Instructor: Sandra Andrews
The Faroe Islands are located between the Norwegian Sea and the North Atlantic Ocean. They are part of the kingdom of Denmark and are self-governing. The Faroe Islands are approximately 540 square miles in area and according to 2010 statistics, have a population of 50,000. While none of this may seem significant to pharmacy practice, a conference there in May 2007 helped lead to a substantial change in how the disposal of pharmaceutical waste is handled. Two hundred professionals from the fields of environmental health, chemistry, developmental biology, toxicology, epidemiology, nutrition, oncology and pediatrics came together at the International Conference on Fetal Programming and Developmental Toxicity to establish what would become known as the Faroes Statement. The essence of the Faroes Statement centers on the idea of fetal program. Fetal program outlines the development of the embryo and fetus and the influence environmental events have on physiological parameters. Even more alarming were the long-term effects that could continue into adulthood and even into subsequent generations resulting in such disorders as diabetes, cancers, attention deficit hyperactivity disorder (ADHD), Alzheimer's, Parkinson's, reduced immune system function and even obesity. As eye-opening as the Faroes Statement was, a second report from the Associated Press added even more validity to the need for pharmaceutical waste management. On March 9, 2008, the Associated Press, after a five-month investigation, produced an alarming report on how pharmaceutical waste was being disposed in the United States and the effect it had on the well-being of its citizens. According to the report, traces of drugs were found in the drinking water of more than 24 major metropolitan cities. Additionally, the report found there were no sewage treatment plants in operation that could effectively remove pharmaceutical wastes from the system. Considering the fact that drugs are ultimately intended to alter the effects disease has on the human body, even traces of drugs could have irreversible or transgenerational effects. In March 2002, the United States Geological Survey (USGS) published the first report that provided irrefutable proof that pharmaceutical waste, such as hormones and other organic wastewater contaminants, were indeed leaching into our country's water supply. In fact, the USGS's report stated that of the 139 streams in 39 states that were surveyed, 95 different organic wastewater contaminants were identified. The survey, which was the first of its kind to identify pharmaceuticals in drinking water, found that 80% of the streams analyzed contained one or more organic wastewater contaminants. The discovery of pharmaceutical waste and contaminants within our water supply may have far-reaching implications we are just now beginning to realize. According to the Associated Press's original report (2008), nearly 250 million pounds of pharmaceuticals and contaminated packaging are created by U.S. hospitals and long-term care facilities each year, making it extremely difficult to estimate just how much of that waste finds its way into the U.S. drinking supply. Unfortunately, the report did not take into consideration the pharmaceutical waste and contaminants that are generated from medical offices and veterinary clinics nor from federal and state correctional facilities, making the true amount of potentially discarded pharmaceuticals substantially greater than first reported. Tom Clark, an associate with the American Society of Consultant Pharmacists, summarized the key reason why discarded pharmaceutical wastes and contaminants find their way into our water supply: When you can flush it down the toilet for free, why would you want to pay -- unless there are some significant penalties. The Environmental Protection Agency (EPA), a federal agency charged with overseeing and protecting the citizens of the United States by instituting controls for pollutants and air quality controls, also recognized the ever-growing issue with discarded pharmaceuticals and other contaminants. In October 1976, the Ford Administration signed into law the first piece of regulation that would govern the issue of the disposal of hazardous waste in the United States. The Resource Conservation and Recovery Act (RCRA), was established to impose regulations and standards for handling the disposal of hazardous waste and air pollutants produced from manufacturing. The Act required states to set their own standards and regulations for hazardous wastes and air pollutants. However, states that failed to comply with developing these standards would be regulated by standards imposed by the federal government. RCRA went so far as to require civil and criminal penalties to be instituted against those found in violation of its regulations, which include monetary fines up to $25,000 per day for each day of non-compliance, up to one year of prison or both. In direct response to reports such as the Faroes Statement and the Associated Press report, RCRA received the first amendment directed at combating the growing issue of improper disposal of pharmaceutical waste. The Environmental Protection Agency (EPA), state environmental agencies, the Department of Transportation (DOT), the Drug Enforcement Agency (DEA), the Occupational Safety and Health Administration (OSHA) and local Publicly Owned Treatment Works (POTW) came together to form a system based not only on the safe disposal of pharmaceutical waste, but also one which categorized pharmaceutical waste based on toxicity. Hospitals, nursing care facilities and long-term care facilities are the principal generators of pharmaceutical waste. Under the amended RCRA regulations, pharmaceutical waste disposal becomes the primary responsibility of the hospital or facility's pharmacy. The new regulations segregated pharmaceutical waste into six manageable categories, with each level based on the potential toxicity of the wastes. Under RCRA regulations, pharmaceutical