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Stand and deliver: Vaccine standing orders program boosts immunizations
Collaboration, education keys to boosting low pneumococcal rates
Determined to improve a dropping in-hospital vaccination rate for pneumococcal polysaccharide vaccinations, University of Pittsburgh Medical Center-Presbyterian (UPMC-P) went on the cutting edge nationally to design and implement a pharmacist-run inpatient program that successfully reversed the trend.
The effort was helped by a 2002 Centers for Medicare and Medicaid Services final rule that removed the federal requirement for an individual patient physician-signed order for the pneumococcal and influenza vaccines in Medicare- and Medicaid-participating institutions. That rule authorized implementation of standing orders programs (SOPs) in health care institutions. Information on the program was published in the American Journal of Health-System Pharmacy.1
Study lead author Denise Sokos, Pharm.D., BCPS, of the University of Pittsburgh School of Pharmacy and UPMC-P, says pneumococcal disease causes significant morbidity and mortality in the U.S. each year despite availability of safe and effective vaccines. One of the objectives for Healthy People 2010 is vaccination of 90% for pneumococcal and influenza coverage among persons age 65 and older and 60% coverage for non-institutionalized high-risks persons aged 18 to 64 years.
In 2003, total national median pneumococcal polysaccharide vaccine (PPV) administration rates for adults anytime during their lifetime were 64% in the elderly population and 37% in persons with diabetes aged 18 to 64. State and national immunization mandates try to address the low vaccination rates. Pennsylvania's 2004 Elderly Immunization Act required healthcare institutions to offer the PPV to all eligible patients year-round and influenza vaccination to elderly patients during October and November. And the Joint Commission on Accreditation of Healthcare Organizations has included pneumonia as a core performance measure in the accreditation process as of July 1, 2002, and recently required hospitals to submit data for a national database.
Sokos reports that a traditional physician-reminder PPV vaccination program for inpatients had been in place in the UPMC-P general medicine units since 2000. The program's computer model generated a daily list of new admissions, including patient age, concurrent medications, and prior vaccination status to identify at-risk patients. Pharmacy personnel performed a patient risk assessment to determine eligibility for vaccination and pre-printed order forms requiring a physician signature were placed in eligible patients' charts.
Rates well below state and national averages
At the peak of the program's effectiveness, researchers say, in-hospital total vaccination rates, including prior vaccinations, were 31%, and the rates fell to 15% by the end of 2003, well below the rates for Pennsylvania and the nation as a whole.
Sokos tells Drug Formulary Review that the major problem with the older system was that physicians had to sign vaccination orders and generally did not do so. "They might have thought it wasn't important," she says, "or were unsure of their patients' past vaccination history, or were not aware of the need for vaccination."
When the change in federal rules permitted implementation of a standing orders program, pharmacists and nurses were authorized, if permitted by state law, to screen for vaccine eligibility and contraindications, to prescribe and administer vaccines, and to observe patients for adverse effects without a physician's examination or order according to an institution- or physician-approved protocol. Pennsylvania approved regulations allowing pharmacists to administer vaccines in July 2006.
Sokos reports that since multiple sources recommend vaccine SOPs as the most effective method to increase adult vaccination rates and the least burdensome to implement, UPMC-P decided that transitioning to an inpatient PPV SOP was necessary to reverse the hospital's steadily declining inpatient vaccination rate. The institution assembled a multidisciplinary expert team to evaluate the existing physician-reminder program and design the tools and processes for converting to a vaccine SOP. On the team were family medicine physicians, health services researchers, and representatives from pharmacy, nursing administration, and information systems support. They identified potential problems at four steps of the medication-use process in the existing chart reminder program.
At the prescribing step, after screening patients for disease risk and contraindications, pharmacists placed preprinted orders in the charts of vaccine-eligible patients. Physicians often did not sign the orders for a variety of reasons as noted above. At that time, the researchers say, the hospital had a nursing-generated, non-computerized three-day medication administration record. They found that the vaccine order was often inadvertently missing from the medication administration record because it was either not initially transcribed when ordered or not recopied when the length of stay went beyond three days. That manual process resulted in omitted doses for some patients.
The researchers say one of the most frequent process breakdowns occurred when an ordered vaccine was not administered before discharge, partially due to ambiguous wording on the pre-printed order form.
Root causes of low rates
The team determined that the root causes of low vaccination rates were (1) unsigned vaccination orders, (2) lack of specific order form instructions, and (3) a knowledge deficit among healthcare workers on the indications, contraindications, and importance of vaccination, especially in inpatient settings. "Understanding the potential barriers that prevented hospitalized patients from receiving vaccinations was instrumental in determining the requirements of a successful vaccination SOP," the study says.
Although the SOP eliminated the need for a patient-specific signed physician order, the researchers say a significant issue to be resolved was the need for the order to be in a recognizable format to facilitate the nursing staff being aware of it and following through on it. The team decided to design the form to resemble other UPMC-P physician order forms. They combined the patient risk assessment form with the actual vaccination order form to familiarize staff with the vaccination process. The patient risk assessment includes the Advisory Committee on Immunization Practices (ACIP) recommendations for assigning a patient's disease risk, contraindications to vaccinations, and previous vaccination history. The order specifies a vaccine administration date and time and provides parameters for intramuscular or subcutaneous administration.
