|PUBLIC POLICY & ADHERENCE
|Since 1982, the National
Council on Patient Information and Education (NCPIE) has focused on raising
awareness about the role of communication in promoting safe, appropriate use of medicines.
NCPIE-sponsored public affairs campaigns have included:
|Medication compliance -- also referred to as medication "adherence" or, in the United Kingdom,
medication "concordance" -- is an issue of much concern to many health care professionals, consumers, and researchers. Below are links to resources on
medication utilization and/or compliance. Some of these resources were developed by NCPIE; others were developed by organizations that are not members of
the NCPIE coalition.
As a courtesy to researchers, direct links are provided where possible. This section will be updated periodically.
|Appropriate Antibiotics Use: "Knowledge is the Best Medicine"
NCPIE is a partner in the Centers for Disease Control and Prevention
"Get Smart: Know When Antibiotics Work" Campaign
NCPIE is a proud partner in the Centers for Disease Control and Prevention "Get Smart: Know When Antibiotics Work" Campaign. For complete details about Get Smart About Antibiotics Week (October 6-10, 2008 and annually thereafter) visit http://www.cdc.gov/drugresistance/community/index.htm.
|Dietary Supplements: Candidates for "Educate Before You Medicate"
Over 40% of Americans (and half of people aged 35-49) have tried alternative medicines.1 However, in 1998, patients did not tell their physicians about a majority of the unconventional treatments they used. These factors led to the inclusion in the federal government's Healthy People 2010 of an objective (#17-3) to increase the proportion of health care professionals who "routinely review with patients aged 65 years and older all new prescribed and over-the-counter medicines."
A Prevention survey of 1,000 adults made the following estimates:2
Prevention also found that while 41% of respondents thought that vitamins and minerals are very safe, only 24% thought that herbal remedies are very safe. Further, only about one-third of respondents thought that labels of such products are very accurate (34% for vitamin labels, and 32% for herbal remedy labels).
- 106 million people use vitamins and minerals daily;
- 44.6 million people use herbal remedies;
- 24.2 million people use specialty supplements.
The FDA has not evaluated scientific data concerning the safety or benefits of most dietary supplements.4 Interestingly, FDA officials have reported that in focus group testing, many consumers have said that they believe dietary supplements to be so safe that FDA testing is unnecessary.
The Prevention survey found that consumers "appear willing, to a certain extent, to assume some risk with the use of these products." Prevention estimated that 11.9 million people experienced a side effect or an adverse reaction from using herbal remedies. That translates to almost one-fourth of the 44 million people using such products. While manufacturers must ensure that label information is "truthful and not misleading," and that the supplement's ingredients are safe, the manufacturers and distributors do not have to register with the FDA, nor get FDA approval, before producing or selling dietary supplements. 5
The top-selling, single-ingredient dietary supplements in the U.S. are garlic, ginkgo and glucosamine. 6 According to the FDA, products about which consumers frequently have questions include:
- Ephedra or Ephedrine
- DHEA (dehydroepiandrosterone)
|Detailed information on these products is provided through the FDA's Center for Food Safety and Applied Nutrition website. 7 Other government resources are available through the National Center for Complementary and Alternative Medicine, a new center within the National Institutes of Health (telephone: 1-888-644-6226). 8
Although dietary supplements may not be regulated as "drugs," their true role in possible interactions with prescription and non-prescription medicines remains a fertile ground for research -- and warrants a cautious approach for many consumers. For example:
- An NIH study (Lancet, Feb. 12, 2000) found a "significant drug interaction" between St. John's wort and indinavir, a protease inhibitor used to treat HIV. As the FDA noted in a related public health advisory, "it is important that health care professionals ask patients about concomitant use of products that could contain St. John's wort." 9
- The FDA has scheduled an Aug. 8, 2000 public meeting concerning the safety of dietary supplements containing Ephedrine Alkaloids.
- The Consumer Healthcare Products Association, which represents manufacturers of non-prescription medicines and dietary supplements, said that members who market St. John's wort will be adding a warning label stating: "If you are taking a prescription medicine, ask a health professional." 10
- Over-the-counter medicines or herbal therapies accounted for one-third of discrepancies between recorded and reported medications. "Miscommunication about herbal remedies is relatively common because patients often self-prescribe without consulting or informing their physicians. Adverse effects from such therapies are not necessarily trivial." 11
Indeed, "Educate Before You Medicate" seems to be sound advice for people using dietary supplements and other alternative medicines, and for health professionals involved in their care.
|Action Steps You Can Take:
|Health Care Professionals: Ask your patients specifically about their use of dietary supplements. Record this information along with prescription and other non-prescription medicines they are taking.
