Laura T. Pizzi, PharmD, MPH, RPh - Associate Professor Thomas Jefferson University School of Pharmacy
Dante A. Gravino, PharmD Candidate - Thomas Jefferson University School of Pharmacy
Kangho Suh, PharmD Candidate - Rutgers University School of Pharmacy

Author Disclosure: The authors (LTP, DAG, KS) report no relationship or financial interest with any entity that would pose a conflict of interest with the subject matter of this article.

Planning Committee Disclosures: The staff of Pharmacy Times Office of Continuing Professional Education and The American Journal of Pharmacy Benefits have nothing to disclose relative to this activity.

Educational Objectives

Upon completion of this educational activity, participants should be able to:

• Discuss the relevance of diabetes as a target of healthcare quality improvement efforts
• Explain what US organizations are involved in diabetes quality improvement, and what types of measures have been implemented
• Discuss the history of and experiences in testing Pharmacy Quality Alliance measures pertaining to diabetes
• Recognize the potential future role of community pharmacists in improving the quality of diabetes care

Target Audience: This activity is intended for pharmacists who wish to increase their knowledge of diabetes quality and who are involved in providing pharmacy benefit decisions for corporations
 

Type of Activity: Knowledge

Diabetes mellitus is a metabolic disorder where the body inadequately produces or uses insulin in response to elevated blood sugar. Type 1 diabetes is characterized by the total absence of insulin production by the pancreas; symptom onset is usually more apparent and marked by polyuria and polydipsia. With type 2 diabetes, the body does not produce normal amounts of insulin and/or does not utilize insulin properly. Long-term complications resulting from poor glucose control include retinopathy, neuropathy, nephropathy, and peripheral artery disease. Therefore, goals of treatment are to maintain blood sugar concentrations within normal range, decrease the chance of long- and shortterm complications as well as comorbidity and mortality, and improve the patient's overall quality of life.1,2 Adherence to the appropriate drug therapy-whether that be insulin replacement or oral hypoglycemic agents-is paramount to achieving these goals. The purpose of this article is to update pharmacists on medical and pharmacy quality measures for diabetes, and discuss the future role of pharmacists in the effort to provide quality care for diabetic patients.

Importance of Quality Improvement for Diabetes

In the United States, diabetes is listed as the number 7 reason for all-cause mortality.3 Approximately 10% of people 20 years or older have diabetes, and the disease is estimated to cost about $175 billion annually.4 Because of its signifi cant economic and humanistic impact, diabetes has long been the focus of healthcare improvement efforts. The National Committee for Quality Assurance (NCQA) Healthcare Effectiveness Data and Information Set (HEDIS) includes several diabetes quality measures, as does the Centers for Medicare & Medicaid Services (CMS) Physician Quality Reporting Initiative (PQRI, soon to be renamed Physician Quality Reporting System [PQRS]). The National Quality Forum (NQF), which reviews supporting data on healthcare quality measures, already has endorsed many of these measures for use in health plans and physician quality initiatives.

Appropriate use of medications has become an increasingly important public health issue. About 40% of the elderly population use more than 5 medications,5 and between 14% and 23% of those patients get improper medications.6 With more than a million new diabetes diagnoses every year, an estimated 57 million patients in the prediabetes category, and more than two-thirds of diabetic patients requiring at least 1 oral medication,4 pharmacists play an increasingly important role in managing drug therapies for this disease. Studies have demonstrated positive outcomes for diabetic patients who are actively monitored by a pharmacist. These positive outcomes included tighter control of blood sugar as evaluated by glycosylated hemoglobin (A1C) levels, higher influenza vaccination rates, and decreased overall costs.7,8 Recognizing the value of pharmacists in improving diabetes care, the Pharmacy Quality Alliance (PQA) has established several measures aimed at improving the quality of medication therapy in the community pharmacy setting. These measures were developed with technical support from NCQA and were intended to be based on information gathered from prescription data.

Overview of Diabetes Quality Measures

NCQA-HEDIS

In 1991, NCQA developed HEDIS as a mechanism to evaluate if the quality of care by accredited plans met established quality standards.9 Though plans are held accountable for HEDIS performance, physicians' and other medical providers' performances are ultimately the subject of HEDIS quality measurement, with the idea being that plans will improve quality by educating and supporting the providers in their network. Presently, there are 8 diabetes-specific HEDIS measures focused on long-term diabetes control (eg, A1C testing), longterm complications (retinopathy and nephropathy), and cardiovascular comorbidities (hypercholesterolemia and hypertension).10

