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4-2 Physician Patient Relationship, Informed Consent & Advanced Directives

Atty. Malaya M. Capulong, MD, DPAFP – January 18, 2012 – June 27, 2012

Advincula, Arteta, Benosa, Bobis, Concepcion, Cruz, Cuenco,

Delgado, Dolleton, Dungca, Grino, Javier, Quirimit, Ramos, Rona,

Ruiz, SALISE, Sorbito, Talan

*italicized words are from dra’s explanation

PHYSICIAN-PATIENT RELATIONSHIP

PHYSICIAN: is a person who after completing his secondary education

follows a prescribed course of medicine at a recognized university or medical school, at the successful completion of which, is legally licensed to practice medicine by the responsible authorities and is capable of undertaking the prevention, diagnosis, and treatment of human illness by the exercising independent judgment and without supervision.” (WHO)

1. What is the NATURE of the Physician- Patient relationship? 2. When does the Physician-Patient relationship BEGIN? 3. When does the Physician-Patient relationship END?

What is the NATURE of the Physician- Patient relationship? ↓

“CONTRACTUAL RELATIONSHIP” (Its nature is like a contract)

Contract:

is the meeting of minds between two persons whereby one binds himself with respect to the other, to give something or to render some service (Art.1305, NCC) – IMPORTANT!!

Meeting of minds: o connotes an AGREEMENT between the parties

Two persons: o the patient and the doctor

o one offered and the other one accepted the offer (meaning nagkaintindihan kayo)

Service: 2 forms o tangible (eg. the doctor agrees to treat the

patient for a certain amount of money) o intangible (eg. rendering of the actual medical

service) 3 ESSENTIAL ELEMENTS A CONTRACT

1. CONSENT manifested by the meeting of the offer and the

acceptance upon the thing and the cause which are to constitute the contract (Art.1319NCC)

2. OBJECT the subject matter of the contract which is the

medical service which the patient wants to be rendered to him by his physician

3. CAUSE OR CONSIDERATION is the consideration or the factor that instigated the

physician to render the medical service to the patient, which could be remuneratory or an act of liberality

“A contract does not exist in absence of any one of these elements”

2 NATURES OF THE RELATIONSHIP

1. It should be “CONSENSUAL” ↓

There should be “MUTUAL CONSENT”

Consensual is the meeting of minds between two persons whereby

one binds himself with respect to the other, to give something or to render some service (Art 1305, NCC)

1. Must be voluntary

o must be based on “FREE WILL” o the element of FEAR must not be there

2. Information is adequate 3. No deceit or fraud involved

For the PATIENT:

In an emergency setting: o consent us PRESUMED in an emergency setting o eg. sa ER nman ndi ka na ngpapaalam na ikaw yung

hahawak sa patient, lalo n kung emergency case yun.

In a non-emergency setting: o the patient has a choice kung sino yung gusto nyang

doktor

For the DOCTOR:

there should be NO FORCE! Ikaw doktor tinatanggap mo siya bilang pasyente, ikaw

pasyente, tinatanggap mo siya bilang doctor. o Doc’s example: The relationship is consummated at

the point where the doctor interviews a patient for history and the patient gives him the information.

o All the duties and responsibilities inherent in a physician patient relationship are now enforced.

There is NO RELATIONSHIP YET when the patient enters your clinic.

QUESTION: kelan nagiging expressed yung consent? o kapag pumirma na sya sa papeles!

Object of the Contract

the subject matter of the contract

REMEMBER: The OBJECT of the contract is MEDICAL SERVICE, NOT CURE!!

Gagamutin hindi pagagalingin!

Iba ang GAGAMUTIN KITA sa PAGAGALINGIN KITA!!

As physicians, WE SHOULD NEVER ASSURE THE PATIENT that you will CURE THEM!! (ndi tayo Diyos) eg. mawawala yung cancer mo o It is ground for MALPRACTICE

2. It should be “FIDUCIARY” ↓

It is based on “TRUST and CONFIDENCE” Fiduciary

A person to whom property or power is entrusted for the benefit of another. (nice to know)

Relating to, or involving a confidence or trust. It is ALWAYS IMPORTANT!!

o Because the relationship is fiduciary, meaning is practically based on trust and confidence.

