Bioethics biomedical experiments .

1. Bioethics biomedical experiments.

2. MOTTO: “ God and the doctor we alike adore But only in danger, not before; The danger o’er both are alike requited, God is forgotten, and the Doctor slighted” John Owen 16th Century

3. Historical overview • The Code of Hammurabbi: punishment of medical mistakes (2200 B.C.) • Hippocrates (460-355 B.C.): ethics of medical practice - long lasting, generally accepted principles • First Medical Law (1972) • The relation of the doctor and the patient: assignment contract • 1993: WHO – declaration of the rights of patiens • 1997. New Medical Law

4. Damages being associated with medical care

5. Numbers from the USA • Adverse events among patients getting into hospitals is 3.7%.Amog these events 6.6-13% may cause death. This means that 44-98 000 people may die because of malpractice in the USA

6. Definition of medical malpractice • An act by a health care provider which deviates from accepted standards of practice in the medical communty and which causes injury to the patent. May be called a professional negligence that causes an injury.

7. Estimated numbers of medical malpractice causing death in different countries (per year) • USA 100 000 • United Kingdom 45 000 • Germany 30 000 • Hungary 3-6 000

8. Responsibility for compensation • Number of cases are increasing • The amounts paid for damages are growing • Official payments and suited compensations are not equal • Judges acting differently these days • Many cases claiming missing correct informations

9. I. The ethical, civil, and criminal responsibilities of medical doctors • Ethical: ethical offence is committed by the doctor if he violates the rules of his profession • These rules are found in different books, post-graduate education, officially accepted methodical descriptions, protocols etc. • Civil: Whoever causing damage unlawfully to someone else, is responsible to compensate it. He s not responponsible, if he can prove, that he acted the way as it is generally accepted.

10. II. • The 4 elements of compensation: • Illegality • Blamability • Damage • Relationship

11. Criminal responsibility • Whoever threatens the lifes or health of other people by breaking his rules of profession because of negligence is causing an offence • The 4 elements of it: • Breaking the professional rules • Negligence • Endangerment • Causative relationship

12. Luxembourg Declaration on Patient Safety • Access to high quality healthcare is a key human right recognised and valued by the European Union, its Institutions and the citizens of Europe. Accordingly, patients have a right to expect that every effort is made to ensure their safety as users of all health services.

13. Facts & figures on patient safety The European Commission estimates that in the EU: • 1 in 10 patients are affected by healthcare-related infections; • 3 million deaths are caused by healthcare-related infections; • 50,000 people die each year of healthcare-related infections. • almost half of all preventable adverse events in the EU are a consequence of medical errors

14. Definitions used with patient safety • 1. Administration error • Mistake, omission, or wrong order by nurse or caretaker or the patient himself • 2. Accident • Not wanted, not planned, unexpected event, generally causing damages

15. Most frequent formes of administration error

16. 3. Protection from accidental damages during medical treatment • Avoiding not wanted effects, predicting them or correcting them • Analyzing and treating risk factors • Safety because of good quality

17. 4. Evidence-based guidelines • A list of recommendations to make the right decision to treat certain group of diseases by the help of new scientific evidences. This helps to improve the effctiveness of health care, to choose the appropriate treatment.

18. 5. Culture of safety • Common working platform of an individual and a community • 6. Human factors • Interactions among humans and between humans and their environment

19. 7. Medication safety • Trying to avoid or correct not wanted effects • 8. Medication error • Preventable evens during production, administration, packaging, labeling of drugs • 9. Negligence • The treatment of a certain patient is not happening according to the expected level of a generally trained doctor

20. 10. Mistakes • Not choosing the right way to define the necessary steps because of 1. the mistake in choosing the rules or because of 2. mistakes in the knowledge • 11. Iatrogenic • Due to the action of a physician or a therapy the doctor prescibed. An iatrogenic disease may be inadvertently caused by a physician or surgeon or by a medical or surgical treatment or a diagnostic procedure.

