Detecting and Managing Pharmaceutical Health Hazards (PDF)

DETECTING AND MANAGING PHARMACEUTICAL HEALTH HAZARDS LECTURE NOTE FOR LEVEL III PHARMACY  LO1 Manage Occupational and Health Safety(OHS) risk, exposure and hazards in Pharmaceutical service  1.1 Defining Health, Safety, Welfare &Hazard 1.2 What is health ? According to WH...

DETECTING AND MANAGING PHARMACEUTICAL HEALTH HAZARDS LECTURE NOTE FOR LEVEL III PHARMACY  LO1 Manage Occupational and Health Safety(OHS) risk, exposure and hazards in Pharmaceutical service  1.1 Defining Health, Safety, Welfare &Hazard 1.2 What is health ? According to WHO, health is state of complete physical , mental and social well-being and not merely the absence of disease. Physical health obtained through regular exercise , balance diet & adequate rest. reduce the risk of an injury or health issue.  Mental health refers to persons emotion, social , psychological wellbeing it is not only the absence of depression , anxiety disorder but it includes on ability to: – Enjoy life – Bounce back after difficult experiences – Feel safe and secure – Achieve your potential  What is Welfare? It is availability of resources & presence of conditions required for reasonably, healthy and secure living. It is the provision of a minimal level of well-being and social support for citizens and other eligible residents. In most developed countries, welfare is mainly provided by The government from tax revenue, and – To a lesser extent by NGO charities – Informal social groups – Religious groups, and – Inter-governmental organizations.  What is Safety ? The condition of being protected from or unlikely to cause danger, risk, or injury What is Hazard ? 1.2 Hazard, incidence, and injury in pharmaceutical service Hazard is simply a condition or a set of circumstances that present a potential for harm. Hazards are the main cause of occupational health and safety problems. Incidence is the rate of occurrence. Therefore, finding ways of eliminating hazards or controlling the risks is the best way to reduce workplace injury and illness.  Hazard Potential source of harm Risk Probability of the occurrence of harm and the severity of that harm. Risk Analysis Systematic use of available information to identify hazards and estimate risk. Risk Evaluation Based on the risk analysis, a judgment of whether a risk is acceptable based on societal values.  1.3 Classification of OHS in pharmacy services 1.3.1.Biological hazard: It is due to viruses, bacteria, parasites, fungi and molds. It is also include insects, pests, rodents, mammals and their toxins e.g. Flies, cockroaches, ticks and mites, rats. HIV/AIDS, Hepatitis B and C viruses and other blood borne pathogens, tuberculosis infections (particularly among health care workers), asthmas (among persons exposed to organic dust) and chronic parasitic infections (particularly among agricultural and forestry workers), are the most common occupational diseases that result from such exposures  Biological hazards can be transmitted to a person through: a. Inhalation b. Injection c. Ingestion d. Contact with the skin  1.3.2 Chemical hazards: Chemical hazards are dependent on their amount:- Amount Concentration Time of exposure Mode of entry to the body Age Sex Health status Resistance of the exposed workers  The effects of chemical agents are as follows:  Asphyxiation  Systemic intoxication  Pneumoconiosis  Carcinogens  Irritation  Mutagencity  Teratogenicity This is due to exposure to hazardous chemicals that may lead to damage to body systems. e.g. Laboratory chemicals, x-ray chemicals, acids, benzene, etc  1.3.3 Mechanical hazards It is resulting from unshielded machinery, unsafe structures in the workplace and dangerous tools. It can be caused by exposure to a heavy physical workload, poor working conditions, involving heavy item lifting and moving, or repetitive manual tasks. 1.3.4 Psychosocial Hazards: - Psychological  Stress is caused by time and work pressures.  Psychological stress and work overload have been associated with  Sleep disturbances  Depression  Cardiovascular disorders and  Hypertension 1.3.5 Physical hazards: High pitch noise Vibration Ionizing and  Non-ionizing radiation Electric and electromagnetic fields Extreme cold and heat are some of physical hazards. Ultraviolet radiation and ionizing radiation are known carcinogens.  1.4 Hazard identification and risk assessment Dealing with Hazards There are 3 basic steps to follow when dealing with hazards Identify Assess Control IDENTIFY The inspection checklist should have identified any hazards in your work area. If you notice a hazard, report it !  ASSESS Complete a Hazard Report 1. Rank the risk by probability - the likelihood of the hazard resulting in injury, illness, damage or loss 2. Rank the risk by consequence - the potential for injury, illness, damage or loss 3. Prioritize the risk for control - indicate the ranking of importance when control measures are to be implemented 1.5 Risk and hazard control strategies Now that the risk has been identified and assessed decisions need to be made about how best to eliminate or reduce the risk as much as possible. The hierarchy of controls provides the steps to making the right decisions in this process are:-. It is important to start at #1 and work though to #6 (ie. PPE is not the first control to put in place)  Elimination Substitution Isolate Engineering control Administration control' PPE 1. Elimination (remove the hazard) 2. Substitution (use an alternative) 3. Isolate (separation from hazard) 4. Redesign (change equipment or process) 5. Administration (change work practices 6. Personal Protective Equipment (ie gloves, glasses, hearing protection)  Risk Assessment - Process of completing risk analysis and risk evaluation. Risk Control - Process through which