The Pharmacy Act defines a prescription to be" an instruction, directing that a drug be dispensed to or for a person or animal, given orally, in writing or by an electronic means approved by the board by a person authorized to do so by an Act of the province or by a prescriber referred to in section 26;
At this time, in Newfoundland and Labrador, physicians, dentists, veterinarians, nurse practitioners and optometrists all have varying authority to prescribe.
As well, as per section 26. referred to above, the Pharmacy Act also allows for prescriptions written by prescribers licensed and practicing in another province of Canada to be filled in this province. However, the acceptance of prescriptions from physicians not licensed in Canada is still not permitted under the federal Food and Drugs Act and Regulations.
Only physicians authorized by the Federal Minister may prescribe methadone. A listing of those physicians authorized in Newfoundland and Labrador may be confirmed by contacting Health Canada as described in FAQ #11.
Prescriptions issued other than in accordance with the applicable legislation and regulations are not valid prescriptions, and pharmacists who fill such prescriptions may be leaving themselves open to significant personal professional liability.
Any time a prescriber dies or otherwise leaves practice, this question arises. Pharmacists wonder about their authority to continue filling prescriptions ordered by the prescriber that may have remaining refills or part-fills, and also about the requirement for notification of the original prescriber when expired prescriptions are continued under the provisions of the Medication Management Standards of Practice.
With respect to refills and part-fills that were authorized by the prescriber on the original prescription, there is no specific regulation that speaks to this issue. It has been a longstanding rule of thumb, which perhaps might be called an unwritten standard of practice for pharmacists, that whenever a physician ceases practice, that physician’s prescriptions should no longer be filled or refilled. When the physician is no longer in practice a patient can no longer be reasonably considered “under the care” of that physician and if issues related to prescriptions arise that physician can no longer be consulted.
Most prescriptions that have expired or for which no refills had been authorized can be dealt with in accordance with our Board’s Standards of Practice for Medication Management. Pharmacists are still required to keep the appropriate documentation of their medication management activities; however, in the case of a physician who is deceased it would make no sense for a pharmacist to forward notification to a sole practice physician’s office, unless the pharmacist is aware that the patient is now being treated by another specific physician.
The former patients of these prescribers should be advised that they need to find another physician to treat them, and that any further prescriptions or refills should be ordered by their new physician. In the meantime, pharmacists will recognize that it may take a reasonable period of time for the patient to find a new physician and should use their professional discretion in providing a continuation of necessary drug therapy until the patient can obtain a new prescription.
It should be noted that this advice applies not only to instances where the physician may have died, but also to situations such as retirement of the physician, where the physician has left the province, or has otherwise ceased practice.
This is an excellent question, and unfortunately one for which there is no clear-cut answer. As pharmacists we make hundreds of professional judgment calls every week. These judgment calls are usually decided after consideration of a number of factors that include the actual wording of regulations or standards, the spirit of those regulations or standards, our past experiences, our knowledge of this specific patient and their health history, and ultimately “the best interests of the patient”. It is important to note, however, that “the best interests of the patient” is not necessarily synonymous with what is most convenient, or easiest, or most inexpensive for the patient, or that the patient’s wishes must be accommodated regardless of all other factors.
To quote advice given by the Ontario College of Pharmacists in response to a similar question, “When making a decision based on professional judgment, you are sure to be on solid ground if your decision is one that any reasonable pharmacist would also make; if your decision is made in the best interest of the patient; and if you document what you did or didn’t do and why.”
Generic Substitution in Newfoundland and Labrador is mandatory for those drugs specifically listed in the provincial Interchangeable Drug Products Formulary (and has been for over 20 years).
The legislation governing generic substitution may be found in the Pharmaceutical Services Act which can be found on our Legislation page. The Interchangeable Drug Products Formulary may be accessed from our Links page.
This legislation allows the pharmacist to automatically substitute any of the equivalent products listed in the Interchangeable Formulary, but requires that the pharmacist charge no more than the lowest price listed for that category. The prescriber or the patient has the right to request “no substitution”, in which case the pharmacist may charge the listed price of the specific brand requested. In cases of “no substitution” the pharmacist is also required to inform the patient of the specific difference in price between the lowest priced item in the category and the product requested as “no substitute”.
There are also specific generic drugs available in the marketplace that are not included in the provincial Interchangeable Formulary. Pharmacists may now substitute these products, with the consent of the patient, in accordance with section 4.(c) of the Standards of Pharmacy Practice for Medication Management by Community Pharmacists, available on our Standards, Policies & Guidelines page.
The Newfoundland and Labrador Pharmacy Board has adopted Standards of Pharmacy Practice for the Facsimile Transmission of Prescriptions for Community Pharmacies, which may be found on our Standards, Policies and Guidelines page.
Prescriptions (including prescriptions for narcotics and controlled drugs) may be received by pharmacists from prescribers and would be considered as equivalent to a written prescription, as long as the requirements of the Standards are met. The faxed prescription from the prescriber must include a statement (on the prescription itself) indicating the specific pharmacy to which the prescription is being sent, and an indication that the original copy of the prescription will be invalidated and not be transmitted elsewhere. (This requirement is meant to prevent multiple filling of the same prescription at different pharmacies.)
There is no specific regulation or standard regarding a pharmacist requesting refills by fax, however, there should not be a problem with such a process, if it was done using the same standards referred to above. It would be expected that a request for authorization of refills would be made by the pharmacist to the prescriber only with the consent of, or at the request of the patient. To avoid the potential of error in the refill request, it would be expected that the prescriber would review his or her own patient files before authorizing the refill request.
Refill authorizations should be treated as new prescriptions and issued new prescription numbers. The refill authorization from the prescriber must include the specific information required by the federal Food and Drugs Act or the Controlled Drugs and Substances Act. For example, orders such as "repeat as before for 3 months" or "renew Rx # 923124 for 6 months" would not be specific enough to meet federal regulations. There would be no problem with indicating that the new prescription is intended as a renewal of a specific previous prescription, however, the prescriber must specify the details required by the regulations for issuing a prescription.
It is important to note that there is currently NO PROVISION for the transmission of prescriptions via e-mail or the Internet. The Standards for Fax Transmission refer only to the physical faxing of a traditional prescription that has been signed by the prescriber.
This incident probably arose from a common misunderstanding of the Standards of Practice regarding faxed prescriptions. Some physicians, and pharmacists as well, mistakenly think that the original copy of the prescription (especially if it’s for a narcotic) must be received by the pharmacist before the prescription can be released to the patient. This is not required by the Standards of Practice, or the TRPP program.
What is required by the Standards of Practice and the TRPP program is that the physician either retain the original copy on file, or invalidate it so that it cannot be re-issued. It is also required that faxed prescriptions for drugs subject to the TRPP program be specifically verified with the prescriber’s office or transmission site by the pharmacist.
If the prescription has been faxed in accordance with the Standards of Practice, it can be considered equivalent to a written prescription and the pharmacist does not require the original copy.
It has also been reported to our office that in some cases the prescriber has indicated the name of the pharmacy on a TRPP prescription, even though it is not being faxed, and then the patient has taken the prescription to a pharmacy other than the on indicated on the prescription. Except for the very few cases where a patient has agreed to be restricted to a single pharmacy, it is the patient’s choice to take their prescriptions to whichever pharmacy they choose. However, if a prescription indicates that it is for another pharmacy, it would be very prudent for the pharmacist to confirm with the other pharmacy that the prescription has not already been faxed to that other pharmacy by the prescriber (similar to the incident above).
Yes, there is a chart that is available in the back of the Canadian Pharmacist's Association's Compendium of Pharmaceuticals and Specialties (CPS). We have published a more detailed Summary of Narcotic, Controlled Drug and Benzodiazepine Regulations that would be very convenient for pharmacists to print off and post in their pharmacies.
You can find it on our Legislation page.
While there is not much clarity in the wording of the relevant regulations, the spirit of those regulations is that there should be documentation of all transactions involving narcotic or controlled drugs, which can be readily accessed upon demand. Each individual part fill of a narcotic prescription must be documented in the same way as the original (including having the dispensing pharmacist physically sign or initial the record of that transaction). Maintaining a copy of the subsequent part fills on the narcotic file (physically initialed by the dispensing pharmacist) would be acceptable documentation. The subsequent part fills, though they would have different transaction numbers, should make reference to the original prescription number so that documentation of the history of the original part fill and subsequent remaining part fills could be readily available for that prescription.
