PHA 204 Ethics in Pharmacology 2022 Dr John PDF

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Lagos State University College of Medicine

2022

Theresa A. John

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pharmacology ethics laboratory procedures animal ethics

Summary

This document contains lecture notes from a pharmacology course (PHA 204) at Lagos State University College of Medicine, focusing on the ethics involved in laboratory procedures, the use of animals in research, biosafety, and chemical waste management. The document addresses topics such as lab etiquette, potential hazards, and good practices for a research environment.

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BSC PHARMACOLOGY LECTURES PHA 204 ETHICS IN PHARMACOLOGY LABORATORY ETIQUETTES Theresa A. John, PhD, MHPE, Associate Professor Department of Pharmacology, Therapeutics and Toxicology, Lagos State University College of Medicine LA...

BSC PHARMACOLOGY LECTURES PHA 204 ETHICS IN PHARMACOLOGY LABORATORY ETIQUETTES Theresa A. John, PhD, MHPE, Associate Professor Department of Pharmacology, Therapeutics and Toxicology, Lagos State University College of Medicine LAB ETHICS WHAT MAKES THINGS WORK WELL FOR ALL ALWAYS REMEMBER: LAB TEAM : diversity of age, culture , background, education, training, experience, exposure, interests, career goal , career projection LAB ENVIRONMENT: expensive, delicate, controlled, disciplined, risky, potentially hazardous (fire, toxins, disease) BY TEAM AND ENVIRONMENT: we are referring to a single unit lab space, a whole laboratory, a series of labs ,or a whole faculty or institute - we all work together and are interdependent FORBIDDEN ❖ Unauthorized personnelincluding co-workers that are not prepared for and not involved in research; avoid friends or family routinely visiting ❖ Unauthorized procedures, not suitable in a particular lab ( e.g. use of radio active substances, use of virus or bacterium culture, use of powerful energies) ❖ Unauthorized experimentation (mad scientist experiments), whimsically trying something to see what will happen , out of spontaneous curiosity) FORBIDDEN continued ❖ Food and drink: avoid eating and drinking in the lab; do not put food and drink on laboratory surfaces, inside laboratory refrigerator or inside laboratory cabinet ❖ Disturbances: when in a running lab: do not talk politics, religion, pop culture, gossips, or other topics that generate distraction, mental disturbance , or emotional imbalance do not arbitrarily change lightings, fan setting, air-conditioning, windo w opening, etc., without first checking if it will upset what someone is doing do not disturb with personal electronic gadgets such as hand sets. Ensure your colleagues can concentrate on their work. DRESS CODE ❖ Be properly covered by protective dress: avoid exposing your skin, wear covered shoes, wear a lab coat and as much as needed personal protective equipment: gloves, goggles, ear plugs (e.g. for sonication) , radiation shielding, etc. Keep long hair packed. ❖ Wear comfortable clothing ❖ Keep bags, umbrellas, and other possessions away from laboratory bench BE PREPARED FOR EVENTUALITIES ❖ Know and follow the rules and organization of the lab ❖ Know the potential hazards in the lab ❖ Know where the safety and precautionary equipment an d facilities are: e.g. instructions and catalogues, eye wash, shower, fire extinguisher, fire blanket, alarms ❖ Be ready to lend a hand FOLLOW THE RULES especially pertaining to ❖ maintenance of clean and functional laboratory ,e.g. clean up spills and contamination, recalibrate equipment, report breakages ❖ labelling and handling of chemicals and reagents ❖ ethical use of bio resources ❖ disposal of used materials, such as PPEs, needles and sharps , chemicals , and biological waste in respective waste disposal systems ❖ safety procedures such us for use of flames, radiation, noisy equipment, volatile substances, etc. ❖ keys , locks, codes, and security measures DO NOT CONTAMINATE ❖ surfaces ❖ compartments ❖ utensils ❖ equipment ❖ supplies ❖ Buffers ❖ Liquids and solutions IN SHARING COMMON USE SUPPLIES AND EQUIPMENT: ❖ follow the agreed procedures – avoid surprises and shocking others (e.g. don’t empty the supplies without informing and arranging fresh orders) ❖ label things well ❖ clean and restore items after use ❖ return items to their place after use, don’t create “missing items” ❖ keep equipment in top form: in place, calibrated, protected, functional ❖ facilitate: make