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Improving safety and satisfaction: knowledge to improve patient outcomes

In Australia all medical products and treatments must be registered with the Government’s Therapeutic Goods Administration (TGA) before they can be legally used. This protects the consumer from unsafe treatments. Obtaining registration is a lengthy and expensive process whereby the supplying company must show scientific data supporting the efficacy and the safety of their product. Once they have passed the stringent criteria, they are given a rating. Those that are deemed more dangerous in non-qualified hands are rated as Schedule 4 or 8. All cosmetic medical drugs and most of the machines used in cosmetic medicine have a Schedule 4 rating. This means that before any treatment can be performed the patient must have a full assessment of suitability for the procedure and be explained the risks and side effects of the treatment by a qualified (and preferably experienced) doctor. If the patient then chooses to treat, the doctor may then give a verbal order for a nurse to carry out the procedure. Adequate notes must be kept of each treatment. Nurses CAN NOT consult and treat without the involvement of a doctor.

So why is this fact so important and relevant? Firstly consider the risks of not having a doctor involved. Even the simplest of treatments has risks. Medical treatments do not always go according to plans even when carried out to perfection. This is because there is so must variation in humans and the fact that the body can sometimes react unpredictably. For example, any trauma piercing the skin can cause an infection, including a needle in a wrinkle relaxer or filler treatment. Consider this if you have medical treatments at beauty salons where there is no level of medical sterility and chances are the person before you has been waxed on the same bed! If an infection did occur, or any other side effect for that matter, you should feel comfortable to return to the practioner for help. But what can a nurse do? They can’t prescribe an antibiotic or perform minor surgery to drain any collection of pus. Chances are they have never even seen some of the possible side effects of Schedule 4 drugs. GPs aren’t trained in cosmetic procedures and their side effects and so might be unsure of what to do, or be unwilling to get involved. If left the infection could grow and create significant tissue damage, or even worse spread to the blood stream making the person septic. Some infections may need specialised antibiotics, or in the case of certain side effects a special protocol of treatment might be required. A fully qualified and experienced cosmetic doctor knows this and will know what to do. This is why a doctor must always be involved with your treatment if a Schedule 4 product is used.

This is all relevant at the moment since WA is seeing an influx of clinics offering Schedule 4 treatments that are run solely by nurses. The schedule 4 products can only be supplied to a doctor. Doctors are illegally supplying these nurses for a kick back on the income generated. They take no active part in the treatment of patients and are usually located in the Eastern States. Sometimes the nurses claim consultations are being carried out via video. Video consults were originally designed for the rural patient with a genuine medical concern who could not reach a doctor. They were never created for cosmetic assessment and are not acceptable as an adequate consult. Logic dictates that a quick Skype look in by a doctor does not provide enough information about a patient’s medical history, skin or body to allow safe prescribing of a Schedule 4 drug. These clinics often have prices set quite low, and it’s for a reason. Minimal overheads, inadequate staff training, no medical supervision and no insurances paid by the nurses, often-inadequate doses, no guarantees, non-medical environments and no medical standards of practice. It all amounts to reduced safety, increased risk and poor outcomes. Essentially you pay for what you get.

By the way, “Cosmetic Parties” are illegal for the above reasons and also because Schedule 4 drugs come under the Poisons Act of 1965. This means that in addition to having to be prescribed by a doctor, to have a Scheduled poison on site there must be a poison’s license held by the property. There are stringent criteria to be met to obtain this license including the fact that only a doctor can obtain the scheduled poison and a visit by the Health Department to check the premises for suitability to hold the poison. Consequently, it is also illegal to have a Schedule 4 drug on a non-authorised premises (including beauty salons), which can lead to hefty fines. Consider this too, if a negative outcome is seen in a treatment that leads to a lawsuit, then the owner of the house or premises where the treatment was carried out can also be sued. And if you think nothing legal ever eventuated from a Schedule 4 treatment, think again! What’s more, the practioners carrying out the procedures aren’t interested in your outcome; they just want the money since they are acting illegally anyway. So if you do have any problems, there is unlikely to be any medical help afterwards. In a non-medical environment the risks of infections go up dramatically, after all the family dog or cat was possibly sitting on that very chair where the treatment is going to occur. Add alcohol and you take out the ability of the person to truly give informed consent which means everyone becomes more liable if something goes wrong. And of course we all know that alcohol increases the risk of bruises. Doctors and nurses are not allowed to engage in the activity of kickbacks either e.g. exchanges of money or goods for the introduction of patients. Cosmetic Parties are risky business for all involved. Patients really need to use common sense when seeking cosmetic medical enhancement.

So if all this illegal and unethical practice is occurring why isn’t the Health Department or Government doing something about it? We ask this every day! The reality is this. There just isn’t enough manpower to police it adequately. If a clinic or doctor is practicing illegally an individual must make a complaint, as the regulatory bodies do not carry out clinic inspections spontaneously. And if you do have a complaint, whom do you complain to? For a long time the Government didn’t know how to consider cosmetic medicine. Is it in the unregulated beauty industry or is it in the highly regulated medical? It remains a grey area, so we would recommend reporting to the Medical Board (AHPRA), the Nurses Board, the Health Department Pharmaceuticals Branch and the Minister of Health. For doctors and clinics that follow the rules this lack of adequate policing is very frustrating and costly at a commercial level. We thus rely on the intelligence and common sense of prospective patients to do their research and base their choice of practioners on what values they hold ideal to their health.