Consumers: Use a simple method like NCPIE's "Medication Wallet Card" to list all medicines you are taking, including dietary supplements. Keep the card updated, and show it to each of your physicians and to your pharmacist every time you receive a new prescription medicine. At the pharmacy, ask to complete a patient profile form and be sure to list any dietary supplements. Some pharmacy's computers can automatically check for possible interactions between prescription medicines and herbal supplements.
- "The Mainstreaming of Alternative Medicine," Consumer Reports, May 2000.
- Eisenberg, D., "Trends in Alternative Medicine Use in the U.S., 1990-1997," Journal of the American Medical Association, Vol. 280, No. 18, Nov. 11, 1998.
- Drug Topics, March 6, 2000.
- "Products That Consumer Inquire About, http://vm.cfsan.fda.gov/~dms/ds-prod.html June 23, 2000.
- Consumer Healthcare Products Association: http://www.ndmainfo.org/chm/10-03.html
- http://nccam.nih.gov ; E-mail: mailto:firstname.lastname@example.org
- FDA Public Health Advisory, http://www.fda.gov/cder/drug/advisory/stjwort.htm (Updated June 9, 2000)
- Washington Post, "Health," May 9, 2000.
- Bedell, S., Jabbour, S., et.al., "Discrepancies in the Use of Medications," Archives of Internal Medicine, Vol. 160, No. 14, July 24, 2000.
|Recommendations to Improve Adherence
The following recommendations are directed to the varied organizations
and individuals who can advance compliance; however, many recommendations
apply to more than one category under which they are listed:
|Physicians and Medical Schools
- Involve the patient in treatment decisions.
- Monitor compliance with prescribed treatment at every patient visit; follow up
outside of scheduled visits as appropriate. Give the patient an alternate
contact person at your office if you might be unavailable when he/ she
calls between visits.
patient compliance using a compliance-monitoring form that can be incorporated
into the patient's record.
patients' medication regimens with health professionals providing remote
site care, including visiting nurses, physician assistants and nurses
in satellite clinics or offices, and pharmacists working with patients
in care facilities or in the pharmacy.
patient communication skills in medical training and continuing education
physicians to communicate with other members of the health care team to
ensure continuity of care
|Pharmacists, Pharmacy-Providers and Educators
proactive about gathering and providing medicine information. Ask questions
that stimulate dialogue, discuss care plans with patients, and use information
to make better decisions.
compliance monitoring and documenta-tion for at least one at-risk patient
per month. Share your findings with the patient and with his/ her other
health care providers.
with management to redesign facilities to increase pharmacist/patient
contact, and to provide a private counseling area.
patient communication skills and new teaching methods into undergraduate
courses and continuing education programs.
with other health professional schools/ organizations to develop interdisciplinary
compliance education programs.
behavioral and clinical sciences in educating pharmacists about compliance.
and as an industry, support development of a national public awareness
campaign promoting patient medication compliance with therapy.
health professionals' education to develop effective communicators in
a patient-centered health care system.
and promote role models who can demonstrate improved compliance from a
NCPIE's "Get the Answers" questions with all responses to consumer information
requests or "800" program responses.
interdisciplinary teams that provide patient education and programs for
compliance and health promotion.
|All Health Professionals
patient care, including medication management, considering factors such
as age, culture, gender, attitudes, and personal situation.
ask patients about use of over-the-counter medications, including vitamins
and dietary supplements.
in a dialogue with patients and involve them as partners in the treatment
process. Explain why you think a treatment plan is most appropriate for
written materials to reinforce oral counseling, not as a substitute for
a patient's right to confidentiality when sharing medication compliance
experience with the patient's other health care providers, including nurses,
pharmacists, physicians, and physician assistants.
an active participant in making treatment decisions and solving problems
that could inhibit proper medicine use.
to your health professionals about why and how to use your prescription
medicines. Give them information about your medicine use (prescription
and over-the-counter medicines, vitamins and dietary supple-ments) and
health. If you stop or change a prescribed treatment, tell them and explain
why you did this. Get the answers to any questions you have.
accept, and carry out your responsibilities in the treatment regimen.
|Managed Care Organizations and Hospitals
existing databases to profile the extent of medicine non-compliance among
your health plan members.
and implement programs for patient compliance support (e.g., group support
programs, educational interventions, monitoring clinics, compliance packaging
aids, and multiple medicine reviews). Keep health care providers informed
about these programs so they can refer appropriate patients as part of
an individualized compliance regimen.
and implement innovative programs that teach patients responsibility for
and involvement in his/her health care.
implement, evaluate and promote successful compliance-promoting organizational
practices and policies.
drug use policies, such as formulary policy guidelines, from a patient
compliance perspective. Revise policies accordingly to facilitate compliance.
and implement computerized systems that allow departments to share clinical
patient information electronically.
