Polypharmacy is a problem that exacerbates drug nonadherence. As people age it is common for their list of prescribed medications to increase. In older adults, the number of prescriptions is more than twice that of the national population and nearly three times that of persons under age 65 years. 1 Polypharmacy is often defined as four or more prescribed drugs.2
It is important to note that 1.5 million Americans are sickened, injured or killed by medication errors each year; seniors most at risk due to the polypharmacy risk factor. 3 Adding pharmaceutical counseling to patients on four or more medications decreases the risk of medication errors.4 Elderly patients use more medications than younger patients and the trend of increasing drug use continues through 80 years of age as medication usage increases. For example, in a survey of drug adherence among 800 elderly outpatients, adherence rates were 81.5%, prescriptions were taken in reduced doses by 13.7% of the patients, in higher doses by 2.1%, and not at all by 2.6%.
Evidence supports pharmaceutical counseling as a method of reducing the risk of medication nonadherence and errors.6 The purpose of this quality improvement project is to address the risk of medication nonadherence for older patients in an outpatient clinic. The goal was to evaluate the results of pharmaceutical counseling on objective outcomes of LDL, A1C, and blood pressure. More specifically, the aim of this quality improvement was to equip patients on a regimen of four or more medications towards greater understanding and adherence of their medication regimens.
Comprehensive medication therapy management is effective in managing chronic disease and drug-related issues in the elderly. Current evidence points to the fact that medication management programs to treat chronic conditions can be improved through collaboration between physicians and pharmacists. Spending more time with patients at the pharmacy translates into important improvements in their health status and in cost reductions. Pharmacists' involvement with individual patients is pivotal to improve medication regimen adherence. Such counseling programs have been used in NC to assist patients with understanding their medication regimens.
A community hospital senior citizen's outpatient clinic was chosen as the site for this project, as this outpatient clinic has 5000+ established patients, ages 60 years and older. This is an ideal setting for this quality improvement project. A needs assessment was conducted to determine the percentage of patients taking four or more prescriptions meds, and it was determined that 60% of the patients in this particular setting were on four or more meds, placing them at risk for medication errors and noncompliance.
This project promotes the Institute of Medicine's six goals in evidence based medicine: patient centeredness, effectiveness, efficiency, safety, timeliness, and equitability.8 LDL, A1C, and BP were chosen as objective measures to determine outcomes results. These chronic disease markers were chosen because pharmaceutical counseling has often been suggested as a way to combat medication noncompliance in the outpatient primary care setting. For example, one study showed that pharmaceutical counseling actually reduced LDL, glucose, and blood pressure readings in patients in an outpatient setting .9
A survey form was chosen as a method to evaluate patients' satisfaction with SafeMed pharmaceutical counseling. These forms were given to patients at the time of the return visit with the nurse practitioner or physician. Patients were given an opportunity to fill out the questions on the form. The form was kept simple as it was filled out in the presence of the provider. Patients were asked if they found the counseling helpful to understand their medication regimen. Patients were asked if their medication questions were adequately addressed at the time of their consult. Patients were also asked if they had changed the time of the day they take their medications for greater efficacy. Finally, patients were given an opportunity to comment on their individualized drug therapy counseling.
The criterion for selecting patients for pharmaceutical counseling was based on the following: patients on four or more medications that had any questions or doubts about their medications with the primary care provider. As discussed above, polypharmacy presents a great risk for medication nonadherence, and therefore polypharmacy was used as the inclusion criteria.
These referrals began in September 08 until March 09. These patients range in age from 60 and above. Patients were asked at the time of their visit with their primary care if they were interested in this counseling. Informed consent was given, and patients were then referred to this telephone pharmaceutical counseling program. Exclusion criteria included those patients who did speak English, as no translator was available for this quality improvement. Patients were also given a form for informed consent at the time of the referral.
A local hospital pharmaceutical counseling, known as SafeMed, was used for telephone based counseling. SafeMed is a hospital based pharmaceutical counseling program for patients being discharged from the local hospital. During the planning stage of this project, it was determined that SafeMed pharmacists could be utilized in the outpatient setting for telephone consulting through referrals from nurse practitioners and physicians in the practice.
Administrative support of this project was achieved through meetings between the nursing staff, providers, manager, and director of the outpatient clinic. Support of this project was achieved during the planning stages, and the office manager assisted with implementation through quarterly meetings with the office staff reviewing questions of the project implementation. Survey reports were reviewed with both the director and manager of the outpatient clinic. The Hospital's Clinical Improvement Committee was chosen to be an avenue for reporting objective outcome results at the conclusion of the project.
Pharmaceutical counseling in the elderly is most effective when based on the Beers criteria 10 to determine safety of the medication regimen of the elderly. The telephone counseling focuses on reviewing medication regimens, determining the most appropriate times to take the meds, and clarifying patients' questions or concerns about their specific medication regimens.
