When Aesthetic Practitioners Go Off Label…

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HERES A TRICKY PROBLEM

As I have mentioned many times before, aesthetic medicine is fairly unregulated.  This means it can be a bit of the Wild West out there in terms of regulation, oversight, and consistently good practices.

However, where there are rules and regulations there really is no excuse for not following them.

Just because practitioners lack rules and clear guidance in some areas doesnt mean you can flout the rules or standards of practice where they do exist.

Here are a few common issues:

1. Compounding drugs
2. Using drugs off-label
3. Lack of consensus statement for use of drugs off-label

Lets talk about the the issue of compounded drugs first.  

Compounding refers the process of combining, mixing, or altering ingredients to create a custom medication tailored to the needs of an individual patient.  A compounded drug is prepared by a pharmacist according to a doctor or nurse practitioners (NP) prescription – its like a recipe for a medication.

Why use a compounded a drug?

The most common reason is because that specific custom prescription of ingredients is not available through a commercially made product. Compounding does not include making copies of commercially available drug products, as this is not allowed by law.  

APPROPRIATE COMPOUNDING

Sometimes we need a compounded drug for use in Aesthetic medicine.

For example, at ArtMed we have a compounded medication called hyaluronidase.  This is an enzyme in a liquid form that can be injected to dissolve hyaluronic acid fillers (such as Juvederm).  In Canada, there is no commercially available form of this drug, so we have to have it made by a compounding pharmacy. In the United States, they do have a commercially available drug called Hyalase and so doctors in the US must use that medication for dissolving filler and they do not (and cannot) compound hyaluronidase.

MURKY COMPOUNDING.

Sometimes practitioners will write a prescription for a medication thats almost identical to an existing Health Canada approved drug.  But it is not identical, just nearly identical.  In fact, so similar it will be used for the same purpose as the Health Canada approved drug.

An example of this is the drug deoxycholic acid.  Deoxycholic acid is a man-made version of an enzyme produced by the human liver.  It is available commercially as Belkyra (Allergan makes it) and is Health Canada approved to treat double chin.  Belkyra, when properly injected kills fat cells thus permanently improving double chin.  

By contrast, phosphatidylcholine mixed with deoxycholate (sometimes known as PC/DC) is a compounded injectable drug that is used by aesthetic practitioners to kill fat cells as well.  It is not a Health Canada approved medication.  It is nearly identical to Belkyra and is used in the same way.

OFF-LABEL USE

Now lets talk about off-label use of drugs.  When a drug is approved by Health Canada it is approved for a specific indication.  So for example, a medication like Belkyra is indicated for the treatment of double chin.  The medication comes with explicit instructions in terms of dose and administration for that use.  

Could Belkyra treat fat around armpit (bra-fat)?  Or excess upper arm fat?  Yes, it could be used to do that, but that usage would be off-label.  This means Health Canada hasnt approved it for that use, but a prescribing physician of NP if properly trained could potentially use it for that purpose.

Off-label use is not to be taken lightly.  Generally speaking, doctors and NPs will only prescribe a medication for off-label use if there is a broadly accepted consensus within the medical community for use of that medication in that way.

CONSENSUS STATEMENTS PROTECT PATIENTS AND PRACTITIONERS

This is where a consensus statement comes in.  What is a consensus statement?

A consensus statement provides specific direction to physicians and NPs from expert peers on how to practice or prescribe.

For example, when the off-label uses of a medication or product has gained enough acceptance among peers a consensus group of expert physicians will gather to revue and study off-label use, come to some conclusions and then issue a statement on how to use that drug off-label.

A consensus statement is very important because it provides directions on the safe use of a medication off-label including dosing, administration, indications and contraindications.  When doctors or NPs use drugs off-label there is a heightened liability risk because Health Canada has not approved that drug for that use.  Theyre going out on a limb.  A consensus statement helps to provide expertise and protect both practitioners and patients on safe off-label use.

For example, in aesthetics there is a unique type of dermal filler called Radiesse.  Radiesse is not like Juvederm, or Revanesse, it is not a hyaluronic acid filler.  It is a filler that contains a medication called calcium hydroxyapatite which stimulates collagen production.  

Radiesse is indicated for jawline contouring of the face.  However, in 2019 a group of 10 experts in the field of aesthetic medicine published a consensus statement in the Journal of the American Society of Plastic Surgeons.  They provided consensus recommendations (dosage, dilutions, injection technique etc. ) on the use of Radiesse in other areas of the body including the neck, chest, hands and more.  

So lets go back to the beginning.

So what about a drug that is both unapproved by Health Canada and is also being used off-label?

Technically, this is legal in Canada.  This is why PC/DC is in common use by aesthetic practitioners.  Should it be?  Its not Health Canada approved and there is no consensus statement on its use (Belkyra does not have a consensus statement for use other than double chin either).

Its the wild west.

Should patients be concerned?  Yes.  As it happens, PC/DC is potentially stronger than Belkyra.  Compounded drugs are not as safe as commercially available drugs.  They are not created by a pharmaceutical company under tightly controlled factory conditions but instead by a pharmacist in their pharmacy.   In the wrong hands, it could most certainly harm people.  There have been numerous lawsuits related to use of PC/DC and the permanent damage it caused patients.  Practitioners who use PC/DC need to know that without Health Canada approval and without a consensus statement on the use of PC/DC they are really out on a ledge in terms of risk.

But it gets worse

PC/DC is legal because its a compounded drug made under prescription.  Doctors and NPs have the authority to provide these prescriptions.

HOWEVER..

Prescribing drugs is a controlled act under Ontario law.  And in Part II of the Controlled Acts it states that a prescriber can only compound a drug for their own patient.  

