievable?

Do you have evidence of MI role-specific training that MI professionals need to undertake regularly, to perform their role? e.g. ABPI Code and other pharmaceutical regulations; internal annual AE reporting training; product and disease state training; miscellaneous annual training etc.

For training completed outside of the training system, e.g. external courses, training at conferences, etc. have you added these to your training system and do they show in your electronic training transcript? If not, do you have documentation (e.g. training roster[s]) as a record of the training?

For other types of training that you provide (e.g. sales representatives, external business partners [e.g. call centre agents] etc.), do you have retrievable training materials and training rosters?

PERSONNEL Is an up-to-date CV available for all MI staff (permanent and contract, including all call centre staff [if any])? Are CV(s) easily retrievable if requested? (Note: CVs for contract staff may be held by the supplier/vendor but should be readily available on request). Are CV(s) updated, signed and dated on an annual basis?

Does the CV align with the job description i.e. do the skills and qualifications of the personnel in the role (this includes past employees) match with those required to perform the job?

Do you have an up-to-date organisational chart?

CONTRACTS Do you have service contracts for outsourced MI service providers (if any)? Are these contracts easily retrievable?

Do these contracts depict clear procedures for the handling of AEs/PQCs reports by these partners?

20

MONITORING Can you describe the quality monitoring program for your database/system? Do you know who to contact globally if questions outside of your scope are asked?

Do you have a process for monitoring the quality of MI responses provided by outsourced MI service providers?

If so, is this process documented? Can you show evidence (documentation) that this is conducted on a regular basis?

Do you have a documented approval/withdrawal process for non-promotional materials that the medical information team are responsible for creating/updating/disseminating e.g. scientific decks for Medical Scientific Liaison (MSLs)? Do you perform spot checks on random job bags/materials to check for compliance with the process?

If you are involved in the provision of risk minimisation materials, do you have a monitoring process in place to ensure that these are sent in line with the specific product’s risk minimisation plan?

REGULATIONS Can you show how you document off-label MI requests (if required) and/or off-label patient exposure? Can you describe how you determine if patient exposure is off-label?

Can you show how you comply with data privacy and copyright regulations applicable to your country/location?

INSPECTION For your department/location, have you assigned the appropriate inspection designee(s)? (Departments/locations may have one or more personnel designated as the point-of-contact for inspections).

Have all MI staff received inspection readiness training? And is this documented?

Are you aware of any previous audit/inspection findings impacting MI? Are they resolved? If they are not resolved, can you explain the status of those findings?

MI DATABASES Are you able to easily retrieve MI enquiry data from your MI database? e.g. in an excel report format.

Can you run the report within your team, or do you have to request this via your MI outsourced vendor?

If using an outsourced vendor do they use your MI system? If so, do you regularly train them on updates to the system?

What is the process for informing the MI teams and keeping them up to date with training and any new releases of the MI system(s)?

21

If your outsourced provider uses their MI system, do you have access to the system to perform quality checks?

What procedure do you have in place in case the outsourced vendor has a system outage?

If you are changing MI systems, have you ensured that you have considered how to access legacy MI enquiries?

(For example, via a report that is saved internally, or via an offline version of the decommissioned system, or by migrating the enquiry data into the new system.)

Is your system validated? Can you guarantee you get the same results each time you run a query against it?

Are appropriate security measures in place so only the correct people are able to access and view enquiries and enquiry responses?

Do you run regular system tests to ensure everything is working correctly?

If your MI team is global, are appropriate local data protection rules followed? Do you have appropriate data retention and data privacy policies in place?

Do you have a process document that explains who has access to the database and why?

MI TELEPHONE LINES AND CALLS Do you use a local rate/freephone medical information phone number? If you use an 0845 or other business rate phone number, have you considered the potential implications of this to patient safety due to the potential call charges?

Do you have ownership of the medical information phone number or is it owned by a third party/outsourced vendor? What contracts do you have in place around this?

Do you or the Quality department regularly check the status of the medical information phone line and perform test calls? Are the line checks and test calls logged in an accessible place, if asked for evidence?

If you change the telephone number, have you conducted an impact assessment to work out where the number appears and what materials/assets need to be updated - including digital assets such as websites as well as product packaging/labelling?

What are your business continuity procedures if there is a phone line outage?

Do you perform regular quality checks of calls handled by the MI team (if calls are recorded)?

22

MAKING MEDICINES INFORMATION MEANINGFUL: REVISITING THE SMPC Introduction Pharmaceutical companies are developing new medicines at an increasing speed. There is more data about the effects and effectiveness of medicines than has ever been seen before, and information about medicines is changing all the time.

Clinical practice is similarly evolving. Pressure on healthcare professionals has never been higher. The pandemic unlocked both the potential and the risks associated with remote consultations, resulting in working practices changing rapidly.

This means it is important, more so than ever, to ensure that healthcare professionals (HCPs) have the right information about medicines in the right medium and at the right views time. on Medicine Information A survey revealing healthcare professionals’ The creation, format and use of HCP targeted safety Information - the Summary of Product Characteristics (SmPC) and Prescribing Information – are rightly highly regulated. They are part of the fabric of medicine today. But in these changing times, do the SmPC and Prescribing Information still meet healthcare providers’ needs, and which is more effective?

To find out, Datapharm has surveyed 241 healthcare professionals, half in secondary half in new primary and other Pharmaceutical companies are care, developing medicines at care settings, for their opinions on medical documentation. an increasing speed. There is more data about the effects and

INTRODUCTION

effectiveness of medicines than has ever been seen before, and information about medicines is changing all the time.

11%

Clinical practice is similarly evolving. Pressure on healthcare professionals has never been higher. The pandemic unlocked both the potential and the risks associated with remote consultations, resulting in working practices changing rapidly.

This means it is important, more so than ever, to ensure that healthcare professionals (HCPs) have the right information about medicines in the right medium and at the right time.

38%

The creation, format and use of HCP targeted safety Information - the Summary of Product Characteristics (SmPC) and Prescribing Information – are rightly highly regulated. They are part of the fabric of medicine today. But in these changing times, do the SmPC and Prescribing Information still meet healthcare providers’ needs, and which is more effective?

53%

To find out, Datapharm has surveyed 241 healthcare professionals, half in secondary care, half in primary and other care settings, for their opinions on medical documentation.

Other

23

Secondary Care

Primary Care

KEY FINDINGS The SmPC is a structured document which is successfully relied upon by the entire healthcare industry. 88% of those surveyed

agreed or strongly agreed that they “prefer looking at the SmPC for gathering Prescribing Information”.

Strongly Disagree

0% Disagree

0%

Neither agree or disagree

13%

Agree

“I prefer looking at the SmPC for gathering Prescribing Information”

31% Strongly agree

57% (%) 0

10

20

30

40

50

60

THE SMPC IS WELL RECEIVED We also asked, “How easy is it to find what you are looking for on the SmPC?”, and only 1% of respondents found it difficult

10%

to use. In almost all settings, between 65% and 95% of respondents rated the SmPC easy or very easy to use

1% 36%

53% Easy Very easy Neither easy nor difficult Difficult Very difficult

HOW EASY IS IT TO FIND WHAT YOU ARE LOOKING FOR ON THE SMPC? 24

“If I am prescribing or advising on a medicine, I like to have read the full information from the SmPC to make sure I haven’t missed anything” “I usually need detailed information, that is not in the BNF, so I need the full SPC”

Pharmacist, Secondary Care

Pharmacist, Secondary Care The SmPC and Prescribing Information with the full SmPC are the first choice for many healthcare professionals seeking key medicine information rather than the truncated version of Prescribing Information (commonly referred to as Abbreviated PI). Pharmaceutical companies traditionally relied on Abbreviated PI to get an acceptable amount of prescribing information across in a compact format while meeting their regulatory obligations.

