The manufacturer combines FDA and United States Pharmacopeial Convention considerations about its drug to calculate an expiration date for the product based on studies that show how quickly the drug degrades under approved storage conditions. Use of the drug product beyond this date is not allowed under federal and state laws in the United States.

Your pharmacy will have a process in place for personnel to regularly monitor the shelf-life of medication inventory and pull expired medications from pharmacy shelves. Many pharmaceutical manufacturers use every-6-month dating, meaning that expiration dates are set in June and December of each year. For these products, you will need to go through the inventory of the pharmacy only twice a year looking for expired drugs. However, other companies assign expiration dates based on the actual month a product is expected to drop below the allowable limit, and these must be removed monthly. Your pharmacy may also have expiration dates in the computer system, so that you can work from an expired drugs list in pulling old products. Whatever method you use, expired medications should be systematically and regularly pulled from pharmacy shelves and stored separately from other medications in the pharmacy.

Pharmacy computer systems generally put a 1-year expiration date on prescription labels; the patient is instructed to throw the medication away after 1 year regardless of the original manufacturer’s date. Several factors should be remembered about this type of dating:

• The reason for the arbitrary 1-year date is that many consumers do not store the drug product under FDA-defined conditions. For instance, many people keep their medications in either the kitchen or the bathroom. The kitchen is generally the hottest room in the house, so medications stored there will be subjected to excessive heat, especially if the family’s house is not air-conditioned. The bathroom is the most humid room in most homes, and humidity is the most important factor in degradation for many drugs. Thus, even if the manufacturer’s original expiration date is several years away, a 1-year expiration date is used for prescriptions at the time of dispensing.
  
• In areas with especially hot or humid climates, you should advise patients to keep their prescription medications in locations where the temperature and humidity are controlled. In particular, advise patients not to expose prescription drugs to excessive heat by leaving them in hot automobiles on warm days.
  
• If you are dispensing a prescription drug product with less than 1 year remaining in the company’s expiration date, then you must place that date on the patient’s prescription label instead of the standard 1-year date.

The United States Pharmacopeial Convention issues standards that govern the conditions under which medications should be stored as they move through distribution channels, from manufacturer to wholesaler to pharmacy to patient. These requirements sometimes mean that products must be placed on ice or otherwise refrigerated during shipment. In addition, pharmaceutical sales representatives who store drug samples in their cars must take care during periods of hot or cold weather to assure the integrity of those medications.

Recalls of Drug Products

Sometimes despite FDA’s and manufacturers’ best efforts drug products must be recalled from the market. While these recalls are usually termed “voluntary” (meaning that the company has recalled the product on its own), almost all are actually negotiated with FDA beforehand.

FDA places recalls into three categories based on the seriousness of the problem and the relative risk to public health in general. Refer to Chapter 3, Pharmacy Law and Regulation, for a description of the three categories.

As with expired medications, you must follow specific instructions from the manufacturer so that the pharmacy can get its money back for recalled products. In addition, pharmacies must contact patients whose prescriptions were dispensed using recalled drug products (or, when the pharmacy can track this, nonprescription drug products that consumers have purchased over the counter). Follow the policies and procedures in your pharmacy for how these notifications are to be handled (for example, mail, phone, fax, or e-mail), considering the relative seriousness of the recall (Figure 14-1).

Shortages of Drug Products

In extreme cases, a voluntary recall can lead to drug shortages. But recalls aren’t the only cause of shortages. They can be influenced by many factors, including unavailability of raw materials to make drug products, natural disasters, manufacturing difficulties, formulation changes, and unexpected increases in demand. Some shortages are predictable, such as generic availability of a product that causes the manufacturer of the brand-name agent to decrease supply. Other shortages remain unpredictable, and sometimes the cause may not even be known.

No matter what brings it about, though, a shortage can wreak havoc in the pharmacy, especially in an inpatient environment where drug products may only be available from a single source and are used in acute or life-threatening situations. In this setting, a drug shortage could potentially mean the difference between life and death for a patient.⁴

Stay updated, free articles. Join our Telegram channel

Join