For example: computer systems have a number of ways to dispense a part-fill. One such way is to 'log' the prescription with a “written quantity” representing the full quantity on the prescription and a “dispensed quantity” being the partial amount actually dispensed (e.g. the prescription is written for 400, dispense in lots of 100). The system will maintain the same RX number for each of the four dispenses, but have a different transaction number for each dispensing. The system will also print a hard copy of each partial fill that can be initialed be the pharmacist and kept on the narcotic file. There would also be an electronic copy of each of the transactions corresponding to that prescription, which could be viewed from the prescription record.
The prescribing of methadone in this province is becoming more frequent, particularly with the increased use of this drug in palliative care settings. In many cases pharmacists who are not familiar with the dispensing of methadone are seeking information and guidelines in this respect.
Health Canada has issued guidelines with respect to the dispensing of methadone for the treatment of opioid dependence. At this time, similar guidelines for the dispensing of methadone for pain management have not been issued.
Only practitioners exempted under section 56 of the Controlled Drugs and Substances Act may prescribe methadone for patients under their professional treatment. Usually a listing of practitioners so authorized is not published, however, a pharmacist wishing to confirm that a prescribing physician is in fact authorized may contact the Office of Controlled Substances. While physicians must be specifically authorized to prescribe methadone, any pharmacist (other than a pharmacist specifically prohibited) may dispense methadone. Sub-section 31(3) of the regulations to the Controlled Drugs and Substances Act) states:
A pharmacist may supply methadone to
a) a licensed dealer;
b) another pharmacist;
c) a hospital employee or a practitioner in a hospital;
d) a person authorized by the Minister pursuant to subsection 68(1); or
e) a person from whom the pharmacist has received a written order or prescription therefore signed and dated by a practitioner of medicine who is authorized by the Minister pursuant to subsection 68(1).
Pharmacists may order methadone from a manufacturer or licensed dealer in the same manner that other straight narcotics may be ordered.
Pharmacists or physicians who have specific questions related to the prescribing and dispensing of methadone may contact the Office of Controlled Substances at:
Copies of the Health Canada or NLPB Standards of Practice can be found on our Professional Practice Resources page.
Section 40(1) of the Narcotic Control Regulations states that, “ A pharmacist shall maintain a special narcotic prescription file in which shall be filed in sequence as to date and number all written orders for narcotics dispensed…”
Section G.03 .009 of the controlled drugs Part of the Food and Drug Regulations has parallel wording to this with respect to controlled drugs.
There has been no change to these regulations, so pharmacists are still required to keep prescriptions for narcotic and controlled drugs on a special file separate from other prescriptions.
Should it be a significant issue in your pharmacy to find Schedule F prescriptions that may be filed in the narcotic files, there would be no problem with placing a copy of the prescription on your regular files, as long as the original was kept on the narcotic and controlled drugs prescription file as required by the regulations. This, however, might create considerable extra work for you.
Our advice to pharmacists was that they not sell natural products that had not received Health Canada approval. Melatonin was particularly singled out in our advice to pharmacists since Health Canada had made a point a few years back of specifically notifying pharmacists that melatonin was not approved for sale in Canada.
If Health Canada has now issued an NPN number to the Vivitas brand of melatonin this would indicate that this product has now been approved for sale in Canada. I would expect that the approval process also requires that this NPN number appear on the product packaging.
I would also note, as you may already know, that NPN numbers are similar to DIN numbers in that the number applies to a specific manufacturer’s product and that different brands of the product require individual approval by Health Canada, with different NPN numbers being assigned.
By the way, neither Health Canada, nor the manufacturer, has not notified pharmacy regulatory bodies of such approvals having been given. This makes it difficult to give clear and consistent advice to pharmacists on such issues.
I’ve also heard, from other pharmacies, that manufacturers of natural products have on occasion (and melatonin is such an occasion) have dealt with non-pharmacist front store buyers to place their products in pharmacies (based presumably on the proposition that natural products are legally not considered “drugs”). It would be very helpful if, internally, pharmacist buyers and non-pharmacist buyers could co-ordinate such issues internally, to avoid potential problems such as the one you recognized and sought advice on.
