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Drug Shortages

Anesthesiologists face an unprecedented number of drug shortages. ASA works to keep members informed of the current drug shortages and informs appropriate parties on the impact drug shortages are having on patients.

Click here to see ASA's one-page information document on Drug Shortages.


Prescription Drug User Fee Agreement (PDUFA) Reauthorization Passes

FDA Holds Briefing on Progress on Drug Shortages

ASA Submits Testimony and Solutions on Drug Shortages to Congress

ASA Responds to Release of GAO Drug Shortage Report

FDA Issues Rule Tightening Drug Shortage Reporting

ASA Praises President Obama's Executive Order on Drug Shortages

ASA Presents Before Hundreds at FDA Drug Shortages Public Workshop on September 26, 2011

ASA Urges HHS Secretary Sebelius to Take Action on Drug Shortages in Face-to-Face Meeting

Senators Blumenthal, Casey, and Harkin Request GAO Investigation of Drug Shortages

Senator Klobuchar Introduces S.296, the "Preserving Access to Life-Saving Medications Act"

Drug Shortage Summit

ASA Drug Shortage Survey

ASA Action on Specific Drugs Currently or Recently in Shortage

Report Adverse Events Due to Drug Shortage

FDA Update on Propofol Shortage: Teva to Restart Production

 


Prescription Drug User Fee Agreement (PDUFA) Reauthorization Passes

PDUFA is a series of user fees that drug and medical device makers pay to fund the enhanced operations of the Food and Drug Administration (FDA). The law must be re-authorized or legally extended every five years and is currently in its fifth iteration. Important to ASA and as a result of ASA and other stakeholders' lobbying, the PDUFA re-authorization legislation in both the House and Senate includes dedicated solely to addressing the national shortages of anesthetic and other drugs.

On May 24, 2012, by a vote of 96-1, the U.S. Senate passed S. 3187, the Food and Drug Administration Safety and Innovation Act, which includes provisions prevent and mitigate national drug shortages.  ASA offered praise for the passage of this legislation.

On May 30, 2012, the U.S. House of Representatives, by a vote of 387-5 passed the Food and Drug Administration Reform Act of 2012, H.R. 5651, commonly referred to as the Prescription Drug User Fee Act (PDUFA) Reauthorization, a legislative package of important Food and Drug Administration (FDA) provisions including one to prevent and mitigate national drug shortages

ASA has actively lobbied Congress to address drug shortages.  In May of 2012 at the ASA Legislative Conference "Lobbying Day," more than 500 anesthesiologists visited Capitol Hill urging support for drug shortage relief and highlighting the significant impact drug shortages have on the practice of anesthesia.

On July 9, President Barack Obama signed into law S. 3187, the "Food and Drug Administration Safety Act" law, which contains important provisions to address drug shortages.

ASA President Jerry A. Cohen, M.D. offered the following remarks:

"We are pleased to report the successful passage and signing of the Food and Drug Administration Safety Act. ASA's consistent leadership and advocacy alongside other key stakeholders proved fruitful in advancing the key drug shortages provisions of this act."

FDA Holds Briefing on Progress on Drug Shortages

On February 21, the FDA held a briefing on drug shortages.  The discussion focused specifically on two cancer-related drug shortages - Doxil and Methotrexate. Speakers included a patient advocate, as well as representatives from the American Cancer Society, the American Society of Clinical Oncology, the Children’s Oncology Group, APP Pharmaceuticals, and Hospira.

Food and Drug Administration (FDA) Commissioner Margaret Hamburg, M.D. emphasized that the agency is working to prevent a record number of shortages. In 2011, the FDA prevented 195 drug shortages, and has prevented 114 drug shortages since President Obama’s Executive Order last fall.  This represents a six-fold increase in voluntary reports by manufacturers of potential shortages and disruptions. 

As you may recall, ASA and the co-conveners of the Drug Shortages Summit offered a series of recommendations to the FDA to combat drug shortages and presented these recommendations before a special FDA panel in September of 2011. One of these recommendations was to reallocate appropriate staffing resources within the FDA to accommodate the growing drug shortages crisis.  Yesterday, Dr. Hamburg also announced that the FDA has almost tripled its staff focused on drug shortages. ASA applauds this decision.   

Finally, the FDA is seeking comments on a draft guidance document for the pharmaceutical industry that encourages voluntary notification of shortages or potential disruptions in supply beyond the scope of reporting that is required existing regulation. 

