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Communicating in the Consumer
Realm
Dannie Newman, Reviewer PAAB
Identify the Audience
HCP:
Messaging directed to licensed members of the professions of medicine, dentistry, naturopathy, nursing, pharmacy and related health disciplines and institutions.
Patient:
Messaging directed to individuals prescribed that product OR messaging in a tool intended for use by HCPs only during counseling.
Consumer:
Messaging directed to the general public. Readily accessible by individuals who have not been prescribed the product.
Are there secondary audiences?
Communicating in the consumer
realm
• A brief look at the PAAB advisory opinion of consumer regulations.
• We will also explore the intricacies of the distribution of your app through a consumer app store.
• We ll e plore guida e arou d sear h e gi e optimization (SEO) and search engine marketing (SEM) in the consumer realm.
• PAAB offers an advisory service (using Health Canada policy documents) for:
• Consumer Information
• Consumer Advertising
• Turnaround time for advisory service is 4 days.
• Materials are reviewed until they reach a "no objection" status and are provided with a no objection number. Materials which have been granted "no objection" status are authorized to bear the PAAB logo as a symbol of that approval.
• Please see the PAAB Fee Schedule under "Resources" for the current advisory fees.
Communicating with Consumers
Communicating with Consumers
Consumer Advertising or Consumer Information?
Definition in section 2 of the Food & Drugs Act:
A represe tatio a ea s hate er for the purpose of promoting directly or
indirectly the sale or disposal of any food,
drug, os eti or de i e
What is Drug Advertising?
Still unsure?
See
Distinction Between Advertising and Other
Activities
on the Health Canada website
Distinction Between Advertising and
Other Activities:
• 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 ?
Breaking down the 7 questions.
2 separate groups of factors
1. Content /creation factors: • What is the content ? • Who sponsors the message and how ? • Extent of drug manufacturer influence over message content ?
2. Distribution/availability factors
• Audience ? • Context of dissemination ? • Who delivers ? • Frequency of delivery ?
No o e facto i itself ill dete i e whether or not a particular message is ad e tisi g.
…If u ce tai , do ’t hesitate to ask PAAB. We’ll espo d to e uests fo itte opi io s ithi 4 days.
Communicating with Consumers
For Consumer Information (non-advertising):
Need to consider the relevant provisions from the Disti tio Do u e t.
Examples:
Help-seeking Messages
Consumer Brochures
The Health Canada policy "The Distinction Between Advertising and Other Activities" can be found on the Health Canada and PAAB website.
Consumer Brochure
Consumer Brochure
Communicating with Consumers
For Consumer Advertising:
Need to o sider produ t s federal s hedule & whether disease/condition treated is on schedule A.
Consumer Advertising Regulations
Prescription
drugs
…So e p oducts ay ha e a dual Fede al d ug schedule
Choose HerpRex
for the prevention
of HPV
Disease Consideration - Schedule A
Acute alcoholism
Acute anxiety state
Acute infectious respiratory syndromes
Acute psychotic conditions
Acute, inflammatory and debilitating arthritis
Addiction, except nicotine addiction
Appendicitis
Arteriosclerosis
Asthma
Cancer
Congestive heart failure
Convulsions
Dementia
Depression
Diabetes
Gangrene
Glaucoma
Haematologic bleeding disorders
Hepatitis
Hypertension
Nausea and vomiting of pregnancy
Obesity
Rheumatic fever
Septicaemia
Sexually transmitted diseases
Strangulated hernia
Thrombotic and embolic disorders
Thyroid disease
Ulcer of the gastro-intestinal tract
See Health Canada website for list of Schedule A Diseases
Consumer content
• While apps and websites may be directed to
patients, there is often a consumer facing
section:
– App store descriptions
– Website landing pages
– Campaigns to direct patients to additional
resources (public posters, tv spots, radio adds,
facebook ads, twitter etc.)
Apps From an App Store
The combined content viewable prior to successful password entry must not exceed the consumer regulations.
The most common elements include:
• app name & icon
• app description
• preview screenshots (typically multiple screen shots revealed by swiping)
• Keywords
• user reviews (list will grow with time)
• usto ers also ought a ha ge ith ti e
• More apps pro ided a ufa turer X list ill gro ith ti e
The three latter elements would require continued monitoring by the manufacturer.
Static
Dynamic
Asclepius Asclepius Patient Helper
Case Study: Jensulin App Jensulin [insulin praspart (rDNA origin)]
Indication:
• JENSULIN [sublingual basal insulin praspart] is indicated for
the treatment of Type 1 or Type 2 diabetes in patients over 17
years of age who require basal insulin for the control of
hyperglycemia.
• Jensulin is a biologic (schedule D)
and
• For the treatment of a schedule A disease
Consumer Advertising Regulations
Prescription
drugs
Static content: Description
Visuals:
• Screen shots are generally
captured from the app
• The current visuals would
identify the therapeutic
area. Need to be revised
Description:
• Also subject to consumer
regulations. Remove
discussion of therapeutic
area
PAABPharma
User Generated Content in the
consumer realm
• Dynamic:
– Social media usually involves user generated content
• Key considerations:
– Content housed on a sponsors site is the sponsors
responsibility
– Monitoring and moderating
• Misinformation, correction of content, adverse events
– Informing users of the rules and regulations of the site
upfront can be helpful
Dynamic content: Social Media (s.6.5.9)
1. This app provided me with all the info I needed to
confidently treat my diabetes
2. This app was no good. Froze all the time. Hard to
find information I was looking for. Print outs would
not load.
