Dispensing Paxlovid and monitoring adverse drug events: A guide for B.C. pharmacists

Page last updated: June 27, 2022

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Contents: Informational videos |  Background | Dispensing and clinical assessment PAX-A fee | Procedures for follow-up and PAX-F fee | Suggested follow-up questions | Classification of ADE severity | Appendix A: Coding table | Appendix B: Sample form | Appendix C: Optional Prescriber Communication Form | Appendix D: Resources | Appendix E: FAQs


Informational videos

Part 1: Overview, Evidence and Dosing
 

Paxlovid video #1

This video provides an overview of nirmatrelvir/ritonavir (Paxlovid) and reviews clinical considerations that support treatment decisions.

Part 2: Drug Interactions
 

Paxlovid video #2

This video reviews drug-drug interactions, drug interaction management strategies and resources for nirmatrelvir/ritonavir (Paxlovid).

Part 3: Procedure Information for Pharmacists

Paxlovid video #3

This video reviews procedures regarding dispensing, counselling, follow-up, adverse reaction reporting and resources for nirmatrelvir/ritonavir (Paxlovid).

If you prefer a live session, your group may book a live information session with time for a Q&A with a pharmacist:

  • For Paxlovid evidence, dosing and drug interaction education session with a Provincial Academic Detailing (PAD) pharmacist (30-60 mins), please email PAD@gov.bc.ca.
  • For Paxlovid dispensing, counselling and follow-up procedures with a Ministry of Health pharmacist (15-30 mins), please email PCI@gov.bc.ca.

Please include the following information in your request:

  • Two or three preferred dates and times
  • Approximate number of attendees (max. is 99, small groups preferred)
  • Name of your business/group and type of practice setting. This will assist in tailoring information to your groups needs
  • Email and phone number of contact person

Background

Nirmatrelvir/ritonavir (Paxlovid™) is an oral antiviral drug used to treat mild-to-moderate COVID-19 in adults who do not require hospitalization and are at high risk of progressing to serious illness. It is new to the market, and information about its safety and effectiveness is limited. The use of Paxlovid is further complicated by the large number of clinically important drug-drug interactions.

Given their close relationship with patients, community pharmacists are well-positioned to provide follow-up and monitor patients for potential adverse drug events (ADEs).

Documentation, follow-up, and entering the correct information in the SIG in PharmaNet are important. Documentation ensures that the information shared with other members of the patient’s healthcare team is accurate. Follow-up and appropriate coding contribute valuable information for evaluation purposes.


Dispensing and Clinical Assessment Fee (PAX-A) *NEW June 13, 2022*

Like other prescription drugs, nirmatrelvir/ritonavir (Paxlovid™) must be dispensed in accordance with the College of Pharmacists of BC’s Community Standards of Practice, including but not limited to patient identification, review of PharmaNet, documentation and counselling. When dispensing Paxlovid, pharmacists should ensure they have the knowledge, skills and abilities to do so. Pharmacists are reminded that every prescription must be reviewed for completeness and appropriateness, and to review patient personal health information for drug therapy problems, therapeutic duplications and any other potential problems.

As of March 1, 2022, all pharmacies will be able to order publicly funded Paxlovid from their regular distributor. Consider carrying adequate Paxlovid courses in order to reduce treatment delays, as patients need to start treatment within 5 days of symptom onset.

Exceptional Plan Z coverage of Paxlovid is available for any patient receiving treatment in B.C.. They may be in the wait period for MSP, or they may live in a different province or country.

In PharmaNet, enter:

  • Drug cost: $0.01 per pack
  • Dispensing fee: $10 maximum
  • Quantity: 1 pack (containing 30 tablets)

Some local systems may not yet be correctly configured for these claims. Please double-check your local system settings when first entering a claim for Paxlovid, and before reporting issues to the PharmaNet Help Desk.