waste would be required to be placed in a colored container, based on pharmaceutical toxicity, and then properly disposed of by a licensed facilitator approved in the disposal of pharmaceutical grade waste. Approved pharmaceutical containers are categorized as: Black- hazardous pharmaceutical waste Yellow- trace chemotherapy waste Red- regulated medical waste Blue- non-hazardous pharmaceutical waste Additional non-container categories for pharmaceutical grade waste include: Municipal solid waste management Sewer system waste management The most significant change to the regulations regarding pharmaceutical waste came about through the addition of the black hazardous pharmaceutical waste container. RCRA clearly establishes the guidelines for pharmaceutical waste that may be disposed of in this container. These categories are: P-listed pharmaceuticals U-listed pharmaceuticals 4-characteristics of hazardous waste Ignitability Toxicity Corrosivity Reactivity P-listed pharmaceutical waste includes: Nicotine (such as) Nicotine patches (Habitrol, Nicoderm, or Nicoderm CQ package empty package containers) Warfarin (Coumadin, Jantoven empty package containers) Anticoagulants (blood thinners) Physostigmine (Eserine Sulfate Ophthalmic) Indirect-acting cholinergic (Parasympathomimetic) Agents primary used as eye drops for glaucoma, but also for anticholinergic overdose Combination drugs such as Bi-Miotic and Bi-Miltic U-Listed Pharmaceutical Waste Chloral Hydrate (Somnote, Aquachloral Supprettes) Sedative (short term insomnia, alcohol treatment withdrawal) Mitomycin (Mutamycin) Antineoplastic (cancer fighting agent) Lindane (Gamene, Kwell, Scabene) Topical pediculicide and scabicide Typically used to treat scabies and lice Chemicals with Characteristics of Hazardous Waste Ignitability (may cause fire under certain conditions) Flammable aerosols Rubbing Alcohol Topical Clindamycin Paclitaxel Toxicity (a degree to which substance can harm humans) Selenium Chromium Barium Silver (silver sulfadiazine cream, Silvadine) Insulin Arsenic Corrosivity (harmful or eating away) Glacial Acetic Acid Sodium Hydroxide Aqueous solution with pH < o r= to 2 (or) > o r =to 12.5 Highly acidic or basic Reactivity (reacting or responding to a stimulus) Only potentially reactive pharmaceutical agent is nitroglycerin (guess what's in dynamite?) Most weak nitroglycerin formulations are excluded from black box pharmaceutical waste The next category of pharmaceutical waste management is the yellow container or trace chemotherapy waste. There are nine chemotherapy agents covered under the language of RCRA, one from the P-list and eight from the U-list. The covered chemotherapy agents are: Arsenic Trioxide (Trisenox) P-list Chlorambucil (Leukeran) U-list Cyclophosphamide (Cytoxan) U-list Daunomycin (Daunorubicin) U-list Diethylstilbestrol (DES) U-list Melphalan (Alkeran) U-list Streptozotocin (Zanosar) U-list Mitomycin C (Mutamycin) U-list Uracil Mustard (Uramustine) U-list (chemical warfare) The RCRA defines three types of chemotherapy waste: Trace Chemotherapy (yellow container) Empty vials and syringes, gloves and gowns Bulk Chemotherapy (black container) Chemotherapy container that is not empty Spill Clean Up (black container) RCRA hazardous waste Blue containers for pharmaceutical waste are those containers that have been identified as containing non-hazardous waste or no bio-hazardous drug in them. This includes pharmaceutical products that cannot be returned to stock for patient use because they have been partially used by another patient, the product has expired, product container is empty or the product has been compromised due to breakage or other circumstances. Good examples of pharmaceutical products that would be considered non-hazardous waste would be a partially filled Diprivan (propofol) container or an antibiotic vial that has expired. Red sharps containers are also listed within the regulations of RCRA. Red sharps containers are perhaps the most easily recognized of the pharmaceutical waste containers. Most patient rooms, nursing stations and medication rooms will employ the use of at least one sharps container. In a hospital pharmacy setting the sharps container will most often be seen in an IV compounding setting or in a retail setting where immunizations are offered. Products disposed in a red sharps container would include: empty needles, ampules, and syringes. Caution should be taken when chemotherapy agents are in use, as they should never be placed within the red sharps containers, but rather a designated yellow chemotherapy container. Municipal solid waste is any product that can be discarded in a regular trash container, such as most empty pharmaceutical packaging, most empty vials or bottles, paper, plastic, but absolutely no unused medications. Municipal solid waste can be compared to the waste that could be discarded safely in your home trash. Last is the pharmaceutical waste that may be disposed of in the sewer system. Those medications that may be put down the drain or flushed. This type of pharmaceutical waste is considered safe to the environment and causes very little or no harm to the ecological system. Pharmaceutical wastes that may be put down the drain or flushed include: Dextrose Saline Sterile Water Lactated Ringers Potassium Salts Calcium Salts Magnesium Salts Controlled Substances No other medications, other than those mentioned, may be placed down the drain or flushed. Violations of RCRA can be costly, not only from an environmental perspective, but also on a monetary scale as well. Health systems that do not comply with the regulations of the RCRA may be responsible for penalties and fees of up to $37,000 for each violation. Since the disposal of pharmaceutical waste within a health care facility is the responsibility of the pharmacy, it is essential that pharmacy personnel are current and knowledgeable of all RCRA laws and regulations as they relate to the proper disposal of pharmaceutical waste. Storage and Disposal of Pharmaceutical Waste Containers