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Medication Recalls (9.2)

Medication Recalls (9.2) - Policies, Clinical, UWHC Clinical, Department Specific, Pharmacy, Purchasing and Inventory

9.2





Effective Date:

July 2003
6 Pharmacy Policy Manual
Chapter: Purchasing - Inventory
 Operations Procedure Manual
Chapter:

Policy # : 9.2



Original
6 Revision 4/14
Page 1
Of 6
Title: Medication Recalls


I. PURPOSE: To ensure the prompt notification and effective resolution of Food and Drug
Administration (FDA) or manufacturer medication (drug, biologic, or radiopharmaceutical)
recalls.

II. POLICY: The Pharmacy Manager of Supply Chain and the Manager of the Drug Policy
Program will manage the hospital’s centralized policy on medication recalls to ensure that
drugs, fluids, or biologics purchased by the pharmacy department are removed from use. All
pharmaceutical manufacturers and wholesalers conducting business with the University of
Wisconsin Hospital and Clinics (UWHC) shall forward recall information to the Pharmacy
Department. To aid in this process, UWHC subscribes to EXP’s comprehensive recall
program RASMAS powered by Noblis. All medication recalls must be coordinated to
include product removal from all pharmacies and patient care areas.


III. DEFINITIONS
A. RASMAS - a web-based subscription service that provides comprehensive notification,
distribution, management, and documentation of product recall alerts.
B. Facility Manager – the pharmacy purchasing coordinator hold the role of facility manager
within the RASMAS system and has oversight of the daily recall process and receives
notifications of overdue tasks assigned within the RASMAS system
C. Alert Coordinator – a stockroom senior-level technician holds the role of alert coordinator
and is responsible for review and management of RASMAS notifications specific to
pharmaceutical products. The alert coordinator receives initial recall alerts through the
RASMAS system, forwards notification to designated pharmacy personnel to check for
recalled product in each area of the pharmacy, and closes alerts once review is completed.
D. Alert Responder – area contact or designee who is responsible for checking pharmacy
locations for recalled product and removal of affected product.
E. Classification of recalls
1. Class I recall: a situation in which there is a reasonable probability that the use of or
exposure to a violative product will cause serious adverse health consequences or death.
2. Class II recall: a situation in which use of or exposure to a violative product may cause
temporary or medically reversible adverse health consequences or where the probability
of serious adverse health consequences is remote.
3. Class III recall: a situation in which use of or exposure to a violative product is not likely
to cause adverse health consequences

IV. PROCEDURE:
A. Initial Notification
1. Recall initiated by RASMAS





Effective Date:

July 2003
6 Pharmacy Policy Manual
Chapter: Purchasing - Inventory
 Operations Procedure Manual
Chapter:

Policy # : 9.2



Original
6 Revision 4/14
Page 2
Of 6
Title: Medication Recalls


a. RASMAS will notify the UWHC of all medication (drug, biologic) recall
notifications.
2. Recall initiated by Manufacturer
a. All medication (drug or biologic) recall letters received by departments of the
UWHC must be sent to the Pharmacy Department at room F6/133 within the
following business day of receipt. The recall/alert is reviewed and verified
against previously released RASMAS alerts. Recall/alert notifications that are not
found in RASMAS are then submitted for incorporation into the RASMAS
system and associated processes.
3. Recall initiated by UWHC
a. If a UWHC employee or physician discovers a problem product (mislabeled,
mispackaged, or otherwise defective that requires recalling the product from
UWHC) the products should be taken to the Central Pharmacy (F6/133) and given
to the Sterile Products Area (SPA) Pharmacist. The SPA pharmacist will notify
the Pharmacy Purchasing Coordinator, Pharmacy Supply Chain Manager and the
Manager of the Drug Policy Program of the problem product.

