2.6. Reducing Unused Pharmaceuticals: Conclusion (Ruhoy)
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This document discusses ways to reduce unused pharmaceuticals entering the environment. It argues that usage control through prudent healthcare practices that minimize unnecessary prescribing and dispensing can significantly reduce pharmaceutical residues more than disposal practices alone. Usage control can eliminate the need for disposal and also reduce residues released through excretion and bathing. The document also notes several collateral benefits to pollution prevention and usage control, such as reduced healthcare costs, improved treatment outcomes, and fewer poisonings from unused drugs.
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3.1. Introduction (Kreisberg)
This document outlines the life cycle of prescription pharmaceuticals from development through disposal. It discusses how current drug development and prescribing patterns relate to unused medications. The focus is on reducing leftover drugs through better understanding of prescribing, patient compliance, and accumulation in homes. The learning objectives are to review the pharmaceutical life cycle, patterns of prescribing that lead to unused drugs, current disposal policies and options, and six action steps to minimize waste.
Update on EPA’s Study of Unused Pharmaceuticals from the Health Care Industry
The EPA is conducting a study of unused pharmaceutical disposal from healthcare facilities. They plan to survey hospitals, nursing homes, hospices, and veterinary facilities to determine how much unused medication is disposed of and how. The objectives are to identify current disposal practices and regulations, as well as potential best practices. The EPA has initiated stakeholder outreach and site visits, and will publish a survey for approval after addressing public comments. The study aims to quantify national disposal amounts and methods by 2010.
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The document discusses biomedical waste management. It defines biomedical waste as waste generated during diagnosis, treatment, or immunization of humans or animals. It notes that biomedical waste includes infectious waste, pathological waste, sharps waste, pharmaceutical waste, genotoxic waste, chemical waste, and radioactive waste. The document also outlines the Ministry of Environment and Forest's classification of biomedical waste into 10 categories and the recommended treatment and disposal methods for each category. Key sources of biomedical waste are identified as hospitals, clinics, labs, and other healthcare facilities.
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Biomedical Wastes -Review-A paper-Final.pdf
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3.5. Facts About Disposal in the U.S. (Kreisberg)
- Flushing unused pharmaceuticals is not recommended by the FDA, EPA, or other organizations due to concerns about contaminating water supplies. Trace amounts of drugs have been found in streams, rivers, and drinking water.
- The FDA only recommends flushing a small number of drugs that could cause harm if ingested. For most drugs, the recommended disposal method is to throw them in the trash mixed with an undesirable substance like kitty litter.
- Take-back programs, drug collection sites, and hazardous waste facilities are better options than flushing or throwing drugs in the trash if available in your area. Proper disposal helps protect water quality and the environment.
3.4. What is Accumulating & How Do We Know? (Kreisberg)
The document summarizes the results of a study that examined pharmaceutical waste collected at take-back sites in the San Francisco Bay Area in 2009. It found that a total of 65,676 pounds of pharmaceutical waste was collected from 126 sites across the region, at a total cost of $119,133. Manual counts of medications returned found that the most common were analgesics, bronchodilators, and dermatological agents, and that the majority of medications were in pill or capsule form and were prescription drugs, with many being expired.
3.2. Life Cycle Dynamics (Kreisberg)
The document summarizes the life cycle of pharmaceutical manufacturing and its environmental impacts. It discusses how the industry uses significant amounts of energy, water, and emits air pollutants and greenhouse gases through its operations. Transportation of pharmaceuticals also contributes significantly to its carbon footprint. The industry is taking steps to improve efficiency and reduce waste, such as increasing reuse of solvents, installing pollution controls, and examining supply chains and models of care to lower emissions. Major companies have sustainability initiatives underway to address these issues across their operations.