CMS Physician Quality Reporting Initiative

The Centers for Medicare & Medicaid Services implemented the PQRI in response to the 2006 legislation requiring establishment of a quality reporting program for physicians and other eligible healthcare professionals who are Medicare providers.11 These providers may obtain a bonus payment on allowable charges for Medicare services rendered by reporting quality data. For 2010 the incentive payment is 2% of the estimated allowed charges for covered services rendered during the reporting period. In 2011, the incentive payment will decrease to 1% of allowed charges. At present, the bonus incentive is limited to payment for reporting, regardless of performance. Payments have been authorized through 2014, with a payment adjustment beginning in 2015 for providers that do not successfully report on quality measures. The PQRI measure set includes several measures specific to diabetes that were developed by NCQA, the American Medical Association–sponsored Physician Consortium on Performance Improvement, and the American Podiatric Medical Association (Table 1).12

Pharmacy Quality Alliance

The Pharmacy Quality Alliance has developed and completed feasibility testing on a total of 15 measures to evaluate and measure medication use–related outcomes. Four of the measure types assess medication therapy for diabetes: (1) gap in therapy, (2) proportion of days covered, (3) excessive doses, and (4) suboptimal treatment of hypertension.13 Within each type are several individual measures pertaining to specific drug classes (eg, proportion of days covered may be measured for sulfonylureas, biguanides, and thiazolidinediones). The Pharmacy Quality Alliance supported 5 phase 1 demonstration projects with the objective of testing the feasibility of implementing these measures and developing a performance-reporting process in the community pharmacy setting. The initial project consisted of 5 different sites that fit into 1 of 3 models. Model 1 was a single health plan, model 2 was a coalition of health plan–pharmacy organization partnerships, and model 3 was a community pharmacy corporation.14

How Pharmacy Quality Measures Are Calculated

Proportion of Days Covered

The proportion of days covered is considered an adherence measurement, which assesses the percentage of pharmacy claims for certain drugs in a therapeutic class (3 drug classes were included for diabetes medications: sulfonylureas, biguanides, thiazolidinediones). The inclusion criteria for this measure are (1) patients must be at least 18 years old and (2) patients must have 2 or more prescriptions filled for agents from the diabetes drug class (Table 2).15

Gap in Therapy

The gap in therapy is considered another adherence measurement. This measure assesses the percentage of patients who have a lapse in medication therapy, as measured in days. A gap in therapy exists if a prescription is not refilled within 30 days of the last scheduled refill date (Table 3). The inclusion criteria for this measure are (1) patients must be at least 18 years old and (2) they must be taking 2 or more prescriptions from the diabetes drug class (sulfonylureas, biguanides, thiazolidinediones).15
 

Excessive Doses of Oral Medications

This measure evaluates the percentage of patients on excessive doses of oral hypoglycemic drugs. The denominator of the calculation represents patients who are at least 18 years old and have received a specified oral hypoglycemic agent. The numerator represents patients who filled at least 1 prescription for that agent at a daily dose exceeding the dose indicated by Food and Drug Administration (FDA) labeling. A lower number indicates more patients who are within the FDA-approved dosage ranges.

Suboptimal Treatment of Hypertension

The last type of PQA measure for diabetes reflects what percentage of patients with hypertension are suboptimally treated based on medical evidence. Evidence-based medicine supports the use of angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs) in diabetic patients with hypertension.16,17 The denominator of this calculation is patients who received an oral hypoglycemic agent or insulin and at least 1 antihypertensive agent. The numerator is those patients on an antihypertensive agent that is not an ACEI or ARB. A lower number denotes more patients receiving optimal care.

Current State of Pharmacy Quality Measurement

The PQA phase 1 demonstration projects began in mid- 2008 and were completed in late 2009. Results of an external evaluation funded by the Agency for Healthcare Quality and Research were recently presented.18 Each demonstration site was responsible for completing an analysis of prescription data to generate scores on the 15 measures. The demonstration projects also entailed distributing results to the team's participating pharmacies using a performance report, fielding a survey on consumers' satisfaction with participating pharmacies, and obtaining pharmacists' feedback on the performance reports.

All sites were able to integrate the quality measures into a performance report once they obtained data, though in some cases there was an insufficient number of patients meeting measurement criteria to provide a score to an individual pharmacy (particularly in rural or low-volume settings). Evaluation respondents agreed that the performance measures made sense clinically and provided a good start for initiating pharmacy quality efforts. Participants across the sites expressed an interest in measuring elements of quality other than those available in prescription data, such as the number of patients who needed and received medication therapy management, medication misfills, and clinical measures. Overall, participants thought that PQA's efforts were important to pharmacy delivery and presented an opportunity to engage pharmacists in clinical activities.