B. Responsibilities of the Alert Coordinator
1. The stockroom senior-level technician holds the role of alert coordinator and is
responsible for review and management of RASMAS notifications specific to
pharmaceutical products.
a. A back-up coordinator has been designated within the RASMAS system and recall
responsibilities will be forwarded to them when the primary coordinator is out of the
office. The back-up will receive all email alerts but will only be able to open and
close alerts if designated to do so in the system.
2. Whenever the Pharmacy Department is notified or becomes aware of a medication
recall, the alert coordinator shall perform the following functions:
a. Verify the previous purchase of affected product in both organization and
wholesaler ordering systems for all pharmacy purchasing locations including
retail pharmacy locations.
b. Assign recall follow-up responsibility within RASMAS to the designated area
contact personnel within 24 hours of initial notification. RASMAS will generate
an email to these individuals identifying the item to be recalled, the affected lot
numbers and specific instructions for required actions to be taken.
i. If the recalled product has been purchased by any pharmacy within the
organization, the alert notification will be sent to all alert responders to check
for recalled product.





Effective Date:

July 2003
6 Pharmacy Policy Manual
Chapter: Purchasing - Inventory
 Operations Procedure Manual
Chapter:

Policy # : 9.2



Original
6 Revision 4/14
Page 3
Of 6
Title: Medication Recalls


ii. If initial notification not assigned or closed within 24-hours will be escalated
within the RASMAS system and an alert will be sent to the facility manager.
c. Ensure that all alert responders have checked their assigned areas and documented
their follow-up in the RASMAS system by the end of the following business day
after follow-up responsibilities have been assigned if feasible.
i. Alert responders that have not documented follow-up in RASMAS within the
following business day will be contacted by phone and prompted to complete
the required recall verification by the alert coordinator. The alert will also be
escalated within the RASMAS system and an alert will be sent to the facility
manager. If area contacts are not available, an alternate will be appointed by
the facility manager or the Pharmacy Manager of Supply Chain.
d. The Pharmacy Manager of Supply Chain or his/her designee will assess if this is a
medication that may, by policy, be stored at a patient’s bedside.
i. Medications that may be stored at a patient’s bedside are listed in both
Pharmacy Policy 1.43 and Hospital Policy 8.17.
e. If this is a product that could potentially be stored in a patient’s room:
i. A group message will be sent to all decentralized pharmacists in the Epic
system. The message will alert the pharmacists that a product that may be
stored at a patient’s bedside has been recalled and that each patient’s room
must be checked for the recalled product within 24 hours.
ii. The decentralized pharmacist will send a response to the Pharmacy Supply
Chain noting the patient care areas that were checked, the number of recalled
products returned to the central pharmacy, and the room number where
recalled product was found.
3. If the alert coordinator determines that affected product had not been purchased by
any pharmacy area, the steps outlined in section 2.0 may be skipped and the initial
notification should be closed within 24 hours. Lack of purchasing for the item will be
verified in both organization and wholesaler ordering systems for all pharmacy
purchasing locations including retail pharmacy locations.

C. Responsibilities of the Facility Manager
1. Alert-specific responsibilities are defined in the RASMAS system. The Pharmacy
Purchasing Coordinator holds the role of facility manager in RASMAS and is
responsible for the oversight of recall program
a. The purchasing coordinator will be notified by the RASMAS of any initial or
assigned alerts that are overdue. The facility manager will follow up with the alert





Effective Date:

July 2003
6 Pharmacy Policy Manual
Chapter: Purchasing - Inventory
 Operations Procedure Manual
Chapter:

Policy # : 9.2



Original
6 Revision 4/14
Page 4
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Title: Medication Recalls


coordinator and/or area contact to ensure that alerts are closed within a timely
manner.
2. The facility manager or designee will provide initial and annual education on the
importance of timely recall response for all individuals assigned responsibilities within
the RASMAS system.

D. Responsibilities of the Alert Responder
1. Upon receipt of an initial recall notification, all affected products will be immediately
removed from use by the contact person or designee.
a. In doing so, the area contact person must follow instructions exactly as indicated
by the alert coordinator in the notification
b. The alert responder must document the quantity by location and all actions taken
within the RASMAS system by the end of the following business day after alert
assignment.
2. Recalled products will be returned to the Pharmacy Stockroom labeled “Attn:
Recall” or segregated and returned through reverse distributor.
3. The contact person will reply through the RASMAS system to the Alert Coordinator
indicating the following:
a. Area that was checked.
b. Date the recall check was performed.
c. Name of the individual that performed the recall check.
d. Recall check results as either:
i. “Product not in inventory/stock.”
ii. “Action Taken – product removed from inventory/stock.”

