Part II of our national survey on
drug shortages:
Proactive guidelines to safely manage scarce supplies
From the April 4, 2001 issue
It is clear from the findings of our recent national survey
that ongoing drug shortages can present a serious threat to
patient safety. In our last issue, we described the wide scope
of the problem and the many challenges that health care organizations
faced. Surprisingly, only 5% of the 344 respondents had established
a formal process for managing drug shortages, but many offered
advice for tackling the issue head on. The recommendations
below incorporate selected survey findings and respondents'
suggestions that can be used to develop proactive guidelines
to manage drug shortages. An ongoing task force that networks
with area hospitals and meets with clinicians from high use
areas where drugs are in short supply may be helpful in carrying
out the recommendations.
Find out about drug shortages.
Assign a staff member to regularly search the literature/web
sites (ASHP, FDA, etc.) for information.
Attempt to obtain needed supplies.
Call the manufacturer for information, a release date, and directions
for ordering drugs on allocation or for emergency supplies.
Determine if current inventory will be sufficient. If not, try
to obtain an alternative from another supplier/wholesaler or
order allocated or emergency supplies directly from the manufacturer.
Perhaps purchasing groups could take a more active role in finding
products in short supply to relieve pharmacy staff of such a
time consuming job. Establish a tickler system to check stock
and reorder at the appropriate intervals.
Perform a literature search and conduct a drug use evaluation
(DUE)1.
Identify clinically appropriate uses of the drug, the lowest
optimal dose for current indications, strategies to decrease
drug waste, alternative products, and priority uses for extreme
shortages. Perform a DUE to determine how the drug is actually
being used in your facility.
Place limitations on use.
Based on the extent of the shortage, availability of alternatives,
and results of a DUE, develop plans to restrict use and reduce
wastage. For example, 33% of respondents restricted fentanyl
use, primarily to specific units (OR, open-heart surgery, labor
and delivery, pediatrics), for certain types of pain control
(epidurals, PCA), or for specific patients (neonates, those
unable to tolerate morphine).
Remove supplies from floor stock when able and have pharmacy
dispense the drug.
Several respondents removed fentanyl from automated dispensing
cabinets so that pharmacy could better control restrictions
and waste.
Select an alternative product.
Obtain suggestions from the literature, web sites, physicians
who use the product, and other local hospitals (to promote consistency
for prescribers who practice at multiple sites). Select alternatives
early so an education plan can be developed in case implementation
is needed. Over half of respondents had selected alternatives
for fentanyl, most commonly sufentanil or alfentanil for anesthesia
and morphine or hydromorphone for analgesia. Most often, respondents
based selections on staff preference/familiarity, presence on
the formulary, and similar pharmacology/side effects. A few
respondents also based selections upon availability, cost, and
similar onset of action/duration.
Alert departments to the shortage, possible substitutes,
and potential adverse events.
In our survey, 92% had alerted affected departments to the fentanyl
shortage (and reason/duration if known). While over half had
selected a substitute, only 27% had issued an alert listing
the substitute(s), dosing information, side effects, and the
phone/pager number of key pharmacy staff. Those who issued alerts
used media such as e-mail, the pharmacy newsletter, biweekly
memos, posters/charts in units, or alerts in information systems
that appeared automatically upon initial log in. No one alerted
staff to potential adverse events with substitute(s)!
Institute strategies to avoid errors with substitutes.
To avoid errors with fentanyl substitutes, only 24% of respondents
had taken precautions, most often citing staff education, use
of auxiliary labels, automatic computer alerts, and anesthesia
consultation if used outside the OR. A few respondents said
they were repackaging larger quantities of fentanyl, which are
currently available, into smaller, 2 mL vials or syringes to
avoid dosing confusion (and minimize waste).
Proactively monitor adverse events.
Only 29% of respondents said they were monitoring adverse events
with the use of fentanyl substitutes. Of those, most relied
upon typical error reporting systems. Only 25% used additional
methods such as actively pursuing information about errors,
a hot line, chart review, focus group meetings, or discussions
during pharmacy rounds.
Monitor and report drug shortages.
Report to the FDA (www.fda.gov/cder/drug/shortages) and ASHP's
Drug Product Shortage Management Resource Center (www.ashp.org/shortage/).
Reference: 1. Schrand LM, Troester TS, Ballis ZK, et al. Preparing
for drug shortages: One teaching hospital's approach to the
IVIG shortage. Formulary. 2001; 36:52-59. |
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