The Full Payment Policy applies to Paxlovid since it is under Plan Z (Assurance Plan), which provides 100% paid coverage. Providers may not charge patients any costs associated with the dispense of Plan Z products.

newClinical Assessment (PAX-A)

As of June 13, 2022, pharmacists dispensing Paxlovid are eligible to claim a temporary $30 clinical assessment fee (PAX-A), in addition to the standard dispensing fee. Pharmacists are eligible to claim a PAX-A fee after assessment of the Paxlovid prescription, including completion of a drug-drug interaction (DDI) check with two independent sources, even if no drug therapy problem is identified.

Document and communicate with the prescriber, as needed, following usual pharmacy procedures or systems already in place. No additional documentation is required to claim the PAX-A fee, however an optional prescriber communication form is available in Appendix C.

The PAX-A fee must be submitted the same day as the Paxlovid claim from the same pharmacy. Only one fee can be claimed per treatment course.

Required activities

  • Assess the Paxlovid prescription for completeness and appropriateness
  • Include *DDI* or *Renal* in the SIG for the Paxlovid dispense as needed
  • Communicate with the prescriber as needed to resolve drug therapy problems, including any DDIs, recommended management plans
    • An optional form in Appendix C may be used to document DDIs and associated management plans but is not required.
  • Submit the PAX-A claim the same day as the Paxlovid claim using PIN 66128340

Procedure

  1. Enter the PAX-A PIN 66128340 in the DIN/PIN field
  2. If necessary, enter $0 for drug cost, mark-up and fee
  3. Enter 1 in the QTY field
  4. In the PRACT ID Ref field, enter P1 – College of Pharmacists of BC
  5. In the PRACT ID field, enter your College ID
  6. At start of SIG, type the 10-digit phone number of the pharmacy where the service took place

Refusal to Fill

It is recommended to ask the prescriber for a Paxlovid prescription so that a Refusal to Fill fee can be claimed if a Pharmacist determines it is inappropriate or unsafe to dispense Paxlovid after the clinical assessment. When submitting a Refusal to Fill claim, document with the appropriate intervention code (such as ‘CI- Significant Drug Interaction (Drug-to-Drug)’) to communicate to others in the patients circle of care that an assessment has been done but the drug has not been dispensed. Patients who are not dispensed Paxlovid are not eligible for a PAX-A fee. 

Refusal to Fill

It is recommended to ask the prescriber for a Paxlovid prescription so that a Refusal to Fill fee can be claimed if a Pharmacist determines it is inappropriate or unsafe to dispense Paxlovid after the clinical assessment. When submitting a Refusal to Fill claim, document with the appropriate intervention code (such as ‘CI- Significant Drug Interaction (Drug-to-Drug)’) to communicate to others in the patients circle of care that an assessment has been done but the drug has not been dispensed. Patients who are not dispensed Paxlovid are not eligible for a PAX-A fee. 

Counselling

  • Provide them with a copy of BCCDC’s Paxlovid™ Patient Information sheet
  • Discuss any drug interaction management plans, and adjustments to other medications, as necessary
  • Inform them that a pharmacist will call them 6 to 10 days after their treatment started for follow-up
  • Advise them to contact the pharmacy if they experience adverse events or worsening of condition
  • Advise them to contact 911 if symptoms worsen

For more information about patient eligibility, please consult BCCDC’s Practice Tool #4.

Patient requiring renal dose adjustments (renal)

Renal dose adjustments are required for patients with an eGFR 30-59 mL/min. Paxlovid is contraindicated in those with an eGFR < 30 mL/min. Pharmacies may now register for CareConnect access to view lab results; refer to PharmaCare Newsletter 21-007 for details.

Enter “renal” at the beginning of the SIG to indicate that the dose has been adjusted.Remove 1 nirmatrelvir 150 mg (pink tablet) from the morning dose and the evening dose on each daily card (circled in red below) and discard.

  • Example: “*Renal* Take 2 tablets in the morning and 2 tablets at night for 5 days”

If the patient has renal dose adjustments, as well as DDI(s), enter “renal” and “DDI” at beginning of the SIG.

  • Example: “*DDI* *Renal* Take 2 tablets in the morning and 2 tablets at night for 5 days”

Remove 1 nirmatrelvir 150 mg (pink tablet) from the morning dose and the evening dose on each daily card (circled in red) and discard. Enter the full pack size under Quantity.

Patient with drug-drug interactions (DDI)

Paxlovid has many drug-drug interactions. As this is a new drug, it is recommended to check more than 1 interaction checker before dispensing. Examples include BCCDC’s Practice Tool # 3, Lexicomp and University of Liverpool’s interaction checker.

Enter “DDI” in PharmaNet at the beginning of the SIG field to indicate DDI(s) and associated management plans

  • Example: “*DDI* Take 3 tablets in the morning and 3 tablets at night for 5 days”

Direct oral anticoagulant (DOAC) drug-drug interaction

For patients being switched to dabigatran for 8-10 days while on Paxlovid, there is an auto-adjudicated/accelerated Special Authority process available. Please consult BCCDC’s Practice Tool #3 for steps.


Follow-up (PAX-F)

Claiming the PAX-F Fee  *new June 13, 2022*

Pharmacists can claim the temporary $25 PAX-F Clinical Service Fee for follow-up and monitoring of patients who receive Paxlovid from their pharmacy (maximum 1 PAX-F claim per Paxlovid course). The PAX-F Fee is a PharmaCare patient support fee, paid as a related service under Plan M. Plan M services are fully covered and subject to the Full Payment Policy. Providers may not charge patients any costs for a related service that is a benefit under Plan M. A future edition of the PharmaCare Newsletter will announce when the fee ends.

Follow up with the patient and bill on day 6 to day 10 after the date of dispensing. For patients residing in assisted living or long-term care facilities, follow up with the patient's caregiver or nursing staff.

If you are unable to contact the patient or caregiver after 3 attempts, or if the patient has passed away between the time of dispensing Paxlovid and the date of follow-up, please document as normal in your local system. No additional documentation is required in PharmaNet, and a PAX-F fee cannot be claimed.

Required activities

  1. Contact the patient or caregiver 6 to 10 days after the date of dispense
  2. Conduct follow-up questions with the patient as necessary (see suggested questions below)
  3. Submit the PAX-F claim with additional information in the SIG field using the coding tool in Appendix A, starting with the pharmacy’s phone number.
    1. The SIG will include days of therapy completed, reason for stopping early (if applicable), and the severity of each ADE, but not the type of ADE (e.g., nausea)
    2. While local software may allow entry of more than 80 characters, PharmaNet will only display the first 80 characters entered
  4. If a moderate or severe ADE has been identified, record in the Adverse Reaction field in PharmaNet

Procedure

  1. Enter the PIN: 66128313 for PAX-F in the DIN/PIN field.
  2. Enter the pharmacist in the Prescriber field with P1 and pharmacist college ID #.
  3. If necessary, enter $0 for drug cost, mark-up, and fee.

Recording moderate and severe ADEs to the Adverse Reaction field in PharmaNet

Any ADE that causes a patient to discontinue Paxlovid should be classified as moderate or severe. All ADEs identified as moderate or severe are required to be entered into the Adverse Reaction field in PharmaNet. Report ADEs, as appropriate, to Health Canada's Adverse Reaction Reporting.

The Adverse Reaction field will capture the actual type of ADE (e.g., nausea, taste disturbances, rash). This field will be free text; however, please indicate if the ADE was severe (S) or moderate (Mod) after the type of ADE.

Procedure:

  1. In the Network tab, select “Add Adverse Reaction”
  2. Search for Paxlovid (DIN: 02524031)
  3. Enter all severe (S) and moderate (Mod) ADEs in the Comment field
    Example: “Heart palpitations (S), fainting (S), vomiting (Mod), nausea (Mod)”

Please note that some steps may differ depending on your local software vendor. Refer to your vendor for additional help for entering information into the Adverse Reaction field, as this may be different from entering the information in a patient’s profile in the local system.