Read the FDA’s press release on the briefing.

 

ASA Submits Testimony and Solutions on Drug Shortages to Congress

Continuing our call for strong legislative action, ASA offered the perspective of anesthesiologists and solutions to the growing drug shortage pandemic in an official submission to the U.S. Senate Finance and U.S. Senate Health, Education, Labor and Pension (HELP) Committees. Among other items, ASA highlighted the dramatic impact of drug shortages on anesthesiologists and our patients as indicated in the ASA drug shortage survey, and urged immediate action by highlighting recommendations offered by the ASA co-convened Drug Shortage Summit Steering Group.

Over the course of the last two years, ASA has actively led efforts to combat the drug shortage issue on both the legislative and regulatory fronts. Some of the most recent government actions on this important topic include the Food and Drug Administration (FDA) interim final rule mandating additional manufacturer notification requirements related to drug shortages and a long-awaited Government Accountability Office report on drug shortages in which anesthesia drug shortages were identified as the class of drugs with the highest frequency of shortages (23 percent of all drug shortages during the last two years).

 

ASA Responds to Release of GAO Drug Shortage Report

Recently, the Government Accountability Office (GAO) released a long-awaited report on the crisis of drug shortages. The report is in response to continuing problems that anesthesiologists and other physicians face as they confront an unprecedented number of drug shortages.

ASA President Jerry Cohen, M.D. offered the following remarks about the report’s release:

“ASA was pleased by the release of the GAO Drug Shortages report and appreciated the opportunity to participate as an expert resource in the production of the report. As anesthesiologists continue to confront unprecedented drug shortages across the country, ASA is proud of our efforts in coordination with members of the Drug Shortage Summit to successfully elevate this critical issue in both Congress and the Administration. We look forward to thoroughly reviewing the GAO report and its recommendations.”

 

FDA Issues Rule Tightening Drug Shortage Reporting

In accordance with President Barack Obama's Executive Order on drug shortages, the Food and Drug Administration (FDA) released an interim final rule tightening restrictions on the reporting of drug shortages by drugmakers. The interim final rule requires drugmakers who are the sole manufacturers of certain drugs to report all disruptions in production —temporary and permanent—by providing at least a six-month warning (situation-permitting) to the FDA.

Covered drugs would include drugs that are “life supporting, life sustaining or intended for use in the prevention of debilitating disease or condition,” as determined by the FDA on a case-by-case basis. This rule tightens previous references to temporary discontinuances by requiring disruption reporting “if the discontinuance could lead to a disruption in supply of the product.”

Over the course of the last two years, ASA has actively led efforts to deal with the drug shortage issue on both the legislative and regulatory fronts. Part of this effort included co-convening a Drug Shortage Workgroup Summit that issued five legislative and regulatory recommendations. ASA was encouraged to see the inclusion of the Summit’s recommendation for reporting of interruptions and discontinuation of drugs at least six months in advance.

 

ASA Praises President Obama's Executive Order on Drug Shortages

On Monday, October 31, the Obama Administration issued an executive order to the FDA to combat continued drug shortages, the first to directly affect the FDA since 1985. The order is expected to have a significant positive impact on drug shortages per the order’s requirements that include: quickening the review process for applications to start or change production of drugs in shortage, widening the reporting of shortages, expanding notifications of shortages and sharing relevant information regarding possible price gouging with the Department of Justice.

ASA President Jerry A. Cohen, M.D. expressed ASA’s support for the Administration’s executive order:

"On behalf of our physicians and patients, we praise President Obama for his bold action in addressing the growing drug shortages pandemic. In particular, we praise the Administration for including many of the recommendations we proposed with other members of the Drug Shortages Summit. We look forward to continuing to work with the Administration to ensure our physicians have the medications they need to care for patients. "

Over the course of the last year, ASA has actively led efforts to deal with the drug shortage issue including co-convening a Drug Shortage Workgroup Summit with 20 relevant stakeholders--providers, drug manufacturers and other relevant organizations. Therefore, ASA was encouraged to see that in today’s executive order the Administration chose to adopt several of the recommendations found in the Drug Shortage Workgroup Summit’s report.

