Bioethics Bioethics biomedical biomedical

experimentsexperiments..

Bioethics Bioethics biomedical biomedical

experimentsexperiments..

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 Owen16th Century

Historical overviewHistorical overview

The Code of Hammurabbi: punishment of medical The Code of Hammurabbi: punishment of medical mistakes (2200 B.C.)mistakes (2200 B.C.)

Hippocrates (460-355 B.C.): ethics of medical practice Hippocrates (460-355 B.C.): ethics of medical practice - long lasting, generally accepted principles- long lasting, generally accepted principles

First Medical Law (1972)First Medical Law (1972) The relation of the doctor and the patient: assignment The relation of the doctor and the patient: assignment

contractcontract 1993: WHO – declaration of the rights of patiens1993: WHO – declaration of the rights of patiens 1997. New Medical Law1997. New Medical Law

Damages being associated with Damages being associated with medical caremedical care

StudyStudy Incidence of damage (%)Incidence of damage (%)

United statesUnited states (New York (New York StateState) (Harvard ) (Harvard Medical Practice Study) (2,3)Medical Practice Study) (2,3)

3,73,7

United StatesUnited States (Utah-Colorado Study) (5) (Utah-Colorado Study) (5) 3,23,2

AustraliaAustralia (Quality in Australian Health (Quality in Australian Health Care Study) (6)Care Study) (6)

16,616,6

Great BritainGreat Britain (4) (4) 11,711,7

New ZealandNew Zealand (7,8) (7,8) 12,912,9

CCanadaanada (9) (9) 7,57,5

DenmarkDenmark (10) (10) 9,09,0

Numbers from the USANumbers from the USA

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

Definition of medical Definition of medical malpracticemalpractice

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

Estimated numbers of medical malpractice Estimated numbers of medical malpractice causing death in different countries (per year)causing death in different countries (per year)

USAUSA 100 000100 000 United KingdomUnited Kingdom 45 000 45 000 GermanyGermany 30 000 30 000 HungaryHungary 3-6 000 3-6 000

Responsibility for Responsibility for compensationcompensation

Number of cases are increasingNumber of cases are increasing The amounts paid for damages are The amounts paid for damages are

growinggrowing Official payments and suited Official payments and suited

compensations are not equalcompensations are not equal Judges acting differently these daysJudges acting differently these days Many cases claiming missing correct Many cases claiming missing correct

informationsinformations

I. The ethical, civil, and criminal I. The ethical, civil, and criminal responsibilities of medical doctorsresponsibilities of medical doctors

EthicalEthical: ethical offence is committed by the : ethical offence is committed by the doctor if he violates the rules of his professiondoctor if he violates the rules of his profession

These rules are found in different books, post-These rules are found in different books, post-graduate education, officially accepted graduate education, officially accepted methodical descriptions, protocols etc.methodical descriptions, protocols etc.

Civil: Civil: Whoever causing damage unlawfully to Whoever causing damage unlawfully to someone else, is responsible to compensate it. someone else, is responsible to compensate it. He s not responponsible, if he can prove, that He s not responponsible, if he can prove, that he acted the way as it is generally accepted.he acted the way as it is generally accepted.

II.II.

The 4 elements of compensation:The 4 elements of compensation: IllegalityIllegality BlamabilityBlamability DamageDamage RelationshipRelationship

Criminal responsibilityCriminal responsibility

Whoever threatens the lifes or health of other Whoever threatens the lifes or health of other people by breaking his rules of profession people by breaking his rules of profession because of negligence is causing an offencebecause of negligence is causing an offence

The 4 elements of it:The 4 elements of it: Breaking the professional rulesBreaking the professional rules NegligenceNegligence EndangermentEndangerment Causative relationshipCausative relationship

Luxembourg Declaration on Luxembourg Declaration on

Patient SafetyPatient Safety

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

Facts & figures on patient safetyFacts & figures on patient safety

The European Commission estimates that in the The European Commission estimates that in the EU: EU:

1 in 10 patients are affected by healthcare-1 in 10 patients are affected by healthcare-related infections; related infections;

3 million deaths are caused by healthcare-3 million deaths are caused by healthcare-related infections; related infections;

50,000 people die each year of healthcare-50,000 people die each year of healthcare-related infections. related infections.

almost half of all preventable adverse events in almost half of all preventable adverse events in the EU are a consequence of medical errors the EU are a consequence of medical errors

Definitions used with patient Definitions used with patient safetysafety

1. Administration error1. Administration error Mistake, omission, or wrong order by nurse Mistake, omission, or wrong order by nurse

or caretaker or the patient himselfor caretaker or the patient himself

2. Accident2. Accident Not wanted, not planned, unexpected event, Not wanted, not planned, unexpected event,

generally causing damagesgenerally causing damages

Most frequent formes of administration Most frequent formes of administration errorerror

