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Ethics in Pharmacy

There are several dimensions in Pharmaceutical ethics -- Practice-, research- and community oriented. This presentation mainly deals with Clinical research oriented Ethics.

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Ethics in Pharmacy

  1. 1. 1 Ethics in Pharmacy Profession Part 1: Ethics in Clinical Research Dr. Bhaswat S. Chakraborty Former Sr.VP, & Chair, R&D Core Committee, Cadila Pharma Former Director, Biopharmaceutics, Biovail, Canada Former Senior Reviewer, TPD, Canada 1 Presented at the Institute of Pharmacy, Nirma University, March 3, 2018
  2. 2. 2 Contents  Ethics in general  Ethics in Pharmacy  History of Clinical Research  Ethics in Clinical Research  Ethics of RCTs and randomization  Ethics of data integrity  Concluding remarks 2
  3. 3. 3 Ethics  Ethics or moral philosophy  Moral values  The term ethics derives from Ancient Greek θικόςἠ (ethikos), from θοςἦ (ethos), meaning 'habit, custom'  Philosophy of axiology comprises the sub- branches of ethics and aesthetics, each concerned with values  Systematizing, defending, and recommending concepts of right and wrong conduct
  4. 4. 4 Ethics..  Ethics seeks to resolve questions of human morality by defining concepts such as good and evil, right and wrong virtue and vice, justice and crime  As a field of intellectual enquiry, moral philosophy also is related to moral psychology descriptive ethics, and value theory
  5. 5. 5 Bioethics  Bioethics is the study of ethics brought about by advances in biology and medicine  Concerned with the ethical questions that arise in the relationships among life sciences, biotechnology, medicine, politics, law, and philosophy  Includes more commonplace questions of values ("the ethics of the ordinary") that arise in primary care, medical research, clinical research etc.
  6. 6. 6 Ethics in Pharmacy Profession  Ethical Principles for Pharmacists  Guidance for decision-making and maintain ethical integrity varies according to the country and professional body that creates the guidelines  However, the ethical principles are similar and can be separated into five main categories: the responsibility for the consumer the community the profession the business and
  7. 7. 7 Ethics in Pharmacy Profession..  Responsibilities of a pharmacist that relate to the consumer include:  To recognize the consumer’s health and wellbeing as their first priority, and utilize knowledge and provide compassionate care in an appropriate and professional manner  To respect the consumer’s autonomy and rights and assist them in making informed decisions about their health. This should include respecting the dignity, privacy, confidentiality, individuality and choice of the consumer  The ethical responsibilities of a pharmacist that relate to the community include:  To maintain the reputation and trust that the public has placed on the profession and refrain from abusing this trust and respect  To acknowledge their place in the wider community, including their professional role and responsibilities to control and supply pharmaceutical goods for optimal health outcomes
  8. 8. 8 Ethics in Pharmacy Profession…  Relating to the profession include:  To commit to the development and enhancement of the profession by becoming involved in activities such as training staff, teaching, being a preceptor or mentor for students, interns or colleagues, participating in initiatives to develop the profession and demonstrate positive leadership.  To keep up-to-date with knowledge of pharmacy practice with lifelong learning and self-development to maintain professional competence and personal health to continue practicing.  To practice only when their professional independence, judgment and integrity remains upheld, and manage situations with a conflict of interest appropriately.  Relating to business practices include:  To conduct the business practices of pharmacy in an ethical and professional manner with the consumer’s best interest in mind and due respect to colleagues and the reputation of the profession.  Relating to other health professionals include:  To work in cooperation and collaboration with other healthcare professionals to achieve the optimal health outcomes for consumers.
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  17. 17. 17 Investigational Sites Product Management Project Management Drug & Clinical Trial Development Extended Picture IRB Regulatory Documents Relationship Building eMails Partners & Affiliates Meetings CROs Contracts Knowledge Information Safety Communication Resource Management Data Capture Data Management Multidirectional Flow of Data and Decisions 17
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  19. 19. 19 ICMR 2006: Ethical Guidelines for Biomedical Research on Human Subjects  Guidelines have elaborated 3 basic ethical principles:  respect for person, beneficence and justice  By inducting 12 general principles: 1. Principle of essentiality:research being carried out should be essential for the advancement of knowledge that benefits patients, doctors and all others in aspects of health care… 2. Principles of voluntariness, informed consent and community agreement: research participant should be aware of the nature of research and the probable consequences of the experiments and then should make a independent choice without the
