Meeting the quality standards for influenza, pneumococcal vaccination

March 2004

The development of vaccines is considered one of the most notable public health achievements of the 20th century. During the 1900s, 21 vaccines were developed or licensed for use in the United States with 11 of the vaccines recommended for routine use in children. Widespread vaccination programs have been credited with the eradication of smallpox and the elimination of poliomyelitis caused by wild-type virus. Additionally, the numbers of cases from vaccine-preventable diseases in children such as Haemophilus influenzae type b and measles have been reduced to low numbers.

Despite the overwhelming impact of vaccines on preventing disease, there remains opportunity for health care providers to increase vaccination rates, especially in adults. The vaccination rate for recommended childhood vaccines exceeds 90%. This may be attributed to the availability of public funds for providing childhood vaccines and the requirement of immunization prior to school entry. In contrast, the rate of influenza and pneumococcal vaccination remains just over 60%, even though the last decade has seen marked increases in adult vaccination rates.

Pneumonia and influenza continues to cause substantial morbidity and mortality in people aged 65 years and older. Influenza vaccination has clearly shown to be a cost-effective preventive care measure. Nichol and colleagues clearly demonstrated the impact of influenza vaccination on reducing the risk of hospitalization from heart disease, cerebrovascular disease, pneumonia or influenza, and a reduction in the overall risk of death in an elderly population during two influenza seasons. The cost effectiveness of the 23-valent pneumococcal vaccine has not been as clearly demonstrated when compared with the use of the influenza vaccine, but has been found to reduce hospitalization and mortality in vaccinated individuals.

The Center for Medicare and Medicaid Services (CMS) has targeted adult immunization in the Medicare Quality Improvement Priorities. In the early 1990s, CMS initiated quality improvement programs to improve the quality of health care provided to Medicare beneficiaries. During the last decade, the quality programs have been expanded to encompass four practice settings (nursing homes, home health agencies, hospitals and physician offices) and use more than 20 quality indicators. Quality measures for immunization against influenza and Streptococcus pneumoniae can be found in both the hospital (specifically the community-acquired pneumonia initiative) and the physician office priorities.

The objectives are to increase the number of hospitalized patients 65 years of age and older to be screened for influenza and pneumococcal immunization status, and to vaccinate individuals prior to discharge if indicated. If an individual is screened and vaccination is not indicated, the results of the screening should still be clearly documented in the patient’s medical record. CMS is accountable for performance improvements under the Government Performance and Results Act, which include “increase annual influenza vaccination and pneumococcal lifetime vaccination” as one of the Act’s goals.

How to meet the standard

In 2000, the CDC Advisory Committee on Immunization Practices (ACIP) published recommendations for standing order programs to increase adult vaccination rates. A standing order program would authorize nurses and/or pharmacists to administer vaccinations according to an approved protocol without the need for a physician exam or physician order, when allowed by state law. Standing order programs can be implemented in inpatient and outpatient settings, long-term care facilities, and home health care agencies, as well as other health care settings. The key elements of a standing order program include:

• Identifying vaccinated people, and those eligible for vaccination based on age or the presence of a medical condition that puts them at risk.
• Assessing contraindications to receiving the vaccine, including medical contraindications.
• Providing adequate information to the patient or caregiver on the benefits and risk of vaccination.
• Documenting patient’s refusal for vaccination or the presence of vaccine contraindications.
• Documenting vaccine administration.
• Providing documentation of the vaccination to the patient and patient’s primary care provider.

Several studies have demonstrated the use of standing order programs on increasing vaccination rates. At one university medical center, a pharmacy-based standing order program showed an increase in pneumococcal vaccination from 7.3% of general medicine inpatients to 64% during a seven-month period. Similar results have been found with nursing-based standing order programs. In October 2002, CMS issued a change to the Conditions of Participation: Immunization standards and removed the requirement for an individual physician order for each vaccine administered. This effectively removes one of the barriers to vaccination, primarily the reliance on the physician remembering to address immunization status along with the patient’s other problems, which may be of greater importance at the time of hospitalization. The rule change also advocates the use of standing order programs to increase the influenza and pneumococcal vaccination rate in Medicare and Medicaid beneficiaries. Although the CMS influence primarily revolves around Medicare beneficiaries, it is anticipated that the change in CMS rules will stimulate a trickle-down effect and also have positive effects on patients other than Medicare beneficiaries.

