paab code revision qualitative research report

PAAB Code RevisionPAAB Code Revision

Qualitative ResearchQualitative Research

ReportReport

CONFIDENTIALCONFIDENTIAL

Produced by:Produced by: L. Meisner & Associates Inc.L. Meisner & Associates Inc.

Produced for:Produced for: Pharmaceutical Advertising Pharmaceutical Advertising Advisory BoardAdvisory Board

Date:Date: March, 2010March, 2010

(490-01)(490-01)

Overview

Introduction 3 Findings 10

2007 Code Revisions 11 Understanding the 2007 Code Revisions 12 Overall Impressions of the 2007 Code Revisions 17 Impact of the 2007 Code Revisions 24

Potential New Code Revisions 31 Winning Option 34 Runner-up Option 39 Least Interesting Option 47

Thoughts Moving Forward 49

PagePage

2

Introduction

3

Research Background

Prior to July 2007, the PAAB Code required Full Disclosure Prescribing Information (PI)

In 2006, a study was conducted with physicians on PI requirements Ultimately industry requested that the PI be revised

On July 1, 2007, PAAB implemented revised requirements for PI, the purpose of which was to: Make it easier for healthcare professionals (HCPs) to find, read and

absorb the most important product information

4

Research Objectives

To determine the impact that PAAB code revisions have had on companies

To assess receptivity to possible new revisions to the PAAB Code regarding PI requirements

5

Method

23 individual depth telephone interviews with senior regulatory and marketing staff members in Rx&D and selected PAAB clients in Toronto & Montreal The target sample size was larger, however, some company contacts

did not return calls, despite several attempts to reach them Interviews conducted in February & March, 2010

Interviews ranged from 10 – 30 minutes in duration

Of the 23 interviews: 14 were with marketing staff members 9 were with regulatory staff members

6

Recruiting Specifications A list of key Rx&D and selected PAAB clients was

provided, with one contact person per company The contact person recommended, where possible, one

marketing and one regulatory individual who: would be sufficiently experienced and knowledgeable on

the subject of PI have enough history with the company to know the impact

of the 2007 Code revisions Unless otherwise specified, there are no significant

differences based on market (Toronto vs. Montreal) In some cases, where noted, there are some slight

differences between the opinions of marketing vs. regulatory staff

7

The Sample The sample consists of an excellent range of appropriate staff

members As expected some were more knowledgeable than others

regarding the details of the 2007 Code Revisions, but all were sufficiently versed to offer valuable opinions

Within marketing, the positions represented include: Promotions Coordinator, Commercial Development Supervisor,

Product Manager, Senior Product Manager, Group Product Manager, Director of Business Operations & Effectiveness, Director of Market Access

Within regulatory, positions include: Director of Regulatory Affairs, Assistant Director of Regulatory,

Regulatory Affairs Manager, Manager of Regulatory Operations, Medical Manager, Associate of Regulatory Affairs

8

Nature of Findings

Please note that these findings are strictly qualitative

Caution – Small number of participants (i.e., not a large quantitative survey)

Participants were not drawn at random from population (as they would be in quantitative survey research) – we wanted to speak to specific qualified individuals

So this research does not measure, for example, awareness of the Code revisions in the general population

Rather, it provides insights on the range of opinions, and depth as to why these opinions are held

9

Findings

10

2007 Code Revisions

11

Understanding of 2007 Code Revisions

12

All understand the intent behind the 07 revisions ...

Both the regulatory and the marketing respondents consider themselves reasonably familiar with the 2007 Code revisions Rating their familiarity on a 10-point scale as:

7 – on average for Marketing

7.5 – on average for Regulatory

13

Note: Familiarity was a requirement of participation. The contacts who were not sufficiently familiar, were not taken through the entire interview

and an attempt was made to find a suitable replacement within the company.

Original intent is understood ...

When asked, “What is your understanding of the revisions that have been made to the PAAB Code as it relates to Prescribing Information requirements? ...

Most speak about the “intent”, and clearly suggest that they had positive expectations

The focus of their comments are on:

Quantity – they expected there would be an opportunity to reduce the overall quantity of the PI, by abbreviating certain sections

Font size changes – to make it easier to read Re-formatting the layout – to make it easier to find the most

important information

14

Issue – expectations did not match experience ...

