Controlling Occupational Exposure to Hazardous Drugs Controlling Occupational Exposure to Hazardous Drugs

Controlling Occupational Exposure to Hazardous Drugs

By: Kelly D. Ogle, BSDH, MIOP, CMPM, CHOP®
Director of OSHA and HIPAA Services

Disposal of Drugs and Contaminated Materials

Hazardous drugs (HDs) and contaminated materials should be disposed of in accordance with federal, state, and local laws. Any discarded HDs greater than residue amounts should be evaluated as to whether they are a hazardous waste under federal U.S. EPA regulations and if so, be disposed of in accordance with 40 CFR part 261 (EPA, 1991a and b). In addition, any discarded antineoplastic HDs should be managed as hazardous waste as a best practice and as required by some states. Since the EPA’s lists of hazardous wastes have not been updated since the 1980s, EPA’s Office of Inspector General has strongly recommended that EPA conduct a review of drugs that have entered the market since that time, particularly chemotherapy agents, to determine which drugs should be managed as hazardous waste in order to protect human health and the environment (EPA OIG, 2012). An independent commentary article on the EPA report (Eckstein, 2012) provides context to the issue of the future regulation of pharmaceutical waste.

Overtly contaminated materials, such as may occur during a spill or the cleanup of a spill, should also be managed as hazardous waste (EPA, 2008). Trace contaminated materials used in the preparation and administration of HDs, such as gloves, gowns, syringes and vials, also present a hazard to clinical support and housekeeping staff. These items should be disposed of in properly labeled, covered, and sealed disposal containers and handled by trained and protected personnel. Since sharps and potentially infectious materials may also be included in the trace contaminated materials, such containers should be managed as biohazardous waste under the Bloodborne Pathogens Standard [29 CFR 1910.1030(d)(4)(iii)] (OSHA, 2012a). Treatment should occur at a regulated medical waste incinerator rather than an autoclave or microwave to prevent aerosolization. Spills involving HDs can also represent a hazard, and employers should ensure that all employees are familiar with appropriate spill procedures as outlined in the Chemotherapy Safety Standards issued by the American Society of Clinical Oncology/Oncology Nursing Society (ONS, 2013).

Disposal of Dental Carpules

Expired medications should always be handled as “pharmaceutical” or “chemical” waste. Many communities periodically provide opportunities to turn these products in to designated facilities at no cost. If that is not an option, work with the medical waste disposal company to properly dispose of expired dental carpules.

Unbroken carpules with no residual chemical and no visible blood technically would not be considered medical waste and could be discarded into the regular trash. However, considering that these carpules could break when compressed, it is better to discard them into sharps containers.

  • Carpules with visible aspirated blood should go into sharps containers.
  • Carpules with residual liquid but no visible blood should be placed in separate containers labeled “pharmaceutical waste” or “chemical waste.”

Medical waste is autoclaved to destroy pathogens; chemicals are not affected. Chemical waste is usually incinerated.

 Disposal of Controlled Substances

The federal government enforces regulations covering the disposal of controlled substances by registrants and ultimate users. Individual states, agencies or municipalities may have stricter rules that must be obeyed. This is not covered by OSHA.

Registrants are persons or entities that handle (i.e., manufacture, distribute, import, export, engage in research, or conduct instructional activities) or propose to handle controlled substances and that are required to register with the Drug Enforcement Administration (DEA) at each principle place of business or professional practice. These include authorized –

  • Manufacturers
  • Distributors
  • Reverse distributors
  • Narcotic treatment programs
  • Hospitals/clinics with onsite pharmacies
  • Retail pharmacies

Registrants must follow strict documentation regulations, such as frequent inventories and security measures. Ultimate users are persons who legally obtain and/or possess controlled substances for personal use by themselves or a member of the household, or for their animals.

Registrants have the following options for handling unused, unwanted, or expired controlled substances:

  1. Onsite destruction – Rendering the controlled substances “non-retrievable” by permanently altering the controlled substance’s physical or chemical state to make it unusable. This is meant to prevent the controlled substance from being diverted for illicit purposes.
  2. Delivering to a reverse distributor.
  1. Recall or return – Transferring to the registered person or manufacturer from whom it was obtained or another registrant authorized by the manufacturer to accept recalls or returns.

Ultimate users have the following options:

  1. Participate in take-back events. These are usually conducted periodically by law enforcement agencies within designated communities.
  2. Mail-back programs are also conducted by law enforcement agencies.
  3. Collection receptacles located inside law enforcement’s physical address.

In each case, the law enforcement agency receiving these items is under strict regulations. The purpose of these regulations is to prevent controlled substances from polluting the environment or from being diverted for illegal purposes. The regulations do not specify destruction methods. These disposal methods can be used for the disposal of all unused or expired drugs, including personal use medications.

Which drugs are considered hazardous to workers?

The National Institute of Occupational Safety and Health (NIOSH) created a list of hazardous drugs in 2004 and has updated it periodically since, most recently in 2016. The list is too long to print here and may be found in its entirety in the publication NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2016, available at cdc.gov.

Most antineoplastic agents are considered hazardous; these agents may be carcinogenic, embryotoxic, fetotoxic, and/or teratogenic, and they can even cause spontaneous abortions. Other hazardous drugs include the vaccine Bacillus Calmet Guerin (BCH), which can also be problematic during pregnancy.

Non-antineoplastic medications on the Hazardous Drug list include antivirals (agents used to treat viral infections), immunosuppressants, anticonvulsants, non-ergot derivative dopamine receptor agents, heavy metal antagonists, chloramphenicols, estrogens, contraceptives, biological response modifiers, androgens, hydrantoins, certain antirheumatic agents, incretin mimetics, progestins, antithyroid agents, some antilipemics, estrogen agonists-antagonists, cell stimulants and proliferants, atypical antipsychotics, non-selective alpha-andrenergic blocking agents, antiparkinsonian agents, and mineralo-corticoic receptor antagonists.

While many of the drugs listed above have adverse reproductive effects among other hazards, a third list adds drugs that primarily have only those issues: anti-gout agents, oxytocics, antiarrhythmics, 5-alpha reductase inhibitors, azoles, antigonadotropin-releasing hormone antagonists, gonadotropins, complement inhibitors, vasodilators, bone resorption inhibitors, selective serotonin uptake inhibitors, somatostatin agonists,  hematopoietics, nucleosides and nucleotides, glycopeptides, cumarin derivatives and benzodiazepines.