3. Protection from accidental 3. Protection from accidental damages during medical treatmentdamages during medical treatment

Avoiding not wanted effects, predicting them Avoiding not wanted effects, predicting them or correcting themor correcting them

Analyzing and treating risk factorsAnalyzing and treating risk factors Safety because of good qualitySafety because of good quality

4. Evidence-based 4. Evidence-based guidelinesguidelines

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

5. Culture of safety

Common working platform of an Common working platform of an individual and a communityindividual and a community

6. Human factors6. Human factors Interactions among humans and between Interactions among humans and between

humans and their environmenthumans and their environment

7. Medication safety7. Medication safety Trying to avoid or correct not wanted effectsTrying to avoid or correct not wanted effects

8. Medication error8. Medication error Preventable evens during production, Preventable evens during production,

administration, packaging, labeling of drugsadministration, packaging, labeling of drugs 9. Negligence9. Negligence

The treatment of a certain patient is not The treatment of a certain patient is not happening according to the expected level of happening according to the expected level of a generally trained doctora generally trained doctor

10. Mistakes10. Mistakes Not choosing the right way to define the necessary Not choosing the right way to define the necessary

steps because of 1. the mistake in choosing the steps because of 1. the mistake in choosing the rules or because of 2. mistakes in the knowledgerules or because of 2. mistakes in the knowledge

11. Iatrogenic11. Iatrogenic Due to the action of a Due to the action of a physicianphysician or a therapy the or a therapy the

doctor prescibed. An iatrogenic disease may be doctor prescibed. An iatrogenic disease may be inadvertently caused by a physician or inadvertently caused by a physician or surgeonsurgeon or or by a medical or surgical treatment or a diagnostic by a medical or surgical treatment or a diagnostic procedure. procedure.

12. Reporting12. Reporting Patient safety systems reporting unwanted effectsPatient safety systems reporting unwanted effects

13. Harm13. Harm Physical, mental or psychical damage, temporary or Physical, mental or psychical damage, temporary or

final, and any kind of painfinal, and any kind of pain 14. Risk assessment14. Risk assessment

Judging the amount of risk factors, the balance of Judging the amount of risk factors, the balance of risk and benefitsrisk and benefits

15. Risk management15. Risk management Clinical and administrative methods to realize, Clinical and administrative methods to realize,

identify and reduce riskidentify and reduce risk

16. Potential error16. Potential error Circumstances or events causing mistakesCircumstances or events causing mistakes

17. High-alert medication17. High-alert medication Mistake in drug administration will cause Mistake in drug administration will cause

serious damageserious damage

18. Adverse drug event18. Adverse drug event Either correctly dosed drug or mistake in Either correctly dosed drug or mistake in

administrationadministration

19. Adverse drug reaction19. Adverse drug reaction Unexpected reacton to a drug which administered in Unexpected reacton to a drug which administered in

generally accepted form and amountgenerally accepted form and amount

20. Adverse event20. Adverse event Caused by a medical intervention or by a missing Caused by a medical intervention or by a missing

nterventionntervention

21. Unpreventable adverse drug events21. Unpreventable adverse drug events No mistake in the administration, an unexpected, No mistake in the administration, an unexpected,

not foreseen eventnot foreseen event

22. Recklessness22. Recklessness Not taking the risk into account, or continue the Not taking the risk into account, or continue the

action after realizing itaction after realizing it 23. Nosocomial23. Nosocomial

Belonging to the health instituteBelonging to the health institute 24. Preventable adverse event24. Preventable adverse event

Not following the general standards or the most Not following the general standards or the most recent scientific resultsrecent scientific results

25. Error of ommission25. Error of ommission Not doing something necessaryNot doing something necessary

26. Cause26. Cause The reason of an event, an effect or a result. May be close or The reason of an event, an effect or a result. May be close or

remote. A result is the effect of many causes.remote. A result is the effect of many causes. 27. Latent error, conditions27. Latent error, conditions

Mistakes in the organization, in the highe decisions, which are Mistakes in the organization, in the highe decisions, which are latent for a long time. Usually with other problems they cause latent for a long time. Usually with other problems they cause accidents, or obvious mistakes. Latent conditions can be accidents, or obvious mistakes. Latent conditions can be realized in tme by risk management.realized in tme by risk management.

