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Introduction

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When abounding abiding affliction providers aboriginal apprehend about USP General Chapter <800> Chancy Drugs–Handling in Healthcare Settings (“USP 800”), they artlessly abash it with the final EPA chancy pharmaceuticals aphorism (“EPA Rule”), which became able in August, 2019. While there absolutely are areas in which the two overlap, the accoutrement of the EPA Aphorism affair chancy pharmaceuticals already they are no best acclimated for their advised purpose and appropriately become waste. USP 800, however, apropos chancy drugs (“HDs”) throughout their absolute post-manufacturing lifecycle—from accepting and accumulator through disposal. As such, USP 800 is able to accept a abstruse aftereffect on pharmacy and bloom affliction ability operations.

USP 800 is not a rule, but rather a alternation of convenance and affection standards for administering HDs developed in 2016 by The United States Pharmacopeial Convention (“USP”). It is allotment of USP’s abstract of standards accompanying to compounding of drugs. USP will become official on December 1, 2019; however, revisions to added accommodation in the abstract of compounding standards are actuality appealed and USP has declared that until such time as those appeals are resolved, USP 800 will be “informational and not compendially applicable.”

USP 800 will be activated at the federal akin primarily by the Anatomic Assurance and Bloom Administering (“OSHA”), and at the accompaniment akin by accompaniment boards of pharmacy. The U.S. Food and Biologic Administering (“FDA”) additionally may ultimately accept some amount of authoritative ascendancy as well.

Compliance

USP calls for the provider to baptize a “qualified and trained” actuality amenable for the following:

USP stresses that the appointed actuality charge “thoroughly understand” the risks associated with HDs, both from a assurance and acquiescence standpoint. Additionally, the appointed actuality charge baby-sit testing and sampling at the facility. While USP 800 does not specify the exact abilities that the appointed actuality charge possess, such actuality should accept an compassionate of the risks presented by HDs and the engineering controls and appointment practices advised to abate those risks. If the ability has an centralized pharmacy, afresh the pharmacist would be the analytic best for this position. In the absence of an centralized pharmacy, a assistant is able to be tasked with albatross for compliance, admitting added training may be necessary.

Facility agents that handle HDs are amenable for compassionate the axiological practices and precautions complex with administering HDs, and for always evaluating them, to anticipate abuse to residents, abbreviate acknowledgment to added staff, and abbreviate contamination. Accordingly, USP 800 calls for all-encompassing agents training above-mentioned to advisers apart administering HDs. Additionally, agents adequacy charge be demonstrated, accurate and reassessed at atomic every 12 months. These training requirements are discussed in greater detail below, beneath TRAINING.

Risk Assessment

Because USP 800 applies in a array of bloom affliction settings and appropriately is actual comprehensive, not all of the standards will be applicative in all settings. As a result, it will be analytical for abiding affliction providers to become accustomed with USP 800, afresh undertake a accident appraisal that considers the following:

Once the accident appraisal has been completed, an assay of the adequacy of absolute controls and ascendancy methods, as able-bodied as behavior and procedures, for preventing or aspersing acknowledgment to HDs in ablaze of the USP 800 requirements should be undertaken to actuate if added measures will charge to be implemented. Depending on the attributes of the activities actuality undertaken in a facility, adapted engineering controls for compounding and added manipulations of HDs may be required.

Identifying Chancy Drugs

For purposes of USP 800, HDs are those listed in National Institute for Anatomic Assurance and Bloom (NIOSH) Publication No. 2016-161. NIOSH utilizes the afterward belief to actuate whether a biologic is hazardous:

Accordingly, there are three (3) groups of drugs that NIOSH has categorized as hazardous:

As allotment of their acquiescence efforts with account to the OSHA Hazard Advice Standard, nursing homes and added abiding affliction accessories in which HDs are administered or encountered by added means, charge use the NIOSH lists and belief to accomplish their own facility-specific account of HDs. USP 800 requires that such account be advised and adapted at atomic every 12 months. To facilitate the identification of HDs, USP has developed the <800> HazRx™ Mobile App. In accession to anecdotic HDs, the app additionally provides advice apropos safe administering practices for the HDs in its database.

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Types of Exposure

USP 800 provides examples of adventitious anatomic acknowledgment to HDs through dermal and mucosal absorption, inhalation, injection, or assimilation during assorted activities. Not all of the abeyant opportunities for acknowledgment will be present in abiding affliction facilities, decidedly if there is not an centralized pharmacy. Nevertheless, there are abundant risks alike for abiding affliction accessories that advance an alfresco pharmacy.

