A Clinic Mix-Up Leaves Pregnant Woman In Dark About Zika Risk

KHN, 21 June 2017
Author: Jonel Aleccia
“Hospital officials in Washington state have apologized after failing for months to inform a pregnant woman she was likely infected with the Zika virus that can cause devastating birth defects. Andrea Pardo was tested for the virus in October, after becoming pregnant while living in Mexico. The results were ready by December, but she wasn’t notified until April just before she delivered her daughter. The delay, blamed on a mistake at the University of Washington clinic where Pardo received care, deprived her of the chance to make an informed choice about her pregnancy.”
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Aspirin increases bleeding risk in older stroke patients: study

MedicalXpress, 14 June 2017
Source: The Lancet
“Long-term, daily use of aspirin to prevent blood clots in very elderly patients leads to an increased risk of serious or fatal internal bleeding, researchers said Wednesday. Heartburn medication would allows people 75 years and older to keep the preventative benefits of aspirin while avoiding its dangerous side-effects. Even among people with no history of heart problems or stroke, the risk of gastrointestinal bleeding goes up with age for aspirin users.”
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Merck & Co. Halts Enrollment in Two Keytruda Trials, Citing Deaths

GEN, 13 June 2017
Source: Genetic Engineering & Biotechnology News
“Merck & Co. said it has stopped enrollment in two Phase III trials assessing its cancer immunotherapy Keytruda® (pembrolizumab) in combination with other therapies to treat multiple myeloma, following reports of patient deaths. Patients currently enrolled in the two studies will continue to receive treatment, Merck said, adding that its other clinical studies of Keytruda will continue unchanged.”
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Women urged to speak up on painful transvaginal mesh implant side effects

ABC, 31 May 2017
Author: Sophie Scott and Alison Branley
“The number of women who have experienced catastrophic side effects from a medical device used to treat prolapse after childbirth is likely to be higher than expected, experts fear. A Victorian health consumer group has conducted the first comprehensive survey of Australian women who have been treated with transvaginal mesh implants and they have received more than 1,850 responses in just six weeks, with more than 750 women saying they have had adverse effects. Reported problems from the device include incontinence, severe chronic pain, problems walking, painful intercourse and even marital breakdown.The Australian Commission on Safety and Quality in Health Care is now reviewing the use of the implants.”
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Valium recall: Worker sacked over Roche diazepam tampering

ABC News, 31 May 2017
Source: ABC News
“A worker has been sacked after the TGA issued a nation-wide recall of Roche Products’ diazepam, because the relaxant had been swapped out for different drugs at a Sydney distribution centre. Roche said the incident occurred at a distribution centre, and this afternoon, Symbion Contract Logistics released a statement saying they had sacked a worker at its Sydney-based distribution facility.”
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Tick for tougher laws to target unsafe health facilities

Queensland Government, 23 May 2017
“Health authorities now have the power to take stronger, swifter action against facilities found to be putting people at risk of developing serious infections. Minister for Health and Ambulance Services Cameron Dick said tough new legislation passed in State Parliament tonight gives the state’s health officials the power to better monitor health care facilities and investigate potential infection control breaches.”
Find media statement here.

State Sepsis Mandates — A New Era for Regulation of Hospital Quality

NEJM, 21 May 2017
Authors: Tina B. Hershey, Jeremy M. Kahn
“Sepsis is a major cause of illness and death in the United States, affecting more than 1.5 million Americans each year at an annual cost of over $20 billion. To improve outcomes of sepsis, policymakers are increasingly using regulatory mechanisms intended to provide incentives to clinicians and hospitals to improve the quality of sepsis care. One such initiative is an unprecedented set of New York State regulations implemented in 2013 and collectively known as “Rory’s Regulations.” Named after Rory Staunton, who died at 12 years of age from sepsis resulting from a soft-tissue infection, Rory’s Regulations mandate that all hospitals in the state use evidence-based protocols for sepsis identification and management and that they report to the state government data on their sepsis-protocol adherence and clinical outcomes.”
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Abbott, Novartis and Sanofi Targeted in NPPA Clampdown on Drugs Sold Without Price Approval

RAPS, 23 May 2017
Author: Nick Paul Taylor
“The National Pharmaceutical Pricing Authority (NPPA) of India is taking action against drugmakers including Abbott, GlaxoSmithKline, Novartis and Sanofi. These top pharmaceutical firms allegedly introduced drugs without seeking price approval and may have to pay back what they overcharged. In a letter to the companies the director of enforcement at NPPA, accused the businesses of altering scheduled formulations, either by changing the dose or combining the drug with a non-scheduled medicine. To NPPA, such changes represent the introduction of new drugs. As such, the companies should have obtained approval from NPPA for the prices of their new products before introducing them to the market.”
Find article here.