 

ASA Presents Before Hundreds at FDA Drug Shortages Public Workshop on September 26, 2011

Hundreds of people gathered for the Food and Drug Administration (FDA) Workshop on Drug Shortages on Monday, September 27, 2011. ASA Vice President for Scientific Affairs Arnold Berry, M.D., M.P.H., and ASA Director of Practice Management, Quality and Regulatory Affairs Jason Byrd, J.D., participated on panels during the meeting. The public workshop, the first open public interaction on this important issue, was intended for all stakeholders to provide additional information and insights about the causes and impact of drug shortages, and to identify possible strategies for preventing or alleviating drug shortages. Throughout the day, the shortages of anesthesia and oncology drugs were the most often mentioned.

During the morning session, Dr. Arnold Berry presented on a health care providers panel that gave perspectives on drug shortages from the point-of-care perspective. During his presentation, Dr. Berry presented the findings of the ASA Drug Shortages Survey, the impact shortages are having on patients in need of anesthesia services and the additional health care costs resulting from drug shortages.

In the afternoon, Jason Byrd along with Juliana Reed from Hospira presented five recommendations from the Legislative and Regulatory Work Group of the Drug Shortages Summit. The Drug Shortages Summit brought together stakeholders including manufacturers, providers, distributors and other individuals to address the issue of drug shortages.

Immediately thereafter, Dr. Arnold Berry and Jason Byrd participated in a health care professional groups panel discussion on recommendations for addressing the shortages. Dr. Berry reiterated ASA’s support for the recommendations of the Drug Shortages Summit.

In May, ASA met with FDA officials to discuss the issues of drug shortages. As a follow up to that meeting, ASA sent a letter to the FDA that discusses the extent of anesthesia drug shortages and offers some recommendations on actions the FDA can take to help reduce drug shortages. In the letter authored by ASA Vice President of Scientific Affairs Arnold J. Berry, M.D., ASA reports the results of the recent drug shortage survey of ASA members and ASA recommends in the letter that the FDA pursue six different actions that could help alleviate drug shortages.

 

ASA Urges HHS Secretary Sebelius to Take Action on Drug Shortages in Face-to-Face Meeting

ASA President Mark A. Warner, M.D., along with representatives from other provider groups, manufacturers and distributors met with Department of Health and Human Services (HHS) Secretary Kathleen Sebelius concerning drug shortages on Friday, September 9, 2011. During the invitation only face-to-face meeting, Dr. Warner spoke on the impact anesthesia drug shortages are having on patients - a message Secretary Sebelius referenced later in the meeting.

Secretary Sebelius along with senior staff from the HHS and the Food and Drug Administration (FDA) Administrator expressed a strong commitment to ending drug shortages. To accomplish that goal, this meeting focused on learning the causes behind the spike in the number of drug shortages over the last few years.

 

Senators Blumenthal, Casey, and Harkin Request GAO Investigation of Drug Shortages

Senator Richard Blumenthal (D-CT), Robert Casey (D-PA), and Tom Harkin (D-IA) sent a letter to the Government Accountability Office (GAO) requesting an investigation of drug shortages. In his letter, the Senators request that the GAO investigation “examine the extent of hospital shortages of pharmaceutical products and the prevalence of these shortages in recent years, the impact of such shortages on patient care, possible explanations, and potential legislative or administrative approaches to addressing this problem.” While speaking before the ASA's 2011 Legislative Conference, Senator Blumenthal reported the GAO has agreed to begin an investigation into drug shortages.

On Friday, June 24, investigators from the Government Accountability Office (GAO) interviewed ASA President Mark A. Warner, M.D., ASA Vice President of Scientific Affairs Arnold J. Berry, M.D., M.P.H., and ASA staff on drug shortages. ASA was able to outline some of the causes of the drug shortages as well as recommend some actions that would help alleviate drug shortages.

 

Senator Klobuchar Introduces S.296, the "Preserving Access to Life-Saving Medications Act"

As a result of the Drug Shortage Summit, Senator Amy Klobuchar (D-MN) has introduced legislation that would serve as an important first step to help alleviate the drug shortages negatively impacting patients.

  • Click here for ASA's posting on the introduction of S.296
  • Click here to read the full text of S.296
  • Click here to read ASA's section by section summary of S.296
  • Click here to read a joint press release in support of S.296 released by the conveners of the Drug Shortage Summit.
  • Click here to read a joint letter ASA signed in support of S.296 with other organizations.
  • Click here to read ASA's letter of support for S.296

 

Drug Shortages Summit

ASA co-convened a Drug Shortages Summit on November 5, 2010 to address drug shortages.