In contrast to what was expected, typically the feedback suggests:

Disappointment, and Expectations were not met

One contributing factor to the ultimate disappointment is that they feel they never got any feedback on the value of the revisions to the HCP customers

So, many were left questioning the value of their efforts (which were substantial) and the unexpected extra costs

15

The tone of the feedback evolved over the interview ... Initially when speaking about their understanding of the 2007

Code revisions, typically the respondents’ tone is best described as:

Politely positive (i.e., focused on the positive motivation behind the changes, and not on the reality of their experiences)

Somewhat reserved By the end of the interview, respondent were open about their

experiences and often their disappointment with the 2007 Code Revisions was apparent

16

Overall Impressions of 2007 Code Revisions

17

Overall impressions = slightly negative impact ...

When asked, “How would you rate the impact that the PAAB Code revision has had on your company’s overall journal advertising for promoted prescriptions products since July 2007? ...

The majority indicate a negative impact:

Very Negative No Very Positive Impact Impact Impact

On average, regulatory have the impression of a slightly more negative impact, compared to marketing At least in part because they had to work through the details of the

content revisions and felt responsible for any potential legal liability

18

Most responses fall in this range A small minority fall in this range

Value of the revisions is questioned ...

When asked why they felt the overall impact was negative, the focus of the justifications differ subtly between regulatory and marketing respondents ...

Regulatory are focused on the extent of extra work that was involved – some really seemed to struggle to abbreviate, but ultimately felt they could not do so

19

“We explored ways to work with the requirement and get it shorter but we couldn’t! It was 4 times

longer than what was budgeted, so we walked away from journal ads ... We negotiate every word in our

product monograph and it’s not appropriate to change things. Our medical department had

significant concerns about editing it.”Regulatory


20

“Overall it takes more time. It adds to the burden, and makes it more difficult to say anything.”

Regulatory

“We had to re-visit every product monograph ... Just juggling things around ... all the same information ... and then to the

agency and they had to reformat it. It added a lot of work that was of no value.”

Regulatory


Marketing respondents had more diverse justifications for the negative impact they felt – they talked about extra work plus other consequences such as cost ...

21

“Cost – after the revision, 52% of our spending was on PI [vs.

colour part of ad].”Marketing

“The PI takes a lot of space and we ended up spending too much

on PI and not enough on the colour ad.”Marketing

“The cost of the PI went up.”

Marketing


Some marketing (and regulatory) respondents also feel there was lack of clarity on how to abbreviate

22

“There was some confusion as to how to abbreviate, and some actually grew

in length.”Marketing

“There were no standard guidelines on how to reduce

content so we prefer to comply with Health Canada.”

Marketing


Importantly, they are not at all clear that the HCPs even look at the PI, so there is a sense of futility due to lack of feedback from physicians

23

“The value of it is so unqualified and the impact is indirect.”

Marketing“At the end of the day, we are

not sure that anyone even reads the stuff.”

Marketing“I haven’t heard that doctors

look at the PI. There is nothing to say the change

helped doctors or that it was read more – and it cost more!”

Marketing

Impact of 2007 Code Revisions

24

Amount of PI, post 2007 revision ...

When asked more specifically about the extent of impact of the 2007 Code Revision (vs. Full Disclosure PI) on: The Amount of Prescribing Information ...

Significantly No Significantly Less Change More

Regulatory respondents, on average, rate the impact slightly higher (i.e., more prescribing information post revision), than do marketing respondents

25

Most responses fall in this rangeA small minority fall in this range

# of PI pages, post 2007 revision ...

When asked about the extent of impact of the 2007 Code Revision on: The # of Prescribing Information pages ...

Results are very similar:


Here again, regulatory respondents, on average, rate the impact slightly higher (i.e., more increase in the # of PI pages), than do marketing respondents

26

Most responses fall in this rangeA small minority fall in this range

Total # of Journal Ad Insertions, post 2007 revision ... Lastly respondents were asked about the extent of impact of

the 2007 Code Revision on: The Total # of Journal Ad Insertions ... Results show neutral to slight decrease in # insertions:


Once again, regulatory respondents, on average, rate the impact as slightly stronger (i.e., decrease in the # of ad insertions), than do marketing respondents A few regulatory (and 1 marketing) respondents did not know the impact on

total # of insertions Some also say it’s difficult to isolate the impact of Code Revisions (vs. other

corporate “belt-tightening” factors) on the total # of ad insertions27

All responses fall in this range

Summary Comments on 2007 Code Revision ...

