Data Collection Requirements Relating to the Standards of Practice for Therapeutic Prescribing
Posted On: October 15, 2024
Introduction
After careful consideration and following upon the consultation undertaken in late 2023 into early 2024, the College of Naturopaths of Ontario (the College) is announcing its intention to begin collecting data from registrants relating to the Standard of Practice for Therapeutic Prescribing.
This document sets out all the parameters of the data collection, including its purpose, authority and specific data to be collected. We will also set out opportunities available for registrants to simplify the data collection process.
Purpose of Collection
The data being collected is an important part of the College’s new Risk-based Regulation (RbR) Program. Risk-based regulation is a fundamental change in the way regulation of a health profession is undertaken. Under the traditional regulatory framework, health regulators react to information that is brought to its attention. Most typically, information comes forward to the regulator through a complaint filed by someone or concerns expressed by someone to the College based upon which the College initiates an investigation. In situations where the subject of the complaint or investigation represents a risk of harm to patients or the public, the regulator can act with a high degree of urgency; however, the threshold to do so is very high.
The RbR Program alters the regulatory process by the regulator using the various data sets available to it to assess existing and emerging areas of risk of harm to patients and addressing those risks before harm occurs and/or a complaint is brought forward. As such, the program fits very well within the College’s public safety mandate as a proactive means of achieving that goal.
A more detailed outline of the College’s RbR Program will be made available shortly.
Authority for the Collection
The data to be collected by the College is being done so in accordance with section 20.12 of the College by-laws wherein the College may forward requests for information to its registrants (ii) for the purposes of compiling statistical data.
Data to be Collected
- Prescribing, Dispensing, Compounding and Selling Drugs
The College will be requiring registrants to submit the following data related to prescribing, dispensing, compounding or selling drugs in their individual practices, including all practice locations:
- Number of drugs prescribed to patients,
- Number of drugs dispensed to patients,
- Number of drugs compounded for patients,
- Number of drugs sold to patients,
- Number of Adverse Occurrences when a patient has been prescribed, dispensed, compounded or sold a drug. An adverse occurrence would be any of the following events if they are known:
- Patient referred to emergency services within 5 days,
- An emergency drug had to be administered to the patient,
- Patient subsequently diagnosed with shock or convulsions within 5 days,
- Patient’s condition did not improve or worsen,
- An unscheduled treatment had to be provided to the patient, or
- Patient had an adverse drug reaction.
- From the following list, which types of adverse occurrences have been encountered in your practice (see list in prior bullet),
- Conditions that emerged requiring an unscheduled treatment (see additional data sets below for details), and
- Types of adverse drug reactions encountered, if applicable (see additional data sets below for details).
- Administering substances by Injection
The College will also be requiring registrants to submit the following data related to administering a substance by injection (non-IVIT), from their individual practices, including all practice locations:
- Number of injections administered to patients,
- Number of patients who experience an Adverse Occurrence (see above for definition of adverse occurrences),
- Types of Adverse Occurrences encountered (see above for definition of adverse occurrences),
- Type of infection encountered, if applicable (see additional data sets below for details),
- Conditions for which an unscheduled treatment was required, if applicable (see additional data sets below for details), and
- Type of adverse substance reactions encountered (see additional data sets below for details).
- Administering a substance by Inhalation
Finally, the College will also be requiring registrants to submit the following data related to administering a substance by inhalation, from their individual practices, including all practice locations:
- Number of inhalations administered to patients,
- Number of patients who experience an Adverse Occurrence (see above for definition of adverse occurrences),
- Types of Adverse Occurrences encountered (see above for definition of adverse occurrences),
- Type of infection encountered, if applicable (see additional data sets below for details),
- Conditions for which an unscheduled treatment was required, if applicable (see additional data sets below for details), and
- Type of adverse drug reactions encountered (see additional data sets below for details).
Additional Data Sets
The College data collection will include the following additional data:
- Where an infection has occurred, the types of infections seen from the following pick list, although number of instances will not be required:
- Bronchitis
- Cystitis
- Gastroenteritis
- Influenza
- Pharyngitis
- Pneumonia
- Sinusitis
- Where an unscheduled treatment has occurred, the types of conditions treated from the following pick list, although number of instances will not be required:
- Anxiety
- Dizziness
- Headache
- Fatigue
- Low back strain
- Muscular spasms
- Phlebitis
- Pneumonia
- Where an adverse drug/substance reaction has occurred, the types of reactions from the following pick list, although number of instances will not be required:
- Anxiety
- Diarrhea
- Headache
- Hypertension
- Hypoglycemia
- Injection site extravasation
- Maculo-papular rash
- Nausea
- Phlebitis
- Pre-syncope
- Seizure
- Shortness of breath
- Syncope
- Urticaria
- Vomiting
Timing of Data and its Submission
The data collected by the College will be based on a calendar year, starting from January 1, 2025 to December 31, 2025 and annually thereafter. This data coincides with the data that is submitted by registrants as part of the annual renewal process.
The first data will be required to be submitted to the College no later than March 31, 2026 allowing three months from the end of the calendar year for registrants to assemble and report the data to the College.
Although the data collection will coincide with current data submissions related to the annual renewal, the actual collection will not be embedded into the renewal process.
Process for Data Collection
In early 2026, the College will launch an intuitive online form to collect the data from registrants to ensure the process is streamlined, easy to use and specific to your practice. For example, if a registrant reports that they only prescribe drugs, only questions relating to prescribing will appear on the form.
Providing Support to Registrants
In recognition that this data reporting requirement may be onerous for some, the College has engaged its system partners to encourage them to provide support to the profession and has established a voluntary, supportive program for interested registrants.
