Safety IQ: New Resources for Discovery and Disclosure of a Medication Incident
Discovering medication incidents and disclosing them to patients can be difficult. Written policies and procedures, training and resources enable pharmacy staff to handle the situation in an open and compassionate manner.
The Medication Incident and Discrepancies or Near-Miss Events Practice Direction outlines the steps pharmacists must follow when a medication incident occurs in their pharmacy as well as the disclosure process to the patient, agent or loved one. The new Safety IQ Quick Guide: Responding to an Incident gives an overview of the discovery, disclosure and learning process when an incident occurs.
The proper disclosure of a medication incident can contribute many benefits to patients, loved ones, and the pharmacy professionals involved, including:
- Building a culture of safety through open, honest, and effective communication
- Healing for the patient and/or family and pharmacy professionals involved in the incident
- Learning from mistakes to prevent recurrence through patient and pharmacy professionals’ input
The College developed a patient safety resource called Safety Improvement in Quality: Facts for Patients and the Public. This resource includes:
- Information on Safety IQ
- What to do if a patient suspects a medication incident
- What happens in a community pharmacy after an incident
- How does a pharmacy learn and improve after an incident
- How patients can keep safe while using medications
Pharmacy staff can use this tool during incident disclosure to help patients (or their agents or loved ones) understand Safety IQ and the process your pharmacy uses to manage medication incidents and prevent recurrence.
For more comprehensive information on Safety IQ and disclosure procedures, please refer to the Guide to Safety IQ and the Community Pharmacy Safety Culture Toolkit.
Keeping Your Pharmacy’s Information Current with the College
Pharmacy managers and owners are reminded of the importance of providing the College with updated relevant and required information. Promptly notifying the College of changes in pharmacy contact information or operations is a requirement of the Pharmaceutical Act and Regulation. This notification of changes assists the College in fulfilling its mandate of protecting the public by ensuring the College’s public pharmacy register as posted on the website is accurate and up to date.
Although this is not an exhaustive list, some examples of pharmacy information that must be kept current with the College are the following:
Ownership
Within seven days of an ownership change, you must submit the following to the College via mail, fax, or in-person to maintain the pharmacy’s licence:
- An Existing Community Pharmacy Licence Application or Existing Hospital Pharmacy Licence Application (if the owner is not a member of the College, we require an original ink signature)
- A copy of the articles of incorporation from the new owner
- The current licence (front and back, which are found on the Pharmacy Manager’s homepage) with the appropriate sections on the back completed
- The fee as stated on the bottom of the licence application. If paying by credit card, once the licence is received, the manager will be provided an invoice to pay online through their new manager profile.
Pharmacy manager
Within seven days of manager change you must submit the following to the College to maintain the pharmacy’s licence:
- The current licence (both front and back which are found on the pharmacy manager’s homepage) with the appropriate section on the back completed, signed, and dated by both the outgoing and incoming pharmacy manager (returned with original ink signatures)
- The fee as stated on the back of the licence. If paying by credit card, once the licence is received, the new manager will be provided an invoice to pay online through their new manager profile.
- The outgoing and incoming managers must complete a narcotic inventory count as outlined in the Narcotic and Controlled Drug Accountability Guidelines. This inventory count paperwork is to be maintained in the pharmacy records/files and easily retrievable for audit purposes. This is NOT to be submitted to the College.
Pharmacy Relocation
- The following is to be submitted to the College to maintain the pharmacy’s licence:
- The current licence (both front and back) with the appropriate section on the back completed indicating the new location’s address.
- The fee as stated on the back of the licence. If paying by credit card, once the licence is received, the manager will be provided an invoice to pay online through their manager profile.
- An inspection is required and must be arranged with Field Operations in advance.
Pharmacy Closure (Temporary or Permanent)
- The procedure outlined in the Permanent and Temporary Pharmacy Closure Practice Direction and Checklist must be followed
Pharmacy Renovation
- Describe the proposed renovation via email to info@cphm.ca with the subject line attention Field Operations
- This must occur if the pharmacy facilities are renovated or changed in a substantial way.
- An inspection is required and must be arranged with Field Operations in advance.
Pharmacy Staff (pharmacists, pharmacy students, or technicians)
- Through the pharmacy’s manager profile on the College website.
Pharmacy Hours
- Through the pharmacy’s manager profile on the College website.
Phone or Fax Number
- Through the pharmacy’s manager profile on the College website.