How? o TELL THE TRUTH and NEVER LIE!! o Lying is not always a positive act, kapag may tinago

ka sa pasyente mo, it is considered lying for them. eg. they will not follow your prescribed regimen

(nagbigay ka ng reseta na Chloramphenicol 500 mg tab every 6 hours eh may possible effect na stomach pain yun tas ndi mo sinabi sa kanya, ndi nya susundin ung pinescribe mo kasi sumasakit ung tyan nya kapag sinunod ka nya)

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I will praise you forever for what you have done; in your

name I will hope, for your name is good. I will praise you in

the presence of your saints. - Psalm 52:9

magtatanong yung patient sa ibang doctor (or kaibigan na doctor) to check kung tama ung dosage mo pati gamot etc. (walang tiwala sayo )

INSTANCES WHERE NO PHYSICIAN-PATIENT RELATIONSHIP

EXISTS

meaning there is NO CONTRACT (see again definition of contract)

The DOCTOR is NOT ACTING AS A PHYSICIAN but as an AGENT/TOOL

I. PRE-EMPLOYMENT PHYSICAL EXAM

o In here, a doctor is a merely a tool of the employer (to determine if fit for employment)

o He is like a diagnostic exam, similar to an X-ray or CBC.

II. Physical examination to determine eligibility for INSURANCE o AGAIN! going back to the definition of contract, there

should be RENDERING OF MEDICAL SERVICE! Therefore wlang physician-pt relationship dito bilang ndi nman serbisyong medical ang bininibgay mo.

III. A physician performing an AUTOPSY

o A dead person is NOT a patient.

IV. Court-appointed physician to determine the if the accused is COMPETENT to stand trial o eg: during “Arraignment” ( or the formal reading of a

criminal complaint in the presence of the defendant to inform the defendant of the charges against him or her) wherein during the process dapat NAKAKAINTINDI SYA at NAIINTNDIHAN NYA YUNG MGA INAAKUSA SA KANYA)

Remember: “The ACCUSED is the one who DIRECTS kung ano ung takbo ng

kaso nya, not the lawyer, meaning dapat competent sya!”

V. When a physician is ASKED A CASUAL QUESTION in an ordinary place, i.e. social gatherings. o mga kamag-anak, kaibigan etc. na nagtatanong sayo

(nakakarelate ka na ba dito? ) We are not asked to RENDER a medical service, SO there is no physician-patient relationship!

DUTIES and OBLIGATIONS Imposed on the PHYSICIAN in the physician-patient relationship

1. He should possess the knowledge and skill

of which an average physician is concerned; General practitioner VS Specialist

2. He should use such knowledge and skill with ordinary care and diligence: “LOCALITY RULE” – the standard of care is measured

by the degree of care in the locality “SIMILAR LOCALITY RULE” – diligence is determined

when the other physicians in the locality or similar locality could have acted the same way

“NATIONAL STANDARD OF CARE” - the diligence is determined on what is applicable on a national standard basis

3. He is obliged to exercise the best judgment; 4. He has the duty to observe utmost good faith.

NOTE: Physician-Patient relationship does not imply guaranty or

any promise that the treatment will be successful it does not imply any promise or guaranty that the

treatment will benefit the patient it does not imply any promise or guaranty that the

treatment will produce certain result it does not promise or guaranty that the treatment will not

harm the patient it does not promise that the physician will not commit

errors in an honest way

DUTIES and OBLIGATIONS Imposed on the PATIENT in the Course of the Physician-Patient Relationship

1. He must give an honest medical history 2. He must inform the physician of what occurred

in the course of the treatment 3. He must cooperate and follow the instructions,

orders and suggestions of the physician 4. He must state whether he understands the contemplated

course of action 5. He must exercise the prudence to be expected of an

ordinary patient under the same circumstances.

STAGES OF PHYSICIAN-PATIENT RELATIONSHIP

I. COMMENCEMENT

It is the very time the physician is obliged to comply with

the legal duties and obligations to his patient.

II. TERMINATION

It is the time when the duties and obligations by a physician

to his patient ceases. The following are some ways of

termination of the relationship:

1. Recovery of the patient or when the physician

considers that his medical services will no longer be

beneficial to the patient;

2. Withdrawal of the physician provided: a) with consent

of the patient, and b) patient is given ample time and

notice;

3. Discharge of the physician by the patient;

4. Death of either party;

5. Incapacity of the physician

6. Fulfillment of the obligations stipulated in the contract;

7. In emergency cases, when the physician of choice of the

patient is already available or when the condition of

emergency ceases;

8. Expiration of the period as stipulated;

9. Mutual agreement for its termination

PATIENT’S RIGHTS

Patients should receive treatment consistent with the dignity and respect they are owed as human beings.

UNIVERSAL DECLARATION OF HUMAN RIGHTS

Basis of patient’s rights Formalized in 1948 Recognizes “the inherent dignity” and the “equal and

unalienable rights of all members of the human family”. However, the recognition, and what rights are available to a

person, still depends upon prevailing cultural and social norms. o We have to recognize that certain cultures view human rights

differently. We cannot force them to accept what we believe are human rights. (Apart from some basic natural laws of course)

o It is part of their human rights for us to accept that they have certain beliefs on what the rights of a person are.

o E.g. a Catholic school in Mindanao prohibits Muslim women from wearing burka in school. This is wrong. They must be given the right to dress according to their religious beliefs.

SO WHY DID WE HAVE THE UNIVERSAL DECLARATION OF

HUMAN RIGHTS? OR THE IMPORTANCE OF DISCLOSURE OR INFORMED CONSENT? THESE ALL STEMS FROM THE

NUREMBERG CODE OF 1947.

INFORMED CONSENT

Respect for a patient’s right to self-determination A choice can only be valid if it is based on adequate

knowledge More current term “Disclosure”

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I will praise you forever for what you have done; in your

name I will hope, for your name is good. I will praise you in

the presence of your saints. - Psalm 52:9

THE NUREMBERG CODE OF 1947

"The voluntary consent of the human subject is absolutely essential."

Resulted from the Subsequent Nuremberg Trials at the end of the Second World War.

It is alright to conduct human experiments as long as the subjects are fully aware and agree to being experimented upon.

Stems from the Nuremberg trials where the experiments made by German doctors on their unknowing Jew prisoners were exposed.

Between 1930-1945 was the rise of Hitler; after the WW2, MDs were tried in November 6, they were punished!

WHAT FACTS DID THEY GAIN FROM THE NUREMBERG TRIALS? ONE IS THE NAZI EUGENICS PROGRAM.

NAZI EUGENICS PROGRAM

Forced sterilization (for less than perfect, non-Aryan race people)

Action T4 -systematically killed between 200,000 to 250,000 people with intellectual or physical disabilities

Target: The UNDESIRABLES! (eg. Jews, Blacks, Gypsies, Mentally disables) – ginagawang Guinea pig!

Happened in a concentration camp in Dachau and Auschwitz, Germany (hindi COW at OSTRICH )

Glimpse of History: Issued on July 14, 1933, the National Socialists aka Nazi issued its “Law for the Prevention of Progeny with Hereditary Diseases”. People with so-called hereditary illnesses had to be sterilized, even if they objected. And the list of persons classified as hereditarily ill included those suffering from "congenital feeble-mindedness, schizophrenia, manic depression, hereditary epilepsy, Huntington's chorea, hereditary blindness, hereditary deafness, and serious physical deformities." People with chronic alcoholism could also be sterilized.

Here are some of the most notorious experiments: o High altitude - Eager to find out how best to

save German pilots forced to eject at high altitude, they placed inmates into low-pressure chambers that simulated altitudes as high as 68,000 feet and monitored their physiological response as they succumbed and died.

o Freezing - For up to five hours at a time, they placed victims into vats of icy water, either in aviator suits or naked; they took others outside in the freezing cold and strapped them down naked to determine the most effective means for treating German pilots who had become severely chilled from ejecting into the ocean, or German soldiers who suffered extreme exposure on the Russian front.

