For Medication: Make it or Fake it is not Good Enough

by | Jul 29, 2013 | Corruption, Fraud and Abuse, Oversight, Public Health


This post is partially in response to an April editorial in JAMA, which begins with:

“When Hippocrates advised physicians to never give a deadly drug, he assumed they would know for sure that the medicines they prescribed were safe. Today, criminals and unscrupulous manufacturers have permeated the global pharmaceutical market, calling into question this basic assumption of clinical practice.â€

We also wrote about this issue several years ago for the Journal of Healthcare Protection Management.

The Accountable Care Act (ACA) with all its promised benefits for the trusting public may have overlooked a major element in the fight to make us healthier and longer lived. Today’s television viewing contains a steady stream of what new drugs will make your life happier but be sure and check with your Doc about the 20 + side effects which may accompany the use of this or that drug, the other half supplies you with important information on which clever Law firm can get you the best deal on the “bad drug†which either killed or disabled you or your loved ones. Then there are others which suggest that is no limits to your love-life. This bliss through chemistry has some unintended consequences; no – not going blind or losing that little bit of hearing that still remains, but the geriatric STD epidemic/endemic or other Age Related Pubic Health Problems (ARPHP). Some suggest that it has influenced the growth of stand-alone Emergency Rooms.

The joint commission logoI was asked by one of my professional groups to look into what appeared to be an increase in “hospital drug diversionsâ€; addicted caregivers who were diverting patient pain drugs for their own use. To make a long story short, the personal use of diverted pain killers has remained consistent; however, the market for these items had become very profitable on the street. That did not diminish the fact that caregiver drug diversion was a real threat to the health and safety to hospitalized patients. Drug diversion for personal use is troublesome in that it has a direct impact on patient care in a number of ways; impaired physicians are an obvious hazard to their patients, the possibility of drug shortage, and caregivers who divert drugs from their patients pose a real threat to their patient’s course of treatment.

The legal, but albeit unscrupulous practice of creating drug shortages through purchase of huge amounts of certain drugs and later making these drugs available at exorbitant prices “grey market†has surfaced as an increasingly dire threat to patient populations across the nation.

The apparent fragile balance between supply and demand is worrisome, among others, from the standpoint of availability of certain drugs during any number of national security threats. The early 90’s  saw the dismantling of the nation’s vast Military Depot System which held, among other things, emergency drugs to be used in time of war or disaster, a so call “cold war dividendâ€.  Not to worry, we had the manufacturing resources to supply surge needs. Not so fast, the national frenzy to move substantial segments of the country’s manufacturing base off-shore did not spare the pharmaceutical industry. Globalizing the manufacture of the bulk of the nation’s formulary medications used by our day-to-day healthcare delivery system could lead to catastrophic consequences.

The joint commission logoThere are few who would vouch for the trustworthiness of the scandal-ridden pharmaceutical industry. Even fewer would suggest that we could face this hostile world without their products. Few would suggest that the industry has a corner on miscreant behavior in the business sector. If we accept the notion that the relocation of drug manufacturing has played a major role in our current threats to the health and welfare of the nation’s medical prescription consumers then must take a look at how it happened.

Or perhaps, how could it happen in the context of the geopolitical threat environment in the last two decades? Pre and post 9/11 the overarching concern was in a post- cold war world the greatest threat would come in the form of non-state actors using loosely controlled Weapons of Mass Destruction (WMD). The available of known classes of medications were the key to treating victims of such events.

In the case of many bioterrorists attacks receiving and continuing to use certain drugs over a long period made the difference between life and death. In the aftermath of a nuclear explosion drug therapy is essential to saving some lives. Those poor souls who were to be the “walking dead†could not be saved but they could be pain free as they died. The same is true with chemical victims. There are no substitutes for quality medications available in a timely manner.

Mother Nature’s form of bioterrorism, pandemics, are only defeated by receiving the appropriate and timely medicines and adjunct treatment. Also, Mother Nature’s natural disaster victims are completely dependent on the appropriate quality and quantity of medicines being available.

The consistent theme is that medicines must be available in a timely manner and contain the appropriate levels of therapeutic content, both of which may be at risk for any number of reasons. Not being able to source key medicines domestically can have devastating effects. For example, some forms of antibiotics have been completely offshored and could be denied to us at a national level.

Today the vast majority of drug manufacturing and essential ingredients are scattered around the world and given the geopolitical chaos brings into question whether we could realistically supply our needs in the event of a large-scale natural or manmade disaster.

In our shortened, yet internationally extended supply chain environment, combined with the just-in-time paradigm, All Hazards readiness is at risk. The hospital industry has benefitted from this economic strategy but this has an obvious downside. We can no longer rely on the assurances of the past; strategically located caches of drug inventories, individual hospital warehouses, and as mentioned above, the dismantling of Emergency Federal/Military stockpiles.

It is one thing to have consumer electroThe joint commission logonics, textiles and auto manufacturing move offshore en masse, but how did the national leadership allow us to lose control of an industry that is literally vital to our survival?

As in other areas of the economy, the rush offshore was driven by the unbridled pursuit of profit, supported by a bloated bureaucracy, with little regard to consequences of their actions. Among the unintended consequences include, the vulnerability to legitimate and artificial shortages (grey market), diminished quality control oversight, increased number of wholesale brokers who increase potential for fraud and abuse, fraudulent labeling of generic for brand names, a burgeoning market for substandard medications, and a black market in fraudulent ingredients and compounds; both bad drugs and worthless drugs. Each link in this chain produces increasingly dire consequences to the trusting public. For the average Medicare patient taking 7 or more drugs, many to reduce side effects of others, what is the potential impact after a 90 day supply of these mixed medications?

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