After thinking specifically about amount of PI content, # of pages and insertions, some respondents had a few final comments on the Code Revisions

Overall the comments are more negative than positive, with key issues including:

Longer PI Increased cost – time (internal & agency), and cost for # pages Increased work Delays in processing approvals Legal liability concerns

28

Summary Comments on 2007 Code Revision ...

29

“It would be nice to know if they accomplished what they wanted

with the 07 code revisions.”Marketing

“Someone should do a survey to see if doctors really read the PI. Our challenge is to

get physicians to even stop and read the colour ad, nevermind the PI!”

Marketing

“I don’t know if it’s easier for doctors. I don’t know if

physicians even read the PI. They should do a survey to see if it’s worth the time and hassle.”

Marketing

Potential New Code Revisions

30

3 Potential Options …

The following 3 potential options were assessed:

1. No change from current requirements/format

2. In Canadian Medical Publications, remove the PI and replace it with copy in a prominent location within the ad that directs the reader to the Health Canada Drug Product database (DPD)

3. At least 1-2 years from the time the product is introduced in Canada, provided there are no reports of unsuspected adverse effects of significance to warrant a warning letter from Health Canada or the manufacturer, remove the PI and replace it with copy in a prominent location within the ad that directs the reader to the Health Canada Drug Product database

31

3 Potential Options …

After hearing all 3 potential options, respondents rated their interest in each one on a 1-10 scale (1= Not at all interested ... 10 = Very Interested)

The order of ranked interest is similar for both marketing and regulatory respondents

Overall, on average:

The Winner = Option #2 (remove PI effective immediately) The Close Runner-up = Option #3 (remove PI 1-2 years post

launch) The Least Interesting = Option #1 (status quo)

Both Options #2 & 3 were far preferred to staying with the status quo (Option #1)

32

Winning Option

33

The Winner – Remove PI Immediately ...

The most frequently mentioned reason for preferring this option is “cost savings” A few also mention that if they could save costs on PI they would run more

journal ads Another very commonly mentioned justification for this

selection is “less work” They say this option would mean there is no additional work beyond

updating the product monograph – which would save considerable time for marketing, regulatory, medical and advertising agencies

A third and interesting reason given is that some believe online access is ultimately better than paper – provided that the link is simple and fast It is readily accessible (just bookmark the link) It will ensure that physicians get the most current PI possible (assuming that

the Health Canada database is up to date) It is a natural evolution in the electronic age

34

The Winner – Remove PI Immediately ...

Online access is ultimately better than paper (cont.) ... It is consistent – physicians go to the same place all the time – they are less

likely to miss updates It is a comprehensive resource

Another reason for liking this option is many believe physicians do not look at PI in journals (or strongly suspect so)

35

“Journal ads just keep products top of mind.”

Marketing

The Winner – Some Concerns Exist ...

Despite the overall preference for removing PI immediately, there are some slight concerns or worries, including: Lack of clarity on exactly how up to date the Health Canada DPD is kept –

for instance, one queried whether the monographs for older products are posted on the site

There is also the concern that the “copy in a prominent location directing the reader to the Health Canada DPD” ultimately might be too much extra copy to insert in the ad It might clutter up the look of the ad if it is too verbose If it simply says something like “For PI go to www....” – that would be

acceptable Because there is lack of certainty about how much, if at all,

physicians look at the PI in journals, some have a lingering thought that maybe for new products physicians may want access to the PI in journals “just in case they are not online”

36

The Winner – Some Concerns Exist ...

One other worry that was mentioned is ... “What if PAAB gets even more restrictive if the PI is removed?”

37

Some reassurance on this issue would be appreciated, if possible.

Runner-Up Option

38

The Runner-Up – Remove PI in 1-2 Years ...

