Transcript: Testimony of Dr. Kasey Thompson on drug shortages
Senate Committee on Finance hearing on “Drug Shortages: Why They Happen and What They Mean” held on Dec. 7, 2011
Testimony of Dr. Kasey Thompson, Vice President of Policy, Planning and Communications for the American Society of Health-System Pharmacists (ASHP):
“Good morning and thank you Chairman Baucus, Ranking Member Hatch, and distinguished Members of the Committee, for holding this hearing.
“My name is Kasey Thompson and I am Vice President of Policy, Planning and Communications for the American Society of Health-System Pharmacists (ASHP). I am here today to talk about the problem of drug shortages and how shortages are affecting patients and the ability of healthcare providers to care for them.
“For the last 10 years, ASHP, in collaboration with the University of Utah Drug Information Program, has been tracking drug shortages, and making that information available to the public on our website.
“In the past five years, shortages have rapidly escalated, increasing from 70 in 2006 to 231 as of this November, and there appears to be no end in sight.
“Generic injectable drugs, which are commonly used in hospitals, comprise the majority of drug shortages. Many drugs fundamental and essential to care are in scarce supply, including oncology drugs, anesthetics and pain medications, antibiotics, life support drugs for emergency care, and intravenous nutrition.
“Because shortages affect our hospitalized and most vulnerable patients, patient safety and quality of care is our primary concern. Without access to the preferred drug treatment, clinicians must use alternatives, which may be less effective or associated with increased risk of adverse outcomes. Examples of these events are described in detail in the Institute for Safe Medication Practices survey in September 2011. In this survey, 1800 respondents reported over 1000 adverse drug events caused by shortages. Twenty-five percent of these reports were medication errors; another 20% were adverse drug reactions. A survey conducted by the American Hospital Association in July 2011 also identified suboptimal care, indicating that 82% of hospitals reported delayed treatment and more than half said they could not provide some patients with the recommended therapy.
“Drug shortages also add to the cost of providing care. A study by Premier in March of this year suggested the cost of purchasing alternative therapeutic products to those in shortage to be $200 million annually. In addition, a survey conducted by ASHP and the University of Michigan indicated that hospital pharmacists are spending 8-12 additional hours per week dealing with shortages. Further, the study estimated that additional annual labor costs to hospitals of managing shortages to be $216 million annually. Every minute spent dealing with a shortage is time taken away from patient care.
“In some cases, we are able to determine why there is a shortage. In other cases, we simply have no idea. As a first step we support the passage of the current bipartisan legislation in the House and Senate that would help the FDA prevent some shortages from occurring if they were notified about a manufacturing problem or planned discontinuation. FDA data indicate that 54% of drug shortages are related to product quality problems followed by lack of capacity or other manufacturing issues. About half of the time manufacturers do not disclose the reason for a shortage.
“Our analysis over the last 10 years has shown that many drug shortages are the result of quality issues in the manufacturing process, loss of a manufacturing site, delays and capacity issues, shortages of raw materials– particularly a single source of an active pharmaceutical ingredient, product discontinuations, and secondary shortages of a therapeutic alternative resulting from a primary shortage. We recognize that there is no one cause of drug shortages, and therefore no one solution.
“We are very pleased to see that other facets of drug shortages, including economic factors, are being considered, but we are not currently in a position to draw any conclusions given a lack of sound data.
“A recent report by the Assistant Secretary for Planning and Evaluation describes the economic analysis of drug shortages. It identified a number of possible factors influencing drug shortages and noted that ‘Shortages have been concentrated in drugs where the volume of sales and drug prices were declining in the years preceding a shortage, suggesting that manufacturers are diverting capacity from shrinking lines of business to growing ones.’
“It has been suggested that Medicare reimbursement policies may be partially to blame for drug shortages. While we believe this is an area that should be explored further, we are hesitant to focus on any one potential cause given the limited data and the numerous factors that contribute to shortages. It will be important to learn from other stakeholders in the supply chain, including pharmaceutical manufacturers, wholesalers, group purchasing organizations, and others in order to fully assess these causes and solutions to this public health crisis.
“Other incentives for manufacturers to stay or re-enter the market should be examined. For example, tax credits awarded to companies for developing new technologies in the production process should be explored. We believe that any incentives should be geared toward increasing production capacity and upgrading facilities in order to meet demand for critically important generic injectables.
“In conclusion, drug shortages continue to be a very serious public health crisis, and compromise our ability to treat adult and pediatric cancer, to feed newborns intravenously who cannot eat, to relieve pain, to battle serious infections, and provide care when the most appropriate drug is unavailable.
“We look forward to working with Congress, the FDA, and other stakeholders to ensure an adequate supply of critical, life-saving medications.
“Again, thank you Mr. Chairman, ranking member, and all members of the committee for the opportunity to provide input on this urgent public health crisis.”
- Written testimony submitted by Dr. Kasey Thompson (PDF)
- American Society of Health-System Pharmacists
- Transcript: Sen. Max Baucus’ opening statement on drug shortages
- Transcript: Sen. Orrin Hatch’s opening statement on drug shortages
- Transcript: Testimony of Dr. Kasey Thompson on drug shortages
- Transcript: Testimony of Dr. Patrick Cobb on drug shortage
- Transcript: Testimony of Dr. Scott Gottlieb on drug shortages
- Transcript: Testimony of Dr. Rena Conti on drug shortages
- Transcript: Drug shortages Q&A by Sen. Orrin Hatch
- Transcript: Drug shortages Q&A by Sen. Jeff Bingaman
- Transcript: Drug shortages Q&A by Sen. John Cornyn
- Transcript: Drug shortages Q&A by Sen. Ron Wyden
- Transcript: Drug shortages Q&A by Sen. Ben Cardin
- Transcript: Drug shortages Q&A by Sen. John Thune
- Transcript: Drug shortages Q&A by Sen. Chuck Grassley
- Transcript: Drug shortages Q&A by Sen. Tom Carper
- Senate Committee on Finance: Hearing on “Drug Shortages: Why They Happen and What They Mean” held on Dec. 7, 2011 (video)
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