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.
For additional information on Metric-Rx, or how Net-Rx
can benefit you, fill out our contact form, or call us at 1-866-336-3879.
Author:
Payton Ebberts
Account Analyst
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 knitting,
skydiving, and road tripping.
Reference
FDA's Role in Drug Recalls. (2018, July 3). Retrieved from fda.gov: https://www.fda.gov/drugs/drug-recalls/fdas-role-drug-recalls