decisions are reached and protective measures are implemented for reducing or maintaining risks within specified levels. Residual Risk - Risk remaining after protective measures have been taken. Risk Management Systematic application of management policies, procedures, and practices toward analyzing, evaluating, and controlling risk What is Occupational Health and Safety (OHS)? It is an area concerned with protecting the safety, health and welfare of people engaged in work or employment. The goals of occupational health and safety programs include fostering a safe and healthy work environment. Occupational Safety and Health  As the term "occupational safety and health" implies, There are two aspects to this field. Safety: This seeks to make workplaces safe for workers so that they do not suffer injuries. Health: the goal is to prevent the occurrence of illnesses among workers because of exposures at their place of work.  Core Occupational Safety and Health Principles Basic principles of Occupational safety and health include : All workers have rights. Workers, as well as employers and governments, must ensure that these rights are protected and must strive to establish and maintain decent working conditions and a decent working environment.  Specific OHS Principles Work should take place in a safe and healthy working environment. Occupational safety and health policies must be established. Such policies must be implemented at both the national (governmental) and enterprise levels. Occupational safety and health programs and policies must aim at both prevention and protection Workplaces and working environments should be planned and designed to be safe and healthy  Objectives of occupational safety and health The promotion and maintenance of the highest degree of physical, mental and social well-being of workers in all occupations. The protection of workers in their employment from risks resulting from factors adverse to health. The prevention among workers of adverse effects on health caused by their working conditions. The placing and maintenance of workers in an occupational environment adapted to physical and mental needs. Health and Safety Policy and Legal Regulations The issue of governing safety and health at work on legal basis in Ethiopia dates back to 1940s when the first legal instrument Proclamation No. 58/1945 was promulgated. The origin of this legislation was a result of the advent of industrialization that took place in the country. A more comprehensive legislation on occupational Safety and Health management replaced this in 1964 i.e. Proclamation 232/1964 in order to address the change occurred.  Ethiopia has its own occupational health and safety policy. According to the labor proclamation no. 377/2003 the ministry of labor and social affairs of Ethiopia is the organ in charge with the responsibility to inspect occupational health and safety.  Manage First Aid Policy First aid is the provision of immediate care to a victim with an injury of illness before emergency medical treatment is available by a lay person, and performed within a limited skill range. The first-aid provider in the workplace is someone who is trained in the delivery of initial medical emergency procedures, using a limited amount of equipment to perform a primary assessment and intervention while awaiting arrival of emergency medical service personnel.  The first aider, on approaching a victim should have: Put their gloves on Checked for danger Checked for responsiveness Looked at the scene for clues about what has happened Gained history on the incident Assessed to see how responsive the victim is. If the victim is unconscious, the first aider should immediately call an ambulance Hazard identification This process is about finding what could cause harm in work task or area. Work areas include: Machine workshops, laboratories, office areas, stores and transport, and teaching spaces etc. Work Tasks can include: Audio and visual equipment, industrial equipment, hazardous substances and/or driving a vehicle, construction. Elements of the Work Environment There are 4 basic elements of the work environment. The worker The tool The process The work environment 1.6 Disposing hazardous medicine and materials Hazardous material (HAZMAT) Materials, substances, or chemicals that are deemed to have adverse effects on human health and the environment. Typical examples of HAZMAT include but are not limited to biological, chemical, and radiological agents and materials. It is necessary to formulate medicines waste management and disposal directive in accordance with Article 55 (3) of the Food, Medicine and Healthcare Administration and Control Proclamation No.661/2009.  Definition ”Antibiotics” means medicines used to treat infections caused by bacteria and other microorganisms. ”Antineoplastics or cytotoxic/anti-cancer medicine” means a medicine that inhibits and combats the development of cancer. ”Biodegradable” means a type of waste, typically originating from plant or animal sources, which may be degraded by other living organisms.  “Central disposal site” means a site established and operated by appropriate organ which provides medicines waste management and disposal service. ”Disposal Firm” means any waste management company licensed to dispose medicines waste. It can be a medicines importer, wholesaler, distributor, manufacturer or any private or public business authorized to dispose medicines wastes for fee.  ”Disposal Referral System” means a system to pass on medicines wastes to a licensed disposal firm, medicines supplier, manufacturer or central disposal site for disposal service for fee. “Central disposal site” means a site established and operated by appropriate organ which provides medicines waste management and disposal service.  "Environmental Impact Assessment" means the methodology of identifying and evaluating in advance any effect, be it positive or negative, which results from the implementation of a proposed project or public instrument.  ”Hazardous Substance” means a waste that poses substantial or potential threats to public health or the environment ignitability, reactivity, corrosiveness and toxicity. ”Health Care Facilities” means hospitals, health centers, health posts, clinics, diagnostic centers and other related facilities which involve in diagnosis and treatment of illnesses..”High Temperature Incinerator” means an incinerator that generates at least 1200°C in the secondary chamber, and is fitted with gas cleaning equipment..”Highly Engineered Sanitary Landfill” means an engineered landfill with landfill gas extraction, groundwater monitoring and leachate treatment facilities and monitored by trained staff. ”Medical Supply” means any article that may be used on the inner or outer part of the body for diagnosis or treatment of a disease in man. This includes, suturing materials, syringes, bandages, gauze, cotton and other similar articles and x-ray films.  ”Medicines Waste” means waste which encompass the following: a. All properly unsealed bulk products or loose tablets and capsules. If unexpired these shall only be used when the container is still sealed, properly labeled or still within the original unbroken blister packs, b. All cold chain damaged, unexpired medicines that should have been stored in a cold chain but were not, c. Counterfeit, substandard and adulterated, d. Discarded items used in the handling of medicines, E.Expired, unused, spilt, and contaminated, f. Improperly sealed or labeled or stored, g. Expired, damaged, and improperly sealed or labeled or stored laboratory reagents, h. Expired, damaged, and improperly sealed or stored medical supplies; i. Prohibited or unauthorized medicines, j. Expired, damaged, and improperly sealed or labeled or stored raw materials, and k. Discarded packing materials.  ”Medium Temperature Incinerator” means a two- chamber incinerator with minimum temperature of 8500oC..”Open Controlled landfill” means a landfill where medicines waste is covered with large amount of municipal wastes but it is still left open..”Open uncontrolled landfill” means a landfill where medicines waste is not covered with large amount of municipal wastes and it is left open..”Quality Incompliance” means non- conformity with the regulatory requirements/standards issued by the Authority. ”Sewer” means a flushing of medicines wastes to the sewerage system after proper dilution and regulation.  ”Supplier” means importer, wholesaler, or distributor which provides medicines to health institutions, universities, research institutions and others. ”Untreated waste” means medicines waste which is not immobilized or incinerated.  ”Waste Inertization” means a variant of encapsulation and involves removing the packaging materials including blister packs, paper, cardboard and plastic from the medicines and then crushing and mixing medicines with cement, lime and water. ”Waste Encapsulation” means a landfill approach to reduce the risk of medicine waste through immobilizing the medicine in a solid block within a plastic or steel drum. Medicines Waste Management and Disposal Systems 1. Medicines which are unfit for use shall not be stored for more than six months. 2. Approval and authorizing of disposal of medicines shall be sought from the appropriate organ. 3. Any medicines waste disposal practice, including diluting and flushing of liquid medicines into sewers and burning of packaging materials, shall be attended by an inspector of the appropriate organ. 4. After disposal of medicines waste have been carried out, disposal certificates shall be issued by the appropriate organ. 5. Disposal sites shall be environment and society friendly and shall be approved by appropriate organ in accordance with Environment Impact Assessment (EIA). 6. Re-use of any medicines waste including re-packing and re-labeling is prohibited. 7. Scavenging of medicines is prohibited and security measures to prevent scavenging shall be in place at disposal sites and temporary storage areas. 8. Any health institution which does not have a disposal facility approved by the appropriate organ shall not carry out medicines waste disposal. 9. Without prejudice to sub-article (8) of this article, any health institution which does not have an approved disposal facility shall use disposal referral system of licensed disposal firms, respective medicines suppliers or central disposal sites. 10. Custom and Revenue Authorities and police officers shall adhere to this directive for proper disposal of confiscated medicines  Handling of Medicines Waste 1. As stipulated by this directive, the disposal of medicines waste shall be carried out according to the sorting procedures and recommended disposal methods by the appropriate organ. 2. All workers who are involved in a disposal process shall wear appropriate personal protective equipment such as overalls, boots, gloves, safety glasses/goggles, masks, and caps. 3. The separation of unfit for use medicines shall be made into those that can be safely used/ returned to the medicines supply system and those that require disposal by different methods. 3. Each medicine waste shall be recorded on the register book 4. Special emphasis shall be given to segregate and store controlled drugs or substances, antineo- plastics or cytotoxic/anti–cancer medicines, anti- infective medicines, radiopharmaceuticals and any other hazardous non-medicine products like antiseptics and disinfectants until their separate and safe disposal. 