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PAAB Offers Guidance on Regulatory Social Media Thought Process

Eye for Pharma organized the 1st eMarketing Canada conference, which was held in Toronto, on November 1-2 2010.

Patrick Massad (Chief Review Officer at the PAAB, Pharmaceutical Advertising Advisory Board) presented an algorithm to facilitate the regulatory thought process when planning a social media promotional activity.  Here is the suggested algorithm:

1) Is this advertising?

2) Who is the intended audience?

3) What restrictions should I consider for this audience with respect to disease and product schedules?

4) What mechanism will I use to limit access to that audience?

5) What is the sponsor’s tolerance for uncertainty & risk?

6) How will I align the site with this tolerance level?

7) What are the regulatory consequences of adding and/or linking other tools/content to my site?

 

Here are some highlights of Patrick’s presentation with regards to the very 1st step to detemine if tactic in mind is advertising or not:

Health Canada’s definition of advertising is as follows:  “any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device” (as per section 2 of Food Drugs Act).

If this does not help to answer the question about whether the promotion is advertising or not, you can then refer to Health Canada’s policy document “The Distinction Between Advertising and Other Activities”, which lists the following 7 questions:

•What is the context in which the message is disseminated?
•Who are the primary and secondary audiences?
•Who delivers the message (the provider)?
•Who sponsors the message and how?
•What influence does the drug manufacturer have on the message content?
•What is the content of the message?
•With what frequency is the message delivered?

By answering these questions, the intent of the promotion becomes clearer as to whether the tactic is advertising or informational.

The intented audience and type of drug will determine which regulatory body needs to be consulted.  See this article here if you need assistance to determine which Canadian regulatory body to consult for your promotional campaign.

For more information about PAAB guidelines regarding social media, see Highlights from “Social Media Marketing in Pharma: What Works in Canada”

What do you think of this algorithm?  Would you add, delete or change any of the suggested steps?  Please leave a comment below.

Stay in touch,
Natalie

Connect with me on the following networks:
FaceBook, Twitter, LinkedIn

Canadian Pharma/Healthcare Regulatory Guideline Revisions – Jan 2010

Love them or hate them, as a medical marketer, you have a ton of regulatory guidelines to follow.  And they seem to change on a regular basis (some guidelines change more frequently than others).  In this blog post, you will find a list of some of the Canadian healthcare guidelines with links that will lead you to the document(s) of interest. The only revisions that took place in January 2010 are in the Rx&D code (see below for details of these changes).  A few other revisions for other sets of guidelines are expected over the next couple of months.  Although the details on the other revisions have not been shared with me, I made a note of when the revisions are expected to take place.

NOTE: If you have marketing collaterals or campaigns that need pre-clearance, but you are not sure which regulatory body to contact, take a look at yesterday’s post; Algorithm on choosing the appropriate Canadian healthcare regulatory guidelines.

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New 2010 Rx&D Code of Ethical Practices (not yet posted on the Rx&D website, but coming soon). Here’s a peak at the upcoming changes.  Only section 15 has been revised in the 2010 code:

Section 15.4 Penalties

  • In 2009, the 1st, 2nd and 3rd code infractions were published in the Rx&D Update.  As of 2010, these infractions will be published on the Rx&D website.  All postings will remain on the website for 24 months from the date of the final decision.

New section 15.4.1 Compliance Statement (3 statements as part of this new section)

  • Within ninety (90) days of the final decision date with respect to any Code infraction, the Member must clearly indicate in writing to Rx&D that they have halted the activity or otherwise addressed the issue that caused the infraction. A copy of this compliance statement will be posted on the Rx&D website with the relevant decision of the IPRC.
  • In the event that Rx&D determines that the Member has not complied with this requirement, the Member will be deemed to have deliberately contravened one of the Guiding Principles, and the penalties set out in Section 15.3, 15.5.1 and 15.5.2 will apply.
  • In exceptional circumstances, a Member, acting in good faith, may believe that more than ninety (90) days will be required to comply with this Section 15.4.1. In this case, the Member must file a written extension request with Rx&D within ten (10) days of the decision date, providing a detailed supporting rationale for the request, and an estimate of the time required. Rx&D will forward the extension request to the IPRC who will evaluate the extension request and make a recommendation to the Rx&D Executive Committee (EC) within ten (10) days of its receipt. The EC, in its sole discretion, may elect to grant such an extension to the Member.

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Pharmaceutical Advertising Advisory Board (PAAB)

Canadian Association of Medical Publishers
It does not appear as though any new guidelines have been posted, since at the bottom of the CAMP advertising guidelines page, the last update appears to have been on May 11 2009.