However, this meant - and still means - the Abbreviated PI can be difficult to use. Comments we received in our survey included “I like the arrangement on SmPC; [in the] Prescribing Information, the words look very crowded” (from a primary care pharmacist).

25

THE SMPC IS A KEY DRIVER OF EFFECTIVE DECISION-MAKING We asked respondents how often they referred to the SmPC as part of their clinical roles. Despite the prevalence of the

Abbreviated PI in Pharma materials, just under half (49%) reported that they used the SmPC every day; 36% at least weekly.

I never use it

0% Less than once a month

3%

A few times a month

13%

A few times a week

36%

Everyday

49% (%) 0

10

20

30

40

50

HOW OFTEN DO YOU LOOK AT THE SMPC AS PART OF YOUR CLINICAL ROLE? However, this belies a significant difference according to role.

Whilst 89% of pharmacists refer to SmPC documents at least

once a week, nurses said that they used the SmPC at least “a few times per month”.

Nurse

0% I never use it

Doctor Pharmacist

26% Less than once a month

1%

31% A few times a month 37%

9%

50% A few times a week

26% 11%

35%

19% Everyday 54% (%)

0

10

20

30

40

26

50

60

“I am usually looking for quite specific information and my job role allows me the time to look through the full information.”

Nurse, Primary Care Unsurprisingly, the top response was “As part of the prescribing/ dispensing process” (80% for primary care doctors, 92% for secondary care doctors, 74% for primary care pharmacists, 68% for secondary care pharmacists).

Perhaps one reason for this disparity is the very different reasons that healthcare professionals give for using the SmPC. We asked our respondents, “Why do you look at the information in the SmPC?”, and the responses differed widely.

80

70

69%

60

49%

50

53%

57% 44%

43%

40

30

16%

20

10

0

As part of the prescribing/ dispensing process

During consultation, to check interations with other medicines taken by the patient

To Check clinical data on effectivness

To advise the patient how to take the medicines

To answer patients questions

To check change information from previous versions

Request from other HCP’s

WHY DO YOU LOOK AT THE INFORMATION ON SMPC? 27

Thereafter, however, we gave our respondents several further options:

•

To check interactions with other medications during a consultation • To check data on clinical effectiveness • To advise the patient on how to take medicines • To answer patients’ questions

In responding to these options, all of the first five on this list were valued by more than 50% of at least one class (primary, secondary, other setting) of pharmacists and nurses. Among doctors, conversely, “To answer patients’ questions” (at 60%) was the only response to be selected by above 50% of doctors.

•

•

To check change information from previous versions To meet requests from other HCPs

HCPS PREFER DIGITALLY DELIVERED CONTENT 86% responded “Digital”. Even for nurses, who have an increased preference for printed materials, no doubt because the availability of digital systems can be patchy on the wards, this only drops to 69%.

Our survey respondents across all roles and settings have overwhelmingly embraced digital resources. We asked, “In which format do you prefer to receive medicine information?”, and overall,

WHICH FORMAT DO YOU PREFER TO RECEIVE MEDICINE INFORMATION?

100

11% 4%

80

60

40

86% 20

0

Pharmacist

Doctor

Nurse

Digital Printed Both

and minimise errors. Digital also reduces the paper waste of printed marketing materials and the risk that content can go out of date.

And that’s the point: we should present information in the best way possible for the context of use. For most doctors and pharmacists, digital tools make access to data easier and faster,

28

KEY TAKE AWAY

1 2

3 4

The SmPC is well received 88% of those surveyed agreed or strongly agreed that they “prefer looking at the SmPC for gathering Prescribing Information”. HCPs in all contexts understand its structure and find it easy to use. It contains the right amount of information to meet most practical needs.

The SmPC is a key driver of effective decision-making 89% of pharmacists refer to SmPC documents at least once a week.

The increasing digitalisation of HCP/Pharma engagement presents HCPs with what we at Datapharm believe is a two-part opportunity.

HCPs prefer digitally delivered content 86% of HCPs prefer to receive information on medicines in a digital format.

Increasing digitalisation of HCP/Pharma engagement There is the opportunity to enable better digital information for HCPs and for medicine adherence.

“Most patients I deal with are frail and have complex medical problems. I need to minimise the risk and magnitude of interactions, complications and sideeffects and to optimise therapeutic benefit / dosage regimes”

The first part of that opportunity is already being taken: to consume the SmPC in digital form in appropriate contexts. As well as being a natural transition, it is testament to the effective evolution of the SmPC’s design that it has transitioned to digital media so seamlessly.

The second part of the opportunity is to present more data in more meaningful ways and in more contexts, as unlocked by digital systems. This may mean presenting subsets of the SmPC (e.g., adverse events, contraindications) to facilitate access for HCPs whilst making the master version still available. We know that HCPs are increasingly time-poor, and our survey suggests that anything which reduces the reading time with the right information is a positive step.

Doctor, Secondary Care

Please access the report via the following link: https://bit.ly/SmPCsurvey https://bit.ly/SmPCsurvey

If HCPs prefer environmentally friendlier digital communications (and usually quickly dispose of printed materials) there is no reason for Pharma to continue printing marketing materials.

Furthermore, if using the SmPC and Prescribing Information meet healthcare providers’ needs, Pharma should do away with Abbreviated PI as it belongs in a by-gone era.

With digital innovation being a key objective for many organisations, we believe it is time to move on and embrace the full potential of technology. This will benefit not only Pharma, but also HCPs when accessing medicine information.

This article is a shortened version of the report, “Making medicines information meaningful: revisiting the SmPC. A survey revealing healthcare professionals’ views on medicines information”.

Written by Nat Knight Director, Datapharm

29

ABPI CODE OF PRACTICE NEWS & TRENDS SUMMARY now wait to see what changes and direction the new Director, Alex Fell will bring.

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

So what is the latest Code news and case trends?

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.

“Shockingly there were 55 complaints from one individual ” 30

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:

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.

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

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

“all posts must be Code compliant and certified or examined before use”

• 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

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.

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.

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.

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

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

Written by Jayne Packham Managing Director, Jayne Packham Consultancy Limited

31

REIMAGINING PATIENT SAFETY Connecting data across the value chain allows timely access to critical information, enabling better decisions and protecting patients from avoidable harm.

Over the past 15 years, pharmacovigilance has grown beyond its traditional compliance role to become an active strategic partner in innovating operations, improving patient outcomes, and ensuring medical governance. Its scope and workload have also grown exponentially during this period, with an increasing number of data sources and adverse events.

Case processing now accounts for 40 to 85% of pharmacovigilance budgets, with case volumes growing at a rate of 15 to 20% per year.1,2 At the same time, overseeing drug safety is even more challenging as global operating models increase in complexity and regulatory requirements continue to evolve.