6. Medicine wastes other than mentioned under sub- article (5) shall be categorized and kept by dosage forms: a) Solids, semi-solids and powders: tablets, capsules, granules, powders for injection, mixtures, lotions, creams, gels, suppositories etc., b) Liquids: solutions, suspension, syrups, ampoules etc., and c) Aérosol canisters : propellant - driven sprays and inhalers 7. Waste paper and packing materials may be sorted and recycled (if facilities are available), burned or disposed of as normal waste to a landfill. 8. Plastic, metal and glass items may be reused, recycled or disposed of in a landfill. Depending on the type of material and the purpose of reuse, appropriate treatment such as cleaning or disinfecting of reusable materials may be needed. 9. Containers shall be kept according to dosage forms to facilitate verification exercise, sorting and selection of disposal methods 10.An area or room for keeping containers of medicines waste shall be demarcated and labeled conspicuously with words “Expired medicines–Not for Sale” or “Unfit medicines–Not for sale” in red ink. 7. Healthcare Facilities & Retail Medicine Outlets 1. Without prejudice to sub-article (9) of article 5, health care facilities & retail medicine outlets shall submit applications for disposal of unfit for use medicines to: a. Central disposal sites, b. Respective suppliers, or c. Licensed disposal firms and shall report/copy to the appropriate organ. 2. To request for approval of disposal of medicines waste, except recyclable materials, cartons, leaflets and labels, health institutions shall submit applications to the appropriate organ. 3. All applications for disposal of medicines waste shall be accompanied with lists of products to be disposed clearly stating trade name and/or generic name, strength (where applicable), dosage form, pack type and size, quantity, batch number, expiry date, manufacturer, supplier, country of origin, and product price. 4. Without prejudice to sub-articles (2) & (3) of this article, after a disposal request has been approved by the appropriate organ, the healthcare facilities shall organize a disposal committee comprising the facility pharmacist, facility environmental health personnel, warehouse personnel and finance head as appropriate to the organization. 5. Without prejudice to sub-articles (2) & (3) of this article, a. The selection of disposal method and the disposal process shall be conducted in the presence of an inspector of the appropriate organ b. After the disposal process is completed, the appropriate regulatory organ shall issue disposal certificate to the health institution within one week. c. Depending on the risk of medicines waste and complexity of the disposal method, health institutions may use disposal referral system. If that is the case, disposal service applications to licensed disposal firms shall be reported/copied to the appropriate organ by the health institutions. 6. Unfit for use medicines of health institutions, except recyclable materials, cartons, & leaflets, shall be returned back to respective suppliers for disposal. The appropriate organ shall be sent a copy of the referral/receipt form by the health institutions. 7. Health institutions shall present their disposal certificates whenever requested by concerned organ. 1. Medicine manufacturers and suppliers shall accept and manage medicines waste disposal requests from respective clients. 2. Medicine manufacturers and suppliers who have their own disposal facilities shall get an approval from FMHACA. In cases where medicines manufacturers and suppliers do not have their own disposal facilities, they shall have contractual agreement with licensed disposal firms. 3. Without prejudice to sub-article (2) of this article, medicine manufacturers and suppliers who provide disposal service for fee at their disposal facilities shall have a separate license. 4. Medicine manufacturers and suppliers shall submit applications to the appropriate organ to get approval for disposing medicines waste at their disposal facilities.  All requests for disposal of medicines waste shall be accompanied with lists of products to be disposed clearly stating trade name and/or generic name, strength (where applicable), dosage form, pack type and size, quantity, batch number, expiry date, manufacturer, supplier, country of origin, and product price. 6. The selection of disposal method and disposal process shall be conducted in the presence of an inspector of FMHACA. 7. After the disposal process is completed, a certificate shall be issued to the manufacturer or supplier by FMHACA within one week. 8. Manufacturers and suppliers shall present their disposal certificates when requested by a concerned organ at any time. 9. Disposal Firms 1. Any person who wants to establish and operate a medicines waste disposal firm shall be licensed by the Authority and the license shall be displayed in a conspicuous place. 2. Medicines waste disposal firm shall have the following professionals: a. Pharmacist, b. Environmental health professional, c. Sanitary Engineer (for landfill only) d. Security guards and other administrative staff for the disposal site. 3. A disposal firm shall have secured disposal site depending on the Environmental Impact Assessment (EIA) conducted with the support of the Environmental Protection Authority (EPA) of Ethiopia. In addition, a disposal firm shall have all the facility and practice standards prescribed under these directives. 4. A disposal firm shall have dedicated and secured transportation vehicles in accordance with national regulations and international conventions on transporting of hazardous substances ratified by Ethiopia. 5. Safe custody of medicines waste shall be maintained in separate, secure premises with security fences to avoid pilferage. However, once received, medicines waste shall be disposed within one month. 6. Disposal firms shall have all necessary equipments for the disposal methods they are implementing. 7. Disposal firms shall have security guards 24 hrs a day and 365 days a year. 8. A contractual agreement made between a health institution and a licensed disposal firm shall be reported to appropriate organ. Prior to disposal, any disposal firm shall request and get approval of disposal of medicines waste from the appropriate organ. 10. All disposal requests made by health institutions shall be reported to the appropriate organ by the disposing firm. 11. Without prejudice to sub-article (10) of this article, the report shall include the name and address of the disposal firm, date of request, name and address of the service requester, generic and/or brand name of the wastes, strength, dosage form, package type & size, quantity, batch number, expiry date, reason for disposal, manufacturer/supplier, country of origin, purchase value and other relevant information 12. A list of medicines waste to be disposed shall be prepared and signed between the applicant and the disposal firm. This form shall have minimum information consisting of generic and/or brand name, strength, dosage form, package type and size, quantity, batch number, expiry date, reason for disposal, manufacturer, supplier (if any), country of origin, purchase value and other relevant data to the appropriate organ. 13. Based on the number of applications for disposal, the disposal firm shall prepare disposal schedule and communicate with the appropriate organ. 14. Disposal method selection and disposal of medicines waste shall be conducted in the presence of an inspector of the appropriate organ. 15. Disposal shall be carried out based on the sorting and disposal methods recommended by the appropriate organ. Sorting may be done either at the health institutions’ premise or at the disposal firms’ disposal site. 16. The disposal firm shall take necessary measures to prevent diversion and scavenging during sorting, transporting and disposal process. 17. After the disposal process is completed, a certificate shall be issued to the disposal firm by the appropriate organ within one week. A copy of the certificate shall be given to the respective disposal service requester. 18. Any person shall present disposal certificates whenever requested by concerned organ at any time.  Disposal Methods 1. Return of Medicines Waste to Supplier/Manufacturer/Donor 2. Controlled Non-Engineered Landfill 3. Highly Engineered Sanitary Landfill 4. Landfill by Waste Immobilization: Encapsulation 5. Landfill by Waste Immobilization: Inertization 6. Sewer 7. Burning in Open Containers or Place 8. Medium-Temperature Incineration 9. High-Temperature Incineration Return of Medicines Waste to Supplier/Manufacturer/Donor As stipulated by Entry - Exit Inspection and Health Quarantine Directive, whenever medicines with quality incompliance are identified at port of entry, the supplier or donation recipient shall be responsible to return them back to their origin for disposal. Controlled Non-Engineered Landfill Controlled non-engineered landfill shall be in compliance with Environmental Impact Assessment (EIA) and shall not affect the aquifer, other watercourses or air.  Controlled non-engineered landfill shall be located at least 50 meters away from any ground water source. The controlled non-engineered landfill shall be protected from flooding, water entry and runoff. It shall also be secured from scavenging by having security guards and security fence Controlled non-engineered landfill operation shall minimize: a) The potential risks for polluting water resources and soil, b) The generation of landfill gas i.e. methane and carbon dioxide, c)Potential human exposure to volatile chemicals, d) Smell, vermin and fire, e) Destruction of natural/virgin sites, and f) Long term cost intensive clean-ups, remediation and monitoring (aftercare, close-up).  Disposal by controlled non-engineered landfill method shall not be used for the following hazardous wastes: a) hazardous liquid wastes and hazardous materials containing free liquids, b) highly volatile and flammable liquid wastes, c) wastes containing appreciable quantities of mineral oils, d) spontaneously flammable or pyrophoric solids, e) strong oxidizing/reducing wastes, f) shock sensitive explosives, g) compressed gases, h) highly reactive wastes, i) water soluble non-convertible materials, j) persistent organo-halogen compounds k) volatile materials of significant toxicity, i) substances that react with water, air or dilute acids and alkalies to produce hazardous gases or hazardous reactions, j) concentrated acids, alkalis, and k) Empty containers unless they are crushed, shredded or similarly reduced in volume.  Medicines waste immobilized by encapsulation/inertization may be disposed using controlled non-engineered landfill method. In cases where immobilization is impossible, medicines waste disposed by controlled non- engineered landfill shall be covered by 15 centimeter thick municipal waste.  Highly Engineered Sanitary Landfill 1. Site selection, design and management of operations of highly engineered sanitary landfill shall be in compliance with Environmental Impact Assessment (EIA). 2. Highly engineered sanitary landfill shall be properly constructed in order to protect the environment, the aquifer, other watercourses or air. 3. Highly engineered sanitary landfill shall consist of an evacuated pit isolated from watercourses and above the water table. 4. The basement of highly engineered sanitary landfill shall be closed and sealed with impermeable materials to prevent gas emission to the open air and water leachate to the environment. 5. Highly engineered sanitary landfill shall be constructed with gas extraction facility, groundwater monitoring facility and leachate treatment facility. 