You were contacted by our office since you are the pharmacist-in-charge of the pharmacy in which you practice. The responsibilities of the pharmacist-in-charge as described in the regulations state:
All pharmacists who are designated and named on a business license as the pharmacist-in-charge of that pharmacy
(a) are accountable to the council, through its designate the Secretary-Registrar, for all professional activities occurring within that pharmacy and
(b) shall be responsible for...
v. notifying the secretary-Registrar in writing of the names of pharmacists employed by that pharmacy and when a pharmacist ceases employment with that pharmacy,...
In addition to this requirement that the pharmacist-in-charge notify our office of any changes at their pharmacy, it is also the responsibility of the individual pharmacist to notify us of any change of practice site (that will be for more than 30days). It is also important to note that if the pharmacist who is moving happens to be the current pharmacist-in-charge, this would also involve a change in business licence (since the business licence lists the pharmacist-in-charge) and notice of this must also be given to our offices.
Another issue that we frequently run into is that many pharmacists don’t realize that if they leave practice for parental leave, or return to practice from parental leave, our office should receive a change of employment notice.
The required change of employment or change of business licence forms that we use can be downloaded from our Forms page, or are available upon request from our office.
If we don’t receive a change of employment notice it could result in the pharmacist being unable to sign for narcotics or controlled drugs at the new site, or mail from our offices would continue to go to the old site and, last but not least (from the Board’s point of view), our registers would not be accurate and up to date.
The list of drugs affected by the Tamper Resistant Prescription Drug Pad Program may be found by looking in the Provincial Drug Schedules at the end of Schedule I, in the Tamper Resistant Prescription Drug Pad Program brochure on the Department of Health and Community Services website or by clicking HERE.
There are no pharmacy regulations or standards of practice that speak directly to this issue; however, there are requirements in the Pharmacy Regulations related to the cessation of operation of a pharmacy that includes a requirement that the prescription records be transferred to another pharmacy, so that they remain accessible to the patient or others who may need access to them.
The common practice in the past has been for the pharmacy ceasing operation to transfer all their prescription records (both original prescriptions and the records of any subsequent refills) in bulk to another pharmacy. In some if not all cases a payment may have been made with respect to such a transfer. Patients can then have access to those files from the receiving pharmacy. If there are any outstanding refills on these prescriptions the patient can choose to either have them filled at the receiving pharmacy or request that they be transferred to another pharmacy of the patient’s choice.
The Pharmacy Board has never, in my experience, considered it inappropriate to transfer all a pharmacy’s prescription files to another pharmacy in the case of cessation of operation. In fact my personal opinion would be that such a transfer is a reasonable way in which access to the patient prescription records can be maintained as required by the federal Food and Drugs Regulations and Controlled Drugs and Substances Regulations legislation as well as the provincial Pharmacy Regulations
With respect to the privacy of patient information, it would go without saying that the receiving pharmacist would only access specific patient information at the request of the patient, either to provide remaining refills, or to transfer to prescription to another pharmacy, or to other wise provide the patient access to those records.
I would also note in closing that the advice we give the pharmacist-in-charge of a pharmacy about to cease operation is to provide as much notice to their patients as possible of the impending closure, so that refills can be obtained, or transfers to the pharmacy of the patient’s choice can be done before closure of the pharmacy. Also we advise pharmacists i n this situation to post or otherwise make available information to patients about where their prescription records have been sent and can be accessed.
Until recently, the Newfoundland and Labrador Pharmacy Board has been issuing authorization letters for the destruction of narcotics and other controlled substances to pharmacies upon written request. However, in February of 2010, the Board received communication from the Manager of the Compliance, Monitoring and Liaison Division of the Office of Controlled Substances indicating that this process was not consistent with the current regulatory context and asked us to inform pharmacists that any further requests should be forwarded to their attention.
As such, the Board will no longer authorize requests for destruction of narcotics and controlled drugs. Instead, we have prepared a revised version of our form, “Request to Destroy Drugs Covered by the Controlled Drugs and Substances Act” as well as Guidelines for Pharmacy Practice on the Destruction of Expired or Unusable Narcotics and Controlled Drugs. These guidelines are available on our Standards, Policies and Guidelines page.
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