  • Click here for the Drug Shortages Summit report and recommendations.
  • Click here to read a statement the co-conveners released after the summit.
  • Click here to read the initial announcement of the summit.
  • Click here to read the five final recommendations of the Drug Shortages Summit Regulatory and Legislative Work Group

 ASA Drug Shortages Survey 2012

 

ASA Drug Shortages Survey (2011 & 2012) 

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%
Thiopental 40.3%
Succinylcholine 21.1%
Propofol 19.2%
Pancuronium 15.2%

3.) Respondents reported that drug shortages had the following impact on patients:
66.7% of patients experienced a less optimal outcome (e.g. post-op nausea and vomiting)
52.8% of patients experienced longer OR/recovery times
27.5% of patients complained
0.2% resulted in death of a patient (6)

4.) Respondents reported drug shortages had the following impacts on his or her practice:
96.3% had to use alternative drugs
50.2% had to change the procedure in some way
7.0% had to postpone cases
4.1% had to cancel cases

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% of respondents reported they are currently experiencing a shortage of at least one anesthesia drug.

98.1% 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%

Thiopental 54.7%

Succinylcholine 47.6%

Propofol 40.3%

Epinephrine 9.1%

The anesthesia drugs with the highest frequency of reported shortage in the last year are as follows:

Propofol 89.3%

Succinylcholine 80.4%

Thiopental 60.2%

Respondents reported that drug shortages had the following impact on patients:

49.2% of patients experienced a less optimal outcome (e.g. post-op nausea and vomiting)

49.1% of patients experienced longer OR or recovery times

Respondents reported drug shortages had the following impacts on his or her practice:

91.8% had to use alternative drugs

51.1% had to change the procedure in some way

6.0% had to postpone cases

4.1% had to cancel cases

 

ASA Action on Specific Drugs Currently or Recently in Shortage

Propofol

  • In 2009, when ASA first learned of the impending shortage of propofol, ASA hosted a series of informational calls with the FDA and encouraged the Agency to authorize the importation of foreign Fresenius Propoven 1 percent to alleviate the impact of the domestic shortage. Currently, both U.S. manufacturers of propofol are releasing product and FDA will continue to monitor the situation and authorize the importation of Propoven until demand can be fully met through domestic sources.

Succinycholine

  • On July 19, the Food and Drug Administration Drug Shortage Division reported that there are now two companies, Hospira and Sandoz, producing succinylcholine injections. The two manufacturers are now able to provide enough products to meet the market demands.
  • Click here to read an update on the shortage of Succinylcholine.

Thiopental

  • Click here to read ASA's statement on Sodium Thiopental's removal from the market.
  • Click here to read a letter ASA sent to the FDA on the Thiopental shortage prior to the removal from the market.

FDA Drug Shortages website

ASHP's Drug Shortages website

Report adverse events due to drug shortage

ASA members are encouraged to report adverse events or near-misses arising from medication shortage to the Anesthesia Incident Reporting System (AIRS). AIRS is maintained by the Anesthesia Quality Institute, a federally-designated Patient Safety Organization.  Your confidential report is protected from legal discovery, and will help ASA advocate on behalf of patient safety.  More information on AIRS.

FDA Provides Update Regarding Ongoing Propofol Shortage: Teva to Restart Production

ASA continues to work with the Food and Drug Administration (FDA) to prevent and mitigate drug shortages.  Captain Valerie Jensen, R.Ph, the FDA’s Associate Director for the Center for Drug Evaluation and Research’s Drug Shortage Program offered the following update regarding Propofol shortages:

“FDA continues doing everything in our regulatory authority to address this shortage.  We are continuing the importation of Propoven and we anticipate seeing steady improvements in supply of propofol and Diprivan over the next couple of months.  Fresenius/APP has increased production and shipments of the product and Teva is expected to be releasing product by end of February.  Teva had discontinued this drug in 2010 and they have responded to this shortage by reentering the market with this critical drug.

 We are also anticipating some relief with etomidate in the coming weeks as production is increasing to meet the shortfall. We know that anesthesia drugs have been severely impacted by ongoing shortage issues and we will continue doing all we can to address these shortages and will continue to update supply information on our CDER Drug Shortage page on these drugs as information becomes available.  http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm “