Guidance for pharmacy teams: Community Based Naloxone Program

Providing Take Home Naloxone Kits (THN) as an Unscheduled Drug (updated February 2018)

Background

Naloxone is an opioid antagonist that temporarily prevents or reverses the effects of opioids, including respiratory depression, sedation, and hypotension. In the absence of opioids, it exhibits essentially no pharmacologic activity. Naloxone is indicated for the complete or partial reversal of opioid depression, including respiratory depression induced by opioids and for the diagnosis of suspected acute opioid over-dosage. The only contraindication to the use of naloxone is in patients known to be hypersensitive to it and even then, the benefits of use often outweigh the risks. Naloxone cannot be abused and it does not increase the likelihood of overdose or of increased drug consumption.

In response to an increasing number of deaths in Alberta associated with opioid overdose, Alberta Health (AH) and Alberta Health Services (AHS) have implemented Alberta’s Community Based Naloxone Program. The Program facilitates the provision of THN kits at no charge to Albertans who are at risk of opioid overdose or who may encounter others who have overdosed. Overdoses occur in individuals who use opioid medications prescribed by a practitioner as well as in those who use opioids for non-medical reasons. THN kits contain vials of Naloxone, syringes, alcohol swabs, latex gloves, and a one-way rescue breathing mask. Since January 2016, pharmacists who have completed the Take Home Naloxone - Information for Pharmacists training program provided by the Alberta Pharmacists’ Association have participated in the provincially funded Community Based Naloxone Program.  

In an effort to improve access for vulnerable populations, effective February 6, 2017, naloxone for use in emergency treatment of opioid overdose outside of a hospital setting was removed from Schedule 2 and is now unscheduled in Alberta.

Despite being an unscheduled product, THN requires training for proper use and the THN kits must be kept in the dispensary. ACP Standards of Practice and the Code of Ethics set expectations including: to provide drugs, non- prescription medications or health related products that are from safe, proven sources; to seek cost-effective therapies that ensure quality care; and to safeguard the well-being of each patient, and, in particular, any patient who is vulnerable. Naloxone is a safe and effective antidote to opioid overdose and it is very unlikely that it would not be appropriate to provide a THN kit to someone who requests it.

While providing an intramuscular injection is a restricted activity, the training required for self-administration is not. Therefore, ACP Council has determined that, after completing appropriate education, THN kits may now be provided in pharmacies by pharmacists, pharmacy technicians, and pharmacy assistants.

The following guidance is based on ACP Standards of Practice for Pharmacists and Pharmacy Technicians, Standards for the Operation of Licensed Pharmacies, and our Code of Ethics. This guidance notwithstanding, pharmacy professionals must always use their professional judgement when dealing with each unique individual and each situation, and provide care accordingly.

 


Guidance in Providing Take Home Naloxone Kits

  1. Pharmacy team members who provide a Take Home Naloxone kit must have adequate training to effectively educate the individual receiving the kit. 
  2. Pharmacy team members must respect the autonomy, privacy, and dignity of each individual requesting a Take Home Naloxone kit.
  3. Pharmacy team members must ensure the individual being provided the Take Home Naloxone kit has sufficient information to enable them to receive the intended benefit of the drug therapy.
    • When a Take Home Naloxone kit is provided to an individual for the first time, a trained pharmacy team member should make every effort to enter into a dialogue with that person.  
  4. A pharmacy team member who provides a Take Home Naloxone kit must record the activity.
  5. Pharmacy team members must identify when it is appropriate to refer an individual requesting a Take Home Naloxone kit to the pharmacist, another healthcare provider, or a harm reduction agency.
  6. Pharmacists should consider circumstances when it is appropriate to offer to provide an individual a Take Home Naloxone kit.

Additional information for pharmacy teams on interpreting this guidance includes, but is not limited to, the points outlined below.  


Additional Interpretation:

1. Pharmacy team members who provide a Take Home Naloxone Kit must have adequate training to effectively educate the individual requesting the kit.

  • The licensee should ensure that each team member providing a THN kit has completed the appropriate education and training required. 
  • The licensee should implement a process to supervise and monitor each team member and be confident in the abilities of the team member to competently deliver that service.
  • The licensee should ensure that all team members consistently adhere to the relevant Standards of Practice and the Code of Ethics when providing THN kits

2. Pharmacy team members must respect the autonomy, privacy, and dignity of each individual requesting a Take Home Naloxone kit.

  • The licensee should ensure that all pharmacy team members:
    • understand and apply the principles of harm reduction;
    • protect each individual’s privacy during any consultation, seek only information that is necessary and aligns with the individual’s treatment goals;
    • treat individuals requesting a THN kit in a non-judgmental manner that does not stigmatize or discriminate against them; and
    • respect the right of an individual to accept or reject any treatment, care or other professional services.

3. A pharmacy team member must ensure the individual requesting a Take Home Naloxone kit has sufficient knowledge to receive the intended benefit of the drug therapy. When a kit is provided to a person for the first time, a pharmacy team member must make every effort to enter into a dialogue with that person.

  • As outlined in the training for participation in the Alberta Health Services Overdose Response program, important information when providing a THN kit includes, but is not limited to
    • how to identify an opioid overdose;
    • the importance of rescue breathing;
    • when to administer naloxone;
    • how to prepare the dose for administration by withdrawing the dose from the vial;
    • how to landmark on the thigh and administer an intramuscular injection;
    • when to use the second and third vial of naloxone; and
    • the importance of calling 911 for medical assistance due to the short half-life of the drug.
  • When a THN kit is provided for the first time, the pharmacy team member should make every effort to enter into a dialogue with the individual.
    • education from a trained pharmacy team member is important to ensure effective and safe use of the THN kit; and
    • written information should not replace a dialogue when possible but can be considered as a last resort if the individual refuses to accept training; and
    • unwillingness to accept training should not result in a refusal to provide a THN kit.

