Analysis of a Prescribing Episode
This essay is a critical analysis of a prescribing episode that took place for a patient presenting with signs of ageing. The evidence base for the use of Botulinum Toxin Type A will be evaluated and the professional responsibilities and clinical governance issues associated with this intervention will be considered.
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Non-medical prescribing is prescribing by a specially trained healthcare professional working within their clinical competence as either an independent or supplementary prescriber (RPS, 2016). An independent prescriber can be defined as a “practitioner, who is responsible and accountable for the assessment of patients with undiagnosed and diagnosed conditions and for decisions about the clinical management required, including prescribing” (RPS,2016).
This essay is written from a community pharmacists perspective, studying to become a non-medical independent prescriber in the field of aesthetics. The GPhC states that a prescription can only be written by a non-medical prescriber who has completed the course and been entered on the register, therefore the actual prescription issued for this consultation was written by a qualified prescriber. All names of patients, clinicians, hospital or community trust have been changed for data protection and confidentiality reasons as per GPhC requirements.
A 35-year-old Caucasian female, Mrs H, attended the clinic, presenting with signs of ageing. Her areas of concern were the wrinkles around her eyes, forehead and frown. The Calgary-Cambridge consultation method was used to gather information about Mrs H and reach a shared decision on the best treatment for her desired outcome. This model encourages patient contribution and ensures the decision takes into consideration the patients best interest and therefore allows a trusting relationship to progress between the practitioner and patient (Kurtz, Silverman and Draper, 1998).
By using this model, all the necessary information was gathered, including a full past medical history, where it was ascertained that Mrs H was not taking any regular prescription medication, herbal or recreational medicines, but she did occasionally take OTC ibuprofen or paracetamol as a pain relief for headaches. She had no known allergies and any red flags associated with anti-wrinkle treatment, such as skin infections, pregnant or breastfeeding and auto-immune disorders, were ruled out. It was also discovered that the patient had not had any aesthetic treatments previously. On taking a full social and family history it was established that the patient is a non-smoker, drinks on occasion, enjoys using sunbeds and exercises regularly. Mrs H also lives with her husband and has no children. The patient completed a Cosmetic Procedure Screening Questionnaire to rule out body dysmorphic disorder (Veale et al., 2012).
A physical examination was taken, the patient was handed a mirror to help highlight her areas of concern. A realistic expectation outcome was given to the patient along with the benefits and risks associated with the proposed treatment, a prescription was written for Bocouture (a brand of botulinum toxin type A) and any aftercare advice was given that the patient must adhere to. A shared decision was agreed and the relevant information was documented. In order to make an informed decision the patient was given a ‘cooling off period’ to think about all the options discussed. The importance of this was highlighted in the Keogh report which reviewed the regulation of cosmetic interventions (Keogh, 2013).
Evidence Base and Critical Justification for Product Prescribed
The treatment options that may be considered for Mrs H are anti-wrinkle injections with botulinum toxin type A, dermal fillers using hyaluronic acid and cosmetic peels. The negative impacts of using dermal fillers such as, causing blindness due to the vascular anatomy to correct the glabella lines, were not favourable to Mrs H and therefore she chose not to pursue that treatment option (Beleznay et al, 2015). In addition, volumising the eyes, forehead and frown area was not a desired look for Mrs H.
The use of cosmetic peels to treat the wrinkles was explained to Mrs H. Cosmetic peels are used to treat the entire face using various different acids which help to rejuvenate the skin, giving the face a more youthful look. However, this treatment requires downtime and after having assessed Mrs H’s face a shared decision was made to disregard this option as the rest of her skin was in good condition and she did not want a treatment that would require downtime. Therefore, the chosen treatment for Mrs H was botulinum toxin type A due to its safety and efficacy profile. A literature search was carried out using PubMed, Cochrane library and various other journals analysing the studies to establish the safety and efficacy of botulinum toxin type A.
Botulinum toxin is a gram-positive bacterium produced by Clostridium botulinum and is broken down into seven serotypes: A-G. It works by blocking the release of a neurotransmitter, acetylcholine from nerve endings, thereby causing temporary muscle paralysis (Barnes, 2003). After approximately three months muscle functions starts to return as the neuromuscular junctions begin to recover (Sattler, 2010). With increasing age, environmental and genetic factors, the skin loses elasticity and wrinkles are formed. By using botulinum toxin type A these lines are flattened, smoothening the appearance of the skin. Botulinum toxin type A was initially approved for the treatment of dystonic and non-dystonic movement disorders in the 1970s. In 1987, it was first used in the aesthetics field, as it was observed that facial wrinkles were caused by repeated muscle contractions (Sattler, 2010). Botox received FDA approval in 2002 for temporarily improving the appearance of moderate to severe glabella lines in those under the age of 65. In 2007, the Medicines and Healthcare products Regulatory Agency (MHRA) decided that the benefits outweighed the risks and approved its use providing the procedure was undertaken by a trained practitioner. Once injected, it can take 3-10 days to notice any change and 14 days for full effect. With regular treatment the lines become less visible due to the muscles becoming more relaxed. (Aoki, 2003).