MEDEC-Canada’s Medical Technology Companies
Revisions scheduled for March 2010.

Consumer Health Products Canada (previously NDMAC)
No changes, but expect some to come once their new website (along with new organizational name) gets launched within the next month or so.

Advertising Standards Canada (ASC)

  • Any change in ASC guidelines would be from a result of changes with the Health Canada documents.  Since there have been no changes for the Health Canada documents, there have not been any changes for the ‘Consumer Drug Advertising Clearance’ documents of either the Prescription drugs or the Non-prescription / Natural health products (see the two boxes on the left of the ASC screen which allow you to choose the documents required based on the product type).


Health Canada’s documents regarding direct-to-consumer (DTC) advertising of prescription drugs

  • Note that both PAAB and the ASC can provide an advisory opinion on DTC collaterals and campaigns.
  • No changes for any of the following documents.

Health Canada’s documents regarding direct-to-consumer (DTC) advertising of non-prescription drugs

  • ASC and MIJO can provide preclearance services with respect to consumer advertising of non-prescription drugs and natural health products.
  • No changes for any of the following documents.

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Note that I am not a pharmaceutical regulatory expert.  I am providing these resources as a service to my blog’s readers.  If you have specific regulatory questions, please contact the appropriate organization.


Stay in touch,
Natalie

Connect with me on the following networks:
FaceBook, Twitter, LinkedIn


To ensure that you receive all new updates to this blog, insert your e-mail address in the box in the top-right corner. Your e-mail will remain private and will not be shared with any third parties.

ALGORITHM: Choosing the Appropriate Canadian Healthcare Regulatory Guidelines

As a pharmaceutical marketer, you need to be creative and innovative to achieve your brand’s strategic and financial objectives, but you must do so while staying within the regulatory guidelines.  In Canada, there are several sets of regulatory guidelines and codes that relate to Canadian pharma / healthcare advertising and promotion.  How do you know which ones to follow for which circumstances?

Patrick Massad, the Chief Review Officer at the PAAB, presented an algorithm at the “Social Media Marketing in Pharma: What Works in Canada” workshop, which is meant to help identify which set of guidelines to follow in certain circumstances. A modified version is found below.

When in doubt, contact the various regulatory bodies and explain your specific situation to determine which organization is responsible for clearing your advertising / promotional collaterals and campaigns. Note that the Health Canada Food & Drugs Act is the basis for the policies, guidelines, and regulations on drug advertising. Regulatory bodies enforce these.

TYPE OF PRODUCT

Rx and Schedule D product

Non-prescription / Natural health product

Promoting to

Healthcare Professionals

Pharmaceutical Advertising Advisory Board (PAAB)

Pharmaceutical Advertising Advisory Board (PAAB)

Promoting to

Patients

(have a prescription for the product)

Pharmaceutical Advertising Advisory Board (PAAB)

Pharmaceutical Advertising Advisory Board (PAAB)

Promoting to

Consumers

Pharmaceutical Advertising Advisory Board (PAAB)

OR

Advertising Standards Canada (ASC)

can provide an opinion on behalf of Health Canada

Advertising Standards Canada (ASC)

OR

MIJO (Formerly BCA)

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For those who are curious, the following is a list of promotional guidelines for some other countries;

Australia:
Medicines Australia

Medical Technology Association of Australia

Brazil:
Agência Nacional de Vigilância Sanitária (Anvisa) / (Brazilian Health Surveillance Agency). Promotional guidelines in Portuguese only.

Denmark:
Danish Medical Association (LF), Danish Pharmaceutical Association (DA), Danish Association of the Pharmaceutical Industry (Lif), Danish Generic Medicines Industry Association (IGL), Parallel Importers of Pharmaceuticals (PI)

Europe: European Federation of Pharmaceutical Industries and Associations (EFPIA)
EFPIA Code on the promotion of prescription only medicines to, and interactions with, healthcare professionals

EFPIA Code of practice on relationships between the pharmaceutical industry and patient organisations

France:
Les Entreprises du Médicament (LEEM)

United Kingdom:
Association of the British Pharmaceutical Industry (ABPI)

United States of America:
Pharmaceutical Research and Manufacturers of America (PhRMA)

Division of Drug Marketing, Advertising, and Communications (DDMAC)

Advanced Medical Technology Association

Note that I am not a pharmaceutical regulatory expert.  I am providing these resources as a service to my blog’s readers.  If you have specific regulatory questions, please contact the appropriate organization.

