Filling a Prescription for the Public’s Health John Babb and Victoria J. Babb

Pharmacists’ services represent a significant portion of the nation’s health system, consuming 6% of the American health care dollar.1 Pharmacists do an exceptional job of dispensing the right drug at the right time to the right patient. They have also become patient educators and are often patient advocates— particularly regarding insurance issues. They perform all these tasks all day long, for one patient at a time. However, pharmacists seldom think of the public, collectively, as a patient. In this context, we define “the public” as that group of people inhabiting the community, town, nation, or planet. Each individual is a potential patient. The profession can reach out to these people and make a gigantic impact on the public’s health if pharmacists simply unite to focus their efforts on tackling problems. Two articles in this issue of JAPhA provide information on how each pharmacist can do this in his or her own way. “Pharmacist Involvement in Healthy People 2010,”2 on page 56, relates how pharmacists can make contributions toward realizing the nation’s public health goals. These goals, published in Healthy

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People 2010,3 are supplemented with information on how to quantitatively measure the impact of pharmacy practice on achievement of the goals. A complementary article, “Using Health Observances to Promote Wellness in Community Pharmacies,”4 on page 61, provides practical methods for pharmacists to contribute to public health on a variety of levels. In fact, everyone in the profession should make sure that advancing the public health is a part of their daily practice.

Patient Protection In March 2000 ParkeDavis/Warner Lambert removed troglitazone (Rezulin) from the U.S. market.5 This action was taken on the basis of a review of safety data on troglitazone and two similar drugs, rosiglitazone (Avandia—GlaxoSmithKline) and pioglitazone (Actos— Lilly), indicating that troglitazone was more hepatotoxic than the other two drugs. Data suggest that rosiglitazone and pioglitazone offer similar benefits to the diabetic patient without the same degree of risk. This action followed the issuance of Dear Healthcare Professional letters from the

drug manufacturer in December 1997, July 1998, and June 1999, wherein readers were cautioned about the need for increased liver monitoring. Several substantiating articles in the professional literature appeared during this time frame.6–8 However, patients taking troglitazone continued to obtain refills from their pharmacy, often receiving no additional information about this medication. In some pharmacies, they read a sign at the counter that said, “If you have questions about your medication, please ask the pharmacist.” However, patients had not received Dear Healthcare Professional letters, nor did they subscribe to the journals that published the case reports of hepatotoxicity with troglitazone. By June 1999, how were patients to know that they were not supposed to receive troglitazone as initial single-agent therapy, that a Patient Information Sheet was available to them in the pharmacy, or that their serum transaminase levels needed to be monitored monthly for the first year of therapy and quarterly thereafter? Did pharmacists and physicians not share joint responsibility for talking with patients about this medication, describing the symptoms of liver damage, and encouraging monthly testing? Why did pharmacists across the country not use this situation in a proactive way to talk about the signs and symptoms of liver damage with every patient who received a troglitazone refill? Why did pharmacists, as a group, not ask patients whether their liver enzymes were being moni-

tored according to the new recommendations? How many thousands of patients needed that information? Dear Healthcare Professional letters and Public Health Advisories about prescription and nonprescription drugs should be viewed as opportunities for increased contact with patients who obtain these medications from pharmacies. Pharmacists cannot be oblivious to the risks described in those important communications; if they are, patients will suffer the consequences.

Adverse Drug Events Adverse drug event (ADE) reporting presents dual opportunities for pharmacists to become proactive, responsible members of the health care team. All health care providers have roles to play in maintaining a balance between product benefits and risks, and their input is especially important in the process of monitoring new drug products. Once a drug is available to the public, making a determination about its safety is the shared responsibility of all who are part of the prescribing process, including patients. Pharmacists understand that no drug product is completely safe and that premarketing trials do not always involve adequate numbers of patients to identify the risks of newly marketed drug products. While the approval process includes extensive safety testing, these trials sometimes exclude the elderly, the very young, patients with comorbid conditions, and/or those too

