Life Science Compliance Update

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30 posts from June 2013

June 28, 2013

Drug Shortages Remain in 2013

While Congress and federal health agencies have been constantly busy enacting new healthcare and drug legislation and implementing various regulations, one key issue has remained at the forefront—drug shortages. For example, the University of Utah Drug Information Service counted 300 "active" -- or ongoing -- drug shortages at the end of April, just about the same as it did at the end of December 2012 (299 shortages) and September 2012 (282 shortages), as reported by Medpage Today.

On the brighter side, the number of new shortages is well off its pace from years past, with 54 so far this year, Erin Fox, PharmD, director of the school's Drug Information Service in Salt Lake City, said. There were 204 new shortages last year and 267 in 2011.

However, a national survey published in the April 1 issue of the American Journal of Health-System Pharmacy found that of almost 25 oncology pharmacists, 93% reported delays in chemotherapy administration or changes in treatment regimens, 85 percent saw higher costs and 10 percent experienced reimbursement challenges, reported FierceHealthCare. "Shortages of cancer drugs also led to additional labor expenses to address the problem, such as the extra hours hospital pharmacists spend trying to locate and purchase scarce medications or find alternatives, according to a research announcement from St. Jude Children's Research Hospital."

Moreover, the drug shortages resulted in potential medical errors for 16 percent of survey participants, while 6 percent attributed one or more actual medication errors to the shortages.

Over the past several months there has continued to be several issues regarding drug shortages—despite the legislative and regulatory fixes that Congress and the Food and Drug Administration (FDA) have put into place. Stakeholders from all areas have attempted to address continuing concerns about such shortages as well as their causes and ways to fix them.

For example, in late May of this year, U.S. Representative Elijah Cummings (D-MD) introduced the The Gray Market Drug Reform and Transparency Act of 2013 (PDF) (H.R. 1958(, who first introduced it in the House of Representatives last year. The 2012 legislation, however, did not pass out of the Energy and Commerce Committee's Subcommittee on Health.

The legislation came after a report Cummings co-authored with Sens. John Rockefeller (D-WV) and Tom Harkin (D-IA), which we previously covered. The report found that "many hospitals and healthcare providers were unable to procure injectable cancer drugs from their usual and reputable sources. At the same time, those sources had reported being bombarded with unsolicited calls offering the hospitals and healthcare providers the same drugs, but with a catch: The drugs were subject to massive markups," reported RAPS.

To address these concerns, the revived legislation (which is nearly identical according to RAPS), would among other things:

  • prohibit wholesale distributors from purchasing prescription drugs from pharmacies
  • establish a "National Wholesaler Database," which would track information about wholesalers' licenses, personal information, contact information and areas of operation
  • establish fees for wholesale distributors
  • require companies selling drugs experiencing a shortage to provide purchasing organizations with the original purchase price of the drugs
  • encourage state regulators to share wholesaler information, including records of disciplinary action, with the proposed National Wholesaler Database

Drug Shortages and Lyme Disease

Next, Senator Susan Collins (R-ME), along with Senator Amy Klobuchar (D-MN) recently sent a letter urging FDA Commissioner Dr. Margaret Hamburg to take steps to alleviate the shortage of doxycycline, an oral antibiotic used to treat Lyme disease and other infectious diseases." In a press release regarding the letter, reported by Bangor Daily News, Collins wrote, "The antibiotic doxycycline is critically important for treating these patients, and it's imperative that the FDA do all it can to help alleviate this shortage."

Both Maine and Minnesota have high incidences of tick-borne illnesses. A record-high 1,100 Maine residents were diagnosed last year with Lyme disease, and public health officials have warned that the risk for Lyme has increased now that ticks have emerged for the season. "According to our state epidemiologist, the number of Maine residents diagnosed with Lyme disease continues to increase each year," Collins said in a press release about the letter. "The antibiotic doxycycline is critically important for treating these patients, and it's imperative that the FDA do all it can to help alleviate this shortage."

The FDA first reported a shortage of doxycycline on Jan. 18. Maine hasn't yet experienced any shortages, according to the Maine Center for Disease Control and Prevention, which is monitoring supplies.

Drug Shortages and Tuberculosis

Healthday recently reported that many health departments have altered treatment practices for tuberculosis (TB) because of drug shortages. The specific drug, isoniazid (INH), was first used in 1951 and is one of four drugs considered to be the core of any first-line treatment for tuberculosis (TB). Patients must take the drugs for six to nine months, according to the U.S. Centers for Disease Control and Prevention.

