Chapter 2 Professional ethics Pharmacists are regulators! 1
Overview of Pharmaceutical Ethics Profession – is an occupation that requires extensive training and the study and mastery of a specialized knowledge has :- A professional associations. Ethical code and Process of certification and licensing. 2 Terminologies
Cont’d… Vocation – is an occupation that requires usually skills and education program range from short units (ten weeks or less) to long term program up to two years length. Ethics – is the science of moral value. It is composed of moral beliefs and rules about right and wrong. 3
Cont’d… The ethical principles are: Autonomy (respect for persons). Non- maleficence (avoiding harm). Beneficence (doing good). Justice (fairness). 4
Cont’d… Professional ethics – is the moral principle which should guide members of the professions in their dealings with:- Each other Their patients The patrons The state, etc… 5
Cont’d… Elements of profession An intellectual discipline and standard of knowledge. A representative body of practitioners. Standard of conduct. Service and advice, in the interest of the patient or client. 6
Is Pharmacy a profession? yes An intellectual discipline and standard of knowledge A university degree and a practical training A representative body of practitioners EPA (Ethiopian Pharmaceutical Association) Standard of conduct There are standard of conducts known throughout the profession. Service and advice Provide service and advice in the interest of the patients 7
Cont’d… Rights and obligation of pharmacy personnel The seven principles As a pharmacist or pharmacy technician you must: Make The Care Of Patients Your First Concern -Take steps to safeguard the well-being of patients, particularly children and other vulnerable individuals -Seek to ensure safe and timely access to medicines - Encourage the effective use of medicines - Promote the health of patients 8
Cont’d… 2. Exercise your professional judgment in the interests of Patients and the public Make sure that your professional judgment is not impaired by personal or commercial interests, incentives, targets or similar measures Be prepared to challenge the judgment of colleagues and other health or social care professionals if you have reason to believe that their decisions could compromise the safety or care of others Conduct research and development 9
Cont’d… 3. Show Respect For Others Recognize diversity and respect the cultural differences, values and beliefs of others Make sure your views about a person’s lifestyle, beliefs, race, gender, age, disability or other perceived status do not prejudice their treatment or care Take all reasonable steps to prevent accidental disclosure or unauthorized access to confidential information 10
Cont’d… Take all reasonable steps to ensure appropriate levels of privacy for patient consultations Maintain proper professional boundaries in the relationships you have with patients and other individuals that you come into contact with during the course of your professional practice 11
Cont’d… 4. Encourage Patients To Participate In Decisions About Their Care Patients have a right to be involved in decisions about their treatment and care When possible, work in partnership with patients and other healthcare professionals to manage the patient’s treatment and care. Explain the options available and help individuals to make informed decisions about whether they wish to use particular services or treatment options 12
Cont’d… Respect a patient’s right to refuse or to receive treatment, care or other professional services. Ensure that reasonable steps are taken to meet the particular communication needs of the patient. 13
Cont’d… 5. Develop Your Professional Knowledge And Competence At all stages of your professional working life you must ensure that your knowledge, skills and performance are of:- a high quality, up to date and relevant to your field of practice. 14
Cont’d… You must: Maintain and improve the quality of your work by keeping your knowledge and skills up to date, evidence-based and relevant to your role and responsibilities Recognize the limits of your professional competence; practice only in those areas in which you are competent to do so and refer to others where necessary Apply your knowledge and skills appropriately to your professional responsibilities. 15
Cont’d… 6. Be Honest And Trustworthy Patients, colleagues and the public at large place should trust in you as a pharmacy professional. You must behave in a way that justifies this trust and maintains the reputation of your profession. 16
Cont’d… You must: Uphold public trust and confidence in your profession by acting with honesty and integrity Be accurate and impartial when teaching others and when providing or publishing information to ensure that you do not mislead others Respond honestly, openly and courteously to complaints and criticism. 17
