5.13 Compounded Prescriptions

PharmaCare does not cover compounds containing non-benefit medicinal ingredients or ineligible non-medicinal bases.

If a compound is not eligible for PharmaCare coverage and is erroneously claimed using a benefit compound PIN, the claim is subject to recovery. PharmaCare does not provide coverage for any compound that is formulated to circumvent the use of a commercially available product. Refer to Health Canada’s Policy on Manufacturing and Compounding Drug Products in Canada (PDF, 180KB).

>> See Non-benefit PINs.

Special Authority for non-benefit compounds

PharmaCare recognizes that there may be exceptional, last-resort circumstances in which the coverage of non‑benefit compounds is justified. In these exceptional circumstances, Special Authority approval is required.

Special Authority approval is for the exact compound indicated on the Compound Costing Worksheet (PDF, 521KB). A new Compound Costing Worksheet must be approved by PharmaCare Special Authority before billing whenever there is a change to the ingredients, concentration, quantity or days’ supply of the original compound.

Any claimed amount that is greater than what was approved is subject to recovery.

Special Authority compound approval is pharmacy-specific and cannot be transferred.

Each pharmacy must submit a Compound Costing Worksheet with a copy of the current compound prescription or transfer record, and obtain approval from PharmaCare before submitting a claim.

>> See below for how to submit a Special Authority request for a compound.

While PharmaCare does not identify specific formulations that must be used for compounds, formulations with evidence-based beyond-use dates should be used if available.  Formulations with untested default beyond-use dates should only be used as a last resort. Formulation and beyond-use dates may be requested for Special Authority adjudication or for audit purposes.

Pharmacare will determine which compound strengths and quantities will be covered, and the associated maximum prices, by using published formulations and evidence-based beyond-use dates, where possible.

After all of these options have been exhausted, the prescriber may submit a Compound Coverage Request (HLTH 5479) (PDF, 536KB) for Special Authority adjudication.

Note: For any Special Authority request, PharmaCare may approve full, partial or no coverage.

Claims for prescription compounds must be entered using the appropriate benefit, non-benefit, or Special Authority–specified compound PIN(s). All eligible PINs have eligibility criteria, as per Compounded Prescription PINs.  If a patient does not meet criteria to use the benefit PIN, a Special Authority request must be submitted.

Claims for non-benefit compounds or  for when a patient does not meet criteria for a benefit PIN must not be submitted with a benefit compound PIN. If a benefit PIN is used, the claim is subject to recovery.

When Special Authority coverage for a compound is granted, PharmaCare will provide the pharmacy with a specific PIN which the dispensing pharmacy must use when submitting the claim to PharmaNet.

PharmaCare does not automatically cover compounds intended to replace products unavailable due to a manufacturer shortage. In event of a drug shortage, consult PharmaCare’s Drug Shortage Information. If the medication is not listed, call the PharmaNet HelpDesk.

If a shortage is expected to last for an extended period of time, and there are no other commercial alternatives, PharmaCare may establish a specific PIN and maximum price in PharmaNet for replacement compounds. The PIN will be in the Current Drug Shortages List. Replacement compounds can be claimed using these PINs for the duration of the shortage only, and subject to all PharmaCare pricing policies as outlined below. A record of the cost breakdown must be kept with the prescription.

If PharmaCare has not assigned a specific PIN for a replacement compound, Special Authority approval is required before a claim is submitted. If a specific benefit PIN has been assigned, Special Authority approval is not required.

PharmaCare does not routinely cover compounds intended to replace commercial products discontinued by a manufacturer, even if the discontinued product was a benefit.

Special Authority coverage for compounds to replace discontinued products will only be considered after the patient’s medical practitioner has

• Reassessed the patient’s need for that specific drug and dosage form; and
• Ensured that there is no other commercial option, including another drug, that is suitable for the patient; and
• Contacted Health Canada’s Special Access Programme to see if the discontinued product is available through that route

When a dispensing pharmacy contracts a compounding pharmacy to provide a compound for an individual prescription, the dispensing pharmacy should ensure that the contracted pharmacy provides the compound at a cost within PharmaCare policy limits. The dispensing pharmacy may not claim more than the permitted amount under the PharmaCare Compounded Prescriptions policy.

The contracted compounding pharmacy must provide a complete cost breakdown. The dispensing pharmacy must keep this breakdown with the compound prescription, as per record-keeping requirements below.

Ingredient costs

PharmaCare expects pharmacies to use the most reasonably priced ingredients and to follow all  PharmaCare pricing policies when compounding. For example,

• omeprazole: use powder, not capsules
• sodium bicarbonate for oral or topical products that do not require sterility: use powder and water, not the injectable formulation

As compounding chemical providers charge a range of prices, the lowest-priced medicinal and non-medicinal ingredients should be used.

Note: All ingredient costs for compounds are subject to all PharmaCare pricing policies.