Required documentation

  • All relevant information must be recorded in the SIG of the PAX-F claim using a coding system, following instructions in Appendix A
  • Moderate and severe ADEs must be recorded in the Adverse Reaction field in PharmaNet
  • Follow-up and additional clinical information may be documented separately, following usual pharmacy procedures, systems or forms already in place. A form in Appendix B may be used as a follow-up tool, but is not required

Suggested follow-up questions

  1. Ask the patient about their Covid-19 symptoms. Assess for worsening of symptoms. Refer patients to the prescriber, the patient’s family doctor or 911 depending on severity of symptoms.
  2. Assess treatment duration. Ask the patient if they completed the full 5-day course.
    • If not, how many days were completed? What was the reason for discontinuation (i.e., adverse effects, felt better, etc.)?
    • Did the patient miss any doses?
  3. Ask the patient if they experienced any adverse effects. If so:
    • Can the patient describe them?
    • When did the adverse effects occur?
    • How severe were/are they? Did they interfere with daily activities? Did they require treatment?
    • How have they been managed so far?
    • Has the patient spoken to a healthcare provider about them?

Note: The most reported side effects in the clinical trial were dysgeusia (taste disturbances) (5.6% vs. 0.3% placebo) and diarrhea (3.1% vs. 1.6% placebo).

  1. Ask the patient about their drug-drug interaction (DDI) management plan (if applicable) and reinforce any changes that were made.
    • Does the patient have a DDI management plan?
    • What was the follow-up plan suggested by the pharmacist or prescriber?
    • Did the patient have any problems adhering to the management plan?

Examples of management plans:

  • Interacting medication was stopped and will need to restart (e.g., lovastatin stopped)
  • Interacting medication dose was lowered and will need to be adjusted (e.g., zopiclone dose lowered)
  • Interacting medication was replaced by another medication (e.g., apixaban stopped and replaced by dabigatran)
  1. Remind the patient to follow all public health orders, even if feeling better.
  2. Ask about vaccination status and encourage initiation, completion of series, or booster doses, as appropriate. Reiterate that vaccination is currently the most effective pharmacologic measure to prevent COVID-19 infection.
  3. Ask any other relevant follow-up questions per your professional judgement.

Classification of ADE severity

  • Any ADE that causes a patient to discontinue Paxlovid should be classified as moderate or severe, and subsequently entered in the Adverse Reaction field in PharmaNet
  • A single ADE (such as nausea) can range from mild to severe. While it may be helpful to classify based on the impact it has on the patient’s daily activities (Mild: does not impact; Moderate: impacts or limits; and Severe: prevents), it may also be classified based on treatment required:
    • Mild (M) – no treatment or non-drug treatments (e.g., taking with food to reduce GI discomfort and nausea)
    • Moderate (Mod) – at home, or non-invasive treatment (e.g., taking dimenhydrinate 30 minutes before to reduce nausea)
    • Severe (S) – requires invasive treatment (e.g., admission to hospital for dehydration caused by intractable vomiting)
  • More information and examples are available in Appendix A

