CONTEMPORARY ETHICAL AND MORAL DILLEMAS IN COMMUNITY PHARMACY’S PRACTICE ON HCP 2022 December, 2022 1 CONTEMPORARY ETHICAL AND MORAL DILLEMAS IN COMMUNITY PHARMACY’s PRACTICE ON HCP 2022 Authors: Mojca Bratun, Irma-Hermina Klemenc Editor: Martina Puc Technical editor: Špela Vozelj Published by: COVIRIAS, Parmova 14, 1000 Ljubljana Phone: +38612322097, info@covirias.eu Ljubljana, December 2022 1st edition Free publication The publication is published in e-format (.pdf). The publication is published publicly on website: www.covirias.eu Kataložni zapis o publikaciji (CIP) pripravili v Narodni in univerzitetni knjižnici v Ljubljani COBISS.SI-ID 132310531 ISBN 978-961-95129-7-5 (PDF) 2 About authors Mojca Bratun Mojca Bratun is a Holistic Consultant at the Community Pharmacy Lekarna Dobrova, Slovenia. She is also the Head of a product group Medical Devices in Lekarna Dobrova. She received a recognition as the first Holistic Community Pharmacist of the Year 2019 by COVIRIAS academia. Irma-Hermina Klemenc Irma-Hermina Klemenc is a Holistic Consultant at the Community Pharmacy Lekarna Dravlje, Slovenia. She is also the Head of two product groups, Food Supplements and Cosmetic products in Lekarna Dravlje. In 2020 she received the title the Holistic Community Pharmacist of the Year by COVIRIAS academia. 2 Table of Contents FOREWORD Page 4 IS IT ETHICALLY AND MORALLY QUESTIONABLE TO ISSUE Page 5 EYE DROPS AS A MEDICAL DEVICE FOR THE TREATMENT OF INFLAMMATION? IS THIS THE BEST OUR HEALTHCARE SYSTEM HAS TO Page 9 OFFER, OR IS THERE PLACE FOR IMPROVEMENT? 3 CONTEMPORARY ETHICAL AND MORAL DILLEMAS IN COMMUNITY PHARMACY’S PRACTICE HCP CONFERENCE 2022 PREDGOVOR¹ Na 4. HCP konferenci naslavljamo suverenost in transformacijo lekarn in lekarništva. Gre za dve temi, na kateri močno vplivata etičnost in moralnost vseh deležnikov lekarne, ne le zaposlenih za lekarniškim svetovalnim pultom. Transformacija je proces, ki za lekarne praktično ni več suverena izbira. Vsaka lekarna je, kot praktično vsi poslovni subjekti, izpostavljena takemu številu in frekvenci sprememb v okolju, v katerem deluje, da brez sprememb enostavno ne more preživeti. Tiste lekarne, ki so že pred covidnim obdobjem imele jasno vizijo, kam si želijo priti, kakšne želijo postati, so že dobile odgovor, ali njihova vizija in strategija preneseta test realnosti. Vse ostale pa premetava kot barke na viharnem morju. Različne lekarne so se različno odzivale na izrazite priložnosti za suverene odločitve. Nekatere so te priložnosti zagrabile, nekatere so se jih otepale do konca in čakale na navodila. Postavljanje v vlogo zgolj izvajalca, neprevzemanje odgovornosti za odločitve, pa pač ne more biti znak suverenosti. Ali je lahko pravna ali fizična oseba, ki ne želi suverenosti, se ji odreka, etična in moralna pri svojem delu, tako ni več le filozofsko vprašanje. Covidno obdobje torej ni razgalilo do obisti le vizij, strategij in poslovnih modelov lekarn in njihove robustnosti, temveč tudi etičnost in moralnost njihovih vsakdanjih odločitev. Ne glede na to, kako sami ocenjujemo posamezne poteze lekarn, pa je smiselno spodbujati ozaveščenost lekarn o pomenu etičnosti in moralnosti. Sedaj lahko namreč v praksi vidimo, da zgolj obstoj strokovnega znanja še nič ne pove o tem, kako bo nekdo to znanje tudi uporabil. Ali sploh vidimo različne možnosti, izbire? Že samo iskanje odgovorov na to vprašanje nas vodi k večji ozaveščenosti, ki je predpogoj za etično in moralno vedenje. Torej pasivnost v razmišljanju je že sama po sebi neetična in nemoralna, ko gre za poklic v zdravstvu. Zato smo v tem izjemnem letu še posebej ponosni na kolegici iz slovenskih lekarn, ki sta vložili svoj čas v strukturiran razmislek o etičnih in moralnih dilemah v svoji vsakdanji praksi. Čestitamo magistri Bratun za njen prvi aktivni prispevek na tem področju, in čestitamo magistri Klemenc za njen že 4. prispevek o etičnih in moralnih dilemah v lekarni. Na vas pa je, da uporabite njuna prispevka kot izhodišče za razmislek tudi v vaši lekarni. MAG. SCI. MARTINA PUC MAG. FARM., SPEC., MBA USTANOVITELJICA COVIRIAS ACADEMIE IN AVTORICA KONCEPTA HOLISTIČNA LEKARNA ¹ V prvih dveh letih smo ugotovili, da imajo lekarniški farmacevti težave pri udeležbi na HCP konferenci zaradi izvedbe v angleškem jeziku. Da bi omogočili lažje spremljanje predstavljenih vsebin in vključevanje čim več zainteresiranim, smo letos pripravili kombinirano obliko tako samih srečanj, kot tudi pričujoče spremne publikacije. 