Equipment and supply costs

PharmaCare does not cover charges for the following:

• Drug administration aids (e.g., syringes, spoons)
• Vials, bottles, and/or ointment jars
• Disposable spatulas
• Gowns, booties, gloves, masks and similar items
• Lab fees, hood fees, and/or pH meter fees
• Equipment use
• Pre-filling syringes or vials

PharmaCare covers the cost of the following supplies and equipment when used in compound preparation:

• Gelatin capsules
• IV bags
• Adapta-Caps™
• EMP jars
• Disposable equipment for a particular compound claim ( e.g., weighing boats, needles, filters)
• Syringes for compounding/measuring (but not for administration, as above)

Reimbursement for eligible supplies and equipment is subject to the Actual Acquisition Cost Policy.

Compounding and dispensing fees

Pharmacies may claim both a compounding fee and the standard dispensing fee.

PharmaCare reimburses compounding fees up to a specified maximum, based on the type of compound. Refer to the Compounding Fee Schedule for the list of maximum allowable compound fees.

The amount entered in the Drug Cost field and submitted to PharmaCare is the combined total of the following: compounding fee, ingredients, and eligible equipment and supply costs.  A maximum of one compounding fee per dispensed prescription is permitted.

Note: If dispensing a compound for less time than allowed by the beyond-use date and/or prescription, the compounding fee must be prorated; for further details see How to Submit a Claim for a Compound to PharmaNet, below.

Compounding costs in excess of PharmaCare maximums or in excess of the amount approved by Special Authority must not be claimed in the Drug Cost field. Excess charges on compounding costs must be entered in the Cost Upcharge field so that the amount becomes payable by the patient or their alternate insurer; excess charges may not be processed under a separate claim, nor invoiced.

Note: Patients who currently receive full drug coverage through their PharmaCare plan cannot be charged a co-pay amount for any additional costs and/or related services fees associated with the compound, in accordance with the Full Payment Policy.

Stock solutions

If a portion of a pharmacy-prepared stock solution is used in the preparation of a compound, only the actual acquisition cost of the ingredients used in that portion may be billed.  Please note that PharmaCare does not provide coverage for a separate compounding fee for the stock solution.  The stock solution mixture breakdown (ingredients, quantities, cost) must also be included either on the costing worksheet or on a separate worksheet.

Procedural requirements for pharmacists

How to submit a Special Authority request for a compound

To obtain Special Authority coverage for compounds, the following documentation is needed:

From a pharmacy:

• A copy of the current prescription, and;
• A fully completed Compound Costing Worksheet (HLTH 5425) (PDF, 521KB)

The pharmacy must retain a copy of the PharmaCare-approved Compound Costing Worksheet with the original prescription.

From the prescriber:

• A fully completed Compound Coverage Request form (HLTH 5479) (PDF, 536KB)

For compounds for patients registered for Plan P (BC Palliative Care Drug Plan), a copy of the prescription may suffice as supporting documentation for Special Authority requests. The dispensing pharmacy should submit the costing worksheet and a copy of the current prescription. PharmaCare will notify the pharmacy if a Special Authority request is also required from the prescriber.

Note: For any Special Authority request, PharmaCare may approve full, partial or no coverage.

PharmaCare will advise the

• Prescriber of
  • Special Authority approval or denial of coverage
• Pharmacy of
  • Special Authority approval or denial of coverage; and
  • maximum cost to submit to PharmaCare for reimbursement; and
  • the specific PIN to be used when submitting the claim

Note: If costs, ingredients, concentration, quantity, or days’ supply change for any reason, a new Compound Costing Worksheet must be submitted and approved by PharmaCare before billing, even if a Special Authority approval for the compound is still active.

How to submit a claim for a compound to PharmaNet

When submitting a claim for a compound, enter the cost in the appropriate fields:

A. In the Drug Cost field, enter the combined amount of

• Eligible ingredient costs; plus
• Eligible compounding fee; plus
• Eligible equipment and supply costs

Note: When dispensing compounds for less time than allowed by the beyond-use date (daily dispense of chronic medication, daily dose tapering, etc.), the full quantity should be prepared and the total in the Drug Cost field prorated to reflect the smaller volumes dispensed.

Frequent Dispensing Examples

Frequent Dispensing Examples
A	Eligible ingredient costs	D	Total day supply
B	Eligible compounding fee	N	Number of days of each fill
C	Eligible equipment and supply costs
Amount to enter into drug cost field: (A + B + C) / (D / N)		Daily dispense (30-day supply example):     (A+B+C) ÷ ( 30 ÷ 1 )
		Weekly dispense (28-day supply example) :   (A+B+C) ÷ ( 28 ÷ 7)

B. In the Dispensing Fee field, enter your standard dispensing fee.

C. In the Upcharge field, enter the amount of the compounding fee, ingredient costs, and/or supply/equipment costs that exceeds PharmaCare reimbursement maximums or the amounts approved by Special Authority. Pharmacies are not permitted to charge any amount directly to patients who qualify for the Full Payment Policy.  “Any amount” includes all charges for preparing the compound and any related services.

For patients who qualify for compound coverage, use the correct benefit PIN or the specific PIN provided by Special Authority. Commercial product DINs must not be used.

