SFDDA 2018 Summer Issue

Page 8

“Navigating”cont. from pg. 7

Additional latitude is permitted when practitioners are prescribing for “non-acute pain” - which should be also indicated as such on the prescription form, and rationale documented within the medical record – for conditions known to coincide with a prolonged period of pain beyond 7 days, such as in burn patients, or jaw fractures. What Constitutes a “3-day” Supply? – And Other FAQ’s Many questions have been raised relative to the implementation of the statute, including our precise responsibilities involved in order to best follow the law and avoid penalties and other associated potential legal harm.

Examples: “Do I need to check the data base every time I prescribe for the same patient, and even if providing say, a second prescription following a 3-day supply?” Answer for now: “yes”. “Do I need to consult the database for the same patient undergoing a separate condition or treatment arising after a previous recent condition or treatment?” Answer again, for now: “yes”.

“Do I need to document information viewed when consulting the data base?” Answer: No. We need only document that the online site was consulted. However, as a separate point, practitioners are inherently expected to rely on their own individual professional judgment, and perhaps have thoughtful conversations with patients regarding past history – much as we would be expected to do for any other aspect of a patient’s medical history – when deciding how such information may play a role in prescribing medication. In the event of obvious over-prescribing and/or failure to take into account a patient’s drug history, one may presume that “red flags” may prompt investigation and potential legal problems for such prescription outliers. Another big question: “What constitutes a ‘3-day’ supply?”

Further Board Clarification Anticipated To answer these questions and others, it is anticipated that further guidance and clarification will be forthcoming from the individual boards within the Department of Health (Boards of Medicine, Dentistry, etc.), a process expected to at least begin within the next several months (the next BOD meeting is scheduled for August 24).

Until then, however, most agree that for now we are left to rely on the current language available within the text of the current statute, such as: “…prescriber or dispenser must consult the system to review a patient’s controlled substance dispensing history before prescribing or dispensing a controlled substance for a patient age 16 or older.” As a result, assume we must check the database each and every time we prescribe, irrespective of whether the patient is an existing patient, or not, and when involving multiple successive treatments.

More on the “3-day” Supply Question Again, this is a question likely requiring further clarification. At face value, it would appear the interpretation of this requirement would rest upon “doing the math.” If a prescription is written with a frequency of “q 4h,” for example, one can divide the number of hours in a day by this number (i.e., 24 hours ÷ 4 = 6), and then multiply that number by three (6 x 3 = 18) to calculate a 3-day supply.

If a prescription were written with a frequency of “q 6h” – a 3-day supply would then amount to a number of 4 pills per 24 hour period x 3 days = 12 total. This method of course does not take into account the amount of medication within a given pill (i.e., 5 mg versus 7.5 mg or 10 mg), and therefore, 3-day prescriptions may result in varying total amounts of a given medication prescribed. Morphine Milligram Equivalent (MME) A different method of calculating daily or multiple-day supplies – based on dosage - is also a topic of frequent discussion or questions – the “Morphine Milligram Equivalent” (MME). The concept of utilizing MME has made its way into pain studies, research papers, journal articles, language or policy utilized by outpatient and hospital pharmacies, regulatory bodies and agencies, and appears in several state laws.

One of a number of recommendations by the Centers for Disease Control and Prevention includes prescribing, “…the lowest effective dosage when starting opioid therapy, and when planning to increase the dosage to > 50 MME/day, assess the patient’s benefits versus the harms of being on the new dose. Avoid increasing dosage to > 90 MME/day or appropriately justify a decision to do so.” However, dosage limitations based on MME are not included within of the language of the new controlled substance prescription law in Florida.

Although not included within the statute, certain pharmacies chains – most notably Walmart and Sam’s Club – have developed their own internal policy of limiting the amount of daily medication they will allow to be prescribed and filled – to no greater than 50 MME per day. Other pharmacies either have or may be anticipated to follow this same pathway.

A phone call was recently placed to my office from a pharmacist who was refusing to fill a patient’s prescription written for “Hydrocodone 7.5 mg q 3-4 h prn pain.” The reason given related to the fact that the range of 3-4 h prn pain (which incidentally is how I have prescribed this and other codeinebased medications for many years) leaves open the possibility of a patient taking the medication as many as 8 times in a 24 hour period (if the patient chose to take one every 3 hours).

When multiplying 7.5 x 8 potential doses per day, and given that hyrdocodone shares the same milligram equivalence with morphine (1 = 1), this equates with 7.5 mg x 8 = 60 MME per day, and exceeding their internal policy limit. However, the pharmacist agreed to fill the prescription if I authorized a change from “q 3-4 h” to “q 4h prn pain” – which would result in a calculation of 7.5 mg x 6 times per day = 40 MME per day.

If a prescription is written, as another example, “take 1-2 q 3-4 h,” pharmacists will typically calculate based on the maximum number and frequency a patient could take. Based on this example, a patient could take a maximum of 2 pills every 3 hours. To avoid confusion, or controversial calls from pharmacists, many have chosen to avoid a “range” of pills or frequency. cont. on pg 10


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