Several clinical studies have been conducted to validate the effectiveness of botulinum toxin type A. One particular study evaluated the safety and efficacy profile of botulinum toxin type A in treating glabellar lines. The study was carried out on 273 patients with moderate to severe glabellar lines, with 202 of these patients being injected with 20 units of Botox and 71 being injected with a placebo. The efficiency of treatment was measured based on the physicians and patients assessment of glabellar line changes. Follow ups were carried out at 7, 30, 60, 90 and 120 days post injection. For the physicians rating after 30 days, 77% of the botulinum toxin group achieved a severity rating of none to mild and 89% of the patients noticed a significant improvement in their lines. At every follow-up the botulinum toxin group achieved a higher responder rate than the placebo group. Rates of adverse effects were similar for both groups, with headaches being the only adverse effect with an incidence of ≥ 5% (botulinum toxin, 11%; placebo, 20%). Eyelid ptosis was observed in only 1% of the botulinum toxin group. Botulinum toxin type A was therefore deemed safe and effective (Carruthers et al, 2003). A limitation to this study is that it portrays only the physicians view of the results and does not take into account the patients opinion, which is vital in cosmetic aesthetics. However, Carruthers et al later created a Facial Line Outcomes Questionnaire (FLO) to allow patients to assess how the facial lines effect their perception of their facial appearance. A double-blind 12-week study took place, involving 70 patients that were randomly given either 20 units botulinum toxin type A treatment or a placebo. The results from the FLO questionnaire showed that patient treated with the toxin achieved a significantly lower median glabellar line severity and a greater proportion of patients felt they looked younger than their age (Fagien, 2007). A limitation of the study is that those with moderate to severe wrinkles were the only subjects tested, whilst Mrs H differs from the cohort as she has only mild wrinkles.
Adverse effects of botulinum toxin type A injections include swelling, redness, bruising and breathing difficulties. Some patients may experience eyelid ptosis; however, this adverse effect is due to the administration technique of the practitioner, therefore it can be avoided when carried out by a trained practitioner with extensive knowledge of the facial anatomy. A study carried out by Fagien also reiterated that botulinum toxin type A is safe and effective and unwanted adverse effects can be minimised by understanding the facial anatomy as well as using minimal effective dosages. (Fagien, 1999). As Mrs H has not had aesthetic treatment previously, the lowest dose would be used and adjusted after the two-week review if necessary. Furthermore, the treatment would be conducted in a sterile environment to minimise the risk of infection. Contra-indications to the use of botulinum toxin type A include a previous allergic reaction to the toxin or any ingredients within the product, a skin infection at the site of injection or on treatment for a urinary tract infection. During the consultation with Mrs H it was established that none of these applied to her.
Immunogenicity is a reported adverse effect when using botulinum toxin type A as it can neutralise antibody formation due to its high protein load, leading to reduced treatment efficiency. Botox, a first-generation toxin, consists of complex proteins of 900 kDa, with the biologically active neurotoxin making up only 150 kDa. Due to complex proteins making up a high foreign protein load, with no therapeutic value, the immunogenic potential of Botox is increased, potentially leading to treatment failure (Nigam, 2010). Newer generation toxins have a reduced foreign protein load, with Bocouture containing only the active neurotoxin and it has not been linked with any biologically relevant immunogenicity (Sattler, 2010). A study analysed 249 patients with cervical dystonia who were treated with older (25ng/100U) or newer (5ng/100U) formulations of Botox. Of the 42 patients treated with the older formulation, 9.5% had neutralising antibodies detected, compared to 0% of the 119 that had the newer formulation (Sattler, 2010). The product chosen to be used on Mrs H was Bocouture for both its effectiveness and cost purposes.
A vital part of cosmetic aesthetics is patient vulnerability and this must be ruled out prior to commencing treatment. Body dysmorphic disorder (BDD) is a psychiatric disorder portrayed by preoccupation with an imagined defect or distorted perception in physical appearance. Many people with this disorder seek cosmetic treatment to improve their appearance (Higgins, 2018).
In a study involving 250 adults with the disorder, 76.4% sought aesthetics procedures and 66% received the treatment, however 68% of these treatments resulted in no improvement or worsening in BDD symptoms. Only 7.3% led to a decrease in concern and overall improvement in BDD symptoms (Phillips et al, 2001). In another study by Veale, 81% of 50 BDD patients that received treatment were unhappy with their treatment outcome, further proving that cosmetic procedures do not improve BDD (Phillips et al, 2001).
Recognising and ruling out BDD prior to treatment is imperative due to its association with a poor quality of life and high suicidal rates. A tool regularly used during the consultation process in order to rule out the disorder is the Cosmetic Procedure Screening Questionnaire (COPS) (Veale et al, 2012). Mrs H was asked to fill out this questionnaire in order to eliminate this red flag.
