Magazine article Health Facilities Management

Safely Managing Controlled Substances: Effective Strategies to Help Facilities Maintain Regulatory Compliance

Magazine article Health Facilities Management

Safely Managing Controlled Substances: Effective Strategies to Help Facilities Maintain Regulatory Compliance

Article excerpt

The growing number and increasing use of pharmaceuticals throughout widely dispersed health care networks has heightened the urgency for hospitals to manage controlled-substance waste more safely and effectively. Four factors make this especially challenging:

* Many health care facilities lack formal processes for the proper disposal of controlled-substance waste that are effective in preventing diversion.

* Hospitals must comply with complicated, confusing and costly regulations from different agencies regarding waste disposal.

* The abuse of controlled substances is skyrocketing, which increases the risks for diversion (i.e., used or expired drugs taken by unauthorized persons).

* Flashing, the most common current practice for controlled-substance waste disposal, is costly due to staff time and can harm the environment.

A 2012 national survey on drug use found that almost twice as many Americans abused pharmaceutical controlled substances than the combined number of users of cocaine, hallucinogens, heroin and inhalants. It also estimated that nearly 110 Americans die every day from drug-related overdoses, and about half of those overdoses were related to opioids, a class of drugs that includes prescription painkillers and heroin, according to a Sept. 8, 2014, notice by the Drug Enforcement Administration (DEA).

A new responsibility

For most hospitals, capturing controlled-substance waste is a challenging process that poses high risks to health care networks and their stakeholders, particularly in regard to regulator)' compliance, patient safety and reputation management. Pharmacy directors and other health facilities professionals are now responsible for ensuring that leftover or unused drugs and drug waste are not taken or used by anyone other than the intended patient.

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As the opioid epidemic continues to rise and regulators clamp down on prescribing requirements, hospitals are becoming bigger targets for diversion of controlled substances.

Detecting diversions, however, can be difficult because people have numerous opportunities to access these medications throughout the hospital and at various stages of patient care and waste disposal. The increasing prevalence of drug abuse heightens the risk that clinicians or staff could be affected by diverted controlled substances while caring for patients.

Workers who abuse controlled substances while at the hospital will have impaired judgment and skills, further increasing the risk that their actions could have an adverse effect on patients.

Confusing regulations

The first challenge in developing strategies for the proper handling and disposal of controlled substances is to understand the regulatory requirements. A 2014 regulation by the DEA states that "the controlled substance dispensed for immediate administration ... remains under the custody and control of the registered institution even if the substance is not fully exhausted (drug wastage) ... such remaining substance must be properly recorded, stored and destroyed in accordance with DEA regulations and all applicable federal, state, tribal and local laws and regulations."

The DEA's Disposal of Controlled Substances final rule in 2014 remained unclear to many hospitals, prompting a "Dear Practitioner letter that emphasizes the important distinction between practitioner inventory and pharmaceutical wastage. It also notes that after a prefilled syringe or single-dose vial is administered to a patient, any remaining substance is not required to be destroyed. However, although pan 1307 in the final rule does not apply to pharmaceutical wastage, the DEA "strongly encourages all practitioners to continue to adhere to security controls and procedures that ensure pharmaceutical wastage is not diverted."

In a survey on pharmaceutical waste-management regulatory challenges published by Pharmacy, Purchasing & Products magazine in February, hospital pharmacy professionals cited the complexity of regulations as their No. …

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