B-R DATA EXPLOSION

SUPPORT PATIENT CENTRICITY

• Data beyond adverse events • Medication errors, effectiveness, supply, quality • Emerging safety issues: local - global

• More aware and involved patients • Customised medication and therapies • Enhanced quality of life and outcomes • Patient voice in regulatory decisions

SAFETY ORGANISATION

DISRUPTIVE R&D MODELS

DISRUPTIVE HEALTHCARE TRENDS

• Early access or licensing • Decentralised trials • Personalised therapies • Increasing RWE and post-market data

• New delivery models • New entrants like Amazon and Google • Health • Costs • Payers and providers evolving role

DIVERGENT REGULATORY DEMAND • ICH and RoW regulations • Growing QPPV, PSMF, local data requirements • Drugs, devices, diagnostics • Patient safety and performance monitoring

(Source: Veeva Systems)

FIGURE 1: GROWING PHARMACOVIGILANCE CHALLENGES 32

Preventable patient safety issues are still a leading cause of patient death worldwide, with societal costs between $1–2 trillion each year in the US and UK alone.3 Initiatives such as The Global Patient Safety Action Plan 2021-2030,4 adopted by the World Health Assembly, provide a much broader context for improving pharmacovigilance. The plan envisions “a world in which no one is harmed in health care, and every patient receives safe and respectful care, every time, everywhere.” It sets drug safety goals within systemic efforts to address healthcare challenges and drive medical

governance oversight while prioritising patient safety, data integrity, and R&D innovation.

Technology is critical to achieving these goals and the industry is making progress, embracing new ways of thinking and unique safety approaches. More safety leaders are reimagining patient safety with modern systems that can move the industry toward a predictive, preventative, and participatory model for pharmacovigilance.5

Proactive surveillance

Preventative and predictive models

Data and Content

With change happening around data transparency, like the mandatory public sharing of market performance data and benefitrisk study results, safety teams must be on an equal footing with drug efficacy and effectiveness. Modern pharmacovigilance systems on a single cloud platform can improve regulatory compliance and provide a competitive advantage.

Real-time benefit-risk

Faster time-to-market

Direct patient participation

Adverse Events and Queries

Claims

Adverse Events and Queries

Sales Data

Adverse Events and Queries

Social Media

Adverse EventsMedical and Queries Literature Patient Registries, EMR/ EHR

Adverse Events and Queries

Adverse Events and Queries Regulatory Data - FAERS, VAERS, VigiBase, EudraVigilance, JADER, MedDRA, WHO Drug

Adverse Events andClinical Queries Safety Biomarkers, Trial Data Clinical Trials

Pre-Clinical

IND Submitted

Phase I

Phase II

Phase III

Agency Approval

Drug Recovery

Product Lifecycle

Basic Research

Adverse Events and Queries Pharmacovigilance Data

Agency Review

API Animal Testing, Information Biomarkers Adverse EventsAdverse andSafety Queries Events and Queries

NDA/BLA Submitted

Insight

Increasing drug safety role and visibility Distributed data ownership limits opportunities for harnessing insights from safety data for cumulative benefit-risk analysis throughout the product lifecycle.

Aided by technology and access to real-time data, analytics, and insights, medical safety teams can play a key role in minimising or mitigating risks and improving patient outcomes.

Post Approval Research & Monitoring Phase IV

Data

CLOUD PLATFORM

2

Continuous feedback loop, rethink to influence outcome

(Source: Veeva Systems)

FIGURE 2: DATA ACCESSIBILITY ACROSS THE END-TO-END PRODUCT LIFECYCLE ENABLED BY A CLOUD PLATFORM 33

Improving patient outcomes and driving innovation Safety science is becoming more complex because of growing regulatory scrutiny, increased customer demands, and a safety data explosion. COVID-19 has heightened the focus on safety and public health benefit-risk discussions, and local regulators in emerging markets have responded with more stringent regulations.

Reducing the operational and compliance burden Safety functions have adopted decentralised models to better support local pharmacovigilance needs. Still, the scope of data required to remain compliant has increased with regulatory changes, including: • • • • • •

EU pharmacovigilance (GVP)6 and subsequent requirements globally by market, portfolio type, etc.

Combination product and vaccine requirements Related GxP requirements such as Identification of Medicinal Product Dictionary (IDMP)7 EU Medical Device Regulation (EU MDR)8 EU Clinical Trials Regulation (EU CTR)9 Real-world data10 requirements for clinical trials

Innovative approaches such as real-time data exchange, coordinated inspections, and global collaboration between different regulatory agencies are becoming routine. The pandemic has made it more important than ever for marketing authorisation holders (MAH) to be agile and act quickly on safety concerns because it only takes a few hours or days for local market issues to become global incidents.

The complexity of global operating models and multi-stakeholder environments requires strong governance. Organisations with siloed drug safety systems or reliance on paper-based and manual processes don’t have a holistic view of pharmacovigilance and will have a hard time keeping up.

The demand for greater transparency and comparative benefitrisk analysis throughout the product lifecycle has shifted questions of ownership and accountability beyond the QPPV and head of safety to the C-level. Chief medical officers and safety officers are becoming accountable for the end-to-end process and timely and transparent communication of drug benefits versus risks to patients, healthcare providers, and related stakeholders.

Cloud-based technologies and other innovations centralise safety information and enable access and collaboration across internal and external parties. With global visibility, controlled processes, and harmonisation of data and content, teams can proactively manage pharmacovigilance and improve compliance.

“COVID-19 has heightened the focus on safety and public health benefit-risk discussions”

For example, companies can leverage modern safety content management applications to reduce pharmacovigilance system master file (PSMF) overhead while quickly meeting regional requirements and gaining global visibility. This is significant progress for the industry since over 60 markets globally require a PSMF, or an equivalent document. Providing a core PSMF binder of all content that local markets can reference, with local annexes or appendices, and empowering teams to keep information up to date reduces the Qualified Person for Pharmacovigilance (QPPV) burden and strengthens compliance.

Emerging regulations will move safety beyond the control of PV As patients and healthcare providers assume a more active decision-making role and new models for data governance emerge, strategic transformation promises to affect every aspect of healthcare, from increased patient access to questions of treatment decisions, safety, and transparent public communications.11,12 Health data is the new currency that will drive innovative solutions for safety issues, public health challenges, and preventive health measures.

Modern safety applications also deliver flexibility to integrate data from other systems (e.g., regulatory, quality, and clinical) more easily. This ensures data integrity, traceability, and real-time access to information across the pharmacovigilance ecosystem.

More product benefit-risk and safety data will not be controlled just by pharmacovigilance as emerging regulations shift ownership of health information under federated governance models.13 At the same time, external data sets that are new to drug safety teams, such as social media and sales data, will become more critical to pharmacovigilance.

