• Get the Answers (for consumers)
  
• Give the Answers (for health care professionals)
  
• Children & Medicines: America's Other Drug Problem
  
• Have Your Medicines Had a Check-Up?
  
• Communicate Before You Medicate
  
• Team Up and Talk
  
• Communicate to Stay Healthy
  
• Educate Before You Medicate
  
• Educate Before You Medicate : Knowledge is the Best Medicine
  
• Educate Before You Medicate : Your Prescription for Good Health
  
• Be MedWise
• Your Medicine Information: Read It and Heed It

As a courtesy to researchers, direct links are provided where possible. This section will be updated periodically.

• In 2003, the number of retail prescriptions was 3.22 billion, up 2.4% from 2002. By 2010, the volume is projected to reach 4.5 billion prescriptions. (National Association of Chain Drug Stores)
• In 2003, retail prescription drug sales were $203.1 billion, up 11.2% from 2002. (NACDS)
• In 2003, the average price of a prescription was $59.28 vs. $54.81 in 2002. (NACDS)
• In 2002, 64.8% of physician office visits ended with a prescription being written. (National Ambulatory Medical Care Survey, 2002)
• In 1998, over four-fifths of visits to cardiologists included a prescription being written, while less than one-fifth (18%) of visits to general surgeons included a prescription (Ibid).
• In 1998, of the physician office visits involving medication therapy, 36.5% of patients received two or more prescriptions; over 10% received four or more prescriptions (Ibid).
• In 2003, the 10 most frequently prescribed brand-name medicines were, in order: Lipitor, Synthroid, Norvasc, Zoloft, Zithromax Z-Pak, Toprol XL, Zocor, Prevacid, Premarin Tabs, Ambien (Drug Topics, 2004)
• In 2003, the top 10 brand-name prescription medicines by retail sales were: Lipitor, Prevacid, Zocor, Nexium, Zoloft, Celebrex, Zyprexa, Neurontin, Effexor XR (Drug Topics, 2004)
• Through the year 2010, the fastest-growing age cohort will be those aged 45-64. After 2010, those aged 65 and older will be the fastest-growing cohort.
• The elderly (aged 65 and older) account for 13% of the U.S. population, but account for 34% of all prescription medicines dispensed, and for 42% of retail prescription expenditures (Cost Overdose: Growth in Drug Spending for the Elderly, 1992-2010, Washington, DC: Families USA, July 31, 2000).
• The average number of prescriptions per elderly person is projected to be 28.5 in 2000, and is estimated to reach 38.5 prescriptions by 2010 (Cost Overdose, Ibid).
• In 1999, based on an eight-state study of community pharmacies, 87% of patients received written information with their prescriptions. However, only 35% of pharmacists made any reference to the written leaflet, and only 8% actually reviewed it with the patient (B. Svarstad, Univ. of Wisconsin-Madison, FDA-commissioned research presented in Feb. 2000, Rockville, MD; and in June 2000, Kuopio, Finland).
• By 2010, 95% of patients should receive from their prescribers and pharmacists verbal counseling on appropriate use and potential risks of medications (Healthy People 2010, Objective 17-5, Jan. 2000).
• As many as 40% of cancer patients are taking unconventional medical therapies but don't tell their physicians unless specifically asked. Examples of such therapies included St. John's wort, shark cartilage, and megadoses of vitamins (J. Metz, Univ. of Pennsylvania Cancer Center, in R. Voelker, "Do Ask, Do Tell," JAMA, Vol. 283, No. 24, June 28, 2000).
• Researchers found a 76% discrepancy rate between what medicines patients were prescribed, and what medicines (Rx and non-prescription) they actually took. Of those discrepancies, 51% stemmed from patients taking medicines not recorded; 29% were from patients not taking a recorded medicine; and 29% were from differences in dosages (S. Bedell et. al., "Discrepancies in the Use of Medica-tions," Archives of Internal Medicine, Vol. 160, July 24, 2000).
• Over half of medication-related injuries identified in a study of 18 community nursing homes were preventable. Psycho-active drugs (antipsychotics, sedatives, antidepressants, and hypnotics) were the most common medications associated with preventable adverse drug events, the researchers found. Given the country's 1.5 million nursing home residents, if the findings are extrapolated, then at least 350,000 ADEs occur each year, over half of which are preventable (Gurwitz et. al., American Journal of Medicine, forth-coming; see National Institute on Aging news release, Aug. 9, 2000, at: www.nih.gov/nia/news/pr/2000/0809.htm
• The leading causes of death in 1998 in the U.S. were, in order: heart disease (724,000), cancer (538,000), stroke (158,000), chronic lung obstruction (114,000), pneumonia and influenza (94,000), accidents (93,000), diabetes mellitus (64,000), suicide (29,000), kidney disease (26,000), and chronic liver disease (24,000).¹
• Adverse drug reactions (ADRs) may be the 4th-to-6th leading cause of death in the U.S.: researchers found that in 1994, over 2.2 miliion hospitalized patients had serious ADRs, and 106,000 patients had fatal ADRs. Serious ADRs occured in 6.7 percent of hospitalized patients.²
• Since 1990, sales of non-prescription medicines (OTCs) have increased by more than 60 percent. In 1999, sales of OTCs are expected to top $20 billion. Sales of dietary supplements are expected to reach $17 billion by the year 2000.³
• Expenditures on direct-to-consumer advertising has grown 50% per year since 1997, totalling $1.9 billion in 1999. A decade ago, spending was just $12 million.
• Among Medicare beneficiaries, 87% need to fill at least one prescription each year. Over half (56%) of these beneficiaries use prescription medicines costing $500 or more; 38% require medicines costing $1,000 or more. One in three Medicare beneficiaries has no prescription drug coverage.⁴