sure things are user friendly ❖ keep rules and instructions handy and with enough copies in relevant places ❖ maintain rosters, schedules and critical arrangements WHEN WORKING WITH OTHER PERSONS IN EXPERIEMENTATION, take care of ❖ effective communication ❖ punctuality and timing ❖ understanding and fulfilling your role ❖ Your own competence and reliability BE HAPPY TO SHARE: ❖ Knowledge ❖ Know-how ❖ Skills and techniques ❖ Tips ❖ Facilities ❖ Rules and instructions ❖ Scientific and professional news and announcements The good of one is the good of all the lab BE GUIDED BY THOUGHTS OF : Safety – avoid harm to self, other persons, property, environment, relationships; practice surveillance cordiality – so that every one is a happy camper facilitation – things should be as easy as possible efficiency – don’t waste time , materials, money , resources, efforts, opportunities (yours and those of others) productivity – encourage all to be their best and do their best BSC PHARMACOLOGY LECTURES PHA 204 ETHICS IN PHARMACOLOGY USE OF ANIMALS IN RESEARCH Theresa A. John, PhD, MHPE, Associate Professor Department of Pharmacology, Therapeutics and Toxicology, Lagos State University College of Medicine Animal ethics is a branch of ethics which examines human-animal relationships, the moral consideration of animals and how nonhuman animals ought to be treated. Why Animal ethics? (i) Animals have an intrinsic value which must be respected. (ii) Animals are sentient creatures with the capacity to feel pain, and the interests of animals must therefore be taken into consideration. (iii) Our treatment of animals, including the use of animals in research, is an expression of our attitudes and influences us as moral actors. FIVE DOMAINS OF ANIMAL WELFARE Nutrition – factors that involve the animal’s access to sufficient, balanced, varied, and clean food and water. Environment – factors that enable comfort through temperature, substrate, space, air, odour, noise, and predictability. Health – factors that enable good health through the absence of disease, injury, impairment with a good fitness level. Behaviour – factors that provide varied, novel, and engaging environmental challenges through sensory inputs, exploration, foraging, bonding, playing, retreating, and others. Mental State – by presenting positive situations in the previous four functional domains, the mental state of the animal should benefit from predominantly positive states, such as pleasure, comfort, or vitality while reducing negative states such as fear, frustration, hunger, pain, or boredom. Generally, before experiments on animals are conducted, the research protocol must be reviewed by animal ethics committees. The guiding principle of these committees is usually the 3 Rs developed by Russell and Burch (1959 ): “The Principles of Humane Experimental Technique.” Animals (Scientific Procedures) Act 1986, revised 2013 The three Rs to consider before using animals: ❖ Replace – can you use non- animal experimentation ❖ Reduce – minimize use of animals, enough for reliable data ❖ Refine – avoid hurting and suffering the animal Weigh benefit against harm Minimize pain, suffering, distress and lasting harm in experimental THE RESEARCHER USING ANIMALS All researchers handling the animals used for experimentation should be trained in: ❖ specific knowledge about the biology of the animal species in question, and ❖ have a willingness and ability to take care of the animals, as well as ❖ know proper handling of the particular species in the study. ARRIVE (Animal Research: Reporting of In Vivo Experiments) guidelines are intended to improve the reporting of research using animals. This checklist provides information that needs to be provided in the different section of the manuscript such as experimental animals, study design, experimental procedures, housing and husbandry, ethical statements, and more. Distribution of the purposes for animal use Baumans, V. Use of animals in experimental research: an ethical dilemma?. Gene Ther 11, S64–S66 (2004). https://doi.org/10.103 8/sj.gt.3302371Bauman s, V. Use of animals in experimental research: an ethical dilemma?. Gene Ther 11, S64–S66 (2004). https://doi.org/10.103 8/sj.gt.3302371 Distribution of vertebrate animal species used for research, testing and education. Development of animal use in the 20th century. Note pharmacology and toxicology use much animal experi- mentation BSC PHARMACOLOGY LECTURES PHA 204 ETHICS IN PHARMACOLOGY ETHICAL HANDLING OF HANDLING OF BIOHAZARDS Theresa A. John, PhD, MHPE, Associate Professor Department of Pharmacology, Therapeutics and Toxicology, Lagos State University College of Medicine WHY BIOSAFETY As pharmacologists, we do experiments which involve use of microbes, genetic materials, and biohazards. “Biorisk is the likelihood of the occurrence of serious infection due to exposure to pathogenic microorganism or biohazards.