The four biomedical ethical principles devised by Beauchamp and Childress (2013) are a fundamental framework encapsulating the professional and ethical responsibilities of healthcare professionals. These principles safeguard the prescriber by ensuring that their responsibilities to the patient, professional body and employer are continually met. The principles are listed below, referencing Mrs H where appropriate:
- Respect for autonomy – respecting each individual’s right to make their own informed decisions. In this context a patient can provide informed consent to any treatment they receive following a discussion of treatment options with the healthcare professional. For Mrs H, following her initial consultation where a full medical, social and aesthetics history as well as a facial examination were taken, several treatment options were discussed in detail, including the risks and recovery time for each. Mrs H made an informed, shared decision to have Botulinum Toxin Type A treatment.
- Beneficence – ensuring the benefits of treatment are weighed against the risks and costs associated with the treatment to act only in the best interest of the patient. Mrs H’s main goal was to reduce the lines on her eyes, forehead and frown. After ruling out any red flags and explaining all the risks and costs of the treatment options, it was decided that Botulinum Toxin Type A would be the most beneficial to her.
- Non-maleficence – not causing any harm to the individual. All treatments involve a degree of harm; however, this should not be disproportionate to the benefit of the treatment. With Bocouture injection, there is a risk of potential side effects, for example bruising and swelling, however this is outweighed by the potential benefits of the treatment. The safety profile for the use of this toxin in facial aesthetics has been confirmed (Cavallini et al.,2014) and the side effects and aftercare advice were explained to Mrs H, therefore following this principle.
- Justice – patients should be treated fairly in a non-discriminatory manner with regards to the benefits, risks and costs of any treatment or intervention provided. Mrs H was given all the treatment options along with the costs associated with each and a consultation was delivered using the Calgary-Cambridge model, as would be the case for any patient under similar circumstances.
Additionally, the GPhC has a set of ‘Standards for pharmacy professionals’ which must be adhered to (GPhC, 2017). These standards include that pharmacists must provide person-centred care and understand the individual’s values, needs and concerns. Mrs H was involved in deciding on the best treatment option and confidentiality and privacy was maintained, another standard set by the GPhC. Within this prescribing episode all nine of the GPhC standards were met.
Clinical governance is defined by the Department of Health as ‘a framework through which the NHS organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care by creating an environment in which excellence in clinical care will flourish” (DoH, 1998).
There are a series of processes which contribute to clinical governance, ensuring the highest quality healthcare is delivered. This is represented by seven pillars. These are:
- Risk management
- Clinical audit
- Education and training
- Clinical effectiveness
- Clinical information
- Patient, carer and public involvement
- Staffing and staff management
The discussion below will focus on the clinical pillar of patient involvement for this prescribing episode.
The Beryl Institute define patient experience as ‘the sum of all interactions, shaped by an organisation’s culture, that influence patient perceptions across the continuum of care’ (The Beryl Institute, 2019). Furthermore, NHS England states that patient experience is one of the three key components of quality (NHSE, 2013).
The NHS Patient Experience Framework 2011 emphasises the significance of allowing the patients to be involved in the decision with regards to their treatment by educating them and providing all the appropriate information to allow an informed decision to be made. The framework outlines eight key areas which contribute to a positive patient experience, including providing emotional support whilst managing patient expectations, access to care, physical comfort and transition and continuity (NHSE, 2011).
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A study conducted in several countries, including London and Canada, which involved 39 randomly selected family physicians and 319 patients proved that patient- centred care had a correlation with an improvement in their health status and the efficiency of treatment (Stewart et al, 2000). With regards to Mrs H she was given all the information needed with regards to treatment with botulinum toxin type A, as well as other treatment options, including the possible side effects and complications of the procedure. This enabled a trusting relationship to be formed and she was given full control of the decision to proceed with the treatment.
Managing patient expectations and educating the patient on their treatment is directly associated with successful treatment outcomes. Giving the patient more responsibility by allowing them to decide on which treatment to proceed with may lead to the patient choosing a different treatment than that which the practitioner deems most suitable. In this case, it is important for the practitioner to make the patient aware of the limitations enforced by not following the practitioner’s advice, however proceeding with an agreed alternative plan is more likely to achieve a more desirable result where expectations have been met (Robson, 2016). Mrs H made her own decision to go ahead with botulinum toxin type A treatment over the other proposed options and was willing to adhere to all the aftercare advice needed to be followed.
Mrs H was prescribed Bocouture to treat her wrinkles. This was the best choice, following evaluation of previous studies, due to its low immunogenic potential. She will be reviewed 2 weeks post treatment to observe the success of her treatment. Although there were other treatment options, Mrs H was at the forefront of the decision to use botulinum toxin type A, with the decision being made taking into account the patient’s best interest. Mrs H was well-informed of the treatment including the implications of not adhering to aftercare advice, minimising the chances of complications arising as a result of poor clinical governance. Professional responsibilities had been accomplished and the prescriber had built a trusting relationship with Mrs H. This has a positive impact on the patient’s treatment as well as her future care.
There is enough clinical evidence to support the use of botulinum toxin type A for anti- wrinkle treatment. However, in this field, social media is very influential in encouraging people to have cosmetic procedures, therefore it is the duty of the prescriber to ensure red flags are ruled out, in particular BDD and to give realistic expectations, all of which is part of the prescribing process.
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