Federal Government to Attempt Limiting Drug Shortages

By: Mahdieh Danesh Yazdi, with special thanks to Dr. Tomasz Jodlowski

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Drug shortages have plagued health care institutions in recent years; they present a serious problem to health care delivery on a national scale. In 2004, there were 58 drug shortages; now, in 2011, this number has increased to 198. Due to limited access to the most effective drugs for their illnesses, patients experienced negative effects and decreased quality of care. Vital chemotherapy drugs, such as leucovorin, cytarabine, methotrexate, paclitaxel, bleomycin, vincrisitine, daunarubicin, and doxorubicin are in short supply. Important analgesics (such as fentanyl) and antibiotics (such as Amikacin) also fall under the umbrella of drug shortages. This issue not only compromises patient care, but may also increase medication errors. Recently, the legislative and executive branches took steps in an attempt to ameliorate this growing problem.

On February 7th of this year, Senator Amy Klobuchar (D-MN) introduced a bill in the Senate known as the Preserving Access to Life-Saving Medications Act (S.296). Subse-quently, on June 21st, Representative DeGette (D-CO) sponsored the same bill in the House of Representatives (H.R. 2245). The bill requires manufacturers to alert the Secretary of Health and Human Services (HHS) about any upcoming drug shortages at least six months before the shortage is predicted to occur. If not possible, the manufacturer must provide a good reason for why they could not alert the federal authorities sooner or they will face penalties for violating the law. It also asks the Secretary of HHS to publish such notices on the FDA website (to inform health care professionals). The bill would also obligate the Secretary of HHS to inform drug manufacturers of drugs suspected to be in low supply, as well as to consult on methods to increase production of such drugs.

In the Senate, the bill has been referred to the Committee on Health, Education, Labor, and Pensions for review. In the House of Representatives, the bill was presented to the House Committee on Energy and Commerce, which then referred it to the subcommittee on Health (where it is currently under review).

In light of the extensive problems caused by drug shortages in recent years and the protracted legislative process, President Obama released an executive order addressing the issue on Monday, October 31st. In his executive order, President Obama addressed the potential causes of the shortages, and would like to resolve some of the problems that are within the authority of the federal government. While he did credit the Food and Drug Administration (FDA) with preventing 137 drug shortages last year through expedited review processes, he stressed further action. He attributes the cause of the drug shortages to demand that exceeds manufacturing capacity, along with inadequate dissemination of information to federal authorities and the public regarding shortages. The President specifically called attention to the shortage of certain cancer treatments.

The demand for these types of drugs has increased, while manufacturers’ capacities to produce the drugs have lagged.

The president, therefore, instructed relevant authorities to make adjustments.

• The FDA should use its enforcement authority to ensure drug manufacturers timely-report terminations (of drug products that are “life supporting or sustaining, or that prevent debilitating disease”) to both federal agencies and the public. This would allow health care organizations and workers adequate time to plan for alternative treatments.
• The FDA should expedite reviews of suppliers and manufacturers as much as possible without compromising safety standards in cases which a drug shortage may be addressed or attenuated.
• The FDA should look at market behavior that may lead to amassing drugs or selling them at unreasonably high prices. The FDA is then obligated to report this to the Department of Justice (DOJ) which will pursue an investigation to determine whether any unlawful activity was involved.

It is hoped that both, the executive order and congressional action, will alleviate drug shortages. The American Society of Health-System Pharmacists (ASHP) supports the bill, and is working with both parties in the House of Representatives and the Senate to gain backing for it. There are also online petitions in support of the bill, which ask citizens to write letters to their congressional representatives. The coming months will reveal the effect of these actions.

In the meantime, health care professionals must work diligently to come up with alternative treatment plans to meet patients’ health demands.

For a current listing of drug shortages please visit:

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050792.htm

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http://www.ashp.org/drugshortages/current

SOURCES

• American Society of Health System Pharmacists. “Legislative Summary: Preserving Access to Life-Saving Medications Act (H.R. 2245).” 21 June 2011. ASHP. 20 November 2011 <http://www.ashp.org/DocLibrary/Advocacy/GAD/DeGetteRooney-bill-Summary.aspx>.
• “Coming Up Short.” Economist 400.8749 (2011): 29. Academic Search Premier. Web. 14 Nov. 2011.
• “H.R. 2245–112th Congress: Preserving Access to Life-Saving Medications Act of 2011.” GovTrack.us (database of federal legislation). 2011. November 24, 2011 <http://www.govtrack.us/congress/bill.xpd?bill=h112-2245&tab=summary>.
• “S. 296–112th Congress: Preserving Access to Life-Saving Medications Act.” GovTrack.us (database of federal legislation). 2011. November 24, 2011 <http://www.govtrack.us/congress/bill.xpd?bill=s112-296>.
• The White House. “Executive Order — Reducing Prescription Drug Shortages.” 31 October 2011. White House. 20 November 2011 <http://www.whitehouse.gov/the-press-office/2011/10/31/executive-order-reducing-prescription-drug-shortages>.