During the pharmaceutical counseling, patients' meds were confirmed with the pharmacist, either on the phone or in a face to face consult. After the consult, the patients were mailed a survey form to evaluate their experience with the counseling session, and were asked to return the surveys to their PCP. The PharmDs also assured that the patients had a follow up appointment with their nurse practitioner or physician. At each follow up visit the nurse reviews the patients' medications, and the nurse practitioner or physician addresses any concerns or questions the patient may have from the counseling.
Adherence with medication regimens is reviewed by the nurse practitioner or physician, and the list of prescribed medications is compared with what the patient is actually taking according the pharmacist. Blood pressure, A1C and cholesterol measurements are taken as a baseline before the consulting session, and compared with readings three months after this session. Using such objective outcomes to measure the success of medication management therapy is pivotal in setting a systems change project. Objective outcomes as markers, such as LDL, A1C, and blood pressure to measure results with outpatient drug therapy is especially important when addressing polypharmacy management in the elderly. 11
Three months after the counseling session, objective lab values were obtained to determine any improvement in chronic disease management that could be associated with the counseling. After the counseling session, a detailed note was provided by the PharmD to the primary care provider with an overview of the counseling suggestions, such as list of the medications changes or labs that were needed. This note was then filed in the patient's chart. When following up with the primary care provider, the patient and provider review the suggestions provided by the PharmD.
In the beginning stages of implementation, it was noted that the reports from the SafeMed pharmacists included recommendations for the primary care provider that were embedded in the pharmaceutical consult note, and were being overlooked. These recommendations were being overlooked due to the layout of the note from the pharmacist. Because of this, a request was made to SafeMed to separate the recommendations into a separate section on the form. A plan section was then integrated into the form of the pharmaceutical consult note to advise the patients' nurse of recommended changes or follow up in drug therapy.
During the implementation stage, a decision was made to train the nurses in the importance of placing these pharmaceutical consult notes on the patients' charts and bringing these notes to the provider, advising the nurse practitioner or physician of the new recommendation section on the form. Nurses also notify the patients of the changes that the provider would like to make based on the recommendations provided by the pharmacist. Only after the form has been reviewed by the nursing staff and signed by the nurse practitioner or physician is the form filed away.
Outcomes are analyzed through a random chart review of patients referred to this counseling. Chart reviews have been shown to be an effective means to review outcomes of quality improvement projects in outpatient settings. 12
Medication review with patients showed improved results with drug adherence and chronic disease markers in Australia. 13 Results were analyzed from charts through comparing A1C, LDL, and blood pressure values with precounseling values.
The outcomes of this counseling are reviewed with the nurse practitioner or physician three months after pharmacist telephone consultation.
Survey forms discussed above are filled out by patients at the time of the follow up with the healthcare provider. Survey forms are kept anonymous and are reviewed by the office manager. One hundred percent of the patients filled out the survey forms, and these results are discussed.
Patient satisfaction was evaluated from the survey forms given by the pharmD and satisfaction rate averaged 95%. Patients' only complaint was the delay in the time of counseling from the time of referral. This apparently was due to language barriers (some patients only speak some Spanish and were unable to find interpreters), and also due to disconnected phone numbers. Patients clearly stated in their survey forms that they were able to understand their medication regimens more clearly, and questions were answered appropriately. Although none of the patients referred to pharmaceutical counseling understood their medication purpose and regimens, ninety percent of the patients confirmed that they understood the indications of their medications after the pharmaceutical counseling.
A total of 120 patients were referred to be included in this quality improvement project from September 08-March 09. Forty charts were selected, as a sample of thirty percent of the patients seen in this project to determine an overview of the outcomes for those patients referred to SafeMed program. A1C levels, blood pressure, and cholesterol levels were obtained, comparing current readings to previous readings from within the past year. The following were the results obtained for the thirty percent sample obtained from chart review:
1) 21 out of the 40 charts revealed patients with DMII. Out of these 21 patients, three patients had A1C levels out of the 5.5-7.0 acceptable range, 14 the rest of whom had stable A1C levels. Five of the patients had actually had an improvement of 1.0 point in their A1C level after five months of pharmaceutical counseling (see graph 1).
2) 36 of the patients referred to pharmaceutical counseling had hypertension. Out of these 36 patients, thirty had blood pressure levels that were within the JNC7 guidelines (not greater than 140/90) 15. Over the six months of PharmD counseling, four had seen improvement in their readings, but fell outside of the JNC 7 guidelines. Two had BP readings that had worsened over the year, and their levels were well above the accepted guidelines. One of these actually declined medication for his treatment, thus the uncontrolled hypertension (graph 2)
3) 35 of the charts of those patients referred to SafeMed had diagnosis of hypercholesterolemia. 34 of these patients had LDL levels < 130, which is within acceptable range for guidelines established by the AHA 16. Only one patient was found to have levels that were above the recommended, and this patient had declined treatment, choosing a lifestyle approach to combat an LDL level of 170 (see graph 3).
