AMA House of Delegates

K. Barton Farris, MD, right, a delegate for the Louisiana State Medical Society, argues against a proposed amendment during a floor debate on the national drug shortage policy. Joseph J. Fallon Jr., MD, an endocrinologist from Marlton, N.J., waits for his turn to speak. Photo by Ted Grudzinski / AMA
AMA delegates detail steps to confront national drug shortage emergency
■ The AMA house backs such recommendations as mandating public notification of market withdrawals up to a year in advance.
New Orleans -- The AMA House of Delegates said the rising number of critical drug shortages constitutes a "national public health emergency" that requires a swift and sophisticated response to address the complex roots of the crisis.
The tally of drugs classified as being in shortage by the Food and Drug Administration tripled from 61 in 2005 to 178 in 2010. Nearly three-quarters of the shortages involved sterile injectables, and 80% of the shortage drugs are generics. More than half of drug shortages are due to manufacturing quality problems, the FDA says.
The agency's figures may underestimate the extent of the problem. The FDA counts a drug as being in shortage only if it is "medically necessary," meaning that there is no other source of the drug or adequate substitute -- even if the alternative is available only after delays or imposes higher costs on patients, hospitals or doctors.
Using a broader definition that includes any drug whose supply is interrupted, the American Society of Health-System Pharmacists lists more than 200 current drug shortages. These are in addition to more than 80 shortages that have been resolved in 2011.
"Our patients are suffering, unable to receive the vital medicines that they need," said Leah S. Mc Cormack, MD, a Forest Hills, N.Y., dermatologist who spoke on behalf of the Medical Society of the State of New York in house reference committee testimony. "The patients of America need to hear from the physicians of America that this is an emergency. We really need the concrete steps on how to solve this problem."
At its November Interim Meeting, the house backed the recommendations of a 2010 summit convened by organizations representing pharmacists, oncologists, anesthesiologists and medication-safety experts. These include:
- Requiring public notification of market withdrawals up to a year in advance.
- Changing the FDA definition of a "medically necessary" drug in shortage to expand the agency's authority to act.
- Offering tax incentives to manufacturers that produce critical drugs or upgrade the quality of their practices to prevent supply disruptions.
- Requiring confidential notification to the FDA when there is a sole manufacturing facility for a drug.
Delegates directed the AMA to advocate that the FDA or Congress require drugmakers to establish a continuity plan for supplying vital and life-sustaining medications and vaccines. The house also asked the AMA Council on Science and Public Health to report back at the June 2012 Annual Meeting on progress in preventing drug shortages, especially in oncology.
The house rejected a proposal made on the floor to call for eliminating Medicare's average sales price formula, which some experts argue is to blame for the rise in drug shortages. Delegates also voted down a measure that would have sought to penalize drug manufacturers that fail to remedy a shortage within 30 days. Financial penalties, if enacted, would discourage entry into a generic-drug market with slim profit margins, said Louisiana State Medical Society delegate K. Barton Farris, MD.
"This would only exacerbate the problem," said Dr. Farris, a specialist in anatomic and clinical pathology from Marrero, La.
Officials in Washington have taken some action on the matter. Bills proposed in the House and Senate would require drugmakers to notify the FDA of any anticipated supply disruptions six months in advance.
On Oct. 31, President Obama issued an executive order directing the FDA to ask drugmakers voluntarily to provide information about interruptions, delays, production or import problems or unexpected increases in demand that might lead to shortages. Obama also told the FDA to expedite reviews of critical drug suppliers and manufacturers and ordered the Justice Dept. to investigate price-gouging of shortage drugs.
Specialty pharmaceutical distributors have come forward to meet the demand for shortage drugs on the so-called gray market. The extent of the markup on the drugs is disputed, but a June American Hospital Assn. survey found 92% of hospitals reporting higher drug costs due to shortages.
Impact on physicians, patients
Although shortages affect only a sliver of the drugs used in the U.S. -- 1% or less, according to an October Dept. of Health and Human Services report -- they can hit physicians and their patients hard, delegates said. Oncology and anesthesiology medicines have been especially affected by the crisis.
"For anesthesiologists across the country, this is an ongoing problem," said Alvin C. Head, MD, a delegate from Augusta, Ga., who spoke on behalf of the American Society of Anesthesiologists in reference committee testimony.
"I consider this a patient safety issue, as the substitute drugs are not always equivalent," he said.
In addition to delays in care and higher costs, shortages have led to harmful mix-ups, according to the council report the house adopted. For example, when morphine was in shortage, intravenous hydromorphone was substituted in its place. But in some cases the drug was incorrectly prescribed at the intended morphine dose, leading to at least two patient deaths.
During an Interim Meeting education session on the shortage crisis, American Society of Clinical Oncology delegate Johannes C. Nunnink, MD, of Colchester, Vt., described cases where he has had to delay care or substitute much more expensive drugs that financially burdened patients faced with 20% co-payments.
"The bottom line is: When you're sitting down with a patient talking about the standard regimen of treatment, you have to spend the extra time to check and say, 'Oh, we don't have Taxol,' " said Dr. Nunnink, referring to the brand name for paclitaxel, an injectable drug used to treat ovarian cancer. "To have that discussion with the patient is incredibly frustrating."
Jane C. Fitch, MD, an American Society of Anesthesiologists delegate from Oklahoma City, also has seen the shortages' effect.
"We have had patients in the operating rooms longer than necessary, and in recovery rooms longer than needed, and we've had significant patient satisfaction issues," Dr. Fitch said. "We have been dealing with this problem for the last decade and more acutely in the last five years. We appreciate any weight the AMA can throw behind this. It really is our patients who suffer."