Unless otherwise indicated by the manufacturer, pharmaceutical products that must be disposed of in a black hazardous waste container do not need to be stored separately from other pharmaceutical products. Black hazardous container products, such as warfarin and insulin, should be labeled to indicate they are hazardous pharmaceuticals and require disposal in a black hazardous container. A black label imprinted with HW will qualify as proper indication of hazardous waste. Pharmaceutical products labeled with a HW sticker will alert nursing staff that empty packaging needs to be placed in a black hazardous waste container or depending upon the facility's policies and procedures, returned to the pharmacy for appropriate disposal. Chemotherapy products should be stored separately from non-chemotherapeutic agents. Additionally, chemotherapeutic agents should not be stored in the same refrigerator as non-chemotherapeutic agents. Yellow pharmaceutical waste containers or trace chemotherapy containers should always be available for the proper disposal of chemotherapy agents such as empty vials, empty syringes, gowns, gloves and product packaging. Vials and syringes that may still have chemotherapeutic agents in them should be disposed in a black hazardous waste container. Black hazardous waste containers must be incinerated in a federally permitted waste container. The waste containers are then incinerated to ash and placed in a lined hazardous landfill. Trace chemotherapy (yellow) containers are incinerated in a medical waste incinerator, which has received EPA approval, and incinerated to ash then placed in a lined non-hazardous waste landfill. Blue non-hazardous containers are handled in the same manner as are red sharps containers. However, many states autoclave or microwave red sharps containers and shred them rather than turn them to ash. Municipal solid waste is disposed of in lined non-hazardous waste landfills. Lastly, pharmaceutical products that may be wasted in the sewer system, such as dextrose, saline and lactated ringers, are disposed of in a publicly owned treatment works (POTW) and eventually runoff into the water supply. Again, the EPA has determined sewer systems pharmaceuticals are safe for disposal in the water supply and add no harm to the ecological system. Drug Take Back Programs It is estimated that nearly 30% of all prescription medications filled in the United States go unused. This can be due to changes in medication, possible allergic reactions, or non-compliant patients. Whatever the reason, medications that go unused by the patient need to be disposed of and most patients do not know how to properly discard unused medications. Some of the most common ways that patients dispose of medications is to throw them in the trash receptacle, pour them down the drain or flush them down their bathroom toilet. None of these methods of disposal are acceptable or safe when discarding unused medications. Prescription medications that are put down a drain or flushed down a toilet may end up in the public water supply or within the ecosystem, such as a river or stream. Medications that are tossed in the trash are particularly troublesome. Prescription medications, especially controlled substances such as OxyContin or Percocet, may be easily sought out by those illegally seeking prescription medications. In fact, the DEA lists drug diversion as one of the leading issues with the improper disposal of prescription medications. It is for these reasons the DEA, in conjunction with local and state law enforcement agencies, have successfully sponsored semi-annual National Drug Take-Back days. The recommendations decided upon by the DEA and the EPA provides a safe and efficient system for the public disposal of unused pharmaceuticals. Specific recommendations include: Develop a set of flexible options for pharmaceutical take-back programs Ensure destruction/disposal of pharmaceuticals in accordance with all federal, state and local environmental regulations Define allowed additional destruction methods and disposal options Streamline recordkeeping requirements for take back programs In October of 2010, President Obama signed into law the Secure and Responsible Drug Disposal Act. The Act, which was an amendment to the federal Controlled Substance Act of 1979, allows the Attorney General to create regulations that would allow patients a safe and effective manner for disposing of unused prescription medications as well as allow long-term care facilities to discard unused prescription medications as an agent of the facility's residents. Additionally, the law would help to alleviate the issue of growing drug diversion, in particular of controlled substances, from unused prescription medications that are inappropriately disposed. Part of the result of this effort was the development of DEA-sponsored take-back programs. The DEA announces take-back days twice a year. Information concerning the location sites for National Drug Take-Back days is readily found on the DEA's website at, http://www.deadiversion.usdoj.gov_disposal/takeback/poc.htm or on the National Association of Boards of Pharmacy (NABP) website at http://www.awarerx.org/get.local. NABP reports that take-back programs have helped to collect 2.8 million pounds or nearly 1,500 tons of unused prescription medications. This program not only discourages drug diversion, but also provides patients with a legal, ecologically-minded way to discard unused prescriptions and OTC medications. However, there are patients who for one reason or another may not be able to take advantage of a take-back program. In cases where the patient cannot or does not have access to the program in their area, the Federal Food and Drug Administration (FDA) and NABP provide the protocol for the safe disposal of unused medications. Home disposal of unused prescription medications can be completed in a safe and environmentally-friendly manner by following the instruction provided by the FDA