3.6. Reducing Pharmaceutical Waste in Clinical Care (Kreisberg)
This document discusses current federal and state activities around minimizing pharmaceutical waste. It outlines research being done on occurrence and treatment options for pharmaceuticals in the environment. It also discusses federal legislation like the Safe Drug Disposal Act and various state legislation regarding take-back programs. The document notes that 54% of people throw medicines in the trash and 35% flush them, contributing to pharmaceuticals in waterways. It provides strategies to minimize waste at the prescribing, dispensing, and patient levels, and encourages proper disposal and take-back programs.
2.3. Evidence for Ecotoxicity (Ruhoy)
Evidence shows that APIs in aquatic environments can have negative effects on organisms. Long term, multi-generational exposure to low levels of APIs may disrupt endocrine systems and cause alterations to sexual differentiation, as seen in studies on Boulder Creek and Potomac River. While APIs have been detected in most US streams sampled, questions remain about their potential low-dose, interactive, and chronic effects. More research is needed to understand risks to both environmental and human health from exposure to multiple APIs at low concentrations over long time periods.
5.5. State Regulations and Guidance (Batz)
State regulations and guidance on prescription drug take-back programs vary. Examples of innovative state programs discussed include those in Arizona, California, Maine, Washington, and Washington D.C. Arizona's TakeAway program uses pharmacies as take-back sites. California's program allows anonymous drug surrender. Maine's mail-back program has disposed of over 2,300 pounds of drugs. Washington's program allows drop-off at pharmacies and police stations. Washington D.C.'s program allows veterans to mail back unused drugs.
5.4. Federal Regulations (Batz)
The document discusses federal regulations regarding the disposal of medicines from the FDA, DEA, and USPS. The FDA recommends mixing most medicines with unpalatable substances and throwing them in the trash or using drug take-back programs. However, some controlled substances should not be thrown in the trash due to the risk of accidental ingestion; these may require approval from the DEA for disposal. The USPS allows returning prescription drugs by mail for recalls, withdrawals, or errors when sent to the manufacturer.
5.3. Methods of Disposal (Batz)
The document discusses guidelines for proper disposal of unused or expired medications. It begins by outlining the FDA's recommendations for flushing certain drugs down the toilet or sink, but notes this should only be done for a small number of medications. Alternative disposal methods such as take-back programs or mixing drugs with an undesirable substance and throwing in the trash are generally preferred. The document then covers various perspectives on flushing from other organizations and provides advice from regulatory agencies on safe medication disposal.
5.2. Reason for Concern (Batz)
This document outlines several reasons for concern regarding pharmaceuticals in the environment and personal care products (PPCPs). It discusses that large quantities of PPCPs can enter the environment after use and treatment plants are not designed for their removal. This poses uncertain risks to aquatic organisms and humans. The document also addresses concerns about rising teen drug abuse, including the abuse of prescription medications obtained from family or online. Additional concerns discussed include accidental ingestion by children and pets as well as occupational exposure risks for healthcare workers handling chemotherapeutics.
5.6. Conclusion (Batz)
Practitioners can help address the issue of improper medication disposal by including special instructions on disposal with prescriptions, supporting take-back programs in their local area, and displaying informational posters in and around pharmacies. Additional resources for practitioners and the public include the Groundwater Foundation, Drug Take-Back Network, and Teleosis Institute websites, which provide information on drug take-back and disposal issues and how to get involved.
5.1. Introduction (Batz)
This document discusses proper disposal of pharmaceutical products by pharmacists. It begins with background information on where pharmaceutical contaminants come from, including manufacturing residues, hospitals, human and veterinary drug use, and agribusiness. Pharmaceutical and personal care products (PPCPs) are discussed as emerging pollutants, comprising thousands of substances like prescription drugs, over-the-counter medications, fragrances, and cosmetics. The document outlines federal and state regulations regarding pharmaceutical disposal and urges pharmacists to do their part in addressing this issue.
2.4. Environmental Impact of Disposal (Ruhoy)
The document discusses the environmental impacts of disposing of unused and leftover medications. It notes that APIs (active pharmaceutical ingredients) enter the environment through excretion, bathing, and disposal. Disposal represents acute but transient pollution from fewer people, compared to the continual low-level contributions from excretion by many people. Indirect entry can occur when drugs are disposed of in trash. Proper disposal is complicated by the need to protect safety and minimize environmental exposure. The document also discusses concerns about potential ecological and human health effects of APIs in the environment.