28. Sentinel event28. Sentinel event Unexpected, serious event when immediate action is neededUnexpected, serious event when immediate action is needed

29. Violation29. Violation Using not accepted methods or action by purposeUsing not accepted methods or action by purpose

30. CPOE: computer physician order entry30. CPOE: computer physician order entry Connection among the pharmacy, the laboratory, Connection among the pharmacy, the laboratory,

the radiology in order to choose the right medicationthe radiology in order to choose the right medication

31. Error31. Error The planned action cannot reach the desired resultThe planned action cannot reach the desired result

32. Error of commission32. Error of commission Mistake in the procedureMistake in the procedure

33. Recklessness33. Recklessness Someone knows exactly the risk but does not careSomeone knows exactly the risk but does not care

Rights of patientsRights of patients

To get medical treatment: especially in the case of To get medical treatment: especially in the case of emergency and heavy pain. Also everybody should be emergency and heavy pain. Also everybody should be treated equally.treated equally.

For human dignityFor human dignity To keep connections (relatives)To keep connections (relatives) To leave the instituteTo leave the institute To recieve correct informationsTo recieve correct informations To self-determination To self-determination To refuse treatmentTo refuse treatment To choose a doctorTo choose a doctor To know medical documentationsTo know medical documentations To have medical confidence, patient’s right for confidenceTo have medical confidence, patient’s right for confidence

Human dignity: only the necessary Human dignity: only the necessary interventions can be usedinterventions can be used

Limitations of individual freedom: only in the Limitations of individual freedom: only in the cases of danger his own or other people’s cases of danger his own or other people’s lives or health, for limited timelives or health, for limited time

Patients may need to wait for treatment, they Patients may need to wait for treatment, they must be informed about thismust be informed about this

Patients have to asked and examined Patients have to asked and examined separately from others, in privacyseparately from others, in privacy

Right for informationsRight for informations

Actual state of health, present conditionActual state of health, present condition The usefulness and risk of suggested The usefulness and risk of suggested

examinations and interventions, and the risk of examinations and interventions, and the risk of not applying themnot applying them

Timecourse of treatmentTimecourse of treatment Right to make decisionsRight to make decisions Possible other methods to usePossible other methods to use The results of treatment and future possibilitiesThe results of treatment and future possibilities To change life style if necessaryTo change life style if necessary

To refuse treatmentTo refuse treatment

Not possible if it dangers somebody Not possible if it dangers somebody else’s life or healthelse’s life or health

Otherwise possible bot has to done in Otherwise possible bot has to done in written form in the presence of witnesseswritten form in the presence of witnesses

Rights and obligations of Rights and obligations of health care workershealth care workers

To look after and treat patients correctlyTo look after and treat patients correctly To choose diagnostic and treating methods To choose diagnostic and treating methods

according their best knowledgeaccording their best knowledge To refuse treatment in special casesTo refuse treatment in special cases To inform patientsTo inform patients To make proper documentationsTo make proper documentations To give privacy to patientsTo give privacy to patients To have development in their educationTo have development in their education To get extra protectionTo get extra protection

Emergency treatmentEmergency treatment

Emergency need: life threating event or the Emergency need: life threating event or the possibility of permanent damagepossibility of permanent damage

Life saving intervention: without this death is Life saving intervention: without this death is suresure

Invasive intervention: operations, intravenal, Invasive intervention: operations, intravenal, intratracheal, gastric etc.intratracheal, gastric etc.

Threatening condition: without any Threatening condition: without any intervention lives or health conditions are intervention lives or health conditions are dangereddangered

Specialitis of emergency Specialitis of emergency treatmenttreatment

Unexpected events, no possibility to choose Unexpected events, no possibility to choose doctor or hospitaldoctor or hospital

May be necessary to have treatment at not May be necessary to have treatment at not ideal conditionsideal conditions

Very important the time while the patient gets Very important the time while the patient gets into an instituteinto an institute

There diffferences among health care institutesThere diffferences among health care institutes Patients have the same rights but may have Patients have the same rights but may have

less optionsless options

Rights of imprisoned Rights of imprisoned personspersons

Basically have the same rights as other Basically have the same rights as other people , right for informationspeople , right for informations

Occasionally the right to refuse treatment Occasionally the right to refuse treatment may be limitedmay be limited

Self-determination rights are restricted: Self-determination rights are restricted: threatening conditions, possibility of threatening conditions, possibility of damages, infectionsdamages, infections

Most frequent mistakes Most frequent mistakes in medical health carein medical health care

Nosocomial infectionsNosocomial infections Mistake in diagnosis and therapyMistake in diagnosis and therapy

Objective or subjectiveObjective or subjective Administration errorAdministration error Technical errorTechnical error „„Defensive Medicine”Defensive Medicine”

Unnecessary actions to protect the institute or Unnecessary actions to protect the institute or the doctorthe doctor

Not doing enough „not to make mistakes”Not doing enough „not to make mistakes”