Guidelines for registered medical practitioners who perform cosmetic medical and surgical procedures

ArticleGeneral, Guidelines

Medical Board of Australia, 2016

The Medical Board of Australia has issued guidelines for medical practitioners who perform cosmetic medical and surgical procedures.

‘The guidelines will help keep patients safe, without imposing an unreasonable regulatory burden on practitioners,’ said Board Chair, Dr Joanna Flynn AM.

They apply to all medical practitioners, including specialist plastic surgeons, cosmetic surgeons and cosmetic physicians regardless of their qualifications.

The Board consulted widely with the profession, the industry and the community about the best way to protect consumers seeking cosmetic medical and surgical procedures from medical practitioners.

In March 2015, the Board circulated draft guidelines and asked for feedback on other ways to protect patients in this area – including doing nothing, providing consumer education, and providing different levels of guidance.

‘There was very clear support from stakeholders for clear guidance in this area and a strong message that other options would not effectively protect consumers,’ Dr Flynn said.

The new guidelines, which will take effect on 1 October 2016 to give medical practitioners time to comply with them, require:

  • a seven-day cooling off period for all adults before major procedures;
  • a three-month cooling off period before major procedures for all under 18s and a mandatory evaluation by a registered psychologist, general practitioner or psychiatrist;
  • a seven day cooling off period before minor procedures for all under 18s, and when clinically indicated, evaluation by a registered psychologist, general practitioner or psychiatrist;
  • the treating medical practitioner to take explicit responsibility for post-operative patient care and for making sure there are emergency facilities when they are using sedation, anaesthesia or analgesia;
  • a mandatory consultation before a medical practitioner prescribes schedule 4 (prescription only) cosmetic injectables, either in person or by video consultation; and
  • medical practitioners to provide patients with detailed written information about costs.

The guidelines provide explicit guidance on patient assessment and informed consent, and require doctors to provide clear information to consumers about risks and possible complications.

The Board also identified a range of safety concerns that it has no power to deal with.

‘When we have the power to act, we have acted. When we identified a problem that we can’t address, we have made recommendations to other authorities,’ Dr Flynn said.

These recommendations include:

  • dealing with inconsistencies in drugs and poisons legislation across jurisdictions, which can cause confusion for practitioners and consumers;
  • reviewing, strengthening and aligning licensing and regulation of private health facilities, including the use of sedation and anaesthesia.

The Board supports changes in these areas but cannot define requirements set out in state or territory legislation.

The guidelines vary from the previous draft by:

  • making it clearer which procedures the guidelines apply to;
  • making it possible to refer a patient to a general practitioner, a psychologist or a psychiatrist for psychological evaluation – previously GPs were not included;
  • setting a different cooling off period for major and minor procedures for patients under 18, with different requirements for psychological evaluation:
    • mandatory evaluation and three month cooling off period for major procedures for under 18s; and
    • evaluation if indicated and seven day cooling off period for minor procedures for under 18s.
  • allowing in person or video consultations for doctors prescribing schedule 4 cosmetic injectables.

‘The Board listened to stakeholder feedback, and responded with a new set of guidelines that will best keep patients safe,’ Dr Flynn said.

‘The changes prioritise patient safety and reduce some of the regulatory requirements proposed in the previous draft guidelines, when either there was no evidence of improved safety or the costs significantly outweighed the benefits of a proposal,’ she said.

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View Medical Board of Australia Guidelines
View Medical Board of Australia Media Statement

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Clinical features of Zika virus

ArticleGeneral

DermNet NZ 2014

The Zika virus was initially isolated in 1947 in a rhesus monkey in the Zika forest of Uganda. The first documented human outbreak occurred in 2007 in the Federated States of Micronesia and was followed by another outbreak in 2013 through 2014 in the nearby Pacific Island nations. The Zika virus outbreak in Africa, Asia, the Americas, and the Pacific has drawn attention to the virus in the media and medical community. As of February 10, 2016, 52 travel-related cases of Zika virus have been reported in the United States.

What is Zika virus?

Zika virus causes an infection that is mainly spread by the bite of tropical zika virus-carrying mosquitoes. It presents as a flu-like illness rather similar to dengue fever, but not as severe. Rash is a prominent feature. There is current concern because birth defects have been reported after zika infection of pregnant women. Pregnant women should take special precautions if travelling to affected areas.

What are the clinical features of Zika virus infection?

Zika virus infection arises about 10 days after a bite from an infected mosquito. It results in headache, mild fever, chills, conjunctivitis (red eyes), joint and muscle aches and rash. Other non-specific symptoms may include headache, fatigue, malaise, abdominal pain and vomiting.

Zika virus infection usually recovers within a week.

What does the Zika virus rash look like?

The rash associated with zika virus is maculopapular (flat and bumpy spots), either morbilliform (small spots) or scarlatiniform (smaller ones). It starts on the face on the first day of illness and spreads all over the body. It begins to fade within 2-3 days and is gone completely within a week.

At the same time, the eyes become sore and red and may be sensitive to the light.

Alexius Salvador Zika-Virus

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Patients with Rosacea Have Increased Risk of Dementia

ArticleResearch

Authors: Egeberg, A., Hansen, P. R., Gislason, G. H. and Thyssen, J. P.
Annals of Neurology 2016

Objective

Rosacea is a common chronic inflammatory skin disorder where upregulation of matrix metalloproteinases (MMPs) and antimicrobial peptides (AMPs) is observed. Notably, inflammation, MMPs, and AMPs are also involved in the etiopathogenesis of neurodegenerative disorders including certain forms of dementia such as Alzheimer disease (AD). Based on several clinical observations, we investigated the association between rosacea and dementia, including AD in Danish registers.