This brings up the topic of who is qualified to carry out treatments. All medical treatments, even those such as wrinkle relaxers which are considered by many patients to be a “simple’ procedure, still require a vast amount of knowledge about the underlying anatomy, the chemistry of the product in and out of the body, and experience in treating side effects. Many doctors, and most nurses, bypass this knowledge by not having adequate training or attending regular educational meetings. Dr Argie is in charge of organising educational meetings in WA, which are free and yet she only has less than 5% of the doctors who perform cosmetic procedures in Perth attend. She sees even less at the National and International conferences, which cost her thousands to attend each year to ensure her skills, and knowledge, stay up to date in order to provide the safest and best service to her patients possible. Those doctors who practice and do not attend educational meetings really are in it for the financial exploitation of their patients. There is no excuse for lack of knowledge in a doctor when it is readily available. Having a Fellowship with a College means that the doctor has sat and passed exams (ACCS is set at 75% to pass), their work has been observed by colleagues, they are committed to ongoing education and must prove attendance yearly, they must practice at the highest of standards and are contributing to the scientific community through research, lecturing or educating. They are specialists. Being a member of a society like the CPSA is the next best thing since it shows a genuine interest in cosmetic medicine and a connection to education and standards. GP’s performing cosmetic medicine can become CPSA members if they apply and meet the criteria. Most do not. GPs are not trained in cosmetic medicine in their routine course work. They, like many other doctors performing these procedures, simply ring the supplying companies who provide a training consisting of 3 to 4 treatments only. They are then free to treat patients. There is no quality of assurance or follow-up to monitor the doctor’s treatments. Nurses of course receive even less training unless they are in a dedicated cosmetic clinic run by a qualified and experienced cosmetic doctor who then performs quality assurance checks regularly. This protects the patient from poor treatment outcomes and the nurse from full accountability. There are plastic surgeons that perform non-surgical treatments but they tend to prefer to make their money from the more expensive surgical procedures. Often they let their nurses perform the treatments. Again, a doctor consultation is required first.

Why is there so much variation in the price of treatments? Firstly consider what we told you about the cost of getting a product registered with the TGA. Every product costs millions in research and development in order to reach the TGA’s strict safety criteria. Every change, even package sizing, means that a product must be resubmitted. The products are of course then taxed as they enter the country, which adds to the costs. Now add the cost of advertising. This is before it even gets to the cosmetic clinic. A dedicated cosmetic clinic running at the highest standards then has large overheads to consider. Maintaining high standards of care protects patients from risks associated with medical treatments. Clinics keeping high standards must use specialised medical cleaning methods, treat with government tested and authorised products (not illegal and often inferior grade overseas imports which can be dangerous), ensure the latest facilities are available, maintain education (this is very costly as courses and conferences are not free) and obtain membership to professional bodies. To not do any of these things would cut costs but puts patients at additional risk. The majority of clinics out there are not meeting professional standards. Hence most of the expense goes into ensuring patient safety. This is why, patients must be wary of ridiculously low prices as there will be a reason or a “catch”. Consider wrinkle relaxers as an example. Since we are not allowed to use trade names we will call the two accepted TGA formulations for wrinkle relaxers formula B and formula D. Formula B and Formula D are both excellent products and work equally well, provided that the dose correction of 2.5 D units for every one B unit is made at the time of treatment. The recommended dose is 20 Formula B units per area. Some people may need 40 units or more if they have strong muscle movement. Thus when one buys 10 Formula B units and either places it in one area or sprinkles it around 2 or 3 areas, there is usually little effect or it wears off very quickly. Treating an area fully ensures it will last its maximum time in the body and that in time the months between treatments may increase. Most of our patients who started at 3 months have gone up to 4 and 6 months between treatments. We know this at our clinic since we keep statistics and accurate records. Inadequate dosing may be a sign of inexperience or lack of knowledge in the injector, or it might be a business ploy to get patients into the clinic by advertising say 50 units of wrinkle relaxer at a low price which is a lot if its formula B, but not if its Formula D. There have also been cases of unethical practioners diluting down their wrinkle relaxers making it go further for them but having little effect in the patient. The patient is then told they have stronger muscle groups and need more, and they need to pay for it! Consider also that wrinkle relaxers are proteins with a 97% standardisation for each batch. This means that occasionally a patient will get a stronger vial and occasionally a weaker one. There is also variation in human physiology, which means that no two treatments on the same person are ever alike. Consequently, sometimes a patient may need an adjustment (or top up) to their wrinkle relaxer treatment once it kicks in. Some clinics compensate for this by offering a complimentary top up 2 weeks after treatment whilst others simply charge for any additional wrinkle relaxer used. One should consider that it also costs a clinic more in injector’s time where they could be seeing other patients, as well as in product costs, to offer such a complimentary service. At ARGERA we have chosen to top up free of charge, since our goal is to have happy patients who feel secure in the knowledge that they will be getting the best treatment every time. There is no worry about doses, dilutions or longevity since the aim is the get the optimal result for that individual patient each time they treat. By the way, every individual’s wrinkle relaxer kicks in at different rates. Even muscle groups on the same person can vary too. Our doctor’s takes 10 days to work whilst one of our staff takes 24 hours. It is not related to which formula is used, the dose or the dilution, just their physiology. We also know that excessive exercise, high periods of stress and increased metabolic rates can reduce the longevity of cosmetic products. If you are unsure if this might affect you then discuss it with your doctor.

There are thus lots of intricacies that go with medical cosmetic treatments that patients are usually unaware of. Our advice is, before having any treatment, do your research, ask questions about realistic results, side effects, longevity, products, doses, the qualifications and experience of your practioners, costs involved and aftercare. If you are not happy with the answers move on to someone who can answer them thoroughly and satisfactorily.


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