Drug Shortages

Print Page

Drug Shortage Resource Page: Understand the Problem, See Where to Report Shortages

By Robert Campbell, M.D.

Intro
Drug Shortages in Pennsylvania
Reasons for Drug Shortage
Current Drugs In Short Supply
Where to Report Shortages
Who Is Addressing Problem?
Notable Public Policies
Lawmakers Voice Concerns
Additional Resources
In the News

Intro

Anesthesiologists in Pennsylvania are increasingly confronted with critical drug shortages when providing clinical anesthesia care to patients. Drug shortages have grown from 70 in 2006 to a high of 211 in 2011. In 2012, there are already more than 225 drug shortages reported by the FDA.

Sterile injectables account for 80 percent of the shortages. Generic injectables are especially vulnerable with the three largest generic injectable manufacturers garnering more than 70 percent of market share. Most branded and generic sterile injectables have one manufacturer that produces 90 percent or more of specific injectable drugs.

Anesthesiology and oncology are the most critically affected medical specialties. Anesthesiology is especially impacted as multiple critical medications are regionally either in short supply or completely unavailable. The list of anesthesia medications impacted in our region is extensive and includes widely used medications such as propofol, pentothal, succinylcholine, midazolam, and fentanyl.

> Back to top

Reasons for Drug Shortages

There are multiple factors contributing to medication shortages. These include disruption in raw material supply, increasingly complex global supply chain, and lean inventory systems from manufacturer to patient bedside. FDA implicated causes include failed inspections and the recent Unapproved Drugs Initiative.

A recent report by the House Oversight Committee placed much blame on FDA over-regulation. Critical supply manufacturers have been shut down for technical violations or insufficient documentation that has marginal safety impact. It is evident that the resulting drug shortages have been a greater threat to patient safety than the regulation violation resulting in manufacturing plant closures. Decreased profitability, industry consolidation, decreased manufacturing capacity, and variable demand have all contributed to specific shortages.

> Back to top

Who is Addressing Drug Shortage Problem?

The American Society of Anesthesiologists is the national leader on this issue in Washington, D.C. While there are innumerable other organizations active, the most actively engaged and influential organizations include:

• American Society of Anesthesiologists (ASA)
• The Food and Drug Administration (FDA)
• The American Society of Health-System Pharmacists (ASHP)
• American Society of Clinical Oncology (ASCO)
• University of Utah Drug Information Service (UUDIS)
• Institute for Safe Medication Practices (ISMP)
• American Hospital Association (AHA)

The FDA Safety and Innovation Act was the only major legislation passed by Congress and signed into law in 2011-2012. It included fees charged to prescription and generic manufacturers. It also re-prioritizes criteria for FDA regulation. In the past, the FDA could shut down manufacturing plants for incomplete paperwork or a technical violation of a regulation. Under the new law, the FDA will need to measure the safety risk of its regulatory activity in the context of drug supply and alternatives available. There will need to be an analysis of the needs of patients at risk when drug shortages are created by regulatory action.

> Back to top

Notable Drug Shortage Actions/Public Policies

The most important national public policy actions include:

 

> Back to top

Lawmakers Voice Concerns

As the number of drug shortages rise, doctors and hospitals have increasingly turned to compounding pharmacies to fill a void. In mid-November 2012, several members of the U.S. House of Representatives requested an investigation by the Government Accountability Office into whether contracting practices by Hospital Group Purchasing Organizations are a driving cause of drug shortages that force hospitals and other providers to rely on compounding pharmacies.
Read more (PDF)
Read Rep. Markley’s Government Accountability Office (PDF)

> Back to top

Drug Shortages in Pennsylvania

PSA members regularly confront the consequences of unprecedented medication shortages in Pennsylvania. An April 2011 survey of anesthesiologists found 98 percent of those surveyed experienced a drug shortage during the past year. Forty-eight percent identified sub-optimal clinical outcomes as a direct result of drug shortages.