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sick to participate in clinical trials. For these patient populations, any vulnerability to adverse events may be missed. Also, based on protocol-driven trials, it is not easy to predict how practitioners will actually use medications in practice. Talking with an individual patient about the ADE he or she is experiencing, and helping that person to fill out a U.S. Food and Drug Administration (FDA) MedWatch form will undoubtedly create a strong bond with that patient. From a public health standpoint, an ADE reported by a pharmacist may be that final straw that elicits a drug product label change or warning. For example, how many practitioners, looking at a single case, would have concluded that fluoroquinolones could contribute to tendon rupturing? However, when many reports about the same problem began to surface, the link was established and the labeling for those products was changed. Even when marketed drugs are used appropriately, adverse effects are estimated to cost more than $30 billion annually and rank among the top 10 causes of death in the United States.9 A meta-analysis extrapolated to all U.S. hospitalized patients estimated that 702,000 patients experienced a serious adverse drug reaction in 1994 while in the hospital, resulting in 63,000 fatalities. The same study stated that 1,547,000 patients experienced serious adverse drug reactions that resulted in hospitalization and 43,000 deaths.9 Who becomes the primary risk manager in this


process? Physicians are expected to make rational choices on behalf of their patients as they weigh the risks and benefits of a drug in light of their patient’s situation. But, given the overwhelming quantities of information they must deal with every day, can primary providers be expected to take all the responsibility for drug safety in this time of complicated medical choices? In a recent survey of voluntary MedWatch reports for all regulated medical products submitted to FDA between June 1993 and June 1999, 73% were drug-related reports. Of these submissions, pharmacists submitted 60%.10 These statistics show that pharmacists play an integral role in gathering information from their patients. But are they actively providing information to their patients to determine improved ways to evaluate adverse events? Many patients are not aware of important risk information about their medications, so they would not know what to expect if they experienced a potentially harmful effect caused by one of their drugs. Conversely, many pharmacists are not aware of the most up-to-date information about drug products and are therefore unprepared to alert their patients to potential problems. How many patients experienced dizziness or syncope when taking terfenadine or astemizole, and yet saw no relationship between the drug and the adverse effect—simply because no one had provided information about symptoms of dangerous ADEs?

Journal of the American Pharmaceutical Association

Pharmacists know that premarketing clinical trials do not involve adequate numbers of patients to identify every drug interaction or ADE that will occur when a product enters the marketplace and is widely prescribed. ADEs with new drugs present a particularly valuable opportunity for pharmacists to get involved in improving the safety of the nation’s pharmaceutical supply system. Pharmacists seeking the most up-to-date information on drug-related problems should join the FDA MedWatch listserv at www.fda.gov/medwatch. But do not stop there. Use this information to talk with patients. They will appreciate this for two reasons. First, they will appreciate the use of technology to keep abreast of current medical issues. And, secondly, they will realize that pharmacists are able to relate the latest information to the personal well-being of their patients.

Drug R esistance The development of resistance to antibiotics and antiviral agents is a global public health problem that is producing increased morbidity, mortality, and health care costs.11 The Public Health Action Plan to Combat Antimicrobial Resistance12 was developed by an interagency task force cochaired by the Centers for Disease Control and Prevention (CDC), FDA, and the National Institutes of Health, and also including the Centers for Medicare & Medicaid Services, Health Resources and Services Administration, Agency for

Healthcare Research and Quality, U.S. Department of Agriculture, U.S. Department of Defense, U.S. Department of Veterans Affairs, and Environmental Protection Agency. The plan incorporates input from state and local health agencies, universities, professional societies, pharmaceutical companies, agricultural producers, consumer groups, and health care provider organizations. Part I of the action plan provides incremental steps in a plan of action to address antimicrobial resistance on a domestic scale: Extend the useful life of antimicrobial drugs through appropriate use policies that discourage overuse and misuse. Improve diagnostic testing practices. Prevent infection transmission through improved infection control methods and use of vaccines. Prevent and control emerging antimicrobial resistance problems in agriculture, human, and veterinary medicine. Ensure that comprehensive programs to prevent and control antimicrobial resistance involve a wide variety of nonfederal partners and the public so these programs become a part of routine practice. Develop and implement a coordinated national plan for antimicrobial resistance. Ensure the availability of reliable drug susceptibility data for surveillance. Monitor patterns of antimicrobial drug use. Monitor antimicrobial resistance in agricultural settings to protect the public’s health by ensuring a safe food