Cont’d… 7. Take Responsibility For Your Working Practices Communicate and work effectively with colleagues from your own and other professions . ensure that both you and those you employ or supervise have sufficient language competence to do this. Take responsibility for all work done by you or under your supervision 18
Cont’d… Ensure that you are able to comply with your legal and professional obligations and that your workload or working conditions do not compromise patient care or public safety Raise concerns if policies, systems, working conditions, or the actions, professional performance or health of others may compromise patient care or public safety 19
Cont’d… Components of unethical behavior Smuggling or trafficking Illegal transport of goods, in particular across a border OR/ bypass customs Taking from one country to another country unlawfully, especially goods without paying necessary tax. 20
Cont’d… Corruption It is a general concept describing any organized and interdependent system in which part of the system is not performing duty. It was originally intended to, or performing them in an improper way to the determinant of the system’s original purpose. 21
Cont’d… Mistreating the patient with drug behavioral Drug dependence The comprehensive use of psychoactive drugs, to that point where the user has no effective choice but to continue use. 22
INTERNATIONAL PHARMACEUTICAL FEDERATION( IPF) STATEMENT OF PROFESSIONAL STANDARDS : CODES OF ETHICS FOR PHARMACISTS 23
IPF…………. Introduction: A profession is identified by the willingness of individual practitioners to comply with ethical & professional standards. The pharmacist continues to be the health professional who is the expert on medicines. 24
Cont’d… Pharmacists are also given the responsibility to: - help people to maintain good health. - avoid ill health. - promote the rational use of medicines and - assist patients to acquire, and gain maximum therapeutic benefit from their medicines. 25
Cont’d… The role of the pharmacist is continuing to develop. These obligations, based on moral principles & values, are provided to enable national associations of pharmacists, via their individual codes of ethics , to guide pharmacists in their r/ships with pts , other health professionals & society generally . 26
Cont’d… Based on this background, the IPF recommends that: 1. In every country, the appropriate association of pharmacists should produce a Code of Ethics for pharmacists setting out their professional obligations take steps to ensure that pharmacists comply with the provisions of that Code. 27
Cont’d… 2. The obligations of pharmacists set out in these codes should include: to act with fairness and equity in the allocation of any health resources made available to them. to ensure that their priorities are the safety, well being & best interests of those to whom they provide professional services. to collaborate with other health professionals to ensure that the best possible quality of healthcare is provided both to individuals & the community at large. 28
Cont’d… To respect the rights of individual patients to participate in decisions about their rx with medicinal products & to encourage them to do so. To recognize & respect the cultural differences, beliefs & values of pts , particularly as they may Affect a pt’s attitude to suggested rx . To ensure that they keep their knowledge & professional skills up-to-date through continuing Professional development. 29
To respect and protect the confidentiality of information. To ensure that information about an individual is not disclosed to others except with the informed consent Of that individual or in specified exceptional cases. To act in accordance with professional standards & scientific principles. 30
To act with honesty & integrity in their r/ships with other health professionals, including pharmacist Colleagues Not engage in any behavior or activity which undermine public confidence in the profession. To ensure that members of support staff to whom tasks are delegated have the competencies necessary for the efficient & effective undertaking of these tasks. 31
Cont’d… ensure the integrity of the supply chain for medicines by purchasing only from reputable sources. to ensure that all information provided to pts, other members of the public & other health professionals is accurate & objective, & is given in a manner designed to ensure that it is understood. To treat all those who seek their services with respect . To ensure the continuity of provision of professional services. 32
Code of Ethics in Pharmacy Objectives To promote high standard of conduct and practice among Pharmacy professionals patients and Pharmacy professionals with other health professionals. To state publicly the principles that forms the fundamental basis of the duties and responsibilities of the Pharmacists. To safeguard the public from unethical and substandard professional practice. 33