2012 survey findings
In March 2012, ASA surveyed its members on drug shortages. The responses to the survey totaled 3,063 anesthesiologists representing 50 states, the District of Columbia, Puerto Rico and six nations. The majority of responses (3,033) were from the United States. Respondents also represented all health care settings including hospitals (88.5 percent), ambulatory surgery centers (44.7 percent), office-based (13.2 percent) and critical access hospitals (8 percent).
Here are some of the surveys’ key findings:

  1. 97.6 percent of respondents reported they are currently experiencing a shortage of at least one anesthesia drug.
  2. The anesthesia drugs with the highest frequency of reported current shortage are as follows: Fentanyl 66.3 percent, Thiopental 40.3 percent, Succinylcholine 21.1 percent, Propofol 19.2 percent and Pancuronium 15.2 percent.
  3. Respondents reported that drug shortages had the following impact on patients: 66.7 percent of patients experienced a less optimal outcome (e.g. post-op nausea and vomiting), 52.8 percent of patients experienced longer OR/recovery times, 27.5 percent of patients complained, 0.2 percent resulted in death of a patient (6)
  4. Respondents reported drug shortages had the following impacts on his or her practice: 96.3 percent had to use alternative drugs, 50.2 percent had to change the procedure in some way, 7.0 percent had to postpone cases, and 4.1 percent had to cancel cases.

2011 survey findings
In April 2011, the ASA surveyed its members on drug shortages. The responses to the survey totaled 1373 anesthesiologists representing 49 states, the District of Columbia, Puerto Rico and six nations.
Here are some of the surveys key findings:

  • 90.4 percent of respondents reported they are currently experiencing a shortage of at least one anesthesia drug.
  • 98.1 percent of respondents reported they have experienced a shortage of at least one anesthesia drug in the last year.
  • The anesthesia drugs with the highest frequency of reported current shortage are as follows: Neostigmine 56.9 percent, Thiopental 54.7 percent, Succinylcholine 47.6 percent, Propofol 40.3 percent, and Epinephrine 9.1 percent. 
  • The anesthesia drugs with the highest frequency of reported shortage in the last year are as follows: Propofol 89.3 percent, Succinylcholine 80.4 percent, and Thiopental 60.2 percent. 
  • Respondents reported that drug shortages had the following impact on patients: 49.2 percent of patients experienced a less optimal outcome (e.g. post-op nausea and vomiting), and 49.1 percent of patients experienced longer OR or recovery times
  • Respondents reported drug shortages had the following impacts on his or her practice: 91.8 percent had to use alternative drugs, 51.1 percent had to change the procedure in some way, 6.0 percent had to postpone cases, 4.1 percent had to cancel cases

These complications include: delay of medical treatment, cancellation of surgery, prolonged awakening from anesthesia, delay of hospital discharge, and death. Regional unavailability of critical drugs has a huge impact on the safe administration of anesthesia and increases costs for providers and patients. The average mark-up for grey market medications is 650 percent. The average mark-up for propofol at one point was a startling 3,161 percent.

Pennsylvania anesthesiologists must deal with the consequences of anesthetic drug shortages. At times, delaying elective care is the best course of action. There are many ethical issues associated with drug rationing policies. Anesthesiologists should be consultants in choosing alternative drugs to replace medications no longer available. At times these alternatives may be less effective and have more side effects. Extra precautions are necessary when administering less familiar medications to reduce error rates. Grey market medications can have unfamiliar packaging and labeling. In addition, potency can vary from familiar branded drugs. Any shortages encountered by institutions should be reported to the FDA and any price hikes reported to the FTC.

How to report drug shortages

Report drug shortages to the FDA

Anesthesiologists are also encouraged to report any episode of patient care that is compromised by drug shortages to the ASA Anesthesia Quality Institute

> Back to top

List: Current Drugs in Short Supply

Additional Resources on Drug Shortages

American Society of Anesthesiologists
American Society of Health-System Pharmacists
U.S. Food and Drug Administration
Canadian Drug Shortages Resource Page

In the News

> Back to top

Our Society

Physicians Protecting Patients