Saturday, June 15, 2013

Deliberate conflation?

This blogger recently ran across an opinion piece, 'Drug compounding should be automated' that makes the case that technology (specifically drug compounding automation) that can reduce errors is readily available and should be implemented in hospital pharmacies as "... an investment in a higher standard of patient care."

The opinion piece starts off by referencing the recent spate of contaminated compounded drugs, including the recent multi-state outbreak of fungal meningitis associated with compounded injectable steroids. Having set the stage, the piece then reports a recent estimate of the annual economic costs of medication errors involving injectable drugs - "... In December, the journal American Health & Drug Benefits reported that medication errors from injectable drugs harm more than 1 million patients annually in U.S. hospitals. Adverse drug events due to injectable medications cost U.S. health care payers between $2.7 billion to $5.1 billion annually, an average of $600,000 per hospital." It then seamlessly goes on to state that "... the technology to prevent it is already available" i.e. automated compounding systems, and ends with the suggestion that as legislation to regulate pharmacy compounding is considered in an effort to enhance pharmacy safety "... Congress and the FDA must seize this opportunity to put medical technology to its highest and best use, not just improving the quality of patients’ lives, but saving them."

Well, if adverse drug events due to injectable medications cost U.S. health care payers an average of $600,000 per hospital annually and can be easily prevented by the adoption of an automated compounding system, then why on earth would this not be the way to go? Including even, perhaps, insisting that your legislator include compounding automation requirements in legislation! You could be forgiven if this is your 'takeaway' on reading this article!

Unfortunately it is not quite that simple - the article artfully juxtaposes several different issues and then skips seamlessly from one to another... As a result the casual reader is rather likely to have a mistaken understanding of the situation (i.e.they are very likely to infer the above).  While the individual parts are all true, this blogger finds the way they are put together misleading at best, and dishonest at worst.

Let's parse it out a little.

First there are the different types of compounding. This can include every drawn up syringe (making patient-specific injectable, oral, etc. doses); drugs, electrolytes, etc. added to a stock IV bag; parenteral nutrition preparations; etc., etc. Per this source, just one hospital system, "... the Cleveland Clinic Health System, a network of 10 hospitals and 15 pharmacies, reported that in 2012, approximately 870,000 doses were compounded at its central facility..." The CRS report qualifies these as "traditional compounding."

Compounding can also include the items that have been recently in the news, quite different from the first group. Again, per the CRS: "... Some have suggested that certain activities not traditionally associated with compounding be considered compounding. Such activities include the large-scale production of drugs to ease certain drug shortages, to meet outsourcing needs of hospitals, and to supply physician-administered drugs. Non-traditional compounding may include (1) the production and shipping of large volume of drugs across state lines; (2) production of drugs that are copies of FDA-approved commercially available drugs; (3) production of drugs outside of a personal relationship with a patient and without a prescription for an individual patient to receive a compounded version; and (4) providing products to third parties, such as hospitals, clinics, physician offices, and home health providers. These activities may be considered more akin to manufacturing than traditional compounding, which is considered part of the traditional practice of pharmacy. In this report, references to these types of activities will be called “non-traditional compounding.  The opinion piece starts off with the recent sterility issues in this 'non-traditional compounding' area, then later jumps to compounding 'writ large' without making any distinction between the two.

Up next. Yes, the economic burden due to adverse events related to injectable drugs is very significant, not to speak of the human costs. However, the numbers cited are for all adverse drug errors related to injectable drugs, i.e. those that occur during all the phases of the medication process - prescribing/ordering (e.g. incorrect drug selection based on indications, contraindications, known allergies, existing drug therapy, etc.; dose, dosing form, route, concentration, rate of administration, etc.); transcription; compounding; dispensing (e.g. wrong medication, wrong dose or strength, wrong formulation, expired medication, etc.); and finally administration.Now it's hard to get exact numbers, but one study (Analysis of Adverse Drug Events, JAMA, 1995; 274, 35-43) showed that "Approximately 39% of medication errors occur during the ordering process; 12% occur during the order verification process; 11% occur during the preparation and dispensing process; and 38% occur at administration." So, at best "the technology to prevent" a nebulous "it" corresponds to a portion of 11% of the numbers quoted.

Add it all up, and this blogger finds this opinion piece rather misleading, even ignoring the egregious and cynical use of the victims of the recent meningitis tragedy -"... as the residents of Tennessee might rightly ask, how much is too much to spend to prevent another outbreak linked to contaminated medicine?"

Now, this blogger does not deny that automation has a place. However its use needs to be justified by improved patient safety (using 'real', validated outcomes and numbers); by the potential reductions in pharmacy drug waste; by making doses more 'just-in-time'(additional waste reduction opportunity); etc. and not by such as this opinion piece. Coming, incidentally, from the CEO of a company that makes an automated compounding system (apparently at a price tag of  "$1.35 million, plus an annual maintenance fee of $130,000")

Some links on pharmacy compounding:
Compounded drugs - (35-page CRS PDF)
Pharmacy Sterile Compounding Summit