E. File Documentation
1. The alert coordinator will confirm that all necessary areas have been checked for
recalled product by reviewing the RASMAS system
2. All documentation for recall alerts will be available from the RASMAS system.
3. The facility manager or designee will provide statistical and informational recall data.
a. Monthly - recall data will be provided to the Pharmacy Office and Pharmacy
Supply Chain Manager for departmental productivity statistics and compliance
with recall policy.
b. Quarterly - a recall report will be submitted to the Drug Product Selection and
Supply subcommittee.

F. Responsibility for Product Returns
1. All recalled items will be returned through a reverse distributor or listed on a Return
Material Instruction Form (RMI) and returned to the manufacturer or wholesaler for
credit.





Effective Date:

July 2003
6 Pharmacy Policy Manual
Chapter: Purchasing - Inventory
 Operations Procedure Manual
Chapter:

Policy # : 9.2



Original
6 Revision 4/14
Page 5
Of 6
Title: Medication Recalls


2. The facility manager will coordinate this item return including competing associated
paperwork.

G. Responsibilities of the Drug Policy Program
1. The Manager of the Drug Policy Program or designee will be notified and shall
perform the following functions:
a. Patient notification is required for all Class I recalls. For all other recalls, review
of the recall information should be undertaken to determine whether or not patient
contact must be made.
b. If patient contact is required, the Manager of the Drug Policy Program or designee
must notify the Risk Management Department at 261-1327.
c. At the discretion of the Risk Management Department and the Manger of the
Drug Policy Program, engagement of Public Affairs may be warranted.
d. Drug Policy Program staff will engage appropriate resources to identify impacted
(inpatient/outpatient) patients.
e. Communication to patients should be coordinated with Risk Management.
Written communication on drug product recalls and alternatives, if necessary, will
be communicated to the medical staff. Email communication will be used for
conveying urgent drug recall information.
f. Consult with the Pharmacy and Therapeutics Committee and other members of
the medical staff as appropriate for assistance in clinical decision-making.
g. Prior to distributing patient communication, the Risk Management Department
will review content.
h. The recall phone line will be monitored by Drug Policy Program staff as
applicable.
i. Documentation of patient contact, course of action and copy of the patient letter
must be compiled and forwarded to the Risk Management Department.

H. Recalls of Sample Medications
1. While sample medications are never stocked in the inpatient setting and are rarely
stocked in clinics (per UWHC Policy 8.36), some sample medications are stocked in
certain clinics. Recalls of these products occur rarely, but when they occur, the
Manager of the Drug Policy Program and the staff of the Vendor Liaison Office will
perform the following functions:
a. If it is determined that a sample medication may be stocked in UWHC clinics (it
falls under an exception to our policy prohibiting stocking, as noted in UWHC
Policy 8.36), the relevant clinics will be contacted (those clinics where the
product is known to be stocked based on the nature of the product and/or the
specific approval given to clinics for that product).





Effective Date:

July 2003
6 Pharmacy Policy Manual
Chapter: Purchasing - Inventory
 Operations Procedure Manual
Chapter:

Policy # : 9.2



Original
6 Revision 4/14
Page 6
Of 6
Title: Medication Recalls


b. Clinics will be instructed to review their sample sign-in log sheets for record of
receipt of the specific lots of the recalled sample product.
c. If no affected lots have been received by the clinic, the clinic will report such.
d. If affected lots were received by the clinic, specific patients who received the
product will be identified via the 3-part sample documentation form, and will be
contacted per the procedure outlined above.
e. If the amount of the recalled product documented as received does not match the
amount dispensed (per the dispensing forms), all patients who have been seen in
the clinic since the date the recalled product was received in the clinic will be
contacted and notified of the recall. Patients will be identified based on queries of
UWHC electronic medical records, and the communication to the patient will
indicate that they are being contacted in the event they did receive a sample
during their visit.
f. All clinic storage areas will also be searched and recalled product will be removed
and returned to pharmacy for disposition.

II. COORDINATION
Inpatient Pharmacy Managers
Director, Risk Management


Approved By:_____________________________
Director of Pharmacy Services

Date:__________________