Question

1. In your opinion, is there an over reliance on international imports of medicines? Explain why or why not.
2. How would you determine the most appropriate method of preventing and/or responding to drug shortages
3. What would be the greatest risks of drug shortages? Please provide examples.

Answer 1

The key to preventing drug shortages might be to find manufacturers of high-quality products and pay them enough for their drugs so that they make a reasonable profit and can invest in their facilities when they need to.

When a shortage is identified, the drug
product shortage team should conduct an operational and therapeutic assessment to evaluate its potential impact. A shortage impact analysis based on the 2 assessments and an evaluation of procedural and financial implications should
be used to assess the potential impact on patient care. The drug shortages team should use that impact analysis to develop a final action plan for approval and implementation. An institution’s success in responding to shortages is typi-
cally dependent on how well the system can change drug products in their system under nonshortage conditions.
Operational Assessment
The operational assessment should be performed by the point person or that person’s designee, working with others as necessary. The assessment validates the details of the shortage, estimates the supply of the drug product in shortage available on hand and from alternative sources, evaluates past usage, and estimates the supply of alternative therapies.
Details and Duration of Shortage. The pharmacy team can contact product manufacturers, distributors, FDA, the Centers for Disease Control and Prevention (CDC), and other sources to determine the cause of the shortage and its
expected timing and duration. This information may already be available on the ASHP Drug Shortage Resource Center website (www.ashp.org/Drug-Shortages) or the FDA Drug Shortages website (www.fda.gov/Drugs/DrugSafety/
DrugShortages). If it is not, visitors to the sites should report the shortage online. Predictions of when the product will be available help the healthcare organization develop its short and long-term strategies. Because the status of a shortage
can change quickly, follow-up communications with manufacturers may be required to obtain updates on previous estimates of product availability.
Inventory on Hand. Once a shortage is identified, pharmacy staff should assess the inventory on hand and estimate the time period it will cover. Available inventory includes all supplies of the drug product within the healthcare organization, including the pharmacies, inpatient units, ambulatory
care clinics, automated medication storage and distribution devices, floor stock, code carts, and prepared trays. The pharmacy should estimate how long the healthcare organization can endure a shortage based on available quantities and
historical usage, converting inventory counts of alternative drug products into common measurement units (e.g., common dose, days of therapy) to augment estimates of use.
Therapeutic Assessment
The therapeutic assessment can be performed by the point person, that person’s designee, or other members of the drug shortage team as neces-
sary. The assessment identifies the primary patient populations affected and identifies therapeutic alternatives.
Patient Prioritization.

When a limited supply of a drug remains avail-
able and alternatives for specific patient groups are undesirable, a healthcare organization may priori-
tize use of the drug for specific patient groups. National organizations (e.g., CDC or an organization of healthcare specialists) may provide guidance on patient prioritization. Medication-use evaluation data on prescribing and utilization trends, if available for the drug in question, may be useful in developing prioritization criteria to guide appropriate
drug use. Additional criteria, such as therapeutic use (curative versus palliative), may also be helpful in guiding appropriate use of the drug. Such
criteria are particularly helpful in dealing with long-term shortages. To restrict product use for select patients or services in the healthcare organi-
zation, criteria should be developed
by an interprofessional team. An ethical framework for allocating particularly scarce or lifesaving products is essential as is evidence-based deci-
sion making with regard to alternatives.

Therapeutic Alternatives.

Therapeuticalternatives should be inventoried and availability assessed to ensure adequate supplies to meet new demand. In many cases, supplies of the best alternative agent may be affected by the response to the shortage. If therapeutic alternatives are not on the formulary or not currently stocked in the system, there should be a pro-ess to expedite adding the new product to all systems (e.g., the electronic health record [EHR], smart pump libraries, automated dispensing cabinets [ADCs]). If a compounded medication is an appropriate alternative, organizations must decide whether resources are available to compound inhouse or if the best solution is to purchase the compounded medication from an FDA-registered outsourcing facility.