For patient safety, all compounds must be identifiable in PharmaNet, including the active ingredient(s), dose and/or concentration, along with the directions for use. The information in the table below shows examples of what must be entered at the beginning of the Directions for Use (SIG) field. If any of the required information is not identified by the description of the PIN, it must be entered at the beginning of the Directions for Use (SIG) field.

Compound Suspension Example

Compound Suspension Example
Benefit compound PINs are drug/dosage form-specific. To ensure the dose and concentration are visible to other PharmaNet users, enter them exactly as indicated below.
Prescription	felodipine 10 mg (in suspension), once daily
PIN	22123241
PharmaNet description	felodipine compounded suspension
Directions in SIG field	take 5 mL (10 mg) once daily
PALLIATIVE BENEFIT CADD PUMP COMPOUND EXAMPLE
CADD pump PINs specify whether the ingredient is a narcotic. The dose is usually included in the prescription directions. To identify the specific drug being used, the drug name must be entered in the SIG field as indicated below.
Prescription	hydromorphone 20 mg/mL for CADD, 3.5 mg/hr and 7 mg BTP q20min
PIN	22123288
PharmaNet description	narcotic CADD pump compound: palliative
Directions in SIG field	run 3.5 mg/hr (hydromorphone) and 7 mg for BTP every 20 min
DERMATOLOGICAL COMPOUNDS EXAMPLE
PINs for these medications identify the ingredient or class of ingredients. As in the example below, it is not mandatory that a pharmacist enter the specific corticosteroid or concentration of ingredients.
Prescription	HC 1% + menthol 0.25% cream, BID
PIN	22123278
PharmaNet description	corticosteroid + menthol +/or camphor
Directions in SIG field	enter usual directions for use (no change required)
COMPOUNDED PRESERVATIVE-FREE EYEDROPS EXAMPLE
PINS for eye drops identify the active ingredient and indicate that the eye drops are preservative-free. Add the concentration of the eye drops to the directions, as indicated in the example below.
Prescription	timolol 0.25% preservative-free eye drops, 1 gtt BID.
PIN	22123295
PharmaNet description	timolol PF cpd eye drop
Directions in SIG field	instil 1 drop (0.25%) in left eye twice daily
PALLIATIVE BENEFIT COMPOUNDED INTRATHECAL INJECTIONS EXAMPLE
Palliative intrathecal injections are an exception to the requirement to identify the active ingredient. Because of variations in ingredients and concentrations, the PINs only give a general description. It is not necessary to add information to the instructions for use, as in the example below.
Prescription	intrathecal fentanyl 1000mcg+bupivicaine 40mcg + clonidine 100 mcg/ml
PIN	22123301
PharmaNet description	narcotic + non-narcotic intrathecal cpd: palliative
Directions in SIG field	No change in entry required. Enter usual directions for use.

Non-Benefit Compound Suspension Example

Non-Benefit Compound Suspension Example
Non-benefit compound PINs are not drug/dosage form-specific. To ensure the dose and concentration are visible to other PharmaNet users, enter them as outlined in the example below.
Prescription	zaleplon 5 mg (in suspension) once daily
PIN	66123252
PharmaNet description	non-benefit compound
Directions in SIG field	zaleplon - take 5 mL (5 mg) once daily
NON-BENEFIT DERMATOLOGIC COMPOUND EXAMPLE
Non-benefit compound PINs are not drug/dosage form-specific. To ensure the dose and concentration are visible to other PharmaNet users, enter them as outlined in the example below.
Prescription	diclofenac 10% topical, apply to affected area BID
PIN	66123252
PharmaNet description	non-benefit compound
Directions in SIG field	diclofenac 10% Apply to affected area twice daily

How to submit same-day/same-PHN compound prescriptions

If a pharmacy submits multiple claims for compounded prescriptions on the same day, using the same PIN for different preparations for the same PHN, PharmaNet cannot determine that they are separate prescriptions and will reject them.

To prevent rejection of multiple legitimate same-day/same-PHN claims for compounds, submit the claim with the intervention code UF - Patient Gave Adequate Explanation. Rx filled as written.

For benefit compounds

Pharmacies must document the following information and retain it on file with the original prescription:

• The compound description and the final volume/quantity being dispensed per fill; and
• Each compound ingredient, including the concentration, dosage form, quantity and cost (compounds using a pharmacy-prepared stock solution require the cost breakdown record to be  attached to the compound breakdown) ; and
• The total supply and equipment costs, itemized; and
• The compounding fee; and
• The details of the patient’s eligibility for compound coverage, as per the Compounded Prescriptions policy

This required information may be recorded on the prescription or on a separate document attached to the prescription. The Compound Costing Worksheet (HLTH 5425) (PDF, 521KB) may be used for this purpose.

If costs change for a refill of a benefit or Special Authority–approved compound, pharmacies must complete and retain a new Compound Costing Worksheet with all of the information above.

For compounds requiring Special Authority

Pharmacies must retain a copy of the approved costing worksheet. If costs change for any reason, a new costing sheet must also be retained.