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

• Twitter

• Snapchat – video of dancing praying mantis by

arthritis bottle.

• Approved users.

• Instagram

• Etc.