Just like Omnibus Budget Reconciliation Act '90 legislation before it, Medicare Part D legislation has been hailed as a turning point in the history of pharmacy. The legislation was signed December 8, 2003; regulations were finalized January 21, 2005, and implemented January 1, 2006. Medicare Part D created the advent of federally recognized Medication Therapy Management (MTM) programs. The legislation dictates that MTM programs must be developed in cooperation with licensed and practicing pharmacists and physicians. This is the first time in history that health care legislation has directly acknowledged pharmacists as direct health care providers.
Also stated in this legislation, MTM programs must reduce the risk of adverse events.1 The World Health Organization's definition of adverse drug event (ADE) is "any response to a drug that is noxious and unintended and that occurs in doses in man for prophylaxis, diagnosis or therapy, excluding failure to accomplish the intended purpose."2,3 Serious adverse drug reactions can be associated with death, hospitalization, prolonged hospitalization, permanent disability, or permanent impairment.4
In its 2006 publication Preventing Medication Errors, the Institute of Medicine reported that the outpatient Medicare population experiences an estimated 530,000 preventable ADEs annually, with an associated treatment cost of approximately $887 million.5 The actual number of ADEs may likely be much higher, because less clinically severe ADEs often go unreported.6
ADEs are a major problem for the elderly population. Hanlon et al discovered that more than one third of ambulatory older adults taking 5 or more medications have experienced an ADE. Of those patients, almost one third required a health care intervention, which might have included emergency department visits and hospitalizations.7
Preventing Hospital Admissions
In their research report "Hospital Admissions Resulting from Preventable Adverse Drug Reactions," McDonnell et al detailed their retrospective chart review of an 11-month period at Temple University Hospital.6 In examining ADEs serious enough to warrant hospital admission, they determined that 62.3% (96 of 158) actually were preventable. What gaps existed in these patients' drug therapy that led to the ADEs? The 4 main factors included inadequate monitoring of therapy, inappropriate dose, patient nonadherence, and the presence of a drug interaction. The authors determined that 98% of all ADEs involved more than one of these factors.
Created in 2000 and updated in 2003, the Beers criteria identified many medications that have the potential to cause ADEs in the elderly population.8 The Beers criteria include recommendations on appropriate elderly dosing and disease state-drug interactions, 2 of the 4 main causes of ADEs found by McDonnell et al.
Calkins et al discovered, in a study of 99 patients, a statistically significant difference between physicians' and patients' perceptions of patients' understanding of the potential effects of their medications.9 This lack of understanding also can contribute greatly to the potential development of ADEs. Fick et al stated in 2001 that prevention and recognition of ADEs in the elderly population might be the principal challenge in patient safety in this decade.10
Various studies have shown that performing some or all of the components of an MTM service can reduce ADEs in a variety of settings.11-16 Pharmacists providing pharmaceutical care in MTM programs are the ideal health care providers to meet this challenge.
Touchette et al surveyed 70 health plans that offer MTM programs covering 12.1 million Medicare beneficiaries throughout the United States.17 They found that 95.2% of the programs employed or contracted pharmacists to provide MTM services. The best MTM programs offer face-to-face interventions with a pharmacist trained or certified in geriatric care. Telephone call centers and mailed interventions, however, were found to be the most common types of MTM programs offered.
The services offered in a good MTM session encompass and address all of the preventable causes of ADEs. Face-to-face interventions with the actual medications, not just a medication list, are important. ADEs can be linked to patients' use of medications, even when the medications are prescribed correctly. It is very difficult to have patients describe and demonstrate correct inhaler technique over the phone or to identify which little white tablet they take when they have a pain.