Future Role of Pharmacists in Quality Measurement for Diabetes

In 2009, NQF reported the recommendations of a committee that was charged with reviewing medication-specific measures and considered them for endorsement. Measures were submitted by NCQA on behalf of PQA, in addition to measures submitted by CMS.19 The National Quality Forum ultimately endorsed 18 medication measures through this process; 4 pertained specifically to diabetes (Table 4).20 Despite endorsements and early successes of pharmacy quality initiatives, real-world barriers need to be overcome in order to achieve wide-scale implementation.

First, the business model of community pharmacy needs to be adapted in order to support pharmacists as agents of healthcare quality. At present, community pharmacists may not have the time or the incentive to participate in quality reporting; in fact, in busy pharmacies the time and distraction associated with these endeavors could be disincentives to participation. Part of PQA's phase 2 demonstration efforts will involve evaluation of the effectiveness of a pay-for-performance model where pharmacies are rewarded for participating in quality initiatives.

Another important issue relates to the need for additional pharmacist training. Healthcare quality programs are relatively new to pharmacy, thus pharmacists need to be educated on the purpose of these programs and what strategies and tools can be used to improve quality in community pharmacy settings. Simulation exercises that cultivate pharmacists' skills in intervening based on quality reports would be particularly valuable to advancing the initiative. There is an opportunity for pharmacy schools to begin including this material in course work related to healthcare delivery and for continuing education providers to call for programs on quality measurement for practicing pharmacists.

Conclusions

Diabetes results in significant morbidity, and the direct costs of this disease and its complications are staggering. The positive impact of pharmacists in improving diabetes care in community settings has been established. There is an opportunity to expand the role of pharmacists as clinical care providers by engaging them in diabetes quality improvement efforts. Trial runs of pharmacy quality programs indicate that it is feasible to run measures of quality and submit reports in a community pharmacy setting. Although the optimal method for measuring the effects of pharmacy interventions on quality and business models still is being determined, it is important for pharmacists to be aware of the current situation, as well as their potential future role in diabetes quality programs.
 

Educational Disclaimer:

Continuing professional education (CPE) activities sponsored by Pharmacy Times Office of CPE are offered solely for educational purposes and do not constitute any form of professional advice or referral. Discussions concerning drugs, dosages, and procedures may reflect the clinical experience of the author(s) or they may be derived from the professional literature or other sources and may suggest uses that are investigational in nature and not approved labeling or indications. Participants are encouraged to refer to primary references or full prescribing information resources.

The author(s), reviewer(s), and editor(s) have made extensive efforts to ensure that the information, including treatments, drugs, and dosage regimens, are accurate and conform to the standards accepted at the time of publication. However, healthcare professionals should always consult additional sources of information and exercise their best professional judgment before making clinical decisions of any kind. In particular, the reader is advised to check the product information provided by the manufacturer of a drug product before prescribing or administering it, especially if the drug is unfamiliar or is used infrequently.

REFERENCES :

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• The Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Report of the expert committee on the diagnosis and classification of diabetes mellitus. Diabetes Care. 2003;26(suppl 1):S5-S20.
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• Centers for Disease Control and Prevention. 2007 National diabetes fact sheet: general information and national estimate on diabetes in the United States, 2007. www.cdc.gov/diabetes/pubs/pdf/ndfs_2007.pdf. Accessed November 19, 2010.
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• Mainous AG, Talbert J. Assessing quality of care via HEDIS 3.0. Is there a better way? Arch Fam Med. 1998;7(5):410-413.
• McLaren Health Plan. HEDIS Quality Indicators for Key HEDIS Measures. www.mclarenhealthplan.org/documents/Provider%20Directory/HEDIS%20Measures.pdf. Accessed October 11, 2010.
• Centers for Medicare & Medicaid Services. Physician Quality Reporting Initiative: overview. www.cms.gov/PQRI/01_Overview.asp. Accessed October 22, 2010.
• Centers for Medicare & Medicaid Services. 2010 PQRI Measures List. www.cms.gov/PQRI/Downloads/2010_PQRI_MeasuresList_111309.pdf. Accessed October 15, 2010.
• Pharmacy Quality Alliance. PQA Approved Measures. www.pqaalliance.org/files/PQA%20approved%20measures.pdf. Accessed October 15, 2010.
• Pizzi LT. Evaluation of phase 1 demonstrations of the Pharmacy Quality Alliance. Slide Presentation from the AHRQ 2009 Annual Conference. September 16, 2009. www.ahrq.gov/about/annualconf09/pizzi.htm. Accessed October 5, 2010.
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