Understanding which agents work
for which patients and at what cost is important in managing the selection of
pharmaceutical therapies and services in a changing health care environment. The
Agency for Healthcare Research and Quality (AHRQ) develops and administers
research programs related to patient outcomes associated with pharmaceutical
therapy.
This program update summarizes
research results and lists published papers to date from AHRQ's research
portfolio on pharmaceutical therapy.
Contents
Introduction
Impact of Pharmaceuticals on Health Care Delivery
The Need for Research
AHRQ's Pharmaceutical Research Program
Overview of Study Findings
Treatment Effectiveness
The Cost and Economics of Health Care
Tools for Patient Management
Target Populations: Racial and Ethnic Groups, the Elderly
Public Health and Prevention, and Chronic and Persistent Disease
RFA HS-92-03 Projects: Study of Patient Outcomes Associated with Pharmaceutical Therapy
RFA HS-96-003 Projects: Research on the Outcomes of Pharmaceutical Therapy
Appendix A. Other Pharmaceutical-Related Projects
Appendix B. CERTs Fact Sheet
Introduction
Impact of Pharmaceuticals on Health Care Delivery
Prescription and
over-the-counter pharmaceuticals are central to many of the most challenging
issues faced in health services delivery and financing today. Representing a
major portion of health care dollars spent in the United States, the role and management of pharmaceuticals raise
multiple complex questions for providers, patients, policymakers, and
researchers. During the past decade significant advances have been made in
developing tools to help providers evaluate current clinical research
information as it applies to individual patients.
Critical appraisal and
evidence-based techniques continue to evolve as new technical approaches to
analyzing research data are developed. The cost of pharmaceuticals continues to
be one of the most debated issues of this decade as Medicare, Medicaid, and
private insurance programs seek to work within public budgets and/or private
competitive products while at the same time making available the best that
medical treatment has to offer. Return to Contents
Understanding which agents
work for which patients and at what cost is important in managing the selection
of pharmaceutical therapies and services within a changing health care
environment. However, this information is often not available for many drugs, since the Food and Drug Administration (FDA) approval process only requires
pharmaceutical manufacturers to provide evidence of safety and efficacy for one
clinical indication and requires pharmaceutical manufacturers to provide
evidence of safety and efficacy for one clinical indication and only within
controlled clinical trials that often include a relatively homogeneous
population. An approved drug may enter the market with relatively little
information available to the practitioner, the third-party payer, or the
patient about how the drug compares with the array of other therapies
available. Once approved by the FDA, medications may legally be prescribed for
any use deemed appropriate by a licensed physician.
Additionally, patients
receiving the medication may differ from patients included in the trials. They
may be sicker, older, younger, or have additional diseases. Frequently, adherence to the prescribed regimen may be different than in trials. Return to Contents
Within the U.S. Department of
Health and Human Services, AHRQ supports the study of the relative effectiveness, appropriateness, and
cost-effectiveness of alternative strategies for the prevention, diagnosis, treatment, and management of clinical conditions. The Center for Outcomes and
Evidence (COE) has the lead responsibility in AHRQ for the development and
administration of research programs related to patient outcomes associated with
pharmaceutical therapy.
A total of 26 research grants
have been funded under three COE programs. Sixteen were funded through COE's
Study of Patient Outcomes Associated with Pharmaceutical Therapy, which focused
on:
- Data and analytic methods involved in the study
of drug therapy effectiveness.
- Factors affecting the appropriateness of drug
prescribing.
- The role of the patient in drug therapy
effectiveness.
Two additional projects were
funded under the program Research on the Outcomes of Pharmaceutical Therapy, which gave preference to projects focusing on pharmaceutical economic analysis
and effects of changes in the health care environment on patient outcomes.
The remaining seven projects and
a coordinating center were funded under the Centers for Education and Research
on Therapeutics (CERTs) program, a national initiative to increase awareness of
the benefits and risks of new, existing, or combined uses of therapeutics
through education and research. Additional information about this program is
contained in the CERTs Fact Sheet.
Return to Contents
In the context of these
research objectives, Pharmaceutical Outcomes and CERTs address many of today's
most critical health care issues, including those related to treatment
effectiveness, the cost and quality of care, research and patient management
tools that support evidence-based practice, racial and ethnic disparities in
service delivery, prevalent chronic conditions in the U.S. population, health
care prevention, and the needs of the elderly.
Following are some of the
notable study findings related to these areas. The grant number is included so
that the original publication may be located further on in this document.
