Preparing Your Pharmacy for Drug Recalls: Safety, Compliance, and Business Impacts
Is your pharmacy prepared for the next drug recall? Understanding the basics of the recall process, developing effective standard operating procedures for responding to a drug recall, and using pharmacy analytics to be proactive are key in demonstrating compliance and minimizing disruptions within the pharmacy. All the while, managing inventory and adapting to market changes are key to help reduce impact to the business.
While the FDA can request or legally mandate an order for a drug recall, many drug recalls are completed on a voluntary basis by manufacturers. Recalls are to protect the health and safety of the consumer when the drug presents a serious health hazard, among other reasons such as mislabeling, contamination, or deviation in potency. The FDA’s role in a recall is to oversee a company’s strategy, assess the adequacy of the recall, and classify the recall as follows (FDA’s Role in Drug Recalls, 2018). See below for the three classifications of drug recalls.
Developing a repeatable, written procedure that can be executed effectively and efficiently by your staff upon receiving a recall notice helps achieve consistency.
Considerations for developing a drug recall procedure (which can be personalized to fit your pharmacy’s needs):
Federal and State Regulations
- Verify standards and requirements for notifying prescribers and patients.
- Check with your organization’s compliance guidelines to establish a period of time at your pharmacy for maintaining recall documentation and records.
Responsibilities for Staff Members
- Define actions to take and set a targeted date for completion.
- Document process sign-off upon completion of tasks.
- Centralize internal communication for staff questions, concerns, and updates.
- Review inventory during the pertinent time frame for affected lot numbers.
- Isolate recalled drug from current inventory in a secure and clearly labeled holding area.
- Discard or return recalled drug in accordance with the recall notice, as needed.
- Contact Patient or Caregiver as directed within the recall notice for Class II and Class III recalls.
- Order replacement inventory to enable the least possible disruption to the continuum of care.
Documentation of Process
Maintain a copy of the recall notice, date received, and process sign-off documentation and record the following:
- Date(s) and location(s) of inventory reviewed, including storage and overflow.
- Quantity of drug removed.
- Date drug was discarded or returned to wholesaler/manufacturer.
- Patient outreach activities and file retention policies for that outreach when applicable.
- Notate tasks that were successful, and tasks that require procedural improvement.
One of the first things pharmacy staff can do is to know where to find an updated list of recall notices. Metric-Rx provides direct access to FDA recall notices allowing you to build in a cadence for periodically verifying what notices have been issued and when, ensuring you never miss a recall notice and your processes enable your pharmacy to avoid surprises by being prepared to respond quickly and efficiently.
Metric-Rx also includes dashboards on drug utilization by GPI codes and therapeutic class, enabling you to manage inventory needs that arise from recalls. Additionally, you can extract customizable reports, providing multiple ways to view impacted drugs, claims, facility, and payer data history to determine how recalls and other market changes affect your business, your patients, and your business partners. Did replacement drugs cost more? Was there an overall impact to availability in the market and if so, were there price fluctuations as a result? Did payer MAC prices change to follow those fluctuations? How many prescriptions were impacted? Did they have refills? All of these data points can help you not only manage the recall but look back at the overall impact and make improvements wherever possible.
Drug recalls are an unfortunate but necessary part of the pharmaceutical distribution life cycle and patient safety, compliance, and pharmacy disruptions are all at stake. Preparing a process to manage recalls will allow for less disruption to you, your patients, and your pharmacy team. Accessing insightful pharmacy analytics like those provided by Metric-Rx can help pharmacies make sound business decisions.
Joined Net-Rx in September 2019
Payton’s day-to-day involves assisting pharmacies with post-edit claim review and reconciliation roadblocks. She is passionate about building authentic relationships with her accounts while navigating new pharmacy trends together. Payton lives in Kelso, Washington and enjoys hiking, duck hunting, and painting.
FDA’s Role in Drug Recalls . (2018, July 3). Retrieved from fda.gov: https://www.fda.gov/drugs/drug-recalls/fdas-role-drug-recalls