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Product Shortage Notification and Therapeutic Alternative (9.3)

Product Shortage Notification and Therapeutic Alternative (9.3) - Policies, Clinical, UWHC Clinical, Department Specific, Pharmacy, Purchasing and Inventory

9.3





Effective Date:

June 2003
⌧ Pharmacy Policy Manual
Chapter: Purchasing-Inventory
Control-Distribution
Operations Procedure Manual
Chapter:

Policy #: 9.3

† Original
⌧ Revision 9/12
Page 1
of 5
Title: Product Shortage Notification and
Therapeutic Alternative

I. PURPOSE: To outline the process in which the pharmacy department handles drug shortages
in order to prevent the compromise of patient care, delay of medical procedures, and increase
in medication errors. Drug product shortages adversely affect health system finances by
increasing the cost of delivering patient care, largely through higher drug acquisition and
personnel costs. In addition, shortages require a high level of coordination on an on-going,
long-term basis for everyone involved, including purchasing agents, pharmacists, nurses,
physicians, and patients.

II. POLICY: Drug product shortages and selection of therapeutic alternatives will be managed
and communicated to UWHC and UWMF personnel in a systematic manner.

III. DEFINITIONS:
McKesson’s Online Purchasing System – McKesson Connect formerly Supply Management
Online (SMO)
IV. FORMS: Drug Shortage Worksheet (9.3a)

V. PROCEDURE:
A. Notification of Drug Shortage by Manufacturer/Wholesaler
1. The associate purchasing agent will be notified during the ordering process by the
pharmacy wholesaler or manufacturer that a product is not available.
2. The associate purchasing agent will contact wholesalers and manufacturer, if
necessary, to determine the nature and estimated duration of the shortage and the
possibility of acquiring alternatives, when available.
a. Review McKesson’s Online Purchasing System website and/or call McKesson to
attempt to find an alternative source or obtain a generic equivalent
b. Review McKesson’s Online Purchasing System, Approved Bioequivalency
Codes, FDA website, RedBook and eFacts to identify alternate manufacturers.
c. Call manufacturers to verify shortage and to attempt to obtain product. The initial
amount of product to be purchased should be enough to bring stock levels to
approximately a two month inventory or greater, depending on the nature of the
shortage, available alternatives, and estimated duration of the drug shortage.
3. For situations when McKesson’s Online Purchasing System indicates that a product
will be in short supply or there is no release date available, the associate purchasing
agent will notify the Drug Policy Program (DPP) technician with known details of the
identified shortage.
4. The DPP technician will consult the American Society of Health-System Pharmacists
shortage website and the Food and Drug Administration shortage website to collect
any useful information not already known.





Effective Date:

June 2003
⌧ Pharmacy Policy Manual
Chapter: Purchasing-Inventory
Control-Distribution
Operations Procedure Manual
Chapter:

Policy #: 9.3

† Original
⌧ Revision 9/12
Page 2
of 5
Title: Product Shortage Notification and
Therapeutic Alternative

