• US Regulators Look to Continue, Expand Support for Medication Adherence Campaign

    The US Food and Drug Administration (FDA) plans to continue providing funding to a campaign first started in 2010 to promote the importance of medication adherence to overall health-a potential boon to companies which have long argued that improper adherence can cause adverse events, result in worse outcomes for patients, cost government programs money and harm their revenues. FDA seemed to back those contentions in its 5 June 2013 Federal Register notice, explaining t...
  • EU Regulators Identify Methods of Reducing Medication Errors, Seek Path Forward

    EU regulators with the European Medicines Agency (EMA) have announced the issuance of six recommendations stemming from a workshop they recently conducted regarding methods to reduce medication errors. That workshop , held in February 2013, brought together regulators across the EU in the hopes of raising awareness around new legal requirements for reporting medication errors and to generate best practices for EU regional regulators. Those errors, as defined by the a...
  • FDA Issues New Drug Labeling Recommendations Intended to Avoid Medication Errors

    The US Food and Drug Administration (FDA) has released a new draft guidance for industry recommending changes to the way companies place safety information on container labels and cartons, saying the changes are intended to reduce the number of medication errors. Background A 2006 report by the US' Institute of Medicine (IOM), a government think tank of sorts focused on healthcare, found that a major source of medication errors could be attributed to product labeling. ...
  • New Emphasis on Reducing Medication Errors to Have Regulatory Implications, Says EMA

    The European Medicines Agency (EMA) is looking to reduce the number of medication errors that take place in the EU through the formation of a new coordinated approach that could ultimately have regulatory implications, the agency announced. The proposal, which came out of an EMA workshop held for two days starting 28 February 2013, would specifically seek to improve the reporting of medication errors in the hopes that additional data could prove useful in preventing futu...
  • New Guidance Aims to Reduce Medication Errors Through Better Preapproval Testing

    The US Food and Drug Administration (FDA) has published a new draft guidance on ways to minimize medication errors through designing products with safety considerations in mind, part of the agency's unfinished efforts under the FDA Amendments Act (FDAAA) of 2007. The guidance , posted to FDA's website on 12 December 2012, notes that it is intended to provide sponsors of pharmaceutical and biopharmaceutical products with "a set of principles for developing drug product...
  • Study: Diagnostic Errors Death Equal Breast Cancer Deaths

    • 31 August 2012
    A study by Johns Hopkins researchers claim medical mistakes in the intensive care unit (ICU) kill as many as 40,500 patents per year, as many deaths as breast cancer patients suffer. The researchers examined more than 5,800 autopsy reports from various ICUs. The study said not all missed errors contributed directly to patient death, but that patients in ICU were twice as likely to suffer a fatal misdiagnosis. "Our study shows that misdiagnosis is alarmingly common in th...
  • FDA Releases Adverse Event Guidance for Small Businesses

    The US Food and Drug Administration (FDA) wants to help small businesses comply with regulations pertaining to adverse event reporting. In 2008, the agency released a new regulation directing all companies to include a hotline number for FDA's adverse event reporting service, which collects information about safety issues. The number must coincide with an explanation of what the number is, and that it is not intended for dispensing medical advice. In its 14 June guidanc...
  • EMA Issues Guidance on Risk Assessment of Potential Medication Errors

    The European Medicines Agency (EMA) is issuing new guidance focusing on the potential for newly-formulated or altered medicinal products to harm patients through substitution, mix-ups and errors. In a 4 June position paper, EMA notes products frequently come onto the market with changes made to a referenced drug. These changes can include variations to the formulation, presentation, route of administration, strength or composition and indications of a medicinal product. ...
  • Industry Comments Indicate Displeasure with Medication Guides, FDA Looking at Single-Page Versions

    • 26 April 2012
    Comments on the US Food and Drug Administration's (FDA) Medication Guide requirements for prescription drug labeling indicate displeasure with the requirements, which are referred to as onerous, costly, excessive, poorly executed and otherwise burdensome. The comments, contained in FDA's Federal Register posting, entitled Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Product Labelin...
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    Regulatory Environment Changes Affect REMS

    To maintain the appropriate regulatory strategy for a product, it is important to stay abreast of continuing changes in the regulatory environment and applicable regulatory requirements. Knowing when regulatory requirements have changed because authorities have deemed an alternative to be sufficient to achieve the same goals can reduce wasted effort and costs for sponsors. One US Food and Drug Administration (FDA) requirement that has undergone an important change is th...
  • FDA, ISMP Announce New Initiative to Reduce Medication Errors

    The US Food and Drug Administration (FDA) announced Monday (2 April) it has formalized an existing relationship with the Institute for Safe Medication Practice (ISMP) to help protect consumers from medication errors. ISMP, a Pennsylvania-based non-profit, is focused on ways to prevent medication errors through making changes to labeling, packaging, prescribing, dispensing and other communications in the dispensing process. ISMP already operates a national Medication Err...
  • Study: Poorly Written Medication Warnings Missed by Busy Doctors

    • 30 March 2012
    A new study conducted by the US Department of Veterans Affairs and the Indianapolis-based Regenstrief Institute has found medication alerts are overly-detailed, poorly targeted and often skipped over by busy doctors, reports Fierce Health IT . The study, published in the International Journal of Medical Informatics , followed 30 doctors, nurse practitioners and pharmacists. That group received 320 medication alerts-which are used to alert medical professionals to new s...