In situations not already captured by the Health Network System (HNS) the pharmacist may implement a pharmaceutical opinion based on one of the following prescription intervention criteria or drug related problem:

1. Therapeutic duplication; drug may not be necessary
2. Requires drug; patient needs additional drug therapy
3. Sub-optimal response to a drug; drug is not working as well as needed
4. Dosage too low
5. Adverse drug reaction; possibly related to an allergy or a conflict with another medication or food
6. Dangerously high dose; patient may, either accidentally or on purpose, be taking too much of the medication
7. Non-compliance; patient is refusing to take the drug, or not taking it properly
8. Prescription has been confirmed false or has been altered

1. Therapeutic duplication; drug may not be necessary
   The prescribed medication or a medication from the same therapeutic class is being taken by the patient. The addition of the prescribed medication may provide no clinical benefit beyond the medication already being taken or it may harm the patient.
2. Requires drug; patient needs additional drug therapy
   Additional drug therapy is required to treat or to prevent a medical condition in the patient.
3. Sub-optimal response to a drug; drug is not working as well as needed
   The drug is not the most effective or is not effective for the medical problem. This may include situations in which:
   • the dosage form for the drug product is not appropriate or
   • the medical condition is refractory to the drug product. (not yielding to drug therapy)
   • the prescribed medication has been previously taken by the patient and the patient did not experience the intended benefit of the medication.

   This would also include refill prescriptions or a second fill to the Trial Prescription Program in which it is determined by the pharmacist that the patient is not receiving the intended benefit of the medication.

4. Dosage too low
   The total daily dose is below the usual recommendation and it is of little clinical value for the patient to take the medication in the dose that is prescribed.
5. Adverse drug reaction; possibly related to allergy or conflict with another medication or food
   The prescribed medication may result in a potential drug interaction between it and the current medication therapy, the prescribed medication and a medical condition or the medication is contraindicated for use during pregnancy or breast feeding or another condition.

   The drug interaction is such that it has the potential to cause significant harm to the patient.

   The prescribed medication has been previously taken and resulted in an adverse reaction, allergy or side effect that resulted in the medication being discontinued. The adverse reaction was such that in the pharmacist’s judgement the medication should not be received again by the patient.

   This would also include refill prescriptions where the patient is having side effects with a prescribed medication and because of the actions of the pharmacist in identifying the problem, the medication is discontinued.

6. Dangerously high dose; patient may, either accidentally or on purpose, be taking too much of the medication
   The total daily dose prescribed is above the maximum recommended daily dose and would harm the patient.
7. Non-compliance; patient is refusing to take the drug, or not taking it properly
   
   • The patient does not understand the instructions.
   • The patient prefers not to take the medication or forgets to take the medication.
   • The patient cannot swallow or self-administer the drug product appropriately.
   • The frequency that the patient is taking the medication does not align with the frequency prescribed.
8. Prescription has been confirmed false or has been altered
   The pharmacist or pharmacy technician must confirm the validity of the prescription with the prescriber or the appropriate references including the respective prescriber’s regulatory authority.

   A copy of the forgery is maintained for the record and cross referenced with the pharmaceutical opinion claim; documentation includes findings regarding the confirmed forgery.

   In the majority of cases recommendations to prescribers regarding forgeries do not apply due to the nature of this prescription intervention.

   Pharmacists are expected to report the prescription forgery to the appropriate authority.

Identification of the Drug Related Problem

• In the course of filling a prescription or when conducting a MedsCheck medication review, a pharmacist identifies a problem or potential problem that he or she feels should be discussed with the patient’s prescriber.

Contacting the Prescriber

• On identifying the potential prescription or MedsCheck intervention criteria, the pharmacist must contact / consult with the prescriber to discuss the drug related problem or concern.
• The pharmacist provides the prescriber with a recommendation and documents the intervention on the prescription or in the case of a MedsCheck, on the medication review documentation template. (i.e., the drug related problem and recommendation).
• The pharmacist must document the outcome on the prescription or on the MedsCheck documentation based on the interaction with the prescriber:
  • Not filled
  • No change to prescription therapy; filled as prescribed; therapy continued.
  • Change to prescription therapy; filled as per change(s) (includes adding new drug therapy and discontinuing drug therapy)
• The main elements of discussion between the pharmacist and the prescriber must also be documented.

