Posted on March 24, 2011 by Albin Paul
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 sense of smell. The adverse events were reported back to the company by several medical professionals and patients, but never amounted to a statistically significant group. Matrixx argued it wasn’t responsible for reporting scattered and unreliable anecdotal evidence of adverse events. But the supremed court said No
Compare that to the Indian Law System
Madras High Court in India allowed a stay on immediate withdrawal of drugs banned due to Severe Side Effects. The pediatric doses of pain reliever nimesulide and anti-cold medicine phenylpropanolamine banned in market due to harmful side effects, Indian Drugs Manufacturers Association & Confederation of Indian Pharmaceutical Industries successfully managers to convince the legal system to set aside the safety of patients & to get a reversal of the ban for a short period. DCGI has a long way to go before effective PV can be enforced in India. The systems failed in France very recently even with the strong arm run EU PV policy in place,
The French Regulatory system was rocked recently in its disability to handle PV issues in proper maner. A report from the Inspection Generale des Affaires de Santé (IGAS). Mediator a lipopenic drug (a drug to lower fat levels in the blood) was discovered to have appetite suppressant qualities and was heavily over-prescribed by doctors whose patients wished to lose a little weight. Controversially, the drug stayed on the market despite a succession of warnings over its side-effects, which include heart valve disease and pulmonary hypertension. It is thought that as many as 2,000 people may have died from the severe Adverse Drug Reactions (ADR) incurred by their use of the drug. However, already in 1997 the drug was banned in the US and in Switzerland ; with France following suit 12 years later. The European Medicines Agency warned in 2002 of the risks associated with the medicine, however the warnings went unheeded.
Filed under: Drug Safety, Patient Safety, pharmacovigilance | Tagged: adverse drug report, Drug Safety, pharmacovigilance, post market surveillance | Leave a comment »
Posted on February 3, 2011 by Albin Paul
Posted on December 21, 2010 by Albin Paul
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 bleeding, a hospital-acquired infection or aspiration pneumonia. Those events, both preventable and not preventable, led to about 180,000 deaths a year.
The complete report available at
Filed under: Patient Safety, pharmacovigilance | Tagged: adverse events, pharmacovigilance | Leave a comment »
Posted on November 18, 2010 by Albin Paul
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 products are often used in numbers far greater and in patient populations more diverse than when studied in premarket evaluations and clinical trials,” the authors write. “Ensuring the safety of medical devices challenges current surveillance approaches, which rely heavily on voluntary reporting of adverse events. Automated surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety.”
“In conclusion, automated safety surveillance of medical devices is feasible using automated monitoring tools applied to detailed clinical registries and can efficiently help identify emerging potential postmarket safety risks. Automated medical product surveillance can complement existing public health strategies, providing an additional mechanism to assess the comparative safety of approved medical products and improve the quality of health care delivered,” the authors write.
Original article on
Filed under: Drug Safety, Patient Safety, pharmacovigilance | Tagged: Drug Safety, medical device safety, patient safety, pharmacovigilance, post market surveillance | Leave a comment »
Posted on November 1, 2010 by Albin Paul
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 information technology products and services to the healthcare and medical research industries in the US and Canada would be happy to hear that
An integrated liability solution from Chubb can help protect healthcare information technology companies from:
- general and products liability when software or hardware that is defective or contains inaccurate or incomplete information causes or contributes to patient injuries;
- errors and omission liability when a product defect or service deficiency results in economic injury to a customer;
- third-party liability to patients, healthcare providers and others associated with database security breaches; and
- costs incurred to comply with state, federal
Chubb is targeting Healthcare Information Technology Companies providing any of the following services
- Electronic health record system providers
- Clinical decision support system providers
- Telehealth and health information exchanges
- Practice management system providers
- Payor system providers
- Drug discovery firms
- Clinical informatics firms
- Healthcare systems consulting firms
Filed under: clinical informatics, clinical research, clinical software, Healthcare Informatics, Healthcare Information Technology, Healthcare IT, healthcare software, Online Data sharing, Patient Safety | Tagged: Clinical decision support system, EHR, Electronic health record system, Healthcare Information Technology, healthcare IT | Leave a comment »
Posted on October 21, 2010 by Albin Paul
Currently, 70% of Pharmaceutical organisations outsource at least one PV activity. This level is expected to increase to 80% by 2012.
Filed under: Drug Safety, Patient Safety, pharmacovigilance | Tagged: pharmacovigilance, PV outsourcing | 1 Comment »
Posted on September 30, 2010 by Albin Paul
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 health care delivery challenges facing health sciences organizations today. Research priorities currently include: artificial intelligence and semantic technology; genomic, genetic and phenotypic data analysis; data mining to support optimization of clinical trials; and predictive algorithms and other technology to advance patient safety and provide advanced decision support at the point of care.Academic institutions interested in collaborating with OHSI in these focus areas should contact OHSI representatives at Oracle http://linkd.in/bXf98c
Oracle starts Oracle Health Sciences Institute (OHSI), in partnership with Sun Labs. This is exiting news and I hope we get to see the participation of Open Source Drug Development Network (OSDD) and initiative by CSIR India earlier supported by Sun Microsystems
Filed under: Drug Safety, genetic medicine, Online Data sharing, open access database, open source, oracle, Oracle Health Sciences Global Business Unit, Patient Safety, personalized medicine, Pharmacogenomics, pharmacovigilance | Tagged: Drug Safety, health sciences global business unit, HSGBU, OHSI, Open Source Drug Development Network, oracle, Oracle Health Science Global Business Unit, Oracle Health Sciences Institute, personalized medicine, Pharmacogenomics, pharmacovigilance, Sun Labs | 1 Comment »