Lecture 3.1 - PBM Ethics and Legal WITS Notes 2024 PDF

Patient Blood Management… is not only about Patient Blood Management. Dr Petro-Lize Wessels Lead Consultant Patient Blood Management and Transfusion Medicine  Health equity “The Law” Patient...

Patient Blood Management… is not only about Patient Blood Management. Dr Petro-Lize Wessels Lead Consultant Patient Blood Management and Transfusion Medicine  Health equity “The Law” Patient outcomes Ethics PBM Aim of this lecture… To introduce you to the basic concepts of Patient Blood Management. To raise awareness on the ethical and legal implications around transfusions. To spark debate as early as possible in your careers. Global Health Definition: Global Health Koplan et al. define global health as: “An area for study, research, and practice that places a priority on improving health and achieving health equity for all people worldwide’. (The Lancet, June 2009). Definition: Health Equity CDC: Health equity is achieved when every person has the opportunity to “attain his or her full health potential” and no one is “disadvantaged from achieving this potential because of social position or other socially determined circumstances.” Iron Deficiency  Negative impacts of iron deficiency Extreme fatigue & Weakness Chest pain, fast heartbeat or shortness of breath Headache, dizziness or light-headedness Inflammation or soreness of your tongue Brittle nails, Pale skin, Cold hands and feet Unusual cravings for non-nutritive substances, such as ice, dirt or starch Negative impacts of ID: Pregnancy and Perinatal period Pregnancy Breathing difficulties, fainting, tiredness, palpitations, sleep difficulties.  risk: Perinatal infection, Pre-eclampsia, Bleeding, Post-partum cognitive impairment, Behavioural difficulties. Foetal brain requires iron for normal development (Food and Nutrition Bulletin, vol. 28, no. 4 (supplement) © 2007, The United Nations University) Adverse perinatal outcomes IUGR, Prematurity, LBW – all with significant morbidity / mortality risks.  Long-term effects of iron deficiency anemia 20 – 25% of infants suffer from iron deficiency anemia (IDA) Even more with ID presenting with normal Hb’s (hidden ID) Results of IDA in children aged 11 -13 years: o Repeating grades, reading- and speech problems, attention problems o Behavior problems - anxiety, depression, thought problems, aggressive behavior, Internalizing problems o Referred to special services and tutoring (lacking services in SA)  Children enrolled between 1 – 2 years of age presenting with IDA With chronic IDA: 58% did not complete secondary school 76% Were not pursuing further education/studies 83% were single Reported poorer emotional health At age 25 - never catching up to their non-IDA peers Struggle to hold a job  Indicating a cascade of adverse outcomes Patient Blood Management  Definition of Patient Blood Managment Association for the Advancement of Blood & Biotherapies “PBM is an evidence-based, multi-disciplinary approach to optimizing the care of patients who may need transfusions. Covers all aspects of patient evaluation and clinical management surrounding the transfusion decision-making process. This includes: - Application of appropriate indications, - minimizing blood loss and - optimizing the patient’s red blood cell mass.”  Definition of PBM (2) Society for the Advancement of Blood Management (SABM): “PBM is the timely application of evidence-based medical and surgical concepts designed to maintain hemoglobin concentration, optimize hemostasis and minimize blood loss, in an effort to improve patient outcomes.”  Core focus points of PBM Timely optimization of the patient’s own red cell mass – diagnosis and treatment of anaemia. Pillar 1 Control / minimize blood loss and bleeding. Pillar 2 Optimize and harness the patient’s physiological reserve / tolerance to anaemia. Pillar 3 Patient empowerment and - participation in the decision-making process. Informed Consent Multi-disciplinary approach.  Optimizing patient outcomes Anemia Iron Trans- deficien fusion Farmer, et al describes cy a Triad of independent risk factors for adverse Blood loss patient outcomes. Bleeding Break the cycle by preventing inappropriate transfusions! 3 Pillars of PBM 3 Pillars of PBM Anaemia Blood loss and Transfusion Iron Deficiency Bleeding Harness and Optimise Minimize blood optimise patient’s own loss and physiological red cell mass bleeding tolerance of anaemia  Optimise the patient’s own red cell mass Pre-op Intra-op Post-op Screen/assess for anaemia ✓ ✓ ✓ Consider drugs / interactions that can contribute ✓ ✓ ✓ to anaemia Identify underlying reason for anaemia ✓ ✓ ✓ Treat / manage anaemia or underlying cause/s ✓ ✓ ✓ optimally Refer for further investigation ✓ ✓ ✓ Assess iron stores if significant / further bleeding is ✓ !!! ✓ ✓ anticipated Consider medication to IV haematinics to ✓ ✓ ✓ increase hemoglobin  Minimize blood loss and bleeding Pre-op Intra-op Post-op Minimize sampling! ✓ ✓ ✓✓ History: Identify bleeding risks ✓ Review and change medication that may cause or  ✓ ✓ ✓ bleeding Plan, discuss / rehearse the procedure. ✓ Meticulous surgical expertise and hemostasis ✓ Use appropriate anaesthesia techniques and patient ✓ positioning. Use autologous donations, ANH, cell saving, fibrin glue or ✓ ✓ pharmacological agents where indicated. Maintain normal volume and temperature ✓ ✓ Observe for and manage bleeding early. ✓ ✓ Avoid hypertension & adverse drug effects. ✓ ✓ Manage anticoagulation ✓ ✓ ✓ Harness and optimize physiological reserves / tolerance to anaemia Pre-op Intra-op Post-op Determine estimated blood loss per procedure. ✓ Determine tolerable blood loss per patient ✓ Develop a patient-specific plan. ✓ Optimize cardiac function, ventilation and oxygenation. ✓ ✓ ✓ Follow restrictive, evidence-based transfusion triggers. ✓ ✓ ✓ Maintain optimum temperature during and after procedure. ✓ ✓ Minimize oxygen consumption. ✓ ✓ ✓ Treat infections promptly. ✓ ✓ ✓ Tolerate normovolemic, anaemia in stable patients. ✓ ✓ ✓ Why do we need PBM?  Anaemia: A common, silent enemy 2019: 1,2 Billion IDA PBM measures Even more Screen for, diagnose and with ID alone optimally treat iron deficiency and anaemia in Iron deficiency is a ALL patients. public health issue  Anaemia: A common, silent enemy 2 ~ 43% PBM measures Screen, diagnose and treat anaemia in ALL patient groups. Correct pre-op anaemia Do not treat pre-op anaemia with red cell transfusions. Pre-operative anaemia was present in ~ 48% of all Multitude of international publications elective surgical patients. showing negative effects of pre- Pre-operative anaemia was independently operative anaemia: associated with: Mortality, Morbidity Length of hospital stay -In hospital mortality (OR 1.66, CI 95%, p = 0.028) Exposure to transfusions -Admission to critical care (OR 1.49, CI 95%, p = 0.015) One KEY recommendation in all:  Mitigating transfusion risks ~ 35 000 papers: Outcomes of allogeneic transfusions. Findings: Dose-dependant negative outcomes to transfusions: Mortality, Morbidity – Infections, Thrombosis, ICU admissions, LOS, Transfusion adverse events.  Optimize patient outcomes Indicator Year 6-value In-hospital mortality 28% reduction Length hospital stay 15% reduction 6 years > 640 000 patients Infection 21% reduction 4 adult, tertiary level AMI/Stroke 31% reduction hospitals Readmission 6% increase Evaluated 17 studies – 235 779 surgical patients > 100 000 was a pre-PBM group > 134 000 was the PBM group Implementation of PBM: -  Transfusion rates by 39% -  Red blood cell units per patient by 0.43 -  LOS (mean difference from 0.45 to 0.25) -  Total number of complications (RR 0.80, CI 95%, p,0.00001) -  Mortality rate (RR 0.89, CI 95%, p = 0.02)  Cost-effective healthcare Product acquisition cost saving = 18.5 million Australian $ “Blood bill” Total associated cost savings Associated costs: = 80 – 100 million Australian $ - Transport One-time investment of $4.5M (5-year change - Logistics management and - Staffing (and time) implementation process). - Equipment Indirect costs due to: - Adverse events - Longer hospital stay Costs to the patient. Legal considerations in Transfusion Medicine  Legal requirements Chapter 2 of the National Health Act Section 6: “User to have full knowledge”. “…health care provider must inform the user…” Section 7: “Consent of the user” + Information!!! Section 8: “Participation in decisions.” Section 9: “Health service without consent.” Section 13: “Obligation to keep record”. Litigation is a reality in SA  Ethical considerations in Transfusion Medicine  Principles of bio-ethics Autonomy Beneficence Non-maleficence Justice Non-hierarchical in nature. May be in conflict with each other. That which weighs the heaviest, should be considered. The decision to transfuse, should be based on these four principles  Autonomy The capacity of a rational , competent individual to make an informed, uncoerced decision. Competent adults have the right to decide what will/ will not be done to their bodies. In transfusion… Informed consent: Requirements: Competent to understand & Comprehend the disclosure Receive full disclosure – information must enable patient to make decision. Consents to proposed intervention / treatment Documented Informed refusal: Ensure Respect the patients values and beliefs when being met with refusal. confidentiality Documented Previously autonomous persons that are presently incompetent: Respect previously expressed preferences. Grainger, b et al. Legal and ethical considerations in blood transfusion. CMAJ, 1997; 97: 156 : S1 Sacchini, D et al. Ethical and deontological issues in Transfusion Medicine. Blood Transfusion, 2013; 11 (1): 14 – 2 Flanagan, P. The Code of Ethics of the International Society of Blood Transfusion. Blood Transfusion, 2015 13(4): 537 – 538. Finfer S. et al. Managing Patients who refuse Blood Transfusion: An Ethical Dilemma. BMJ Volume 308, 28 May 1994. Varkey, B. Principles of Clinical Ethics and Their Application in Practice. Med Princ Prac 2021;30:17-28. DOI: 10.1159/000509119 McCormick, TR et al. Principles of Bioethics. Ethics in Medicine – University of Washington School of Medicine.  