In its 2009 report The state of the world’s vaccines and immunizations,the World Health Organization (WHO) described vaccines as “one of the most powerful and cost-effective of all health interventions. It prevents debilitating illness and disability, and saves millions of lives every year. Vaccines have the power . . . to . . . save . . . lives.”1 Vaccines, according to the WHO, are ranked second only to clean water for the prevention of disease and improvement of all human life.
In the U.S., a child can receive a dozen or more shots and be vaccinated against 23 diseases before the age of 18. The most recently published recommended immunization schedule furnished by The Centers for Disease Control and Prevention (CDC) states that the cost to immunize a child in the U.S. through adulthood is $1,195 for males and $1,483 for females.2 A vaccination administrator will typically hold between $5,000 and $15,000 of vaccine inventory in a refrigerator at any one time.3 The fragile nature of vaccines requires that they must be stored at proper temperatures. To maintain their efficacy, most vaccines require refrigeration, while some must remain frozen. All vaccines must be protected from heat. The CDC also estimates that between 15-35% of all vaccines distributed in the U.S. become unusable and are wasted as a result of temperature spoilage.4 The proper procurement, storage and administration of vaccines is essential for maintaining both the social value and economic value of these drugs.
Under New Administration
Pharmacists regulated by individual states’ laws have been administering vaccines to patients for many years. It was only in October of 2009 that the state of Maine passed a law to become the last of the 50 states to allow pharmacists to administer vaccines.5 Advancements in the training of pharmacists initiated by the American Pharmacy Association (APhA) in 1996 accelerated the practice when they published the Pharmacy-Based Immunization Delivery Program, which was endorsed by the CDC.6 By 2006, 43 states had laws on the books allowing registered pharmacists to provide immunizations. The H1N1 pandemic influenza scare of 2009 motivated the few remaining states to enact legislation removing legal hurdles to allow pharmacists in all 50 states to administer vaccines.7
The nationwide shift in vaccine administration by pharmacists received additional legislative endorsement when the Patient Protection and Affordable Care Act was signed into law on March 23, 2010 as part of the Healthcare Initiative created by President Obama. Under PPACA, which will become effective September 23, 2011, “children 0 -18 years that are enrolled in new group or individual private health plans will be eligible to receive vaccines recommended by the CDC Advisory Committee on Immunization Practices (ACIP) prior to September 2009 without any cost-sharing requirements when provided by an in-network provider.” Essentially, this means that co-payments or deductibles will no longer be accepted for the administration of vaccines for preventive care.
Conventional wisdom holds that this economic pressure on primary care physicians and pediatricians will discourage them from administering vaccines. At the 2011 APhA conference in Seattle, WA, the association’s president, Harold Godwin, stated that he believes this will increase the flow of patients to pharmacists for vaccinations, and that pharmacy owners should work with local physicians to facilitate information sharing to complete patient history files.
Studies Show Pharmacists are Qualified
Each year, nearly 90,000 Americans die of infections that can be prevented by vaccination, such as influenza, pneumococcal disease, and hepatitis B, according to the ACIP. Influenza and pneumonia together are the fifth leading cause of American deaths.8
A study published in 2004 in the journal Vaccine compared influenza vaccination rates in states where pharmacists were authorized to administer vaccines versus states where they were not. Researchers reviewed and compared data from 1995, when only nine states allowed pharmacists to vaccinate patients, with data from 1999, when the number of states had grown to 30. The research concluded that states allowing pharmacists to provide immunizations had significantly more people in all age groups who were immunized against influenza than in states that did not. Among patients ages 18 to 64, states allowing pharmacist administration of vaccines had a 5% increase in vaccination rates between 1995 and 1999. And for patients age 65 years and older, influenza vaccination rates were significantly higher in states allowing pharmacist vaccination (10.7%, compared with 3.5% in states without authorization).9 This demonstrates that making vaccines more accessible to the general population through pharmacists results in a higher vaccination rate. The time-strapped American consumer is often influenced by convenience. The administration of vaccines at a local pharmacy without the need, time or costs associated with scheduling a doctor’s appointment is a tempting convenience indeed — just one more thing to add to the list of things to get while at the pharmacy. This model can be leveraged to improve vaccination rates for conditions other than influenza.