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supply as well as animal and plant health. Additionally, the plan addresses improvements in the field of antimicrobial resistance research and product development. In a study involving 34 U.S. medical centers in 1998, the overall rate of resistance of Streptococcus pneumoniae to penicillin was 29.5%. Multidrug resistance, defined as a lack of susceptibility to penicillin and at least 2 other non– -lactam classes of antimicrobials, was observed in 16.0% of isolates. This multidrug resistance increased from a 9.1% prevalence rate in a similar study in 1994–1995.13 Pharmacists must accept some of the responsibility for addressing antimicrobial resistance. This problem will not be resolved without the involvement of prescribers and pharmacists at all levels of health care delivery. The main thrust of the action plan is to involve all health care providers in this battle; everyone participating in the delivery of antimicrobials to patients must be engaged. Pharmacists should make sure that patients know to complete antibiotic regimens and should never give the patient the idea that it is appropriate to stop taking antibiotics in mid-course, share antibiotics with a family member, ignore warnings against inappropriate dosing, or encourage antibiotic use to treat a cold. Also, community-based pharmacists need to work with their pharmacist colleagues in other settings (e.g., hospitals, nursing homes) as well as with public health officials to solve or prevent antibiotic

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resistance problems in the community. The development of drug resistance in the treatment of human immunodeficiency virus is commonly thought to occur when patients miss 10% of prescribed doses.14 There is clear evidence that suboptimal dosing can lead to rapid viral rebound and the development of resistance. In one study of patients on ritonavir–saquinavir, significantly fewer of those who were nonadherent (missing 15% or more of doses) reached a viral load of 200 copies/mL or less (66% versus 90% in patients who adhered to their regimens).14 Remember that the drug resistance that develops with an antiviral agent is not just an individual patient’s problem. If the patient should infect others, the drug resistance is extended to the newly infected individuals. At that point, it becomes a public health problem. To control the emergence of resistant pathogens in hospitals, nursing homes, and the community, infection control programs must be adhered to and antibiotics used more judiciously.15

Vaccination Program Given the large number of recently published articles devoted to pharmacist involvement in vaccination programs,16–18 we provide here only sources of information. Whether or not pharmacists personally participate in providing vaccinations, they need to let patients know that pharmacy practitioners are interested in this aspect of patients’ health. Remind older

patients and those with chronic diseases about the dangers of influenza and pneumonia, which are responsible for more deaths each year in America than acquired immunodeficiency syndrome. Every year in the United States, an average of 110,000 hospitalizations and 20,000 deaths are attributed to influenza, while pneumococcal infection kills an estimated 40,000 Americans. Of these deaths, 90% occur among the elderly.19 Provide information to patients who intend to travel internationally about vaccination recommendations issued by the World Health Organization, which are available on the CDC Travelers’ Health Web site (www.cdc.gov/ travel/vaccinat.htm). Distribute the CDC recommendations on infant and childhood vaccinations to every pregnant patient and all parents of young children.20 While the nation has made considerable progress regarding children’s immunizations, great disparities persist in the rates of immunization among adults over 65 years of age. In 1997, 67% of older whites received influenza vaccinations, while only 50% of African American seniors and 58% of older Hispanic Americans were vaccinated. Greater differences were observed in pneumococcal vaccination rates for patients over 65 years of age: 47% of white adults, 30% of African Americans, and 34% of Hispanic Americans were immunized.21 This is of particular significance for African Americans because they have a 2- to 3-fold greater incidence of serious

pneumococcal disease, compared with whites.21 No plan for improving public health can be meaningful if it does not aggressively address the disproportionate needs of minorities. Measurements of the nation’s health status cannot be significantly improved unless health care providers help everyone. Pharmacists should make a special effort to either set up a vaccination program themselves or to encourage older patients to visit their physicians or local health departments to be vaccinated. Pharmacists should make a special effort to communicate this message to patients in population segments that are sometimes neglected. This meshes very well with the second primary goal of the Healthy People 2010 initiative, which targets the elimination of health disparities among different segments of the population. These differences include those based on gender, race, education, income, disability, living in rural localities, or sexual orientation.3 After reading the goals and objectives set forth in Healthy People 2010, pharmacists should ensure that they are proactive in eliminating health disparities.

Conclusion In today’s economy, unmet needs will not go unaddressed for long. If pharmacists choose not to be active participants in protecting patients, elevating their level of understanding about their drug therapy and diseases, and addressing disparities in vaccination status as well as other health

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indicators, then rest assured that niche will be filled by other market-savvy health care providers. Despite the large hurdles that remain to be cleared, pharmacists can make dramatic progress in building a healthier nation in a relatively short period of time. RADM John Babb, RPh, MPA, is director, Commissioned Corps Readiness Force, Office of Emergency Response, Office of the Assistant Secretary for Public Health Emergency Preparedness, Rockville, Md. Victoria J. Babb, PharmD, is special assistant for counterterrorism, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Md. See related articles on pages 56 and 61.