Cont’d… Definition Code of ethics of pharmacy – Moral principle Should guide members of the pharmacy profession In their dealing with their job, patients , fellow professionals , public and other profession in management of pharmaceuticals. It is a governing conduct of all pharmacy personnel both within and outside the practice of pharmacy . 34
Cont’d… A, Pharmacist in relation to his/her patients Always follow the rule: Patient first or Service first. Therefore, the Pharmacist should Be morally obliged to the gift of trust received from the patients. Not show partiality between his/her customers. Nationality Color Religion Social status Political standards, etc… 35
Cont’d… Not abuse his/her relationship with the patient for personal use. Dedicate himself/herself to protect the dignity of the patient. He/she should respect the patient right not to take a drug unless the disease condition requires. 36
Cont’d… b. Pharmacists in relation to the public Always provide quality service. Therefore the Pharmacist should: Maintain good personal qualities. Be on duty with clear mind. Be presentable/tidy and attractive. Master communication skills. Be knowledgeable. Always provide accurate and appropriate information. Always update him/her self. 37
Cont’d… Strive to create public awareness on Rational use of drugs. The profession in general. Be accountable for Ones action. Services rendered under his/her supervision. 38
Cont’d… Maintain standard premises clean environment order paint/ color , lighting handling of controlled substances price clearly labeled 39
Cont’d… c. Pharmacists in relation to other health professionals The Pharmacist should: respect the skills and competencies of other health care providers and endeavor to work cooperatively with them. not enter into any secrete arrangements or negotiation, with other health professionals. 40
Cont’d… Not to recommend a particular medical practitioner to the patient. Endeavor to maintain the confidence and trust placed in other health professionals by patients. Expose any act of malpractice committed by other health professionals through the appropriate channel. 41
Cont’d… Just accept that we are not alone; so play your position well and leave others play theirs. Drug without proper diagnosis is simply a shot in the dark. Drug without proper care is a bed room without bed. 42
Cont’d… d. Pharmacists in relation to fellow professionals The pharmacist should: Extend all support, respect and cooperation to fellow members of his/her profession during needs for scientific and technical information. Have responsibility to expose any act of misconduct or malpractice committed by a fellow professional. 43
Cont’d… e. Pharmacists in relation to his/her job The pharmacist should Get involved in the profession only after having been registered to practic e and legal license to operate a pharmaceutical establishment. Not delegate his/her subordinate and/or assistant to tasks which he/she should perform personally. 44
Cont’d… Immediately report any observed unwanted reactions, side effects to the attending physician and/or patient authority. Update his/her knowledge and maintain professional competence directly related to his/her specific area of practice. Provide current drug information to the public as well as to other health professionals/DIS 45
Ethical standards of practice 1. Dispensing of medication in Pharmacy a. Prescription handling The pharmacist should, Personally fill all prescriptions or ensure appropriate filling of orders. Accept prescriptions only in written form except under emergency or compelling conditions. 46
Cont’d… Handle only products approved by FMHACA (FDA). Not dispense prescription only drugs without prescriptions. immediately inform the prescriber due correction or clarification if the prescription has been found to be illegible or appears to be wrong. eg . Chlorpromazine and carbamazepine 47
Cont’d… Not dispense any drug to patients who do not appear in right mental state. Not alter prescriptions in any way. It is free to make generic substitution Do not dispense for prescribers self use. 48
Cont’d… Dispense medications as original packs whenever possible; If not repack materials should be labeled appropriately. 49
Cont’d… Labels should contain Name of medicine Batch number Expiry date Strength Dose Frequency of dosing Duration of treatment 50
Cont’d… b. Instructing, educating and counseling patients The Pharmacist should, Have appropriate knowledge and skills for patient education and counseling. Adapt messages to fit patients. Give ample verbal and written information on dispensed drugs. Conduct counseling or education in a conductive environment/ avoid any physical barrier. 51