4 IS IT ETHICALLY AND MORALLY QUESTIONABLE TO ISSUE EYE DROPS AS A MEDICAL DEVICE FOR THE TREATMENT OF INFLAMMATION? MOJCA BRATUN LEKARNA DOBROVA A patient comes to the pharmacy with red eyes and sees a product on the shelf he wants to use. The product packaging is exposing a medicinal plant , which is used in folk medicine to relieve inflammation of the eyelids, barley and tired eyes. The patient is familiar with the product and says that he has already used it to treat mild inflammation, because it contains an extract of a medicinal plant. However, the product does not contain enough medicinal plant extract to effectively treat inflammation. Furthermore, the official product status is a medical device. Moreover, the official active compound is intended for moisturizing and is not marked pictorially on the packaging. How should the community pharmacist respond to the patient's expectations without losing the patient's trust or misleading him, without exposing the patient to the further eye damage due to inadequate self-medication and to act by the profession and the law? According to the Regulation on medical devices, a medical device must not exhibit pharmacological effects, in this case medicinal plants. Otherwise it must be registered as a medicine. If the product has a pharmacological effect, it must be registered as a medicine by the Medicinal Products Act. 5 The community pharmacist must also consider the protection of patient’s and human rights and make sure to avoid unnecessary injuries, even assuming that such injuries are possible. The community pharmacist must present the risks to the patient. Treatment of eye inflammation is not suitable for self-medication and as such giving the medicinal product is unprofessional and illegal. Currently, the product is sold in various sales channels (pharmacies, specialized stores and the Internet) with exposed medicinal plant on the packaging. However, legally prescribed professional advice for self-medication is not guaranteed everywhere. Moreover, none of the competent institutions supervises the execution of the sale and the accompanying advice. The community pharmacist's dilemma is how to react in this situation. The rights and needs of the patient, the legislation, and the guaranteed product performance must be met. The product is suitable for self-treatment dry eyes with an eye moisturizing ingredient. The user, or rather the patient, expects an anti-inflammatory effect since this type of medicinal plant is exposed on the packaging. The exposed medicinal plant in the product is not in sufficient quantity to ensure such an action. Additionally, eye inflammation is not allowed for self-treatment but must be treated only by the doctor. The community pharmacist must first determine with appropriate advice whether the patient has a condition that is suitable for self-treatment or if it is necessary to refer him to a doctor. The consequences of an inappropriate decision, as to whether the patient's condition is even suitable for self-treatment and what the appropriate therapy is, represent a considerable risk for the patient. For example, if the patient expects the product to treat the inflammation, he may forego visiting the doctor and thereby risk further deterioration. In addition, harmful consequences such as severe chronic inflammation, impaired vision and blindness may occur without adequate counseling. Short-term consequences are mostly not expected. After all, patients quickly contact a doctor in case of serious eye problems. Long-term consequences of self-treated chronic inflammation, can be expected. Inflammation may occur in 12 to 19 percent of dry eye patients. In the last year, 290 eye drops with medicinal plant extracts were sold in the community pharmacy Dobrova. 6 If only 10 percent of patients did not self-medicate correctly, 15 to 30 patients could have eye problems. According to statistics, in 2012, 30 patients were admitted to the SPP hospital due to complications during dry eye treatment. Adequate counseling is urgently needed when dispensing eye self-treatment products. Therefore, it is necessary to call on the competent authority to dispense such products only in pharmacies. At the same time, all pharmacies must provide appropriate professional advice when dispensing such products, including checking what kind of problem is being treated and whether it is suitable for self-medication or not. It is necessary to address this issue in special professional inspections, and all individual pharmacies should receive appropriate training. The responsiveness and systematicity of JAZMP as the competent authority for both medical devices and medicines is questionable, as there is no such practice. The field of medical devices might require the support of an expert group with the appropriate competences for evaluating the risks of individual products. Another question is, how quickly are pharmacies able to systematically respond to the exposed dilemma. The answer will be shown in practice. 