o Sulfanilamide - For the benefit of the German Army, whose frontline soldiers suffered greatly from gas gangrene, a type of progressive gangrene wherein they sliced up the leg, and aggravated the resulting infection by rubbing ground glass and wood shavings into the wound, and they tied off blood vessels on either side of the injury to simulate what would happen to an actual war wound.

o Twins - performed experiments on twins at Auschwitz in hopes of plumbing the secrets of multiple births.

o Poison - developed a method of individual execution by injecting Russian prisoners with phenol and cyanide

o Tuberculosis - injected live tubercle bacilli (bacteria that are a major cause of TB) into the lungs of inmates at the Neuengamme concentration camp.

o Phosgene - In an attempt to find an antidote to phosgene, a toxic gas used as a weapon during World War I, Nazi doctors exposed 52 concentration-camp prisoners to the gas at Fort Ney near Strasbourg, France.

o Bone, muscle, and joint transplantation - To learn if a limb or joint from one person could be successfully attached to another who had lost that limb or joint, experimenters at Ravensbruck amputated legs and shoulders from inmates in useless attempts to transplant them onto other victims.

o Sterilization - To come up with an effective means of sterilizing millions of people with a minimum of time and effort, doctors at Auschwitz, Ravensbruck, and elsewhere conducted

experiments on both men and women. They radiated the genitals of young men, then castrated them to study the resulting changes in their testes. A woman had caustic substances forced into her cervix or uterus, which caused horrible pain, bleeding, and bursting spasms in the stomach. The thousands who were sterilized suffered untold mental and physical anguish.

o Artificial insemination - Some 300 women at Auschwitz subsequently underwent artificial insemination at the hands of Clauberg, who reportedly taunted victims strapped down before him by informing them that he had just inseminated them with animal sperm and that monsters were now growing in their wombs.

o Seawater - The doctors forced roughly 90 Gypsies to drink only seawater while also depriving them of food.

THE TUSKEGEE EXPERIMENTS IS ANOTHER EXAMPLE OF HUMAN EXPERIMENTS MADE ON UNKNOWING SUBJECTS.

THE TUSKEGEE EXPERIMENTS, 1932-1972 US PUBLIC HEALTH SERVICE STUDY

also known as “Tuskegee syphilis experiment”

400 African American who had syphilis were identified

Their diagnosis was withheld and they were never given treatment, even though penicillin was then available and identified as the treatment for syphilis.

They wanted to know the natural progression of the disease. Some of these men were single, and those who got married

naturally infected their wives and children. The study has been going on for 40 years until it was

discovered and exposed by a NY reporter. The public outcry forced them to stop the experiment.

Disclosed in 1972 Glimpse of History: The Public Health Service, working with the Tuskegee Institute, began the study in 1932. Investigators enrolled in the study a total of 600 impoverished, non-Euro Americans sharecroppers from Macon County, Alabama; 399 who had previously contracted syphilis before the study began, and 201without the disease. For participating in the study, the men were given free medical care, meals, and free burial insurance. They were never told they had syphilis, nor were they ever treated for it. According to the Centers for Disease Control, the men were told they were being treated for "bad blood," a local term for various illnesses that include syphilis, anemia, and fatigue. – O.O REGARDING INFORMED CONSENT:

1. There must be RESPECT FOR A PATIENT’S RIGHT TO SELF-

DETERMINATION 2. A choice can only be valid if it is based on adequate

knowledge. o E.g. the patient foregoes being treated for syphilis despite

being adequately informed that a treatment exists and he can avail of it.

WHAT IS HIPAA LAW?

known as "Health Insurance Portability and Accountability Act"

Bill Clinton signed the bill into law on August 21, 1996.

The HIPAA law is a combination of regulations aimed at reducing waste, fraud and abuse in the health care industry.

The HIPAA law is a multi-step approach that is geared to improve the health insurance system.

One approach of the HIPAA regulations is to protect privacy. This is in Title IV which defines rules for protection of patient information.

All healthcare providers, are required to comply with the privacy regulations of the HIPAA law.

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I will praise you forever for what you have done; in your

name I will hope, for your name is good. I will praise you in

the presence of your saints. - Psalm 52:9

BASIC TENETS OF DISCLOSURE OF INFORMED CONSENT BASED ON PATIENT’S RIGHTS:

1. The right to receive information from physicians and to

discuss the benefits, risks, and costs of appropriate treatment alternatives.