Several European initiatives will have significant implications for drug safety data and, in general, healthcare data:

34

•

EU Health Data Space will allow secure exchange of data, such as electronic health records and genomics and disease registries, while ensuring privacy14

•

EU Data Governance Act sets out rules for data reuse and data sharing with data intermediaries acting as data sharing service providers.15 Companies, notably Roche, are embracing data altruism and data availability using a common framework16

•

EMA EU Telematics strategy paves the way for EU regulatory master data, governance, interoperability, digitisation, and regulatory innovation to increase quality, speed, and collaboration17

•

EUDAMED database follows the EudraVigilance model, providing data transparency, patient engagement, and real-time on-market device performance communications

•

EU electronic product information (ePI) initiative aims to bring together data availability and governance efforts with better communication of drug risks and benefits through more effective labels and product information sheets targeted to end-users through digital channels.18

The existing disconnect between pharmacovigilance and other departments like marketing or commercial systems makes it challenging to manage the increased burden of business-driven programmes such as patient support, market research, and product registries.19

“Health data is the new currency that will drive innovative solutions for safety issues”

Moving toward greater data transparency and predictive PV Although the collection and reporting of key pharmacovigilance risk indicators to enterprise risk committees are common practice, identifying the correct leading indicators earlier in the R&D stage is becoming crucial to protect patient safety. Supported by innovative technologies, safety teams can quickly analyse large data sets as well as find and share insights to reduce risk.

As use of modern technologies grows, companies need to address key questions, such as: •

•

•

How can we design an integrated pharmacovigilance system that can monitor performance and help with early interventions?

What are the impacts of federated data governance and a growing number of benefit-risk data residing outside the organisation?

How are we managing emerging risks as we leverage AI and predictive algorithms from R&D through commercialisation and post-market surveillance?

More companies are leveraging artificial intelligence (AI), analytics, and predictive models instead of traditional approaches via retrospective audits and Corrective Action and Preventive Action (CAPA) plans.20

“Trust will be the central currency”

Trust will be the central currency for building a unified benefit-risk data platform The development of more agile and interactive drugs and medical devices will require product data to be accessible cross-functionally to influence better outcomes. Progress in this area has been slowed by a lack of visibility across systems that prevent the right data from reaching the right people at the right time to act.

Having end-to-end drug safety data on a single platform delivers data accessibility, a prerequisite for meeting new safety communication transparency requirements, and establishing trust.21,22 It also permits rapid response and proactive communication during crises.

35

3

FIGURE 3: FUTURE INTEGRATED SAFETY VISION

Clinical Sites

Clinical Data Management

Clinical Operations

Regulatory

Quality

Medical Communications

SAFETY Adverse Events

Periodic Reports Products, Labels Quality Complaints Safety Letters Clinical Info Adverse Events, Queries, and Reconcilliation Adverse Events and Queries

CLOUD PLATFORM (Source: Veeva Systems) A single platform that connects data and content across the end-to-end value chain from patients to product development improves data quality and communication and provides a more holistic view of safety. By taking a platform approach, the industry can enable a data-centred approach to help transform healthcare for the better.

In the digital age, companies have far less control over their product message than they did in the past.23 The need for readiness and speed became abundantly clear during the pandemic. Companies had to manage business continuity virtually while preventing patients and the public from receiving misinformation before they receive the facts about a drug or product.24

Supporting good data practices with a connected platform lays the foundation for data sharing, aggregation, analytics, and insights. It also provides visibility into a complete audit trail, improves data control, and strengthens security.

Under the current climate, speed and data integrity have become even more critical for pharmacovigilance teams. Key questions to ask are: How are patients being protected? Is the scientific integrity of the data sufficiently robust?

36

The efficiencies and broader impact of using one technology platform can help solve key safety issues, such as:

•

Signal to label: this has been a consistent inspection finding for the past ten years. The ability to connect signal workflow metrics with regulatory, technical operations, labelling, and supply chain is critical.

•

Better connections with marketing and commercial: being able to manage patient and healthcare professional (HCP) queries and product complaints can enhance treatment adherence and prevent medication errors.

Closer collaboration between commercial and safety can reduce the governance risks associated with solicited programmes like market research, patient support programmes, registries, and organised data-collection systems. It also makes it easier to meet the need for effective measures and outcomes information, which are making patient experience data and outcome metrics increasingly important in regulatory decision-making.

•

Manufacturing, supply, and distribution quality concerns: using technology on a single platform that delivers better connections across quality and safety systems allows quality challenges to be addressed in real-time. This can also deliver local, regional, and global visibility and oversight for rapid response and crisis management.

•

Clinical trial safety, effective medical monitoring strategies, and integrated development safety plans: all of these require real-time data flow for rapid action.

•

Access to cumulative lifecycle benefit-risk data: this can drive integrated development and post-market decisions, including real-world patient experiences. A platform that allows for end-to-end processes delivers real-time insights to influence behaviour change and enable proactive actions that can optimise patient safety and health outcomes.

Healthcare transformation and the speed of change, accelerated by the pandemic, have forced the industry to rethink how its stakeholders interact across the ecosystem.

Technology is proving critical in helping to protect patients, public health, and scientific data integrity.

Today, pharmacovigilance organisations are focusing more on what they need from technology to minimise daily disruption and increase efficiency. With a unified and connected platform, safety teams can sense and act proactively to drive innovation and early access to therapies. In the end, this can enhance societal value, and that is what safety is all about.

“With a unified and connected platform, safety teams can sense and act proactively” 37

REFERENCES [1] “The Evolving Pharmacovigilance Landscape,” Deloitte US/ Lifesciences and Healthcare White Paper, 2018, https://www2. deloitte.com/content/dam/Deloitte/us/Documents/life-scienceshealth-care/us-lshc-transforming-pharmacovigilance.pdf

[14] EC, EU Health Data https://ec.europa.eu/health/ehealth/ dataspace_en [15] “Proposal for an EU Data Governance Act,” iapp.org, iapp.org/ news/a/proposal-for-an-eu-data-governance-act-a-first-analysis/ [16] Roche, “Roche Policy on the EU Health Data Space,” www. roche.com/sustainability/policy-eu-data-health-space.htm

[2] M. Raizada, “Digitally Transformed Pharmacovigilance,” a Navitas Life Sciences White Paper, 2018.

“Pharmacovigilance 2030”. Peter Arlett, Sabine Strauss and Guadi Rasi, Clinical Pharmacology & Therapeutics, 2020

[17] EMA, “EU Extended Telematics Strategy Implementation and Roadmap,”www.ema.europa.eu/en/documents/other/extendedtelematics-strategy-implementation-roadmap-2019-2020_en.pdf

[3] World Health Organization, The Global Patient Safety Action Plan 2021-2030 , WHO Technical Document, 3 August, 2020, https:// www.who.int/publications/i/item/9789240032705

[18] P. Chaudhary and V. Shetty, “E-Labeling: Change is Underway,” Pharmaceutical Executive, June 29, 2020, /www.pharmexec.com/ view/e-labeling-change-underway

[4] Big win for patients: Global Patient Safety Action Plan 2021– 2030 adopted by 74th World Health Assembly www.iapo.org.uk/ news/2021/jun/8/big-win-patients-global-patient-safety-actionplan-2021%E2%80%932030-adopted-74th-world#

[19] EMA, “Guidelines for Registry-Based Studies,” www.ema. europa.eu/en/guideline-registry-based-studies-0

[5] P. Arlett, S. Strauss, and G. Rasi, “Pharmacovigilance 2030,”Clinical Pharmacology & Therapeutics, 2020

[20] EMA, “Joint HMA/EMA Workshop on Artificial Intelligence in Medicines Regulation,” 19 & 20 April, 2021

