Some people are ashamed to admit that they choose generics over name brand drugs. Even worse, dare I say vitamins or drugs altogether! I read an enewsletter article today published by Dr. Kevin Pho in response to this NY Times article written by Alex Williams. The gist is hard times are forcing some people to turn increasingly to over-the-counter, self-help therapies. I think it makes sense for a large part of the population, but that’s just me.

As Alex points out, this is clearly part of a broader trend called consumer-directed healthcare and not necessarily the part that the healthcare industry wants to talk about. Sure there are cons to not going to a professional and receiving accurate diagnoses with a few prescriptions to go along with them. The problem is everywhere we consumers look, it just looks like doctors, pharmaceutical companies and insurance firms are benefiting  even while insurance premiums, drug costs and co-pays are on the rise. How can consumers be expected to trust a system, especially during hard economic times, that is attempting to bankrupt them?

Surely, some key industry players are staying awake at night. Insurers thought consumer-directed healthcare would become what they want it to…high deductible insurance plans, health savings accounts and the like…

What’s surprising, but not really that surprising, is consumers haven’t exactly leaped onto the bandwagon. Maybe they’re out buying vitamins…

A new administration is running things in Washington D.C. and its key priorities are reforms in healthcare, education and energy. Already, over $20 billion in economic stimulus has been earmarked for healthcare.

Many challenges abound in the current healthcare system. Since 1994, the cost per person of American health care has more than doubled, with an annual growth rate regularly more than twice that of inflation. Fueled by rising costs of prescription drugs, inefficient outpatient care, expensive and unnecessary medical procedures, and ballooning insurance premiums, these costs are a burden on state and federal governments, businesses, and families. It is clear that reform is needed. 

Post marketing surveillance plays a critical role. Adverse events caused by medicines add significant costs to the healthcare system. The U.S. Food and Drug Administration (FDA) has come under increased scrutiny for safety issues associated with approved drugs. The FDA requires drug manufacturers to do extensive safety and efficacy testing of proposed new medications during the approval process. However, after FDA approval, there are concerns that the current post marketing reporting systems fail to:

• Detect drug safety risks and adverse events (AEs) in a timely fashion
• Monitor drug safety in populations that were not included in the drug approval process (e.g., children, pregnant women, and the elderly)
• Identify and contain AEs resulting from off-label medication use 

In response to criticisms that the FDA has not been able to ensure post marketing drug safety at acceptable levels, the FDA has responded with increased drug therapy rejection rates. The investments made in these therapies are placed at risk and may never be recouped, driving up the cost of drugs that do make it through the FDA approval process. 

To address this vicious cycle, the Veterans Health Administration (VHA) Patient Safety Center of Inquiry (PSCI) in Tampa, Florida has determined, by undertaking a series of proactive medication safety surveillance studies, that the use of large-scale national datasets allows researchers to conduct more sophisticated epidemiologic studies to better inform clinical decision-making. Also, it was found that a proactive medication safety surveillance system can be used on a national level to identify adverse outcomes and events in different settings of care that are associated with selected medications.

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