There is an interesting contradiction in what respondents say about this option – one could argue that they speak out of both sides of their mouths: On the one hand there is some comfort in the way things have

“always” been done (even though they voice significant complaints about the status quo) – change can be a bit scary

At the same time there is a strong belief among many, that physicians do not read the PI in journals – this is not their 1st, or even their 2nd most used source

But then they go on to justify this “Runner-Up Option” saying, “ Well for the first 1-2 years it might be good to keep it in the journal, just in case” – to avoid any risk (yet they are hard-pressed to clearly articulate the exact nature of what is at risk)

39


The justifications for considering this option suggests that there is a delicate balance between:

40

Wanting to save money and spend less on PI

Wanting to do due diligence and allow physicians immediate access to PI if they need & want it


The most frequently mentioned reason for preferring this option is “maybe doctors will want to go there for new products”

Another reason given for this option is that paper may be the only source for some doctors (i.e., not all doctors are online) They say this without any certainty or true conviction ... again it’s a “just in

case” justification

A few respondents also say that this option allows them to feel they are being prudent – providing necessary information to customers

41


One unique perspective from a regulatory respondent was that there is more comfort in having the PI in the journal just while the product is new, but for older more established products the website is fine ...

42

“Not because doctors necessarily read the PI in journals, more from a legal

regulatory standpoint – it’s how it has always been and we are risk averse.”

Regulatory

The Runner-Up – Some Reservations Exist ...

The downside of this option (relative to the winning option) is that cost savings would not be as great

Another interesting reservation that was mentioned by several respondents relates to consistency:

43

“The other option is better because you need to be

consistent – train people to always go to the same

place.”Regulatory

“This is less desirable because it is less consistent – do it one way or the other!”

Marketing


Concern about interpretation issues was also raised by several – this option opens up the potential for misinterpretation which is undesirable:

44

“I worry about interpretation around the AE clause – what’s unexpected vs.

expected? ... in the product monograph or not?”

Marketing

“They would need to be very clear on all time frames. I

worry about interpretation. For instance do they mean 1-2 years from the date of DIN notification or from NOC?”

Regulatory


45

InsightRegardless of how valid or not these concerns seem, it is important to recognize that they seem to be symptomatic of an underlying concern about interpretation of the Code in general. These people do not want to have to deal with the inconveniences (time and effort) that all parties experience when approvals are delayed due to inadvertent misinterpretations and misunderstandings.

Least Interesting Option

46

Least Interesting Option – Status Quo ...

It is interesting to see that the status quo pales in comparison to the other 2 options that were assessed, particularly given that initially respondents were not overly negative about the current Code – they were just slightly negative

As soon as other interesting options were tabled the Current Code quickly sank to the bottom rank ... Why?

They simply prefer the other options

The other options are interpreted to potentially result in significant cost savings

They are not certain that physicians read the PI in journals

Consistently, they do not feel that the benefits they expected from the 2007 Code Revisions, were actually realized

Not shorter, not cheaper, and certainly not less work47

Thoughts Moving Forward

48

Thoughts Moving Forward ...

The following thoughts are offered for your consideration, based on the findings of this exploratory research

Although there is not a high degree of abject dissatisfaction with the current Code, the opportunity to improve upon it seems clear

The two new options that were assessed both have merit, and pros and cons, with one (remove PI immediately) having a slight edge over the other

Either one would likely be a great improvement over the current Code

49


One theme that permeates many of the comments is that all communication related to this potential change needs to be abundantly clear: Why the change is being made

Reassurance about ease of use for physicians

Accurate information regarding the status of Health Canada’s DPD update status – for example:

How frequently are updates made?

Are there backlogs?

Are monographs for both new and old products posted? Any exclusions?

50


Communication issues (cont.): What copy exactly needs to be added to the colour part of the ad (Note: If it

is too lengthy it will certainly dampen enthusiasm for the change)

Ideally, some indication of the proportion of HCPs who have internet access

Since the impression is that there was little if any feedback on the ultimate impact of the 2007 Code Revisions (i.e., Was it easier for physicians to read and find the main points?) ...

Ideally they would like PAAB to measure and provide feedback on the impact of future Code changes

They want to know - How much does it help the end customer?

51

paab code revision qualitative research report

Documents

paab code revisions

regulatory affairs manager

regulatory individual

code revisionsunless

director of regulatory

regulatory staff members

senior product manager

group product manager