Reporting Obligations for Pharmacy Professionals

Log into the OCP online account portal within 30 days to update your:  

• Address and telephone number of your principal residence
• Preferred address, telephone number, and e-mail address for communications from the College 
• Details about each place of practice, inside or outside of Ontario
• Designated Practice Assessment (DPA) site¹ in Ontario  

Legislative reference(s) 

College’s By-Law No. 7 

Additional resources 

Practice Assessment 

New Non-Accredited Workplace form 

RegistrantServices @OCPInfo.com

¹A practice site in Ontario where a registrant provides patient care and their practice assessment takes place, which may be or may not be their primary place of practice.  

File a mandatory report to the Health and Supportive Care Providers Oversight Authority within 30 days if you have:  

• Reasonable grounds to believe a registered PSW has sexually abused a patient  

Legislative reference(s) 

Health Professions Procedural Code (Schedule 2 of the Regulated Health Professions Act, s. 85.1[b]) 

Additional resources 

Mandatory Reporting 

File a mandatory report to OCP by fax to 416-847-8499 or by email to [email protected] within 30 days if you have:  

• Reasonable grounds to believe a registrant has sexually abused a patient
• Terminated, revoked, suspended, or imposed restrictions on the privileges of a registrant for reasons of professional misconduct, incompetence, or incapacity
• A registrant employee who has resigned or voluntarily relinquished or restricted their practice for reasons of (or, during an investigation into allegations of) professional misconduct, incompetence, or incapacity
• Dissolved a partnership, health profession corporation, or association with a registrant for reasons of professional misconduct, incompetence, or incapacity 

Legislative reference(s) 

Health Professions Procedural Code (Schedule 2 of the Regulated Health Professions Act, s. 52[1], 85.1, 85.5)  

Additional resources 

Mandatory Reporting 

Fitness to Practice – What Does Incapacitated Mean

File a mandatory report to the regulatory body for the health professional being reported within 30 days if you:  

• Have reasonable grounds to believe that an RHP has sexually abused a patient
• Have terminated, revoked, suspended, or imposed restrictions on the privileges of an RHP for reasons of professional misconduct, incompetence, or incapacity
• Employ an RHP who has resigned, voluntarily relinquished or restricted their practice for reasons of (or, during an investigation into allegations of) professional misconduct, incompetence, or incapacity
• Have dissolved a partnership, health profession corporation or association with an RHP for reasons of professional misconduct, incompetence, or incapacity 

Legislative reference(s) 

Health Professions Procedural Code (Schedule 2 of the Regulated Health Professions Act, s. 85.1, 85.5) 

Additional resources 

Mandatory Reporting 

Health Profession Regulators of Ontario

File a report to the local police detachment or OPP within 24 hours upon discovery of:

• Unusual waste or disappearance of a Class A precursor that cannot be explained by normally accepted business practices 

Report to the minister of Health (Canada)² within 72 hours after discovery of:

• Theft of a Class A precursor set out in column 1 of the schedule, if in a package not intended for retail sale and the quantity exceeds the maximum quantity specified in column 2 of the schedule 

Legislative reference(s) 

Precursor Control Regulations under the Controlled Drugs and Substances Act s. 91.96   

Additional resources 

Reporting loss or theft of controlled substances or precursors 

[email protected]

¹Class A precursor means any substance set out in Part 1, and any preparation or mixture referred to in Part 3, of Schedule VI to the Controlled Drugs and Substances Act.

²Include confirmation that the police have been notified.

 

Report to the Minister of Health (Canada) within 10 days: 

• Any loss or theft of controlled substances¹ (including dispensed prescription forgeries)
• If you are moving/transporting/transferring a controlled substance from one pharmacy to another (e.g., due to a relocation or permanent closure) 

Legislative reference(s) 

Narcotic Control Regulations, s. 42, s. 45(3) 

Benzodiazepine and Other Targeted Substances Regulations, s. 56, s. 72(2) (cont.) 

Food and Drug Regulations, Part G, G.03.012, G.03.016 

Additional resources 

Controlled Substances: Reporting Loss or Theft 

Pharmacy Closing Statement  

Office of Controlled Substances

¹A drug named in the federal Controlled Drug and Substances Act (CDSA), Schedules I, II, III, IV, V. These drugs are also listed in the schedules to the regulations as narcotics, controlled drugs, benzodiazepines, and other targeted substances.