- A study examining short-term outcomes in diabetic patients found that improved glycemic control
of the patients' diabetes was associated with substantial short-term quality of
life and health economic benefits (Testa, Simonson, 1999). Grant HS07767.
- A study examining
the difference in quality of life produced by the same hypertension treatment
(calcium channel blockers) using two different medication delivery systems
(nifedipine gastrointestinal therapeutic system and amlodipine) suggested
medication-specific effects on quality of life may be due to difference in
delivery (Testa, Turner, Simonson, Krafcik, Calvo, Luque-Otero, 1998). Grant
HS07767.
- Focus
groups of HIV-infected individuals were conducted to assess how the HIV wasting
syndrome had affected them in several areas (physical, psychological, social). Generic
measures of quality of life fail to provide the sensitivity and depth required
to evaluate major issues raised by the focus group participants with respect to
the specific impact of HIV wasting on their lives (Testa, Lenderking, 1999). Grant
HS07767.
- A retrospective
cohort study that used linked New Jersey Medicare and drug claims data found
that the use of long-acting dihydropyridine calcium channel blockers after
acute myocardial infarction (AMI) was associated with substantially lower rates
of re-hospitalization and death compared with use of their short-acting
counterparts (Gillman, Ross-Degnan, McLaughlin, Gao, Spiegelman, Hertzmark, Goldman, Soumerai, 1999). Grant HS07631.
- Only 21 percent
of eligible New Jersey Medicare beneficiaries who survived an acute myocardial
infarction (AMI) receive beta blocker therapy following the heart attack. These
patients were almost three times more likely to receive a new prescription for
a calcium channel blocker than for a beta blocker after their AMI. Eligible
patients receiving calcium channel blockers instead of beta blockers doubled
their risk of death (Soumerai, McLaughlin, Spiegelman, 1997). Grant
HS07631.
- The Lyme Disease
Project calculated the incidence of Lyme disease in the 24 Maryland jurisdictions by gender and age from 1993 through
1996. The State's overall incidence rate was 7 cases per 100,000 inhabitants, with males being 1.2 times more likely to be affected than females, peaking
during the age groups 10-19, 20-29, and 50-59 (Pena, Strickland, 1999). The Project also conducted an
epidemiological assessment of antibiotics prescribed by physicians in Maryland to treat Lyme disease between 1993 and 1995 (Pena, Mathews, Siddiqi, Strickland, 1999).
Grant HS07813.
Return to Contents
- Thirty percent of
children treated for new-onset acute otitis media in Colorado's fee-for-service Medicaid program received expensive
antibiotic therapy, rather than less costly, equally efficacious products. More
expensive antibiotics accounted for approximately 77 percent of the dollars
spent for medications to treat otitis media in this population, but were not
associated with better outcomes (Berman, Byrnes, Bondy, Smith, Lezzotte, 1997). Grant
HS07816.
- Prior
authorization by Tennessee Medicaid programs for expensive arthritis
medications (non-steroidal anti-inflammatories, or NSAIDs) reduced prescription
NSAID expenditures by 53 percent over 2 years and saved $12.8 million, without
increasing the use of other medical services or less desirable drugs (Smalley, Griffin, Fought, Sullivan, Ray, 1995). Grant HS07768.
- The impact of a
three-prescription per month cap in New Hampshire on the use of resources by
Medicaid enrollees with schizophrenia resulted in reductions in the use of
drugs, coincident increases in visits to community mental health clinics, and
dramatic increases in the use of emergency services. Limits on prescription
drug coverage may increase the use of acute mental health services among
low-income patients with chronic mental illnesses and increase costs to the
government (Soumerai, McLaughlin, Ross-Degnan, Casteris, Bollini, 1994).
Grant HS07631.
Return to Contents
- An automated
Web-based patient interview tool was developed to elicit individuals'
willingness-to-pay (WTP) utilities under conditions of uncertainty and to
evaluate the tool's potential usefulness for clinical decisionmaking (Flowers, Garber, Bergen, Lenert, 1997). Grant HS07818.
- This randomized
controlled trial utilized a pharmacy intervention group and two control groups
to develop algorithms to facilitate pharmaceutical care for the treatment of
asthma. Similar levels of medication compliance and health related quality of
life improvement were observed in the pharmaceutical care group and in both
control groups (Weinberger, Murray, Marrero, Brewer, Lykens, Harris, Tierney, 2001). Grant
HS09083.
