Hazardous and Non-Hazardous Waste

• he definition of what constitutes hazardous waste, and how this differs from non-hazardous waste. 

• The dangers associated with hazardous waste and the precautions needed. 

• Examples of both hazardous waste and non-hazardous waste encountered in pharmacies. 

• Differences between P and U-listed pharmaceutical waste. 

• Hazardous drug preparation and Safety Data Sheets (SDS). 

• Study Notes

• Quiz

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15.1

Introduction to Unit 15

Medicines are designed to treat patients, but they can also harm patients, healthcare workers, the public, and the environment.

Medicines that must be disposed of – as hazardous waste – must be disposed in a careful and regulated manner. Otherwise, exposure increases substantial risk to any of the category of people mentioned above.

Hazardous waste can:

• Be absorbed through the skin into the bloodstream

• Be inhaled as fine particles into the lungs

• Burn the skin

• Cause harm to the fetus (teratogenic substances)

Given these risks, two pairs of gloves must be worn when handling hazardous substances – offering must-needed extra protection.

Throughout this Unit, medication waste is defined as medicines that are unused, or expired, or can no longer be used for the intended clinical purpose. It does not apply to stock that is returned to the pharmacy or to medicines sent to a reverse distributor.

Definition: “A reverse distributor is an agent who acts as a ‘middleman’, who collects controlled substances or pharmaceutical waste from registrants and either returns them to the manufacturer or arranges for their disposal.”

15.2

Non-Hazardous Waste

Most medicines in the pharmacy setting are non-hazardous.

Typically, non-hazardous waste is disposed in a blue or white bin or, if the substance is to be incinerated, it may be disposed in the trash. Non-hazardous waste of this kind is typically removed using a reverse distributor.

Other non-hazardous waste, such as:

• IV solutions

• Ringer’s lactate solution (Hartmann’s solution)

• Saline

• Dextrose

…may be disposed by pouring down the drain. They are non-toxic and so pose no additional risks to people and the environment.

The mechanism by which pharmacies operate differs. Some states mandate other waste disposal approaches, and so the precise way waste is disposed should be determined by following state legislation.

15.3

Hazardous Waste

Disposing hazardous waste requires a different approach – not least because there are significant risks involved, both to the health of workers and the public, but also to the environment too.

Disposal of hazardous waste must comply with the EPA – or Environmental Protection Agency.

The EPA has four classifications of waste – P, U, K, and F.

The EPA classifies hazardous waste into four types: F-listed, K-listed, P-listed, and U-listed. These classifications are based on the source, characteristics, and type of waste. Proper disposal of each type is crucial and requires adherence to specific regulations.

F-listed Wastes: These are generated from non-specific manufacturing and industrial processes. Examples include spent solvents and wastewaters. They are generally disposed of through specialized treatment facilities or recycling programs.

K-listed Wastes: These have specific industry sources like pesticide manufacturing and petroleum refining. Examples include wastes from wood preservation and petroleum refining. Disposal methods can vary depending on the specific waste, but often involve treatment and then land disposal or incineration.

P-listed Wastes: These are acutely hazardous commercial chemical products, like cyanides. They are highly toxic and require specialized disposal methods, often involving incineration or other advanced treatment technologies.

U-listed Wastes: These are hazardous commercial chemical products that are not acutely hazardous, but still require proper disposal. Examples include acetone and chloroform. They are typically disposed of through treatment and then land disposal or incineration, but may also be recycled depending on the specific waste.

Disposal Considerations: Regardless of the waste type, proper handling and disposal are crucial to prevent environmental contamination and protect human health. This includes proper labeling, storage in secure containers, and use of approved transporters. Many businesses also opt to use hazardous waste disposal specialists to ensure compliance with regulations.

For more detailed information on specific waste types and disposal methods, it's recommended to consult the EPA's regulations and guidelines.

Pharmaceutical waste is classified under both P and U lists, and whether the waste in question has a specific hazardous characteristic – for example: whether it has the capacity to burn or ignite.

P-list pharmaceutical waste includes:

• Warfarin

• Nicotine patches, gum, or lozenges

• Physostigmine

• Arsenic trioxide

• Nitroglycerin

• Epinephrine

U-list pharmaceutical waste includes:

• Lindane

• Selenium sulfide

• Chloral hydrate

• Mitomycin C

• Formaldehyde

• Benzene

There are four characteristic waste categories, as set out in the Resource Conservation and Recovery Act, which include:

• Ignitability – include liquids with flash points below 60-degree Celsius, non-liquids that cause fire through specific conditions, ignitable compressed gases, and oxidizers.

