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Results of Pharmaceutical Care Program Disappoint Researchers

Donna Young

Results of one of the first randomized controlled studies to examine the effectiveness of outpatient pharmaceutical care programs have left researchers disappointed, according to one of the study’s investigators.

Pharmacists practicing in community pharmacies, the largest provider of prescription drug services, have a substantial opportunity to help improve patients’ health by monitoring symptoms providing medication counseling, and helping resolve drug-related problems, according to researchers at the Regenstrief Institute of Indianapolis, Indiana, a joint research organization of the Indiana University and the Richard L. Roudebush Veterans Affairs Medical Center.

But a Regenstrief-conducted study, published in the Journal of the American Medical Association (JAMA), found that patients enrolled in a pharmaceutical care program had only slight improvements in their medical condition and were more likely to visit emergency rooms or be hospitalized than patients not in the program.1

On the positive side, patients in the pharmaceutical care program reported being more satisfied than other patients with the pharmacists and the health care received.

The study was conducted from July 1998 to December 1999 in Indianapolis at 36 community pharmacies owned by CVS Corporation of Woonsocket, Rhode Island. Investigators enrolled 1113 patients with chronic obstructive pulmonary disease (COPD) or asthma and randomly divided them into three groups. The patients’ lung function was assessed initially and at 6 and 12 months.

Pharmacists in the pharmaceutical care program received training, patient education materials, and a special computer, separate from the pharmacy’s system, that allowed access to specific patient information, including emergency department visits and hospitalizations, medication compliance, and patients’ peak expiratory flow rate (PEFR)—the maximum velocity of exhalation that can be generated after full inhalation. Each patient in the pharmaceutical care program was provided with a peak flow meter and instructions about its use. Research personnel called those patients each month to record the PEFRs, which were then provided to pharmacists in the program.

The second patient group was also given peak flow meters, but pharmacists in that group were not provided with the PEFRs and special computer. Patients in the usual care group did not receive a peak flow meter.

Although not one of the study’s main inquiries, the researchers found that the patients with peak flow meters but no pharmacist intervention made twice as many breathing-related emergency department or hospital visits as did the usual care group. Perhaps, the researchers suggested, patients with a peak flow meter—regardless of pharmacist involvement—sought more medical care because they associated their PEFR with symptoms of COPD or asthma. Increased involvement by patients in their medical care may increase their use of health services, the researchers added.

But the most likely explanation for the study’s results, the investigators wrote, was that, despite their efforts to design a pragmatic program and reinforce its use, the program was not used consistently by the pharmacists.

The community pharmacists, the researchers noted, failed about half of the time to access and document patient information in the computers designated for study use. Having to access patients’ data on a computer separate from the pharmacy’s main one, the investigators wrote, may have been cumbersome for the pharmacists in the pharmaceutical care program. (See May 1, 2001, AJHP for a description of the special computer system.)

When the study was designed in 1998, said coauthor Michael D. Murray, Purdue University professor of pharmacy practice and a Regenstrief research scientist, Internet-based programs that could easily integrate patients’ data with a pharmacy’s information system were not as evolved and ubiquitous as they are today.

Future studies may show that using one computer to access and enter patient information, Murray said, can help community pharmacists better adapt a pharmaceutical care program to their busy daily routine.

Pharmacists participating in the program were enthusiastic at the beginning of the program, Murray said.

"All of the pharmacists wanted to do something different that might lead to a healthy outcome for patients," he said. "But when they returned to their practice setting and were faced with the reality of everything else they had to do, it all changed."

Murray said the investigators made regular personal visits with the pharmacists to reinforce their training and encouraged them to continue accessing and documenting patient data. Near the end of the study, he added, the investigators rewarded pharmacists with CVS coupons as additional motivation.

But, Murray said, the results indicate that a better model is needed to keep pharmacists engaged in pharmaceutical care.

In an editorial in the same issue of JAMA, researchers at the University of Pennsylvania Center for Clinical Epidemiology and Biostatistics said that, despite the study’s results, rigorous scientific investigations of that nature are needed.2 Even when a program intuitively makes sense, the editorial’s authors noted, evaluations of interventions, such as the Regenstrief study, are crucial.

Had the results in the intervention group been examined only as a beforeand-after comparison, the editorial noted, "the conclusion would have been a misleading indication of the apparent effectiveness of the pharmacy-based intervention, when in fact it was ineffective."

  1. Weinberger M, Murray MD, Marrero DG et al. Effectiveness of pharmacist care for patients with reactive airways disease. JAMA. 2002; 288:1594-602
  2. Strom BL, Hennessy S. Pharmacist care and clinical outcomes for patients with reactive airways disease. JAMA. 2002; 288:1642-3. Editorial.