Stay in touch,
Natalie

Connect with me on the following networks:
FaceBook, Twitter, LinkedIn


To ensure that you receive all new updates to this blog, insert your e-mail address in the box in the top-right corner. Your e-mail will remain private and will not be shared with any third parties.

Any Canadian AE’s Reported via Social Media?

Pharmaceutical companies have concerns about initiating social media campaigns due to the potential reporting of adverse events (AE). Having been on the client side for most of my career, I admit that this would be a concern of mine as well. To completely dismiss the possibility of AE’s being added to a social network would be irresponsible.

Have there been any Canadian AE’s reported via social media? I’m sure there have been AE’s reported by Canadians on social networks, but whether they have been reported or even identified, that is unknown to the general public.  Despite the fact that the public has access to the AE’s reported to Health Canada by searching the Canada Vigilance Adverse Reaction Online Database, this does not include data about the method of transmission of the report. Health Canada receives AE’s via fax, e-mail, telephone, mail, and online via MedEffect Canada which collects information about the AE, the reporter, the patient and the drug in question, but does not display the details about the method of transmission of the report itself. Therefore, there is no way for the general public to know if any Canadian AE’s have been reported to Health Canada via social media or online communities unless they do their own social media market research.  If somebody has done this type of research in Canada, and it is allowed to share the information, please feel free to contact me via the comment section or send me an e-mail.

If you are looking for more information about AE reporting in Canada, you may want to take a look at Health Canada’s MedEffect Canada website.

The following data in this post is actually a bit old by now, so I will not dwell on the details.

In August 2008, Nielson Online published an article called “Listening to Consumers in a Highly Regulated Environment”. The author is Melissa Davies. You can download a complimentary copy of the article here. I first learned about this report via a blog post by Pharma 2.0.

The key message from this report is that from an analysis of 500 random healthcare-related messages on social networks, only 1 actually met all 4 criteria for being a reportable AE ; 1) identifiable patient, 2) identifiable reporter, 3) specific drug / medication, and 4) an adverse event.

Nielson Online - August 2008

Jonathan Richman (Dose of Digital) recently did a few calculations of his own based on some of the additional information that he received from Ms. Davies, the author of the Nielson Online report. Here was his conclusion;

“The ENTIRE PHARMA INDUSTRY, assuming they were responsible for EVERY SINGLE discussion online, would have to manage 166 reportable adverse events per day. Divide that out across the number of companies out and there’s not a lot of work for people to do.”

Of course there are measures that you can take to reduce the risk of having AE’s mentioned on your company’s or brand’s social network (ie. such as removing the option to make comments, or editing comments with prior warning that mentions of AE’s or even just product mentions may be edited to remain within the industry’s guidelines), but these reduce the level of engagement with the consumers … and that is the whole point of social media. Die-hard social media gurus will warn you against such measures, but as somebody who has walked in the pharma clients’ shoes as well as the Health 2.0 advocates’ shoes, I realize that there sometimes is a need for commenting restrictions. Plus, our Canadian pharmaceutical promotional guidelines are quite different than those of the U.S., especially when it comes to promoting drug information to consumers. As a result, us Canadian medical marketers might find ourselves in a situation where we have no choice but to limit commenting abilities or take on the responsibility of editing consumer comments in order to abide by our industry’s promotional guidelines. The PAAB hosted social media workshops in 2009 to help Canadian pharmaceutical marketers better understand what could and could not be done on social media when promoting their brands.

Before jumping in, do some market research and take a look at the types of comments that have been made about your brand(s) on social networks over the past year. This will give you an idea of the sentiment of the comments and whether there are AE’s being reported. As your company begins to embrace social media, allow yourself to take one step at a time as your level of comfort with social media grows. Your social network members will appreciate it far more if you add new social media features rather than if you remove them.

Stay in touch,

Natalie

Connect with me on the following networks:
FaceBook, Twitter, LinkedIn

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To ensure that you receive all new updates to this blog, insert your e-mail address in the box in the top-right corner. Your e-mail will remain private and will not be shared with any third parties.

Highlights from “Social Media Marketing in Pharma: What Works in Canada”

The Pharmaceutical Advertising Advisory Board (PAAB) recently held 3 sessions of a workshop called “Social Media Marketing in Pharma: What Works in Canada”.  Originally, only one session in each Montreal (September 29 2009) and Toronto (September 30 2009) was planned, but due to popular demand, a 3rd session took place in Toronto this week (November 9 2009).  In total, there were 250 Canadian pharma marketers (client and agency side) who registered for these sessions.