|Nurses and Educators
into each patient encounter an educa-tional assessment of patient medicine
with other health care providers, including prescribers and pharmacists,
about patient compliance issues.
programs to increase nurses' knowledge and skills for compliance-enhancement.
compliance questions in examinations for professional degrees, licensing,
and continuing education.
|New Healthy People 2010 Objectives Strike at Heart of NCPIE's Mission
Surgeon General Satcher launches Healthy People 2010 on 25 January 2000
Bethesda, MD - Healthy People 2010, unveiled this week in Washington, includes several objectives that strike at the heart of the mission of the National Council on Patient Information and Education - ensuring appropriate use of medicines. "Since our founding in 1982, NCPIE has focused on a solution that involves all players, what we call the Medicine Education Team," said N. Lee Rucker, M.S.P.H., Senior Vice President of Policy and Public Affairs. "That solution is to improve communication about safe, effective medicine use, which is emphasized in the new Healthy People," she said.
Rucker spoke at "Partnerships for Health in the New Millennium: Launching Healthy People 2010." HHS Secretary Donna Shalala, who opened the conference on Jan. 25, said that Healthy People 2010 represents "the first public health goals of the new century: it's a portrait of this nation. It's about responding to real problems facing real people, and developing strategies to enable people to meet those goals," she explained. The "Partnerships" conference, which attracted over 1400 participants from around the world, concluded today.
Joining Shalala was Surgeon General and Assistant Secretary for Health David Satcher, M.D., Ph.D., who noted that HP 2010 is the largest Healthy People ever, with 467 separate objectives. "More objectives means more involvement, and we have many new people committed to HP 2010," he said. To achieve these objectives, "Personal responsibility and community responsibility are key," Satcher emphasized. "Look closely into HP 2010, and look for mutual areas of concern," he advised.
Indeed, personal and community responsibility has been a catalyst for NCPIE and its members to help develop, and to inform stakeholders about, the "Medical Product Safety" objectives in Healthy People 2010. These include:
- Increase the proportion of primary care providers, pharmacists, and other health care professionals who routinely review with their patients aged 65 years and older, and with patients with chronic illnesses or disabilities, all new prescribed and over-the-counter medicines.
- Increase the proportion of patients receiving information that meets guidelines for usefulness when their new prescriptions are dispensed.
- Increase the proportion of patients who receive verbal counseling from prescribers and pharmacists on appropriate use and potential risks of medications.
The lead agency for all Medical Product Safety objectives is the Food and Drug Administration, which sponsored a Jan. 25 session at the conference where Rucker, FDA and National Consumers League representatives spoke. Rucker cited a recent survey of older adults where only 12% of respondents said they used "information sheets from pharmacists," and only 14% used "instructions from a doctor or nurse," to help them increase medicine compliance. "The Healthy People 2010 objectives in this focus area - especially those that are more qualitative such as emphasizing the perceived usefulness of written medicine information - are in marked contrast to the more quantitative objectives in Healthy People 2000," she said.
"This new compliance data indicate that simply meeting distribution targets for written information may still leave many consumers without information they need to use their medicines appropriately," Rucker said. [The survey, conducted by FCB Healthworks, New York, NY, was released in Dec. 1999.]
Also at the session, Jerry Phillips, R.Ph., with FDA's Center for Drug Evaluation and Research, discussed the agency's role in addressing the "complex" problem of medical errors, particularly those involving medications. "Poor communication" was at the top of his list of factors contributing to errors. "Our challenge is to minimize risk," Phillips said. While the FDA can employ regulatory approaches (labeling, warning letters to physicians, postmarketing surveillance, etc.), other stakeholders have important roles, too. He advised patients to "ask for counseling," and he said that practitioners' responsibility includes "providing clear and understandable directions, and communicating with patients."
Brett Kay, Program Associate for Health Policy at the National Consumers League (Washington, DC), noted that today's "new consumer is armed with health care information." However, consumers "must tell their providers about all the medicines they're taking, and be truthful about their lifestyle, and about their medicine compliance," he said. Kay said that NCL plans to work with NCPIE and other organizations to enhance patient safety. NCL's President, Linda Golodner, serves as NCPIE's Chair.
Rucker said, "As befits NCPIE's coalition, we will continue working closely with the Food and Drug Administration, and with our consumer, health care professional, pharmaceutical industry and managed care members to get the word out about these Healthy People 2010 objectives." NCPIE has a solid track record of implementing practical programs for the entire Medicine Education Team to help achieve these objectives. Those programs include the annual October observance of Talk About Prescriptions Month, now in its 15th year; the Paul G. Rogers / NCPIE Medication Communicator Awards program, launched in 1999; the National Medication Check-Up Kit; and a variety of educational resources for consumers and health care professionals. NCPIE also played an active role throughout the development of Healthy People 2000.
For more information: