This document discusses informed consent and refusal of treatment issues. It begins by defining informed consent as a process where a health care provider discloses appropriate information to a competent patient so they can voluntarily accept or refuse treatment. It notes that consent was not historically required, as professionals were expected to determine treatment themselves, but it became important in the 20th century. The document then outlines the legal requirements for informed consent, including adequately informing patients and obtaining consent except in emergencies. It discusses standards for informed consent, including the professional standard of disclosing what colleagues would and the reasonable person standard of disclosing what patients need to make an informed choice. The document analyzes cases involving these standards and issues like ensuring understanding and voluntary consent.

1. Dr. Mohammad AlmermeshDr. Mohammad Almermesh
Pharmacology & Clinical Pharmacy DepartmentPharmacology & Clinical Pharmacy Department
College of PharmacyCollege of Pharmacy
PHARMACY PROFESSIONAL ETHICS, CLNP321PHARMACY PROFESSIONAL ETHICS, CLNP321
LECTURE :5

2. Elucidate the concept of informed consent
Discuss refusal of treatment issues

3.  Informed consent has emerged as a central issue in therapeutic medicine.
 Recent informed consent literature reveals its increasing importance.
 As the Hippocratic ethical tradition has no provision for consent of the patient
for any treatment.
 Its central ethical approach was to assume that the health professional could
figure out what was in the interest of the patient and act accordingly.
 The Hippocratic Oath actually prohibits the health care professional from
sharing any medical knowledge with patients.
 It was not until the 20th
century that consent of the patient became morally
important.

4. - As a general rule, no operation, procedure or treatment may be undertaken without the
consent of the patient, if the patient is a competent adult.
- Adequately informing patients and obtaining consent in regard to an operation, procedure
or treatment is both a specific legal requirement and an accepted part of good medical
practice.
- The NSW Health Patient Charter ( ) also contains a commitment to patients that public
health organizations will clearly explain proposed treatment including significant risks and
alternatives in a way patients can understand and obtain patient consent before treatment,
except in an emergency or where the law says patients must have treatment.
- Consent to the general nature of a proposed operation, procedure, or treatment must be
obtained from a patient.
- Failure to do this could result in legal action for assault and battery against a practitioner
who performs the procedure.
NSW : New South Wales Health Patient Charter, UK

5.  INFORMED CONSENT is the process by which the treating health care
provider discloses (shows up) appropriate information to a competent patient
so that the patient may make a voluntary choice to accept or refuse treatment.
 Informed consent is an interactive process between a doctor and patient
where the patient gains an understanding of his or her condition and receives
an explanation of the options available including an assessment of the
expected risks, side effects, benefits and costs of each option and thus is able
to make an informed choice and give their informed consent.
 Under the Code “every patient has the right to make an informed choice and
to give informed consent, except in certain circumstances.”

6. In addition, several pieces of legislation determine how consent should be handled and
these requirements can override (replace) the requirements of the Code.
This statement has been written to inform doctors of the standards of practice that are
expected of them in meeting their legal obligations.
A pharmacist “respects the autonomy and dignity of each patient.”
A pharmacist promotes the right of self-determination and recognizes individual self-
worth by encouraging patients to participate in decisions about their health = morally
equivalent of consent
A pharmacist communicates with patients in terms that are understandable.
In all cases, a pharmacist respects personal and cultural differences among patients.

7.  An adequate consent to treatment must be informed.
 For it to be informed it must contain several types of
information (sometimes called elements), not only information
about the benefits and harms, but also their probabilities of
occurring as well as information about treatment alternatives.
 There may be other kinds of information that patients would
desire as well, including information about the costs of the
treatment, inconvenience, the time consumed, risks relating to
confidentiality breeches, any changes in lifestyle that will or
could result from treatment, and the competence of the
provider.

8.  CASE 15-1 Therapeutic Privilege: The Case of the Placebo
Narcotic
 This case show how pharmacists may face problems in deciding
whether patients have been given enough information for their
consent to be adequately informed.
The sTandard for consenTThe sTandard for consenT
 Deciding what to disclose based on what one’s colleagues would
disclose is what is called the Professional Standard.
 Traditional legal and moral practice relied on the professional
standard for determining what must be disclosed.

9.  Beginning about 1970 the standard began to change.
 There emerged what is now called the Reasonable Person
Standard.
 It replaces the idea that one is required to disclose what one’s
colleagues similarly situated would have to disclose with the
idea that one is required to disclose what the reasonable person
would want or need to know in order to make an informed
choice for or against the proposed treatment.
 If the goal is to give information needed in order to make
autonomous choices, then it really is not decisive what
professional colleagues similarly situated would disclose.
 They may also have developed a practice that does not provide
the patient with everything he or she wants or needs to know.