PAAB social media workshop audience - Toronto September 30 2009

The panel members for this workshop are listed below.  I was quite humbled to be included as part of this stellar cast;

Ray Chepesiuk, PAAB Commissioner

Patrick Massad, Chief Review Officer (CRO), PAAB

Ann Sztuke-Fournier, Manager, Regulatory Advertising and Risk Communications/ Therapeutic Effectiveness and Policy Bureau, Marketed Health Products Directorate, Health Canada

Henry Anderson, Interactive Marketing – The Americas, Novartis Consumer Health, Inc.

Christian Roy (Montréal Session), Vice President, Marketing, Primary Care Business Unit, Pfizer Canada

Pat Forsythe (Toronto Session), Neuroscience Business Director, Allergan Canada

and me, Natalie Bourré, Medical Marketing and Social Media Consultant, Marketing 4 Health Inc.

Here is a summary of some of the key takeaways from the workshop.  Keep in mind that my expertise is medical marketing and social media, and not regulations and guidelines.  Therefore I must disclaim that what you will read in the following statements are my interpretations of how the Canadian regulatory guidelines impact the use of social media in the Canadian pharmaceutical marketing environment.  Furthermore, guidelines may change over time.  This post is considering regulatory guidelines as they exist as of November 2009.

If you would like to brainstorm and strategize ideas about the use of social media as part of your medical marketing, then please contact me at marketing4health@yahoo.ca .  But if you already have an idea of what you want to do and just need to determine if your plans are within the Canadian pharmaceutical regulatory guidelines, then I would advise that you contact CRO Patrick Massad at the PAAB directly (http://www.paab.ca).

Before looking at some examples that were discussed during the workshop, the following statements need to be reviewed because these comments were mentioned over and over again during the workshops;

1. Every situation is evaluated on a case-by-case basis. As the PAAB looks at a promotional campaign in its entirety, it is difficult to give a clear-cut answer without knowing all the facts.  For example, your social media program may be non-branded and acceptable as is because it is informational and not advertising.  However, if it is somehow tied to an advertising piece, then it is considered advertising and must be reviewed by PAAB.

2. The intent of the campaign often determines if it is considered promotional or informational. To help you determine if your campaign is considered to be advertising (thus requiring PAAB review), take a look at the 7 questions provided by Health Canada’s policy on the “Distinction Between Advertising and Other Activities” (link to: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/actv_promo_vs_info-eng.php) .

In fact, this point supports the 1st, as Health Canada states that it is only after having determined that the primary purpose of a message is advertising that an assessment can be made regarding compliance with the regulations pertaining to drug advertising.” Get to know these questions because they apply to all promotional campaigns related to the pharmaceutical industry, not just social media.

3. Canadian guidelines are different than American guidelines. This post is not meant to go into details about these differences.  However, it is important to note that direct-to-consumer (DTC) advertisement is highly restricted in Canada, where only the brand name, price and quantity can be mentioned while staying within our Canadian guidelines.  So if the promotion’s intent is targeted to consumers in general and is considered to be promotional in intent (see point #2), it is not allowed in Canada.  If the promotion is considered to be information only (no product focus), then it might be allowed in Canada.  If you are unsure if your campaign is promotional or informational, contact The PAAB for guidance.

Keep in mind that DTC is not the same as direct-to-patient (DTP) information.  DTP information distributed through health professionals is allowed in Canada as long as it is consistent with part 3 of the Product Monograph. It should be reviewed and approved by the PAAB with respect to section 6.4 of the PAAB Code of Advertising Acceptance.  The difference between the two is that the target market for DTP are patients who have received a prescription for the drug in question and for DTC it is the general public.

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Here are just a few samples of the discussions that took place during the workshops.  Each discussion point mentioned below is meant as a stand-alone and does not necessarily have anything to do with the discussion point(s) mentioned prior to it;

Discussion 1:  Assuming that a social network is developed for patients who have received a prescription for a drug (DTP), does the company have any responsibility with regards to any off-label comments made by a patient who is a member of the network?

Yes.  As the owner of the network, the pharmaceutical company holds responsibility for ALL comments that are posted on the network, and these comments become part of the network, therefore they become part of the promotional campaign.  As such, all comments made which are visible to other members must comply with the PAAB guidelines.  Therefore, any off-label comments made by patients must be removed.

Discussion 2:  The point of social media is to allow discussions to take place.  What will patients think if pharmaceutical companies start removing or editing comments?