References 1. Evans C, Dukes E, Crawford B. The role of pharmacoeconomic information in the formulary decision-making p r o c e s s . J Manage Care Pharm. 2000; 6:108–21.


2. Babb VJ, Babb J. pharmacist involvement in Healthy People 2010. J Am Pharm Assoc. 2003;43:56–60. 3. U.S. Department of Health and Human Services. Healthy People 2010: Understanding and Improving Health. 2nd ed. 2 vols. Washington, DC: U.S. Government Printing Office; 2000. 4. Ciardulli LM, Goode J-V R. Using health observances to promote wellness in community practice. J Am Pharm Assoc. 2003;43:61–8. 5. Rezulin to be withdrawn from the market [news release]. Rockville, Md: U.S. Food and Drug Administration; March 21, 2000. 6. Misbin RI. Troglitazone-associated hepatic failure [letter]. Ann Intern Med. 1999;130(4 pt 1):330. 7. Neuschwander-Tetri BA, Isley WL, Oki JC, et al. Troglitazoneinduced hepatic failure leading to liver transplantation. A case report. Ann Intern Med. 1998;129:1:38–41. 8. Miller JL. Advisory panel hears contradictory evidence, backs keeping troglitazone on market. Am J Health Syst Pharm. 1999;56:840, 842. 9. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. 1998;279:1200–5. 10. Adverse Drug Events Reports—Statistics Between June 1993 and June 1999 [unpublished data]. Rockville, Md: AERS Reporting System, Office of Drug Safety, Center

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for Drug Evaluation and Research; 2001. Shlaes DM, Gerding DN, John JF Jr., et al. Society for Healthcare Epidemiology of America and Infectious Diseases Society of America Joint Commission on the Prevention of Antimicrobial Resistance: guidelines for the prevention of antimicrobial resistance in hospitals. Clin Infect Dis.1997;25:584–99. Interagency Task Force on Antimicrobial Resistance. A Public Health Action Plan to Combat Antimicrobial Resistance—Part I: Domestic Issues. Atlanta, Ga: Centers for Disease Control and Prevention; 2001. Available at: www.cdc. gov/drugresistance/ actionplan. Accessed January 29, 2001. Doern GV, Brueggemann AB, Huynh H, Wingert E. Antimicrobial resistance with Streptococcus pneumoniae in the United States, 1997–98. Emerg Infect Dis. 1999;5: 757–65. Chesney MA, Ickovics J, Hecht FM, et al. Adherence: a necessity for successful HIV combination therapy. AIDS. 1999; 13(suppl A):S271–8. Kaye KS, Frainow HS, Abrutyn E. Pathogens resistant to antimicrobial agents: epidemiology, molecular mechanisms, and clinical management. Infect Dis Clin North Am. 2000;14:293–319. Grabenstein JD. Low immunization rates in ethnic minorities—a problem pharmacists can help solve. J Am Pharm Assoc. 1999;39:708.

17. Van Amburgh JA, Waite NM, Hobson EH, Migden H. Improved influenza vaccination rates in a rural population as a result of a pharmacistmanaged immunization campaign. Pharmacotherapy. 2001;21:115–22. 18. Madhavan SS, Rosenbluth SA, Amonkar M, et al. Pharmacists and immunization: a national survey. J Am Pharm Assoc. 2001;41:32–45. 19. Influenza and pneumococcal vaccination levels among persons aged 65 years—United States, 2001. MMWR Morb Mortal Wkly Rep. 2002;51: 1019–24. 20. Recommended Childhood Immunization Schedule— United States, 2002. Atlanta, Ga: National Immunization Program, Centers for Disease Control and Prevention; 2002. Available at: www.cdc.gov/ nip/recs/child-schedule.PDF. Accessed December 4, 2002. 21. Satcher D. Influenza and pneumococcal vaccine for adults [press conference]. Washington, DC: National Press Club; October 7, 1999. Available at: www.nfid.org/ pressconfs/flu99/transcript. html. Accessed December 4, 2002.

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Filling a Prescription for the Public's Health.

V IEW P O IN T Filling a Prescription for the Public’s Health John Babb and Victoria J. Babb Pharmacists’ services represent a significant portion o...
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