6. The gas extraction facility shall be designed either to burn collected gas or convert into energy. 7. Each day’s solid waste shall be compacted and covered with soil to maintain sanitary conditions.  Landfill by Waste Immobilization: Encapsulation 1. Clean drums made of steel or plastic shall be used for encapsulation. Using drums that have previously been used to store explosives or hazardous materials is prohibited. 2. In encapsulation, drums shall be filled to 75% capacity with solid and semi-solid medicines waste and the remaining space shall be filled with medium such as cement, cement/lime mixture, plastic foam or bituminous sand. 3. The mixture of lime, cement and water added to fill the drums to capacity shall be in the proportions of 15:15:5 (by weight). 4. After their lids have been sealed with seam or spot welding, the drums shall be placed at the base of a landfill and covered with fresh municipal solid waste.  Landfill by Waste Immobilization: Inertization 1. A grinder/road roller, a concrete mixer and supplies of cement, lime and water shall be required for inertization. 2. Packaging materials including blister packs, paper, cardboard and plastic shall be removed from the medicines waste. 3. The medicines waste shall be ground and a mix of water, cement and lime with the approximate ratio by weight of medicines waste: 65%, Lime: 15%, Cement: 15%, Water: 5% or more shall be added to form a homogenous paste. 4. Without prejudice to sub-article (3) of this article, the paste shall be transported in the liquid state by concrete mixer truck to a landfill, decanted into the normal municipal waste and dispersed.  Sewer 1. Proper dilution to make liquid wastes neutral and PH monitored (between 6 and 9) at purpose built pits shall be done before flushing into the sewer. 2. Diluting and flushing of liquid wastes to sewers shall be conducted under the supervision of an inspector from the appropriate organ (Refer Guideline Ambient Environment standard for Ethiopia). 3. Diluted liquids, syrups, intravenous fluids and maximum of 50 liters/day of diluted disinfectants shall be flushed into sewers. For disposal of liquid anti-infective medicines see article 23 sub-article 3. 5. Disposing by sewer shall be monitored to avoid impact on the environment and public health. 6. Disposal of antineoplastics, undiluted disinfectants and antiseptics into the sewer is prohibited.  Burning in Open Containers or Place 1. Paper and cardboard packaging, if they are not to be recycled, may be burnt. 2. Expired cotton and gauze may be disposed by burning. 3. Medicines waste shall not be disposed by burning at low temperature in open containers. 4. Polyvinyl chloride (PVC) plastic containers shall not be disposed by burning.  Medium-Temperature Incineration 1. The medium-temperature incinerators shall be of double chamber design or pyrolytic which operate at a medium-temperature combustion process (850- 1,0000oC) with a combustion retention time of at least two seconds in the second chamber. 2. The incinerators shall be calibrated by an appropriate body and the certificate shall be presented to the appropriate organ upon request.  The following medicines waste shall not be incinerated by medium-temperature incineration: a) Antineoplastics, b) Pressurized gas containers, c) Large amounts of reactive chemical waste, d) Silver salts and photographic or radiographic wastes, e) Halogenated medicines, f) Halogenated plastics such as polyvinyl chloride (PVC) g) Waste with high mercury or cadmium content, such as broken thermometers, used batteries, and lead-lined wooden panels, and h) Sealed ampoules or ampoules containing heavy metals.  The final ash shall not be left to open air. It shall be collected and dumped into landfill which appropriate bodies have participated at selecting.  High-Temperature Incineration 1. High-temperature incinerators shall be double chamber design or pyrolytic which operate at a temperature combustion process in excess of 1,2000C with a combustion retention time of at least two seconds in the second chamber. High-temperature incinerators shall be fitted with gas cleaning equipment. 3. The incinerators shall be calibrated by an appropriate body and the certificate shall be presented to the appropriate organ upon request. 4. Health institutions and disposal firms may use industrial plant cement kilns for halogenated products and antineoplastics. Medicines waste shall be introduced into the furnace as a reasonably small proportion of the total fuel feed (i.e. not more than 5%) at any one time. 6. It may be necessary to remove packaging materials and/or to grind the medicines to avoid clogging and blocking the fuel feed mechanisms. 7. High temperature incinerators may be used for disposal of halogenated compounds, antineoplastics, X-ray contrast media and povidone iodine. 8. The final ash shall not be left to open air. It shall be collected and dumped into landfill which appropriate bodies have selected. Sorting, Storing and Transporting of Medicine Wastes 1. Sorting of medicines waste shall be done before choosing the appropriate disposal method. 2. An inspector of the appropriate organ shall supervise and verify that sorting of medicines waste is done properly and shall determine the optimal disposal method. 3. The health institution or disposal firm shall assign personnel who are trained on sorting criteria, safety and risks associated with handling medicines wastes. 4. During sorting and verification process, staff shall be supplied with personal protective equipment. 