During their routine visits, inspectors from the Bureau of Drug Surveillance (Drug Control Unit) and the Ontario College of Pharmacists often discuss issues related to part-fills and prescription refills with pharmacists. It's apparent that there is confusion in this area of jurisprudence, among pharmacists and prescribers. The purpose of this article is to provide a current synopsis of what constitutes a part-fill.
In 1981, the Bureau of Dangerous Drugs, Health and Welfare Canada published a bulletin to pharmacists (Information Bulletin to Pharmacists No. 3., October-November), addressing prescription part-fills and prescription refills. The 1981 bulletin is still relevant today, with one exception. Methylphenidate has been transferred to Schedule G of the Food and Drugs Act, from the schedule to the Regulations (i.e., same as Secobarbital). The results were:
1. that all refills have to be in writing, with an interval between refills which must be written at the time the prescription is written; and
2. that all sales of Methylphenidate must be reported.
These requirements have not changed under the present Controlled Drugs and Substances Act, of which both the Narcotic Control Regulation and Food and Drug Regulations, Part G are now part.
Neither the Narcotic Control Regulations nor the Food and Drug Regulations define refills, repeats or part-fills. However, refills and repeats are treated synonymously, as:
"the dispensing of a medication without a new authorization from the practitioner"
Narcotic refills are specifically forbidden by the Narcotic Control Regulations, Section 37, which states:
"A pharmacist shall not use an order or prescription, written or verbal, to dispense a narcotic after the quantity of the narcotic specified in the order or prescription has been dispensed"
This same Regulation, however, permits part-fills, defined as:
". . . the dispensing of a quantity of medication which is less than the total amount of the drug specified by a practitioner when the prescription was originally written or issued.”1
"Prescription" is defined in Section 2, Narcotic Control Regulations, as:
". . . in respect of a narcotic, an authorization given by a practitioner that a stated amount of the narcotic be dispensed for the person named in the prescription"
Thus, if the drug is not identified, the quantity of drug is not specified, or a practitioner (as defined in the Regulations) has not given the authority, there is no legal prescription and a pharmacist cannot dispense the drug. "Stated amount" is a single, unambiguous figure.2
The key words to keep in mind in the definition of a part-fill are "total amount" and "specified" "Total" means sum and "specified" means precise, or well defined. In Bulletin No. 3, it goes on to state:
"Part-fills are legal for both Narcotics and Controlled drugs if the total quantity dispensed does not exceed that originally authorized. The principal requirement is, however, that the doctor must authorize, either in writing or verbally, the total quantity involved as a single figure and not as a smaller figure multiplied by the number of times the medication is to be dispensed. The practitioner must be conscious of the total amount which he is prescribing"
The following examples should illustrate what is acceptable and what is not.
Example 1
In example 1, the prescription is valid for 20 tablets only, after which a new prescription is required.
Example 2
Example 2 shows a legal part-fill. The pharmacist may dispense 20 tablets at weekly intervals until 100 have been dispensed. He/she should not dispense more than 20 per week, without documented prescriber authority. Each dispensing requires the record to reference to this original authority (Rx number), not the last-filled number. Once all 100 have been dispensed, the prescription is expired. Any new authorization becomes a new prescription authority. All subsequent part-fills dispensed must then cross-reference to the new authorization number.
Example 3
In example 3, the pharmacist may dispense 60 tablets on three occasions at intervals of no less than 28 days.
Example 4
The prescription shown in example 4 is valid for 60 tablets only. The total quantity could be interpreted as either 60 + 3 repeats (240 tab), or 60 x 3 repeats (180 tabs). Thus, the quantity is not stated as a single figure and the “x 3” cannot be accepted.
It is important that pharmacists remember that whenever there is a legally prescribed par-fill, each (paper) record of dispensing must document where the authority (original) for that part-fill exists. Once the entire stated amount of a prescription has been dispensed, any new authorization becomes a new prescription. The record of part-fills issued pursuant to that new prescription must show a reference to the new prescription – not to a previous authority that has since expired (and by referencing to it, would violate Section 37 of the Narcotic Control Regulations).
Pharmacists have the privilege of being able to legally dispense all drugs (except heroin, which is limited to hospital-use only). However, with this privilege comes the inherent responsibility to know the prescription requirements in order to legally dispense the drugs. This is a challenging area of practice, since laws change periodically and pharmacists must be cognizant at all times of the current legislation.
Practice-Related Problems
Inspectors have found, and calls from pharmacists indicate that some prescribers still remain ignorant of the requirements for part-fill prescriptions. These prescribers attempt to write repeats on narcotic prescriptions, even though part-fills became available in 1981. Such illegal repeats cannot be honoured by pharmacists and this can escalate interprofessional stress levels.
Taking the time once to properly explain to a practitioner how to legally order part-fills results in less time spent on the phone for both pharmacist and prescriber. It also results in the pharmacist spending less time having to (delicately) explain to the patient why the prescription is only valid once, when the patient "thought the doctor put three repeats on it." Educating the patient during dialogue can result in fewer problems in the future, since the patient can check the order over before leaving the practitioner's office, to ensure it is properly documented.
Should the unfortunate situation arise where a practitioner, after being enlightened to the part-fill requirements, continues to pressure a pharmacist into accepting illegal repeats/refills on narcotic prescriptions, the pharmacist can always contact the practitioner's licensing body with his/her concerns. After all, it is the pharmacist's Certificate of Registration that is at risk if drugs are dispensed without legal prescriptions. Pharmacists agree to be "gatekeepers” to the legal supplying of drugs when they accept a Certificate of Registration.
References
- Bureau of Dangerous Drugs Information Bulletin to Pharmacists No. 3., October-November 1981, Health and Welfare Canada.
Bureau of Dangerous Drugs Information Bulletin to Pharmacists No. 8., March-April 1985, Health and Welfare Canada.
