Drug Shortages, May 2012 Update

Thursday, May 17, 2012

Alerts

President Obama Orders FDA to Prevent Drug Shortages

While the Food and Drug Administration has successfully prevented 137 drug shortages since the beginning of 2010, drug shortages have been increasing in frequency and severity in recent years and adversely affecting patient care. A small number of drugs in the U.S. experience a shortage in any given year, but the number of reported prescription drug shortages in the United States nearly tripled between 2005 and 2010, going from 61 to 178. There are many causes and potential solutions to this challenge and addressing this significant public health problem will require the urgent attention of industry, other stakeholders, and government.

Today, President Obama issued an Executive Order directing the FDA and Department of Justice to take action to help further reduce and prevent drug shortages, protect consumers, and prevent price gouging. These additional steps for early notification will help achieve some of the goals of bipartisan legislation in Congress, which the President supports, that will strengthen the FDA’s ability to prevent prescription drug shortages in the future.

20111031 We Can't Wait to Take Action on Drug Shortages

From left: pharmacy manager Bonnie Frawley from Brigham and Women's Hospital in Boston, Mass.; Health and Human Services Secretary Kathleen Sebelius; cancer patient Jay Cuetara from San Francisco, Calif.; and FDA Commissioner Peggy Hamburg during signing of executive order (Official White House Photo by Pete Souza).

The Executive Order is one in a series of steps that will help address the shortage of prescription drugs and ensure patients have access to the lifesaving medicines they need. Today, the Obama Administration also:

Sent a letter to drug manufacturers reminding them of their legal responsibility to report the discontinuation of certain drugs to the FDA. The letter also encourages companies to voluntarily notify FDA about potential prescription drug shortages in cases where notification is not currently required.

Increased staffing resources for the FDA’s Drug Shortages Program to address the increased workload that will result from additional early notification of potential shortages by manufacturers.

Released a report from the Department of Health and Human Services Office of the Assistant Secretary for Planning and Evaluation (ASPE) that assesses the underlying factors that lead to drug shortages, and an FDA report on its role in monitoring, preventing, and responding to these shortages.

Watch the following short video of why cancer patients can't wait

CBS News Report on Drug Shortages and the Gray Market

In the CBS news report they focus on the gray market, and several companies that anticipate shortages, hoard live saving medicines and then sell those medicines at incredible mark ups. CBS reported that in Miami, a company called Allied Medical Supply sells Cytarabine - a drug to treat leukemia and typically sells for $12 a vial, is offered to hospitals for nearly $1,000 by Allied Medical Supply.The US Congress and the FBI have initiated investigations into US Drug Shortages.

Rx-360 has previously presented and publicized that during shortages, opportunities are presented for noncompliant companies, unethical players and even criminals to enter the supply chain and introduce substandard, contaminated, adulterated and even counterfeit materials, often with tragic consequences. In fact, shortage of raw material in China was one of the contributing factors in the economically motivated adulteration of Heparin which led to numerous deaths in the USA and Europe.

With the current shortages of drugs in the USA, the Institute for Safe Medication Practices has issued a safety alert based on their survey of 549 hospitals, indicating widespread accounts of frustration, outrage, and serious compromises to patient care. To view the survey, click here

According to the press release from ISMP: "When critical medications become scarce and are no longer available through a hospital’s usual channels of distribution, unscrupulous gray market distributors have been quick to jump in with inexplicably obtained supplies of these drugs that they are more than willing to sell to healthcare providers at exorbitant costs. Capitalizing on the desperation of pharmacy directors and buyers, these distributors have been unrelenting in their quest to make huge profits by supplying hospitals with lifesaving medications that are otherwise unavailable."

See ISMP's "Managing the drug shortage crisis" for suggested actions, including a template of a failure mode and effects analysis to promote safe use of alternative drugs used during a drug shortage by clicking here

Rx-360 also published an editorial calling for stricter criminal penalties for economically motivated adulteration, counterfeiting and other nefarious activities. The editorial stated "Looking at events over the past several years, it is clear - unethical individuals and criminals are present in the pharmaceutical supply chain. The reason for this growing phenomenon is simple “greed”. Unethical individuals and criminals have learned that selling substandard, adulterated or counterfeit medicines is highly profitable and involves very little if any personal risks." The entire editorial can be read by clicking here

