​How To Ensure Your Staff Is Prepared For A Prescription Recall

A recall is a notice issued by the FDA to alert consumers about prescription drugs that may be unsafe or ineffective. On average, about 4,500 drugs and devices are pulled from U.S. shelves each year.The goal of a recall is to remove potentially dangerous products from the market before they are sold to consumers. Pharmacies need to take extra precautions when preparing for recalls because it can happen at any time and without warning. To prepare your staff for this type of situation, you should have an emergency plan in place so your employees know exactly what their responsibilities are during a recall event.

What Can Cause A Prescription Recall?

There are a number of reasons why a prescription drug may be recalled. Some common causes include:

• Prescription drugs that are not effective
• Drugs that may cause serious side effects
• Drugs that have been contaminated with another substance
• Packaging errors, such as incorrect dosage information or wrong medication listed on the label
• Prescription drugs that are not made to FDA standards

According to a recent medical study, 85.1% of drug recalls were due to quality while 14.9% were because of labeling issues. Of the quality issues for drug recalls, lack of sterility was the most frequent issue.

What Happens When A Prescription Drug Is Recalled?

When a drug is recalled, the manufacturer will send out an official public announcement called a press release. The purpose of this statement is to inform consumers about the recall and what they should do with any medications affected by it. In addition, the FDA will also post information about the recall on their website.

Pharmacies should take a number of steps when a drug is recalled:

1. Remove all affected medications from store shelves and inventory
2. Notify any customers who may have purchased the drugs
3. Destroy all affected medications
4. Contact the manufacturer to find out if the recall affects any additional products
5. Notify your insurance carrier and pharmacy benefit manager, if necessary

How To Prepare For A Recall Ahead Of Time

In order to ensure that your pharmacy is prepared for a prescription recall, you should have an emergency plan in place. This document should outline the steps your employees need to take if a recall occurs. Some key things you should include in your emergency plan:

• A list of all affected medications, including their brand names and dosage information
• How to contact the manufacturer and obtain additional information about the recall
• How to notify customers who have purchased recalled drugs
• How to destroy affected medications
• What actions to take if other products are recalled

It's also important to practice your emergency plan regularly. This will help ensure that everyone involved knows what they need to do in case of a recall. Regular practice will also help reduce the stress that everyone feels when a recall happens.

How Does the FDA Evaluate A Drug or Device For Recall?

The FDA uses a process called a Health Hazard Evaluation to determine if a prescription drug should be recalled. This process includes reviewing complaints from consumers, healthcare professionals, and death reports. The FDA will also inspect the manufacturing facility and review test data.

The goal of this evaluation is to ensure that all prescription drugs on the market are safe, effective, and meet quality standards. If a drug does not meet these criteria, the FDA will take action, which may include issuing a recall.

Pharmacies should be aware of this process and understand that a recall can happen at any time, without warning. By being prepared for a recall, your pharmacy can ensure that all affected medications are removed from store shelves and customers are notified promptly.

For a more detailed description of the recall process, check out The U.S. Department of Health and Human Services website.

What Are The Different Levels of Prescription Recalls and What Do They Mean?

Pharmacies should also be aware of the different types of recalls:

• Type I: A product is defective and can cause serious health problems or death.
• Type II: A product does not meet quality standards or is contaminated.
• Type III: A product has been mislabeled or contains incorrect information.
• Type IV: An impurity or contaminant has been found in a product.
• Type V: A product has been recalled for other reasons.

It's important to be familiar with all five types of recalls, as they can each present their own challenges. For example, a Type I recall requires the immediate removal of all affected products from store shelves, while a Type IV recall does not.

How Is A Prescription Drug Recall Announced?

A prescription drug recall can be announced in a number of ways. The most common way is through a press release from the manufacturer. The FDA also posts information about recalls on their website. Pharmacies should be sure to check both of these sources regularly for updates on any recalls.

In most cases, pharmacies should have at least 24 hours notice before a prescription drug recall goes into effect. However, there are some cases where a recall may be announced with less than 24 hours notice. In these cases, it's important to be prepared for the possibility that you may need to remove affected products from store shelves immediately.

Pharmacies should also keep in mind that recalls can affect other products manufactured by the same company, so it's important to stay up-to-date on all recall announcements.

What Else Should You Know About Prescription Recalls?

Contrary to popular belief, the FDA can not issue a drug recall. That power lies in the manufacturer's hands. The FDA can only issue a recommendation and the manufacturer can do with that recommendation what they will.In January 2020, U.S. Rep. Rosa DeLauro reintroduced a bill called the Recall Unsafe Drugs Act, which would grant the FDA the ability to issue a mandatory recall on a drug. However, it is unclear whether this bill will become law as pharmaceutical industries reported that they largely comply with FDA recall requests anyway.