Starting in January 2025, registrants will be invited to begin submitting their data to the College’s Therapeutic Prescribing Data Collection Support program and to do so for the full calendar year on a regular, self-set schedule. At the end of the year, the College will send back to each participating registrant a summary of all the collected data for review. Once the accuracy of this data is confirmed by the registrant, they will then be able to submit their data through the reporting system.
The College will not automatically take collected data from the support program into the reporting system. Each registrant will be required to make their own reporting system submission as they are responsible for the accuracy of this data.
Although reporting data to the College is mandatory, using the College’s data collection support program is not. We encourage registrants to find their own ways or engage other organizations who may be able to support this process. Regardless, this program is available for use at no cost.
To enroll in the College’s Therapeutic Prescribing Data Collection Support program, please click here.
What is required now?
At this time, no data is required to be submitted to the College. Affected registrants will receive a notice to submit the data in early 2026 for the 2025 calendar year. Registrants will be expected to have enabled their own tracking of this data within their practice.
In order to meet these new requirements, registrants are encouraged to prepare now for the start of the new calendar year and assemble the data requirements.
Questions and Answers
Based on feedback from registrants and system partners, the following Q&A has been developed to provide additional information on data collection relating to the Standard of Practice for Therapeutic Prescribing.
What is the impact of this on registrants?
Registrants who have met the Standard of Practice for Therapeutic Prescribing would be required to provide the College with data relating to their own individual practices, including all practice locations on an annual basis. As noted above, this will impact approximately 51% of registrants. Registrants will want to consider methods by which they may individually collect actual reliable data. The stronger the data sets, the better insight the data provides.
The College will mandate that every registrant who has met the Standard of Practice for Therapeutic Prescribing provide the data. Provisions in the by-laws would be used to mandate the provision of data, meaning that individuals who fail to provide the data can be subjected to an administrative suspension for failing to provide information to the College.
It is important to note that registrants of the College who have met the Standard of Practice for Intravenous Infusion Therapy are currently already providing similar data to the College annually through the Type 2 Occurrence Reports. That process will remain unchanged.
What are the costs to the College for the program?
The financial impact on the College is negligible. The data would be collected using online processes currently available to the College set up by staff. Analysis of the data would be part of the responsibilities of staff within the College responsible for the Risk-based Regulation Program.
Why is the data being collected identifiable back to each registrant?
Since the authority for the data collection is based on the by-laws and a formal, legal request by the College to registrants to provide the data, the College is obligated to track who has submitted the requested data and follow up with those who do not. However, once the data is collected, data for all registrants will be combined into one system to allow for analysis and trend identification over time.
What happens if a registrant does not submit the data?
In addition to being subject to an administrative suspension, for any registrant who does not submit the required data, the College will be asking the Inquiries, Complaints and Reports Committee for permission to appoint an investigator on the basis that the registrant may have committed an act of professional misconduct as set out in paragraph 44 of section 1 of the Professional Misconduct Regulation, which states that the following would be an act of professional misconduct:
- Failing to reply appropriately and within 30 days to a written inquiry or request from the College.
Can the College follow up on the data that is provided and if so, how?
The purpose of the collection of the data is to support the Risk-based Regulation (RbR) Program and not to hold the profession accountable. For the most part, the data will be reviewed globally for the profession rather than for one specific registrant.
It is anticipated that the most common questions coming from this process will be identifying registrants who have met the Standard of Practice for Prescribing and have not submitted data or identifying registrants who have not met that standard and have submitted data. In the first instance, the inquiry would be to ensure that no drugs or substances were prescribed/administered or sold. In the second instance, the inquiry will be ensuring that the data reported did not include any drugs or substances not listed on the tables to the General Regulation, i.e., the data did not include supplements and natural health products.
With that said, there is always the possibility that the data provided by a registrant could be remarkable or unusual and would warrant clarification from the College. This clarification would likely come from the Regulatory Programs section of the College as opposed to the Professional Conduct section.
Why is CoNO doing this when no other College or profession is doing anything similar?
Although CoNO may be one of the few Colleges who have established a formal RbR Program, many other Colleges are already using data available to them in support of identifying risk of harm to patients and means to mitigate those risks. Nonetheless, this College and its Council have determined that it will take the first bold steps to move formally in the direction of RbR.
From a public interest perspective, Ontarians would expect the College to be taking any measures available to it, to identify risk of harm to patients and take steps to prevent the harm from occurring.
What is the point of collecting this data when there has been no problem with the profession performing these controlled acts to date?
As of mid-2024, 21 (7%) of all complaints and CEO Investigations since proclamation have been related to prescribing, dispensing, compounding or selling drugs. Three of these cases were referred to the Discipline Committee for hearings. These numbers increase when consideration of administering substances by injection (non-IVIT) are added. These numbers would reflect situations where the harm or potential harm to the patient was clear and evident but would not include lower risk scenarios such as infections, added treatments or referrals to emergency services.
This means that it would not be entirely accurate to suggest that there have been no problems with performing these controlled acts as there have been many investigations and several discipline matters. Furthermore, these only reflect the situations that have been brought to the College’s attention. The broader concern are situations where the College has no awareness.
Finally, if the data suggests that the profession is successful in the performance of these controlled acts, such data might support the potential future expansion of the scope of the profession.
Can the profession oppose this program moving forward?
The RbR Program for which this data is required has been mandated by the Council of the College through its Strategic Plan. RbR is an important strategic priority set by the Council and incorporates a significant part of the College’s operational plan. While a future Council could potentially determine that such a program is no longer a priority, given the current Strategic Plan, such a change is not likely to occur without a significant change to that plan.
The RbR Program has been presented to and accepted by the Council, including the various data sets that are being devoted to the program.
Additional Questions?
Please email general@collegeofnaturopaths.on.ca
Andrew Parr, CAE
Chief Executive Officer