“ We thus have to know and practice biosafety procedures. All laboratories should have a Hazardous Materials Management and Disposal Policy and Procedures Manual WHAT ARE BIOHAZARDS? ❖ microbial infectious agent or other biological materials posing a risk for human health, parasites, viruses, prions, or ❖ biologically derived toxins, allergens, venoms, or ❖ recombinant DNA that can adversely affect human or animal health and environment PATHOGEN TRANSMISSION The experimenter must be aware of these ways of transmission: ❖ contact with exposed part of the body, e.g. skin, eye, or mucous membrane ❖ inhalation ❖ needle or sharp objects ❖ accidental ingestion ❖ insect bites For biosafety, laboratory workers and students should be trained on : ❖ Usage of microbiological techniques ❖ Safe use of biosafety cabinets ❖ Medical and laboratory waste management ❖ Blood/human samples/tissue handling ❖ Recombinant DNA technology with viruses or bacterial vectors or working with animal or plant systems Biosafety involves: Effective policies for biosafety, biocontainment, and biosecurity. Appropriate risk identification, assessment, and continuous monitoring for minimal chances of exposure. Training all those working in the laboratory regarding safety, responsibilities, handling in accidental situations, and reporting of concerns. Both workers and management should work with full cooperation and critically perform self-review. Biocontainment, e.g. use of biosafety cabinets BIOSAFETY LEVELS “Biosafety levels (BSL) are laboratory designations, which are based upon the degree of risk. They are designated as BSL-1, BSL-2, BSL- 3, and BSL-4. These safety levels ensure different levels of protection when working with virulent microbial strain. These laboratories are very sophisticated and have very good design, engineering control, and safe work practices” “Biosafety level 1 (BSL-1) in this open bench work can be done in basic teaching or research laboratory. Work involves using chemicals and agents, which do not cause any disease in humans as E. coli (nonpathogenic strains) and yeast. This facility may not have biosafety hood.” Most pharmacology laboratories have at least this level biosafety. “Biosafety level 2 (BSL-2) it can handle moderate-risk microorganisms responsible for infection and pose risk for infection via percutaneous or mucous membrane exposure. In these laboratories provisions for biosafety cabinets are present for containment of aerosols. Protective clothing and biohazard sign is required. The diagnostic and research laboratories are equipped with all these facilities for handling pathogens like mumps virus; A, B, and C virus; measles virus; and Salmonella.” If your work involves this type of experimentation, it is best to collaborate with workers in those departments that have such facility, such as a microbiology department High and Maximum Containment “Any kind of activity that includes usage of potential hazardous human pathogens, zoonotic agents ( rabies virus, influenza virus, Trypanosomes (sleeping sickness)), toxins, and agricultural threats which may pose danger to human civilization is recommended for use only in high biosafety levels. The various biosafety levels appropriate for these works are biosafety levels 3 and 4, animal facility/vivarium (ABSL-3 and ABSL-4), and biosafety level 3 agricultural facilities (BSL-3-Ag). High containment refers to the highest level of biosafety” BSC PHARMACOLOGY LECTURES PHA 204 ETHICS IN PHARMACOLOGY ETHICAL HANDLING OF CHEMICAL WASTE Theresa A. John, PhD, MHPE, Associate Professor Department of Pharmacology, Therapeutics and Toxicology, Lagos State University College of Medicine Example of how countries regulate chemical waste: “Chemical waste is regulated by the Environmental Protection Agency (EPA) through the Resource Conservation and Recovery Act (RCRA). It must be disposed of through the Hazardous Waste Disposal Program.” ❖ agency ❖ law ❖ procedure IN HANDLING CHEMICALS ❖ read the label thoroughly ❖ use appropriate personal protective equipment such as gloves, goggles, masks ❖ follow safety