Month: July 2015

Botox® and regulations

Dr Singh who runs his botox clinic in Stevenage, Hertfordshire, in his latest blog shares his thoughts on botox and regulation.

In 2013, the Department of Health predicted that the value of the cosmetic surgery industry in the UK would rise from £2.3bn in 2010 to £3.6bn in 2015. This is certainly something that many dentists are becoming more interested in offering their patients, since they are ideally placed, once appropriately trained, to deliver non-surgical facial aesthetics complementary to dental treatment. With this in mind, dentists need to know from the outset what regulatory framework exists to help keep patients safe.

Overseeing cosmetic care

Currently, there is no regulatory body or any formal process of regulation regarding the administration of non-surgical facial aesthetics. However this will be changing in the not too distant future – more on this later. In the meantime, there are, of course, bodies that regulate dentists (and their requirements will apply to dentists who carry out facial aesthetics).

Initially, the GDC did not see the provision of facial aesthetics services as part of the act of dentistry but this changed several years ago. Now non-surgical aesthetics comes under there remit of dentistry. Therefore, the GDC expects any practitioner to provide the same level of care and competence for this service as they would for dental treatment.

All of the GDC’s Standards need to be applied to the facial aesthetics business, namely:
• Standards for dental professionals
• Principles of patient consent
• Principles of patient confidentiality
• Principles of dental team working
• Principles of complaints handling
• Principles of raising concerns
• Principles of management responsibility
• Principles of ethical advertising.

If you are providing facial aesthetics within your dental practice, then it will come under the Care Quality Commission’s (CQC) remit. If you are providing these services away from your premises, then currently it will not. However, bear in mind that irrespective of your premises, if you are treating hyperhidrosis (excessive underarm sweating), the CQC may feel it comes under their remit. This is because hyperhidrosis is classed as a disorder that must be diagnosed before any treatment can be provided. It is further defined as such by the NHS. This makes it a ‘regulated activity’ within the CQC in England (with similar requirements in Wales, Scotland and Northern Ireland).

Looking to the future, as a result of the PIP implant scandal, Sir Bruce Keogh was asked by the Department of Health to investigate the cosmetic interventions industry. He was asked to look at:
• Standards for cosmetic surgery practice and training
• Fillers as a POM (prescription only medicine)
• Registration
• Accreditation
• Record of consent
• Advertising restrictions
• Professional indemnity cover.

The Keogh report was produced in April 2013 and the Government responded to it in February 2014. Work is underway to create documentation and, where necessary, legislation to implement a number of the key recommendations, which included:
• A register of everyone who performs surgical or non-surgical cosmetic interventions
• Classifying dermal fillers as a prescription only medical device
• Ensuring all practitioners are properly qualified for all the procedures they offer
• All non-surgical procedures must be performed under the responsibility of a clinical professional who has gained the accredited qualification to prescribe, administer and supervise aesthetic procedures
• A ban on special financial offers for surgery
• An advertising code of conduct with mandatory compliance for practitioners
• Compulsory professional indemnity in case things go wrong
• An ombudsman to oversee all private healthcare, including cosmetic procedures, to help those who have been treated poorly.

 

For more information about botox hertfordshire, please call us on 01438 300111.

Botox® and ethics

Dr Singh who runs his botox clinic in Stevenage, Hertfordshire, in his latest blog shares his thoughts on botox and ethics.

Needs versus wants – Botox® services are elective and therefore no patient ‘needs’ these services. It’s a ‘wants’ driven business. This is advantageous as patients will seek these services, will be more willing to pay for these services and will be more appreciative of the results of these services. However, it can be a double edged sword in that we need to base our treatments and recommendations on sound based evidence, long term studies and whether we can improve upon the patients current situation.

I look like to follow the 4 P’s in terms of providing ethical solutions to my botox patients:

P – Person – are you the right person to see and treat this patient
P – Patient – are you happy to see and treat this patient
P – Product – are you using the right product
P – Place – are you injecting in the right plane

Advertising – Since Botox® is a P.O.M (Prescription Only Medicine) you cannot advertise this to the general public. The word Botox®® cannot appear in any print media, posters, flyers, etc that is exposed to the general public. Regarding websites, at the moment you cannot have the word Botox®® on the homepage of your website and Google will not allow any PPC (Pay Pert Click) campaigns on this medicine.