• Toxicity – harmful when ingested or absorbed. Toxic wastes present a concern as they may be able to leach from waste and pollute groundwater.

• Corrosivity – include aqueous wastes with a pH of less than or equal to 2, a pH greater than or equal to 12.5 or based on the liquids ability to corrode steel.

• Reactivity – may be unstable under normal conditions, may react with water, may give off toxic gases and may be capable of detonation or explosion under normal conditions or when heated. EPA assigned D003 as the waste code for reactive hazardous wastes.

15.4

Hazardous Drug Preparation and SDS

Preparation of hazardous drugs in pharmacies must abide by strict regulations.

For example – pharmacies must prepare these drugs in a negative pressure environment. This environment must only be used for the preparation of hazardous drugs and not non-hazardous drugs.

Definition: “A negative pressure room has a lower air pressure within it, meaning that outside air flows into the room but any inside air that attempts to flow out of the room must pass through a filter”.

The purpose, then, of a negative pressure room is to contain hazardous waste and/or particulates within the room, thus ensuring that any contaminated air that leaves the room must pass through a filter and so does not come into contact with either people or the environment. If any part of the safety clean kit touches a hazardous substance/waste, then it must be discarded as hazardous substance/waste.

Hazardous drugs can be prepared in a biological safety cabinet, or a vertical laminar flow hood, as recommended by OSHA (Occupational Safety and Health Administration).

Hazardous drugs/chemicals come with an SDS, or safety data sheet.

Safety data sheets are written by the manufacturer, who outlines details on:

• Associated hazards with the drug/chemical

• How the drug/chemical should be handled

• What clean-up procedures should be followed in the event of spillage or exposure

• What PPE, or personal protective equipment, should be worn

• First-aid measures to be followed if workers are harmed through exposure

• Physical and chemical properties of the drug/chemical

• How the drug/chemical should be optimally, and safely stored

• Fire-fighting measures, in cases of ignition

Safety data sheets come with all hazardous drugs/chemicals. They should be consulted where necessary and are typically readily accessible by being located near to the drug/chemical in question.

Any inadvertent exposure to hazardous substances must first be documented using an IIR – or Initial Incident Report.

Hazardous waste from hospital pharmacies is typically removed using a hazardous waste vendor, who collects the waste at a defined collection point outside the hospital from black bins, or other bins which are clearly designated as containing hazardous material. The vendor must have received the appropriate license from the EPA.

Controlled substances may also be removed, but the vendor must be registered with the DEA. Any transfer of Schedule II controlled substances must be done using DEA Form 222. For Schedule III-V drugs, an inventory log is instead used to document the transfer of these drugs.

15.5

Module II Summary

• Federal legislation – Pure Food and Drug Act, 1906; Food, Drug and Cosmetic Act, 1938; Durham-Humphrey Amendment, 1951; Kefauver-Harris Amendment, 1963; Controlled Substances Act, 1970; Poison Prevention Packaging Act, 1970; Occupational Health and Safety Act, 1970; Drug Listing Act, 1972; Federal Hazardous Substances Act, 1960; Orphan Drug Act, 1983; Drug Price Competition and Patent Term Restoration Act, 1984; Prescription Drug Marketing Act, 1987; Anabolic Steroids Control Act, 1990; Health Insurance Portability and Accountability Act, 1996; FDA Modernization Act, 1997; Medicare Prescription Drug, Improvement, and Modernization Act, 2003; Combat Methamphetamine Epidemic Act, 2005.

• Regulatory Bodies – Food and Drug Administration (FDA); Drug Enforcement Administration (DEA); The Joint Commission (TJC); State Boards of Pharmacy (BOP); National Association of the Boards of Pharmacy (NABP); United States Pharmacopoeia (USPs <795>, <797, <800>).

• REMS – Risk Evaluation and Mitigation Strategies; Drugs with REMS Programs; Case Study: Isotretinoin.

• Controlled Substances – Drug Enforcement Administration; Ordering of controlled substances; DEA Forms; Documenting controlled drugs; Maintaining inventory; Scheduled drug refills and prescription transfers; Damaged controlled substances; Loss or theft of controlled substances.

• Hazardous and Non-Hazardous Waste – Definitions of hazardous and non-hazardous waste; Role of reverse distributors; Handling and disposal of non-hazardous waste; Environmental Protection Agency (EPA); P and U-list pharmaceutical waste; Resource Conservation and Recovery Act; Hazardous drug preparation; OSHA; safety data sheets (SDS); Removal of controlled substances/waste.