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E-DRUG: Standardization of terms

Dear colleagues: I recently sent a response to Andrew Herxheimer
based on his request for info about standardization of terms. He
suggested I do the following with my e-mail:

James -
I really liked your letter about 'exercise caution' etc; it deserves to be
sent to all drug companies, drug regulators, the USP, and teachers of
pharmacy of course so that they can debate it with their students. For
a start you ought to put it out on the E-drug conference.

My e-mail to Andrew Herxheimer:

I wholeheartedly agree with you that there should be some
standardization and your interpretation sounds reasonable. If you do
find the meanings of these words could you also please ask what the
following terms actually mean: "monitor closely", "exercise caution",
"use with caution", "caution must be exercised" and the very popular
"when the risk benefit has been carefully weighed". It is my belief
that all these terms mean that the author's really did do not know
what to recommend so they baffle us with vagueness.

For your amusement (I hope) I have attached a copy of a letter I
published 3 years ago which attempts to deal with the frustration of
the lack of precision, so to speak, in the medical literature. 


A number of products available on the market today contain a
combination of ingredients and while a few combination products are
useful, most are unnecessary and do not allow for flexible dosing
which is important in dosing medications to the individual patient.
While not wanting to promote the use of combination products, there is
apparently an ingredient that if added to all single entity drugs,
would revolutionize the use of, and improve the safety of all

Almost without exception, recommendations in drug monographs, drug
reviews etc. state that in certain instances drugs be "taken with
caution" or "used with care" and to us it makes sense that either
caution or care, in varying doses should be added to all drugs. It may
be that this combination is not presently available because no one
really knows how much "caution" or "care" to use. This is evidenced
by the fact that drugs, in general, are rarely prescribed with enough
caution or care. Presented below are guidelines to help practitioners
decide how much caution/care should be added to drugs. Once these
drugs have been given with appropriate doses of caution or care, then
the clinician must properly monitor the drug therapy. Specific
recommendations are provided.  

Quotations come from actual recommendations from a variety of drug
review articles and monographs from the Physicians Desk Reference.

"Use with caution" 
    A normal dose (1 gram) of caution should be given with this drug
    to prevent toxicity from occurring 

"Special precautions should be taken" 
    Give a unique/special dose (3.14159 grams) of caution in a
    sustained release preparation at least 6 hours before giving the

"Administer with caution" 
    Give drug with an extra large dose (4 grams) of caution because
    this drug is so toxic that it must be given with a member of the
    clergy present (add minister?)

"Caution should be exercised" 
    Give drug with a healthy dose (V8 grams) of caution and suggest
    a weekly exercise program to prevent excess toxicity from

"Use with extreme caution" 
    This drug is so toxic that it requires a dose of caution so large
    (14 kilograms) that in fact the amount of caution may cause
    toxicity (or at least damage should the tablet fall on the patient)
    and, therefore, the drug should likely not be used at all 

"Administration should be performed with extreme caution"
    This, to our knowledge, has nothing to do with drugs, but is a
    warning to all hospital administrators that their duties should be
    done with extreme caution in order to avoid annoying clinicians

"Applied with caution"
    This is for topical preparations, and one must mix in an equal
    amount of caution before applying this drug to any surface area

"Care should be taken"
    If one does not have any caution handy, or a combination product
    with caution is not available, then these drugs can be used with
    care, an effective alternative to caution

"Watch closely" 
    Drugs with this warning must only be prescribed if one has keen
    eyesight and is willing to chaperon the patient 24 hours a day to
    identify potentially strange "goings on". Aging clinicians with
    presbyopia should, for obvious reasons, not use this drug 

"Monitor closely" 
    This warning suggests that these drugs have specific toxicities
    that can only be identified by placing a monitor (likely a CAT
    scan) on or close to the patient at all times (infinitely long
    extension cords or battery packs may be required) 

"Monitor periodically"
    For energy-conscious clinicians or those without extension cords,
    these drugs may be monitored by reading journals or other

"Measured periodically"
    Drugs with this caution have the potential to cause loss of weight
    but unfortunately at the expense of height. Patients who find it
    becomes difficult getting on rides at amusement parks should be
    taken off the drug, measured, and then watched closely(see above) 

"Followed carefully"
    FBI surveillance is mandatory for drugs with this warning as they
    cause patients behave strangely and inappropriately 

"Monitoring must be done at regular intervals"
    Many things should be done at regular intervals (sleeping, eating,
    sexual intercourse etc.) and the appropriate regular intervals are
    determined by the ease of giving these drugs during these

"Should be given with great care and under close observation"
    This caution requires that these drugs must only be given by
    mothers or grade school teachers

"When the risk/benefit has been carefully weighed"   
    A portable balance is available from most brand name manufactures
    which allow this ratio to be accurately weighed. Balances are
    available to clinicians by sending 4 non-generic drug labels plus
    $500 for postage, handling, and quarterly price increases   

"Very carefully supervised"
    These drugs can only be given to patients in maximum security
    prisons or in 4 point restraints

Terms such as those presented above provide little useful information.
We encourage authors not to use terms such as "monitor closely", "use
with caution", etc. These terms are likely used because it is often
difficult to be concise and specific about such issues. Despite this,
drug companies/authors/clinicians should attempt to provide
recommendations that are more meaningful and which allow the clinician
to use and monitor drug therapy more effectively.

James McCormack, Pharm.D.
Associate Professor
Faculty of Pharmaceutical Sciences
604-631-5150 Fax 604-631-5154

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