website, http://www.fda.goc/ForConsumers/ConsumerUpdates/ucm101653.htm#GuidelinesforDrugDisposal or the NABP website, http://www.awarerx.org/get-informed/find-disposal-informed/option-3-home-disposal . The recommended steps for home disposal of unused prescription medications per FDA and DEA recommendations are: Check the label on your medication and follow any instructions for safe disposal provided Do not flush drugs down toilet, unless the label says to flush them. If the label says to flush the drugs, that's because the FDA and the drug manufacturer determined that was the safest method of disposal to prevent harm to others If there are no instructions on the label, dispose of the drugs in the home garbage. But first, take them out of the container and mix them in an undesirable substance, such as coffee grounds or cat litter. Seal the mixture in a sealable bag, empty can or other container that can be disposed of in the garbage The table below is a list of FDA approved drugs that should be flushed Patients should always check with their local authorities, state board of pharmacy or pharmacist before disposing of any unused medications in case there are specific regulations within their area. Patients should always be cautioned that pharmacies are not permitted to receive any unused medications. Pharmacists and pharmacy technicians should be aware of the regulations within their state in order to provide the patient with most accurate information. Disposal of Dispensed Controlled Substances: The Secure and Responsible Drug Disposal Act of 2010 It is no secret that prescription drug abuse is on the rise. Statistics tell us that illegal prescription drug abuse is the highest among teenagers and continues to grow. Only the use of marijuana among teenagers is greater. Controlled substances are the most attractive to abusers. Narcotics such as OxyContin and Vicodin are among the most frequently abused controlled substances. Frequently the abuser has access to the controlled substance through the family medicine cabinet, but sometimes the need for the controlled substance becomes so great the abuser will begin seeking controlled substances from family or friends. Controlled substances that have been thrown in the trash or discarded because they have expired are also ways abusers acquire drugs for illicit use. Too many times expired or unwanted drugs are thrown in the trash, poured down a drain or flushed down a toilet, but these ways of destruction, we have learned, has begun to have an effect on the ecosystem. Traces of unused drugs have shown to be in streams and rivers, but most alarmingly, in drinking water. The White House Office of National Drug Control Policy and U.S lawmakers have taken notice of alarming situations concerning the disposal of unused medications, specifically including controlled substances The Director of the White House Office of National Drug Control Policy (ONDCP), R. Gil Kerlikowske testified before Congress concerning the disposal of controlled substance and the emerging issue of drug abuse from prescription drugs in July 2010, stating the following: These drugs are dispensed for legitimate purposes and too often, the public's perception is that they are safe for uses other than those for which they are prescribed. We must change public perception so the societal norm shifts to on where unused or expired medications are disposed of in a timely, safe and environmentally responsible manner. We envision a future where disposal of these medications is second nature to most Americans, in much the same way as proper and responsible recycling of aluminum cans has become. Creating a method of disposal of expired or unused prescription drugs is essential to public health, public safety and the environment. Shortly after Kerlikowske testified before Congress, President Obama signed the Secure and Responsible Drug Disposal Act into law. While the new law helped to establish DEA-sponsored take-back programs, improper disposal of controlled substances and abuse linked to illicit prescription medications continues to be a growing problem. In 2011, the Substance Abuse and Mental Health Services Administration released its National Survey on Drug Use and Abuse. The statistics confirmed the seriousness of abuse of prescription medications. The report stated that nearly six million Americans abuse prescription medications. 70% of the prescription drugs that are abused are controlled substances that the abuser acquired through diversion, such as a friend or family member's medicine cabinet, purse or bedside. Reading statistics such as these places a sense of urgency to the role pharmacies when it comes to the safe disposal of unused medications. Pharmacists and pharmacy technicians alike should take care to understand the regulations within their state as to the disposal of unused medications. Pharmacy based awareness programs also alert the public to this growing epidemic. Pharmacists and pharmacy technicians that are uncertain of their state's drug disposal regulations should contact their state board of pharmacy. Information concerning U.S. boards of pharmacy can easy be obtained by logging on the NABP website. The RCRA continues to go through changes. The safe disposal of pharmaceutical waste is a major concern, not only for the safety of our drinking water and ecological system, but also to help with the growing concern over drug diversion. Recognizing the severity of improper disposal of unused pharmaceutical products, the DEA and EPA formed a collaborative effort in order to develop a regulated program that would allow the public to safely dispose of unused pharmaceuticals. While the RCRA has gone a long way in creating legislation aimed at combating the illegal and irresponsible disposal of unused prescriptions, there are other pieces of legislation and governmental agencies that have contributed to building an improved standard of safety when it comes to hazardous drugs and their disposal. The National Institute for Occupational Safety and Health (NIOSH), under the United States