Fox News Reports on Drug Shortages

May 3, 2012 Update

Six Month Check-Up: FDA’s Work on Drug Shortages
Posted on May 3, 2012 by FDA_Voice By Margaret Hamburg, M.D. This week marks the six-month anniversary of President Obama signing an Executive Order to help FDA in our ongoing efforts to prevent and resolve prescription drug shortages. At FDA, we saw the Executive Order as an important step in bringing awareness to this critical public health issue and signaling the necessary tools and resources, such as early notification and additional staff, FDA must have to help address this problem. Following the Executive Order, we sent out letters to drug manufacturers asking them to voluntarily report to FDA if they saw the emerging potential for a drug shortage.
	Six months later, I am both amazed and delighted to see the progress that’s been made. Early notification to FDA of potential disruptions in drug supply has made a huge difference in our efforts – and the numbers really tell the story. Since reaching out to industry, there has been a six-fold increase in early notifications from manufacturers. Also in that six month timeframe, we have been able to prevent 128 drug shortages, and we’re seeing fewer numbers of shortages occur – 42 new drugs in shortage reported in 2012, compared to 90 new shortages at this time last year. This data is a testament to how FDA exercises flexibility and discretion in much of our work on drug shortages and the importance of strong collaboration and constant communication with industry, health professionals, and patients.
But these are simply statistics. Consider instead the impact of our work on patients, who need particular drugs to treat life-threatening diseases. For instance, supplies of methotrexate, a cancer drug used to treat childhood leukemia and osteosarcoma, are currently meeting all demand, and we do not expect any further supply issues.
	Also, to address the shortage of Doxil (liposomal doxorubicin), a drug used for ovarian cancer and other cancer regimens, FDA exercised enforcement discretion for the importation of Lipodox, another brand of liposomal doxorubicin, from India, meeting patient needs until Doxil is available again. While many shortages of cancer drugs are resolving, we are still working hard to address others. Leucovorin injection, a cancer drug that is used along with methotrexate for children with a serious form of leukemia, has been in short supply for some time. We are working with the manufacturer, Teva Pharmaceuticals, to produce additional shipments in the coming weeks to help improve supplies.
Mustargen (Mechlorethamine HCl) – another cancer drug used in multiple cancer regimens — has also been in shortage. FDA has worked with the manufacturer to resume production of Mustargen, and the company is planning to have product available again by August.
	We are equally concerned about other types of drugs in shortage. Anesthesia drugs, such as benzodiazepines and fentanyl injections, have recently been in short supply. Here again, early notification is helping. One manufacturer, Hospira, notified FDA of anticipated delays in supply of the critical anesthesia drug propofol. This advanced notice allowed FDA to work with the other manufacturer of propofol who was able to increase supplies to keep the product available for patients undergoing surgery.
Drug shortages remain a serious, complex problem, and the agency remains extremely concerned about all current and potential drug shortages, not just those that I mentioned. Our efforts require a multifaceted approach involving industry, regulators, payers, and others. And we’re working with Congress on bipartisan legislation to expand early notification of drug supply problems that could cause shortages. All of us have a responsibility to help ensure that patients have reasonable access to the drugs they need. Drug manufacturers in particular have a responsibility to manufacture quality drugs and to have a process to ensure supply continuity of critical drugs.

2005 about 60, 2006 about 55, 2007 about 85, 2008 about 110, 2009 about 160, 2010 about 180, 2011 about 445 and about 105 prevented, 2012 about 130 and about 100 prevented; Data on Shortages prevented only available for 2011 and 2012. Data for 2012 are projected.

In a blog I wrote earlier this year, I reminded readers that “the critical issue of drug shortages isn’t about industry; it isn’t about government, or even about the drugs themselves. It is about getting people the treatments they trust, they need, and they rely on.” While that remains as true as ever, I would like to add a different kind of reminder. Today’s six-month check-up demonstrates what government and industry can accomplish when we work together. While there’s no simple solution, we are making progress. And we’ll remain vigilant – doing all we can and using every resource available – to make sure patients have access to the critical medicines they need, when they need them.

Margaret Hamburg, M.D., is Commissioner of the U. S. Food and Drug Administration

January 5, 2012 Update

Many publications have described the drug shortage issue and its causes and potential remediation. The GAO recently published a report titled “Drug Shortages, FDA’s Ability to Respond Should be Strengthened.” The data provided in this report do not appear to be substantially different from those of other publications, including an earlier one from FDA. The GAO recommends that Congress consider establishing a requirement for manufacturers to notify FDA of any changes that could impact the supply of drugs they manufacture. This recommendation seems to be addressed in the interim final rule amending the existing post-marketing reporting requirements of 21 CFR314.81(b)(3)(iii) (see the Rx-360 Summary of this rule). Further, the GAO encourages FDA to develop information systems that will permit tracking and management of drug shortages.

To view or download the US GAO Report, click here

To view or download the Rx-360 Summary, click here

December 15, 2011 Update

FDA Notifications:

News reports have announced that an interim final rule has been published regarding amending the postmarketing reporting requirements, specifically those in 21 CFR 314.81.(b)(3)(iii) published as final on October 18, 2007. This addressses the need to notify FDA in advance when a sole manufacturer plans to discontinue manufacture of a “life supporting,life sustaining, or intended for use in the preventino of a debilitating disearse or condition”.