However, a national survey of local health departments around the country in January found that many health departments and clinics were having trouble getting INH. According to the report, published in the May 24 issue of the CDC publication, Morbidity and Mortality Weekly Report, the shortage first became severe in November 2012 and was attributed to manufacturing and supply problems.

The January survey, conducted by the National Tuberculosis Controllers Association online, was sent to 68 jurisdictions in all 50 states, including health departments in 10 large U.S. cities.

The survey found that 79 percent of the TB programs that responded said they were having difficulty obtaining INH, 41 percent said they would run out of the drug within a month and 15 percent no longer had any of the drug left.

To deal with the shortage, 69 percent of the TB programs said they switched suppliers, 72 percent prioritized high-risk patients, 68 percent delayed treatment and 88 percent tried alternative treatments. Forty-four percent said they switched to more expensive TB drug regimens.

The CDC researchers said that while the shortage of INH is easing, many health departments still can't get supplies of the drug and have changed their treatment practices to deal with the shortage. The CDC is working with local, state and international officials, along with suppliers of INH, to alleviate the shortage.

FDA Importing Injectable Nutrition Drugs

Next, in late May of this year, FDA announced that it would begin importing injectable nutrition drugs to address shortages of drugs needed to treat premature infants, patients unable to eat or drink by mouth. FDA announced that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients in late May, early June of this year.

TPN is an intravenous food solution containing several drugs that have been in short supply, including  trace elements, potassium phosphate, and sodium phosphate. Hospitals nationwide rely on TPN, which is primarily used to treat premature infants who are unable to eat or drink by mouth or who are experiencing other deficiencies. Cancer patients and those who have had gastrointestinal surgeries who are also unable to eat or drink by mouth have been affected by these shortages.

"While we have made progress on the critical issue of drug shortages, we remain extremely concerned about all current and potential drug shortages, and we are vigilant in our efforts so patients have access to the medicines they need, when they need them," said FDA Commissioner Margaret A. Hamburg, M.D. "The FDA is doing all it can, using every tool we have to resolve and prevent drug shortages."

The FDA is exercising regulatory discretion for Fresenius Kabi USA, LLC, based in Lake Zurich, Ill., to import trace elements and phosphate injection from its Norway plant so the drugs can reach Americans in need.

The shortages are largely the result of a decision by American Regent/Luitpold, a large manufacturer of TPN products, to temporarily shut down at the end of 2012. The FDA worked with American Regent in an effort to avoid a shutdown. The company, however, ultimately decided that it had to cease operations temporarily in order to address quality issues that included particulate matter in its injectable products.  The FDA continues to work with the company to prioritize the most critical drugs in shortage as it restarts production, and on the quality issues, to protect patient health.

Previously, 14 bipartisan senators, led by Sen. Al Franken (D-Minn.), wrote the FDA last week urging action to mitigate the drugs. "It is essential that we do all we can to prevent shortages in products that compose total parenteral nutrition so that children's hospitals can again focus on providing the best care to their patients," the senators wrote, as reported by Medpage Today.

Upon learning of American Regent's decision to temporarily shut down, the FDA looked for ways to increase supply and ultimately sought foreign companies willing and able to help the United States resolve these shortages. When the FDA looks for a foreign source to bolster supply in the U.S., the agency evaluates the foreign drug to ensure that it is of adequate quality and does not pose undue risks for U.S. patients.

"TPN component shortages have been a high priority for the agency. Since the onset of these shortages, the FDA has been very concerned about the dwindling supply of injectable nutrition products and the effect this is having on children's hospitals treating vulnerable patients," said Valerie Jensen, R.Ph., associate director of the drug shortages program in the FDA's Center for Drug Evaluation and Research. "We believe the import of these injectable nutrition drugs is going to meet current supply needs over the coming weeks."

The FDA's exercise of enforcement discretion for these TPN components is temporary, and applied to address this critical shortage. While the FDA cannot force a manufacturer to make a product, the agency will continue to provide expedited regulatory review and advice to manufacturers of TPN components and other drugs most in need.

Other manufacturers of TPN components, including Hospira, Inc. of Lake Forest, Ill., are also working to increase supplies of these critical drugs.