Communication with the Patient

• The pharmacist must inform the patient (or caregiver) why the prescription will not be dispensed as written / prescribed. Or in the case of a MedsCheck appointment what the potential drug related problem is.
• The pharmacist must also discuss any alternative therapeutic plan (if applicable) and convey such information to the patient and the prescriber.
• The pharmacist will provide the patient with an updated MedsCheck medication review based on the outcome of the drug related problem if the intervention resulted from a MedsCheck.

Documentation

Documentation must be on the patient’s electronic profile or on the prescription hardcopy record. In the case of the MedsCheck, documentation is as per the MedsCheck standards. All documentation must be in a readily retrievable format. The use of a pharmaceutical opinion form is also accepted as documentation provided the pharmaceutical opinion is cross-referenced with the original prescription and revised prescription if applicable. Documentation must include as a minimum:

1. Details of the drug related problem (there are 8 reason for not dispensing the prescription as written / prescribed)
2. Medication(s) involved
3. Recommendation to the prescriber
4. The date and the name of the prescriber who was contacted
5. Action plan / discussion with the patient
6. Wording to indicate the outcome; there are three possible outcomes. (Not filled due to a confirmed forgery or clinical concern; recommendation provided by pharmacist but prescription filled as prescribed / therapy continued as prescribed; recommendation provided by pharmacist and prescription therapy changed.)
7. The date of the transaction and the pharmacist’s signature
8. Other comments required to substantiate the decision
9. In the case of a MedsCheck, an updated MedsCheck medication review list is provided to the patient and the physician as per MedsCheck standards.

Record Keeping

If payment is made for a claim, the original prescription or a copy, whether verbal or written, or the MedsCheck medication review form along with the documentation criteria must be retained by the pharmacist in a readily retrievable format and kept on file at the pharmacy for a minimum period of two years for audit purposes. All patient records must be retained by the pharmacist in a readily retrievable format and kept on file at the pharmacy for a minimum period of ten years.

It is imperative that pharmacists submit claims using the appropriate PIN indicating the outcome of the drug therapy intervention that was conducted in relation to the prescription presented or to the MedsCheck medication review.

What is NOT considered part of the pharmaceutical opinion program:

Other than a confirmed prescription forgery or falsified prescription, a pharmaceutical opinion may not be claimed if the pharmacist has not made a recommendation to the prescriber.

The following are some of the examples of what is NOT eligible for payment:
(The list is not inclusive.)

1. A decision not to fill a prescription when a pharmacy does not have the medication in their inventory or when the prescription is placed on hold.
2. Decisions taken in response to a drug utilization review alert such as “fill too soon” or “late fill” when no additional follow up was conducted with the prescriber. This includes situations where the ODB program has rejected a claim on the Health Network System (HNS).
3. Contacting the prescriber to obtain missing information on the prescription such as the dose or to clarify illegible handwriting.
Clarifying a dose or a concentration without making a recommendation does not qualify as a clinical intervention.
4. Providing a patient profile or list of medications to the prescriber or to a patient without additional consultation.
5. Contacting the prescriber to change a drug to an eligible benefit.
6. Recommendations to the prescriber for medical device therapy

Ontario Drug Benefit recipients are eligible for the pharmaceutical opinion program at the time of dispensing a prescription effective April 1, 2011; and if identified when conducting a MedsCheck medication review, effective September, 1, 2011.

Payment
The amount paid to the pharmacy for a pharmaceutical opinion is: $ 15

Claim

• A claim for payment is made after the pharmaceutical opinion has occurred, the patient has been informed, the prescriber has been contacted and documentation is completed and signed by the pharmacist.
• Specific Intervention Codes will be used per claim
  • The intervention code “PS” will be required.
  • The pharmacist’s ID code must be included with the claim.

The claim submission follows the same process for submitting a claim for other professional services with the use of a Product Identification Number (PIN) that is associated with the pharmaceutical opinion outcome:

All claims documentation must be cross-referenced to the prescription or the MedsCheck medication review and include the reason for the pharmaceutical opinion.

All claims will be monitored by the ministry and any claims submitted for non-ODB recipients will be automatically recovered from a future ODB payment.