10.  The reasonable person standard makes a controversial
presumption: that what the reasonable person would need is what
a particular patient would need.
 But what about the patient who is unique, who would like some
information that the typical reasonable person would not want?
Or what about the patient who is unique in not wanting some
information that the typical reasonable person would need? Some
are now proposing a Subjective Standard.
case sTudycase sTudy
 The following case requires the pharmacist to choose which of
these three standards is appropriate.
 CASE 15-2 Explaining Phenytoin Side Effects: The Problem of
Adequate Disclosure. Page :260

11.  Discussing
 Dr. Stone seems to be appealing to what is often called the
professional standard, under which the clinician is obligated to
disclose what his or her colleagues similarly situated would
disclose.

 If a legal charge of failing to get an adequately informed consent
is brought against the clinician, the defense would be to bring in
colleagues similarly situated to testify about what they would
have done.
 Assuming that there is a duty to get an informed consent in such
cases, Dr.Stone and Dr. Kindelin must realize that they cannot
tell patients literally everything about any drug.

12.  There are virtually infinite effects that could occur, many of
which patients clearly would not be interested in learning
about. There is no way they can tell everything.
 Knowing what to disclose depends on which standard is
appropriate.
 According to the traditional professional standard, clinicians
need tell only what their colleagues similarly situated would
claim.
 The reasonable person standard holds that she must tell what
the reasonable person would want to know before consenting.
 A majority expressed a desire to know about each of the side
effects mentioned. That, of course, does not imply they want to
know “everything.”

13.  The moral principle behind this reasonable person standard is
autonomy: the patient must be told what he or she needs to know
to make an informed choice, even if the information is upsetting.
 If the patient says he or she has been told enough, is that
sufficient to satisfy the ethical principle of autonomy.
 Some people are now advocating what is called the subjective
standard whereby a patient should be told information that fits
his or her needs.
 This would seem to conform to the principle of autonomy even
better than the reasonable person standard.
 Under it, patients would have to be told information according to
the reasonable person standard adjusted according to what the
clinician knows or has reason to know is unique about the
patient’s interests.

14.  It is not enough that the patient be adequately informed if the
consent is to satisfy the requirements of the principle of
autonomy.
 The information must also be understood, and the consent must
be voluntary.
 Consent may be constrained either because the information,
though communicated, was not understood or because the
individual’s choice was somehow not voluntary.
 Understanding is jeopardized when the words cannot be
comprehended because they are unfamiliar, either because the
patient is not a native speaker or, even if he or she is a native
speaker, the terms are simply too complex.

15. ◦ A 68 year old female
◦ Diagnosis of schizophrenia for 40 years
 Severely ill
 Never able to live in the community
◦ Guardianship established long before
◦ Order written to give an injectable form of an antipsychotic if
she refused oral antipsychotic.
The patient refused to take the oral medication
◦ Despite the order, and the consent of the guardian, the nursing
home refused to give the IM antipsychotic
◦ They claimed “The patient has a right to refuse treatment.”
◦ The medication is essential for her health
 She denies she has schizophrenia
 Noncompliance will lead to hospitalization

16.  Eating
 Bathing
 Ambulating
 Medications
 Other therapies and treatments
 Appointments
 Toileting

17.  Informed Consent
◦ A legal concept
 An agreement to do something or allow something to
happen
 Take a medication, e.g.
 Made with complete knowledge of all relevant facts
 Risk versus benefit
 Adverse events which may occur due to the
medication
 Improvement due to taking the medication
 Available alternatives
 Not taking the medication
 Other medications
 Nonpharmacological treatments

18.  A bit tricky and commonly misunderstood
 Most state and federal guidelines contain a provision stating
that a resident can refuse medical treatment
◦ Even though this is couched by “but this could be harmful to
your health.”
◦ This is independent of any knowledge of whether he /she
resident has a legal decision maker or not

19.  Can you force someone to take a bath?
◦ Yes, but do you really want to…
 Understand how often he needs to be bathed
 Certainly there are sound medical reasons he needs to
be bathed, plus day-to-day pericare
 Try and determine what environmental issues there are, if
any
 Doesn’t like women to bathe him, e.g.
 Like any task, slowly talk them through steps
 Let him set the schedule
 See if family can be there
 If this still doesn’t work
 Ensure safety
 Low dose medication can help with bathing
 But not with daily wash-ups

20. The End