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 [...]

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 [...]

One in 10 hospital prescriptions in UK ‘is wrong

I am not concerned about the number of mistakes made in UK hospitals. As a pharmacist I am concerned, if UK has such a high rate of medication errors, then what would be the rates in countries like India, where Pharmacists almost never over ride the prescriptions and physicians treat more than 100 patients every [...]

India looses USD 1 Billion Investment in Drug R&D to China due to lax Indian patent laws-

Did I really read the news correct or was I just plain drunk on a weekend while reading it. Turns out it is true. Just a week after the Novartis CEO has blasted the Indian IP laws, Novartis has announced plans to invest 1 Billion US Dollar in China for Drug Discovery and Developement. The [...]

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 [...]