5. Sorting shall be done in open air or at a well ventilated covered area as close as possible to the stockpile The sorting process shall include: a) Identifying each item (quantity, type of packaging material and state of the product e.g. expired, damaged, spilled, unsealed or any other), b) Determining whether it is useable, c) If usable, leaving packaging intact, d) If not usable, making a judgment on the optimal method of disposal and sorting accordingly, and e) Leaving packages and boxes intact until reaching definitive disposal location. Sorting shall be done to separate the following medicines waste depending on the disposal method needed: a) Controlled drugs or substances, b) Antineoplastics or cytotoxic/anti–cancer medicines and other toxic medicines, c) Radiopharmaceuticals, d) Anti-infective medicines, e) Hazardous non-medicine products like antiseptics and disinfectants, and f) Other medicines waste by dosage form: I. Solids, semisolids and powders (tablets, capsules, granules, powders for injection, mixtures, creams, lotions, gels, suppositories, etc.), II. Liquids (solutions, suspensions, syrups and ampoules), and III. Aerosol canisters (propellant-driven sprays and inhalers) 9. The containers/receptacles containing sorted medicines waste shall be labeled and kept in a dry, secure and preferably a separate room. 10. Transporting of sorted medicines waste to temporary storage place and disposal sites shall be done in closed motor vehicles to avoid pilferage. Types of Medicines Waste and Their Disposal Methods Solids, Semi-Solids and Powders 1. Solid, semi-solid and powder dosage forms of anti- infectives, controlled medicines, antineoplastics, and disinfectants shall be disposed according to article 23, 24, 25, and 26 respectively. 2. Solid, semi-solid and powder medicines waste shall be disposed by high temperature incineration. 3. Without prejudice to sub-article (2) of this article, in the absence of high temperature incineration, medium temperature incineration and landfill after immobilization shall be used. 4. Medicines categorized as readily biodegradable organic material in a solid or semisolid form shall be disposed of in a landfill and covered immediately by 15 centimeter thick municipal waste. 5. The disposal of solid, semi-solid and powder medicines shall comply with the following procedures: I. Tablets and capsules in plastic/foil blisters shall be removed from all outer packaging but not from blisters; II. Tablets and capsules in bottles shall be removed from outer packaging but not from bottles; III. Tablets and effervescent in tubes shall be removed from outer packaging but not from tubes; V. Powders in sachets or bottles shall be removed from outer packaging but not from sachets or bottles d) Loose tablets may be mixed with other medicines waste in several different steel drums Liquid Medicines 1. Liquid medicines waste may be disposed of using the cement encapsulation method, high temperature incineration or in cement kilns. 2. Medicines with no or low toxicity that can be categorized as readily biodegradable organic material such as liquid vitamins and IV fluids may be diluted and flushed into sewer. Harmless solutions of different concentrations of certain salts, amino acids, lipids or glucose shall also be disposed of in sewers. 3. Without prejudice to article (15), small quantities of liquid medicines may be flushed into sewer. 4. It is not acceptable to discharge liquid medicines, diluted or not, into any surface waters. Ampoules 1. Ampoules shall be crushed on a hard impermeable surface or in a metal drum or bucket. 2. Without prejudice to sub-article (1) of this article: a. The crushed glass shall be swept up, placed in a container suitable for sharp objects, sealed and disposed of in a landfill, b. The liquids released from the ampoules shall be diluted and disposed in accordance with article 21. 3. Ampoules of ant-ineoplastics or anti- infective medicines shall not be crushed and the liquid shall not be discharged to sewers. They shall be disposed using the encapsulation or inertization method. 4. Ampoules shall not be burnt or incinerated. 5. When disposing ampoules, workers shall wear personal protective equipment.  Vials Vials shall be crushed and disposed using the encapsulation or inertization method. 1. Vials of antineoplastics and anti-infective medicines shall not be crushed and the liquid shall not be discharged to sewers. 2. Liquids released from vials of medicines other than antineoplastics or anti-infective medicines shall be diluted and disposed in accordance with liquid disposal procedures of this directive.  Anti-infective Medicines 1. Anti-infective medicines shall not be discarded in an untreated form. 2. Anti-infective medicines shall be incinerated, but if that is not possible shall be encapsulated or inertized. 3. Liquid anti-infective medicines shall be diluted in water, left for a minimum of two weeks and disposed to the sewer.  Controlled Substances 1. Controlled substances shall be closely monitored during disposal. 2. Controlled substances shall be segregated from other medicines waste and shall be kept separately in clearly marked containers with rigid walls, 3. Controlled substances shall not be crushed or removed from their packages until they are disposed. 4. Controlled substances shall be disposed by high temperature incineration or product immobilization (encapsulation or inertization) followed by covering with 15 centimeter thick municipal waste in landfills. 5. Disposal of untreated controlled medicines waste at landfills is prohibited  Antineoplastics or cytotoxics/anti- cancer 1. Anti-neoplastic medicines waste shall be handled with great care. 2. Antineoplastics shall be segregated from other medicines waste and shall be kept separately in clearly marked containers with rigid walls. 3. Antineoplastics shall not be crushed or removed from their packages until they are disposed. 4. Anti-neoplastic wastes shall be disposed using two- chambered high temperature incinerators. 