5. The DPP technician will collect the following information (and other information as
necessary) and enter it into the drug shortage database maintained by the DPP. The
following procedure will be implemented:
a. Name of the drug
b. Initial backorder date
c. Nature of the shortage (recall, discontinuation by manufacturer, other)
d. Length of time the product will be unavailable and when it is expected to be
available (if known)
e. Current quantities on hand of product at UWHC
f. Copies of any communications received regarding the shortage (e.g. letters from
the manufacturer, emails from the wholesaler or Novation, etc)
g. Determine historical utilization by running Peoplesoft Issue by Item Report for
the past 12 months
h. Run McKesson’s Online Purchasing Systemuse history report and/or Peoplesoft
Supply Variance Report for the past 12 months on inpatient and clinic accounts
i. Detect any stocking locations for research/ laboratory areas by running Peoplesoft
Issue Transfer by Item Report for past 36 months
j. Determine inventory locations and levels outside of Central Pharmacy stocking
areas: automated dispensing cabinets, clinics, and operating room by running
reports from ConnectRx
k. For all products, ascertain where the product is used (i.e. inpatient, OPP, clinics,
Infusion Center etc.)
l. The DPP technician will post current information (no more than one week old)
about drug shortages and possible alternatives in the UConnect “Medication
Shortages” table
6. The DPP pharmacist will alert the HealthLink team of the drug shortage.
a. A Heat ticket will be entered by a DPP pharmacist alerting the Medication
Management team of necessary alternative or best practice alerts that should be
associated with short medication eRX or any other information necessary to
manage the shortage in the electronic medical record and for physician order
entry.
b. Any uncertain information will be discussed by the Medication Management team
and the DPP pharmacists. Confirmation of the Heat ticket can also be made
through discussion.
c. For complex shortages involving changes to AcuDose Cabinets or other central
pharmacy operations, the DPP pharmacist and HealthLink analyst on call will
work with a central pharmacy manager to coordinate changes to distribution
systems.
7. The DPP Pharmacist will run drug shortages report in HealthLink as needed to
monitor the use of items that are identified as being short to facilitate coordination for





Effective Date:

June 2003
⌧ Pharmacy Policy Manual
Chapter: Purchasing-Inventory
Control-Distribution
Operations Procedure Manual
Chapter:

Policy #: 9.3

† Original
⌧ Revision 9/12
Page 3
of 5
Title: Product Shortage Notification and
Therapeutic Alternative

patients using items that have very limited availability and supplies are almost
exhausted.
B. Use of Alternate Package Sizes and Strengths when Formulary Item is Unavailable
1. The associate purchasing agent will review McKesson’s Online Purchasing System,
the Red Book, and eFacts to determine if an alternate size or strength of the product
would be available to meet the needs of the department.
a. Larger or smaller package size (i.e. 20 mL vs. 2 mL vial, 60 gram vs. 30 gram
tube, etc.)
b. Larger or smaller strength product (1% solution vs. 0.5% solution, 500 mg
tablet vs. 1 gram tablet, etc.)
2. The associate purchasing agent will verify that an alternate strength or package size is
available and review these alternatives with the appropriate DPP pharmacist.
3. If an alternate size or strength product is approved for use, the following activities
will be conducted.
a. If the alternate strength or package size will not be directly dispensed to a patient
(i.e. larger vial for SPA extemporaneous preparations or IV admixture use, a
larger bottle for compounding oral extemporaneous products, etc.) and it is
expected to be a temporary remedy to the shortage, then items b. to d. of this
section of the policy are not required.
b. An electronic drug notification form (eForm) will be completed by a DPP
Pharmacist or Purchasing Staff to be used by appropriate individuals to update the
following systems:
i. Peoplesoft
ii. Healthlink
iii. Connect Rx
iv. Online formulary
c. Drug Policy Program personnel will send an email to the pharmacy staff and to
Nursing Administration outlining the change.
d. The DPP technician or the DPP pharmacist will update the drug shortages web
page to include the information on alternate package size and strength product as
a substitute under the DPP recommendations.
C. Selection of Therapeutic Alternative
1. If neither a generic equivalent (as defined in UWHC Pharmacy Department Policy
9.5 – Generic Alternative Selection Procedure) nor an alternative package size or
strength is available, the DPP technician will notify a DPP pharmacist of the drug
shortage and provide the information outlined above with attached reports and
documents.
2. Drug Policy Program personnel will review the situation with appropriate physicians
and pharmacy staff to determine if an appropriate alternative should be
recommended.





