Frequently Asked Questions
FAQ’s Regarding Pharmacists’ Authority to Refill Existing Prescriptions (Updated March 12, 2012)
On March 15, 2011 the OCP issued an Advisory Notice pertaining to new regulations under the Drug and Pharmacies Regulation Act (DPRA). Under the authority of those regulations, pharmacists practicing in accredited pharmacies are now able to refill existing prescriptions without the further authorization of a prescriber under the criteria specified in section 42 of the Regulation. (see below)
1. Does this authority only apply to pharmacists practicing in community pharmacies?
Yes, only pharmacists in community pharmacies have the authority to authorize refills of existing prescriptions under specific criteria. This authority is contained in the Drug and Pharmacies Regulation Act (DPRA) which regulates pharmacies in Ontario.
2. What is the intent of this new legislation which allows pharmacists to refill an existing prescription?
The intent of the legislation is to prevent delay in refilling prescriptions for patients on chronic medication. In 2008, the College of Physicians and Surgeons (CPSO), the Ontario Medical Association (OMA), the Ontario Pharmacists Association (OPA) and the Ontario College of Pharmacists (OCP) developed the principles for pharmacist’s authority to refill existing prescriptions. These principles ensure consistency in practice across the province and continuity of care for patients.
3. What are the criteria that must be met in order for a pharmacist to authorize a refill of an existing prescription without further authorization from a prescriber?
All of the following criteria must be met:
- reasonable efforts to contact the prescriber have been made and were unsuccessful;
- the prescriber of the prescription to be refilled, if available, would have authorized the refill;
- the patient for whom the drug is to be refilled has been prescribed the drug for a chronic or long term condition; AND
- the patient for whom the drug is to be refilled has a stable history with that drug.
4. If the original prescriber has a “no refill policy” does this mean the original prescriber would not have authorized the refill?
The reference to “The prescriber of the original prescription would likely have authorized the refill” means that it would be in the best interest of the patient to keep taking the drug. This has nothing to do with office policies of “no refills”, which OMA and CPSO do not believe is consistent with good clinical practice. If the pharmacist believes, in his or her professional judgment, that the physician is going to continue the drug for this patient, they should continue it provided the other criteria are met.
5. What conditions could be considered to fit the description of chronic and long-term?
A chronic and long-term condition is one that cannot be cured but which can be managed on an ongoing basis through medication and/or therapy. While there is no definitive list of long term conditions, conditions such as, diabetes, asthma, coronary heart disease, chronic obstructive pulmonary disease and mental health issues can all be regarded as long term conditions.
6. What if the patient requests a refill for a drug that has been newly prescribed for a chronic condition?
The pharmacist will need to use their professional judgement about whether the patient is tolerating the medication, including their history of previously prescribed medications and the known risks and benefits of the drug. The pharmacist should also consider the impact of an interruption in drug therapy if a refill is not authorized.
7. Can a refill of a prescription for a narcotic drug be authorized by a pharmacist?
No, pharmacists do not have the authority to authorize refills of prescriptions for narcotic or controlled drug or targeted substances. Although targeted substances are not referred to specifically in this regulation, the new anticipated expanded scope legislation does indicate that pharmacists cannot extend prescriptions for targeted substances. Therefore for continuity of care and management of patient expectations, it is recommended that refills for targeted substances not be authorized.
8. Are pharmacy interns allowed to authorize refills?
No the Regulation specifically makes reference to pharmacists
9. Can a pharmacist authorize a refill of a prescription from an out-of-province prescriber?
Yes, if all 4 criteria have been met and the prescriber is notified
10. What quantity can be refilled and how often?
The total amount of the drug dispensed cannot be more than the amount previously dispensed or a three month supply, whichever is less. The pharmacist may use their professional judgment to determine if further refills at future dates should be authorized; however, the pharmacist must apply the required criteria each time s/he considers authorizing a refill authorization.
11. Can a prescription be refilled for less than three months or less than the original amount dispensed?
Yes, the pharmacist should also use their professional judgment on the quantity. For example, a pharmacist may choose to refill for one month if the physician cannot be reached for authorization and the patient can see their physician in the next few weeks. In cases where there is prolonged physician absence, two or three months may be more appropriate. Remember that all four criteria must be met.