• U.S. Centers for Disease Control, National Center for Health Statistics, Dept. of HHS, October 1999.
  
• Lazarou, J., Pomeranz, B., Corey, P., "Incidence of Adverse Drug Reactions in Hospitalized Patients," Journal of the American Medical Association, Vol. 279, No. 15, April 15, 1998, pps. 1200-1205.
  
• Consumer Healthcare Products Association, Drug Topics, April 5, 1999, p. 43; "Rite Aid, GNC Form an Alliance, The Washington Post, Jan. 8, 1999, p. F3.
  
• Michael Hash, Health Care Financing Administration, Dept. of HHS, prepared statement, Subcommittee on Health and the Environment, House of Representatives, U.S. Congress, Sept. 28, 1999.

Perhaps it is no surprise that one of the most common examples of patients not following their prescription regimen involves antibiotic therapy, usually when they stop taking their medicine prematurely. This can cause a recurrence of the condition that the antibiotics were originally prescribed to treat.

Another potentially dangerous situation involving antibiotics is when they are prescribed before a test confirms that the patient's condition is caused by a bacterial infection, and not by a virus. For example, physicians who prescribe antibiotics for patients suffering from cold-like symptoms or a sore throat -- without confirming that the patient has strep throat - may contribute to the problem of "antimicrobial resistance."

Further, the Agency for Healthcare Research and Quality reported that almost two-thirds of children with uncomplicated, acute otitis media recover from pain and fever within 24 hours of diagnosis without treatment with antibiotics. Over 80% recover within one to seven days.² The AHRQ said that while it is routine for U.S. physicians to prescribe antibiotics for this condition, in countries such as the Netherlands, "watchful waiting" for one to two days is the standard practice.

As the AMA observed, "the rapid spread of resistant bacteria, inappropriate prescribing of antibiotics by health professionals and unskilled practitioners, and inadequate surveillance exacerbate the problem."³

The Centers for Disease Control and Prevention (CDC) estimates that about 100 million courses of antibiotics are prescribed by office-based physicians each year. CDC claims that about half of those are unnecessary, being prescribed for patients presenting with colds, coughs, and other viral infections.⁴ To combat this public health threat, in 1999 the CDC, Food and Drug Administration, National Institutes of Health and many other federal agencies formed an Interagency Task Force on Antimicrobial Resistance. CDC has:

• Sponsored videoconferences on antimicrobial use;
  
• Developed guidelines for the use of antibiotics in hospitals.

