Implications of Non-Medical Prescribing

Introduction

This care study will discuss the legal, ethical and professional implications that were experienced during a prescribing and non-prescribing behaviour whilst being a non-medical prescribing student (NMP). Prescribing decisions carried out were under the supervision of a designated medical practitioner (DMP). The aim of this assignment is to critically appraise available evidence on the non-medical prescription by focusing on the legal, professional and ethical aspects around prescribing with references to the case study. The author is a clinical nurse specialist in dermatology with two years’ experience. The rational foe choosing the case of acne vulgaris is the author’s encounter with acne patients bearing in mind that suicidal ideation among such patients is a known but uncommon side effect. On completing the case study, the author will be more knowledgeable and experienced in prescribing medication for patients, and more awareness to understanding the legal, ethical and professional issues that underpin safe prescribing. The chosen patient has been given a pseudonym in accordance with the nursing and midwifery code of conduct (NMC, 2018). Bella is an 18-year-old female attending the authors list for acne vulgaris (AV) more information can be found in (Appendix A). Changqiang et al (2019) states AV is the most common skin disease worldwide and can have significant negative impact on life.

The National Institute for Health and Care Excellence (NICE, 2018) set clinical guidelines for referral of patients with AV into a hospital setting and must be assessed by a trained dermatologist with expertise in retinoid. AV is a chronic inflammatory disease whose main manifestations are inflammatory lesions, papules, pustules, nodules, and cysts which can occur if left untreated (Mohammed Abu El-Hamd et al, 2018). Isotretinoin is used regularly in the treatments of AV, a recent piece of research provides supports that the use of isotretinoin as a second line therapy is very effective, (Tan, A., et al 2018). The British Association of dermatologists (2018) describe Isotretinoin as a vitamin A derivative (13-cis retinoic acid introduced in 1982) called a retinoid that works on blocking the production of sebum that is involved in the formation of AV, common side effects, (see appendix A) (Joint Formulary Committee 2018). A full history was taken (see Appendix A) where all important factors before a prescribing decision can be made (Nuttall et al 2016 127). She was taking Isotretinoin whose prescription was generated at 120 mg\kg (Joint Formulary Committee 2018 1234) for 16 weeks. The consultation unfortunately revealed Bella had experienced suicidal ideations therefore the decision making must be done in negotiation with her to stop medication, (Coulter, A. and Collins, A. 2011). DMP agreed not to continue with the medication advising to monitor and support appropriately. A robust literature review was carried out (Appendix D) to identify research that had looked at psychological impact on participants whilst taking Isotretinoin. Only a limited amount of studies and data was found. The critical appraisal skills programme (CASP) was used to review and evidently support the findings (CASP, 2013). A PICO has been used as it is helpful to develop a question to allow the author to focus on and gather the relevant information (Sacket et al, 1996, 72) (see Appendix B).

Legal perspectives

The above case study points to various legal frameworks that guide the care and management of diseases including acne vulgaris and equally protect the patient from unlawful practices by the medical practitioners. The common and most applicable legislations are herein discussed The Human medicine act 1992 section 58 has enabled nurses to prescribe now, the nursing role has changed considerably over the years and the medicine Act (1968) was amended in 1992 to reflect these changes. This act is law and governs decisions the author makes when prescribing. In this case study the non-medical prescriber is able to prescribe as independent and supplementary prescriber and also part of this role is to identify any adverse effect of the medication on patient and act on this information, relevant advice giving and informing consultant the designated medical practitioner is to ensure author keeping with this law (NMC 2019). Furthermore, the human medicines Regulations (2012) schedule 7 details the educational qualifications and experience necessary to practice as a medical practitioner. The other crucial legislations that are applicable in the prescribing and medical treatment in general are the mental capacity Act (2005) and the Mental health Acts (1983 and amended in 2007). These legislations provide the criteria for assessing the mental capability of the patient in making decisions regarding medical treatment to be accorded to them and describing the very limited circumstances when a patient can be forced to be hospitalised for assessment respectively. Basing on the profile of Bella, the mental capacity Act (2005) will be applicable as the patient will be required to consent to the medication prescribed prior to administration.