Regulators understand that comments enrich the discussions on social networks.  However, as a highly regulated industry, we must abide by the guidelines.  One remedy to the situation is to ensure that all members are made aware of certain requirements for posting comments right from the beginning.  For example, let the network members know that any comments that mention prescription products will be removed or edited in order to comply with the industry’s guidelines.

How your company will decide to manage these situations will depend on your company’s level of risk aversion.  To be entirely safe, your network may not allow any comments to be made at all.  Perhaps your network will allow members to “like” certain information (ie. As in FaceBook), but will not allow written comments.  Or perhaps your company will accept comments and will assign a person or preferably a team to monitor the comments and make changes as appropriate.  Keep in mind that when you start a social network, it may evolve with time.  You may wish to test the water at first by allowing members to “like” comments and then take the plunge to allow comments.  Go at your company’s comfort pace.  It is easier to add functionality than remove it later on.

If your company is comfortable with allowing comments, here are a couple of things to consider as part of your planning process;

i)                    Identify who in your company will be responsible for monitoring and making appropriate changes.  If your network becomes very popular, this could become a very time-consuming task.  Consider the personnel workload and costs that will be involved.

ii)                   Develop an SOP before initiating the process.  In this SOP, consider as many scenarios as possible.  In fact, you will probably have to demonstrate to the PAAB how you will deal with certain scenarios before they will approve your social network anyway (this is just my opinion – it is not something that PAAB stated).

Discussion 3:  If a company has not set up a social media network themselves, but they are monitoring their product mentions throughout multiple social network sites, are they responsible for reporting adverse events?

Yes, but only if all 4 criteria that define an adverse event are met (drug, patient, reporter, event).  Here is the link to the Health Canada guidance for ADR reporting:  http://www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2009-guidance-directrice_reporting-notification/index-eng.php

Of course adverse events are a concern in our industry.  It would be irresponsible for any one of us to dismiss the possibility of adverse events being reported online.  Adverse events do get reported on social networks, but according to a recent study, this is a rare occurrence.  In August 2008, Nielson Online published an article called “Listening to Consumer in a Highly Regulated Environment”.  The article states that of 500 product reports that they looked at, and only 1 actually met all 4 adverse event criteria.  Please remember that this study identified cases that included all four criteria and in real life you may have to follow up to get more information that would be available. At the moment, this is the only data that I am aware of that quantified adverse events reported online.  If I find any others, I will be sure to blog about it.  If you know of others, please let us know via the comments section.

Discussion 4:  If a pharmaceutical company sponsors an online health professional journal, can that company include a reminder ad with a link to the full Product Monograph?

If the journal can be accessed by the general public, then linking to a product monograph for a prescription drug would not be acceptable.  This would contravene the Canadian DTC restrictions which only allow drug name, price and quantity to be promoted to consumers.

If the journal is gated and is only accessible to healthcare professionals (HCP), then linking to a product monograph for a prescription drug would be acceptable.

This discussion generated comments that there is a discrepancy in how the regulators are viewing online journals versus printed journals.  Printed journals for HCPs may contain approved drug ads, and the product label can be found at the end of the journal.  Some HCPs leave their printed journals in their patient waiting rooms, thus giving access to patients to the ads within the journal.  How is this different than a consumer having access to a link to a product monograph in an online journal?  The answer is “intent”.  With printed journals targeted to HCPs as seen by the name and address label, the intent is to advertise to the HCPs.  HCPs leaving the journals in their waiting room is not under the pharmaceutical company’s control.

Discussion 5: Assume that a company sales rep posts comments on Twitter about a new study regarding a product that he or she promotes for your organization, and that the study is off-label.  Should this be allowed since it was done during off-business hours?

No.  This type of information should be removed and corporate policy should clearly dictate internal actions.  An organization would not allow any of its employees to discuss upcoming strategies or prices with other individuals, whether it be during or outside of business hours.  This should be considered as a breach of the company’s policies.  Don’t have such a policy or SOP?  It might be time to put together a team to start working on them.  Looking for some social media policy guidelines from other companies?  Take a look at Dave Fleet’s e-book on developing social media policies;   http://davefleet.com/downloads/social-media-policies-ebook.pdf

I hope this helps clarify some questions, and I’m sure it has generated a whole bunch of new ones.  Let’s keep the discussion alive.  Send me your comments and feedback.

Stay in touch,

Nat

Marketing 4 Health Inc.

http://www.facebook.com/NatBourre

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http://www.linkedin.com/in/NatBourre

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