Meeting the demands to vaccinate

Health care professionals have to deal with the new challenges and frustrations of vaccine shortages. In the beginning of 2001, the United States experienced an unanticipated shortage of routinely recommended vaccines. The vaccines most affected by shortages were diphtheria and tetanus toxoids with acellular pertussis vaccine (DTaP, Pediarix, GlaxoSmithKline), measles, mumps, and rubella (MMR, Priorix, GlaxoSmithKline), varicella (VariVax, Oka/Merck), pneumococcal conjugated vaccine (PCV7, Prevnar, Wyeth) and adult tetanus and diphtheria toxoids (Td). This resulted in vaccination schedules having to be adjusted due to shortages and then having to catch-up vaccinations once vaccines became available. The vaccine shortages have been mostly resolved with the exception of the pneumococcal-conjugated vaccine, which continues to have supply problems.

The cause of vaccine shortages is multi-factorial and a result of coincidental independent occurrences; a manufacture discontinuing some vaccine product lines, another manufacturer upgrading vaccine production equipment to meet Good Manufacturing Practices, and unanticipated demand for some vaccines. The production lead times for vaccines is long when compared with other pharmaceutical products and often requires a year from start of production to reaching the market for use in patients, thus, making adjustments in production nearly impossible. Additionally, some vaccines are only produced by a single source, and most have no more than two or three suppliers. Therefore, any breakdown in the manufacturing process may result in substantial supply shortages of vaccines.

The influenza vaccine presents a unique set of problems for manufactures, which greatly affects the yearly supply. The composition of the influenza vaccine changes almost every year not allowing for stock piling of supply from year to year. If the yield from candidate strains for the vaccine is not as high as anticipated, this may result in fewer than desired doses being produced. Additionally, some strains may take longer than anticipated to produce the desired yield resulting in delays in vaccine availability. Both of these scenarios have occurred in recent years. The beginning of the 2003-2004 influenza season saw increased numbers of early influenza cases resulting in an unprecedented demand for the influenza vaccine. The supplies of influenza vaccine were rapidly sold and resulted in a relative shortage of vaccine. Having to pre-order influenza vaccine more than six months in advance complicates purchasing influenza vaccine by large health care suppliers, both public and private health care institutions. At this time, health care institutions have to anticipate their need for influenza vaccine for the 2004-2005 influenza season and place those orders with vaccine suppliers; these orders are not easily changed after July.

The development and use of vaccines is unquestionably one of the most notable achievements in the battle against infectious diseases. Healthy People 2010 as well as other public and private agencies have made increasing the rate of all immunizations a major health priority. This is an excellent opportunity for health care practitioners to collaborate in order to meet this important health priority.

For more information:

• CDC. Impact of vaccines universally recommended for children – United States, 1900-1998. MMWR. 1999;48:243-248.
• Nichol KL, Nordin J, Mullooly J, et al. Influenza vaccination and reduction in hospitalizations for cardiac disease and stroke among the elderly. N Engl J Med. 2003; 348:1322-32.
• Medicare Quality Improvement. www.medqic.org.
• CDC. Use of standing orders programs to increase adult vaccination rates: recommendations of the Advisory Committee on Immunization Practices. MMWR. 2000;49(No. RR-1):15-26.
• Noped JC, Schomberg R. Implementing an inpatient pharmacy-based pneumococcal vaccination program. Am J Health-Sys Pharm. 2001;58:1852-55.
• Department of Health and Human Services. Centers for Medicare and Medicaid Services. Medicare and Medicaid Programs: Conditions of Participation: Immunization standards for hospitals, long-term care facilities, and home health agencies. Federal Register. Vol 67, No. 191, pp 61808-61814. October 2, 2002.
• Department of Health and Human Services, National Vaccine Program Office. Strengthening the supply of routinely recommended vaccines in the United States: A report of the National Vaccine Advisory Committee. January 2003.

• Marianne Billeter, PharmD, BCPS, is Clinical Pharmacy Specialist, Infectious Diseases, Ochsner Clinic Foundation, New Orleans.