The observance, preservation and upholding of human rights is one of the core objectives of the nursing practice. Patients seeking medical care deserve to be treated in a humane way with dignity, which is one of the principles of patient centred care. As a medical practitioner, the human rights act (1998) provides a legislative emphasis on the upholding of the rights of the people, patients included. This Act therefore acts as a legislative guide in the provision of care to the patients. The human rights act (1998) further emphasizes on the principles of justice and fairness and the right for information, among other important aspects that are linked to the case of Bella. As a practitioner therefore, I endeavoured to treat Bella with dignity and respect by communicating effectively the condition she was suffering from, and providing the alternatives of the available medication that can be used to alleviate the condition of Bella.

Professional practice

The consultation had identified that Bella had suicidal ideations. The NMC sets professional standards for nurses. As an independent prescriber the nurse is accountable for their actions and omissions and should always prepare patients about risks and effectiveness of prescribed medication as well as the instances of ineffectiveness of the same medication (NMC, 2018). Additionally, all prescribers must adhere to the Royal Pharmaceutical Society (2016) competency framework whose relevance is paramount for safe prescribing to take place. The framework also underpins professional responsibilities, fosters effectiveness in medication management, and seeks to benefit patient’s outcomes in health and improve their quality of life. A legislation underpinning nurse prescribing is the Medicines Act (DOH, 1968) which dictates what nurses can prescribe and what they could not prescribe. The professional practice of nurses is emphasized through numerous professional standards that have been developed by relevant professional organizations tasked with monitoring and fostering the nursing practice. For instance, According to NMC (2018), nursing practice is enhanced through a demonstration of skills that nurses should demonstrate in practice when handling the patients. In this case, the nursing practitioner ought to base their operations on seven platforms such as accountability, promotion of health and prevention of ill health, assessing needs and planning care and providing and evaluating care. Additionally, the nurse should manage nursing care, improve the safety and quality of care and coordinate care. These crucial requirements were crucial in the management of Bella’s condition. The NMC code (2018, 9) sets out the importance of using evidence-based practice and the need to practise in line with these to ensure patient safety. Best evidence should be utilised when making decisions for individuals. One of my roles entailed advising Bella on the best medication that is effective to manage her condition. There is controversy surrounding whether Isotretinoin affects mood or not (Chee et al 2002). The first literature research carried out from 1984-2017 was a systematic review and meta-analysis worldwide study, using electronic search engine, PubMed, Embase, Cochrane library. The study focused on identifying whether there was an association risk between isotretinoin and depression in patients with acne, (all participants had acne). Twenty studies were analysed, seventeen showed that participants experienced improved mood whilst taking isotretinoin, the advisory from this study was to carry out future randomised controlled trials which would be of benefit to conclude these finding further (Changqiang et al 2019). Concerns relating to the negative impact on mood was not only from patients experiences but bore out of an experiment study with mice which revealed the hippocampus was significantly affected on learning ability and a deterioration in long term depression in mice was seen when given 13-cis retinoic acid (RA), (Crandall, J.et al 2004). A further study was carried out that strengthened this. It looked at effects of RA and antibiotic on brain function before and after four months treatment, revealing the orbitofrontal cortex was slower, the part of the brain associated with depression in the RA group (Bremner et al 2005). However, with only 28 participants, therefore limited data, small sample sizes can weaken the validity of a study (Faber & Fonseca, 2014, 3).

A similar study looking at the same criteria was conducted involving 30,496 participants in a retrospective, controlled case crossover study. The findings showed around 50 cases of depression, 10 suicide attempts whilst taking isotretinoin (Azoulay, L. et al 2008). Importantly to these findings Rademaker, (2010) carried out retrospective review isotretinoin verse placebo, and included 1743 participants over six years and the evidence found no suicidal ideation from isotretinoin use, it did reveal thirteen patient had to stop treatment for mood changes, however it did not expand on what these changes were, therefore the data is insufficient. The author is aware that there are possible links to isotretinoin but the skin condition itself can drive the negative psychological effects. As a non-medical prescriber, it is important to highlight at this point, the Medical and Healthcare products agency (MHRA 2014) reported via the yellow card system, ten most common side effects associated with Isotretinoin was psychological complaints, of the 2200 reported side effects, 268 was depression, 499 suicidal ideation. To strengthen the likeliness there is a risk associated, the electronic medicines compendium that is governed by MHRA (2014), have up to date information leaflet on Isotretinoin and the summary of product section 4.8 confirms, although rare, it can cause depression, aggressive tendencies, anxiety, mood changes (accounting for one in every thousand) and abnormal behaviour such as psychotic disorder; suicidal ideation; suicide attempts and suicide- although very rare, (accounting for one in every ten thousand).The first official warning regarding potential psychiatric problems were put on the product label in 1998 as awareness was increasing (MHRA, 2014).