5. Without prejudice to sub-article (4) of this article, if disposal by high temperature incineration is not possible, antineoplastics or cytotoxics/anti-cancer medicines waste shall be disposed using landfills after encapsulation or inertization 6. Disposal of antineoplastics or cytotoxics/anti-cancer wastes using landfills after encapsulation shall comply with the following procedures: a) The drums shall be filled to 50% capacity with medicines waste. b) A well-stirred mixture of lime, cement and water in the proportions of 15:15:5 (by weight) shall then be added to fill the drums to capacity c) The drums shall then be sealed by seam or spot welding and left to set for 7 to 28 days to form a firm, immobile, solid block of securely isolated wastes. d) The drums shall later be placed at the working face of a landfill which has been lined with impermeable layer of clay or membrane. 7. Discarding antineoplastics or cytotoxics/anti-cancer medicines waste into the sewerage system, disposing by medium temperature incineration and landfill without encapsulation is prohibited  Disinfectants 1. Small quantities of diluted disinfectants shall be disposed to the sewer provided that the operation is supervised by the appropriate regulatory body and the quantities are strictly controlled to set limits of maximum of 50 liters per day with the disposal spread over the whole working day. 2. Large quantities of disinfectants shall not be flushed into the sewer. 3. Disinfectants diluted or not, shall not be disposed into any surface water.  Aerosol Canisters 1. Aerosol canisters may be disposed of using landfill after encapsulation. 2. Provided that aerosol canisters and inhalers do not contain poisonous substances, they shall be disposed of in a landfill after dispersion in municipal solid wastes. 3. Disposable aerosol canisters and inhalers shall not be burnt or incinerated at high temperature.  Laboratory Reagents 1. Chemical waste shall be maintained in a secure area and access shall be limited to personnel who are properly trained. 2. Solid chemical waste may be collected in plastic bags, fiber boxes, or plastic containers. 3. Solid and liquid chemical waste shall not be mixed. 4. All chemical waste shall be segregated and properly stored to ensure chemical reactions will not occur if containers were to fail. 5.All hazardous chemical waste shall be stored in suitable containers which are compatible with the chemical contents of the waste and shall be sealed at all times unless waste is being added or removed. 6. Liquid containers shall not be filled full. An air gap of 5- 10% shall be left in the container to allow for expansion of the liquid. 7. Before collecting waste in used containers, the containers shall be rinsed to avoid any incompatibility with the waste to be collected. 8. Accumulated chemical wastes (mixed liquid) shall be labeled with the date the accumulation started and the list of the chemical mix. 9. Hazardous chemical waste shall not be accumulated for more than one year. 10. Dilute acids or bases (free from heavy metals or halogens) shall be flushed with large amounts of water into the sewer system after being pH adjusted (between 6 and 9) in neutralization tanks. 11. Solutions of non-toxic chemicals that are miscible in water may be flushed into the sewer system. a) Flammable b) Concentrated acids or base c) Toxic heavy metals, carcinogenic/mutagenic or teratogenic chemicals that have not been neutralized or deactivated, d) Radioactive wastes, e) Unknown or unidentified chemicals, Solids, non-water soluble solvents, and viscous substances (oils and greases), and f) Expired or concentrated stock solutions of dyes. 12. The following organic chemical waste may be acceptable for sewer disposal in quantities of 25 liters or less: a) Acetates: Na, K, Ca, and NH4, b) Alcohols: water soluble, diluted to 10% or less, c) Amino acids and their salts, d) Citric acid and salts of Na, K, Mg, Ca, and NH4, e) Ethylene glycol: diluted to 10% or less, f) Lactic acid and salts of Na, K, Mg, Ca, and NH4, and g) g) Sugars: dextrose, fructose, glucose, sucrose. 13. The following inorganic chemical waste may be acceptable for sewer disposal in quantities of 25 liters or less: a) Common acids and bases: neutralized, pH (6-9), no metals present, b)Bicarbonates: Na, K, c) Bleach, d) Bromides: Na, K, e) Carbonates: Na, K, Mg, Ca,  f) Chlorides: Na, K, Mg, Ca, g) Iodides: Na, K, h) Phosphates: Na, K, Mg, Ca, NH4, and i) Sulfates: Na, K, Mg, Ca, NH4. ii) Flammable liquids which are chemically compatible and have low halogen content shall be blended together. The flammable solvent waste may be burned as fuel in cement kiln 14. Halogenated solvents and toxic liquids shall be disposed by incineration. 15. Aqueous metal solutions shall be treated for metal recovery before disposal. 16. Organic solvents shall not be disposed in landfill. 17. Solid chemical wastes and non-blendable solvents are packed into plastic or fiber drums and shall be incinerated  Medical Supplies 1. Expired syringes shall be buried in sharp pits or disposed using landfill after encapsulation 2. Plastic syringes after being detached from the needles may be: A. Buried on-site or disposed of in a land fill after shredding by hand mill/ electric shredder, or B. Buried on-site or disposed of in a land fill without being shredded, or C. Recycled if plastic recycling plant exists. 3. Without prejudice to sub-articles (1) & (2), detached needles shall be disposed by incineration or landfill after encapsulation 4. Expired gauze, cotton, suturing materials, bandages or IV sets may be disposed of as normal waste to landfill. 5. Used syringes, suturing materials, cotton, bandages, gauze, used IV sets, other similar articles and x-ray films are not treated in this directive.  THANKS