Mgmt 351 study

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Mgmt 351 study

The NIOSH work group also added a sixth criterion to address "structure and toxicity profiles of new drugs that mimic existing drugs determined [to be] hazardous by the above criteria.

To help readers interpret the "low dose" description, the NIOSH work group cited a series of publications authored by pharmaceutical industry toxicologists that describe industry "performance" practices for defining "low dose" effects.

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Under the NIOSH approach, characterizing a drug as "hazardous" requires a "hazard identification" process, in which the descriptive criteria of the drug are reviewed and screened against the six HD characteristics.

The presence of any one of the HD characteristics is enough to define a drug as hazardous. As such, this analysis does not comprise a complete four-step risk assessment. It is important to understand the rationale and logic that is used to identify a drug as "hazardous" so that employers can independently assess the hazardousness of new drugs that have not yet been evaluated by NIOSH.

Moreover, investigational new drugs INDwhich may be undergoing clinical trials in a given healthcare setting, are new chemicals for which there is often little information on potential toxicity. Structural or activity similarities to other chemicals and in vitro data can be considered when determining the potential toxic effects of INDs.

Investigational new drugs should be prudently handled as HDs unless adequate information becomes available to exclude them. Is the drug designated as Therapeutic Category Does the manufacturer suggest the use of special isolation or other techniques in its handling, administration, or disposal?

Is the drug known to be a human mutagen, carcinogen, teratogen or reproductive toxicant?

Mgmt 351 study

Is the drug known to be carcinogenic or teratogenic in animals or mutagenic in multiple bacterial systems or animals? Is the drug known to be acutely toxic to an organ system? In addition to publishing the Alert on HD safe handling, NIOSH biennially updates their HD list to reflect newly Food and Drug Administration FDA -approved agents, and also to address any listings which may be modified in light of newly published scientific literature or other governmental agency determinations.

These reports document how vial contamination, preparation, administration, disposal, and other HD handling activities may expose pharmacists, nurses, physicians, and other HCWs to potentially significant workplace levels of these chemicals.

It is difficult to set safe levels of exposure to HDs on the basis of current scientific information because the degree of absorption that takes place during work, and the significance of early biological effects on each individual, are difficult to assess and may vary depending on the HD.

However, several lines of evidence support the toxic potential of these drugs if handled improperly. In addition, most HCWs are exposed to multiple agents during any work shift, yielding a "mixed exposure" scenario.

Mgmt 351 study

Therefore, it is essential to minimize exposure to all HDs. Summary tables of much of the data presented below can be found in the scientific literature Sorsa, ; Rogers, ; Connor and McDiarmid, Mechanism of Action While most commonly used HDs are members of several chemically unrelated classes of agents, most of those used for anti-cancer chemotherapy exert their action by binding to cellular macromolecules, including deoxyribonucleic acid DNAor through disruption of DNA and protein synthesis Skeel, ; Chabner and Longo, The potential fates of a cell exposed to a HD include transformation to malignant potential, mutation, cell death, or, through repair, a normal cell may remain Harris, Importantly, HDs do not distinguish between normal and cancerous cells, thus normal cells are often affected during treatment.

Animal Data Numerous studies document the carcinogenic, mutagenic, and teratogenic effects of HD exposure in animals. Alkylating agents present the strongest evidence of carcinogenicity e. However, other classes, such as the Topoisomerase II inhibitors Pedersen-Bjergaard, and some anthracycline antibiotics, have been implicated as well.

Extensive evidence for mutagenic and reproductive effects can be found in all antineoplastic classes. The antiviral agent ribavirin has additionally been shown to be teratogenic in all rodent species tested Harrison, ; Kilham and Ferm, The development of secondary malignancies in cancer patients is a well-documented side effect of chemotherapy treatment Sieber, ; Weisburger, ; Pedersen-Bjergaard, ; Choi, Leukemia is the most frequent adverse outcome, but other secondary malignancies, such as bladder cancer and lymphoma, have been documented in patients treated for other primary malignancies Socie, ; Bermejo, ; Krishnan, Chromosomal aberrations can result from chemotherapy treatment as well Chabner and Longo, Numerous case reports have linked chemotherapeutic treatment to adverse reproductive outcomes reviewed in NTP, Testicular and ovarian dysfunction, including permanent sterility, has occurred in male and female patients who have received anti-cancer HDs, either singly or in combination Chapman, ; Ajala, In addition, most antineoplastic agents are known or suspected to be present in breast milk Briggs, The literature also documents the effects of these HDs on other organ systems.

Extravasation of some agents can cause severe soft-tissue injury, consisting of necrosis and sloughing of exposed areas Duvall and Baumann, ; Perry, ; Rudolph, MU Grade Distribution Application Monday, September 17, Term.

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