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Protocol Sharing Requires Diligence by Recipients

Cheryl A. Thompson

Pharmacists developing a therapeutic guideline or protocol for their health system may not have to reinvent the wheel but, in relying on others’ generosity, should not neglect to ascertain the relevant standard of practice, verify the reliability of the document’s original authors, and double-check the details.

“We look for what is the national standard,” said L. Midori Kondo, pharmacy director at Washington’s Kindred Hospital Seattle, a long-term acute care hospital where the stay averages about 30 days and patients, who are “very complicated, very sick,” typically arrive directly from the critical care unit of a regular acute care hospital.

“So, for anticoagulation, what is the thing that establishes the standard? Well, it’s the Chest guideline” published from the periodic American College of Chest Physicians consensus conference on antithrombotic therapy, she said, as if no one would argue with her statement.

“Basically, if you are going to be sued, they [the lawyers] are going to go back to the standards of practice,” Kondo explained. “Did you do what was the standard of practice?”

For protocols on the treatment of hypertension, Kondo said she relies on the guidelines written by the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure.

Cholesterol management at the Seattle hospital is based on guidelines from the National Cholesterol Education Program.

Both the Joint National Committee and the National Cholesterol Education Program are large multidisciplinary efforts coordinated by the federal government.

But when she was developing the protocol for conscious sedation, Kondo said, no group was viewed as having set the standard of practice. So she turned to guidelines written by the professional organization specializing in critical care medicine.

“Most of the time,” she said, “if you go to one of the specialists in the field—whether they’re a doctor or a pharmacist—you get some good information, you get a place to start.”

Kondo said she also contacts other hospitals “to see if they’re willing to share some of their protocols.” Sylvia Chen, a clinical pharmacist specializing in internal medicine at the Saint Margaret Mercy Healthcare Centers campus in Hammond, Indiana, said she likes to see other hospitals’ protocols when she develops one for her facility. As an employee of Cardinal Health pharmacy management group, she also can access protocols it has amassed from various sources.

Recently when updating her hospital’s protocol for preventing nausea and vomiting due to cancer chemotherapy, Chen sought assistance from fellow users of the listserver for the ASHP Section of Clinical Specialists and Scientists.

“The only thing that was somewhat problematic is a lot of the protocols that I did receive were a little bit outdated,” she said, adding that “it’s always interesting to see what everyone’s doing.”

With regard to the up-to-date protocols she received from listserver users, Chen said she placed more weight on protocols from institutions with a national reputation for the practice area covered in the document.

Likewise, Anne Schapman at St. Luke’s Hospital in Duluth, Minnesota, sought assistance from listserver users in her project to develop a sedation protocol with a delirium assessment scale for use in her facility’s intensive care unit.

Schapman, who splits her workweek between clinical and distributive activities, said she received multiple responses “referring me to different references that are out there or letting me see what they also use at their hospitals as a resource.”

The references were recently published guidelines, some of which were written or endorsed by a professional organization such as ASHP. Schapman, like Chen, placed more weight on protocols and guidelines from reputable societies familiar to her.

Chen said the Web-based National Guideline Clearinghouse is a good place to start searching for guidelines because of its wide range of sources. But practitioners in search of specific protocols ready for adoption by an institution, she said, should look elsewhere.

The five-year-old clearinghouse, sponsored by the federal Agency for Healthcare Research and Quality, is an electronic database of clinical practice guidelines from the public and private sectors.

Developed in partnership with the American Medical Association and the American Association of Health Plans, the clearinghouse aims to ease clinicians’ access to credible, peer-reviewed scientific information.

ECRI, the Pennsylvania health services research agency formerly known as Emergency Care Research Institute, developed the current version of the clearinghouse and its content.

Recent additions to the clearinghouse include the American Gastroenterological Association guidelines on osteoporosis in gastrointestinal diseases, the American Academy of Orthopaedic Surgeons clinical practice guideline on osteoarthritis of the knee, and the Brigham and Women’s Hospital guide to the prevention, diagnosis, and treatment of upper-extremity musculoskeletal disorders.

As of mid-December, the clearinghouse claimed to contain summaries of 1162 guidelines that had been submitted and met the inclusion criteria, such as completion in the past five years.

Cynthia L. LaCivita, ASHP director of clinical standards and quality, said the clearinghouse is useful for more than simply locating guidelines.

The clearinghouse’s summaries, she said, describe the methods used in developing the guideline and can be used to answer the following important questions about each recommendation: “Was the recommendation graded with regard to the evidence? Was it a randomized controlled trial? Was it based on clinical opinion?”

LaCivita works with the ASHP Commission on Therapeutics to develop therapeutic guidelines and position statements. Before coming to ASHP, she helped develop guidance documents at a large teaching hospital and clinical protocols and pathways at a small community hospital.

“If you have a colleague who is willing to share a protocol or a pathway with you, it would probably be a good idea—even if it comes from a reputable institution—to go back and do some of the research yourself,” LaCivita said. “Go back and compare it to nationally published guidelines and see if the recommendations that have been published are matching up to the things that are in the protocol or pathway that was given to you . . . . It will give you some insight into why some of these recommendations were made and some of the evidence that backs them up.”

A recipient of another institution’s protocol, LaCivita added, should also determine whether the information is accurate and reflects the most current evidence on the subject.

In addition to the National Guideline Clearinghouse, she said, treatment recommendations can be found at the National Library of Medicine’s Health Services/Technology Assessment Text, a searchable collection of clinical practice guidelines, technology assessments, and health information, and the National Quality Measures Clearinghouse, a searchable collection of evidence-based quality measures and measure sets.

“Even though somebody may share their guidelines with you, it’s always important, I think, to go back and just kind of double-check and make yourself familiar with those documents that are out there—verify the process and actually document that the information in there is actually accurate,” she said.

LaCivita offered the following additional tips for protocol developers:

  • Keep in mind the reason why you’re developing the protocol.  
  • Ask for input from the other health care professionals who may use or be affected by the protocol.  
  • Seek the help of your organization’s specialists when the available evidence-based guidelines lack specific recommendations for individual medications. 
  • Do not fret if the cumulative evidence does not clearly support the use of one drug over its alternatives.  
  • Plan to revise the protocol to keep it relevant to practice.