Since 2010, the FDA has used its regulatory discretion for the importation of 14 drugs. With the addition of these injectable nutrition drugs, the total will be at 17

 Drug Shortages and Anesthesia

On somewhat of a positive note, a survey in early May of this year released by the American Association of Nurse Anesthetists showed that improved communication between drug manufacturers, pharmacists, anesthesia providers, and FDA would help mitigate anesthesia drug shortages that continue to disrupt patient access to healthcare by forcing the cancellation of surgical and other procedures. Approximately 2,500 Certified Registered Nurse Anesthetists (CRNAs) responded to the survey conducted by the American Association of Nurse Anesthetists (AANA).

"Cancellations imperil our healthcare system by increasing costs, inconveniencing patients, and potentially placing both anesthesia professionals and their patients at risk for adverse health outcomes," said Janice Izlar, CRNA, DNAP, president of the 45,000 member AANA. "However, the results of the AANA's recent drug shortage survey suggest that cancellations can be reduced through better communication among those who manufacture, regulate, and administer anesthesia drugs."

The February 2013 survey showed that little progress has been made to alleviate anesthesia-related drug shortages. Ninety percent of CRNAs reported that their facilities are currently experiencing shortages, as compared with 95 percent in 2011. Nearly six percent of CRNAs responding to the survey indicated that the drug shortages have caused cases to be cancelled, virtually unchanged from a year and a half ago.

While the shortages continue, healthcare facilities are taking action to minimize schedule disruptions as much as possible by  modifying anesthesia techniques, group purchasing drugs, using in-house pharmacies to compound syringes, and conserving drugs that are in short supply when other anesthesia options are available. However, according to survey respondents the most effective measure has been timely communication between pharmacy and anesthesia staff about drug shortages.

"Equally important to effective communication within facilities," said Izlar, "is consistent, timely communication about shortages from the FDA and drug companies to the healthcare professionals in the facilities." Interestingly, only 27.3% of respondents said they found FDA's drug shortage website "valuable", relying more on formal facility planning (66.3%) and facility/departmental meetings (41.4%). CRNAs responding to the survey identified the following drug shortage information as most valuable to their practice:

  • advance notice of a drug shortage (77 percent);
  • anticipated duration of a shortage (76 percent);
  • alternative drug choices and techniques (64 percent);
  • medication inventory availability (53 percent); and
  • source of the shortage (47 percent).

Other findings show that respondents had a number of restrictions or changes to their practice because of drug shortages. For example:

  • ~75% had conservation measures placed on drugs
  • ~73% had large, single-does vials as the only size of drug available
  • 68.2% had to modify the anesthesia technique or management of hemodynamic changes
  • 57.5% had to use a pharmacy to prepare smaller, single-dose syringes (which is troubling given all the recent compounding pharmacy scares)
  • 45.6% said they themselves prepared smaller, single-dose syringes
  • 21.7% had delayed emergency or recovery.

Despite government intervention, drug shortages remain. One solution may be eliminating the price controls for generic injectable drugs which would allow for additional manufacturers incentives to enter the market and expand the supply.

 

June 27, 2013

AMA House of Delegates Calls for Limits to Maintenance of Certification (MOC)

MedPage Today reported that the AMA "made its disapproval of board and licensure recertification programs heard loud and clear Monday at its annual meeting." The article notes that AMA's House of Delegates (HOD) "approved a spate of resolutions aimed squarely at the American Board of Medical Specialties' (ABMS) controversial Maintenance of Certification (MOC) program. Additionally, delegates approved the commissioning of a study that will evaluate the impact of MOC and Maintenance of Licensure (MOL) requirements on physicians."

The article reports that the anti-MOC resolutions adopted by the HOD included:

  • Opposition to mandatory specialty board recertification programs and discrimination by hospitals and other entities against physicians who don't recertify
  • Support of lifelong continuing medical education and lifelong specialty board certification
  • A call for increased transparency by the ABMS and its component specialty boards through published reports on revenue, expenses, and compensation of board members and senior staff
  • A request that the AMA work with ABMS and component boards to integrate existing data-reporting programs with certain recertification programs

But those changes in AMA policy didn't go far enough for New York delegation chair Robert Goldberg, DO. "Goldberg offered an amendment to the Council on Medical Education report regarding MOCs and MOLs that would have the AMA commission a study to evaluate the recertification program's impact on physicians. To be examined would be the impact on physician workforce, practice costs, patient outcomes, patient safety, and patient access."

The amendment passed with the support of roughly 60% of the delegates on Monday. The complete report is due to the House of Delegates at the 2015 annual meeting. The New York delegation chair said there is little evidence to show MOC programs improve patient outcomes, safety, or access. "Where is the evidence? Show us," Goldberg said to MedPage.

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