University of California San Diego Pharmacy Law & Drug Product Integrity Discussion

It is Tuesday morning. Your pharmacy has ordered and received 200 of the new NOCOVID-20 vaccines which cost the pharmacy $10,000. The vaccines are in high demand and this supply is all that your wholesaler could send (there may be more in a month or so). The order arrived on Friday evening after the pharmacy closed and it sat secured in the clinic loading area (which is not air conditioned) until Monday morning (yesterday). The temperature reached 95 over the weekend. As you begin to schedule your patients for immunization you notice that the pharmacy technician who unpacked the order yesterday put the vaccines in the freezer. You examine the vaccines and see they are frozen but they soon melt and appear to have the same color and clarity as photos you have seen of the vaccine. NOCOVID-20 has the same storage and stability profiles as the previously available H1N1 influenza vaccines (in the range of 2-8° C (35-46° F)) . Your patients have been waiting for months for the NOCOVID-20 vaccine. They are in a hurry to be vaccinated and are grabbing up the opportunity to get on your schedule.

What do you do with the information you have on hand? What do you do next?

Answer the following questions:

1. What is the importance of the manufacturer’s storage guidelines for drug product integrity?
2. What are the issues apparent with this situation?
3. Are there exceptions in how you must store drugs during times of pandemic?
4. What are your options? What will you do and why?
5. What may happen if the vaccine isn’t fully potent?
6. What references do you rely on in making your decision?

Technical Requirements:

1. No more than ½ page for each answer written in 12 point type with single spacing of the lines and no more than 1 inch margin on the sides