[6] EMA, “EU Good Pharmacovigilance Practices,” www. ema.europa.eu/en/human-regulatory/post-authorisation/ pharmacovigilance/good-pharmacovigilance-practices

[21] FDA, “Patient-Focused Drug Development Approval Process,” www.fda.gov/drugs/development-approval-process-drugs/fdapatient-focused-drug-development-guidance-series-enhancingincorporation-patients-voice-medical

[7] EMA, EU Data on Medicines: Identification of Medicinal Product Dictionary (IDMP) www.ema.europa.eu/en/human-regulatory/overview/datamedicines-iso-idmp-standards-overview

[22] “Edelman Trust Barometer 2021,” Healthcare Sector: Global, Edelman UK, www.edelman.com/sites/g/files/aatuss191/ files/2021-05/Global%20Health%20Sector%20Barometer.pdf

[8] EC, EU Medical Devices Regulation https://ec.europa.eu/health/md_sector/overview_en

[23] “Into the Infodemic,” Uppsala Reports, 2021, www. uppsalareports.org/articles/into-the-infodemic-countering-covid-smedicine-myths/

[9] EU Clinical Trials Regulation https://www.ema.europa.eu/en/ human-regulatory/research-development/clinical-trials/clinical-trialsregulation

[24] C. Paul, “Health Trust in a COVID-19 World: A Unique Opportunity for Pharma,” Edelman UK, June 19, 2020, www. edelman.co.uk/research/health-trust-covid-19-world-uniqueopportunity-pharma

[10] FDA Real World Evidence Approval Decision Making Drug Effectiveness https://www.fda.gov/drugs/news-events-humandrugs/fda-approval-demonstrates-role-real-world-evidenceregulatory-decision-making-drug-effectiveness’ [11] EMA, “EMA Regulatory Science Strategy to 2025,” www. ema.europa.eu/en/about-us/how-we-work/regulatory-sciencestrategy#regulatory-science-strategy-to-2025-section [12] Cumberledge Report https://www.immdsreview.org.uk/index. html [13] Patient and Public Involvement Strategy 2020-2025 https:// assets.publishing.service.gov.uk/government/uploads/system/ uploads/attachment_data/file/1022370/Patient_involvement_ strategy.pdf

Written by Sharmila Sabaratnam Senior Director, Veeva Systems

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ENSURING MEDICAL INFORMATION IS ACCESSIBLE TO ALL SUMMARY Dan Wills, Quality Manager at the Patient Information Forum (PIF), discusses the importance of helping the public find trusted, reliable medical information. Crucially, he says people must be able to use that

information once they have found it. Dan runs the PIF TICK – the UK’s only assessed quality mark scheme for both printed and online health information.

Medical information which is easy for patients to find, understand and use has a vital role to play in improving outcomes and adherence to medications. The right information can help people understand the early warning signs of adverse events and manage long term conditions. Yet 42% of the working age population are unable to understand or make use of everyday health information, rising to 61% when numeracy skills are also required1.

At PIF, we believe everyone should have access to high quality health information to enable them to make informed decisions about their health, wellbeing and care. To make this a reality we need to ensure every communication with patients – from invitations to attend clinics to medicines information - is easy to understand and use.

So how can we do this?

This leads to poor health outcomes across a range of indicators including increased health inequalities, lack of engagement in disease prevention and an increased risk of hospitalisation.

“42% of the working age population are unable to understand or make use of everyday health information” 39

“80% of the public would look for a quality mark on health information”

Helping patients easily find trusted medical information One way to help patients easily find trusted health information is the use of quality marks. In 2019, the NHS Information Standard ceased to be an assessed scheme. However, consumer research

by PIF found 80% of the public would look for a quality mark on health information. In addition, our membership felt there was a need for a robust assessment process.

That is why we launched the PIF TICK in May 2020. To gain the PIF TICK, organisations must meet 10 key criteria. These ensure information is created using a consistent and documented process, that it is based on up-to-date evidence and that it meets an identified need.

In a recent survey, 95% of PIF TICK members said they had made changes to their information production process since signing up to the scheme and found it beneficial to have external review of their information production process.

Crucially, the PIF TICK also says information must be ‘easy to use and navigate’

Making medical information accessible for all While medical information must, of course, be accurate if patients cannot understand it then it has no purpose. Plain and simple language and clear risk communication are vital elements of health information – whether it is printed materials, patient tools or online resources.

Use numbers not words Illustrate risk with visual aids • Consider using both positive and negative framing • Communicate the uncertainty of data • Pre-empt misunderstandings • •

We also have a guide to help the public make sense of risks and benefits on the PIF TICK website.

Currently, 6.5 million people cannot measure or record height and weight on a chart2 and 9 million people are unable to use digital tools unaided3.

How we can help If you would like to know more about how the PIF TICK scheme could help you improve the quality of your health information, email me on:

We believe this has to change. More than 100 organisations have signed our health and digital literacy charter. By doing so, they commit to becoming a health-literacy friendly organisation, making it easier for people to navigate, understand and use information and services to take care of their health.

dan.wills@pifonline.org.uk More information on PIF membership is available here. PIF members get exclusive access to guidance and webinars, as well as discounts on our popular online training courses in health literacy and writing in plain language.

Our popular Health Literacy Matters poster is a simple one-page document with tips and statistics to help you make the case for health-literacy friendly materials in your organisation.

Our PIF TICK website also features simple guides for the public on understanding patient data and evidence.

Using numbers to communicate benefits and risk Some of the most complex information to convey clearly is around benefits and risks. Yet we know patients want to be informed. In our Maternity Decisions: Being Induced survey of more than 2,300 women, the top information need was statistics on risks, benefits and alternatives. Women also wanted to know the absolute rather than relative risk.

Using absolute rather than relative risk is just one of the recommendations in our Communicating Benefits Risks and Uncertainties guide. The guide highlights a range of approaches and tools for unbiased communication of benefits, risks and uncertainties to patients. Other top tips include:

1

https://pubmed.ncbi.nlm.nih.gov/26009533/

2

Lloyds Bank, 2020. www.lloydsbank.com

3

Survey of Adult Skills 2015 oecd.org/skills/piaac

Written by Dan Wills

Quality Manager, Patient Information Forum

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MHRA PV INSPECTION

METRICS REPORT SUMMARY SUMMARY

From 01 April 2020 to 31 March 2021, the MHRA’s Good Pharmacovigilance Practice Inspectorate (GPvP) conducted 37 pharmacovigilance (PV) inspections on 36 marketing authorisation holders (MAHs) to evaluate its PV processes and compliance with existing EU and national PV regulations. The 2020/21 report was released by the MHRA with the intention to inform the public and have those in the industry evaluate and consider improvements within their own organisation.1 Since the UK’s exit from the European Union (EU) on 31 January 2020, GPvP inspections were conducted in accordance with the EU regulations and guidance during the transition period, up until 31 December 2020. From then on, the inspections were conducted in accordance with Human Medicines Regulations 2012 (as amended) and GVP Module III (as modified for UK MAHs). All 37 PV inspections were carried out remotely.