7 References 1. Zakon o medicinskih pripomočkih. Uradni list RS, št. 98/09, 2. Zakon o zdravilih. Uradni list RS, št. 17/14 in 66/19, 3. Pravilnik o razvrščanju, predpisovanju in izdajanju zdravil za uporabo v humani medicini. Uradni list RS, št. 86/08, 45/10, 38/12 in 17/14 – ZZdr-2, 4. Pisk N. et al Samozdravljenje - priročnik za bolnike. Ljubljana: Slovensko farmacevtsko društvo, 2011, 5. Zakon o lekarniški dejavnosti. Uradni list RS, št. 85/16, 77/17, 73/19 in 186/21, 6. Nurnberški kodeks, dostopano https://en.wikipedia.org/wiki/Nuremberg_Code, 7. NIJZ podatkovni portal, dostopano www.podatki.nijz.si, 8. Lekarna Dobrova, Pregledi, Prodaja po artiklih 8 IS THIS THE BEST OUR HEALTHCARE SYSTEM HAS TO OFFER, OR IS THERE A PLACE FOR IMPROVEMENT? IRMA-HERMINA KLEMENC LEKARNA DRAVLJE A 40-years old woman who was having problems with constipation, came in seek of advice to our pharmacy. She was prescribed a syrup Lactecon containing lactulosis as well as galactosis and fructose. In the colon, Lactecon is metabolised by bacterial enzymes to short chain fatty acids, mainly lactic and acetic acid as well as methane and hydrogen. This effect leads to a decrease of the pH-value and an increase of the osmotic pressure in the colon. This causes stimulation of peristalsis and an increase of the water content of the faeces. However, I advised her to be cautious as Lactecon should be administered with care to patients who are intolerant to lactose, and completely inadvised in case of galactose or fructose intolerance or malabsorption. She expressed doubt of her being able to follow through the prescribed therapy as she was lactose intolerant and subsequently following keto diet for the past 3 years. Moreover, in her general physician’s office were acquainted with her condition along with her lifestyle choices. However, she already was moderately physical active and according to her, she daily consumed sufficient amount of water. 9 According to the valid Slovene pharmaceutical code of deontology, a pharmaceutical professional should be impartial and shouldn't distinguish people on the basis of gender, race, lifestyle, sexual orientation, religion, nationality, social status, beliefs or values. As a healthcare professional, he provides his expertise knowledge to each patient. The pharmaceutical professional must provide the patient with comprehensive and objective information in an intelligible manner, without misleading the patient, so that he or she can make the right decision. The Patients’ Rights Act states that »in order to ensure exercise of the right to independently decide on treatment and to participate in the treatment process, patients shall have the right to be informed of the possible risks, side effects, negative consequences and other inconveniences related to the proposed medical procedure or treatment, including the consequences of the suspension thereof and alternative treatment possibilities«. (1,2,7) “Food as medicine” may be an emerging concept in the Western world but has existed for centuries as the cornerstone of health for many cultures. Moreover, it generally refers to prioritizing food and diet in an individual’s health plan, with the goal of either preventing, reducing symptoms or reversing a disease state. Foods that proponents claim have medicinal properties, often due to supposed high levels of a particular micronutrient or biomolecule. Furthermore, scientific findings support the integral role of diet in health management which is acknowledged by WHO, as some diet regimes may help provent chronic inflammation, an underlying risk factor in the development of heart disease, type 2 diabetes, poor gut health, and other chronic diseases. However, the “food as medicine” approach to health management challenges the construct of conventional medicine, which relies primarily on technological medical advancements to manage health and disease with pharmaceutical drugs. Be that as it may, it is worth nothing that conventional, Western medicine does prescribe dietary and lifestyle changes as a first-line treatment for some conditions, hypertension and PCOS being some of them. Nevertheless, the focus is on the balance of macronutrients in the diet, and there is as yet little clarity as to what that should look like for humans. The pharmaceutical treatment of a patient should be the individual, comprehensive, proactive, periodic and systematic treatment of patients. (4,5) 10 Through my concern for the woman’s problems with constipation, we had a discussion about her diet. I advised her to include more fibre and unsaturated fats such as omega-3 found in fish and avocado into her daily diet regime. Consistently with her diet choice, I suggested increased consumption of fibre with psyllium husk. Overall, my advices on improvements of her diet completely coincided with her choice of keto regime. On what ground could someone label which variety of diet is better for which individual? Although, there is a vast assortment of nutrition reasearch, I am confident to state, there is still little clarity if there is an optimal balance of macronutrients that applys for general population of humans. The truth of the matter is, that each individual's organism is unique and as long as major health problems unable one to live their everyday life of choice, they have the right to independently decide on thier treatment as well as their lifestyle. According to the 3rd article of Pharmacy Practice Act “a pharmacist shall act in such a manner so as to maintain impartiality and professional independence in the performance of a pharmacy practice”. Furthermore, we are obligated as community pharmacists to counsel visitors of our pharmacy with respect for thier autonomy in decisions on thier preferred treatment. Be that as it may, by attempting to convince our visitor into abandoning her keto regime, my credibility would come into question. (2, 7) Medical nutrition therapy is a part of evidence-based health practice that uses diet and food to support the treatment of diseases, and it is a clear demonstration of diet and food's role in managing chronic disease. As commonly acknowledged, improvements in diet quality can also reduce disease symptoms and improve quality of life.