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Why
Refills... Not Office Visits...
Should be your DTC Goal
DTC's
New Job: Boosting Compliance
Dorothy L. Smith, Pharm.D.
Read why "Refills,
not office visits, should be the goal of consumer communications,"
in the September 2003 Health Literacy Supplement to Pharmaceutical
Executive Magazine. In this article, Dr. Dorothy Smith
explains how DTC ads can reinforce pharma company messages
when patients enter the long-term treatment cycle, help patients
stay with that treatment as long as the condition persists
-and increase pharma's profits.
FDA
Direct-to-Consumer Promotion: Public Meeting
On
September 22 and 23, 2003, the FDA held their Direct-To-Consumer
Promotion: Public Meeting. Two important topics include
"Brief Summaries" and DTC effect on consumer behavior,
summarized below.
Guidelines for "Brief
Summaries"
The FDA is preparing new draft guidance for direct-to-consumer
advertising that addresses the need to improve the effectiveness
of "Brief Summaries" in response to an FDA-commissioned
study of written information disseminated during 2001. Four
widely-used prescription drugs reported the average ``usefulness''
of the information was only about 50 percent. The statute's
goal for 2006 is that 95 percent of individuals receiving
new prescriptions would receive useful written information.
Another survey conducted by the Department of Psychiatry at
Louisiana State University Medical Center in 2000 showed that
almost half of all patients were unable to understand pharmacy
printouts.
Commenting that most FDA-mandated
"Brief Summaries" in DTC advertising are neither
"brief" nor "summaries", CDER Office of
Medical Policy Director Robert Temple, MD, acknowledged the
need for improvements. The new draft guidance is expected
by year's end.
According to Dr. Temple,
readability and consistency must be improved, and the relative
risks and benefits of prescription drugs need to be presented
with more balance.
Consumer Health Information
Corporation (CHIC) applauds the sentiment, as our emphasis
has always been about improving
health literacy through readable, consistent, and understandable
consumer drug messages.
More effective DTC materials
will help consumers make more informed decisions about their
medications and learn how to prevent and manage potential
side effects.
DTC Effect on Consumer
Behavior
CDER Office of Medical Policy Director Robert Temple called
for further study of the effect of DTC advertising on consumer
behavior.
Presentations at the FDA
session examined the effect of DTC advertising on consumer
behavior, with results ranging from inconclusive to positive.
The Pink Sheet quoted
Temple's remark that "It's hard to feel that it's not
reasonable to let people know about conditions they might
have but have never explored, and about conditions that they
didn't know could be treated with prescription drugs, in some
cases, better than OTC."
The potential impact of
DTC advertising on the improvement of patient compliance is
definitely an area that needs to be researched.
As discussed in the September
2003 Health Literacy Supplement to Pharmaceutical Executive,
DTC's
New Job: Boosting Compliance, "To persuade patients
to remain in therapy, pharma marketers must develop a compliance
strategy that meets the varying needs of consumers, patients,
and health professionals through all stages of treatment.
It must take into account the specific product, disease, and
patient population. A patient compliance strategy must be
part of the DTC program and subsequent patient information
materials."
DTC programs that are
tied to an overall compliance strategy might be able to reverse
the alarming patient dropout statistics. For example, 25 percent
of patients taking cholesterol medications stopped therapy
in the first month and 50 percent quit within three months
of starting treatment.
Incorporate
Agencies into Early FDA Discussions of DTC Advertising
At
the October 2003 Pharmaceutical Marketing Congress, the FDA
encouraged pharmaceutical companies to directly involve their
marketing and advertising agencies early in the process of
developing DTC ad campaigns.
This FDA recommendation underscores
the need to bridge the gap between marketing laypeople and
the regulatory process. Regulatory issues such as adequate
provision and fair balance are at stake - "it is really
as much a regulatory discussion as a communications and marketing
one" said Associate Commissioner for External Relations
Peter Pitts.
Pitts also challenged DTC marketers
to strive for balance in their delivery of risk and benefit
information. He said, "Challenge yourselves and your
ad agencies to address and redress this critical public health
disconnect."
Consumer Health Information Corporation
urges pharmaceutical companies to seriously address the impact
of patient compliance on clinical trial results. Waiting until
prior to product launch usually puts a company in a tailspin.
There are several advantages to developing patient education
materials early in the product development process:
- Patient compliance will be improved
during the clinical trial
- The clinical trial results will
be more accurate
- The patient compliance strategy
and patient materials can be pre-tested during Phase III
and refined for the product's NDA
Every product entering Phase III needs
the following:
- Patient instructions that meet the
requirements for an FDA-approved Patient Package Inserts
(PPI) when the NDA is submitted;
- Educational materials for clinical
trials;
- "Patient-friendly" informed
consent documents;
- Integrated instructional materials
for clinical investigators that outline each step of a carefully
standardized educational process
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