2.1. Pharmaceutical in the Environment: An Evidence-based Review: Introductio...
This document reviews current research on pharmaceutical residues found in water sampling studies. It discusses the various sources of pharmaceuticals entering the environment from improper storage, disposal, and prescribing of leftover drugs. The document examines the potential ecological and human health impacts of long-term exposure to low levels of multiple active pharmaceutical ingredients found in the environment.
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- 1. Reducing Unused Pharmaceuticals: Conclusion GreenPharmEdu.org
- 2. Actions can be directed not just at prudent alternatives for disposal, but also (and more significantly) to reducing the contributions from excretion and bathing. Reducing Leftover Drugs Actions can be directed at improvements to any part of the life cycle of medicationssuch as those spanning the vast, complex chain beginning with design/discovery, manufacturing, packaging, and advertising, and proceeding to prescribing (as also modified by practices of healthcare insurers) and dispensing, and ending with whether the medications are eventually consumed or used by the consumer.
- 3. Stewardship and Pollution Prevention Disposal control vs. Usage control (or Down-stream vs. Up-stream):two basic approaches for reducing the entry of APIs to the environment. Disposal control: prudent andenvironmentally sound engineered practices for disposal of unwanted medications. Usage control:prudent healthcare practices to minimize or optimize prescribing and dispensing of medications by eliminating unnecessary or imprudent customs and practices. Significantly, usage control perhaps has greater potential for reducing overall entry of APIs to the environment. It can eliminate the need for disposal PLUS also minimize the residues that would otherwise be released by excretion and bathing.
- 4. Aspects of Sources/OriginsImportant to Design of Stewardship Programs Fate of APIs and creation of by-products during non-optimized incineration The creation and fate of toxicologically significant by-products during manufacture, wastewater treatment, metabolism/biotransformation, and physicochemical processes in the environment The extent of occurrence and fate of PPCPs in biosolids and in recycled water (especially when applied to arable land) Whether the nanomaterialsused in the expanding field of nanomedicine pose risks once they enter the environment The extent to which plant-made pharmaceuticals pose a hazard if released to the environment Proactive environmental monitoring for new molecular entities at the time they are introduced into commerce Apportioning the sources from which APIs gain entry to the environment
- 5. Collateral Benefits toPollution Prevention & Usage Control In addition to reducing environmental contamination by APIs, stewardship actions aimed at ensuring prudent, efficacious usage of medications might also: lessen healthcare costs(via more effective treatment, reduced purchase costs, fewer prescribing/dispensing errors) improve therapeutic endpoints and healthcare outcomes(via better patient adherence/compliance) reduce morbidity and mortalitycaused by poisonings of infants, children, adults, pets, and sometimes wildlife by unused stored drugs or by drugs improperly disposed in trash.
- 6. Dogma Masquerading as Knowledge Drug disposal is a significant source of APIs in the environment Trace levels of antibiotics in the environment serve as a driver of selection for antibiotic-resistant human pathogens Use of antibiotics in confined animal feeding operations pose a risk with regard to the selection of antibiotic resistant bacteria and genetic transfer of resistance to human pathogens Manufacturer waste streams are a minor source of APIs in the environment APIs are generally not subject to comparable bioconcentrationbecause of their lower lipophilicity and ionizability Excipients do not need to be considered since they are not “active” ingredients
- 7. Final Thoughts The types and trends in levels of chemical contaminants in the environment serve as direct measures of our progress toward sustainability, spanning green and virtual chemistry, to smart manufacturing and intelligent consumption. Sustainability could be advanced from consumers understanding more fully their individual roles in both causing (via combined miniscule inputs) and preventing the release of chemicals to the environment. PPCPs serve to highlight that the environment and humans are intricately interconnected in a complex system that would benefit from examination as an integral whole:Humans and the environment as a single patient.