The Task Force released its Public Health Action Plan to Combat Antimicrobial Resistance in January 2001.⁵

Meanwhile, the AMA has pledged to educate practicing physicians and medical students about the appropriate prescribing of antimicrobials. This will help prepare physicians for "what may be the most important task of all: educating their patients about their antimicrobial therapy, the importance of compliance with the prescribed regimen and the problems of antimicrobial resistance."

Talk About Prescriptions Month is a perfect opportunity for you do your part in ensuring appropriate antibiotic prescribing and utilization. Remember, "Educate Before You Medicate: Knowledge is the Best Medicine."

• American Medical News, July 24, 2000.
  
• "Clinical Evidence Shows Limited Effect of Antibiotic Treatment on Children with Acute Otitis Media," AHRQ press release, Aug. 9, 2000: http://www.ahrq.gov/news/press/pr2000/otitispr.htm
  
• American Medical News,po.cit.
  
• Antibiotic Resistance: A New Threat to You and Your Family's Health, available at: http://www.cdc.gov/ncidod/dbmd/antibioticresistance/ and http://www.cdc.gov/drugresistance/index.htm
  
• http://www.cdc.gov/drugresistance/ (updated Jan. 19, 2001).

A Prevention survey of 1,000 adults made the following estimates:²

• 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:

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.

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.
  
• Ibid.
  
• Consumer Healthcare Products Association: http://www.ndmainfo.org/chm/10-03.html
  
• http://vm.cfsan.fda.gov
  
• http://nccam.nih.gov ; E-mail: mailto:nccamc@altmedinfo.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.

• 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.
• Document patient compliance using a compliance-monitoring form that can be incorporated into the patient's record.
• Coordinate 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.
• Include patient communication skills in medical training and continuing education curricula.
• Train physicians to communicate with other members of the health care team to ensure continuity of care

• Become proactive about gathering and providing medicine information. Ask questions that stimulate dialogue, discuss care plans with patients, and use information to make better decisions.
• Provide 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.
• Work with management to redesign facilities to increase pharmacist/patient contact, and to provide a private counseling area.
• Incorporate patient communication skills and new teaching methods into undergraduate courses and continuing education programs.
• Work with other health professional schools/ organizations to develop interdisciplinary compliance education programs.
• Integrate behavioral and clinical sciences in educating pharmacists about compliance.

• Individually and as an industry, support development of a national public awareness campaign promoting patient medication compliance with therapy.
• Support health professionals' education to develop effective communicators in a patient-centered health care system.
• Recognize and promote role models who can demonstrate improved compliance from a patient-centered approach.
• Provide NCPIE's "Get the Answers" questions with all responses to consumer information requests or "800" program responses.
• Support interdisciplinary teams that provide patient education and programs for compliance and health promotion.

• Individualize patient care, including medication management, considering factors such as age, culture, gender, attitudes, and personal situation.
• Specifically ask patients about use of over-the-counter medications, including vitamins and dietary supplements.
• Engage 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 your patient.
• Use written materials to reinforce oral counseling, not as a substitute for it.
• Respect 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.

• Become an active participant in making treatment decisions and solving problems that could inhibit proper medicine use.
• Talk 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.
• Recognize, accept, and carry out your responsibilities in the treatment regimen.

• Use existing databases to profile the extent of medicine non-compliance among your health plan members.
• Develop 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.
• Develop and implement innovative programs that teach patients responsibility for and involvement in his/her health care.
• Identify, implement, evaluate and promote successful compliance-promoting organizational practices and policies.
• Review drug use policies, such as formulary policy guidelines, from a patient compliance perspective. Revise policies accordingly to facilitate compliance.
• Develop and implement computerized systems that allow departments to share clinical patient information electronically.

• Integrate into each patient encounter an educa-tional assessment of patient medicine knowledge.
• Collaborate with other health care providers, including prescribers and pharmacists, about patient compliance issues.
• Develop programs to increase nurses' knowledge and skills for compliance-enhancement.
• Include compliance questions in examinations for professional degrees, licensing, and continuing education.

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:

www.talkaboutrx.org
www.health.gov/healthypeople/
www.health.gov/partnerships