Both these objective and subjective outcomes were reported to the hospital's Clinical Improvement Committee at the end of the six month period.
Pharmaceutical counseling is linked to improvement in medication adherence. The objective outcomes of pharmaceutical counseling showed the following:
-Eighteen patients had A1C levels within acceptable ranges, four patients had an improvement in their A1C levels.
-Thirty six of the patients had acceptable BP levels within acceptable JNC 7 range of < 130/90
-Thirty four of patients with hyperlipidemia referred to counseling had LDL levels within AHA range of < 130, ten of whom had improvements in their LDL levels.
These outcomes seem to substantiate the evidence that pharmaceutical counseling is correlated with improved outcomes for patients A1C, blood pressure, and cholesterol readings. The Clinical Improvement Committee conferred the value of this project, and is currently reviewing the possibilities for the sustainability of such a project through further grant funding for SafeMed outpatient pharmaceutical counseling.
It is also apparent that drug therapy counseling provided by a multidisciplinary team of nurse practitioner, physician, nurse, and pharmacist also provides greater patient satisfaction with understanding drug regimens. This also leads to a reduction in medication errors and greater patient compliance.
1) Al-Rashed, SA, Wright, DJ, Roebuck, N., Sunter, W., Chyrstyn, H. The value of inpatient pharmaceutical counseling to elderly patients prior to discharge. British Journal of Clinical Pharmacology. 2002; 54(6):657-64.
2) Hayes,TL, Larimer, N, Adami, A, Kaye, JA.. Medication adherence in healthy elders: small cognitive changes make a big difference. Journal of Aging and Health. 2009; 21(4):567-80.
3) More than 1.5 million Americans sickened, injured or killed by medication errors each year; seniors most at risk. DailyMed, retrieved from:http://biz.yahoo.com/prnews/080128/nym119.htmlv=88. Accessed June 20, 2008.
4) Doucette,W., McDonough R., Klepser D., McCarthy, R. Comprehensive medication therapy. Research in Social Administrative Pharmacy. 2005; 1(12): 565-58.
5) Aspinall, S., Sevick, MA., Donohue, J., Maher, R., & Hanlon, JT. Medication errors in older adults: a review of recent publications. American Journal of Geriatric Pharmacotherapy. 2007; 5(1): 75-84.
6) Gatti ME, Jacobson KL, Gazmararian JA, Schmotzer B, Kripalani S. Relationships between beliefs about medication and adherence. American Journal of Health System Pharmacy. 2009; 66(7):657-64.
7) Hansen, R.A., Roth, M.T., Brouwer, E.S., Herndon, S., Christensen, D.B. Medication therapy management services in North Carolina community pharmacies: current practice patterns and projected around. Journal of American Pharmaceutical Association. 2003; 46(6):700-6.
8) Institute of Medicine. (2008). Available at:http://www.iom.edu/CMS/2954.aspx Accessed on December 25, 2008.
9) Lee, J., Grace, K., Taylor, A. Effects of pharmacy care program on medication adherence, persistence, blood pressure, and low-density lipoprotein cholesterol. Journal of American Medical Association. 2006; 296(21): 2563-2571.
10) Flinders, A, Nair, V, Nazarko, L, Beck, D.Prescribing for older people. Nursing Older People. 2009 Mar; 21(2):27-8.
11) Vermeulen, L., Beis, S., & Cano, S. Applying outcomes research in improving the medication-use process. American Society of Health System Pharmacy. 2000; 57(1): 2227-2282.
12) Luck, J, Peabody, JW, Dresselhaus, TR, Lee, M & Glassman, P. How well does chart abstraction measure quality? A prospective comparison of standardized patients with the medical record. The Journal of the American Medical Association. 2000;283:1715-1722.
13) Pit, SW, Byles, JE., Cockburn, J. Medication review: patient selection and general practitioner's report of drug-related problems and actions taken in elderly Australians. Journal of American Geriatric Society. 2007; 55(6):927-34.
14) American Diabetes Association. Type 2 Diabetes Guidelines. Available at:http://www.diabetes.org/type-2-diabetes.jsp. Accessed June 28, 2008.
15) The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure - Complete Report. Available at:
http://www.nhlbi.nih.gov/guidelines/hypertension/jnc7full.htm. Accessed June 2, 2009.
16) American Heart Association Recommended Levels. Available at:http://www.americanheart.org/presenter.jhtml?identifier=4500. Accessed June 2, 2009