Effective Date:

June 2003
⌧ Pharmacy Policy Manual
Chapter: Purchasing-Inventory
Control-Distribution
Operations Procedure Manual
Chapter:

Policy #: 9.3

† Original
⌧ Revision 9/12
Page 4
of 5
Title: Product Shortage Notification and
Therapeutic Alternative

3. The Pharmacy and Therapeutics Committee will approve any decisions to ration or
restrict product to specific patient populations/
4. The DPP pharmacist will communicate with the Medical Staff Office and the Chief
Medical Officer to ensure that all prescribers have necessary information about drug
shortages. Routine updates will occur no less than once monthly, although necessary,
timely alerts can be sent at any time.
5. Pharmacy and Nursing staff will be informed routinely about drug shortage by the
DPP on a routine basis, but no less than every 2 weeks.
6. Minimal information included in the communication to physicians, pharmacists,
nurses, and technicians include:
a. Name of the drug
b. Nature of the shortage (recall, discontinuation by manufacturer, other)
c. Length of time the product will be unavailable and when it is expected to be
available (if known)
d. Recommended alternatives if any are available
7. Drug Policy Program personnel will generate an eForm entry if a drug entity that is
not currently on the formulary should be temporarily added to the pharmacy
inventory. In most cases, these medications will no longer be utilized after the
resolution of the shortage. The eForm notification will be used by appropriate
individuals to update the following systems:
a. Peoplesoft
b. Healthlink
c. Connect Rx
d. Online formulary
8. The DPP will involve the Drug Product Selection and Supply Committee or the
Pharmacy & Therapeutics Committee as needed.
9. If the supply of a drug is nearly exhausted and changes must be made in order to meet
patient care needs, the DPP will work with the Medication Management team to
identify all inpatients with active orders for the drug in short supply and work with
decentral pharmacists to notify physicians of the shortage and discuss pharmaceutical
alternatives.
10. Drug Policy Program personnel will add recommendations to the information in the
UConnect “Medication Shortages” table.
D. The DPP technician will review the UConnect “Medication Shortages” table weekly and
contact manufacturers periodically as needed to coordinate re-release of the drug with
UWHC pharmacy purchasing personnel.
E. The DPP technician will review the following websites on a weekly basis to look for new
information concerning drug shortages:
1. ASHP Drug Shortages Resource Center (http://www.ashp.org/shortage)
2. FDA Drug Shortage Page (http://www.fda.gov/cder/drug/shortages)





Effective Date:

June 2003
⌧ Pharmacy Policy Manual
Chapter: Purchasing-Inventory
Control-Distribution
Operations Procedure Manual
Chapter:

Policy #: 9.3

† Original
⌧ Revision 9/12
Page 5
of 5
Title: Product Shortage Notification and
Therapeutic Alternative

F. Any information on drug shortages not currently being experienced at UWHC will be
used to proactively plan for the possibility of a future shortage at UWHC.
G. Any new information on drug shortages experienced at UWHC will be used to update
recommendations/information on the UConnect “Medication Shortages” table, and Drug
Shortage Database.
H. Products on the drug shortage list will be loaned to close colleagues (Middleton VA,
Meriter, St. Mary’s, Froedtert) only when specifically approved by the Pharmacy
Manager over supply chain management in consultation with the DPP. Conversely, these
colleagues will be routinely contacted in severe shortages, in the event that they may be
able to temporarily loan short drug or sell it outright.
I. All medication borrowed from another institution will be replaced, unless acquired
through outright purchase.
J. A drug shortage warning will be placed in PeopleSoft by the DPP technician.
K. The Pharmacy Manager over supply chain management will quantify the financial impact
of each shortage and prepare budget variance reports as needed outlining costs incurred
as a result of drug shortages.
L. Pharmacy purchasing personnel will be responsible for monitoring of contractual issues
related to drug shortages.
VI. REFERENCES
A. UWHC Pharmacy Department Policy 9.5 - Generic Alternative Selection Procedure
VII. COORDINATION:
A. AUTHORED BY: Manager, Supply Chain and Purchasing
B. REVIEWED BY: Manager, Drug Policy Program



Approved By: ____________________________
Director of Pharmacy Services

Date: ________________