Primary Pharmacy Email Address
- Via email to info@cphm.ca
- Please note that the pharmacy’s primary email should not appear to be a personal email address. This email address should be monitored by the pharmacy manager
Pharmacy Website
- Via email info@cphm.ca.
- Please note that the main website used by a pharmacy will be subject to review by Field Operations for compliance.
Your prompt attention and assistance in maintaining current pharmacy profiles/registers is greatly appreciated.
Oxycodone Controlled Release Formulations
Oxycodone is an opioid analgesic that is available in immediate or controlled release formulations. Like all opioids, oxycodone is a potential drug of abuse and misuse. The potential risk of overdose and death highlight the importance of careful monitoring and interprofessional collaboration between the prescriber and pharmacist.
Currently controlled release oxycodone is available as the brand name product OxyNEO or other generic controlled release products. OxyNEO and generic oxycodone CR are not listed as interchangeable on the Manitoba Drug Interchangeability Formulary. OxyNEO is a controlled release tablet with tamper resistance properties. OxyNEO tablets are resistant to crushing and form a thick gel like substance when added to water, making the product more difficult to misuse or abuse by intranasal and intravenous routes of administration. The generic controlled release oxycodone products do not have tamper resistant properties. While the tamper resistant properties of OxyNEO do not eliminate the potential for misuse or affect the formation of tolerance and physiological dependence to oxycodone, they do create additional barriers against the abuse of the drug and reduce the drug’s street value on the illicit market.
When filling a prescription for generic oxycodone CR pharmacists are reminded of their responsibility under the Pharmaceutical Regulations section 83 (i), Ensuring patient safety:
83 Subject to any practice directions, a member must review each prescription and the patient’s record and take appropriate action if necessary with respect to
(i) a drug that has not been prescribed consistent with standards of care and patient safety
Because the generic product lacks the tamper resistant safeguards present in the OxyNEO formulation there are significant patient safety concerns with generic oxycodone CR. As such, prior to dispensing generic oxycodone CR, pharmacists in collaboration with the patient and the prescriber, must take appropriate action to ensure patient safety. Pharmacists are encouraged to review the Ensuring Patient Safety Practice Direction. All interventions, the rationale for the action(s) taken and the outcome should be thoroughly documented and auditable. In short term instances where OxyNEO is currently not an option, such as a drug shortage, the need for generic oxycodone should be re-evaluated on an ongoing basis.
References
OxyNEO product monograph
http://purdue.ca/wp-content/uploads/2018/02/Oxyneo-PM-EN.pdf
Apo-Oxycodone CR product monograph
https://pdf.hres.ca/dpd_pm/00047062.PDF
Pharmacists’ Authority to Administer Drugs and Vaccines Through an Advanced Method
Please be reminded that a prescription is required from an ‘authorized practitioner’ for any drug or vaccine (regardless of its scheduling status on the NAPRA National Drug Schedules) to be administered by a pharmacist through an advanced method (e.g., injection). Pharmacists are not considered authorized practitioners according to the federal legislation (only medical practitioners, dentists and nurse practitioners are included). Therefore, although pharmacists can prescribe NAPRA Schedule II and III products, pharmacists cannot administer a vaccine or drug that they themselves have prescribed, or was prescribed by another pharmacist.
However, under the Manitoba provincial immunization program, pharmacists can administer the following five vaccines, listed in Schedule 2 to the Pharmaceutical Regulation, without a prescription and free of charge to patients who meet the provincial eligibility criteria and are at least 7 years of age:
- Human papillomavirus (HPV) vaccine
- Influenza vaccine (regular dose or high dose)
- Pneumococcal polysaccharide (Pneu-P-23) vaccine
- Tetanus-diphtheria-acellular pertussis (Tdap) vaccine
- Tetanus-diphtheria (Td) vaccine
For clarification, NAPRA Schedule II, and Schedule 2 to the Pharmaceutical Regulation, are not the same. NAPRA Schedule II are non-prescription products sold from the dispensary by pharmacists. Schedule 2 to the Pharmaceutical Regulation are publicly funded vaccines that do not require a prescription to be administered by a pharmacist through an advanced method.
Professional Development Opportunities & Events
Pharmacists Manitoba Fall Conference
September 18, 2021
View the full program and register here.
ISMP Medications Safety Considerations for Compliance Packaging E-learning Module
Complete the module here.
Community Connectors Workshops
For a list of accredited workshops and dates, click here.
Opioid Agonist Therapy 101 Introduction to Clinical Practice
September 23 and 24 2021 Killarney MB
Register here.