3. Jensulin saved my life. This app gave me so much
information. Was easy to follow. Would recommend
this app and Jensulin to anyone.
4. Hypoglycemia symptoms chart was not complete or
user friendly.
PAABPharma
Identifies
therapeutic area
Absolute
therapeutic claim
Identifies
therapeutic area
Ok
User Generated Content
• Can render a compliant page non-
compliant
• Options:
• Dea ti ate Re ie s se tio
• Monitor Correcting misinformation:
e.g. misinformation about company or disease
Corrections must be made promptly. PAAB
preclearance not required if limited precisely to the
minimum needed to correct misinformation.
Remove:
Content which exceeds advertising regulations.
Adverse event monitoring:
Not enough to only provide a statement referring
reporters to the pharmacovigilance / medical
department.
Tip: P o ide a clea Te s a d Co ditio s
After i stallatio o to the user s de i e: The patient encounters this screen
Once validated as a patient, the user
has access to all app features including
a direct link into the patient website.
Search Engine Optimization (s.6.5.10)
Meta data text provided by the manufacturer (or it s age t to a search engine for PAAB approved app/website:
• Must not exceed consumer advertising regulations.
• Must not refer to competitor products.
Search Engine Marketing (s.6.5.11)
• Same as Search Engine Optimization, with the
addition of purchased keywords.
SEO –Keywords
URL Meta description H1 tag Keywords
Jensulin.ca Jensulin.ca, an online resource
designed to provide valuable
information about Jensulin for
healthcare professionals, diabetes
patients and the general public.
Taking Jensulin? Diabetes
Insulin
Glycemic control
Hypoglycemia
Jensulin.ca/
patientlogin
Jensulin patient information Taking Jensulin? Diabetes Patient
Jensulin.ca/
hcplogin
Jensulin information for healthcare
professionals
Jensulin for
healthcare
professionals
Healthcare professional
Diabetes treatment
Jensulin.ca/
talktodoctor
See icebreakers to help you talk to
your doctor about hypoglycemia,
low blood sugar and more.
Help talking to
doctors
Talk to your doctor about
low blood sugar
Jensulin.ca/
realdeal
Learn the dangers of counterfeit
products
Dangers of
counterfeit drugs
Counterfeit
Real Jensulin
Jensulin.ca/
seenontv
See the latest Jensulin commercials
online
As Seen on TV
Key Words
Keywords (search engine):
Jensulin
Jennsulin
Gensulin
Jensalin
Drug information
Prescribe
PAABPharma
URL Meta description H1 tag Keywords
Jensulin.ca Jensulin.ca, an online
resource designed to provide
valuable information about
Jensulin for healthcare
professionals, diabetes
patients and the general
public.
Taking Jensulin? Diabetes
Insulin
Glycemic control
Hypoglycemia
Jensulin.ca/pat
ientlogin
Jensulin patient information Taking Jensulin? Diabetes Patient
Jensulin.ca/hc
plogin
Jensulin information for
healthcare professionals
Jensulin for
healthcare
professionals
Healthcare professional
Diabetes treatment
Jensulin.ca/tal
ktodoctor
See icebreakers to help you
talk to your doctor about
hypoglycemia, low blood sugar
and more.
Help talking to doctors Talk to your doctor about
low blood sugar
Jensulin.ca/rea
ldeal
Learn the dangers of
counterfeit products
Dangers of counterfeit
drugs
Counterfeit
Real Jensulin
Jensulin.ca/se
enontv
See the latest Jensulin
commercials online
KeywordsSeen on TV
URL Meta description H1 tag Keywords
Jensulin.ca Jensulin.ca, an online
resource designed to provide
valuable information about
Jensulin for healthcare
professionals, diabetes
patients and the general
public.
Taking Jensulin? Diabetes
Insulin
Glycemic control
Hypoglycemia
Jensulin.ca/pat
ientlogin
Jensulin patient information Taking Jensulin? Diabetes Patient
Jensulin.ca/hc
plogin
Jensulin information for
healthcare professionals
Jensulin for
healthcare
professionals
Healthcare professional
Diabetes treatment
Jensulin.ca/tal
ktodoctor
See icebreakers to help you
talk to your doctor about
hypoglycemia, low blood sugar
and more.
Help talking to doctors Talk to your doctor about
low blood sugar
Jensulin.ca/rea
ldeal
Learn the dangers of
counterfeit products
Dangers of counterfeit
drugs
Counterfeit
Real Jensulin
Jensulin.ca/se
enontv
See the latest Jensulin
commercials online
As Seen on TV
Other examples:
• Subject to consumer regulations; should not identify the
therapeutic area
Keywords:
Jensulin
Gensulin
Jennsulin
Jensalin
Insulin passad
Diabetes
Injection
HbA1c
Hyperglycemia
Hypoglycemia
Foot care
Blood sugar
Safety profile
Prescribe
Ad related to Jensulin
Jensulin | Jensulin.ca www.Jensulin.ca
Learn about diabetes treatment
microblogs
• Snapchat – video of dancing praying mantis by
arthritis bottle.
• Approved users.
• Etc.