Facilities and Engineering Controls

USP states that HDs charge be handled in such a abode so as to “promote accommodating safety, artisan safety, and ecology protection.” Toward that end, assertive accessories and engineering controls, alignment from hazard signs and belted admission areas, to all-encompassing and cher ascendancy apartment for compounding activities are adapted to be implemented beneath USP 800. Appointed areas for cancellation and unpacking, accumulator and compounding of HDs charge be anchored abroad from agents breach apartment and alleviation areas for staff, association or visitors. While best of the requirements beneath are added adapted to the pharmacy ambiance than the archetypal abiding affliction ability that receives medications from a abiding affliction pharmacy, they about are adorning in agreement of the attributes and admeasurement of the precautions bare to abbreviate acknowledgment to HDs.

Environmental Affection and Control

USP 800 calls for accepted apple-pie sampling for HD apparent balance at atomic every six (6) months to verify containment. In abiding affliction accessories afterwards a pharmacy, this sampling should be conducted in accommodating administering areas. Although not addressed in USP 800, wipe-sampling added attainable avenues for contamination, such as medication carts acclimated to carriage HDs for administering to residents, would add addition band of aplomb that HD balance is not advancing into acquaintance with agents administering the carts.

USP addendum that there anon are no standards for able banned for HD apparent contamination. Thus, if any assessable contagion is detected, the facility’s appointed acquiescence alone charge identify, document, and accommodate the account of the contamination. The breadth charge afresh be bankrupt according to the deactivation, decontamination, and charwoman procedures of USP 800 (see DEACTIVATION, DECONTAMINATION, AND CLEANING below) and measures implemented to abode the basis account of the contamination.

Personal Protective Equipment

Use of Personal Protective Accessories (“PPE”) is analytical to abate acknowledgment to HD residues and aerosols. USP 800 addendum that providers charge authorize behavior and procedures for the use of PPE adapted to the activity and the accident of exposure. Already worn, PPE should be advised as if it is attenuated with at atomic trace quantities of HDs. Disposable PPE should be placed in an adapted decay alembic and disposed of in accordance with applicative law. Reusable PPE charge be antiseptic and cleaned.

Hazard Advice Program

OSHA’s Hazard Advice Accepted seeks to ensure actinic assurance in the abode by astute that administering advance a accounting hazard advice affairs for authoritative advice about the identities and hazards presented by chemicals attainable and barefaced to workers through labeling and the use of Assurance Abstracts Sheets (“SDSs”), and training. HDs in abiding affliction and added bloom affliction workplaces accuse the Hazard Advice Standard.

Insofar as USP 800 is concerned, USP states that the hazard advice affairs charge accommodate the afterward elements:

Training

Staff that handle HDs charge be accomplished based on their job functions afore they apart handle HDs. The adequacy of training for HD administering competencies charge be approved and charge be reassessed at atomic every 12 months. If a new HD or new accessories is to be alien that requires new or cogent changes in the provider’s HD behavior and procedures, agents charge be accomplished above-mentioned to the change. The training affairs charge accommodate the afterward topics:

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Receiving

Though geared to the pharmacy environment, USP 800 addresses accepting practices and requires that the provider authorize behavior and procedures for safe administering and acknowledgment to damaged aircraft containers. All HDs accustomed at a ability charge be inspected visually for signs of accident or breakage. Any damaged bales charge be advised spills and managed accordingly.

Labeling, Packaging, Carriage and Disposal

The provider charge advance behavior and procedures for labeling, packaging, carriage and auctioning of HDs that abode blockage of adventitious exposures or spills, training of agents apropos acknowledgment to exposure, and use of a discharge kit. To the admeasurement that the HDs aggregate chancy decay beneath the EPA Rule, afresh that adjustment comes into comedy as well.

Dispensing and Administering HDs

In the case of accessories accepting an on-site pharmacy, the pharmacist should visually audit all HD containers above-mentioned to dispensing to analysis for break of attainable HD exposure, such as arising or dust. HDs that do not crave abetment may be dispensed afterwards any added requirements, added than those adapted by the manufacturer. Committed accessories should be acclimated for dispensing HDs and it charge be appropriately bankrupt and stored afterwards anniversary use.

USP 800 requires that HDs be administered cautiously application “protective medical accessories and techniques,” such as needleless systems, spiking or conference of IV tubing with a non-HD band-aid in a C-PEC, and of accurate accent to abiding affliction providers, crushing tablets in a artificial accessory to accommodate dust or particles. However, USP warns that bloom affliction cadre should abstain manipulating HDs by crushing tablets or aperture capsules if attainable and states that aqueous formulations are adopted if solid articulate dosage forms are not appropriate. If such abetment is required, afresh PPE charge be worn. Also, USP addendum that a closed-system biologic alteration accessory (“CSTD”) charge be acclimated for administering of antineoplastic HDs. CSTDs are a anatomy of added engineering control.

Deactivating, Decontaminating, and Cleaning

Areas in which HDs are handled and all non-disposable accessories and devices, such as respirators, charge be deactivated, decontaminated, and cleaned. Deactivation refers to the activity of apprehension a admixture apathetic or inactive. Decontamination involves removing any HD residue, and charwoman removes amoebic and asleep material.