Department of Health and Human Services, routinely publishes a list of antineoplastic and other hazardous drugs commonly found within health care settings. The most recent list, in 2012, adds 26 new drugs from the 2010 list that are labeled as hazardous. Warnings concerning the safe handling of these drugs are an essential reason for the development of the list. The process for drug review and how the list is assembled can be found on the Federal Register at http://www.cdc.gov/niosh/docket/archieve/pdfs/NIOS-190/0190-080211-frn.pdf . The NIOSH defines a hazardous drug as drugs that are used for cancer chemotherapy, antiviral drugs, hormones, some bioengineered drugs, and other miscellaneous drugs. This definition, which was developed by the American Society of Health Systems Pharmacists (ASHP) in 1990, does not completely encompass current toxicity criteria, particularly due to newer generations of drugs that are brought to the market each year. NIOSH acknowledges that this definition of hazardous drugs is insufficient, but continues to gather information with other health and pharmaceutical organizations in order to release a much more precise and effective definition. Given the previous findings, health care workers should take all necessary precautions when working with drugs that have the potential to be labeled as hazardous. If a question does arise to whether or not a drug should be considered as hazardous, it is always best consult the manufacturer's Material Safety Data Sheet (MSDS) The NIOSH list of antineoplastic and other hazardous drugs in the health care setting provides criteria for the health care facility or institution to use in order to develop a hazard communication program that is specific to that facility. Per regulations established by OSHA, employers are required to maintain a list of hazardous drugs within their facility. The hazardous drug list is provided by NIOSH at the CDC website, http://www.cdc.gov/niosh/topics/hazdrug/ is good starting point for facilities when developing their facility specific OSHA-mandated hazard communication program. Other information and criteria that may be used to develop a hazard communication list are: MSDS Packaging inserts or product labeling that has been provided by the FDA Special health alerts that have been put out by the manufacturer, the FDA or other health professionals groups or organizations Case studies and reports that may have been published in pharmacy or other health care professional journals Evidence-based recommendations from other health care facilities Criteria should meet NIOSH definition of a hazardous drug (or) one or more of the following characteristics Carcinogenicity Teratogenicity (interferes with normal embryonic development) Reproductive toxicity Organ toxicity at low dose Genotoxicity (capable of causing genetic mutation) Structure and toxicity profiles of new drugs that mimic existing drugs that have been labeled as hazardous, because they meet specific criteria As we previously mentioned, OSHA requires employers to develop a hazard communication program anytime there is risk of exposure to hazardous materials in the workplace. In a health care setting and in particular a pharmacy setting, exposure to hazardous materials is not uncommon. OSHA was developed under the federal Occupational Safety and Health Act of 1970. As stated on the OSHA homepage, the purpose of the Occupational Safety and Health Act of 1970 was to ensure safe and healthful working conditions for every working man and woman in the Nation and to preserve our human resources by providing medical and other criteria that will ensure, insofar as practicable, that no workers will suffer diminished health, functional capacity, or life expectancy as result of their work experience. It is clear that the central purpose of OSHA and the Occupational Safety and Health Act of 1970 is aimed at protecting the health care worker and ultimately transferring this to the patient. Regulations under the authority of OSHA concerning the health care worker focus largely on the safe use of hazardous materials and hazardous material waste. In 2012, OSHA took safety steps further by updating the chemical labeling requirements of those agents that fall within the guidelines of a facility's hazard communication program. The regulations, which meet the United Nations' Globally Harmonized System of Classification and Labeling of Chemicals (GHS), will ultimately improve patient care by allowing the health care worker access to improved information concerning the chemotherapy and antineoplastic agents used in their care. While antineoplastics will make up the largest group of pharmaceuticals considered to be hazardous, pharmacists and pharmacy technicians should remember drugs such as progestins, tetracyclines, testosterones, estrogens, and vaccines are also listed among the drugs on the current NIOSH alert. The new regulations mandated for OSHA's Hazard Communication Standard began in June of 2012, but will not go completely into effect until 2015. Some of the benefits the improved regulations will afford to the health care worker are: Enhance worker comprehension of hazards, especially for low or limited literacy workers, reduce confusion in the workplace, facilitate safety training and result in safer handling and use of chemicals Provide workers quicker and more efficient access to information on the safety data sheets Result in cost savings to American business of more than 475 million in productivity improvements, fewer safety data sheet and label updates and simpler new hazard communication training Reduce trade barriers by harmonizing with systems around the world According to OSHA, the changes associated with the Hazard Communication Standard are: Hazard classification: Chemical manufacturers and importers are required to determine the hazards of the chemicals they produce or import. Hazard classification under the new, updated standard provides specific criteria to address health and physical hazards as well as