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 [...]

How to improve R&D productivity: the pharmaceutical industry’s grand challenge

   

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 [...]

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 [...]

Insurance coverage for healthcare IT software, to protect healthcare IT companies from damages inflicted by their software

Ah. well they should be protected, with the number of physicians unhappy with the Healthcare IT systems rising. We ll thank goodness patients will also get third party coverage if the software errs. Chubb Group of Insurance Companies has established the “Healthcare Information Technology” liability insurance to protect Healthcare IT companies. Over 1,000 companies supply [...]

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 [...]

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 [...]

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 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 [...]