Beneficence Duty to act to the benefit of the patient. Promote patient welfare. Beneficent actions can help to prevent harm and remove conditions that may cause harm. McCormick, TR et al. Principles of Bioethics. Ethics in Medicine – University of Washington School of Medicine. Varkey, B. Principles of Clinical Ethics and Their Application in Practice. Med Princ Prac 2021;30:17-28. DOI: 10.1159/000509119 Flanagan, P. The Code of Ethics of the International Society of Blood Transfusion. Blood Transfusion, 2015 13(4): 537 – 538. Grainger, b et al. Legal and ethical considerations in blood transfusion. CMAJ, 1997; 97: 156 : S1  Beneficence (2) In transfusion… Transfusion must be based on a genuine clinical need. If, post-transfusion information becomes available of possible/potential/probable harm, the patient must be informed = Lookback Program. Information concerning the transfusion received, must remain confidential. Do not limit your patient’s options. (Patient Blood Management principles!) McCormick, TR et al. Principles of Bioethics. Ethics in Medicine – University of Washington School of Medicine. Varkey, B. Principles of Clinical Ethics and Their Application in Practice. Med Princ Prac 2021;30:17-28. DOI: 10.1159/000509119 Flanagan, P. The Code of Ethics of the International Society of Blood Transfusion. Blood Transfusion, 2015 13(4): 537 – 538. Grainger, b et al. Legal and ethical considerations in blood transfusion. CMAJ, 1997; 97: 156 : S1 World Health Organization, 2002: WHO/BCT/03.03. Blood Safety Aide-Memoire  Non-maleficence To “do no unnecessary or unreasonable harm”. Do not expose patients to unnecessary risks. Do not deprive others from the goods of life. In transfusion… Transfusions must be based on a genuine clinical need. Weigh benefits and risks and choose the best course of action for the patient. Unnecessary transfusions / products Inadequate knowledge of treatment Uncrossmatched EF* blood use Standard of care Treating pre-op anaemia with a red cell transfusion (elective cases) Grainger, b et al. Legal and ethical considerations in blood transfusion. CMAJ, 1997; 97: 156 : S1 Sacchini, D et al. Ethical and deontological issues in Transfusion Medicine. Blood Transfusion, 2013; 11 (1): 14 – 2 *EF: Emergency fridge Flanagan, P. The Code of Ethics of the International Society of Blood Transfusion. Blood Transfusion, 2015 13(4): 537 – 538. McCormick, TR et al. Principles of Bioethics. Ethics in Medicine – University of Washington School of Medicine. Varkey, B. Principles of Clinical Ethics and Their Application in Practice. Med Princ Prac 2021;30:17-28. DOI: 10.1159/000509119  Justice Equitable distribution of benefits and burdens to individuals / social institutions. Fair, equitable and appropriate treatment of all patients. In transfusion… Patients should be treated equitably for the same healthcare condition. Medical decisions relating to transfusion should be based on best available evidence and treatment – adapted to local circumstances. Patient should receive the most appropriate blood products available. Patient should only receive those products that are clinically appropriate and will afford optimal outcomes and safety. Wastage of a scarce resource may impact on the greater patient population. Grainger, b et al. Legal and ethical considerations in blood transfusion. CMAJ, 1997; 97: 156 : S1 Sacchini, D et al. Ethical and deontological issues in Transfusion Medicine. Blood Transfusion, 2013; 11 (1): 14 – 2 McCormick, TR et al. Principles of Bioethics. Ethics in Medicine – University of Washington School of Medicine. Flanagan, P. The Code of Ethics of the International Society of Blood Transfusion. Blood Transfusion, 2015 13(4): 537 – 538. Varkey, B. Principles of Clinical Ethics and Their Application in Practice. Med Princ Prac 2021;30:17-28. DOI: 10.1159/000509119  Distributive justice Fair, equitable and appropriate distributing of healthcare resources - determined by justified norms. Allocation of scarce resources Care of uninsured patients Varkey, B. Principles of Clinical Ethics and Their Application in Practice. Med Princ Prac 2021;30:17-28. DOI: 10.1159/000509119  Take home message regarding PBM ❖ Follow a PBM guideline when making decisions. ❖ Diagnose anaemia – primary healthcare level is crucial. ❖ Treat anaemia – adequately. ❖ Minimise blood loss – in all ways possible. ❖ Optimize your patient’s reserves. ❖ Monitor, monitor, monitor! ❖ The HPCSA expects all doctors to have adequate knowledge of the treatment modalities they expose their patients to. ❖ Empower your patient with adequate knowledge and allow them to participate in the decision making process. As we men of medicine grow in learning, we more justly appreciate our dependence on each other…… ….The best interest of the patient is the only interest to be considered, and in order that the sick may have the benefit of advancing knowledge, union of forces is necessary. - Dr. W.J. Mayo Founder of Mayo clinics (1910) Thank you for your attention…