classification of chemical mixtures Labels: Chemical manufacturers and importers must provide a label that includes a single word, pictogram, hazard statement, and precautionary statement for each hazard class and category Safe Data Sheets: The new format requires 16 specific sections, ensuring consistency in presentation of important protection information Information and Training: To facilitate understanding of the new system, the new standard requires that workers be trained by December 1, 2013, on new label elements and safety data sheet format, in addition to the current training requirements Maintaining the disclosure of exposure limits (Threshold Limit Values, or TVLs) established by the American Conference of Governmental Industrial Hygienists (ACGIH) and carcinogen status from nationally and internationally recognized lists of carcinogens on the safety data sheets Clarification that the borders of pictograms must be in red on the label Flexibility regarding the required precautionary and hazard statements to allow label preparers to consolidate and or eliminate inappropriate or redundant statements Longer deadlines for full implementation of the standard OSHA has also established deadlines of compliance for employers and manufacturers. Deadlines for employers and manufacturers are as listed: December 1, 2013- employers must train employees on the new label elements and SDS format. June 1, 2015 - chemical manufacturers, importers, distributors as well as employers must comply with all provisions of the modified rule with one exception, distributors may ship products labeled by manufacturers under the old system until December 1, 2015. June 1, 2016- employers must update alternative workplace labeling and hazard communication program as necessary, and provide additional employee training for newly identified physical or health hazards. Below are examples of the new labeling and pictogram requirements for hazardous drugs and materials as mandated by OSHA and the Hazard Communication Standard. The regulations and standards set by OSHA go hand-in-hand with the regulations standards set by RCRA. While it may seem from first glance that these rules have little to do with the practice of pharmacy, it soon becomes increasingly clear that compliance with these regulations is essential to the practice of pharmacy. Not only do these laws go a long way in the protection of the pharmacist and pharmacy technician, but ultimately the patient as well. Take for example the safe handling requirements for oral methotrexate. Methotrexate is a cancer drug that treats several types of cancers of blood, bone and lung as well as being effective at fighting rheumatoid arthritis and psoriasis. Like all cancer fighting agents, methotrexate has special requirements for the safe handling of the drug. Pfizer, a manufacturer of the drug methotrexate, both in IV and oral forms, gives the following instructions for the safe handling and disposal of methotrexate: Storage and Stability- Methotrexate tablets - store at 15 C- 30 C and protect from light Methotrexate Injection- store at 15 C-30 C, avoid freezing and protect from light General Handling Instructions: Individuals who have contact with anti-cancer drugs or work in areas where these drugs are used may be exposed to these agents in air or through contact with contaminated objects. Potential health effects may be reduced by adherence to institutional procedures, published guidelines and local regulations for preparation, administration, transportation and disposal of hazardous drugs. Safe Handling and Disposal: Methotrexate is a potent antineoplastic drug. Good medical practice will minimize exposure of persons involved with frequent handling of this drug as outlined below: Handling Methotrexate or solution of Methotrexate have no vesicant properties and do not show acute toxicity on topical contact with the skin or mucous membranes. However, person involved with handling cytotoxic drugs should avoid contact with skin and inhalation of airborne particles Preparation of antineoplastic solutions should be done in a vertical laminar flow hood or a Biological Safety Cabinet -Class II Personnel preparing methotrexate solutions should wear PVC gloves, safety glasses and protective clothing such as disposable gowns and masks Personnel regularly involved in the preparation and handling of antineoplastics should have bi-annual blood examinations Disposal Avoid contact with skin and inhalation of airborne particles by use of PVC gloves and disposable gowns and masks All needles, syringes, vials and other material for disposal which have come in contact with Methotrexate should be segregated in plastic bags, sealed and marked as hazardous waste. Incinerate at 1000 C or higher. Sealed containers may explode if a tight seal exists. Tablets: Place container and tablets in a plastic bag, seal, and mark as hazardous waste. Incinerate at 1000 C or higher If incineration is not available, rinse all needles, syringes, tubing and other materials of disposal which have come in contact with Methotrexate solutions with water and discard in the sewer system with running water. Pfizer goes on to state the following concerning the safe disposal of methotrexate in the health care setting: Rinse vials with the appropriate quantity of water with the aid of a hypodermic syringe. Withdraw the solution and discard in the sewer system with the water running. Dispose of rinse equipment and vials in a safe manner. Note that this is a case where materials would be disposed of in a yellow chemotherapy container per RCRA regulations. Tablets: Dissolve tablets in a suitable quantity of normal sodium hydroxide (40g per liter of water) and discard in the sewer system with running water. Note that this would be a case of the manufacturer's instructions allowing for disposal down a drain per RCRA regulations. Pharmacist and pharmacy technicians must also know how to properly handle the cleaning of non-disposable equipment and spillage and containment procedures. Keeping with