2. The right to make decisions regarding the health care that is recommended by the physician.

RIGHTS OF PATIENTS

1. Right to choose his physician o SCENE: doctors na pinagaagawan yung pasyente (ayaw

na kasi ng patient dun sa dati nyang doctor) 2. Right to give consent to diagnostic and treatment

procedures o remember, in every procedure ALWAYS ASK FOR THE

CONSENT (written kung possible) o SCENE: may matandang naaksidente,sumakit yung

tuhod, balakang etc. tas pina-x-ray. tas umabot ng P5,000.00 yung bill dahil marami ngang xray yung ginawa, nagalit, ndi dw nya babayaran kasi ndi daw sya “pumayag” na magpa-xray in the first place (eh considering na pumose-pose sya dun every procedure tas ndi daw pumayag tsk tsk)

3. Right to disclosure of information

o Inform the patient what he/she needs to know *remember fiduciary*

4. Right of treatment o It is not enough to give them treatment; you should

TREAT THEM CORRECTLY and PROMPTLY! o SCENE: may patient na in pain, tas pinagantay mo yung

pasyente kasi inis ka sa kanya

5. Right to refuse necessary treatments o Remember Autonomy!

6. Right to religious belief

o eg. Jehovah’s Witness on Blood Transfusion

7. Right of privacy o SCENE: each hospital (ideally, should have an

INTERVIEW ROOM) o YOU DO NOT INTERVIEW A PATIENT IN FRONT OF

OTHER PEOPLE (lalo na sa mga pinoy, mga inherent na tsismoso at tsismosa x5)

8. Right to confidential information

BASES OF CONSENT

1. The physician-patient relationship is FIDUCIARY in nature 2. Patient’s right to SELF-DETERMINATION 3. CONTRACTUAL RELATIONSHIP

PURPOSE OF INFORMED CONSENT/DISCLOSURE

1. To PROTECT THE PATIENT from unnecessary/unwarranted procedure applied to him without knowledge

When we say “BATTERED” we do not only pertain to maltreatment or physical abuse (eg battered wife) NO INJURY NEEDS TO BE DONE! (eg. absence

of actual physical violence; Somatic disturbances and depression as an adaptation to stress.) eg. touching patients without consent = battery

2. To PROTECT THE PHYSICIAN from any consequences for failure to comply with legal requirements

INSTANCES WHEN CONSENT IS NOT NECESSARY

1. In cases of emergency, there is an “implied consent” or the

physician is “privilege because he is reasonably entitled to assume consent

1. If unconscious: GOOD SAMARITAN RULE! 2. When the law made it compulsory for everyone to submit

to the procedure

GOOD SAMARITAN LAW

In legal terms refers to someone who renders aid in an emergency to an injured person on a voluntary basis. Generally, where an unconscious victim cannot respond, a good samaritan can help them on the grounds of implied consent. However, if the victim is conscious and can respond, a person should ask their permission to help them first.

REQUISITES OF A VALID CONSENT

1. INFORMED OR ENLIGHTENED CONSENT

o Awareness and assent o Full disclosure of facts and willingness of the patient to

submit

2. VOLUNTARY o SCENE: CASE OF RABID DOG BITE: ndi yun tatakutin

mo yung patient na “mamatay ka! kapag ndi ka ngpainject!” or ssbhin mo na “cge bubula yun bibig mo tapos mababaliw ka!” – tell them professionally na ndi sa pananakot na paraan!

3. SUBJECT MATTER MUST BE LEGAL o eg. ABORTION – may consent ka nga, pero LEGAL BA

YUNG ABORTION?

PAANO MO MALALAMAN NA SAPAT NA

YUNG INFO NA BINIGAY SAYO?