Are Pharmacists Ready for This New Responsibility?
Properly trained pharmacists are taking proactive steps to improve their potential for success. It is proposed that the standard concern of pharmacists is centered around the procedures for injecting the patient and informing them of potential side-effects while not enough emphasis is placed on the processes for receiving vaccines, storing them at proper temperature levels, and reporting their administration to physicians or state registries. Pharmacists may be experienced with managing tablet-style drug inventories, but the physical fragility of temperature-sensitive vaccines carries additional responsibilities. If they are stored or administered at temperatures that are too high or too low, efficacy can be negatively affected and the patient may be inadequately protected.
Managing Temperature-Sensitive Vaccines at the Pharmacy Level
Vaccines have great social value allowing for an improved quality of life by preventing debilitating diseases. They carry a high inventory value because of their typically high cost per dose, making temperature management a critical component to inventory, cost and patient well being. Improperly stored vaccines can lose their efficacy. They must be maintained at required temperatures as determined by the manufacturer’s stability studies, up to the point of administration to the patient. For these reasons, pharmacists are encouraged to be trained on proper vaccine storage and handling procedures and be equipped to execute appropriate measures to insure that proper temperature conditions are maintained during storage and administration. Prior to administering vaccines, a pharmacist will receive certification training from a state-approved agency. However, in some cases they may not be fully trained to handle temperature management.
Good and Best Practices
The CDC has clearly indicated that proper handling and storage of vaccines is paramount. An organization’s basic quality management plan should ensure that each receiving location identifies an individual as the primary vaccine inventory person, and another as the secondary/backup person. They should be responsible for receiving, storing and handling all vaccines. They should maintain an inventory log documenting the vaccines received. This should include the drug name, date received, lot number, expiration date and arrival condition — including temperature. When receiving vaccines, it is important to inspect the product to insure the temperature has been maintained, and the product should be stored according to its recommended label conditions immediately upon arrival. This in accordance with the CDC Vaccine Handling and Storage Tool Kit, an on-line tool that can be found at www2a.cdc.gov/ vaccines/ed/shtoolkit/. The guide goes on to state that if vaccines arrive without a temperature monitor device or data logger or the temperature appears to be above or below that which is listed on the manufacturer’s storage label, the supplier and/or the manufacturer should be contacted. These vaccines should be quarantined or segregated and kept in the cold-chain but clearly marked so as not to be mistakenly used until it is determined if they are acceptable for use or if they are to be returned for replacement.
When storing vaccines the CDC recommends the use of a unit with separate refrigerator and freezer space. Vaccines should be placed into “breathable plastic mesh baskets” on the middle shelves (never on doors, in drawers/bins or against walls). Separate vaccines by bin and label them according to the vaccine within. Refrigerators or freezers used to store vaccines should not contain food or beverages. It is recommended to place bottles with water on door shelves to stabilize internal temperatures.10 Refrigerator temperatures must be maintained between 2º and 8º C (35ºF and 46ºF). Vaccine efficacy will decrease if they are exposed to temperatures beyond their allowable range. Diminishing efficacy is not necessarily a linear process. Often degradation is accelerated over time as the result of excessive temperature exposure or after multiple exposures to temperatures outside the recommended storage condition.
The CDC advocates the use of a mercury bulb thermometer or a digital thermometer inside a vaccine storage unit and manually recording the storage equipment or facility twice a day at a minimum. However, not only can such devices and processes be inaccurate, but they fail to document an elapsed history of temperature exposure. Continuous monitoring of the internal temperature of the storage unit is considered a best practice. This is most reliably achieved through the use of an electronic temperature-monitoring device. It is important to have an accurate, calibrated device that can provide the high and low temperatures observed each day as well as alert the user to situations when the temperature has gone beyond the required range. The WHO, for example, recommends the use of a 30-day device (such as the Fridge-tag®).11 This device will record and display high and low temperature data for the preceding 30 days. It will also provide a visual indicator if temperatures have exceeded a specified range, and if so, for how long. Such a device may be helpful to pharmacies that are closed overnight and need visibility of temperatures when no one is present.