21. 12. Reporting • Patient safety systems reporting unwanted effects • 13. Harm • Physical, mental or psychical damage, temporary or final, and any kind of pain • 14. Risk assessment • Judging the amount of risk factors, the balance of risk and benefits • 15. Risk management • Clinical and administrative methods to realize, identify and reduce risk

22. 16. Potential error • Circumstances or events causing mistakes • 17. High-alert medication • Mistake in drug administration will cause serious damage • 18. Adverse drug event • Either correctly dosed drug or mistake in administration

23. 19. Adverse drug reaction • Unexpected reacton to a drug which administered in generally accepted form and amount • 20. Adverse event • Caused by a medical intervention or by a missing ntervention • 21. Unpreventable adverse drug events • No mistake in the administration, an unexpected, not foreseen event

24. 22. Recklessness • Not taking the risk into account, or continue the action after realizing it • 23. Nosocomial • Belonging to the health institute • 24. Preventable adverse event • Not following the general standards or the most recent scientific results • 25. Error of ommission • Not doing something necessary

25. 26. Cause • The reason of an event, an effect or a result. May be close or remote. A result is the effect of many causes. • 27. Latent error, conditions • Mistakes in the organization, in the highe decisions, which are latent for a long time. Usually with other problems they cause accidents, or obvious mistakes. Latent conditions can be realized in tme by risk management. • 28. Sentinel event • Unexpected, serious event when immediate action is needed • 29. Violation • Using not accepted methods or action by purpose

26. 30. CPOE: computer physician order entry • Connection among the pharmacy, the laboratory, the radiology in order to choose the right medication • 31. Error • The planned action cannot reach the desired result • 32. Error of commission • Mistake in the procedure • 33. Recklessness • Someone knows exactly the risk but does not care

27. Rights of patients • To get medical treatment: especially in the case of emergency and heavy pain. Also everybody should be treated equally. • For human dignity • To keep connections (relatives) • To leave the institute • To recieve correct informations • To self-determination • To refuse treatment • To choose a doctor • To know medical documentations • To have medical confidence, patient’s right for confidence

28. Human dignity: only the necessary interventions can be used • Limitations of individual freedom: only in the cases of danger his own or other people’s lives or health, for limited time • Patients may need to wait for treatment, they must be informed about this • Patients have to asked and examined separately from others, in privacy

29. Right for informations • Actual state of health, present condition • The usefulness and risk of suggested examinations and interventions, and the risk of not applying them • Timecourse of treatment • Right to make decisions • Possible other methods to use • The results of treatment and future possibilities • To change life style if necessary

30. To refuse treatment • Not possible if it dangers somebody else’s life or health • Otherwise possible bot has to done in written form in the presence of witnesses

31. Rights and obligations of health care workers • To look after and treat patients correctly • To choose diagnostic and treating methods according their best knowledge • To refuse treatment in special cases • To inform patients • To make proper documentations • To give privacy to patients • To have development in their education • To get extra protection

32. Emergency treatment • Emergency need: life threating event or the possibility of permanent damage • Life saving intervention: without this death is sure • Invasive intervention: operations, intravenal, intratracheal, gastric etc. • Threatening condition: without any intervention lives or health conditions are dangered

33. Specialitis of emergency treatment • Unexpected events, no possibility to choose doctor or hospital • May be necessary to have treatment at not ideal conditions • Very important the time while the patient gets into an institute • There diffferences among health care institutes • Patients have the same rights but may have less options

34. Rights of imprisoned persons • Basically have the same rights as other people , right for informations • Occasionally the right to refuse treatment may be limited • Self-determination rights are restricted: threatening conditions, possibility of damages, infections

35. Most frequent mistakes in medical health care • Nosocomial infections • Mistake in diagnosis and therapy • Objective or subjective • Administration error • Technical error • „Defensive Medicine” • Unnecessary actions to protect the institute or the doctor • Not doing enough „not to make mistakes”