Overview of Inspections A total of 37 inspections were conducted on 36 organisations during the reporting period, 16 of which were planned as routine inspections, 16 were conducted due to intelligence received by the GPvP and 5 were conducted due to a previous critical finding. A total of 140 findings were reported: 5 Critical findings: • 2 related to risk management • 2 for ongoing safety evaluation • 1 for the management of adverse drug reactions (ADRs) 59 Major findings: • Majority of which were related to risk management and management of ADRs • Other major findings were associated with ongoing safety evaluation and the quality management system (QMS) 76 Minor findings: • Most common minor finding was for the QMS • This was followed by risk management, ongoing safety evaluation and management of ADRs Four inspections had no reported findings Regardless of grading, the most common finding (28%) was related to the QMS, followed by risk management (22%) and ongoing safety evaluation (21%). These three topics were also the most common findings in 2019/20.

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Routine Pharmacovigilance Activities Arm Under this arm, 15 inspections were routine inspections (nontriggered). The following findings were reported:

Revised Inspection Model Since 2019, the GPvP inspection programme has had four discrete inspection arms which inspections are conducted under. This inspection model allows the GPvP Inspectorate to assess specific PV activities against a set of objectives and evaluate specific technical topics within a scope. They are summarised below:

1 Critical finding: • In the area of ongoing safety evaluation – signal management • Fundamental weaknesses in the PV processes resulted in the delay of identifying and rectifying a specific safety issue with a product • Numerous product quality complaints affecting patient safety were received but a signal was not raised. MAH did not consider taking any further actions based on aRMMs that were in place • Data in software used to conduct signal detection activities were inaccurate • Product technical complaints (PTCs) with associated AEs had not been entered into the safety database for years and not submitted to EudraVigilance. Also, the PTCs were not considered in routine signal detection • The standard operating procedure (SOP) for signal detection lacked detail, leading to non-standardised processes in document review, analyses and decisions made relating to signals

Routine pharmacovigilance activities: • Objective: Assess whether the MAH has the ability to identify, characterise and report new or changed risks for their medicinal products.

• Collection and collation of safety data • Management of ICSRs • Periodic safety update reports (PSURs) • Signal management by the MAH Routine risk management and safety communication: • Objective: Assess whether important safety updates have been communicated to patients and healthcare professionals in the UK. • Maintenance of reference safety information (RSI) • Implementation of approved changes to product information • Safety communication, including DHPCs and educational materials Additional risk minimisation measures (aRMMs): • Objective: Assess whether aRMMs are implemented in accordance with the agreed risk management plan (RMP).

• Tailored to individual risk management systems • aRMMMs can include controlled access programmes, controlled distribution systems and pregnancy prevention programmes

33 Major findings: • Most reported in the area of ongoing safety evaluation (11 findings)

44 Minor findings: • Most common finding was associated with the QMS (17 findings)

Non-interventional post authorisation safety studies (NI-PASS): • Objective: Assess whether NI-PASS are conducted in accordance with the approved study protocol and that safety data is collected and reported appropriately.

• Study-specific inspections with visits to UK investigator sites as necessary

As for triggered inspections, 10 were conducted under this arm. The following findings were reported: 1 Critical finding: • In the management of ADRs – case processing activities • Identified in a triggered inspection based on intelligence obtained by the GPvP Inspectorate • The MAH failed to record all reports of ADRs and did not process or capture them in the safety database • Safety reports were received in a mailbox as attachments with no means of prioritising serious cases or adverse events of special interest (AESI) • There was a backlog of cases which were subsequently not considered in signal detection activities • There was no evidence of follow-up of reporting fatalities, AESIs and SAEs. This was linked to a major finding of lack of detail in the SOP of the follow-up process

In the 2020/21 reporting period, the majority of inspections (25 of 37) were in the routine pharmacovigilance activities arm, six were in routine risk management, five were in aRMMs and one was in NI-PASS.

12 Major findings: • Most were reported in the management of ADRs

15 Minor findings: • Similarly, most were reported in the management of ADRs

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Routine Risk Minimisation Arm All six inspections under this arm were triggered, five of which were due to intelligence obtained by the GPvP Inspectorate and one was due to a previous critical finding. The following findings were identified:

•

There were no documented procedures to describe the process of implementing aRMMs

3. Ongoing safety evaluation – periodic safety update reports • The MAH failed to prepare and submit PSURs for two products • Also failed to submit variations to the MHRA to implement the outcome of Periodic Safety Update Single Assessment (PSUSA) procedures for both products – these variations were particularly important as the PRAC recommendations included adding safety warnings in SmPCs and PILs for the products

3 Critical findings: 1. Risk management – maintenance of RSI: • Outdated PILs (patient information leaflets) were packaged with the product • The product information was not updated in time as the quality safety variation submissions were too poor to be accepted by the authority • The SOP for the maintenance of product information had deficiencies

10 Major findings: • Most were reported in the area of risk management (6 findings) 10 Minor findings: • Most were associated with risk management and the QMS

2. Risk management – implementation of aRMMs • The MAH failed to implement aRMMs for several marketed products for years

Additional Risk Minimisation Measures (aRMMs) Arm Under this arm, one routine inspection was conducted which had no reported findings.

As for triggered inspections, four were conducted under this arm, three of which were triggered due to intelligence obtained by the GPvP Inspectorate. Findings were only reported in one of these inspections:

•

•

1 Major finding 2 Minor findings

changes in the GPvP inspection model as outlined above – more targeted approach to inspection activity focused on different aspects of the PV system. the COVID-19 pandemic – prioritising specific for cause inspections and high-risk routine inspections conducted in line with the priorities of the MHRA’s Vigilance and Risk Management of Medicines division and the regulatory flexibilities that were introduced in April 2020.

This new targeted and more efficient approach could also explain the significant increase in the number of inspections conducted (from 22 in the 2019/20 reporting period to 37) and the decrease in the mean number of days per inspection (from ~10 in 2019/20 to ~7) in the 2020/21 reporting period.

These were related to the risk management subtopic of additional risk minimisation activities in Part V of the RMP. Non-Interventional Post Authorisation Safety Studies (NI-PASS) Arm: One inspection was conducted under this arm which was triggered due to a critical finding from a previous inspection.

A total of six findings were reported:

In the coming year, the GPvP Inspectorate will apply a revised riskbased methodology by performing separate risk assessments for each inspection arm. PV systems, products and non-interventional studies which are considered to be the highest risk will be prioritised for inspection.

3 Major findings: • One related to additional PV activities in Part III of the RMP • One reported under the management of ADRs as there were deficiencies with case processing activities • One reported under the QMS, specifically related to audit of NI-PASS

Pharmacovigilance inspection metrics, 2009 to present - GOV.UK (www.gov.uk)

1

3 Minor findings: • One also related to additional PV activities in Part III of the RMP • Two findings were reported under the QMS regarding PSMF management and documented procedures

The evolving GPvP inspection model Over the years, the average number of major findings per inspection has decreased from the previous reporting period, 2019/20 (from 6 findings per inspection to 4). This could be due to the inspections being conducted with more targeted objectives and a reduced scope as a result of:

Written by Ki Mei Drive Phase PV

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WHY SCIENTIFIC LITERATURE AND COPYRIGHT COMPLIANCE ARE ESSENTIAL TO MEDICAL AFFAIRS SUMMARY The role of Medical Affairs within a pharmaceutical or medical device company is largely centred around critical communications. If your organisation doesn’t yet have a literature management tool, there are many reasons why implementing one will benefit Medical Affairs. This article will examine the important features a tool needs to ease the burden placed on the functional groups by facilitating collaboration, enabling alerts to keep abreast of the latest literature, streamlining access to subscribed content, and simplifying copyright compliance.

