IV Infusion Clinic Case Scenario: What Does “Medical Director” Really Mean?

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Case Scenario: Should Dr. B Agree?

Ms. A, a regulated health professional, approaches Dr. B with an opportunity to act as the “medical director” for her new intravenous (IV) infusion clinic. The clinic markets itself as state-of-the-art, offering customized IV formulations for concerns ranging from headaches to hangovers.

Dr. B’s proposed role seems minimal: provide prescriptions for drugs, procure products for clinic use and lend medical credibility. Ms. A and her team would manage everything else — client recruitment, assessments, formulation of IV cocktails and administration of infusions. A social media campaign is already planned, complete with claims about what IV therapy can treat or prevent, and promotional discounts to attract clients.

At first glance, the offer may seem attractive. But should Dr. B agree?

Matters to consider

Titles matter

The term “medical director” has a specific legal meaning under Schedule 21 of the Health Professions Act (HPA) in relation to accredited medical facilities and carries defined responsibilities under CPSA Bylaws. In this scenario, the proposed role more accurately resembles that of a “medical lead” — a distinction that does not reduce accountability or regulatory responsibility.

Prescribing and drug procurement

Prescribing drugs for office or clinic use, rather than for a specific patient, raises significant regulatory concerns. Many products commonly used in IV clinics, including prescription-dose vitamins, ketorolac, ondansetron and onabotulinumtoxin A (Botox), are listed on Health Canada’s Prescription Drugs List and require a valid, patient-specific prescription within an established practitioner–patient relationship.

Federal legislation does not recognize prescriptions written for unnamed or non-existent patients. Writing prescriptions to stock a clinic, particularly one that is not the physician’s own practice, may contravene the Food and Drugs Act and Food and Drug Regulations, exposing physicians to serious legal consequences.

For example, Botox is a prescription drug and must be prescribed for an individual patient following an assessment. It cannot be obtained through bulk prescriptions; clinic stock must be sourced through licensed distributors in compliance with federal and provincial requirements.

Compounding and IV formulations

Under federal law, drugs that are altered (such as being added to IV bags) are considered compounded drugs. Vitamin infusions are compounded sterile preparations and must be prepared for an individual patient with a valid prescription.

If an IV clinic is creating standardized IV products at scale for sale, it may be considered a manufacturer, triggering the requirement for a Health Canada Drug Establishment Licence and compliance with Good Manufacturing Practices. This goes well beyond traditional patient-specific compounding governed by provincial standards.

Depending on the formulations offered, some IV therapies may also fall under CPSA’s Practising Outside of Established Conventional Medicine standard of practice.

Advertising restrictions

Most, if not all, components used in IV therapy are considered drugs under federal legislation and their advertising is tightly regulated. Health Canada prohibits advertising prescription drugs for the treatment, prevention or cure of diseases listed in Schedule A.1 of the Food and Drugs Act.

If Dr. B becomes involved with the clinic, CPSA’s Advertising standard of practice would apply. Advertisements must be factual, accurate and supported by evidence — and must not:

• be misleading or deceptive;
• include testimonials or endorsements;
• create unrealistic expectations of benefit; or
• offer inducements such as discounts, time-limited promotions or packaged events.

Delegation, supervision and records

In this scenario, Dr. B would effectively be delegating the compounding and administration of prescription drugs to other healthcare providers and potentially unregulated staff. These are restricted activities under Alberta legislation.

As outlined in the Restricted Activities standard of practice, physicians must be personally competent to perform the restricted activities they supervise, remain readily available during their performance and ensure appropriate follow-up. Inadequate supervision may place both the physician and other regulated professionals at risk of contravening their respective standards.

If Dr. B is not on site, he may also lack visibility into critical documentation, such as what was administered, to whom, dosages and lot numbers, increasing patient safety risks and potentially contravening CPSA’s Patient Record Content standard of practice.

Prescribing for individuals Dr. B has not personally assessed also raises concerns under CPSA’s Responsibility for a Medical Practice and Continuity of Care standards.

It would also be important to consider the following:

• the Infection Prevention and Control standard of practice
• Infection Prevention & Control Requirements for Medical Clinics (specifically section 7)
• Medication & Vaccine Injection Safety IPAC Program Guidelines
• requirements to comply with the Personal Services Regulation and Personal Services Standards (including the requirement to notify Environmental Public Health before offering any new or existing personal services to the public)

The bottom line

This arrangement is complex and carries significant regulatory, legal and professional risk. Acting as a “medical lead” does not insulate a physician from responsibility for compliance with legislation, CPSA Standards of Practice or oversight of clinic activities.

Physicians considering similar arrangements are strongly encouraged to consult CPSA and seek medico-legal advice from the Canadian Medical Protective Association (CMPA) before agreeing to participate in scenarios like this.