Rasacee couperose zones

Methods

All Danish citizens aged ≥18 years between January 1, 1997 and December 31, 2012 were linked at the individual level through administrative registers. Cox regression was used to calculate unadjusted and adjusted hazard ratios (HRs).

Results

The study comprised a total of 5,591,718 individuals, including 82,439 patients with rosacea. A total of 99,040 individuals developed dementia (any form) in the study period, of whom 29,193 were diagnosed with AD. The adjusted HRs of dementia and AD were 1.07 (95% confidence interval [CI] = 1.01–1.14), and 1.25 (95% CI = 1.14–1.37), respectively, in patients with rosacea. Stratified by sex, the HRs of AD were 1.28 (95% CI = 1.15–1.45) and 1.16 (95% CI = 1.00–1.35) in women and men, respectively. When results were stratified by age at study entry, the risk of AD was only significantly increased in individuals ≥60 years old (adjusted HR = 1.20, 95% CI = 1.08–1.32). When analyses were limited to patients with a hospital dermatologist diagnosis of rosacea only, the adjusted HRs of dementia and AD were 1.42 (95% CI = 1.17–1.72) and 1.92 (95% CI = 1.44–2.58), respectively.

Interpretation

Rosacea is significantly associated with dementia, particularly AD. Increased focus on symptoms of cognitive dysfunction in older patients with rosacea may be relevant. Ann Neurol 2016

Author Information
  1. National Allergy Research Center, Department of Dermato-Allergology, Herlev and Gentofte University Hospital, University of Copenhagen, Hellerup
  2. Department of Cardiology, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup
  3. Danish Heart Foundation, Copenhagen
  4. National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark

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DOI: 10.1002/ana.24645

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FDA approves new psoriasis drug Taltz

ArticleGeneral

U.S. Food and Drug Administration, March 2016

Release

The U.S. Food and Drug Administration today approved Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis.

Psoriasis is a skin condition that causes patches of skin redness and flaking. Psoriasis is an autoimmune disorder that occurs more commonly in patients with a family history of the disease, and most often begins in people between the ages of 15 and 35. The most common form of psoriasis is plaque psoriasis, in which patients develop thick, red skin with flaky, silver-white scales.

“Today’s approval provides patients suffering from plaque psoriasis with another important treatment option to help relieve the skin irritation and discomfort from the condition,” said Julie Beitz, M.D., director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.

Taltz’s active ingredient is an antibody (ixekizumab) that binds to a protein (interleukin (IL)-17A) that causes inflammation. By binding to the protein, ixekizumab is able to inhibit the inflammatory response that plays a role in the development of plaque psoriasis.

Taltz is administered as an injection. It is intended for patients who are candidates for systemic therapy (treatment using substances that travel through the bloodstream, after being taken by mouth or injected), phototherapy (ultraviolet light treatment) or a combination of both.

Taltz’s safety and efficacy were established in three randomized, placebo-controlled clinical trials with a total of 3,866 participants with plaque psoriasis who were candidates for systemic or phototherapy therapy. The results showed that Taltz achieved greater clinical response than placebo, with skin that was clear or almost clear, as assessed by scoring of the extent, nature and severity of psoriatic changes of the skin.

Because Taltz is a medicine that affects the immune system, it is being approved with a Medication Guide to inform patients that they may have a greater risk of an infection, or an allergic or autoimmune condition. Serious allergic reactions and development or worsening of inflammatory bowel disease have been reported with the use of Taltz. Monitor patients closely for these conditions. The most common side effects include upper respiratory infections, injection site reactions and fungal (tinea) infections.

Taltz is marketed by Indanapolis, Indiana-based Eli Lilly and Company.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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1970’s Public Service Announcement

ArticleTV

A 1970’s TV public service announcement from the American Academy of Dermatology.

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A Phase 3 Randomized Trial of Nicotinamide for Skin-Cancer Chemoprevention

ArticleGeneral, Research

Authors: Andrew C. Chen, Andrew J. Martin, Bonita Choy, Pablo Fernández-Peñas, Robyn A. Dalziell, Catriona A. McKenzie, Richard A. Scolyer, Haryana M. Dhillon, Janette L. Vardy, Anne Kricker, Gayathri St. George, Niranthari Chinniah, Gary M. Halliday, and Diona L. Damian.
The New England Journal of Medicine 2015

Abstract

Nonmelanoma skin cancers, such as basal-cell carcinoma and squamous-cell carcinoma, are common cancers that are caused principally by ultraviolet (UV) radiation. Nicotinamide (vitamin B3) has been shown to have protective effects against damage caused by UV radiation and to reduce the rate of new premalignant actinic keratoses.

Results

At 12 months, the rate of new nonmelanoma skin cancers was lower by 23% (95% confidence interval [CI], 4 to 38) in the nicotinamide group than in the placebo group (P=0.02). Similar differences were found between the nicotinamide group and the placebo group with respect to new basal-cell carcinomas (20% [95% CI, −6 to 39] lower rate with nicotinamide, P=0.12) and new squamous-cell carcinomas (30% [95% CI, 0 to 51] lower rate, P=0.05). The number of actinic keratoses was 11% lower in the nicotinamide group than in the placebo group at 3 months (P=0.01), 14% lower at 6 months (P<0.001), 20% lower at 9 months (P<0.001), and 13% lower at 12 months (P=0.001). No noteworthy between-group differences were found with respect to the number or types of adverse events during the 12-month intervention period, and there was no evidence of benefit after nicotinamide was discontinued.

Conclusions

Oral nicotinamide was safe and effective in reducing the rates of new nonmelanoma skin cancers and actinic keratoses in high-risk patients. (Funded by the National Health and Medical Research Council; ONTRAC Australian New Zealand Clinical Trials Registry number, ACTRN12612000625875.)

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DOI: 10.1056/NEJMoa1506197

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