RULE: Do Unto Others As You Would Have Them Do Unto You - Matthew 7:12

Explain mo sa patient ung detail, what he wants to hear and know, and in return, they will also tell you everything what you want to know

FORMS OF CONSENT

1. EXPRESSED CONSENT

o written or oral 2. IMPLIED CONSENT

o may be deduced from the conduct of the patient

SCOPE OF THE CONSENT

1. General or Blanket consent

o Eg. sa ER at Admission: may BLANK CONSENT FORM wherein lahat ng ggwin mo sa patient, ilalagay mo dun

2. Limited or conditional consent o “I am only consenting to these (enumerate)” -pili lang

3. Non-liability or exculpatory clause

o WAIVERS! o A waiver is essentially a unilateral act of one person

that results in the surrender of a legal right o Para ndi kasuhan yung doctor

QUANTUM OF INFORMATION NECESSARY FOR VALID CONSENT

1. NATURE OF HIS CONDITION

o The person who should know his condition/or that he is dying is the PATIENT HIMSELF!

o SCENE: kamag-anak to doc: “doc wag nyo po sabihin sa nanay ko kasi baka ndi nya kayanin” – eh ndi nya talaga kakayanin kasi mamatay na tlga sya!

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I will praise you forever for what you have done; in your

name I will hope, for your name is good. I will praise you in

the presence of your saints. - Psalm 52:9

2. NATURED OF PROPOSED TREATMENT OR PROCEDURE 3. POSSIBLE ALTERNATIVE METHODS

o For number 2 and 3, there are MANY TREATMENT OPTIONS

o DO NOT ASSURE of SUCCESS if the success rate is less 20%

4. RISK INVOLVED 5. CHANCES OF SUCCESS OR FAILURE

“Consent must be given freely or voluntarily"

ELEMENTS OF DISCLOSURE

1. The prognosis if the patient remains untreated.

2. Alternative treatment goals, and accessible means of

treatment to serve such goals.

3. Success and failure rates of treatment options.

4. Known effects and material risks of treatment options, and

their likelihood to occur.

5. The limits of relevant knowledge.

“Provide enough information for choice, but not so much as to

coerce or frighten patients into compliance.”

MEDICAL PATERNALISM

“The doctor knows best” and patients were expected to follow “doctor’s orders”

This was the prevailing notion before the emphasis on patients’ self-determination came to fore. (Patients know their own temperament and disposition best.)

Treating patients in a paternalistic manner is unethical because it demeans a patient. (Some of our patients may be uneducated but definitely, they’re not stupid—always treat our patients with respect!)

Provide enough information for choice, but not so much as to coerce or frighten patients into compliance.

THE PHYSICIAN STANDARD

What a reasonable physician would consider it necessary to disclose

‘REASONABLE PERSON’ STANDARD

What a reasonable, prudent person in the patient’s position would find material to know.

The focus is on risk, both of following and not following medical options, including the physician’s recommended option.

In proposing treatment, NOTE OF THE FOLLOWING:

Whether the doctor’s proposal is a minor procedure or major surgery

The nature and purpose of the treatment. (cure or palliative) Intended effects versus possible side effects The risks and anticipated benefits involved All reasonable alternatives

VALID INFORMED CONSENT

Disclosure of appropriate information to a competent patient who is permitted to make a voluntary choice.

Strike a proper balance between respecting the autonomy of patients who are capable of making informed decisions and protecting those with cognitive impairment.

WHO MAY GIVE CONSENT?

• THE PATIENT :

o If patient is minor - PARENTS o In the absence of the parents - GRANDPARENTS o In the absence of parents and grandparents: ELDEST

BROTHER OR SISTER, OF LEGAL AGE AND NOT DISQUALIFIED BY LAW (eg. nakakulong na kuya, may schiz na ate etc.)

o Kapag wala sa above mentioned: Other person who may have substitute parental authority. eg. TEACHER and PRINCIPAL OF THE SCHOOL

SCENE: sa school kapag may accident, si teacher ndi na inaantay yung magulang pra dalhin sya yung bata sa ospital (bilang 2nd parent), iinform nlng doon.

SUBJECT MATTER IS LEGAL

• The subject matter or procedure applied to the patient and which the patient consented must not be that which the law penalizes or against public policy.

SPECIAL CASES

• CONSENT OF MINOR is not valid if the procedure will not benefit him

• Expressed refusal of a minor to surgery shall not prevail over the existing emergency

• If unconscious: PRESUMED CONSENT is applied (concept of NOBODY WANTS TO DIE)

• Doctrine of parens patriae: o “parent of the country/nation” o A doctrine that grants the inherent power and

authority of the state to protect persons who are legally unable to act on their own behalf.

o The court may grant consent for the minor.