12. How is the prescription processed and what name is entered in the prescriber field? What prescriber name should appear on the prescription label?
A unique prescription identification number must be assigned to the authorized refill and the name of the original prescriber must be recorded in the patient record as well as the name of the authorizing pharmacist. The Ontario Pharmacists Association is working with private and public payors regarding their acknowledgment of the pharmacist identification in the prescriber field. The prescription label must indicate the name of the authorizing pharmacist.
Further information about submitting a claim for reimbursement under the ODB program can be found in OPDP Notice No.11026, posted March 18, 2011.
13. A unique prescription identification number must be assigned to the authorized refill. Does this mean a third set of prescription numbers are to be created besides narcotic and regular prescriptions?
No this simply means that the prescription must be generated as “new” or “reauthorized” (depending on the software system) with a new number so that the audit trail clearly identifies when the authorization occurred. The refill cannot be “piggy backed” onto the original prescription.
14. Must the pharmacist notify the prescriber?
Yes, within seven days, the prescriber and the patient’s primary health care provider, if known, must be notified of the authorization/dispensing date, name of drug and quantity dispensed. This is important for the maintenance of patient records with all health care providers.
15. How much and what documentation is needed to indicate that the pharmacist attempted to contact the prescriber?
The pharmacist, using their professional judgment, can determine how much and what information is appropriate to document considering that they may need to refer back to this documentation in future. You should consider third party payor documentation requirements as well.
16. What if the prescriber does not respond to pharmacist’s faxes? How can the pharmacist “confirm the refill authorization” with the prescriber?
The obligation of the pharmacist is to apply the required criteria and make reasonable efforts to contact the prescriber. The pharmacist is not responsible for ensuring receipt of the notification and approval from the prescriber is not required.
17. If a physician has retired and closed their practice or he/she has died and the patient does not have a new physician, for how long can the pharmacist authorize a refill and who is to be notified?
In this case the first criteria would not apply; however, professional judgement must always be applied and demonstrated when considering the patient’s specific situation, and to ensure continued patient care. Proper documentation to describe the specific situation is important for completeness of the patient record.
18. What happens if after notifying the prescriber, the prescriber indicates that the pharmacist should not have authorized the prescription refill?
Although the pharmacist is notifying the prescriber of the authorization and not seeking permission, it is best practice to collaborate with the prescriber to ensure mutual understanding for future patient care.
19. Can this process be used to circumvent a scenario where a prescriber charges for prescription refills?
The intent of this authority is to ensure continuity of care when the prescriber is not available to the patient or to the pharmacist who is requesting refill authorization on behalf of the patient. It is not intended to circumvent other arrangements/processes in place between the prescriber and the patient. The pharmacist can only authorize the prescription refill if the patient is in need of the medication and prescriber cannot be reached for authorization, providing the required criteria are met.
20. Do oral contraceptives meet criteria (c) “the patient for whom the drug is to be refilled has been prescribed the drug for long term condition”?
Yes, and remember that the other three criteria have to be met as well.
21. Will there be communication to prescribers?
The College of Physicians and Surgeons of Ontario and the College of Nurses of Ontario have communicated information regarding this new pharmacist authority to their members. (see the CPSO website home page). However since this legislation is new and prescribers may not be aware, the College recommends that pharmacists communicate with their local physicians and nurse practitioners to ensure clear understanding of the process and intent of the regulation.
On May 14, 2011, the College of Physicians and Surgeons of Ontario (CPSO), the Ontario College of Pharmacists (OCP), the Ontario Medical Association (OMA), and the Ontario Pharmacists Association (OPA) agreed on the wording of a joint letter to be sent to members to clarify the regulations.
22. What if a physician has a blanket “no refill” policy? Does that mean I cannot refill the prescription even if the patient needs the medication?
The communiqué sent jointly by OCP, CPSO, OPA and OMA clarified this circumstance:
In the communiqué, it was stated:
- Some physicians have blanket “no refill” policies, meaning they will not authorize refills for any patient, any drug and in any circumstance. This is not consistent with patient-centred care and has no clinical basis. If there are situations where refills may not be advisable, we encourage open discussion between our two professions so that all professionals involved in the patient’s care are best positioned to exercise judgement where necessary and appropriate.
