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 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

http://www.bloomberg.com/news/2011-03-22/drugmaker-investor-lawsuits-backed-by-u-s-supreme-court-4-.html

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,

http://www.business-standard.com/india/news/hc-stayimmediate-withdrawalbanned-drugs/429458/

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.

http://www.imt.ie/opinion/2011/03/regulating-the-regulator.html)

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 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

http://oig.hhs.gov/oei/reports/oei-06-09-00090.pdf


 

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 produce specialized documentation to help ensure compliance in a validated environment.

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I have not come across any new updates after that. But apparently Accenture  has acquired Knowledge Rules, Inc., a Philadelphia-based consulting company that focuses exclusively on implementing and integrating business solutions using Pegasystems’ Business Process Management (BPM) software.

Accenture has a very large Pharmacovigilance division serving several large pharmaceutical companies. It would not be very suprising if Accenture roles out the BPM software for their pharmacovigilance services.

I think that is a possibility because Accenture  has announced plans to use the applications for all its Fortune 500 customers.

I would predict that United Health Group could be one of those customers as they are an existing customer of Pega.

Speaking of which Pega sounds like an attractive target Oracle can acquire

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 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

http://www.scientificcomputing.com/news-DA-Computer-automated-System-for-Identifying-Medical-Devices-with-Safety-Risks-111110.aspx

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 the public,” on British Medical Journal, November 6, 2010.

Lenzer is a medical investigative journalist, and Brownlee is an instructor at the Dartmouth Institute for Health Policy and Clinical Practice.

“Most devices and drugs on the market are supported by studies that are underpowered to detect rare but potentially life threatening events that can kill tens of thousands of people if the drug or device is widely used,” the authors write. “The impracticality of conducting large scale clinical trials before approval for every drug and device places a burden on post-approval surveillance.”

The authors also note that “FDA’s ability to detect potentially unsafe devices is further hampered by the fact that many post-approval studies required as a condition of the device’s approval are not conducted or conducted so poorly as to be meaningless.”

FDA’s Manufacturer and User Facility Device Experience (MAUDE) database is its most “comprehensive source of information about the safety and effectiveness” of medical devices, the authors claim. But they cite several problems associated with this “imperfect tool,” especially “the fact that manufacturers—not the FDA or any other independent body—can decide whether the device is connected with a negative outcome.” Other alleged problems with MAUDE include (i) “the voluntary nature of the reports,” (ii) “fear of litigation by surgeons and others in a position to report the event,” and (iii) “failure by patients and healthcare providers to connect new medical problems with a device.”

In response to the report, an FDA spokesperson reportedly said that the agency considers “very seriously” post-approval device monitoring, that FDA has “a variety of initiatives underway to bolster postmarket surveillance” and that the agency is reworking its 510(k) premarket approval process for lower-risk medical devices.

That FDA response comes  little more than two weeks after the FDA rescinded approval of the Menaflex Collagen Scaffold knee replacement device. The agency admitted that the medical device was approved without being properly researched due to political pressure and the overly flexible requirements of a program designed to fast-track certain devices through the approval process.

It also comes just three months after DePuy Orthopaedics issued a recall for 93,000 artificial hips, which had failure rates of 12% and 13%. Many individuals who received one of the defective hips are pursuing a DePuy hip lawsuit, alleging that doctors were expressing concerns to DePuy about a higher-than-expected failure rate for the metal hip system before the recall. The implants have been found to shed metal particles into the bloodstream, which could lead to cobalt toxicity.

A study by the Government Accountability Office (GAO) released in June 2009 found significant shortcomings in FDA medical device approval procedures, and a heavy reliance on the 510(k) process. The GAO report identified gaps in the FDA reviewing process, deficiencies in the agency’s postmarket surveillance, and also found that FDA has not kept up with regular inspections of medical device manufacturing facilities. Many devices which should be put through the more stringent premarket approval process are put through the premarket notification process instead, the GAO found.

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 Canada received 27,496 adverse reaction reports — a number that has increased steadily over time. Health Canada needs the power to require pharmaceutical companies to conduct more post-market monitoring and to share the results, Abbott said. The council also would like to see the federal government hold the power to impose penalties for companies that do not comply.

Health Canada is already modernizing its regulations to allow for stronger monitoring after the drug goes to market. The government also has established a Drug Safety and Effectiveness Network to study the safety of drugs in the market.

The Canadian pharmaceutical industry welcomes modernized regulation, said Mark Ferdinand, vice-president of police research and analysis for RX&D, the pharmaceutical industry association in Canada.

However, Ferdinand said consumers should recognize that there is already a formal, rigorous post-market reporting system in place.

“No one has any interest in seeing a drug used inappropriately in the real world. A lot of people have invested a lot of time, effort, certainly money … to ensure what they are producing and what they are providing to patients is safe and effective,” he said.

Ferdinand said drug safety often depends on the way medicine is prescribed. He said it has to be “the right medication, for the right person, at the right time.”


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.

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