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HDA Media And Political Bulletin – 11 July 2016

ABPI welcomes opportunity to collaborate with local NHS stakeholders and patient groups to ensure the appropriate use of biosimilar medicines.

11 July, ABPI

 

The ABPI has welcomed NHS England’s new publication summarising the recent regional workshops held on biosimilar medicines. Discussions at the workshops focused on how to ensure an appropriate and patient-centred approach to the use of biosimilar medicines in order to benefit from the opportunity presented by increased competition between different biological medicines, including biosimilar medicines.

 

Federal auditor finds FDA struggles with ongoing drug shortages.

8 July, Modern Healthcare, Adam Rubenfire

 

The U.S. Government Accountability Office found that while new shortages have generally decreased since 2011, the number of ongoing shortages has remained high. An audit directed by Congress seems to have found a link between manufacturing interruption and drug shortages. As a result, group purchasing organisations want the FDA to process manufacturing applications faster for drugs that are frequently affected by shortages.

 

This story was also reported by CT Post .

 

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ABPI welcomes opportunity to collaborate with local NHS stakeholders and patient groups to ensure the appropriate use of biosimilar medicines.

11 July, ABPI

The Association of the British Pharmaceutical Industry (ABPI) has welcomed NHS England’s new publication summarising the recent regional workshops held on biosimilar medicines.

 

​​​​ Supported by the ABPI and in collaboration with a range of national partners; NHS England hosted two workshops on biosimilar medicines for local stakeholders with decision-making responsibility for commissioning, prescribing, dispensing and monitoring biological medicines, as well as patient representatives.

Discussions at the workshops focused on how to ensure an appropriate and patient-centred approach to the use of biosimilar medicines in order to benefit from the opportunity presented by increased competition between different biological medicines, including biosimilar medicines.

As noted by Dr Keith Ridge in the report’s executive summary, “this patient-centred, outcome based and value driven approach to medicines use will ensure the safe, effective and consistent use of all biological medicines, including biosimilar medicines, across the NHS; and a sustainable market for biological medicines.”

Through the workshops, local stakeholders highlighted a number of key considerations including:

  • the need for patients to be involved in decisions about their medication, including the opportunity to discuss any changes to their current medication
  • the importance of appropriate clinical monitoring and real world evidence collection
  • the appropriate use of biosimilar medicines requires an assessment of each medicine individually on its own merits taking into account variable factors such as care setting, mode of action and method of administration to ensure a consistent patient centred approach

NHS England is working with national partners to develop a toolkit to provide practical materials and guidance for use locally on the introduction and appropriate use of biological medicines, including biosimilar medicines.  ABPI are pleased to be working with the British Biosimilar Association (BBA) to provide industry’s views and support for this work.

As set out in the workshops report published today by NHS England, many of the differentiating features about biologic medicines are due to the way they are manufactured, and this was identified as an area for further exchange.  To help address this need, today ABPI and BBA are also publishing a factsheet on bio-manufacturing, which sets out some of the key points simply.

Dr Virginia Acha, Executive Director, Research, Medical and Innovation at the ABPI said,“As more biosimilars come to market, this NHS England report and our factsheet are timely and welcome in ensuring NHS England and other national partners provide consistent messaging and support appropriate knowledge and implementation tools are in place to deliver patient outcomes.”

Matt Regan, Chair, ABPI Biological Medicines Access Group and UK General Manager, AbbVie said, “Such workshops prove that practical partnerships between the Pharmaceutical industry, the NHS and various patient groups is an excellent way to stimulate discussion and debates that are vital to safeguard the appropriate and safe use of biological medicines. It is crucial to ensure these recommendations made by local stakeholders are considered and implemented.”

 

Federal auditor finds FDA struggles with ongoing drug shortages.

8 July, Modern Healthcare, Adam Rubenfire

 

The Food and Drug Administration has made strides in preventing new drug shortages but the agency is still struggling to address the glut of ongoing deficits.

The U.S. Government Accountability Office found that while new shortages have generally decreased since 2011, the number of ongoing shortages has remained high. In 2015, 291 ongoing shortages were reported. That’s a 5% increase from 2014 and more than double from 2010. Providers and public health officials alike worry that persistent drug shortages can delay patient care or leave patients with less-effective alternatives.

Directed by Congress to study drug shortages, the auditing agency found that the FDA issued an increasing number of warning letters to the makers of sterile injectible drugs, like antibiotics, cancer medications and anesthetics. Sterile injectables represent some of the most persistent shortages. They are difficult to produce safely because of issues with sterility, bacterial or fungal contamination, visible particulates in the medication, or crystallization, among other reasons.

While the FDA has increased the amount of inspections it performs at manufacturer facilities, the GAO found that the overall number of warning letters resulting from those inspections – beyond sterile injectables – has remained relatively small. Only eight were delivered in 2013, the most recent year for which data is available. There weren’t more than 11 warning letters between 2007 and 2013, and for every year besides 2007, there were at least five.

Those warning letters don’t order a halt to production, so it’s unlikely that they’re contributing to supply disruption, and some of the warning letters were sent to repeat offenders. During the GAO review period between January 2010 and July 2014, seven of the establishments that received warnings letters had a previous history of compliance problems.

Group purchasing organizations and providers want the FDA to expedite the review of manufacturer applications to produce drugs that are frequently in shortage, especially for sterile injectables. GPOs have gotten creative in contracting and sourcing to make up for shortages, sometimes launching their own private generic drug labels or contracting with active-ingredient suppliers to ensure a steady supply.

