semmelweis university 2 0 1 2 / 2 0 1 3
semmelweis university 2 0 1 2 / 2 0 1 3 semmelweis university 2 0 1 2 / 2 0 1 3
Basic concepts and importance of the Biopharmaceutical Classification System. Biopharmaceutical considerations of drug distribution and metabolism. Bioanalytical methods. Excretion and clearance of drug. The biological half-life. Bioavailability and influencing factors. Studies and regulations on bioequivalence. Importance of food-drug interactions. Compartmental and non-compartmental modeling. Physiologically based pharmacokinetic models. Pharmacokinetics of multiple dosing. In vitro – in vivo correlation and relationship. Pharmacokinetic and metabolism investigations during preclinical and clinical development. Practice Study on the distribution of salicylic acid in a three-phase system. In vitro test for drug liberation from a patch system. In vitro drug release from oinments with local effect. In vitro dissolution profile of conventional and modified release nitrofurantoin containing preparations. Determination of diclofenac sodium in synovial fluid samples. Urinary excretion kinetics of aspirin. Determination of theophylline plasma levels in beagle dogs after iv. administration. Determination of theophylline plasma levels in beagle dogs after po. administration. Calculation of bioavailability. Computer modeling and analysis in pharmacokinetics. Analyzing data to establish in vitro-in vivo correlation. PHARMACEUTICAL ETHICS Credit: 2 Lecturer: Prof. Dr. József Kovács Syllabus (14 hours) SEMMELWEIS UNIVERSITY / FACULTY OF PHARMACY Course objectives: a. To enable students to recognize ethical issues when encountered in everyday practice and research b. To provide students with a conceptual-logical system, which helps them to address ethical questions and to resolve ethical dilemmas in an efficient way c. To introduce students to a body of knowledge, which helps them to understand, respect and protect the rights of patients, research subjects and fellow health care professionals d. To help the would be health care professional to understand the responsibility of the individual, of the health care system and of the society as a whole in maintaining health Faculty of Pharmacy 465
SEMMELWEIS UNIVERSITY / FACULTY OF PHARMACY 466 1. week (Lecture) Basic concepts of ethics. Descriptive ethics, normative ethics, metaethics. General ethics and applied ethics. Bioethics, medical ethics, health care ethics. Similarities and differences. The role of bioethics in a pluralistic society. The relationship between law and ethics. Reasoning in ethics. The most common mistakes. 2. week (Lecture) Normative theories of ethics. The basic principles of medical ethics. Deontological theories of ethics. (The Golden Rule, Kant and the categorical imperative, the principle of double effect, W.D. Ross and the prima facie duties,) Teleological theories of ethics. (Act and rule utilitarianism.) Theories of natural law. Contractarian theories of ethics. (The theory of justice of John Rawls) The principle of respect for autonomy. The principle of non-maleficience. The principle of beneficience. The principle of justice. Arguments against „principalism”. 3. week (Lecture) Justice in Health Care .. Ethical questions of macro- and microallocation Higher and lower level macroallocational problems. The principles and practice of rationing in contemporary health care systems. (Soft and hard rationing.) Medical ethics and medical economics. Ethical questions of cost-benefit and cost effectiveness analyisis. The problem of right to health care. (The libertarian, the liberal and the socialist views about the right to health care.) The role of the market and that of the state in the health care system. The concept of microallocation. Ethical analysis of various selection criteria. (Medical benefit, psychological ability, supportive environment, social value criterion, resources required criterion, age, ability to pay, random selection, personal responsibility for the illness, etc.) 4. week (Lecture) Informed consent and truth telling Simple consent and paternalism in medicine. The emergence of the doctrine of informed consent. Standards for information disclosure for patients. When is informed consent not necessary? Standards of competence and incompetence. The right to refuse medical treatment. Some psychological and communicational aspects of informed consent. The history of information disclosure to terminally ill patients. Pros and cons for lying to terminally ill patients. The weaknesses of the arguments in favour of lying. The dying process according to E. Kübler-Ross.
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SEMMELWEIS UNIVERSITY / FACULTY OF PHARMACY<br />
466<br />
1. week (Lecture)<br />
Basic concepts of ethics.<br />
Descriptive ethics, normative ethics, metaethics.<br />
General ethics and applied ethics.<br />
Bioethics, medical ethics, health care ethics. Similarities and differences.<br />
The role of bioethics in a pluralistic society.<br />
The relationship between law and ethics.<br />
Reasoning in ethics. The most common mistakes.<br />
2. week (Lecture)<br />
Normative theories of ethics. The basic principles of medical ethics.<br />
Deontological theories of ethics. (The Golden Rule, Kant and the categorical imperative, the<br />
principle of double effect, W.D. Ross and the prima facie duties,)<br />
Teleological theories of ethics. (Act and rule utilitarianism.)<br />
Theories of natural law.<br />
Contractarian theories of ethics. (The theory of justice of John Rawls)<br />
The principle of respect for autonomy.<br />
The principle of non-maleficience.<br />
The principle of beneficience.<br />
The principle of justice.<br />
Arguments against „principalism”.<br />
3. week (Lecture)<br />
Justice in Health Care .. Ethical questions of macro- and microallocation<br />
Higher and lower level macroallocational problems.<br />
The principles and practice of rationing in contemporary health care systems. (Soft and hard<br />
rationing.)<br />
Medical ethics and medical economics. Ethical questions of cost-benefit and cost effectiveness<br />
analyisis.<br />
The problem of right to health care. (The libertarian, the liberal and the socialist views about the<br />
right to health care.)<br />
The role of the market and that of the state in the health care system.<br />
The concept of microallocation.<br />
Ethical analysis of various selection criteria. (Medical benefit, psychological ability, supportive<br />
environment, social value criterion, resources required criterion, age, ability to pay, random<br />
selection, personal responsibility for the illness, etc.)<br />
4. week (Lecture)<br />
Informed consent and truth telling<br />
Simple consent and paternalism in medicine.<br />
The emergence of the doctrine of informed consent.<br />
Standards for information disclosure for patients.<br />
When is informed consent not necessary?<br />
Standards of competence and incompetence.<br />
The right to refuse medical treatment.<br />
Some psychological and communicational aspects of informed consent.<br />
The history of information disclosure to terminally ill patients.<br />
Pros and cons for lying to terminally ill patients.<br />
The weaknesses of the arguments in favour of lying.<br />
The dying process according to E. Kübler-Ross.