File a report to Health Canada (Canada Vigilance Program or MedEffect Canada) within 30 days about serious adverse drug reactions (ADRs)² involving therapeutic products regulated under the Food and Drugs Act such as:  

• Pharmaceuticals (e.g., prescription and non-prescription drugs; drugs released in response to an urgent public health need)
• Biologic drugs (i.e., biotechnology products, blood products with a Drug Identification Number, and vaccines – except those administered under Ontario’s routine immunization program)
• Radiopharmaceutical drugs 
• Hard surface disinfectants³ with a Drug Identification Number 

Legislative reference(s) 

Food and Drugs Act, s. 21.8  

Food and Drug Regulations, C.01.020.1 

Medical Devices Regulations 

File a report to Health Canada (Canada Vigilance Program or MedEffect Canada) within 30 days about a medical device incident (MDI)⁴ involving therapeutic products regulated under the Medical Device Regulations such as:  

• Hospital beds, wheelchairs, leg prostheses
• Infusion sets, syringes, tracheostomy tubes, urethral catheters
• Infusion pumps, anesthesia gas machines, intrauterine devices 
• Pacemakers, defibrillators, breast implants, bone grafts 

Legislative reference(s) 

Food and Drugs Act, s. 21.8  

Medical Devices Regulations 

Additional resources 

Overview of Vanessa’s Law and Mandatory Hospital Reporting Requirements 

Health Canada guidance document: Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals

¹Pharmacy professionals should follow the hospital’s procedures for reporting. Outpatient clinics that are legally part of the hospital are subject to these obligations even if they are physically separate from the hospital. Pharmacy professionals in other practice settings should report these events, as per the Standards of Operation for Pharmacies.
²“Serious adverse drug reaction” is defined as a “noxious and unintended response to a drug which occurs at any dose and requires in-patient hospitalization or prolongation of existing hospitalization, causes congenital malformation, results in persistent or significant disability or incapacity, is life-threatening, or results in death.”
³ “Disinfectant” is defined as “a substance, or mixture of substances, capable of destroying or irreversibly inactivating pathogenic (disease-causing) and potentially pathogenic (opportunistic) microorganisms, but not necessarily bacterial spores, present on environmental surfaces and inanimate objects due to the antimicrobial action of the active ingredient(s).”
⁴ “Medical device incident” is an incident related to a failure of a medical device or a deterioration in its effectiveness, or any inadequacy in its labelling or in its directions for use that has led to the death or a serious deterioration in the state of health of a patient, user, or other person, or could do so were it to recur.

File a report to the Ontario Drug Benefit program by email ([email protected]) as soon as possible after discovery about a prescription forgery for a monitored drug¹ including the following information: 

• The prescriber’s name, address, phone/fax number (cont.)
• The name(s) of the drug(s)  
• A copy of the prescription and any additional forged documents  

If any quantity of the fraudulent prescription was dispensed, refer to the section on incidents involving controlled substances. 

Legislative reference(s) 

Narcotics Safety and Awareness Act (NSAA) 

Ontario Regulation 381/11 – General 

Additional resources 

Management and Reporting of Fraudulent Prescriptions 
Tips for Identifying Fraudulent Prescriptions  
Executive Officer Notice: Forgery Notification Alerts 
Frequently asked questions

¹“Monitored drug” means a controlled substance as defined in the Controlled Drugs and Substances Act and any drug that is an opioid. 

Give written notice to the appropriate regulatory college within 30 days if, due to the unauthorized collection, use, disclosure, retention, or disposal of personal health information¹ (PHI), you have: 

• Terminated, suspended, or taken disciplinary action toward a regulated health professional
• Revoked, suspended or restricted privileges of, or affiliation with, a regulated health professional
• Reasonable grounds to believe a regulated health professional has resigned or relinquished or voluntarily restricted their privileges or affiliation with you due to an investigation or other action with respect to an alleged privacy breach 

Legislative reference(s) 

Personal Health Information Protection Act (PHIPA), s. 12(3), s. 17.1, s. 55.5(7)(b) 

Additional resources 

Health Profession Regulators of Ontario 

File a report with the Information and Privacy Commissioner of Ontario as soon as possible after discovery when: 

• Personal health information is lost or stolen, used, or disclosed without authority²
• Written notice is given to a regulatory college of an event that relates to a loss, unauthorized use or disclosure of personal health information by a healthcare professional  

Legislative reference(s) 

Ontario Regulation 329/04 – General under the Personal Health Information Protection Act, s. 6.3, s. 6.4, s. 18.3 