(4, 5) It is repeatedly as well as frequently overlooked by healthcare professionals that the term »patient« does not necesseraly mean a sick person, but also a user of healthcare services in relation to a healthcare professional or healthcare service providers, regardless of one's health condition. Consequently, in our pharmacy we have resolved the dilemma by referring to our costumers as visitors. This way the active preservation of health, the prevention of disease, deterioration of health, as well as the proper use of medicines and other disease control measures are established. (1) Unfortunately, it recurrently happens in recent times that people are not provided with total healthcare service. Furthermore, it appears that people are forced into accepting therapy and health counsel in line with conventional medicine, either by being opportunistically presented treatment information or by withholding complete information about other possibilities of alternative treatments. 11 Never the less, the total information should be explained to the patient by a health professional in a direct manner, with due discretion, in understandable language, in accordance with the individual's capacity to comprehend information, fully and in a timely manner. (1) Basic service provided in community pharmacies should be one of customer well-being service. Community pharmacists have the knowledge and experience to determine whether self-medication is appropriate, and how important role diet has in health management at issue, considering the health condition of our visitor. Nevertheless, pharmacist also takes on responsibility for consequences of the advised form of treatment. (2) However, it is of utmost importance that every professional advice is given with respect for all moral, cultural, religious, philosophical and other personal convictions of our customers, otherwise our professional opinion will not be convincing. In the past few years, the gap between segment of population who is comitted to conventional medicine, and those who are devoted to improve thier health condition in some other manner has escalated. Fair share of accountability hence must be put upon majority of healthcare professionals altogether. For they are the ones who ignore and refuse to hear their patients. Furthermore, by continuing to do so, healthcare professionals neglect the patient's right to cooperation with their treatment and to recieve complete information about all aspects of possible therapies. (1) Constant improvement should be the highest standard in order to provide quality service activities. To conduct so, it is obligatory for the provider of specific service to implement a system of continous improvement of services, as well as the system to apprehend as many as possible aspects of potential risks. Never the less, to present the customer with thorough service, it is crucial to monitor quality indicators through the process of internal assessment of good practice. (6) In conclusion, principal patients' rights must be respected by all healthcare service providers in the framework of contemporary medical doctrine. Professional standards, norms and the level of development of the healthcare system in the Republic of Slovenia depends on it. 12 References 1. Zakon o pacientovih pravicah/ZPacP, Uradni list RS, št. 15/2008, 55/2017, 177/2020 in 100/2022 – ZNUZSZS (Patients’ Rights Act) 2. Zakon o lekarniški dejavnosti/ZLD-1, Uradni list RS, št. 85/2016, 77/2017, 73/2019 in 186/2021 (Pharmacy Practice Act) 3. Troyer J L, Racine E F, Ngugi G W.: The effect of home-delivered Dietary Approach to Stop Hypertension (DASH) meals on the diets of older adults with cardiovascular disease. The American Journal of Clinical Nutrition, Volume 91, Issue 5, May 2010, Pages 1204–1212, https://doi.org/10.3945/ajcn.2009.28780 4. https://nutrition.org/nutrition-and-chronic-disease/ 5. Witkamp R F, van Norren K: Let thy food be thy medicine….when possible. Eur J Pharmacol . 2018 Oct 5;836:102-114. doi: 10.1016/j.ejphar.2018.06.026. Epub 2018 Jun 21 6. Zakon o varstvu potrošnikov/ZVPot, Uradni list RS, št. 20/98, 25/98 – popr., 23/99, 110/02, 51/04, 114/06 – ZUE, 126/2007, 86/2009, 78/2011, 38/2014, 19/2015, 55/2017 – ZKolT in 31/2018) (Consumer Protection Act) 7. Kodeks lekarniške deontologije, (3) člen 21, 23; Uradni list RS, št. 85/2016 in 77/2017 (19.6.2019) (Code of deontology) 13 www.covirias.e u 9