manuals ❖ use fume hoods as appropriate ❖ used appropriate dispenser and aliquot containers ❖ store as recommended SPECIAL CAUTION FOR DISPOSAL ❖ Do not place any liquids in the municipal waste ❖ Do not dispose of chemical waste, including stock containers with unused product, in the municipal waste ❖ Empty containers of their contents before disposal AVOID RISKY BEHAVIOUR Such as ❖ leaving bottle tops on the bench top, recap bottles immediately ❖ smelling inside an opened chemical container ❖ Mislabelling or not labelling containers with chemicals ❖ Keeping inflammable chemicals out of their storage location BSC PHARMACOLOGY LECTURES PHA 204 ETHICS IN PHARMACOLOGY ETHICAL LABORATORY WASTE MANAGEMENT Theresa A. John, PhD, MHPE, Associate Professor Department of Pharmacology, Therapeutics and Toxicology, Lagos State University College of Medicine RESEARCHER RESPONSIBILITY Ensure the safe and correct disposal of all wastes produced in the course of your work. All bins must be emptied regularly and should never be allowed to overflow LEGAL IMPLICATIONS In many countries, improper and irresponsible disposal of chemical wastes down drains, to the municipal refuse collection, or into the atmosphere is forbidden by law. DISPOSAL PROCEDURES ❖ Wash down drains with excess water ❖ Incineration ❖ Laboratory waste bins and controlled waste WASH DOWN DRAINS WITH EXCESS WATER ❖ Concentrated and dilute acids and alkalis ❖ Harmless soluble inorganic salts (including all drying agents such as CaCl2, MgSO4, Na2SO4, P2O5) ❖ Alcohols containing salts ❖ Hypochlorite solutions ❖ Fine (TLC grade) silica and alumina "RED LIST" should never be washed down a drain. This list is as follows: compounds of the following elements:- antimony, arsenic, barium, beryllium, boron, cadmium, chromium, cobalt, copper, lead, mercury, molybdenum, nickel, selenium, silver, tellurium, thallium, tin, titanium, uranium, vanadium and zinc. organohalogen, organophosphorus or organonitrogen pesticides, triazine herbicides, any other biocides. cyanides mineral oils and hydrocarbons poisonous organosilicon compounds, metal phosphides and phosphorus element fluorides and nitrites INCINERATION (SOLVENT WASTE COLLECTION) all organic solvents including water-miscible ones soluble organic waste including most organic solids paraffin and mineral oil (from oil baths and pumps) LABORATORY WASTE BINS AND CONTROLLED WASTE TYPES OF BINS ❖ general (municipal) waste bins: dirty paper, plastic, rubber and wood ❖ recycle waste bins: clean glass, paper, cans ❖ Special waste containers SPECIAL WASTE CONTAINERS(BINS, BOXES) “manage hazardous wastes in accordance with the Hazardous Materials Management and Disposal Policy and Procedures Manual. This type of waste may only be removed by Environmental Health and Safety Personnel. SPECIAL WASTE CONTAINERS(BINS, BOXES) ❖ SHARPS WASTE CONTAINERS are puncture resistant containers Sharps are items that can cut skin or puncture a garbage bag. Examples are broken glass, needles, razor blades, syringes, knives, lancets, capillary tubes, metal shavings, glass or plastic pipettes and pipette tips, broken glass, glass slides, cover slips, plastic, metal, pottery with sharp edges, etc. SPECIAL WASTE CONTAINERS(BINS, BOXES) ❖ BIOLOGICAL WASTE AND REGULATED MEDICAL WASTE CONTAINERS Biological waste are various and disposal must follow appropriate manuals and instructions LABORATORY WASTE BINS AND CONTROLLED WASTE ❖ RADIOACTIVE WASTE CONTAINER Radioactive wastes is disposed of in accordance with the Radiation Safety Manual. SPECIAL WASTE CONTAINERS(BINS, BOXES) ❖ BOTTLES CONTAINERS The tops must be removed from all bottles being disposed of and there should be no detectable smell of chemicals from any bottle placed in the bin STUDY QUESTIONS 1. Your Principal Investigator has gone on leave for 2 months and has put you in charge of the lab with six persons working together. What factors would you take care of to keep the lab in good working order slides 2-10 2. Write an essay on how you can work well as a team in a laboratory slides 11-14 3. What is animal ethics and why animal ethics slides 16-18 4. What is the animals ethics committee involved with slides 19-22 5. Write an essay on the importance of biosafety and how we ensure biosafety in research slides 27-36 6. Discuss factors important in the handling of hazardous chemicals slides 37 - 41 7. Write a discussion on ethical laboratory waste management slides 42 -55

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