Managing vaccine inventories: Tips for pharmacy services

Oluwole WilliamsVaccines are specialty medicines in pharmacy inventory management, and their handling, storage, delivery, and administration require additional training and/or licensure. Typically, strict state-level pharmacy laws govern vaccine administration and inventory management in ambulatory care pharmacy.

Certain vaccines, particularly the live attenuated virus vaccines such as herpes zoster vaccine (HZV) for shingles and varicella zoster vaccine (VZV) for chickenpox, must remain frozen before use. Others, such as rotavirus vaccine (RV) and the measles, mumps, and rubella (MMR) vaccines may be stored, delivered, and refrigerated before administration; often they have manufacturer-supplied diluents for their use.

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Precautions and protocols

Additional important recommendations of note are as follows:

• MMR vaccines should be refrigerated or frozen, depending on brand requirements, between -58º F and 35º-46º. Manufacturer-supplied diluent should not be frozen. Reconstitute or dilute immediately before administration; discard if not injected within 8 hours of dilution (for some brands, 30 minutes).

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• Human papilloma virus (HPV) vaccines have been reported to cause recipients to faint. HPV2 vaccine is not approved for use in males in the United States. HPV4 vaccine is licensed for both male and female use. Both types are restricted to patients 9-26 years of age and may not be used by those older than 26. Although indicated for eligible candidates by the Advisory Committee on Immunization Practices (ACIP), HPV vaccination is not mandatory for school-age children or adults undergoing employment screening. Store HPV vaccines in refrigerator at 35º-46º, shield from light, do not freeze, and do not combine with other vaccines in a single syringe. Patients must remain seated for at least 15 minutes post-vaccination. Monitoring and emergency preparedness are compulsory.

• Pneumococcal vaccines such as PCV13 and PPSV23 should not be frozen. Refrigerate them at 35º-46º. Some vaccines are intramuscular (PCV13), while either subcutaneous or intramuscular administration would be appropriate for some (PPSV23), depending on manufacturer’s recommendation.

• Certain vaccines are routinely prescribed for chronic conditions and for seasonal administration. Some pneumococcal and influenza vaccines have additional preventative recommendations, such as for smokers, hypertensive patients, asthmatics, and patients with diabetes or certain chronic diseases, such as sickle cell anemia. Meningococcal vaccines (MCV) are indicated for college sophomores, military personnel, professional microbiologists, and visitors to Saudi Arabia or sub-Saharan Africa. At present, ACIP approves MCV4 use in routine immunization in adolescents between the ages of 11 and 12. Some MCV manufacturers require rigorous monitoring of patients with a history of Guillain-Barré syndrome.

• Vaccines against mosquito-borne viruses such as yellow fever and Japanese encephalitis are required for international travelers to certain areas. The rabies vaccine is compulsory for post-graduate pharmacology students, zoo and animal-care workers, veterinarians, bird-handlers, and park rangers based in forested areas with significant bat populations. The Occupational Safety and Health Administration requires Hepatitis B vaccination and education for healthcare personnel.

• Vaccines may be given orally or by modes other than injection. Examples are the oral polio and typhoid vaccines, and the live attenuated influenza vaccine (LAIV), given intra-nasally. These types carry special considerations for administration, dosing, storage, and revaccination where indicated. For instance, no revaccination is required if a patient sneezes after a nasal influenza vaccine. Yellow fever vaccines can be given only by specially licensed providers and only in approved locations. Active immunity to typhoid fever from the oral vaccine wanes in five years, while the immunity acquired through the inactivated typhoid vaccine type (given intramuscularly) wanes in two years; both require revaccination. The oral polio vaccine (OPV) was taken off the U.S. market in 2001 and replaced by the intramuscular inactivated polio vaccine (IPV); this contains certain aminoglycoside antibiotics - streptomycin, neomycin, and Polymyxin B - that may cause adverse reactions in allergic individuals.

• Latex allergy is an important screening item for patients receiving vaccination from multi-dose vials, which typically have sterile rubber seals. In the process of completing the vaccine information sheet (VIS) required by law, the pharmacy practitioner should ask the patient about allergies, medical conditions, recent sicknesses, history of seizures and/or fainting spells, and past vaccination experiences, with times and dates. Some vaccines are prepared in egg embryo, which may be an important issue for those with hypersensitivity reaction to egg albumin.

Transport, handling, and administration

The integrity of vaccine products and their therapeutic efficacy may be compromised if storage temperatures are not maintained in the “cold chain,” if inappropriate diluents are used, or if products are administered by the wrong route. These points are especially critical in the case of live lyophilized virus vaccines.

Pharmacists should inspect their vaccine-handling protocols and systematically evaluate their facility’s storage temperature, as well as cold-chain transport and the physical conditions of the vaccine products delivered to them.

The dispensing or administration of damaged or poorly stored vaccines invites immunization failures and expensive disease outbreaks. To assume the effectiveness of a vaccine product contained within broken, melted ice- or gel-packs that have been sitting in summer temperatures in an unrefrigerated wholesale delivery truck for several hours compromises professional standards and is an unethical approach to practice by any healthcare practitioner or business.

Potential for certification

There is an opportunity in this sector for pharmaceutical wholesalers who may offer specialized delivery of vaccine products via refrigerated trucks only, instead of the current use of plastic totes containing ice- or gel-packs. Since some vaccines must be frozen before use, during storage, or when transported to pharmacies, it is reasonable to offer specialized vaccine delivery to all locations using specially fitted delivery vans.

Personnel in pharmacy services or pharmaceutical wholesalers could be specially trained and assigned to the monitoring and maintenance of vaccines and other refrigerated biological products at the required minimum standards, whether statewide or regional, to ensure consistent inventory management and delivery.

Such persons might be designated as Biological Products Specialists or Vaccine Management Pharmacists, and they could be given responsibility for impromptu periodic inspection for the required standards.

This assignment could be similarly copied by pharmacists working in regulatory agencies, for the purpose of enhancing vaccine efficacy and safety of use in the United States.

References

1. APhA. National Certificate Program for Pharmacists, 2014. Immunization Delivery. Module 3, pages 3, 7, and 18–44.

2. British National Formulary. Immunological products and vaccines, BNF 68. September 2014–March 2015, chapter 14, pages 829, 830, and 850–857.

Oluwole Williamspractices pharmacy in the Philadelpha, Penn. area. Contact him at pharmwillie@yahoo.co.uk.