Appendix A: Coding table

Field Values What it means Definitions
Pharmacy Phone Number ###-###-#### Pharmacy phone number To facilitate information sharing when requested by other members of the patients’ healthcare team
Days Taken 0, 1, 2, 3, 4, 5 0 to 5 days Number of completed days of therapy
Stopped Early/Reason YA Yes – Adverse effects Stopped due to ADE
YP Yes – Patient choice Stopped due to patient choice (felt better/didn’t feel it was helping, etc.)
YHCP Yes – Healthcare Provider Stopped due to recommendation from a healthcare provider (could not manage drug interactions/other drug was deemed necessary to start, etc.)
NA Not stopped early – Adverse effects Not stopped early but the patient experiences adverse effects
NN Not stopped early – No Adverse effects Not stopped early and the patient did not experience any adverse effects
ADE # ADE1-ADE10 Which ADE are you recording? Enter 1 for the first ADE, 2 for the second ADE, etc. until 80 characters is reached. If no ADEs, do not enter anything after the previous step
ADE - Severity M Mild Bothersome but mild or transient discomfort. Does not limit or interfere with daily activities.
Mod Moderate Distinctly annoying, distressing or intolerable. Limits or interferes with daily activities.
S Severe May be life threatening, result in persistent or significant disability, or hospitalization. Prevents normal daily activities.
ADE – Management P Patient Patient managed/is managing ADE on their own with or without treatment
RPh Pharmacist Patient consulted a pharmacist for management
HCP Other healthcare provider Patient consulted or was referred to a HCP other than a pharmacist (811, physician, nurse, etc.) for management
H Hospital Patient went to hospital for management of ADE

Format

[Pharmacy Phone Number]_[Days taken (#0-5)]_[Stopped early & reason (YA, YP, YHCP, NA, NN)]_[ADE #, severity and management (ADE1-10, M/Mod/S, P/RPh/HCP/H)]
Format examples
Code What it means
604-358-9457_5_NN Patient completed all 5 days with no ADEs
604-358-9457_3_YP Patient took 3 days of medication and chose to discontinue the medication due to reasons other than ADEs
604-358-9457 _2_YA_ADE1SH_ADE2SH_ADE3SHCP Patient took 2 days of medication, stopped early due to ADEs, experienced 2 severe ADEs requiring hospitalization, and 1 severe ADE managed by a HCP other than a pharmacist
604-358-9457_ 5_NA_ADE1ModRPh_ADE2MP Patient took all 5 days, did not stop early though there were ADEs, experienced 1 moderate ADE managed by the pharmacist, and 1 mild ADE managed by the patient)

Important notes

  • Enter the information in order (phone number_days taken_stopped early and reason_ADE_severity_management)
  • Use underscores between fields so the responses can be grouped for evaluation
  • While hopefully rare, if you do not know or do not have a response for a field, enter X followed by an underscore to get to the next field
  • If patient did not experience any ADE(s), you can stop the SIG after “Treatment stopped early and reason”

The following explain the coding table fields in more detail:

Days taken

  • If the patient was dispensed nirmatrelvir/ritonavir and did not take it, enter 0 days
  • If the patient missed a dose but followed the missed dose protocol and completed the entire course, enter 5 days

Treatment stopped early and reason

  • If treatment was stopped early due to ADEs, regardless of who decided to stop it (patient or HCP), enter Yes – YA (Adverse Effects)
  • If treatment was stopped early for any reason other than ADEs, indicate who discontinued it, the patient or a HCP (YP or YHCP)
  • If the treatment was not stopped early (i.e., they completed the entire course), and the patient experienced adverse effects, enter NA (Not discontinued – Adverse effects). If the patient did not experience any adverse effects, enter NN (Not discontinued – No ADEs)

ADE #

  • ADEs will be entered as a generic ADE1[Severity][Management], ADE2[Severity][Management], ADE3[Severity][Management] format
  • You may enter multiple ADEs up to the 80-character limit
  • The type of ADE (e.g., nausea, diarrhea, rash) will not be entered here

ADE - severity

  • Any ADE that causes a patient to discontinue Paxlovid should be classified as moderate or severe, and subsequently entered in the Adverse Reaction field in PharmaNet
  • A single ADE (such as nausea) can range from mild to severe. While it may be helpful to classify based on the impact it has on the patient’s daily activities (Mild: does not impact; Moderate: impacts or limits; and Severe: prevents), it may also be classified according to the treatment required:
    • Mild (M) – no treatment or non-drug treatments (e.g., taking with food to reduce GI discomfort and nausea)
    • Moderate (Mod) – at home, or non-invasive treatment (e.g., taking dimenhydrinate 30 minutes before to reduce nausea)
    • Severe (S) – requires invasive treatment (e.g., admission to the hospital for dehydration caused by intractable vomiting)

ADE - management

Pharmacists are an integral part of a patient’s care team. Many mild and some moderate adverse effects can be managed by the pharmacist using non-drug measures and OTC treatments. To evaluate the effect of pharmacists on the management of these adverse effects, it is important to classify who managed the adverse effects.