Cont’d… c. Premises The pharmacist should maintain the premises that fulfill the following. The external and internal appearances of the pharmacy should be inspiring and attractive. 52
Cont’d… Premises should permit Flow of work. Communication and supervision. Cleaning and maintenance. Minimization and avoidance of Cross contamination. Adverse effect on the quality of the product, service and health of the public. 53
Cont’d… d. Special segments of public Premises should allow easy access and service and to disabled persons. Do not supply any medicinal products to children unless satisfied that the product will be used safely. 54
Cont’d… 2, Compounding and manufacturing of pharmaceuticals A, Compounding Only authorized personnel should be involved in compounding. Only healthy, mentally and physically fit personnel should be involved in compounding. Have procedures for compounding. 55
Cont’d… Have working procedures for every technical operation, cleaning (SOP). Label products properly. Product identity. Strength. Route of administration/application. Instruction of use. Beyond use date. Name of the institution. 56
Cont’d… B, Manufacturing of drugs and medical supplies in The Pharmacist should, give due consideration to safety, efficacy and quality. make sure every operation is in accordance to the national current GMP standards. maintain records and keep track of all key processes ensure that products carry unique batch number, manufacturing date and expiry date. 57
Cont’d… look after the needs of his employees. Space Safety and comfort Professional respect and independence Only engage in fair, transparent and free competition. Have working procedures for every technical operation, and cleaning (SOP). 58
Cont’d… 59 Proactively, protect and support the environment in accordance with the national guideline. Siggarate smoking Any waste Avoid any flammable substance. Correct or expose any malpractice through the appropriate channel.
Cont’d… 3. Pharmaceutical supply management and rational drug use Set your priority according to national need. Circulate only products approved by FMHACA. Always acquire pharmaceuticals through appropriate procurement procedures. Legal bids 60
Cont’d… Inspect products up on receipt/receiving. Store drugs and other substances as per the current Good Storage Practice throughout the supply system. Distribute pharmaceuticals only to authorized clients. in fair and equitable manner. 61
Cont’d… Distribute free sample to health professionals only. Maintain records and keep track of sold products. Promote rational drug use. 62
Cont’d… 4. Handling of narcotics, psychotropic and other dangerous drugs Store these substances in a separate secured area. Only the pharmacist himself/herself should carry of the dispensing. Dispense through only prescription paper approved by FDA. 63
Cont’d… Handle properly poisonous substances to prevent any injury to the public. Immediately report breakage, loss or theft to FDA. Store securely and separately expired and damaged products and dispose according to the procedure set by FDA. 64
Cont’d… 5. Drug research and development The Pharmacist should: strive to direct research focus to address national need. be committed to one’s proposal and agreement. be honest. 65
Cont’d… strive to uphold the sprit of cooperation. avoid bias. honor patents, copy rights and other forms of intellectual properties. adhere strictly to international institutional protocols experimental animals handling. 66
Cont’d… Not put participants in a situation where they might be at risk of harms as a result of their participation. Guarantee the participates’ confidentiality whenever necessary. When situation demands, participants should remain anonymous throughout the study even to the researchers themselves. 67
Quality Assurance(Q/A) of Pharmaceuticals The purpose is that to make certain that each drug reaching the pt. is: Safe Effective & of required quality. A Pharmacist engaged in these area should: Ensure that all standards, including those of GMP & Good Laboratory Practices are followed. 68
Cont’d… Ensure that each batch of manufactured drugs must Have a batch processing record based on the master manufacturing formula & instruction. Make all efforts to incorporate Q/A concepts in all the components of drug supply cycle. Not make available for sale/distribution of products, W/h he/she believes, Sub-standard Expired, Mislabeled Adulterated. 69
Disposal of Unfit for Use Products you should ensure that all reasonable care is taken when disposing medicinal products & chemicals. Disposal should carried out in accordance with the procedure set by the DRA. Keep “unfit for use drugs” in segregated areas separated from other stocks & maintain proper records until appropriate action is taken. 70