the regulations OSHA has established along with maintaining any and all requirements of the RCRA, Pfizer clearly lays out these procedures as well. Cleaning: Non-disposable equipment that has come in contact with methotrexate solutions may be rinses in water and washed thoroughly with soap and water Spillage/Contamination: Wear gloves, mask, protective clothing. Place spilled material in an appropriate container and then in a polyethylene bag, absorb remains with gauze pads or towels. Wash area and absorb with gauze or towels again and place in bag. Seal, double bag and mark as hazardous waste. Dispose of waste by incineration or by other methods approved for hazardous materials. Personnel involved in cleanup should wash with soap and water. Note that all material would, per RCRA and OSHA regulations, need to be placed in a black hazardous material container for incineration. The steps necessary in handling methotrexate are numerous, time-consuming and evoke an atmosphere of extreme caution. Yet, Pfizer has been sure to follow the necessary precautions in order to stay in compliance with federal regulations regarding the safe handling and disposal of hazardous waste. Methotrexate is considered a hazardous drug due to its antineoplastic drug classifications and therefore will be found on the NIOSH routinely published list of antineoplastic and other hazardous drugs found within a health care setting. Undoubtedly these types of regulations are put into action in order to protect the health care worker. Pharmacists and pharmacy technicians within a health care setting are exposed to hazardous drugs on a routine basis; therefore, it is the responsibility of not only the facility, but the pharmacist and pharmacy technician, to have full knowledge of the safety precautions that have been implemented on a federal as well as a state level, in order to protect all who may have exposure to these drugs. If you work within a health care setting, hospital, long-term care facility, or other institution, you have no doubt heard of the Joint Commission. Joint Commission is an independent, not-for- profit accrediting body that certifies health care facilities and programs within the United States. Although recognized as a badge of outstanding performance, Joint Commission accreditation is strictly voluntary and is not associated with any federal or state run government bodies. However, the criteria that Joint Commission uses to accredit a health care facility or program follows guidelines instituted by federal and state agencies, such as RCRA and OSHA. In order to understand what drives the Joint Commission and their accreditation standards, we need to first understand the mission and the vision behind these values. Above all, patient safety is of key concern to the practice of pharmacy. Joint Commission is obvious in their approach towards the safety of patients as well. Keeping this in mind, Joint Commission addresses the following areas when a health facility or programs seeks accreditation: Electrical and Fire Safety Emergency Management Hazardous Waste and Materials Infection Control Medical Equipment Management Medication Management Refrigerator Management Security Several of these key accreditation areas require the involvement of the facility's pharmacy department. Hazardous waste and material, infection control, medication management, refrigerator management and security are just an example of areas where pharmacy involvement is necessary. As we stated earlier, Joint Commission accreditation is strictly voluntary. However, few health care facilities operate without Joint Commission accreditation. Areas of key concern for pharmacy during Joint Commission accreditation are as follows: Hazardous Waste and Materials: Every container within a pharmacy setting must be labeled with the name of the product as well as the appropriate hazard warning as mandated by federal regulations All standards for RCRA as they relate to hazardous waste must be enacted. The pharmacy must maintain hazardous waste containers (black), red sharps containers, and chemotherapy containers (yellow) within the facility as well as have these containers available to nursing areas All staff within the pharmacy must be able to find the MSDS, which are to be specific to the hazardous material kept within the pharmacy department Refrigerators: All refrigerators within the pharmacy and areas where the pharmacy may store medications, i.e. nursing medications stations, must be labeled for their specific use Medication Food Specimen All refrigerators maintained by the pharmacy must be cleaned on a regular base. Never may a refrigerator designated for medication, store food or specimens or vice versa Temperature monitoring of refrigerators under the maintenance of pharmacy are the responsibility of the pharmacy staff. Medication refrigerators should be kept between 36-46 degrees F All temperatures should be read on external digital monitors Pharmacy staff should regularly verify that temperature monitor is not blocked in order to maintain an accurate and consistent reading Refrigerators must have an alarm system that will be set off once the temperature goes above or below a safe range Medication Management: Medication carts must be locked at all times Medication rooms must be locked at all times and there must be no visible evidence of the combination anywhere No unsecured medications may be unattended on top of the medication cart, on the tops of counters or in an open bin Refrigerators that store medication must also be locked at all times Medications must labeled and any expired medications must be removed and returned to the pharmacy for disposal or destruction All opened vials of insulin must receive an expiration date of no greater than 28 days All insulin's must be stored in separate compartments according to their type All discharge medications must be returned to the pharmacy once the patient has been discharged from the unit Needles and sharps containers must be stored securely and out of the