Category:

Food and Drug Administration is reconsidering whether doctors who prescribe painkillers like OxyContin should be required to take safety training courses...The review comes as regulators disclosed that the number of doctors who completed voluntary training programs is less than half that targeted by the agency...Under the current risk-management programs, drugmakers fund voluntary training for physicians on how to safely prescribe their medications...many experts - including a previous panel of FDA advisers - said those measures don't go far enough and that physician training should be mandatory...The FDA's initial ideas to improve safety included mandatory certification for doctors and a national registry to track patients taking the drugs. But industry pushed back. Drugmakers and the pain specialty groups they fund argued that certification would be too burdensome for doctors, leaving many patients undertreated. And patient groups said that registries would unfairly stigmatize those who rely on painkillers to deal with long-term pain....

Walgreens has agreed to pay $500,000 in penalties, fees, and costs related to misleading advertising practices that led to New York customers being overcharged for products..."Businesses are required to ensure that their advertisements are truthful and not misleading..."When consumers purchase products at retail stores in New York, they should be able to rely on the prices displayed in advertisements and on shelf tags and not have to worry about being overcharged when they get to the register."...Walgreens has agreed to reform its advertising and business practices in New York...It must remove expired shelf tags within 36 hours, restrict the use of "Smart Buy" or "Great Buy," and refrain from using "Last Chance" or "Clearance" tags when the item is available at a reduced price for an extended period of time...Walgreens will also conduct internal and external price check audits in stores. If a store fails 2 consecutive external audits, it will have to pay a $2500 penalty.

India's lower house of parliament passed a bill this week to back a regional biotech center aimed at promoting expertise and research in South Asia and wider in the Asian region...The Regional Centre for Biotechnology--to be located in the northern state of Haryana--would offer degrees up to the doctorate level, while also serving as a home to academics with access to research facilities in biotechnology...India has lagged in comparison to other Asian nations such as Japan, China and Australia in growing a local biotech industry...The new center would seek to aid growth domestically in biotech as well as establish links abroad by offering course work training and research in biotechnology to students and researchers...

Pharmacists may do a better job than doctors helping chronically ill patients manage their blood pressure, cholesterol and blood sugar levels if they're allowed to direct people's health care, a new evidence review suggests...The review also found that pharmacists could manage chronic diseases with about the same efficiency as doctors...current evidence doesn't show whether pharmacists can actually improve a patient's overall health if they take over someone's care from a doctor...The reason for the interest in pharmacist-driven care is that some areas of the United States don't have enough doctors. Due to these shortages, other types of health care workers, such as nurse practitioners or physician assistants, are being called on to help fill the gaps...New legislation introduced in Congress would establish pharmacists as health care providers, and pay them accordingly through Medicare in communities where there aren't enough doctors...Pharmacists are paid less than physicians, and having them handle day-to-day chronic disease care would free up doctors to see patients with more serious and complex health problems...

Mike Glaicar, Business Development: Pharmacy Times...(PTNN) This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Nevada ranks below the national average in emergency preparedness and health security...The Silver State scored a 5.9 overall on a 10-point preparedness scale in the 2016 National Health Security Preparedness Index...The Robert Wood Johnson Foundation, which directs the index and also supports the national County Health Rankings, found the United States is "relatively well-prepared" in the field of emergency management, averaging a 6.7 on a 10-point preparedness scale...Nevada struggled with lower than average marks in all but two of the six fields measured — incident and information management and environmental and occupational health...Nevada may be falling slightly behind other states in its emergency management preparations.

Importance The optional free-text Notes field in ambulatory electronic prescriptions allows prescribers to communicate additional prescription-related information to dispensing pharmacists. However, populating this field with irrelevant or inappropriate information can create confusion, workflow disruptions, and potential patient harm.

Objectives To analyze the content of free-text prescriber notes in new ambulatory e-prescriptions and to develop recommendations to improve e-prescribing practices.

Main Outcomes and Measures Reviewers classified free-text prescriber notes as appropriate, inappropriate, or unnecessary.

Results 66.1% contained inappropriate content...

Conclusions and Relevance The free-text Notes field in e-prescriptions is frequently used inappropriately, suggesting the need for better prerelease usability testing, consistent end user training and feedback, and rigorous postmarketing evaluation and surveillance of EHR or e-prescribing software applications. Accelerated implementation of new e-prescribing standards and rapid adoption of existing ones could also reduce prescribers’ reliance on free-text use in ambulatory e-prescriptions.

Pfizer Inc has agreed to pay $784.6 million to resolve allegations that Wyeth, which it acquired in 2009, underpaid drug rebates to Medicaid, the federal health insurance program...The settlement resolves claims by the U.S. and states that Wyeth knowingly reported false and fraudulent prices on two of its anti-acid drugs, Protonix Oral (pantoprazole) and Protonix IV...Wyeth offered hospitals deep discounts on bundles that included both drugs when made available to staff and patients...Wyeth wanted to induce hospitals to buy and use Protonix Oral, a drug they would otherwise have little incentive to prescribe because of other drugs that were already on the market and competitively priced...Wyeth hid the bundled discounts from Medicaid...

Germany’s strict drug pricing controls may be about to get a whole lot harsher as the country’s government is mulling over whether to lift a lucrative pricing amnesty...The current system sees healthcare insurers in the country negotiate discounted prices with pharma companies on their new meds--but the German government has for some time allowed those insurers to pay full price for the latest drugs up to a year from the time they win regulatory approval...following consultations with pharma companies, the health ministry said it would draw up new plans in the coming months to limit prices for new drugs and halt this one-year amnesty...Under this proposal drugmakers could still charge full price for new drugs--but it would mean health insurers would be able to start negotiating discounts once a drug’s sales hit around €250 million ($282 million)--a fairly low limit for blockbuster meds that can easily make two to three times that amount...Germany is struggling to pay its healthcare bills. Despite the efforts of the government to curb pricing, total expenditure in Germany’s statutory health sector rose 19.7% to €202 billion ($228.4 billion) in 2015 from 2011--with prescription-drug spending alone jumping 27.1% over the past 5 years...

A pair of FDA final guidance documents may help drug manufacturers reduce the risk of deadly medication errors...Both guidance documents are part of the FDA’s efforts to meet the goals of the 2007 Prescription Drug User Fee Act, which include establishing "measures to reduce medication errors related to look-alike and sound-alike proprietary names, unclear label abbreviations, acronyms, dose designations, and error-prone labeling and packaging designs."...In its first guidance document, the FDA recommended that submissions from applicants or sponsors include the following components to help the agency more thoroughly review the proprietary name appropriately:

• Primary or alternative proposed proprietary name
• Intended pronunciation of that name
• Derivation of the name
• Intended meaning of the name’s modifiers
• Pharmacologic/therapeutic category
• Proposed label and labeling, and what should be included when a product does not yet have a proposed label and labeling
• Information about product dispensing and delivery