4. A pharmacist team member who provides a Take Home Naloxone Kit must record the activity

  • Providing a THN kit does not require the pharmacy team member to collect or document any personally identifying information, and this should not be required or documented unless the individual requests it.
  • A pharmacy team member should ensure an appropriate entry is made indicating that a THN kit was provided, the date, and the identification of the pharmacy team member who provided it.
  • Documentation and record keeping shall be consistent with relevant public policy.

5. Pharmacy team members must identify when it is appropriate to refer an individual requesting a Take Home Naloxone Kit to the pharmacist, another healthcare provider, or a harm reduction agency.

  • A pharmacist should be available and accessible to a person who wishes to obtain a THN kit in a pharmacy.
  • Team members who are not regulated should be given clear direction, by the licensee, about the scope of their role and the limitations of their role within the pharmacy.
  • Pharmacy technicians and assistants should identify when it is appropriate to refer an individual receiving a THN kit to a pharmacist. This includes, but is not limited to, when an individual
    • requests a dialogue with a pharmacist;
    • has a history of hypersensitivity to naloxone;
    • has questions that require therapeutic knowledge, clinical analysis, or assessment; or
    • if any of the criteria listed in point #6 below are identified.
  • Pharmacy team members who provide THN should be familiar with harm reduction agencies and resources in their area and can direct individuals to contact Alberta Health Link at 811 or the AHS 24 Hour Addictions Helpline (1-866-332-2322).

6. Pharmacists should consider circumstances when it may be appropriate to offer to provide a Take Home Naloxone kit to individuals they determine to be at risk of an overdose. 

  • In addition to requests from individuals for a THN kit, pharmacists should consider offering to provide a THN kit to individuals who through their assessment, they have identified may be at risk. This includes, but is not limited to, individuals
    • using chronic opioid therapy,
    • receiving large quantities or high doses of opioid medications,
    • with a history of overdose,
    • being actively treated for addiction,
    • with a history of addiction, and/or
    • determined to be at risk of addiction or misuse.

Provincial Program Policy

The provincial program policies continue to evolve and the information provided below may be subject to change.  Licensees and pharmacy team members involved in providing THN should regularly review Alberta Blue Cross Benefacts and communications from the Alberta Pharmacists’ Association for policy updates.

  • Rules and information on ordering, billing, and provision of the THN through the provincial program can be found in Benefact #575 January 2016; Benefact #612 May 2016; Benefact #672 February 2017; and Benefact #715 December 2017. 
  • The pharmacist should create a record indicating that a THN kit was provided to an unknown patient, the date, and the identification of the pharmacist who provided the kit. (see Benefact #715 for information regarding the use of a pseudo PHN for unknown patients)

Individuals representing groups or organizations and requesting more than one THN kit at a time should be referred to Alberta Health Services at naloxone.kit@ahs.ca. First Responders and Police and Peace Officers should be directed to AHS: drugsafe.ca (previously stopODs.ca)

As a result of the provincial polices, ACP does not currently support the sale of injectable Naloxone to individuals outside of the provincial program


References and Additional Resources

  1. ACP; Code of Ethics https://pharmacists.ab.ca/code-ethics   

 

  1. ACP; Standards of Practice for Pharmacists and Pharmacy Technicians;  https://pharmacists.ab.ca/standards-practice  

 

  1. ACP; Standards for the Operation of Licensed Pharmacies;  https://pharmacists.ab.ca/sites/default/files/StandardsPharmacies_May2014.pdf

 

  1. Alberta Blue Cross; Benefact Number 715 December 2017; https://www.ab.bluecross.ca/pdfs/pharmacy-benefacts/pharmacy-benefact-715.pdf

 

  1. Alberta Blue Cross; Benefact Number 672 February 2017;
    https://www.rxa.ca/media/449170/Benefact_201702_672.pdf

 

  1. Alberta Blue Cross; Benefact Number 612 May 2016; https://www.rxa.ca/media/382727/BENEFACT612.pdf

 

  1. Alberta Blue Cross; Benefact Number 575 January 2016; https://www.ab.bluecross.ca/pdfs/pharmacy-benefacts/pharmacy-benefact-575.pdf

 

  1. Alberta Health Services; Drug Safe; www.drugsafe.ca (previously www.stopODs.ca)

 

  1. Alberta Health Services; Assessing Mature Minors; http://www.albertahealthservices.ca/assets/healthinfo/mh/hi-amh-thn-mature-minor-assessment-prescribing-and-dispensing.pdf

 

  1. Alberta Pharmacists’ Association; Take Home Naloxone – Information for the Pharmacist;  https://www.rxa.ca/professional-development/thn-program.aspx

 

  1. Alberta Health Services; SAVE ME Patient Poster; http://www.albertahealthservices.ca/assets/healthinfo/mh/hi-amh-save-me.pdf

 

  1.  Alberta Health Services; Patient Information Sheet; http://www.albertahealthservices.ca/assets/healthinfo/mh/hi-amh-thn-presentation-for-clients.pdf

 

  1. Alberta Health Services; Naloxone Information Sheet; http://www.albertahealthservices.ca/assets/healthinfo/mh/hi-amh-naloxone-drug-information-sheet.pdf

 

  1. Omega Laboratories Ltd.; Product Monograph Naloxone Hydrochloride Injection USP; September, 2012;   http://www.omegalaboratory.com/index.php/download_file/view/2153/327/