  20. 20. 20 ICMR 2006: Ethical Guidelines for Biomedical Research on Human Subjects.. 3. Principle of non-exploitation:Research participants should be remunerated for their involvement in the research or experiment. The participants should be made aware of all the risks involved irrespective of their social and economic condition or educational levels attained…either through insurance cover or any other appropriate means to cover all foreseeable and hidden risks. 4. Principle of privacy and confidentiality:All the data acquired for research purpose should be kept confidential to prevent disclosure of identity … not be disclosed without valid legal and/or scientific reasons. 5. Principle of precaution and risk minimisation: Due care and caution should be taken at all stages of the research and experiment (from its beginning as a research idea, formulation of research design/protocol, conduct of the research or experiment …
  21. 21. 21 ICMR 2006: Ethical Guidelines for Biomedical Research on Human Subjects… 6. Principle of professional competence:Clinical research should be carried out only bycompetent and qualified persons in their respective fields. 7. Principle of accountability and transparency: The researcher should conduct experiments in fair, honest, impartial and transparent manner after full disclosure of his/her interests in research. They should balso retain the research data, … 8. Principle of the maximisation of the public interest and of distributive justice: The results of the research should be used for benefit of all humans, especially the research participants themselves and/or the community… 9. Principle of institutional arrangements: It is required that all institutional arrangements required to be made in respect of the research and its subsequent use or applications should be duly made in transparent manner.
  22. 22. 22 ICMR 2006: Ethical Guidelines for Biomedical Research on Human Subjects…. 10. Principle of public domain: The results of any research work done should be made public through publications or other means.Even before publication, the detailed information of clinical trials should be made public before start of recruitment via clinical trial registry systems … 11. Principle of totality of responsibility: All those directly or indirectly connected with the research should take the professional and moral responsibility, for the due observance of all the principles, guidelines or prescriptions laid down in respect of the research. 12. Principle of compliance: All those associated with the research work should comply by the guidelines pertaining to the specific area of the research.
  23. 23. 23 Ethics of Randomization in CTs  Randomized clinical trials pose a number of fundamental ethical questions:  Placebo control?  Will control arms get standard treatment at all?  Cross-over?  …?  Morally sensitive investigators must give careful consideration to these questions  The randomized double-blind clinical trial is ethically justified and the preferred method of demonstrating therapeutic effectiveness and safety  Use of randomized double-blind clinical trials must assure adequate explanation of the research plan to the patient, the documentation of informed consent, adequate consideration of safety, and an acceptably low risk/benefit ratio
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  27. 27. 27 Ethics of Data Integrity  Quality of clinical trial data can make or break an NDA or BLA – all phases  Clinical development is very complex and highly expensive Quality monitoring of CT data may cost up to 30% of total trial cost  Quality of trial data, whether of patient safety or of effucacy & scientific conduct of the entire trial is determined by accuracy, completeness and proper documentation of all data
  28. 28. 28 Data Integrity in Clinical Research  “Data integrity is the degree to whicha collection of data is complete, consistent and accurate through the data lifecycle.” – WHO  Research integrity depends on data integrity  Includes all aspects of collection, use, storage and sharing of data.  Data integrity is a shared responsibility  Although the main responsibility belongs to the PI asnd the sponsor, there is a broader role and responsibility for the institute and scientific community.  Transparency of the research data is its CREDIBILTY 28 Free and accurate information exchange is fundamental to scientific progressVan Eyk J., JHU NHLBI Innovative Proteomics Center on Heart Failure
  29. 29. 29 Sources of Data Integrity & Its Lack  Data integrity is based on accurate and traceable: Collection Recording Storage Reporting.  Data integrity can be compromised numerous ways: Malicious proprietors Human mistakes and naivety Technical error 29 Van Eyk J., JHU NHLBI Innovative Proteomics Center on Heart Failure Fraud & cooked data are the highest risk of intefrity but errors can also give misleading results
  30. 30. 30 Concluding Remarks  Ethics is an unbiased morality = not only what shouls be done but what must be done  Various dimensions of ethics exist for Pharmacists  Ethics is CTs in very complex, involves intricate responsibilities and accountabilities at various levels  A CT is as good as the quality of its data  ICMR and other authorities have issued comprehensive guide;ines on human ethics ad clinical research  ICMR has 12 specific principles covering all aspects of relevant ethics  Ethics of randomization must be carefully examined for all aspects of patient beneficence and safety  Ethics of data integrity is being specially attended to by the regulatory authorities lately  All… all aspects of clinical research have ethical implications and resposibilities 30
  31. 31. 31 Thank You Very Much
  32. 32. 32 QUESTIONS?