AMA: Drug Shortage Disruptive but Limited to a Few Key Areas

Caroline Helwick

November 14, 2011

November 14, 2011 (New Orleans, Louisiana) — A new report issued by the IMS Institute for Healthcare Informatics shows that 168 drugs are currently in short supply, and most of the shortage clusters around 4 key areas. Supplies of other scarce drugs are stable or have improved, according to the report released today.

The report coincided with a presentation here at the American Medical Association (AMA) 2011 Interim Meeting by Bona Benjamin, BS Pharm, director of medication use quality improvement for the American Society of Health-System Pharmacists (ASHP). Ms. Benjamin presented the findings during her discussion of drug shortages with delegates at the AMA meeting.

The ASHP maintains the Drug Shortages Web Resource Center, which is more comprehensive than the Food and Drug Administration (FDA) Drug Shortages Program Web site, she said. FDA information is limited to "medically necessary" drug shortages and approved indications, she noted.

"The drug shortage of 2010 and 2011 is marked by unprecedented numbers and scope, and the number of shortages continues to rise, and I don't see an abatement of this trend," Ms. Benjamin said. "It involves generic drugs that are fundamental to care, leads to increased costs for hospitals and health systems, causes significant duress for practitioners, and is associated with adverse patient outcomes."

IMS Institute Updates Drug Shortage Numbers

The new study, "Drug Shortages: A Closer Look at Products, Suppliers and Volume Volatility," comprehensively examined drug shortages, and the authors recommend that healthcare stakeholders work to create an early-warning system to minimize future disruptions in patient care.

There are 168 drugs officially reported in shortage as of October 7, 2011. Analysts at the IMS Institute took that list and combined it with proprietary supply-chain sales data to determine that the problem is more concentrated than overall figures suggest. Of drugs believed to be scarce, manufacturers reported stable supplies of 56 drugs and increasing availability for 31 drugs, but for 75 products the decline in availability has been steep, dropping 47% over a 5-year period.

More than 80% of the shortage pertains to generic sterile injectables. Half the generic injectable drugs sold in the United States are on the shortages list, the report stated.

"Four drug classes are always in the top 5 — oncology, anti-infectives, cardiovascular drugs, and central nervous system agents — and they jockey for first position," Ms. Benjamin noted.

Oncology drugs are currently taking the biggest hit, with 22 agents accounting for 16% of the total list and potentially impeding the care of some 550,000 cancer patients, she said.

The IMS report also found great volatility in the availability of some drugs in recent years, with considerable unpredictability of the month-to-month supply to providers. Although almost 100 companies in all are supplying the 168 products in short supply, 50 drugs are made by only 1 supplier and 23 are made by 2. Two thirds of shortage drugs have, at most, 3 suppliers.

"Three is the magic number," Ms. Benjamin noted. "We had only 3 suppliers of propofol. One could no longer produce, and the remaining two could not meet the additional 30% demand. This led to a year-long shortage of propofol."

AMA Debates Reasons for the Shortage

Many reasons have been cited for drug shortages. The IMS study found that manufacturing problems, discontinuations and suspension of production, inability to meet demand, raw material problems, and contamination or other quality issues are particularly relevant.

Older generics and "drugs that have been around forever" weigh heavily on the list, but 38 of the 168 drugs on the IMS list have been approved since 2000 and 4 are new drugs that are still awaiting FDA approval, Ms. Benjamin noted.

"There is a misconception that the main problem is older unprofitable generics," she said. "The IMS study actually found manufacturing problems to be the main reason."

Such problems often include difficulties meeting quality assurance specifications, an issue she called "serious, pervasive, and persistent." Although many wonder how older generic drugs could cause such problems, she pointed out, "It's just as hard to safely manufacturer potassium chloride as any other newer drug."

Meeting safe manufacturing practices while maximizing capacity is a balancing act, Ms. Benjamin stressed.

Business decisions by manufacturers, often involving profitability, also play a key role in shortages, and this issue extends beyond the low return on investment of generics, she added. For instance, production infrastructure and schedules are designed to maximize output of product, and when shortages exist and capacity needs to expand, changes cannot be simply imposed upon this structure to correct deficiencies, she explained.

Recommendations From IMS Institute

The IMS Institute indicated the drug shortage is more complex, though narrower, than expected, and a systematic study across the supply chain is needed. To help the FDA, providers, pharmacists, and other stakeholders monitor drug shortages and identify new or worsening shortages, the IMS recommended that the FDA or pharmaceutical industry create an early-warning system that includes risk identification; continuous long-term demand forecasting; a supply volatility index; a comprehensive predictive model; and a self-reporting mechanism for practitioners, wholesalers, group purchasing organizations, and manufacturers.

Physicians Feeling the Pressure

Jane C.K. Fitch, MD, an anesthesiologist from Edmond, Oklahoma, who is first vice president of the American Society of Anesthesiologists, commented, "We have been dealing with drug shortages for at least the last decade and more acutely in the last 5 years. The way the drug shortage impacts our specialty relates particularly to patient safety. We have had [wrong] dosages of drugs and even deaths reported. The drug shortage has forced us to change procedures, has led to prolonged recovery times and more postoperative nausea and vomiting due to the drugs we have had to use. This translates into significant patient satisfaction issues and to economic issues for the healthcare system," she said. "Our patients suffer and we as practicing physicians are not able to the best that we have been trained to do."

Lee Morisy, MD, AMA's Chair of the Council on Science and Public Health, commented that the drug shortage also has economic issues for physicians. "For example, hospitals can allocate propofol among their regional centers, but a small physician-owned surgery center has no backup resources. Such occurrences are intensifying the pressure on physicians within their practice settings, whether you are talking about needing propofol for a plastic surgery procedure, influenza vaccines for the elderly or chemotherapy drugs for an oncologist. It's affecting how physicians practice, and it's why the AMA is trying to take steps to deal with these issues."

Ms. Benjamin and Dr. Fitch have disclosed no relevant financial relationships.

American Medical Association 2011 Interim Meeting. Presented November 14, 2011.

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