reach of the public (concern here for small children) No medications may be kept or stored at the patient bedside All nursing units must have a secured cart or cabinet dedicated to the storage of non-medicated IVs These are just a few of the requirements for Joint Commission accreditation as they relate to the practice of pharmacy. The pharmacist-in-charge will be able to provide the pharmacy staff with the training necessary in order to comply with Joint Commission accreditation, including where MSDSs are stored in the pharmacy and RCRA regulations regarding the use hazardous waste containers (black), chemotherapy waste containers (yellow) and sharps containers (red). Pharmacists or pharmacy technicians that are uncertain how employer handles the regulation requirements for Joint Commission accreditation should speak with the pharmacist-in-charge or possibly consult their employee handbook for further instructions. Patient safety continues to be a hot button issue in the United States. Keeping the health care worker safe is one of the central ways patient safety can be accomplished. The RCRA attacks the protocol needed for the safe and responsible disposal of hazardous waste and medications. The Secure and Responsible Drug Disposal Act was created in order to prevent the illegal and irresponsible disposal of unused medications. The Occupational Safety and Health Act of 1970 was aimed at secure a safe and secure working environment, which in turn results in safer care for the patient. As pharmaceutical manufacturers and researchers learn more about the safety of the medications we prescribe and dispense, not only will the safety practice of pharmacy evolve, but also the standards and regulations that govern their use. Patient safety goes beyond providing the patient with the right drug for the right diagnosis. As we have obviously been able to see, safe disposal of medications and hazardous waste affects more than just the patient or the health care worker, but also the environment as well. Evidence has shown traces of hormones and other pharmaceutical waste have been found in drinking water, streams and rivers. Continued accidental exposure to these drug can lead to disease states such as diabetes, some types of cancer, Alzheimer's, Parkinson's and even obesity and attention deficit disorder. Growing concern over the safety of medications forces the medical community to overview of the practice standards that regulate the disposal of unused pharmaceuticals and hazardous waste. It is no longer acceptable to dispose of all unused medications down a drain or quickly flush them in a toilet. Proper steps must be maintained in order to keep unused waste out of the landfills, drinking supply, rivers and streams. Furthermore, safety of the health care worker must also enter into the equation. OSHA, FDA, NIOSH, CDC, as well as the White House Office of National Drug Control Policy have joined forces with several professional pharmacy associations, such as ASHP, American Pharmacists Association (APhA) and NABP, to improve the standards of safety for the safe disposal of unused medications as well as safety of the health care worker that administers them. Joint Commission, while not being a government-regulated body, has become the defining point for health care institutions and programs seeking accreditation. Pharmacy plays a key role in the accreditation of a health care facility, essentially becoming guardian of safe medication practices. Guidelines, which can easily be maintained, include such areas as medication management, refrigerator monitoring, hazardous waste and materials and security of medications. A consistently safe environment where medications are concerned leads to greater continuity of care for the patient as well as security in the safety of the care they receive. Pharmacy technicians should never be counted out of the equation when discussing the laws and practice standards that provide a safe work environment. If a pharmacy technician feels uncertain about safety measure as they relate to the handling and disposal of hazardous waste and pharmaceuticals, they should immediately contact the pharmacy's pharmacist-in-charge for further instruction. Seeking the correct course of action may prevent a patient or the pharmacy technician from potential harm. References: About the Joint Commission, Joint Commission, 2013, http://www.jointcommission.org/about_us/about_the_joint_commission_main.aspx, 29 August, 2013 Ad Spotlights Teen Abuse of Medicinal Drugs, Food and Drug Administration, 2013, http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048782.htm, 29 August, 2013 Agin, D, More Than Genes 1:So What is Fetal Programing, Psychology Today, http://www.psychologytoday.com, October 2009, Disposal of Controlled Substances, The Federal Register, 2012, http://www.federalregister.gov/articles/2012/12/21/2012-30699/disposal-of-controlled-substances, 31 August 2013 Guidelines for Protecting the Safety and Health of Health Care Workers Centers for Disease Control and Prevention, 2012, http://www.cdc.gov/niosh/docs/88-119/, 28 August 2013 Hazard Communication Standard: Labels and Pictograms Occupational Safety and Health Administration, http://www.osha.gov, 29 August, 2013 How to Dispose of Unused Medicines, Food and Drug Administration, 2012, http://fda.gov/consumer, 28 August, 2013 Methotrexate Product Monograph, Pfizer, 2012, http://www.pfizer.ca/en/wr_products/products/monograph/280, 29 August, 2013 National Association of Boards of Pharmacy, 2013, http://www.nabp.net, 28 August 2013 Principles of Modern Drug Policy, Office of National Drug Control Policy, http://www.whitehouse.gov/ondcp/policy-and-research/principles-of-modern-drug-policy, 30 August 2013 Resource Conservation and Recovery Act, The Environmental Protection Agency, 2013, http://www.epa.gov, 30 August 2013 Smith, C, Management of Pharmaceutical Waste, 14th CUPA Training Conference, February 2012, http://www.calcupa.org/presentation/CUPA-U-B1-Management_of_Pharm_Waste.pdf, 30 August 2013