23. Are pharmacists taking the place of physicians?
Not at all; the pharmacist authority to authorize refills of existing prescriptions is solely for the purpose of continuity of care in circumstances where there may be a delay in refilling prescriptions for patients on medication for a chronic condition. All four criteria will need to be met every time a pharmacist makes a decision to authorize a prescription refill.
24. What if the patient presents in the evening or during the weekend and the pharmacist cannot reach the doctor? If the prescriber’s office is closed on Friday, may the pharmacist authorize a full refill or should they wait until Monday when the physician is back in the office?
The pharmacist can authorize the refill if the patient requires the medication immediately and the criteria have been met. In the past, many pharmacists would “advance” a few days supply until the prescriber could be reached. This regulation provides the pharmacist with the authority to dispense a quantity appropriate to the situation.
25. In the case of a visiting patient who is not a regular patient of a pharmacy but requires a refill, can the pharmacist accept a transfer of prescription authorized by another pharmacist who has a complete patient record?
There is no prescription to transfer. This would be a copy of a prescription. A pharmacist can only refill the prescription if all criteria have been met. As always, complete documentation is required, describing the situation and how the decision was made.
26. Are pharmacists covered under personal professional liability Insurance?
Yes, all pharmacists are required to maintain personal professional liability insurance which covers the practice of pharmacy as regulated by the College
27. Is it the responsibility of the Designated Manager (DM) to ensure that prescription refills authorized by all pharmacists in the dispensary meet the requirements as set out in the regulation?
No, the DM is not responsible for the individual clinical and professional decisions of other pharmacists.
28. How can I learn more about all aspects of the new regulation?
Click here to access Regulation 58/11 to the Drug and Pharmacies Regulation Act.
29. Is this the expanded scope legislation we have been hearing about?
No the draft regulation to the Pharmacy Act (Bill 179) was recently approved by Council and it will enable an expanded scope of pharmacy practice; however, this regulation is not yet approved by government. Once the new regulation is passed, pharmacists in all practice settings, not just accredited pharmacies, will have the authority to extend, adapt and initiate prescriptions and the provisions outlined in the DPRA Regulation will be revoked.
The proposed Pharmacy Act regulation will specify requirements that must be met in order to practice the expanded scope. At the appropriate time, the OCP will provide more details on those requirements, including policies and guidelines to assist members in their practice. Right now, it is unknown when the Pharmacy Act regulation will be passed by government. In the meantime, under the authority of the DPRA regulation pharmacists in accredited pharmacies may refill prescriptions without authorization from a physician under the specified conditions
From the Regulation under the Drug and Pharmacies Regulation Act
Refills
42. (1) Subject to subsections (2) to (6), a prescription may be refilled in a pharmacy without a further prescription from a prescriber if the refill has been authorized by a pharmacist.
(2) A pharmacist shall not authorize the refill of a prescription under subsection (1) unless the pharmacist reasonably believes that,
- reasonable efforts to contact the prescriber have been made and were unsuccessful;
- the prescriber of the prescription to be refilled, if available, would have authorized the refill;
- the patient for whom the drug is to be refilled has been prescribed the drug for a chronic or long term condition; and
- the patient for whom the drug is to be refilled has a stable history with that drug.
(4) The total amount of the drug dispensed pursuant to the refill shall not exceed the amount of the drug previously dispensed by the pharmacy or a three months supply, whichever is less.
(5) A drug shall not be dispensed in a pharmacy in respect of a prescription which has been refilled under the authority of subsection (1) unless all of the following conditions have been met:
- A unique prescription identification number has been assigned to that refill prescription.
- The assigned prescription identification number and the name of the original prescriber have been recorded in the pharmacy’s patient record.
- The fact that the refill has been made with the authorization of a pharmacist and the name of that pharmacist have been recorded on the pharmacy’s patient record.
- notice that a refill of the prescription was made on the authorization of a pharmacist; and
- the date, drug and quantity of drug dispensed by virtue of that refill.
