Ongoing refills. After patients have received the information needed to fill the prescription, manage their medication, and deal with the
potential adverse effects, it is up to the brand team to ensure that all DTC and patient materials leverage that groundwork
by reinforcing compliance messages. Research indicates that once patients have learned how to incorporate medication into
their daily routines and have taken their medication for a year, they are less likely to drop out of chronic medication therapy.
Fujisawa's Prograf (tacrolimus) is a good example of a brand with an effective patient compliance strategy. The brand team
first developed FDA-approved official patient labeling and then used that language to craft the subsequent product-specific
materials. The team also developed disease awareness programs, consumer decision-making programs, and websites, which are
practical, understandable, and motivational for transplant patients.
However, what distinguished that company's program was the "Sharing Your Experiences: Transplant Mentor Program," which trains
volunteers to become mentors to patients who are awaiting transplants and living donors. This program was built on the premise
(unearthed through research) that transplant patients find it helpful to speak with someone who understands the medical, emotional,
and financial concerns of the transplant process.
The mentors are also trained to detect potential discontinuation of prescription medications—thus preventing the most common
cause of unnecessary transplant rejections and deaths. In addition, they are trained how to report this information back to
the healthcare professionals that comprise the transplant team so they can better manage patient care.
Risk Information or the PPI
FDA places great importance on ensuring that patients have understandable and readable risk information—and given its role
in patient compliance, the industry sees eye to eye with the agency. To help move those initiatives along, the FDA issued
draft guidances that gave pharma companies an option: replace the brief summary with a more condensed version that concentrates
on the risk information or with official patient labeling.
The FDA notes that risk information "must include all warnings, the major precautions, including any that describe serious
adverse drug experiences or steps to be taken to avoid such experiences; and the most common nonserious adverse reactions
most likely to affect the patient's quality of life or compliance with drug therapy."
However, if executives take a patient-centric approach, the question becomes, "Is the presentation of risk information enough?"
After all, including just the risk information does not provide patients with enough information to weigh the benefits against
Instead, marketers should substitute the brief summary with a PPI, a one-page, consumer-friendly version that is based on
the package insert. A PPI presents risk-benefit information in "fair balance" and gives additional information such as behavior
modification techniques that will help motivate patients to stay on their therapy. It also addresses the major risk to patients
of not taking the drug and dropping out of their treatment prematurely.
That's akin to going to a surgeon and learning that your leg needs to be amputated. If the surgeon told you only the risks
associated with the procedure, and not why the surgery was necessary, then chances are, you wouldn't agree to it. Similarly,
patients need to know that they are risking a heart attack by not taking their medication. Once they have this information,
they can weigh the benefits against the risks, and then decide what to do.
Although the FDA encourages companies to use PPIs, there is no mandate to use them. As a result, some companies continue to
use the brief summary on the back of their print DTC ads because they believe it is easier and cheaper than translating the
professional labeling into consumer-friendly language—and making the language acceptable to the company's legal, regulatory,
medical, and marketing teams as well as FDA. However, other companies find the effort worthwhile and submit PPIs as part of
the new drug application or as a supplemental new drug application. Once approved, the PPI can be used in place of a print
DTC ad's brief summary and as part of any educational material for patients and consumers, including collateral materials,
websites, patient videos, starter kits, and compliance packaging.