Law of the land can help or destroy the Pharmacovigilance system

U.S. Supreme Court, ruling allows shareholders to sue Pharma and biotechnology companies for failing to report adverse drug events/ dangerous side effects. Maker of homeopathic remedies Matrixx Initiatives, was sued by investors once it came to know their marketed nasal spray linked to a string of instances in which people using the treatment lost their [...]

Adverse Events in Hospitals- United States Department of Health Report slams current measures in US hospitals

OFFICE OF , INSPECTOR GENERAL of US Department of Health and Human Services, released a report on the national incidence of adverse events for hospitalized Medicare beneficiaries, the preventability of such events, and associated costs to Medicare. The report released last month month found that one in seven of the patients experienced an adverse event such as excessive [...]

Clinical Trial and Pharmacovigilance process automation

I had posted last month about the Pegasystem pharmacovigilance solution. Pega Systems the industry leader in Business Process Management (BPM) software solutions, released a Pharmacovigilance case processing software. Pega has experience in clinical trial space, specifically in Clinical Trial Management. The solution is designed for rapid deployment to quickly leverage existing adverse event processing rules and requirements and can [...]

MNC Pharma tries to capture the $1.9 billion Indian OTC market by selling Drugs through India’s 170000 post offices

The multinational pharma companies are planning to approach the health ministry with a proposal calling for the utilisation of the 1.7 lakh post offices across the country to distribute over the counter drugs. The move if implemented would increase the reach of OTC drugs by 20%. The plan initially submiited 2 years ago requires  the approval [...]

Harvard Medical Schools new automated safety surveillance system provides faster early warnings in the postmarket evaluation of medical device safety

Implementation of a computer-automated safety surveillance system of clinical outcomes registries for cardiovascular devices resulted in the identification of a drug-releasing stent that had significantly higher rates of major adverse cardiac events than similar stents “Monitoring the safety of approved medical products is of vital public health importance, given that in clinical practice such medical [...]

FDA has poor oversight in medical device monitoring and post market surveillance

According to a British Medical Journal, article on the effectiveness of post-market surveillance, medical device manufacturers “often fail to properly conduct safety studies” and the Food and Drug Administration (FDA) “provides scant oversight” in post-approval monitoring of these devices. The article is published by Jeanne Lenzer and Shannon Brownlee, called  “Why the FDA can’t protect [...]

Health Council of Canada says some prescription drugs approved for use in Canada may be less safe than consumers think, due to poor Pharmacovigilance/Post Market Surveillance rules

Canada’s Food and Drugs Act relies on drug companies to submit adverse reaction reports, which drug users submit if they suspect they are experiencing negative side effects. Drug users also can submit the reports directly to Health Canada, but it still leaves the government to rely on outside parties to report problems. In 2009, Health [...]

70% of Pharmaceutical organisations outsource at least one PV activity. This level is expected to increase to 80% by 2012

Currently, 70% of Pharmaceutical organisations outsource at least one PV activity. This level is expected to increase to 80% by 2012.

Oracle starts the Oracle Health Sciences Institute (OHSI), in partnership with Sun Labs

The Institute is focused on research that will accelerate IT innovation to advance personalized medicine and the delivery of safe and effective   treatments and health care services to patients around the globe. OHSI will work in tandem with academic research centers, focusing on a targeted set of research areas fundamental to the R&D and [...]

GE’s healthymagination initiative lead Smart Patient Room to improve patient safety goes live at Bassett Medical Center

GE Healthcare announced that the Smart Patient Room pilot at Bassett Medical Center has been approved by the site’s Institutional Review Board to begin data collection. The innovative technology solution was installed as part of GE’s healthymagination initiative with the goal of helping healthcare providers to reduce patient safety risks and improve patient outcomes. “GE [...]

How useful would be the Single-patient clinical trials for improving the hopes of Personalized medicine

Single patient Clinical Trial are not new idea, FDA did not focus since such trial canot prove the efficacy and safety of medicine over a large pool of patient with sufficient data. But I was forced to re-think after reading the article http://www.technologyreview.in/biomedicine/12537/ why cant we use the the concept mentioned in to overcome the [...]

FDA launches “Basics” transparency microsite

The FDA unveiled phase 1  of its transparency initiative with the launch of FDA Basics, a microsite aimed at demystifying the agency’s workings for the public. It’s the first of a 3 phase transparency initiative launched FDA as part of the Obama Administration’s broader commitment to openness. Phase 2, will deal with disclosure of sensitive information [...]

India begins serious efforts to ensure patient safety- Rejoice if you are in US Obama is going to penalize hospitals with high one-month readmission rates for transitioned patients

MUMBAI: A mop left inside a patient’s stomach after a surgery, an expired drug administered to an ailing person or a hospital-acquired infection-medical errors are a nightmare for both doctors and patients. Such incidents, which are usually swept under the carpet, will now be recorded and reported to an independent body in India. This will [...]

How should you safely outsource pharmacovigilance to an Indian contract research organization?

Published in hte Indian Journal of Pharmacology. Edwards B. How should you safely outsource pharmacovigilance to an Indian contract research organization?. Indian J Pharmacol 2008;40:24-7 The articles focus on different types of CRO that operate in India and the concerns western companies should address before deciding to oursource the trial to Indian companies. exerpts from [...]