Additional resources 

Responding to a Health Privacy Breach – Guidelines for the Health Sector 

Reporting a Health Privacy Breach – Guidelines for the Health Sector 

Report a Privacy Breach 

File a report with the Information and Privacy Commissioner of Ontario at the Online Statistics Submission website annually, by March 1, if: 

• You have statistics of privacy breaches related to PHI within your custody from the previous calendar year  

Legislative reference(s) 

Ontario Regulation 329/04 – General under the Personal Health Information Protection Act, s. 6.3, s. 6.4, s. 18.3 

Additional resources 

Annual Reporting of Privacy Breach Statistics to the Commissioner  

Health Privacy Breach Statistical Report – FAQ – IPC

¹⁰As defined in the Personal Health Information Protection Act, s. 4.
¹¹This includes theft of physical and electronic health records, theft of a device containing records, and ransomware/malware attacks.

File a report Health Canada (Veterinary Antimicrobial Sales Reporting) annually, by March 31, on annual sales of compounded preparations for veterinary use containing: 

• Antimicrobial active pharmaceutical ingredients (API) on List A, even if sourced from a drug in dosage form and not the raw ingredient 

Legislative reference(s) 

Food and Drug Regulations, C.01.612 (1) 

Additional resources 

Guidance on veterinary antimicrobial sales reporting 

[email protected]  

File a self-reporting form to OCP (by fax to 416-847-8499 or email to Concerns@ OCPInfo.com) as soon as possible if you: 

• Have been charged with and/or found guilty of any offence¹ and any conditions of release (e.g., bail, restrictions)
• Have been the subject of a disciplinary finding or a finding of professional misconduct or incompetence² by another regulatory or licensing authority, in any jurisdiction
• Have had a civil court finding of professional negligence or malpractice (cont.)
• Are the subject of an investigation, review, or proceeding for professional misconduct, incompetence, or incapacity³ with respect to the practice of pharmacy or any other profession or occupation, in any jurisdiction
• Are the subject of a civil court proceeding in any jurisdiction with respect to the practice of pharmacy or any other profession or occupation
• Are a member of another body that governs a profession in any jurisdiction 
• Have failed to maintain personal professional liability insurance in Ontario
• Are no longer a citizen or permanent resident of Canada
• No longer have a valid work permit 

Legislative reference(s) 

Ontario Regulation 256/24, s. 9 under the Pharmacy Act 

Health Professions Procedural Code (Schedule 2 of the Regulated Health Professions Act, s. 85.6.1, 85.6.2, 85.6.3, 85.6.4) 

Ontario Regulation 261/18 under the Regulated Health Professions Act 

OCP By-Law No. 7 

Additional resources 

Self-Reporting 

Personal Professional Liability Insurance 

Canadian Citizenship or Legal Status in Canada 

Fitness to Practice – What Does Incapacitated Mean 

OCP Concerns: 1-800-220-1921, ext. 3800

¹An offence defined under the Criminal Code or the Controlled Drugs and Substances Act (CDSA) of Canada.
²When the panel of a discipline committee finds the registrant’s professional care of a patient displayed a lack of knowledge, skills, or judgment of a nature or to an extent that demonstrates that the registrant is unfit to continue to practice or that their practice should be restricted.
³Suffering from a physical or mental condition or disorder that makes it desirable in the interest of the public that the registrant’s certificate of registration be subject to terms,conditions, or limitations, or that the registrant no longer be permitted to practice. 

File a mandatory report to the Children’s Aid Society or Indigenous Child and Family Well-Being Agency as soon as possible if you have reasonable grounds to suspect that a child under the age of 16 years needs protection because: 

• They have suffered, or are at risk of suffering, physical harm inflicted by their caregiver¹ or resulting from that caregiver’s failure to adequately care for, provide for, supervise, or protect the child
• They have been sexually abused or exploited or are at risk for sexual abuse or exploitation, including child sex trafficking
• Their caregiver does not provide (or provide access or consent to) the service or treatment when they:
  • require treatment to cure, prevent, or alleviate physical harm or suffering
  • have suffered or are likely to suffer emotional harm² resulting from their caregiver’s actions, failure to act, or pattern of neglect
  • are younger than 12 years old and have killed or seriously injured another person or caused serious damage to another person’s property
  • suffer from a mental, emotional, or developmental condition that, if not remedied, could seriously impair their development
• They are younger than 12 years old and have more than once injured another person or caused loss or damage to another person’s property either with the caregiver’s encouragement or due to the caregiver’s failure or inability to supervise the child adequately
• Their parent has died or is unavailable to exercise their rights of, or has not made adequate provisions for, the child’s care and custody 
• They are in a residential placement and their parent refuses or is unable or unwilling to resume the child’s care and custody 

