Surviving Drug Shortages: Assessment of Shortage
During the assessment phase, the coordinator of purchasing and inventory control determines the duration and reason for the shortage. If it is determined that a short-term shortage will occur, drug quantities are ordered based on allocation by the wholesaler. If long-term shortages or unexpected emergent shortages are confirmed, the director of pharmacy delegates clinical assessments of the drug shortage to a clinical pharmacy specialist. For both long- and short-term shortages, an assessment is made of utilization specific to our organization. This includes the number of doses used per week, the supply on hand, the frequent prescribers, and the usual indications.
The clinical pharmacy specialist subsequently conducts a clinical assessment to determine if formulary alternatives are available for the drug shortage, based on the usual indications. Standard drug information references are utilized, in addition to conducting a MEDLINE literature search. When necessary, a survey might be conducted to determine which drugs other institutions are utilizing. This is often determined via telephone interviews, emails, or drug information listserv surveys. Web sites devoted to drug shortages are also accessed to determine whether nationwide recommendations exist. The two sites commonly utilized are located on the American Society of Health-System Pharmacists’ (ASHP’s) Drug Product Shortages Management Resource Center and the FDA’s drug shortages site If the drug shortage is not listed on the ASHP Web page, an online report can be initiated.
The group purchasing organization frequently prepares recommendations for alternatives, but it might not be timely. Occasionally, pharmaceutical manufacturers allocate drugs for specific patients only, based on specific criteria (e.g., caspofungin). In this case, the utilization information provides valuable insight into the possible impact on patient care.
The clinical assessment also examines any risk or safety concerns: Will the replacement product be a different concentration or package size? Will the product be a multidose vial or a single-dose vial? Does the replacement product contain preservatives (e.g., with epidural steroid shortages)? Is the packaging clear and does it have a high-quality label? Extemporaneous compounding of commercially available products might be considered if the product is not available, but there must be careful consideration of safety risks and legal implications.
If it is determined that a formulary alternative can be utilized, the staff pharmacist will contact the prescriber upon receipt of the order to discuss formulary alternatives. If it is determined that further therapeutic intervention is needed, the clinical pharmacy specialist will follow up on the daily usage of the drug in short supply. An example of a drug that was affected by this intervention is intravenous. In cases involving drugs affected by shortages, the specialist assesses whether the use of the drug meets the institution’s drug usage guidelines as approved by the P&T committee. If the use does not meet the guidelines, the prescriber is paged to discuss alternatives. See Table 1 for examples of alternative recommendations/decisions made at Allegheny General Hospital.
Table 1 Examples of Alternative Recommendations/Decisions About Drug Shortages at Allegheny General Hospital*
|Medication Affected by|
|Drug Shortage||Alternative Recommendation/Intervention|
|Dexamethasone PO or Methylprednisolone IV/PO or Prednisone PO or Hydrocortisone IV/PO|
|Fentanyl IV||Reserved for cardiothoracic surgical procedures|
|Furosemide 40 mg/4 ml vial||10 ml vial|
|Influenza vaccine 2000 shortage||Vaccine provided per CDC guidelines|
|Influenza vaccine 2001 delay||Vaccine provided per CDC and local health department guidelines|
|Isoproterenol||Restrict to electrophysiology lab and heart transplantation|
|Penicillin G IV||per Centers for Disease (CDC) guidelines or frozen minibags of penicillin G, if available|
|Heparin 5,000 units/ml||Other generic heparin dosage form|
|Hyaluronidase||Revised hospital extravasation guidelines to reflect permanent unavailability of the product|
|Intravenous Immune Globulin (IVIG)||Restricted to department chair approval|
|Canadian Pantoprazole IV||Pantoprazole PO (or lansoprazole via feeding tube). If patient unable to take PO, famotidine IV|
|Prochlorperazine||Droperidol,H Metoclopramide, Thiethylperazine, or Trimethobenzamide|
|Tetanus diphtheria toxoid (Td)||Limited use per CDC guidelines|
|* This list includes resolved and current drug shortages. HNote QT prolongation black box warning.5 IV=intravenous; PO=orally.|
The assessment of the financial impact of the shortage is prepared to assist with decision-making. This assessment includes not only the cost of the alternative product, but also the impact on operations. For example, the shortage might affect the length of time for procedures, or it might result in the inability of procedures to be performed. This was a concern with the fentanyl shortage; fentanyl is preferred for a number of surgical procedures. Although few of the shortages have actually resulted in significant changes in the cost to deliver care, cost needs to be considered when evaluating the impact of a shortage.