The information gathered during the literature search was important since it did not always demonstrate direct causation regarding the use of Isotretinoin and suicidal ideations, and however it could not exclude it either. The studies all suggested further research to assess further the links between. There may not be a huge amount of research to support psychiatric adverse events (Rademaker 2010) however that does not mean it should not be dismissed. The argument when looking at the data suggests that although the risk of isotretinoin use is there, it use is more likely to have positive effect on patient as it improves the appearance of the patient’s skin (Sundstrom, A. et al 2010). Isotretinoin has been identified to be linked with several safety concerns therefore as a non-medical prescriber the necessity to be fully aware of the concerns and patient information, close monitoring and the necessary action must be taken to avoid harm. Under tort law any prescriber who works outside their sphere of competence would be considered as being neglectful and if harm is caused to the individual they would be very nearly be found guilty in a court of law (Broadhead, 2011). Due to teratogenic effects on an unborn baby Isotretinoin has strict guidelines and restriction (BAD 2018). The MHRA (2014) and United Lincolnshire hospital trust, (ULHT, 2018, policy for medicines management section 3, Prescribing BAD 2018) stipulate these strict guidelines and processes must be adhered to when prescribing to avoid harm. Concordance is a vital component of the prescribing decision (Coulter and Collins, 2011) if there are concerns regarding concordance, the prescribing practitioner should consider not prescribing due to the high-risk factor associated with this medication. Relationships and risks of treatment generates tension for practitioners (Coulter and Collins, 2011). There is a large volume of literature highlighting the need for concordance and the importance for shared decision-making, this in turn increases the possibility of improving a joint acceptance for all involved (Felzman,2012) (Royal Pharmaceutical society, RPS 1997). The national prescribing centre (NPC) incorporate seven principles of good prescribing (NPC, 1999) including advising and reviewing patients regularly as a way of assessing the safety and efficacy of medication since without such measures potential harm may happen. Everything was documented, always being accurate, clear and concise and ensuring confidentiality is achieved (NMC, 2015). Additionally Good record keeping is a legal and professional requirement. Once the decision was made and consultation ended, information is handwritten into patients’ medical notes (Coulter and Collins, 2011). Electronic dictation was completed about the consultation and a copy was sent to GP and patient.

The department of Health (DOH,2009) State that consent should be gained before any physical contact, examination, treatments is started; in order to comply, the patient should be fully aware and understand the information given- if this is not achieved- the consent is not valid legally nor ethically, consent can be withdrawn at any time (Menendez,2013). If consent had not been obtained prior to authors interventions it could result in a prosecution for trespass, battery of the individual (General medical council GMC, 2009; Department of Health, DOH,2009). Further consideration was given to the two types of consents, first being implied consent- non-verbal actions and secondly informed consent- being expressed written or orally, the latter was obtained. Consent must not be obtained under coercion or forced; the patient should also be deemed to have the capacity to make the decision. If a person lacks this capacity under the Mental capacity act (2005) any decision must be in their best interest (DOH, 2009), however it must be assumed a person has capacity except if it has been determined they lack capacity under the mental capacity Act (2005), Bella did not lack capacity, Consent was gained verbally. Gaining written consent only provides confirmation of consent and in most instances not a legal necessity but best practice, (DOH, 2009). Patients should fully understand benefits and risks associated with their treatment for informed consent to be valid, a vital part of any prescribing decision. Respect should be given to the patients’ rights to decide what they want from their care and to be free to stop this at any time, (General Medical Council (GMC), 2009).