Legislative reference(s) 

Child Youth and Family Services Act (CYFSA), s. 74(2), s. 125 

Additional resources 

Yes, You Can. Dispelling the Myths About Sharing Information with Children’s Aid Societies 

Reporting Child Abuse and Neglect: It’s Your Duty

¹The Child, Youth and Family Services Act, 2017, does not define or differentiate between kinds of caregivers. The language used in the legislation is “parent” or “person having charge of the child.”
²Emotional harm can be demonstrated by serious anxiety, depression, withdrawal, self-destructive or aggressive behaviour, or delayed development.

File a mandatory report to the director of the long-term care home as soon as possible if you are an employee of the home or of their pharmacy service provider² and have reasonable grounds to suspect that any of the following has occurred or may occur: 

• Improper or incompetent treatment or care that resulted in harm or a risk of harm to the resident
• Abuse of a resident by anybody or neglect by the licensee or staff that resulted in harm or a risk of harm to the resident
• Unlawful conduct that resulted in harm or a risk of harm to a resident 
• Misuse or misappropriation of a resident’s money 
• Misuse or misappropriation of funding provided to a licensee  

Legislative reference(s) 

Fixing Long-Term Care Act (FLTCA), s. 28 

Additional resources 

Long-Term Care Home Complaint Process 

Elder Abuse Prevention Ontario – Reporting  

OntarioHealthAtHome.ca

¹“Long-term care home” means a place licensed as a long-term care home under the FLTCA, and includes a municipal home, joint home or First Nations home approved under Part IX. May also be referred to informally as a “nursing home,” “assisted living,” “group home,” etc. Check www.ontariohealthathome.ca to confirm that a home is licensed.
²Any person can report harm or neglect or make other complaints by calling the Long-Term Care ACTION Line toll-free at:1-866-434-0144.
 

File a mandatory report to the registrar of the Retirement Homes Regulatory Authority as soon as possible if you have reasonable grounds to suspect that any of the following has occurred or may: 

• Improper or incompetent treatment or care¹ that resulted in harm or the risk of harm to the resident
• Abuse or neglect² by the licensee or staff that resulted in harm or risk of harm to the resident 
• Unlawful conduct³ that resulted in harm or risk of harm to a resident 
• Misuse or misappropriation of a resident’s money 

Legislative reference(s) 

Retirement Homes Act, s. 75 

Additional resources 

Reporting Harm 
Elder Abuse Prevention Ontario – Reporting

¹Improper or incompetent treatment or care could include mishandling of a resident during care or a mistake/error in providing care (e.g., with medications).
²Abuse could be emotional, physical, sexual, verbal, and/or financial. Neglect could include failure to provide care or assistance to a resident.
³Unlawful conduct could include theft of medication by staff, unlawful fees being charged, unlawful eviction, or other illegal activity. 

File an Adverse Event Following Immunization (AEFI) Reporting Form to the Medical Officer of the Public Health Unit¹ as soon as possible if you recognize the presence of a reportable event and form the opinion that it may be related to the administration of an immunizing agent (vaccine). Reportable events after administration include: 

• Persistent crying or screaming, anaphylaxis or anaphylactic shock occurring within 48 hours
• Shock-like collapse, high fever, or convulsions occurring within 3 days
• Arthritis occurring within 42 days
• Generalized urticaria, residual seizure disorder, encephalopathy, encephalitis, or any other significant occurrence occurring within 15 days
• Death occurring at any time following a symptom described above  

Legislative reference(s) 

Health Protection and Promotion Act (HPPA), s. 38 

Additional resources 

AEFI Reporting Form 

AEFI Reporting Fact Sheet 

File a report with your local public health unit as soon as possible if you form the opinion that the person to whom you are providing professional services has or may have:  

• A disease of public health significance (DOPHS) listed in Column 1 of the Table in O. Reg. 135/18. 

Legislative reference(s) 

Health Protection and Promotion Act (HPPA), s. 25 

Ontario Regulation 135/18: Designation of Diseases 

Additional resources 

Infectious Diseases Protocol 2023

¹In hospitals, the hospital administrator has the duty to report (s. 27) and pharmacy professionals should follow the hospital’s procedures for reportable events.