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Pew, Other Groups Identify Potential Measures to Address Drug Shortages

Pew, Other Groups Identify Potential Measures to Address Drug Shortages.

Ritalin

 

 

 

 

 

 

 

 

From the 5 February 2015 report

Pew and other health care organizations released a report on February 5, 2015 exploring measures that should be considered to address the ongoing issue of drug shortages in the United States, which impacts lifesaving medicines including antibiotics, chemotherapy, and cardiovascular drugs. The report summarizes manufacturing, regulatory, and economic issues related to drug shortages, as well as potential solutions identified at a 2014 Summit attended by 22 stakeholder groups, including health care professionals, non-profit organizations, industry, public interest, and government agencies.

The report explores the potential manufacturing, economic, and regulatory causes of drug shortages, and considers several possible solutions that merit further exploration, including:

  • Improving quality systems in pharmaceutical manufacturing to better prevent production problems that can lead to shortages by encouraging companies to foster a corporate quality culture, and use FDA’s set of quality metrics to support early collaboration between manufacturers and the agency.
  • Identifying regulatory efficiencies, such as synchronizing reviews by regulators in different countries to shorten the overall time for full approvals for facility upgrades.
  • Allowing for commercialization of trial batches of drugs that meet quality specifications to help mitigate losses during the approval process for upgrades to plants or production lines.
  • Incentivizing manufacturer investments in capacity and reliability by increasing contractual penalties for failing to supply a product, and also allowing price increases.
  • Supporting the market through better guarantees of demand by committing to the purchase of specified volumes of drugs vulnerable to shortage, either by a group purchasing organization or through a government program.
  • Establishing limited and/or shared exclusivity agreements to incentivize companies to produce needed drugs where there are no active producers.
  • Standardizing commonly used doses and concentrations in unit-of-use packaging to reduce waste and avoid contamination.

The 2014 Drug Shortages Summit was organized by the American Hospital Association, the American Society of Anesthesiologists®, the American Society of Clinical Oncology, the American Society of Health-System Pharmacists, the Institute for Safe Medication Practices, and The Pew Charitable Trusts. Previous summits were held in 2010 and 2013.

 

February 6, 2015 Posted by | Uncategorized | | Leave a comment

[Press release] Top 10 challenges facing global pharmaceutical supply chains

English: Value, supply and demand chains

English: Value, supply and demand chains (Photo credit: Wikipedia)

 

 

 

 

 

From the 2 February 2015 New York University press release

Ten years after the 2005 Paris Declaration on Aid Effectiveness reported on the need for better coordination in the global fight against disease, global pharmaceutical supply chains remain fragmented and lack coordination, facing at least 10 fundamental challenges, according to a newly published paper by professors at NYU Wagner and MIT-Zaragoza.

“Heroes may win battles, but it is capable supply chains that win wars [against disease],” write Natalie Privett, assistant professor of management and policy at the Robert F. Wagner Graduate School of Public Service at New York University, and David Gonsalvez, professor of supply chain management at the MIT-Zaragova International Logistics Program, and former global supply chain director with General Motors. Yet, they add, the global health pharmaceutical delivery (GHPD) supply chains are wanting.

The research article, entitled “The top ten global health supply chain issues: Perspectives form the field,” has been published in Operations Research for Health Care, an academic journal. It sheds light on the key areas of weakness and what specifically is needed to strengthen the pharmaceutical supply chains.

Privett and Gonsalvez interviewed and surveyed 22 individuals with various roles in supply chains and asked them to identify the “top ten” challenges as they see them. The areas of concern which were most often cited include: lack of coordination; inventory management; absent demand information; human resource dependency; order management; shortage avoidance; expiration; warehouse management; temperature control; and shipment visibility.

“Lack of coordination in the GHPD supply chain is a root cause issue whose existence aggravates nearly every other issue director or indirectly,” according to the article.

The paper draws attention to both the needs and opportunities in GHPD supply chains in an attempt to “drive future actions, policies, and research which can ultimately improve pharmaceutical delivery in developing regions and save lives.”

To read the article, please visit:http://www.sciencedirect.com/science/article/pii/S2211692314200002.

 

February 3, 2015 Posted by | Public Health | , , , , , , , | Leave a comment

Newly published survey shows drug shortages still have major impact on patient care

Newly published survey shows drug shortages still have major impact on patient care.

According to newly published results from a survey of pharmacy directors, drug shortages remain a serious problem for patient safety. Nearly half of the responding directors reported adverse events at their facilities due to drug shortages, including patient deaths.

Screen Shot 2014-01-22 at 5.24.47 AMIn 2009, the American Society of Health-System Pharmacists put drug shortage management guidelines in place for health care providers to try and minimize negative impacts patient care, and in 2011, following an Executive Order from President Barak Obama on reducing drug shortages, the U.S. Food and Drug Administration (FDA) increased its efforts to prevent and resolve drugs shortages. While the FDA recently reported that the number of new shortages in 2012 was down to 117, from 251 in 2011, drug shortages are still having a major impact on patient care.

A common practice to help mitigate the problems caused by a drug shortage is to use an alternative medication when possible. Even when alternate medication can be used, there can be many unintended consequences and additional side effects. In general, drug shortages have been known to cause, or contribute to a variety of issues, which were also represented in the newly published survey responses including:

  • Medication errors (such as wrong dose, wrong drug, wrong frequency),
  • Increased institutional costs,
  • Cancelled care, and
  • Delayed treatment.

In addition to the more well-known impacts, the new JMCParticle revealed that nearly 10 percent of the reported adverse patient outcomes were increased readmissions due to drug shortage related treatment failures.

Read the entire article here

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January 22, 2014 Posted by | health care | | Leave a comment

   

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