This interim final rule supports the Executive Order 13588 from October 31, 2011 that directs FDA to “take steps that will help to prevent and reduce current and future disruptions in the supply of lifesaving medicines…one important step is ensuring that the FDA and the public receive adequate advance notice of shortages whenever possible”. The changes put forth in this document add two definitions to the existing rule, one for “discontinuance” and one for “sole manufacturer”. The intent of these changes is to provide FDA assistance in the management of the dramatic increase in drug shortages. The definition of “discontinuance” has been expanded to include “…both temporary and permanent interruptions in manufacturing, if the interruption could lead to a disruption in supply of the product”. The FR announcement includes examples of situations that would trigger such a notification as well as those instances where no notification would be necessary. The definition of “sole manufacturer” is clarified to mean “…the only applicant currently supplying the U.S. market with the drug products.” It does not mean the sole NDA/ANDA holder.

To view or download Federal Register Notice, click here

To view or download Final Rule, click here

ISMP Issues Medication Safety Alert

There has been significant national news coverage in the USA of drug shortages, especially related to drugs used to treat cancer.

With the current shortages of drugs in the USA, the Institute for Safe Medication Practices has issued a safety alert based on their survey of 549 hospitals, indicating widespread accounts of frustration, outrage, and serious compromises to patient care.

According to the press release from ISMP: "When critical medications become scarce and are no longer available through a hospital’s usual channels of distribution, unscrupulous gray market distributors have been quick to jump in with inexplicably obtained supplies of these drugs that they are more than willing to sell to healthcare providers at exorbitant costs. Capitalizing on the desperation of pharmacy directors and buyers, these distributors have been unrelenting in their quest to make huge profits by supplying hospitals with lifesaving medications that are otherwise unavailable."

The survey generated hundreds of comments from respondents "who feel unsupported by regulatory agencies that have not stepped in to control the gray market, betrayed by some pharmaceutical manufacturers or wholesalers who they presume may have sold medications in short supply to gray market vendors, perplexed regarding how gray market vendors know about pending drug shortages before hospitals do, outraged by the price gouging that accompanies the sale of these vital medications, and frustrated by the wasted time spent on unsolicited communications (telephone calls, emails, faxes) from gray market vendors."

The follow findings also come from the ISMP Survey:

About half (52%) of all respondents reported purchasing one or more pharmaceutical products from gray market vendors during the past 2 years. Most (80%) of these respondents told us that their purchases had increased in the past 2 years as drug shortages began hitting record highs.

Numerous respondents reported feeling pressured by physicians and hospital administrators to purchase medications from the gray market. Any resistance to the purchase, despite expressed risks, pegs the pharmacist as the “bad guy.” While some states have enacted regulations that require documentation of authenticity (pedigree) of any purchased pharmaceutical products, half (50%) of respondents in these states with pedigree laws still reported purchasing medications from the gray market during the past 2 years. Of these, only 35% reported always receiving the required documentation of authenticity.

In general, the most common reasons respondents did not purchase medications (48%) from gray market vendors during the past 2 years were: concerns with authenticity (74%), ethical concerns (66%), cost (69%), and concerns about the storage conditions prior to purchase (58%).

Among all respondents, only 23% told us they require documentation of authenticity from the gray market vendor before purchase.

Up to 12% of respondents reported awareness of a product authenticity issue, medication error, or adverse drug reactions associated with the use of gray market products in the past 2 years.

Numerous respondents made recommendations for improvement but until these actions are implemented, ISMP recommendations are summarized in Table 1 (below), which includes a series of actions developed by Premier to help organizations ensure a safe, reliable medication purchase. Readers are also referred to our October 7, 2010, newsletter article, "Weathering the storm: Managing the drug shortage crisis" www.ismp.org/Newsletters/acutecare/articles/20101007.asp for suggested actions, including a template of a failure mode and effects analysis to promote safe use of alternative drugs used during a drug shortage.

Table 1. Actions to Ensure A Safe, Reliable Medication Purchase

1

Understand the risks associated with purchases from the gray market, including the possibility that the drugs may be counterfeit, stolen, diverted, mishandled, and/or adulterated.

2

Develop a policy on how your pharmacy will deal with gray market vendors, including details regarding any exceptions that may be allowed.

3

Purchase supplies only from distributors that are an authorized distributor of record for the drug manufacturer (which are listed on the manufacturer’s website) or an otherwise appropriately licensed and Verified-Accredited Wholesale Distributor (VAWD) (which are listed on the National Association of Boards of Pharmacy [NABP] website).

4

Require any non-authorized distributors of record to provide a pedigree prior to or upon purchase of a product (which they are required to keep), and authenticate and track each transaction back to the manufacturer’s authorized distributors of record.

5

Keep a list of suspect distributors as a resource to check prior to making purchases.

6

Compare the package, label, and contents of products from a non-authorized distributors of record with the manufacturer’s original product. If differences are identified, question its authenticity.

7

Report any suspect suppliers and violations to pedigree laws to your State Board of Pharmacy, the FDA, the Federal Trade Commission, and other applicable law enforcement authorities.

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Six Month Check-Up: FDA’s Work on Drug Shortages