- A study to
incorporate complex heart failure treatment guidelines into a
physician-interactive network of microcomputer stations revealed key challenges
for the development of interactive information systems, including the need for
explicit definitions and the need to account for co-morbid conditions, concurrent drug therapy, timing of interventions, and followup (Tierney, Overhage, Takesue, Harris, Murray, Vargo, McDonald, 1995). Grant HS07763.
- A study
evaluating the validity of patient report, pharmacy dispensing records, and
pill counts as measures of medication adherence found that: pharmacy dispensing
records demonstrate predictive validity as measures of cumulative exposure and
gaps in medication supply; adherence levels determined from pill counts and
pharmacy dispensing records correlate more closely with quantity than with dose
timing; and patient-reported non-adherence is a valid predictor of reduced
adherence (Choo, Rand, Inui, Lee, Cain, Cordeiro-Breault, Canning, Platt, 1998). Grant
HS07821.
Return to Contents
- An evaluation of
the relationship between non-steroidal anti-inflammatory drugs (NSAID) use in
community-dwelling elderly found no substantial protective effect of
prescription NSAID use on cognitive function, and in fact suggested that higher
doses may be associated with memory deterioration in this population (Hanlon, Schmader, Landerman, Horner, Fillenbaum, Pieper, Wall, Koronkowski, Cohen, 1997). Grant HS07819.
- Inadequate
routine primary care among African American patients may increase their risk of
asthma exacerbation and hospitalization, and is associated with higher
emergency department use compared with white males (Murray, Stang, Tierney, 1997).
Grant HS07763.
- Researches found
racial disparities in the receipt of medication to prevent Pneumocystis carinii pneumonia (PCP) among patient with HIV disease (Moore, Stanton, Gopalan, Chaisson, 1994).
Grant HS07809.
- Among patients
with HIV infection who received medical care from a single urban center, there
were no differences in disease progression or survival associated with gender, race, injection drug use, or socioeconomic status. Differences found in other
studies may reflect differential use, quality, and access to care (Chaisson, Keruly, Moore, 1995). Grant HS07809.
- Two randomized
controlled trials, one for community dwelling elderly and the other for nursing
home patients, were conducted to reduce the use of non-steroidal
anti-inflammatories (NSAIDs) for osteoarthritis in an elderly population. The
nursing home intervention effectively reduced NSAID use, while the
community-dwelling intervention only modestly reduced NSAID exposure among
elderly patients without undesirable substitution of other medications (Stein, Griffin, Taylor, Pichert, Brandt, Ray, 2001). Grant HS10385.
Return to Contents
- An assessment of
the long-term safety of adjunctive corticosteroids in the treatment of Pneumocystis carinii pneumonia (PCP)
found that adjunctive corticosteroids do not increase mortality or the risk of
most common HIV-associated complications (Gallant, Chaisson, Moore, 1998). Grant HS07909.
- Researchers
concluded that active injection drug users who are HIV positive but without
clinical disease have less contact with health care providers and are less
likely to receive antiretroviral therapy than other HIV positive patients (Celentano, Vlahor, Cohn, Shadle, Obasanjo, Moore, 1998). Grant HS07809.
- An analysis of
information stored in electronic medical records for patients with evidence of
ischemic heart disease or heart failure successfully predicted patients at high
risk for mortality. Routine clinical data store in patient's electronic medical
records are capable of predicting mortality and can be used to focus
increasingly scarce health resources on those at highest mortality risk (Tierney, Takesue, Vargo, Zhou, 1996). Grant HS07809.
- A retrospective
cohort study examined factors associated with failure to suppress HIV-1 RNA
levels and adverse drug reactions in patients receiving protease inhibitor-containing
therapy. The study concluded that patients in whom highly active antiretroviral
therapy (HAART) is started in a clinical setting achieved viral suppression
substantially less frequently than patients in controlled trials (Lucas, Chaisson, Moore, 1999). Grant HS07809.
These grants answer many
important questions regarding the management of drug prescribing. Their
findings are successfully being used by organizations such as the Centers for
Medicare & Medicaid Services to evaluate programs that seek to manage care
and improve quality and outcomes. In addition to studies funded through the
Pharmaceutical Outcomes and CERTs programs, AHRQ has other projects in its
portfolio that, although not solely focused on pharmaceuticals, have findings
of interest to the pharmaceutical research community. These are listed in
Appendix A.
Return to Contents
AHRQ Publication No. 04-R205
Current as of June 2004
Internet Citation:
Outcomes of Pharmaceutical Therapy Program (OPT) Update. AHRQ Publication No. 04-R205, June 2004. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/clinic/pharmtherapy/optupdat.htm
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