As part of the Medical Affairs team, you lead the effort to explain to potential healthcare prescribers the real-world applications of a drug through the dissemination of unbiased clinical and scientific information. You communicate with payors, patients, physicians, regulators and government agencies. You manage relationships with key thought leaders and stakeholders, and serve as the voice of the company to the outside world. You often need to respond to unsolicited requests for information about a drug or device, and also plan publications to broadly disseminate information. You provide insight to the broader organisation based on external interactions and are a partner in shaping an organisation’s strategies. Your connections to external opinion leaders help the organisation monitor the pulse of the market. You’re able to highlight gaps in the data, weigh in on early development decisions, and evaluate opportunities for partnering.

All of these activities, and your reputation as a trusted, reliable source for both internal and external clients, require compliant access to comprehensive and up-to-date information via scientific and medical literature.

Because of this need for information within Medical Affairs, your role is evolving. You may now find yourself responsible for managing scientific literature and access to subscriptions for the broader organisation, either with a librarian/information manager role falling under this larger umbrella or as Med Affairs professionals wearing multiple hats, including information management.

Now, let’s take a deeper dive into the various aspects of Medical Affairs and what to look for in a content management solution to support you in your role and help make you a more strategic partner to the organisation:

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Medical Scientific Liaison (MSL) Whether monitoring published scientific literature for mentions of your company’s drug or device, or preparing for a meeting with a Key Opinion Leader (KOL), your ability as the Medical Scientific Liaison (MSL) to find the latest and most relevant information is critical to your credibility. As experts in communicating complex scientific and medical information to a variety of stakeholders, having easy, remote access to a cloud-based literature management tool is essential, as the most urgent need for scientific information usually occurs when out in the field.

Medical Information Developing fair and scientifically balanced materials for patients and healthcare professionals, and responding to unsolicited enquiries with information that is pulled from scientific literature or pre-approved articles is fundamental to your role as a Medical Information professional. Using a literature management tool that clearly indicates whether or not this type of use is covered under a copyright license simplifies compliance for you and your team.

A workflow with shared libraries and alerts is important for identifying, organising and tagging articles for this purpose. Alerts can also help you to stay on top of any new information that becomes available that would be useful in your role.

Publication Planning As part of the Publication groups within these organisations, you are responsible for the timely presentation of your company’s scientific and clinical data – developing articles for publication in scientific/medical journals to support the marketing of your product. These publications often reference other articles and require a bibliography. Using a literature management tool that has built-in cite-and-write functionality can be highly beneficial. As medical writers, not only do you have all of the relevant articles that you’re referencing organised and available at your fingertips in a central location or shared library, but having the convenience of citing directly from the same tool helps improve accuracy and saves valuable time often spent manually creating bibliographies.

“With the added benefit of integrated rights management and copyright licensing, you can also reuse articles in a more copyright compliant manner”

By providing easy remote access to content, shared folders and cite-and-write functionality, you are creating a streamlined workflow for each functional group within the larger group of Medical Affairs (not to mention, the organisation as a whole).

With the added benefit of integrated rights management and copyright licensing, you can also reuse articles in a more copyright compliant manner and minimize additional risk to the organisation. All of these features are important to Medical Affairs and should be considered when transitioning to a new literature management tool.

Written by Heather Desmarais

President, HJD Consulting LLC on behalf of CCC (Copyright Clearance Center)

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INTRODUCING AN AI-POWERED MEDICAL INFORMATION CHATBOT:

TRIALS AND TRIUMPHS SUMMARY

and experience matters when engaging with companies. In this article, I will describe a journey of triumphs and challenges whilst introducing an Artificial Intelligence (AI)-powered Chatbot in to my organisation - from organisational impact, to regulatory and audit requirements but ultimately keeping the customer at the centre – what have we learned?

Pharmaceutical companies are rarely at the forefront of innovation. Medical information (MI) teams are often seen as ‘doing the same thing in the same way’ as we did last century. However, times are changing; more of us are looking at innovative solutions to deliver medical information services based on the realisation that customer behaviours are changing

The Bright Idea At the beginning of the pandemic it became evident ‘things were changing’; call volumes fell and we received our first quality complaint via Twitter! Our customers’ behaviour was changing to contacting us via digital methods, and most of these requests were being received out of conventional working hours. It seemed the right time to re-evaluate how medical information services were delivered. So the journey began……

The Solution Technology as an enabler to our Medical Information function was a no-brainer. Having looked at trends across the industry, we knew we wanted Chatbot capability to provide additional support to both us and our customers.

• Did the vendor understand the constraints on the pharmaceutical industry and the regulatory environment in which we work?

• Was a conversational AI agent available?

Pretty early on, we realised user experience was important and we wanted to go beyond simple question and answer functionality: we wanted the user to be able to ask a question in their own words, just like making a phone call.

• What experience did we want to create for our customers?

• Did the technology have the capability to scale across the business?

In the end, the choice of a partner company to help Orion deliver the project was easy, once we had defined our selection criteria, these being:

• Could the vendor help navigate the stakeholders and bring everyone along the journey?

• Did the vendor offer an industry leading solution?

We selected conversationHEALTH because they offered us the opportunity to deliver a medical information Chatbot that can be integrated into our current systems, with an opportunity to work towards a human+AI hybrid approach over time, where humans deal with expert tasks, leaving the Chatbot to deal with the ‘routine’ whilst all working in the same MI ecosystem.

• What experience did the vendor have? Had they delivered Chatbots to the pharmaceutical industry before?

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Implementation

Reflections So, as we launch our Chatbot – would we do it again?

‘You can’t do that – the Chatbot may collect adverse events and quality complaints’

We are wondering why we did not embrace this new technology earlier. The Chatbot is integrated as another channel for medical information, much like our vendor that answers our phone calls. However, in this instance, we have greater control over consistency and accuracy of responses and can see trends in questions in real time, rather than waiting for periodic reports.

We have greater flexibility to understand what our customers want from us and can flex to meet these needs much more easily.

Our Chatbot has a persona that reflects our organisation and can represent us all day, every day; we would rather a user interact with Orion’s Chatbot than look for the answer on Google or social media.

Starting the project brought challenges, some of which were unexpected. The project touched many areas of the business (both local and global), from the regulatory and compliance teams, to the legal team, the tech teams and digital therapeutics, to name but a few. Everyone was excited and wanted to get ‘in on the act’, but there was resistance – mainly driven by thoughts of regulation and inspections. Would the Chatbot pass? Did we have the expertise to perform validation tasks? Was the Chatbot a medical device?

Now that the platform is in the organisation, we can continue to add Medical Information services to the Chatbot, as well as extend it across markets and even to other departments. All built from the groundwork and cross-functional team involvement at the start.

What have we learned?

We can offer a ‘full service’ to our medical information customers out of hours.

Looking across the industry, many companies are now leveraging Chatbots to support medical services, freeing up resource to allow our teams to get on with the expert tasks they are so skilled at doing.

The competence and thoroughness of the team at conversationHEALTH guided us expertly through all these regulatory challenges and in particular through the intricacies of the validation of a GxP-relevant, AI-powered Chatbot something that was a first for us. The global team were eager to get involved in this activity and understand more about this technology ‘for the greater good’.