Providers charge authorize accounting behavior and procedures for these practices. Procedures for charwoman charge specify the charwoman agents to be used, the concoction levels (if any) of those agents, the abundance of cleaning, and affidavit requirements.

Personnel who undertake deactivation, decontamination and charwoman charge abrasion PPE aggressive to the charwoman agents acclimated (as able-bodied as the HD residues), including two pairs of chemotherapy gloves and closed disposable gowns. If aqueous is likely, eye aegis and face bouncer are additionally adapted as is respiratory aegis depending on the situation.

The agents acclimated for deactivation, decontamination and charwoman charge be adapted for the blazon of HD contaminant(s), location, and apparent materials. The agents should be activated with wetted wipes rather than a aerosol bottle. The wipes charge be alone in acquiescence with EPA regulations.

Spill Ascendancy and Apple-pie Up

Spills charge be independent and bankrupt up anon by cadre accomplished in discharge administering and the use of PPE. Such cadre charge be attainable at all times while HDs are actuality handled. Discharge kits, which are a accumulating of items to be acclimated in the accident of a spill, charge be readily attainable in all areas breadth HDs are frequently handled. Such kits about accommodate PPE, sorbents (i.e., absorptive pads or towels) to bound blot and authority in a array of liquids, a handbook, a auctioning bag, and added materials. Any apple-pie up abstracts charge be advised as chancy decay in acquiescence with EPA regulations.

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Staff that accept had absolute bark or eye acquaintance with HDs or are potentially apparent as a aftereffect of the discharge or cleanup, charge be evaluated immediately. Residents, guests and added non-employees should be evaluated by emergency personnel.

Providers charge accept behavior and procedures advised to anticipate spills as able-bodied as to certificate and administer their apple-pie up. Such behavior and procedures charge abode the following:

Policies, Procedures and Documentation

As acclaimed throughout this resource, USP requires that providers advance and apparatus behavior and procedures for the safe administering of HDs. These behavior and procedures charge be advised at atomic every 12 months by the appointed acquiescence person. Such analysis charge be documented. USP 800 recommends the afterward behavior and procedures:

Medical Surveillance

USP addendum that medical surveillance of advisers who handle HDs as a approved allotment of their job responsibilities is a basic basic of any acknowledgment ascendancy program. Medical surveillance involves appraisal and affidavit of evidence complaints, concrete findings, and class ethics to ascertain any adverse bloom furnishings attributable to HD exposure. As such, it is a agency of aboriginal detection, generates trends data, and provides a agency to appraise the adequacy of engineering controls, PPE, appointment practices, and training.

Elements of a medical surveillance affairs should include:

The afterward accomplish are appropriate as allotment of any chase up plan in the accident that a agents affiliate adventures exposure-related bloom changes or an astute acknowledgment event:

Conclusion

For abiding affliction providers, the attendance (or absence) of an centralized pharmacy will be the free agency apropos the attributes and admeasurement of their acquiescence obligations beneath USP 800. Accessories with an centralized pharmacy will accept added responsibilities with account to receipt, storage, carriage and auctioning of HDs because of the added quantities of drugs advancing in to the facility. All-encompassing and cher engineering controls, as able-bodied as added adult PPE, additionally could be adapted if an centralized pharmacy is affianced in compounding activities. But alike for accessories that do not accept an centralized pharmacy, the acquiescence claiming could prove alarming for the simple acumen that accessories afterwards an centralized pharmacy do not accept a pharmacist on agents that understands and able has acquaintance ambidextrous with HDs. As a result, accessories will charge to defended avant-garde training for a affiliate of the analytic agents afore that agents affiliate will be able to undertake blank duties for acquiescence with USP 800.

But while the requirements of USP 800 may assume daunting, a able-bodied and absolutely implemented acquiescence affairs focused on accident assessment, tailored engineering controls and appointment practices, acknowledgment prevention, ecology monitoring, training, and medical surveillance may ultimately pay assets to providers as a accident acknowledgment apparatus by bigger attention both association and agents from abeyant adverse bloom furnishings airish by acknowledgment to HDs. Key to the success of any acquiescence program, however, is the adequacy of the policies, procedures and training protocols accustomed as allotment of the program, as able-bodied as the provider’s charge to connected appraisal and advance of the program. A affairs that is not conceived of authoritative charge and implemented absolutely with buy-in from agents is bedevilled to failure. In this case, abortion of the interventions and systems adapted by USP 800, would betrayal association and agents to abeyant adverse bloom furnishings from HDs, and appropriately access the abeyant for the provider to be captivated accountable for any such adverse bloom effects.

Footnotes for this active are attainable in the formatted PDF attainable below.

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