Pharmaceutical Regulatory Service: You should make decisions & act solely in the public interest & not in the interest of the individual. Be as open as possible while making decisions, making sure to justify actions taken & promote transparency of the institution in w/h you works. Establish & implement mechanisms & procedures For handling complaints about actions taken & for Appealing against their decisions. 71
Cont’d… Not disclose information of confidential or private nature unless you are forced to do so by law. Nor use such information with the intent to have financial gains. Be free from misleading, bribes & /or nepotism. Not work in, & own or have any business or financial association with any pharmaceutical establishment, where you have a supervisory or regulatory power , to avoid conflict of interest. 72
Cont’d…. Not issue & renew certificate of competence without making adequate evaluation or investigation of their quality. Drug Trade or service & authorize the use or Distribution of drugs or raw & packaging materials Exercise legitimate powers & authority, only within the scope of your institution’s legal responsibilities, giving respect to human right & privacy. Participate in the promotion of rational use of drugs. 73
Pharmacy Education: in a training institute you should: Ensure that basic (first degree) education programmes should provide pharmacy students & graduates with a sound & balanced ground. Ensure that the programme maintains the university character of education, balancing: Scientific knowledge With practical training. 74
Cont’d…. Education programs are based on a research oriented environment at a university or institute. Educational programs & curricula are designed to be consistent with required educational outcomes. 75
Ethical Principles & Obligations on Special Ethical Issues The Right to Confidentiality: The pharmacist: Should only use or disclose personal health information With the consent of the pt. May disclose personal health information only to those Who have a legitimate right to that information. 76
Cont’d… Should ensure that consent is obtained in writing. Up on request of the pt , is obligated to allow the pt to inspect records carrying personal health information & provide a copy. 77
Euthanasia & Abortion: you should not: participate in the use of drugs & chemicals for the purpose of euthanasia in human beings & shall refuse to participate in this practice . participate in the use of drugs for the purpose of abortion except in cases where abortion should be conducted for medical reasons. But this does not bar the pharmacist from supplying drugs for avoiding conception immediately after forced sexual abuses. Cont’d… 78
Procedures in the Execution of Breach of Code of Ethics: The prime concern of a professional association should be safety of the public & the reputation of the profession. The association should do its best to establish mechanisms of building professional ethics. Such mechanisms include: Educational mechanisms , w/h should be implemented via basic & continuous education process to inculcate professional ethics. Cont’d… 79
Cont’d… 2. Encouragement mechanisms, w/h should be expressed in terms of system of rewards. 3. Binding mechanisms, w/h is a system of enforcement of the Articles of Code of ethics when ever breach is observed. 80
The EPA is a due legalized body registered by the Ministry of Justice with an approved constitution. The associations has established standards of conduct known to all professionals & approved by its General Assembly. Cont’d… 81
Cont’d… These standards of conduct are expressed in the Articles of the Code of Ethics, w/h represent the collective views of the members . The constitution of EPA has also established an Ethical Committee and will take disciplinary measures in case of breach of the Articles in the Code of Conduct . 82
Rationale, Ethical Clinical Pharmacy Services Ethiopian Context Pharmaceutical Care in Ethiopia: Curricular revision 2008: nation wide Pharmacy undergraduate curriculum: - more patient oriented (4 years + 1 internship). More than 40% of courses under new pt oriented curriculum are clinical pharmacy courses. Post Graduates training JU AAU 83
Transition/shift Drug product Pharmacy Dispenser Solo Knowledge As ordered Drug therapy Bedside Caregiver Team Information As best prescribed 84
85
Hospital Pharmaceutical Services Minimum requirements (FMHACA): The pharmacist shall attend and participate: at multidisciplinary ward rounds morning meetings contribute to patient care through the provision of medicine information(DIC), dose calculations & adjustment, assisting in the rational prescribing decision, alternative regimens & reducing the frequency & duration of medication errors. 86
Cont’d… Ethical Clinical Pharmaceutical Services: patient-oriented services promote the rational use of medicines Right drug Right indication Right time Right dose Right duration Right pt. Right cost 87
Clinical pharmacy service at schools Seminars Morning sessions Preparing drug monographs Bed sides and ward rounds 88