IMPORTANT NOTES ON INFORMED CONSENT

• Even when a patient’s condition presents only one choice of

medical intervention, THE PATIENT STILL HAS AN OPTION, namely to decline it. • As such, if there is only one treatment modality available

for a certain patient, it is still lawful to ask the patient whether to accept and undergo the treatment procedure or not.

• Declining treatment is a valid option as long as the person making the decision is competent.

• Even successful treatments can have significant adverse effects of which patients must be informed and warned.

• The legal duty of care requires specialists TO CONFORM to

the standard of knowledge and skill expected within the specialty.

• Inform patient that not every possible effect of treatment options is known.

• Physicians should abandon any residual posture of omniscience!

• Physicians are not guarantors of the effectiveness or safety of their procedures, but may be liable for appearing to claim that specific effects will be achieved or, in particular, that certain feared results cannot occur. o Not because you agree to treat the patient guarantees

that there will be NO SIDE EFFECTS or you will 100%

CURE THE PATIENT! (there is possibility of “infinitesimal” or small, untoward effect esp. for drugs)

o There are only 2 SURE THINGS in life: (sbi ni doc) 1. Death 2. Tax

INFORMED CONSENT IN RESEARCH

• Consent is not an event or signed form, but an on-going process or quality.

Clinical Trial

• A controlled study involving human subjects - designed to evaluate prospectively the safety and effectiveness of new drugs or devices or of behavioral interventions.

Phase 1, 2, 3, 4 Drug Trials:

• Different stages of testing drugs in human o PHASE 1: from first application in humans o PHASE 2-3: through limited and broad clinical tests o PHASE 4: postmarketing studies

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I will praise you forever for what you have done; in your

name I will hope, for your name is good. I will praise you in

the presence of your saints. - Psalm 52:9

o Even for clinical, drug trials and postmarketing studies, you have to disclose, and get informed consent. – follow up on adverse effects after years of treatment

CONTENT OF THE INFORMED CONSENT IN A CLINICAL TRIAL RESEARCH

1. A statement that the study involves research

o Eg: Sa Framingham Heart Study (which is a cohort, and ongoing cardiovascular study in US), inform the patient na susundan mo sya for LIFETIME!

2. An explanation of the purposes of the research and the expected duration of the subject’s participation

3. A description of the procedures to be followed 4. Identification of any procedures which are experimental 5. A description of any reasonably foreseeable risks or

discomforts to the subject; 6. A description of any benefits to the subject or to others

o Do not entice the patient join the research PRIMARILY due to the INCENTIVES (eg. money, free medication) or mag-attract/advertise (eg. gagaling ka in 6 months!)

7. A disclosure of appropriate alternative procedures or courses of treatment

8. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained o Ensure that their privacy is protected

9. For research involving more than minimal risk, an explanation as to whether any compensation and any medical treatments are available if injury occurs

10. Whom to contact for answers to pertinent questions about the research and research subjects’ rights, and in the event of a research-related injury to the subject

11. Statement that participation is voluntary and the subject may discontinue participation at any time

Blanket Consent- The consent signed upon admission. Note however, that when another procedure is needed to be done, another consent needs to be secured (e.g. when one has abdominal pain, he will be treated for such but when appendectomy is needed, then another consent is required)

EVALUATING THE ETHICS OF CLINICAL RESEARCH STUDIES

Value Scientific validity Fair subject selection Favorable risk-benefit ratio Independent review Informed consent Respect for enrolled subjects

ADVANCE DIRECTIVES

• Written instruction recognized under state law relating to the provision of health care when the individual is incapacitated. o Included in the ‘end of life care’

HISTORY

• Karen Ann Quinlan – 1976, New Jersey Supreme Court o Born: March 29, 1954; Died: June 11, 1985

The earliest case involving euthanasia and advance directives.

o Becoming unconscious after gobbling up diazepam, dextropropoxyphene, and alcohol from a party, the paramedics came and took her to the hospital - where she lapsed into a persistent vegetative state. She was only kept alive through a ventilator for several months, but to no avail. Under such a predicament, the parents requested the health facility to discontinue active care and should rather allow her to die.

o Her parents decided to withdraw life support, however the doctors, and the state refused to - naging magkalaban dito ‘yung parents ni Karen and the state; based on the Parens Patriae, wherein the state is supposed to be the parent of a citizen, and is supposed to look after the welfare of the citizen, they did not want to withdraw life support from Karen; the

principle is that the state was trying to hold sanctity of life…but the parents eventually prevailed.

