Should pharma Companies avoid Mobile apps? and DigitalHealth

Its easier to say current mobile app model is broken, but at same time they still offer advantages atleast in the first few years when a drug enter the market. But the truth is these apps seldom becomes useful for the larger audience.

Pharma Mobile App Problems

Study among 1814 physicians in 25 specialties shows often pharmaceutical sales reps show medical information that physicians have seen already through other digital and non-digital channels, and most often those digital channels and content are often not even created by pharma companies

Thats because current Pharma Digital projects often run in isolation to a range of existing patient/physician outreach channels, including: e-mail marketing, rep-triggered emails, web-events (webcasts, of conferences and meetings), videos, self-guided e-detailing, remote detailing, product websites, treatment and diagnostic tools (apps), training courses (CME)

Digital to Beyond the Pill

Most pharma companies already uses a central system to manage their websites but nothing of similar nature exists for other digital channels especially the mobile apps. The early concepts of “Digital Factory” where confined to merely outsourcing resources involved in infrastructure and content development to a single IT/BPO vendor. The mobile app Factory need to become essential part of the Digital Pharma 2.0 changes.

Most of the DigitalHealth apps have failed or have seen usage metrics going down after initial hype. Most #digitalhealth apps and #startups fail after initial success because, while we cherish our health we hate being reminded about our sickness.

Read the rest of the Original article at Linkedin 

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)

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 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


 

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

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 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

 

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 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

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 ethical and other challenges in current mode of trials.

So I decided to ask the question to the linkedin audience http://www.linkedin.com/answers/technology/biotech/TCH_BIO/667022-9262868?browseIdx=0&sik=1272969161323&goback=.amq

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 day.

Read about the study published in Gurdian which states that   Doctors in UK make mistakes in about 8% of the prescriptions they write for hospital patients, and depends on pharmacist and nurses to correct them- the study was commissioned by the General Medical Council (GMC).

http://www.guardian.co.uk/commentisfree/2009/dec/03/prescription-errors-junior-doctors

http://www.timesonline.co.uk/tol/life_and_style/health/article6942289.ece

http://www.guardian.co.uk/society/2009/dec/03/junior-doctor-prescription-mistakes-study

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 be done in an attempt to streamline and improve the Indian healthcare system.

Indian Confederation for Healthcare Accreditation (ICHA), a non-profit organisation consisting of various associations, would spell out clear-cut healthcare standards, train employees of hospitals, nursing homes and clinics in spotting medical errors and adverse reactions as well as encourage them to report the same in order to create a database

ICHA is organizing the first Patient Safety Conference in India on November 27-29 at Delhi. India is still trying to increase the number  Adverse Event Reporting related to cliical trials and post makret surveillance. Indian community doctors and helath expert swamped with treating more ethan  hundered patients every day ( yes I mean more than Hundered, average Indian physician attemps to more than 100 patients in Indian community hospital and governments run medical colleges), has no time to report Adverse Event and Drug Safety concerns on time and effectively. This is despite the formation of a National Drug Safety and Pharmacovigilance Programe supported by severl regional centres.

In United States one in five patients discharged from the hospital experiences an adverse event within three weeks. Two-thirds of those outcomes are drug-related, with many of them potentially avoidable, according to a recent report issued by an expert panel of internists, hospitalists and emergency physicians.

The Transitions of Care Consensus Policy Statement published jointly in August in the Journal of Hospital Medicine and the Journal of General Internal Medicine by the American College of Physicians, the Society of Hospital Medicine, the Society of General Internal Medicine, the American Geriatrics Society, the American College of Emergency Physicians and the Society for Academic Emergency Medicine.

The panel said hospitals and outpatient physicians should be held accountable for properly transitioning patients, coordinating care, involving family in decision-making and communicating key information in a timely fashion. The group also called for national standards and performance metrics.

It proposed that the following elements about patients should always be communicated as quickly as possible:

  • Principal diagnosis and problem list.
  • Medication list, including over-the-counter items.
  • Medical home or transferring physician or institution and contact information.
  • Patient’s cognitive status.
  • Test results and pending test results.

The recommendations come on the heels of increased scrutiny of how well doctors and hospitals prevent readmissions. President Obama has proposed bundling payments for hospitalization and care delivered within 30 days after discharge, penalizing hospitals with high one-month readmission rates. The administration says the move would save $8.4 billion and give hospitals more financial incentive to reduce the 20% 30-day readmission rate among Medicare patients.

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