As a result of the PIP scandal and the subsequent Keogh report, regulatory bodies such as the ASA (Advertising Standards Agency) and GDC are clamping down on a diverts that include any of the following:

– Time-limited deals
– Financial inducements
– Package deals, such as ‘buy one get one free’
– Offering cosmetic procedures as competition prizes

 

 
The GDC have certain requirements regarding advertising as can been seen in section 1.3.3.‘You must make sure that any advertising, promotional material or other information that you produce is accurate and not misleading, and complies with the GDC’s guidance on ethical advertising. All information or publicity material regarding dental services should be legal, decent, honest and truthful.’
Managing expectations – Never treat anyone that you cannot improve upon. The botox patient will be mainly concerned with their appearance and it is vital that you can confidently improve upon this. its the old adage of, under promise and over deliver.

Consent – You cannot stop patients from suing you, but you can stop them from suing you successfully. The GDC has 3 parts in their document ‘Principles of Informed Consent’.

– Informed consent – the patient has enough information to make a decision.
– Voluntary decision-making – the patient has made the decision.
– Ability – the patient has the ability to make an informed decision

Photographs – Take before and after photographs of every botox treatment you perform. This is vital to track and show patients the improvements.

Notes – These should be made contemporaneously. To include, but not limited to; details regarding, patients initial concerns, options discussed, patient input, explanation of procedures, what to expect, duration of results, potential complications, after care, post op instructions.

Summary

The rewards from aesthetic treatments can be dramatic in terms of improving patients confidence and financially for the practitioner. These can only be achieved if you adhere to medico legal requirements and offer all treatments in a safe and ethical manner.

 

 

For more information about botox hertfordshire, please call us on 01438 300111.

botox legal requirements

Dr Singh who runs his botox clinic in Stevenage, Hertfordshire, in his latest blog shares his thoughts on botox and the medico legal aspects providing this service.
Regulation – Currently there is no regulatory body or any formal process of regulation regarding the administration of botox. However this will be changing. With the completion of the Keogh report and the Governments response to this together with the European Aesthetics Surgery regulatory standards gaining CEN (European Committee for Standardisation)approval, it will be wise to be prepared and ready for any imminent regulation.

Who can perform botox procedures – As mentioned above, since there is no regulation in place currently, in theory anyone can perform non surgical facial aesthetic procedures. However the indemnity providers will only insure certain medically trained professionals such as; dentists, medical doctors and medical nurses.

Indemnity – There are various options regarding indemnity (mandatory) to allow you to be covered and perform these procedures. This information is correct at the time going to press, but terms and conditions may change, so it is advisable to regularly check with your indemnity provider.

– MPS – You may be able to be covered for facial aesthetics as long as certain requirements are meant, such as, but not limited to; cap on earnings per year from aesthetics, areas to treat (mainly neck and above), registration with ‘Treatments you can trust’/IHAS scheme

– DDU – You may be able to have this included as part of your dental indemnity as long as you have evidence of training and competence in the areas you will be treating.

– HFIS – Hamilton Fraser Insurance Services. I personally use this company. There is no limit on your earnings and what areas are covered (as long as you can prove you have been adequately trained).

Other specialist indemnity providers include Cosmetic Insure and HISCOX.
Training – You will need to attend an approved botox training programme (such as www.botoxtrainingclub.co.uk) and provide evidence of a certain level of competence before you will be allowed to carry out these procedures.

Pharmacy – Botox® is a P.O.M (Prescription Only Medicine) therefore only prescribers can order this and subsequently you can only order it from a pharmacy. You will need to set up a Pharmacy account before you order the toxin. Currently Dermal Fillers are not classified as prescription only medicines, so you can order either from a pharmacy (to save on the VAT) or directly from the filler companies.

Premises – You will require suitable premises to provide botox treatments. If you are providing aesthetics within your Dental Practice, then it will come under CQC remit. If you are providing these services away from your premises, then currently it will not come under the CQC remit.

***A word of warning here, if you are treating hyperhidrosis (excessive underarm sweating) , irrespective of the premises, the CQC may feel it comes under their remit due to the fact that this is because, the condition of hyperhidrosis is classed as a disorder which must be diagnosed and then it can be treated. It is further defined as such by the NHS. This makes it a ‘regulated activity’ with the Care Quality Commission (CQC) in England (with similar requirements in Wales, Scotland and Northern Ireland).

 

For more information about botox hertfordshire, please call us on 01438 300111.