The CDC recommends every pharmacy have an emergency vaccine retrieval and storage plan. Facilities should be equipped with a back-up generator, or an uninterrupted power supply or an approved alternate or off-site storage location. In the event of a power outage, emergency plans need to be in place and practiced well before they need to be implemented. It is important to have an emergency call-tree readily accessible for managing vaccine inventory and escalation procedures. Portable insulated coolers and pre-conditioned refrigerants will help if vaccines need to be moved to a new location. In the absence of a back-up generator or uninterrupted power source, it is important to keep the refrigerator and freezer doors closed and to rely on a continuous temperature monitoring device for information on inventory viability. Should temperatures go outside of the required range it is important to contact the manufacturer with the maximum temperature recorded and total time out of temperature. Only the manufacturer of a vaccine can determine the proper dispensation of a product that may have been compromised due to exposure to high or low temperatures.
Changing U.S. laws and shifting payment policies ensure that pharmacists will play a growing role in the administration of vaccines in the future. This increased access to vaccines among the U.S. population will result in lower costs and will benefit patients and society by preventing or potentially irradiating diseases. It is important for all involved within the vaccine supply chain that this paradigm shift is recognized and actively planned for and that appropriate records of temperature conditions in storage and transportation are maintained. States’ Boards of Pharmacy requiring certification for vaccine administration by pharmacists can improve patient outcomes by including training on proper handling and storing of vaccines. Continuous temperature monitoring and proper management of vaccine storage facilities at the pharmacy level decreases wastage, lowers costs and improves patient outcomes.
Proper planning, training and temperature management will improve a facility’s ability to demonstrate that vaccines have been handled correctly. After all, if the vaccine’s efficacy, potency, safety or quality is compromised due to temperature excursions prior to administration to the patient, it may not stop the very disease it is meant to prevent.
- WHO, UNICEF, World Bank. State of the world’s vaccines and immunization, 3rd ed. Geneva, World Health Organization, 2009.
- Recommended Immunization Schedules for Persons Aged 0 Through 18 Years - United States, 2009, Centers for Disease Control and Prevention, January 9, 2009. MMWR 2008;57(51&52).
- CDC Vaccine Price List, http://www.cdc.gov/vaccines/programs/vfc/cdc-vac-price
- Egarvary, Alex. Maine Legislature Approves Pharmacist Immunization, Pharmacist.com. 24 June, 2009.
- Terrie, Yvette C., RPh, Vaccinations: The Expanding Role of Pharmacists, Pharmacy Times, January 2010.
- Hogue, Michael, D., et.al., Pharmacist Involvement with Immunizations: A Decade of Professional Advancement, Journal of the American Pharmacist, March/April 2006, Vol.46 No.2.
- Spikoff, Martin. Should Pharmacists Be Allowed To Vaccinate Their Patients?, Managed Care Digest, January, 2008.
- Chojnacky, M., Miller, W., Ripple D., and Strouse, G. Thermal Analysis of Refrigeration Systems Used for Vaccine Storage (NISTIR 7656). November 2009.
- Kartoglu, U., Erida Nelaj, E., Maire, D., Improving temperature monitoring in the vaccine cold chain at the periphery: An intervention study using a 30-day electronic refrigerator temperature logger, Vaccine, Vol. 28, 2010, pages 4065-4072.
Kevin O’Donnell is a senior partner at Exelsius Cold Chain Management – U.S. He serves as chair for the International Air Transport Association (IATA) Time & Temperature Task Force, is a member of the USP Expert Committee on Packaging, Storage and Distribution, and is a temporary advisor to the WHO. He blogs at www.coolerheadsblog.com. He can be reached at email@example.com.
Patrick McGrath is general manager, Berlinger USA LLC. He has an MBA from Temple University, is a long-standing member of the Parental Drug Association and is serving as a temporary member of a CDC advisory committee.