We learned that we already had the skills to successfully introduce and validate an AI-powered Chatbot; we just needed to apply our skills, rather than get side-tracked or intimidated by the words ‘Artificial Intelligence’ or ‘Machine Learning’.

It is possible to innovate in medical information – we should embrace new technologies and make them work for us!

‘We are wondering why we did not embrace this new technology earlier’

Julie Boothe

Medical Director, UK and Ireland, Orion Pharma (UK) Ltd

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PRESIDENTS REPORT

As we start the new year, I am pleased that I am able to write my first President’s report for PIPELINE with what we hope will be an exciting year ahead.

So far, we’ve kicked-started the year with our PV and MI webinars with the next ones scheduled for 20th and 21st February 2023. If you haven’t already registered for these, take this as your sign to do so.

Our Training Working Party has been incredibly busy with further revamps to our courses online and face to face (yes, these are finally back!). Keep an eye on our training page of the website for all the latest offerings…If there are any training topics you feel are missing, get in touch and let us know your thoughts! Don’t forget to add any training to your CPD. As an association that is committed to seeing our members develop professionally, PIPA became a professional accreditation association in 2010. With this, we have an associated CPD points system of membership allowing you to move through the levels of membership as you develop in your career. For more information, have a look at the CPD portal under the Professional Development area within the members login on the website.

also recommend that you secure your manager approval for attendance so you can take advantage of our early bird rates once booking opens!

I’d like to end with a final thank you, to Tom and Janine, for the amazing work they have both done as President and Vice President over the last couple of years. We’ve been lucky enough to have them both remain on the PIPA committee.

Chris and I look forward to continuing building on what PIPA have managed to achieve over the years. If you have any suggestions for the association, please do get in touch with us and share any ideas you may have.

We’ve also been working on updating our guidance documents for PV and MI as well as adding new additions to our collection. Do have a look at the resources available to you via our website.

2022 ended with PIPA’s busiest period and an extremely successful PIPA conference. Our first face to face one since the pandemic, and it was definitely a great opportunity, not only to learn and get involved in discussions and sharing of best practices, but to make new connections with fellow members and to catch up with old acquaintances – something which we’ve all missed out on in the previous two years.

The PIPA committee took a very short break from all things conference related but we are now back to focusing on making sure our next conference, which is planned for 8th and 9th November 2023, is an even bigger success.

If the dates are not blocked out in your diary yet, please make sure you do as it would be great for the committee to connect with you all. Whilst we are in the prime of our conference planning, we would welcome any suggestions you may have for this year’s event – please do reach out to us via conference@pipaonline.org with your ideas. We

Pooja Patel

PIPA President

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MEET THE PIPA COMMITTEE 2023 POOJA PATEL

CHRIS ISAACS

President

Vice President

Email: president@pipaonline.org

Email: vicepresident@pipaonline.org;

Role: Leadership – strategy & committee / KOL liaison / PIPA representation

Role: Correspondence / Membership matters / Constitution compliance / AGM leadership / Consultation responses

SANJAY MOTIVARAS

DORA AMENE

Treasurer Audit PV

PV Compliance; PIPELINE Co-Editor PharmaLex

E-mail: treasurer@pipaonline.org

E-mail: pv-liaison@pipaonline.org; journaleditor@pipaonline.org

Role: Financial lead / Audit & compliance / Invoice payment

Role: Assisting the PIPA membership with ensuring their PV compliance.

Preparation and proof-reading of PIPA’s journal, PIPELINE.

ANNE LLOYD

SINEM CASTRO

PV Compliance; Conference Co-organiser; CPD lead

Medical Information Workstream Springer Healthcare

E-mail: pv-liaison@pipaonline.org; conference@pipaonline.org

E-mail: medinfo@pipaonline.org Role: Assisting the PIPA membership with ensuring excellence in MI.

Role: Assisting the PIPA membership with ensuring their PV compliance.

Assisting with PIPA Conference preparation and delivery. Updating and maintaining a CPD programme relevant to the membership.

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RASHMI PAPNEJA

EMMA BOULTON

Code & Compliance Workstream RedefineCompliance

PV Compliance; CPD; Training Workstream Co-Chair Napp Pharmaceuticals Ltd

E-mail: code@pipaonline.org

E-mail: pv-liaison@pipaonline.org; training@pipaonline.org

Role: Assisting the PIPA membership with ensuring excellence Code Compliance.

Role: Assisting the PIPA membership with ensuring their PV compliance.

Updating and maintaining a CPD programme relevant to the membership. Co-ordinating training courses for the PIPA membership.

STEPHANIE BETTESWORTH

MEHRNOOSH ENSAN-THEODOROU

PV Compliance; Medical Information Workstream; Training Workstream Novo Nordisk

Medical Information Workstream; Training Workstream Co-Chair E-mail: medinfo@pipaonline.org; training@pipaonline.org

E-mail: pv-liaison@pipaonline.org; medinfo@pipaonline.org; training@pipaonline.org Role: Assisting the PIPA membership with ensuring their PV compliance.

Assisting the PIPA membership with ensuring excellence in MI. Assisting the PIPA membership with ensuring excellence in MI. Co-ordinating training courses for the PIPA membership.

TOM NICHOLS

Role: Assisting the PIPA membership with ensuring excellence in MI. Coordinating training courses for the PIPA membership.

JANINE GAVIN-POULTER

PV Compliance; Communications & Profile Drive Phase PV

PV Compliance Collaborative Pharma E-mail: pv-liaison@pipaonline.org

E-mail: internet@pipaonline.org; pv-liaison@pipaonline.org

Role: Assisting the PIPA membership with ensuring their PV compliance.

Role: Raising awareness and engagement within & beyond PIPA. Assisting the PIPA membership with ensuring their PV compliance.

DR. MONIKA GOYAL

LAURA AVANZO LEEKE

PV Compliance APCER Life Sciences Limited

Medical Information Workstream PPD part of Thermo Fisher

E-mail: pv-liaison@pipaonline.org

E-mail: medinfo@pipaonline.org

Role: Assisting the PIPA membership with ensuring their PV compliance.

Role: Assisting the PIPA membership with ensuring excellence in MI.

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CATHERINE KENNY

EM NORMAN

PV Compliance; Signal Pharma Experts

Medical Information Workstream; Training Workstream Acccord Healthcare

E-mail: pv-liaison@pipaonline.org;

E-mail: medinfo@pipaonline.org; training@pipaonline.org

Role: Assisting the PIPA membership with ensuring their PV compliance.

Role: Assisting the PIPA membership with ensuring excellence in MI. Coordinating training courses for the PIPA membership.

ANNE TURNBULL

SARAH ANTHONY Contractor

Contractor

Administrative and Treasurer’s Support

Operations Manager

PO Box 254, Haslemere, Surrey, GU27 9AF

PO Box 254, Haslemere, Surrey, GU27 9AF

E-mail: sarah.anthony@pipaonline.org

Tel: 07904 164812 E-mail: anne.turnbull@pipaonline.org

SHARON BRAITHWAITE Contractor Membership and Events Co-ordinator PO Box 254, Haslemere, Surrey, GU27 9AF Tel: 07340 519234 E-mail: sharon.braithwaite@ pipaonline.org

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