Ethical issues

Autonomy is considered a fundamental important principle morally (Hendrick, 2004, 30). The nurse plays a crucial role in respecting freedom of choice by encouraging individual patients to make decision. To stop the medication with consideration of facts and values, Bella had the ability to rationally consider the information regarding her psychological needs. (Kitchener, K. S. 1984). When taking everything in mind when prescribing decisions are made, for autonomy to be achieved, a shared decision-making process must take place, patient choice and a partnership between patient and professional must be established (Coulter and Collins, 2011). As a registered professional nurse, the NMC, (2018) states that nurses should act in the patients’ best interest- the author ensured Bella agreed a mutual decision to stop medication and an understanding of the reasons why (Coulter and Collins, 2011). Kitchener, K. S. (1984) states that justice is treating everyone fairly and being fair minded irrespective of values and beliefs. Bella was reviewed on an individual basis and her needs were identified and taken into account. The principle of non-maleficence- relating to doing no harm is the most imperative pillar for all professionals. This was a consideration, when the decision to stop prescribing isotretinoin which was causing psychological symptoms (Broadhead (2016, 79). The NMC, (2018 8) state that nurses should act in the patients’ best interest when prescribing and monitoring care delivery and thus the author, in the course of monitoring the condition of Bella following the prescription with isotretinoin, discussed everything with Bella and an agreed decision was made to stop medication and prevent any further deterioration in mental state with a review and subsequent support planned. (Coulter and Collins, 2011). Prescribing more medication could possibly lead to negligence and therefore a breach of the duty of that care in any prescribing process. (Broadhead, 2011; Dimmond, 2011). The author has a duty to care and to ignore such information and continue with treatment would breach this. The principle of non-maleficence and the duty to care relates to not intentionally causing harm, (Beauchamp and Childress, 2013). To follow this applied principle, it is essential to have the right level of knowledge of the harm, side effects involved, also consideration to stopping treatment may have consequences, the acne may flare leading to further distress (Kitchener, 1984). The principle of beneficent means to “do good” and to prevent harm, to not give a repeat prescribing thus the author had a duty as an independent prescriber to be of benefit to Bella, (Mc Cormick, 2013). Therefore, stopping the treatment was to gain maximum benefit and far weighed out the risk to continue. There is strong evidence that patients that are passive recipients of care decisions tend to have poorer outcomes than those who take an active role in shared decision-making process (Coulter and Collins, 2011).

Conclusion

The evidence reviewed appears not to give a clear-cut answer therefore the author must apply caution when faced with important situations on prescribing decision and review them on an individual basis. There is a wealth of information pertaining to the legal, professional and ethical issues entwined in prescribing. Duty of care must always be the primary end point. This case study has provided a valuable learning and underpins knowledge in the prescribing decision. The use of Isotretinoin and the side effect on mood has been critically reviewed and a full awareness that the findings are limited but there are concerns regarding isotretinoin use, these are well documented and the casual relationship between psychiatric symptoms and isotretinoin continue to be disputed. The need to review patient on an individual bases is therefore paramount for future practice. The author endeavours to ensure all patients are fully assessed prior to starting using a system similar to the one used in the research literature as previously this has not been their practice, therefore very difficult to measure the effects of treatment, distress and psychological impact of the disease over the actual medication side effects, benefits of taking isotretinoin still outweighed the risks of side effects for most people. (MHRA, 2014). The author is obligated to maintain competency in relation to treatment and care of patients and will achieve this by keeping a professional portfolio and continuing to work as part of a team using the specialised guidelines drawn from the royal pharmacology and NMC. The author is aware of their limitations and will always seek advice from other independent prescribers. Two appropriate psychological assessment tools have been implemented into the author’s future practice and a PowerPoint presentation has been created to share with other practitioners working with AV patients. The author identified limitations in assessing patient prior to the case study in dermatology.

This new process will ensure a more robust screening and assessment tool be implemented in future practice, starting at the beginning of patient’s treatment and beyond to increase insight into isotretinoin and it impact on patient’s mental wellbeing. The completion of the care study has given the author the opportunity to reflect on a decision not to prescribe. The evidence points that acne too causes psychological problems associated with suicidal ideations, however the effects of treatment also impacted on certain individuals and must be considered carefully (Appendix D).

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