Saturday, July 4, 2009

Michael Jackson's Death: A Wakeup Call for Healthcare Providers

By: N. Parker Cowand
Chief Executive Officer (CEO)
Cooperative Management and Consulting (Cmac)

What can the sudden death of the “King of Pop” teach the world about the way the healthcare industry operates?

We were all shocked to learn of the pre-mature death of Michael Jackson this past week. Many speculated that drugs played a role but few would have guessed that Jackson was being administered a potent anesthesia to help him sleep. It has been widely reported that Jackson craved anesthesia and used the drug Diprivan which is currently marketed as Propofol; the drug is said to have euphoric side effects. Propofol is a potent, injectable Emulsion for IV administration and is an agent that is used widely for the induction and maintenance of anesthesia, as well as, for sedation in the intensive care unit. It is also a global central nervous system depressant and is used in ambulatory settings. The drug’s approved indications are: Initiation and maintenance of Monitored Anesthesia Care (MAC) sedation; Combined sedation and regional anesthesia; Induction of General Anesthesia; Maintenance of General Anesthesia; Intensive Care Unit (ICU) sedation of intubated, mechanically ventilated patients.

It is no secret that Jackson used an alias or two to get prescriptions filled at pharmacies for drugs like Demerol but that doesn’t explain how he got his hands on ampoules of Propofol. Perhaps, one of his medical providers brought it to him but access to drugs like this doesn’t necessarily require the cooperation of a physician. It is not too difficult to compromise the lackluster controls that many medical groups have half-heartedly implemented in their organizations.

For the general public, the idea that a drug like Propofol can be obtained easily without a hospital stay is mind boggling. How does the drug get out of the hospital setting without being noticed? Did anyone report the missing ampoule? Was there an accounting or tracking procedure in place? It is said that the DEA will be investigating how Jackson was able to obtain a drug that was not available to the public. The following anecdote will show one very easy way in which a regular person like you or I could acquire a drug like Propofol with very little effort and very little money.

Hospitals have internal pharmacies that receive and store medications. Drugs like anesthesia are couriered on carts by staff members to the operating room (OR) storage areas where they are kept in a drug closet under lock and key. The drugs are then carted to the individual surgerical rooms in the OR area (large hospitals may have dozens of these rooms) where they are stored in smaller drug carts next to the operating table. The Joint Commission (formerly JCAHO) accredits hospitals and sets guidelines and best practices for medication reconciliation procedures and patient safety parameters. The guidelines require hospitals to track and log the chain of custody of drugs from receipt in the pharmacy…through storage… to the usage, dispensing or disposal of the therapy. One reason for this is to track down, account for, and/or purge expired or recalled drug therapies.

Many times this chain of custody is broken somewhere along the line, usually at a level that is far removed from the watchful eyes of the pharmacy. Many times this occurs due to negligence and mismanagement rather than by nefarious intent. As a healthcare consultant, I have witnessed countless areas where the tracking mechanisms fall far short of any reasonable type of control. I have seen drug cabinets with their doors swung wide open at all times, drug carts without locks on them, and, in some cases, no drug log anywhere near the areas where the drugs are stored. If one of these hospitals were ever audited, then the auditor could follow the drug’s chain of custody into the pharmacy, to the OR room, and then to the drug cabinet. Since many times the chain of custody ends at that point, an auditor can’t determine where the drug went from there; the tracking mechanism would improperly show that the drug remained in the drug cabinet into perpetuity. The paper trail would end here without so much as a hint of the drug; in this scenario heads will likely roll. Through Vicarious Liability and the Doctrine of Respondeat Superior, those held immediately and directly accountable will be those sitting on the Executive Board of Directors (BOD.)

More times than not the drug storage units remain unlocked partly because the room itself, which houses the storage bin, is typically equipped with an electronic card swipe for keyless entry and therefore it is considered to be adequately under lock and key. Here’s the problem with this scenario and one of the ways in which a normal every day person could obtain Propofol without any involvement of a physician or medical professional: security access cards are issued to many staffers including the cleaning staff or janitors as well as other personnel and vendors not directly associated with the OR. It is easy, extremely easy, for a janitor to gain access to the OR and open up a drug cabinet or drug cart where ample drugs sit for the taking. There is a black market for such drugs as the Jackson scenario teaches us. Propofol comes in a 20mL ampoule that can easily be smuggled inside of a coat pocket or in a purse. The worse part about this scenario is that it commonly occurs and the hospitals either don’t catch it or fail to address it.

We don’t know if Jackson’s physician provided the Propofol or not but it is clear that Jackson would not necessarily need the services of a physician and could have obtained the drug easily on the black market.

For hospital administrators, the questions go deeper and the spotlight intensifies on practices that put people, not just their patients, in harm’s way. The BOD’s of ALL medical organizations must take their collective heads out of the sand and implement an enterprise-wide system where a third party professional organization can come in and provide an assessment on their policies, procedures, and practices relating to medication reconciliation and information assurance. Recommendations for these third party assessors will need to be holistic and involve the implementation of a training and education program tailored to ALL employees in the organization. Failure to do so can be considered an “unfair trade practice” by the FTC and could lead to scenarios like the Jackson tragedy where people die and investigations begin.

Hospital administrators heed this warning: do not leave your medication reconciliation implementation up to your staff. Do not, under any circumstances, rely on your IT department to provide information assurance or computer security when it comes to patient confidentiality. It is well documented that 88% of ALL security breaches are due to insider negligence. A professional, well trained, certified third party assessor is just what the doctor ordered.

For further information please visit www.cooperativemac.com.

1 comment:

  1. Thanks for sharing this wonderful blog with us. Nice post with great information and it is indeed informative and useful.

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