Sokos says the expert team determined that day 2 of admission was the earliest that vaccination could practically be approached during an inpatient stay. That time was optimal, leaving adequate time for screening admissions, writing orders, allowing physicians to cancel the order if they chose, delivering the vaccine to the unit, educating patients, and administering the vaccine to consenting patients. The team found, however, that vaccine doses were being omitted because of morning and afternoon discharges on admission day two and revised the order to specify to administer the vaccine "now." The order stays active on the patient's profile until the vaccine is administered, refusal is charted, or the patient is discharged.
Pre-printed sticker to help nurses comply
To ensure compliance with the vaccine documentation requirements, the team developed a pre-printed medication administration record sticker to simplify procedures for nurses. Nurses are required to document the date and time of administration, indicate the administration site, initial the sticker, and attach it to the people record. Vaccine refusals and prior vaccinations are handwritten on the sticker to document patient vaccination status. A pharmacy technician documents the vaccine manufacturer and lot number before delivery of the vaccine to the patient care unit. All who are vaccinated receive a Centers for Disease Control and Prevention Vaccine Information Statement for education before vaccination.
An important early planning step was determining whether pharmacy or nursing staff would maintain the SOP, since that decision affected all other planning steps," Sokos says. The pharmacy department operated the physician reminder program and the expert team decided the SOP should also be pharmacy driven. With that decision made, a pharmacy-nursing process work group that included pharmacists, a pharmacy technician, nurses, and specially trained pharmacy students designed SOP flow and defined roles of pharmacy personnel and nursing staff.
UPMC-P uses student pharmacists and a pharmacy technician as a workflow support structure to sustain the vaccination program so pharmacists can focus on patient risk assessment and evaluating vaccine contraindications. The hospital's pharmacy and therapeutics and medical executive committees approved the expert team's PPV SOP program and procedures in November 2003 and it was implemented the following May. As the SOP workflow stabilized, Sokos says, the team formalized a vaccine program written hospital policy that was approved by the hospital's policy review committee in February 2006. Key policy elements include a statement that a physician's signature is not required on each order; the explicit ACIP vaccine eligibility criteria; responsibility for patient screening, order writing, and vaccine administration; and documentation procedures for administration, prior vaccinations, and refusals. The policy also sets forth the mechanism for notifying patients' primary care physicians that patients received a vaccination during the hospital admission.
Educational programming a key to success
Sokos tells Drug Formulary Review that educational programming was a key element in the program's success, especially since a knowledge deficit was believed to be one of the root causes of low vaccination rates under the prior chart-reminder program. UPMC-P developed all educational materials in-house, tailoring educational sessions to each audience, focusing on the risk of pneumococcal disease, the importance of inpatient vaccination, vaccine safety, and the new SOP workflow. Groups targeted for educational programming included doctors, nursing administration and staff, unit clerks, and pharmacists. A single-page handout was developed for nursing that included the most important program details. Nursing and pharmacist staff meetings and electronic communications described the program in detail, while 10-minute nursing in-services provided key elements for understanding the SOP operation.
Physicians were informed on the program through medical executive committee meetings, pharmacy and therapeutics committee processes, and e-mail alerts. Also, expert team members made themselves available for anyone to ask questions by pager or e-mail. "Physician, nurse, and pharmacist champions were important providers of education to their colleagues during the planning and implementation periods," Sokos says.
Vaccine SOP effectiveness was evaluated through continuous quality improvement monitoring. Chosen indicators were the vaccination rate and the percentage of omitted doses. The pharmacy department assumed responsibility for monitoring the two indicators. The vaccination rate threshold was set at 90% of elderly inpatients, consistent with the Healthy People 2010 goal.
Since launching the program, pharmacy personnel have screened more than 800 patients per month, requiring about 90 minutes a day to perform their designated duties. The PPV vaccination rate increased dramatically after the SOP was launched. Some 30% of screened at-risk patients are not vaccinated under the SOP. The 30% primarily includes patients who refuse vaccination (about 13%) and omitted doses.
Make sure team is multi-disciplinary
"Compared with other published PPV vaccination rates from SOPs, we are among the most successful to date," the researchers wrote. "Factors contributing to success include the careful design of the SOP through multidisciplinary support and planning, early determination of persons responsible for patient screening, analysis of barriers to vaccination in the existing chart-reminder program, design of user-friendly implementation tools, ongoing quality improvement monitoring, and real-time problem solving. As problems are identified during the daily process, attention is given to determining the cause and finding solutions. Contact with nurses provides a means to resolve problems, and ongoing education is used to prevent further problems. The process continually works toward improving the vaccination rate."
Other facilities wanting to emulate the UPMC-P vaccine SOP success should ensure that the planning team is multi-disciplinary, and that hospital administration is supportive and will help develop policies and procedures, Sokos tells DFR.
(Editor's note: Contact Dr. Sokos at (412) 647-0828 or e-mail firstname.lastname@example.org.)