  • If the patient managed on their own without consulting an HCP, and told you about it during follow-up, please enter P (Patient)
  • If the patient spoke to a pharmacist and received any kind of recommendation for the ADE other than referral to another HCP or hospital, enter RPh (Pharmacist)
  • If the patient spoke to or was referred to another HCP in regard to the ADE, enter HCP (Healthcare Provider)
  • If the patient went to the hospital or ER because of the ADE, enter H (Hospital)

Appendix B: Sample form

This form is an optional tool to guide counselling and follow-up. It will not be required documentation for receiving the PAX-F fee.

Nirmatrelvir/ritonavir (Paxlovid) Follow-up                    Date of follow-up:________________________

Patient Information
Patient Name
 
PHN
 
Date of Birth (YYYY/MM/DD)
 
Follow-up

Did patient complete the full 5-day course? [] Yes  [] No

If “No”, complete table below:

Start of Paxlovid
(YYYY/MM/DD) (e.g. 13:00)
Last dose taken
(YYYY/MM/DD) (e.g. 13:00)
Reason(s) for discontinuation
     

Any adverse drug reactions experienced: [] Yes  [] No

Description of adverse event or problem(s) Start of reaction
(YYYY/MM/DD) (e.g. 13:00)
Severity
(Mild, moderate, severe)
Self-limiting (Y/N)

End of reaction
(YYYY/MM/DD) (e.g. 13:00)
       
       
       

If not self-limiting, describe treatment and/or referral:
 

Hospitalization required: [] Yes  [] No

Drug-Drug Interaction Management Plan Adherence
If patient temporarily stopped or adjusted doses of chronic medication(s), describe the management plan and adherence:

 

Appendix C: Optional Prescriber Communication Form 

Click to download:

Optional prescriber communication form


Appendix D: Resources

COVID-19 Antiviral Support Line for Clinicians

Starting June 27, 2022, questions about prescribing and dispensing Paxlovid should be directed to the Ministry of Health’s phone line:

  • Monday to Friday, 8:30 am to 4:30 pm
  • 1-844-915-5005

When calling, please be ready to provide patient information and a call-back number. A pharmacist will respond as soon as possible to help with your question.

If additional support is needed to manage cancer patients or those on antiretrovirals, please contact program pharmacists for consultation.

BC Cancer:

  • 604-877-6000 x 67-2515 (voicemail only)
  • Monday to Friday, 8 am to 4 pm PST; weekends 9 am to 5 pm PST

St. Paul's Hospital Ambulatory Pharmacy (HIV):

  • 1-888-511-6222

Appendix E: FAQs

  1. Where can I find the Counselling Checklist for Pharmacists?
    Answer: In Practice Tool #4 on the BCCDC website
     
  2. Can I dispense Paxlovid to patients who are out of province or out of country?
    Answer: As of February 14, 2022, Exceptional Plan Z coverage of Paxlovid is available for any patient receiving treatment in B.C.. They may be in the wait period for MSP, or they may live in a different province or country.
     
  3. Can patients get more than one course of Paxlovid?
    Answer: Paxlovid is indicated to reduce the risk of hospitalization in patients with mild to moderate COVID-19 with symptom onset within 5 days. Treatment is for a total of 5 days. If a patient remains symptomatic after 5 days of treatment, another course of Paxlovid is not indicated. For patients previously treated with Paxlovid who are reinfected with COVID-19, there is no evidence to support an additional course of Paxlovid.