The report notes that the FDA expedited the review of 383 drug applications and supplements between January 2010 and July 2014, the same period as the GAO review. That represents about 3% of all applications it received. Sixty-three percent of those expedited applications were for sterile injectables.

The GAO found that, among the 38 drugs for which applications were received, 15 drugs were associated with at least one expedited application that was approved before a shortage was resolved or prevented a potential shortage from occurring. The report cautions against drawing a causal link from this data, but this does suggest that the agency has followed up on itsprevious promises that it would work swiftly to ensure there are multiple producers for drugs that are prone to shortage.

Recognizing the difficulty of drug shortages and the affect they can have on hospital operations, some providers have gone outside of their GPO contract and forged direct relationships with manufacturers to buy drugs when the usual channels run scarce. These relationships often come at a premium cost, and aren’t common.

 

Acute drug shortages force hospitals to adapt.

11 July 2016, CT Post, Cara Rosner

In hospitals across Connecticut and nationwide, workarounds to compensate for medication shortages are daily routines for treating patients — and health experts say it’s not about to change anytime soon.

Some acute-care drugs in short supply nationally are antibiotics, antipsychotics, intravenous saline and morphine, according to the latest shortage list from the U.S. Food and Drug Administration.

In Connecticut, hospital officials said they are turning to alternative drugs, rationing supplies or seeking new suppliers to work around the shortages.

Bridgeport and Greenwich hospitals are facing shortages of antibiotics, including Cefepime, Tigecycline and Ceftin; anesthetics used in surgeries; and intravenous bags and saline solutions, according to Stacy Vaeth, director of corporate pharmacy services for the hospitals. That is on top of ongoing shortages of various cancer drugs, she said.

At St. Francis Hospital and Medical Center in Hartford, Dr. C. Steven Wolf, chief of emergency medicine, said doctors have been dealing with shortages of dextrose, used to treat dehydration and low blood sugar, as well as intravenous saline and other basic medications.

The hospitals can’t get 150-milligram doses of amiodarone, which is used to treat irregular heart rhythms. Instead, they can get 18-milliliter vials of the medication, but that is not a ready-to-administer dose, Vaeth said.

Hospitals sometimes go months without the medications. A study of drug shortages led by Yale Universityfound the median duration of shortages was 210 days overall, and 242 days for acute-care drugs.

“It really affects everybody,” said Wolf. “There have been times when we have not had (certain) medications. I don’t think patients have any clue that this is occurring. It definitely risks patient care.”

The situation has become so urgent that U.S. Sen. Richard Blumenthal, D-Conn., wants pharmaceutical companies subpoenaed and investigated to determine whether drug shortages are naturally occurring or being artificially created.

The Pharmaceutical Research and Manufacturers of America, the trade group that represents branded biopharmaceutical makers, referred a reporter to a website statement regarding shortages. The statement reads, “Patient access to medicines is vital for the health of patients and the economy. The issue of drug shortages demands attention and collaboration from everyone involved in providing life-saving medicines.”

Health experts say drug shortages have not improved in recent years, despite a law enacted in 2012 giving the FDA broader authority and regulatory powers to react to drug shortages. The FDA, which tracks shortages, listed 58 medications as being in short supply as of July 8, but that number has topped 200 at times.

Big pharma

The Yale study, which used data from the University of Utah’s Drug Information Service from 2001 to 2014, found the number of drug shortages since the federal act passed has declined. But shortages remain, more than half involving acute-care drugs used to treat critically ill patients. Drug shortages have more than tripled in the past decade, the study found.

“Our key finding was that, up to 2012, shortages were rising for both non-acute and acute drugs,” said Dr. Arjun Venkatesh, senior author of the study and assistant professor of emergency medicine at Yale School of Medicine. But while shortages for non-acute drugs are decreasing and getting shorter, the shortages for acute drugs “are increasing and getting longer” since the 2012 law took effect, Venkatesh said.

Vaeth said drug shortages often trace back to mergers or acquisitions by pharmaceutical companies. If two drugmakers that manufacture a certain medication merge, typically only one of the medications will be produced, said Vaeth.

Shortages result from production disruptions, such as when FDA inspectors order a drugmaker to suspend manufacturing because of quality concerns.

At Bridgeport and Greenwich hospitals, Vaeth said staff members do their best to find alternatives, with pharmacists working closely with physicians.

In 2012, the Academy of Managed Care Pharmacy surveyed pharmacy directors at hospitals, ambulatory centers and other facilities about drug shortages. Of 193 respondents, 101 said an adverse event at their site was “possibly/probably” related to shortages, two attributed patient deaths to shortages, three said shortages caused a disabling adverse event, and 46 said events requiring intervention were spurred by shortages.

Blumenthal, who helped craft the FDA Safety and Innovation Act, said a much deeper examination is needed of all pharmaceutical companies reporting shortages. Blumenthal has questioned whether drug distributors are hoarding certain medications to create shortages, increase prices and make more money. It’s also possible, he said, manufacturers of certain drugs are “colluding” to create artificial shortages to justify raising prices.

“There have to be subpoenas, investigations and document production, so that the potential antitrust violation is explored and documented, if it exists,” he said.

“Hospitals cannot forever triage. There are real health threats.”

HDA Media And Political Bulletin – 11 July 2016

From Factory to Pharmacy

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