• Nancy Beth Cruzan – 1990, US Supreme Court o After her case, the US Congress

passed a law on advance directives, recognizing the right of a person to direct what will happen to him when he isn’t able to make the decision for himself; it outlined the pre requisites to recognize a valid advance directive.

o She was rendered incompetent as a result of severe injuries sustained during an automobile accident. Co-petitioners Lester and Joyce Cruzan, Nancy's parents and co-guardians, sought a court order directing the withdrawal of their daughter's artificial feeding and hydration equipment after it became apparent that she had virtually no chance of recovering her cognitive faculties. The Supreme Court of Missouri held that because there was no clear and convincing evidence of Nancy's desire to have life-sustaining treatment withdrawn under such circumstances, her parents lacked authority to effectuate such a request.

o Eight years after the auto crash that left her in a vegetative state, six months after the United States Supreme Court's ruling on her right to die and 12 days after her parents won their fight to remove the feeding tube that was keeping her alive, she passed away.

TYPES

I. LIVING WILL

• A written, legal document that describes the kind of medical treatments or life-sustaining treatments a person would want if he were seriously or terminally ill.

• A living will doesn't appoint someone to make decisions for the patient.

• PROBLEM: kapag ndi maka-let go yung kamag-anak (ayaw nila i-honor yung will

II. DURABLE POWER OF ATTORNEY FOR HEALTH CARE (DPAHC)

• A patient designates an agent to make health-care decisions for them if they become mentally incapacitated.

• It becomes active any time the patient is unconscious or unable to make medical decisions.

• The agent is not empowered to make decisions on behalf of the patient unless the patient is deemed, usually by his or her physicians, to be incapable of informed consent or refusal.

• Physicians are legally bound to respect an agent's wishes. • The agent must act consistently with the terms of the DPAHC,

as well as with the patient's known wishes. • The agent must act in the patient's best interests. o Are advance directives valid in the Philippines? There is no

law against or prohibiting advance directives. What the law says is that any person can validly waiver his right, provided that it is not contradict to law, morals, constitution or public policies.

o Remember, executing an advance directive is different from performing euthanasia. An advance directive is just withdrawal of life support, unlike euthanasia which is active killing (equivalent to homicide).

o When it comes to personal relations, the national laws of a person’s country will apply to him. Remember Doc’s example of a British national who dies here but has executed an advance directive. If their law allows advance directives, we have to recognize their own personal law and give credit to the advance directive that he has executed.

o According to doc, THERE ARE NO LAWS THAT PROHIBIT ADVANCE DIRECTIVES!

• PROBLEM: baka PUMAPEL si ATTORNEY!! o make sure na NAGKAINTINDIHAN SI ATTY AT SI PATIENT!

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I will praise you forever for what you have done; in your

name I will hope, for your name is good. I will praise you in

the presence of your saints. - Psalm 52:9

III. DO NOT RESUSCITATE (DNR) ORDER

• A more specific advance directive • A request not to have cardiopulmonary resuscitation (CPR) if

the patient’s heart stops or if he stops breathing. • PROBLEM: NOT PREPARED RELATIVES (or hindi nila alaam

na may DNR order!!) o SCENE: In a terminal case, sinugod sa ER yung patient.

There is a DNR ordered previously by the patient, then you will do “palliative care” na lang (eg. O2 cannula lng kahit sobrang DOB na yung patient) THEN HERE COMES THE RELATIVES, sasabihan ka ng “yan lang gagawin mo sa kanya!!” kasi hindi nila alam yung regarding the DNR order OR mapilit lang sila na buhayin ung patient…