In aesthetics it becomes murky because many aesthetic injectors work under medical directive.  This means, the injector (an RN or RPN) does not have the independent authority to prescribe or inject a drug or product let alone a compounded drug.  They can only provide that treatment or service under direct order (a medical directive) from a medical professional who is authorized to perform controlled acts.  In Ontario, only a medical doctor or a nurse practitioner has that authority.

Many aesthetic RN or RPN nurse injectors have a doctor or NP briefly visit their patient (often remotely via video) to meet this regulatory requirement.  Is such a visit adequate to establish a doctor or NP/ patient relationship as defined by regulation? Is this sufficient relationship to be prescribing a compounded drug? Again, this is not clear and unregulated at present.  

So if a prescribing doctor or NP provides a large vial of PC/DC to an RN or RPN this prescription was no longer for a specific patient for a specific need. If thats the case, that compounded drug falls under Federal regulation, specifically the Food and Drugs Act and the Controlled Drugs and Substances Act.  

According to those laws, compounding is only allowed under specific circumstances:

4. The compounded product must provide a customized therapeutic solution to improve patient care without duplicating an a proved drug product
5. Compounding should only be done if there is a therapeutic need or lack of product availability and should not be done solely for economic reasons for the healthcare professionals
6. Compounding must not be used to bypass the drug review and approval system
7. Drugs should not be compounded in order to be sold to third parties who in turn sell/deliver to patients outside of their defined patient-healthcare professional relationship (sellincludes distribute, give away, supply or offer to sell, distribute, give away or supply)

Hmmm. This is very tricky territory.  If a doctor prescribes PC/DC and provides it to a nurse and she does a quick video chat with that patient to approve the use of the PC/DC is she safely avoiding the Federal Regulation?  Perhaps, if she wrote a specific prescription of PC/DC for that patient including dosage and where it will be injected.  If she provided a big vial of PC/DC to the nurse for use in multiple patients then it wasnt a specific prescription and all of the above Federal Regulations kick in.

THERE ARE SO MANY QUESTIONS..

Is PC/DC sufficiently different from Belkyra to get around rule#1?

Is it necessary to compound PC/DC because Health Canada approved Belkyra wouldnt do the job?  (Belkyra is equally effective for the off-label uses for which PC/DC is currently used)

Is PC/DC being compounded because there is a therapeutic need not met by the commercial market? (Health Canada approved Belkyra can be used off-label to meet that need)

Or is it being compounded because PC/DC is cheaper than Belkyra? (PC/DC is far cheaper than Belkyra..)

Is there a financial reason the practitioner is using a compounded drug instead of a Health Canada approved drug (PC/DC instead of Belkyra)?

Is the doctor effectively supplying or distributing the PC/DC to the nurse? (not providing a specific amount for a specific patient with a unique prescription)

LOTS OF RED FLAGS

Should nurses who work under medical directives provide compounded injectable prescription drugs off-label?  At ArtMed, we think not.  

Regulations exist to protect patients.  

At ArtMed, we strictly adhere to the laws that govern controlled acts, prescription drugs and compounding of drugs.  We do not provide compounded PC/DC for off-label use.  At present we do not use Health Canada approved Belkyra off-label because there is no consensus statement to support its use in areas of the body outside the chin.  When a consensus statement on the off-label uses of Belkyra is published we will consider it.

At ArtMed, our primary concern is the health and welfare of our patients.  But in the broader industry thats not always the case. It still falls to patients to do their research.  Understand the risks. Buyer beware.

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Showing 2 comments
  • Ivonne Sanchez
    Reply

    Thank you for this very helpful article! I wondered if you could elaborate further on how Consensus Statements are formed? Are they the result of a clinical study or trial? Acquiring enough data to make a consensus statement would in itself also be risky, too?

    Who Can Perform Cosmetic Injections in Canada was a topic that we had recently covered in our blog which I’ll leave below:
    https://ivonnesanchez.com/blog/who-can-perform-cosmetic-injections-fillers/

    Effectively, the regulating colleges in Canada would, in our view, not really get behind the delegation of injectables for cosmetic purposes alone. It seems that only physicians should be performing cosmetic injections.

    • Dr. Mary Peirson
      Reply

      Hi Ivonne,
      Thanks for contacting us! Your blog on cosmetic injections was great! Very well researched 🙂

      Re your question:
      The area of clinical practice guidelines (CPG) and consensus statements is quite interesting.

      Many organizations develop CPGs – medical speciality societies or associations that focus on patient advocacy for specific diseases/conditions, government, and other health care and medical organizations. The development of CPGs almost always involves a standard and systematic process that adheres to specific criteria. CPGs provide physicians with a framework for diagnosing, assessing and treating clinical conditions commonly encountered in practice but do not replace professional judgement.

      By contrast, a consensus statement synthesizes newly available information that can be change or addition to generally accepted medical practices (for eg. adding an off-label use for a drug) but do not give specific algorithms or guidelines for practice. Consensus statements tend to rely on the expertise of physician specialists rather than a review of the literature for example. This is because the literature may be limited in scope for that topic at that point in time. Nonetheless, a consensus statement does provide professional guidance and best practices (for eg. use of medications off-label) and provides a published standard of care reference document.

      Regarding cosmetic injections, we believe they should only be delegatable when the medical director physician or nurse practitioner is physically on-site supervising those nurse injectors. A medically controlled environment is also essential (ie.health facility that is for clinically invasive procedures). As you mentioned and the CPSO stated, delegation should be for patient need, for quality of care and for access. There are certainly circumstances where in order to provide timely access to care or to insure a particular quality of care we will delegate to our nurse injectors. This is in keeping with a client-centred approach to care. However, the medical director should be present at all times because patient safety should be the number one priority of all aesthetic clinics.

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