Complete Medical Histories
The American Pharmacists Association has issued definition and program criteria for MTM services.18 A patient's complete medical history is taken, including all medical conditions, surgeries, medications (Rx, OTC, and alternative), allergies, laboratory results, tests, and contributing behaviors and habits. This collection allows the pharmacist to evaluate the patient as a whole and not by considering individual medications. By comparing the medications to the disease states, the pharmacist is able to determine their appropriateness. By assessing dose, route, and frequency, the pharmacist is able to determine whether adjustments need to be made based on weight, disease state, or other factors. The collection of medication allergy history is necessary to avoid allergic reactions, whether severe or minor. It also allows the pharmacist to better recommend changes in therapy by avoiding certain classes of drugs.
Assessing patients for drug interactions is paramount to determine whether the interaction may be causing patient nonadherence, suboptimal therapy, or potential toxicities. Minor interactions may be a necessity in patients with multiple disease states and poor response to therapy. Providing patient education and management strategies for these minor interactions is an important part of an MTM service and increases patient adherence and disease state control.
Determining when and how medications were added to therapy is important as well. Trends can be seen as to when toxicities presented, symptoms arose, or adherence changed. Knowing the history of adherence in and of itself can determine whether therapy is appropriate or not. Initiating someone who has a history of nonadherence on a medication that has a narrow therapeutic index may produce toxicities or suboptimal outcomes, which may lead to progression of the disease.
At the conclusion of an MTM session, both verbal and written communication can help patients understand and remember their medications' potential. Therefore, MTM sessions should decrease ADEs through patient education by increasing patient awareness of the correct way to take their medications and why.
Pharmacists have been providing MTM for many years, under different names and in varied environments. Medicare Part D, however, may provide pharmacists with an avenue to demonstrate their knowledge and competence to both patients and other health care providers, while decreasing patient harm and the economic impact of ADEs.
Dr. Knudsen is an assistant professor of pharmacy practice at Midwestern University College of Pharmacy?Glendale, Glendale, Ariz. Mr. Burtenshaw and Mr. Foggatt are both PharmD candidates at Midwestern University College of Pharmacy?Glendale.
1. Department of Health and Human Services. MA/PDP Operational User Group Call March 15, 2006. Medication Therapy Management (MTM) Submissions Contract Year 2007. Available at: http://www.asapnet.org/memberarchive/MTMP_Submission_Announcemen.pdf. Accessed January 5, 2007.
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4. Schmader KE, Hanlon JT, Pieper CF, et al. Effects of geriatric evaluation and management on adverse drug reactions and suboptimal prescribing in the frail elderly. Am J Med. 2004;116:394-401.
5. Aspden P, Wolcott J, Bootman JL, Cronenwett LR, eds. Institute of Medicine. Preventing Medication Errors. Washington, DC: National Academies Press; 2006.
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7. Hanlon JT, Schmader KE, Koronkowski MJ, et al. Adverse drug events in high risk older outpatients. Am J Geriatr Soc. 1997;45:945-948.
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14. Schnipper JL, Kirwin JL, Cotugno MC, et al. Role of pharmacist counseling in preventing adverse drug events after hospitalization. Arch Intern Med. 2006;166:565-571.
15. Schumock GT, Butler MG, Meek PD, et al. Evidence of the economic benefit of clinical pharmacy services: 1996-2000. Pharmacotherapy. 2003;23(1):113-132.
16. Zermansky AG, Petty DR, Rayner DK, Freemantle N, Vail A, Lowe CJ. Randomised controlled trial of clinical medication review by a pharmacist of elderly patients receiving repeat prescriptions in general practice. BMJ. 2001;323:1340-1343.
17. Touchette DR, Burns AL, Bough MA, Blackburn JC. Survey of medication therapy management programs under Medicare Part D. J Am Pharm Assoc (Wash DC). 2006;46:683-691.
18. American Pharmacists Association. Medication Therapy Management Services. Definition and Program. Available at: www.aphanet.org/AM/Template.cfm?Section=Home&CONTENTID=4577&TEMPLATE=/CM/ContentDisplay.cfm. Accessed January 5, 2007.