Written by: Ben Regalado, contributing writer
If you thought OHSA and Biohazards were all you had to be concerned about, it’s time to think again. The US Pharmacopeial Convention, or USP, standard published this past spring by National Institute of Occupational Safety & Health (NIOSH), established increasing requirement for healthcare providers when it comes to establishing processes and enhancing staff training when it comes to the handling of specific types of hazardous drugs.
Healthcare providers need to examine the entire process of handling of these drugs, from arrival to dispensation, in addition to ensuring there are processes in place to deal with unexpected potential exposures.
While hospitals and other providers frequently have pharmacists or other resources on site they can rely on, the lack of resources in physician practices does not create an excuse for lack of attention. In fact, it may require thoughtful consideration as to whether you will continue to handle these drugs.
NIOSH notes that “drugs considered hazardous include those that exhibit one or more of the following six characteristics in humans or animals: carcinogenicity, teratogenicity or other developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity (and) structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous by the above criteria.”
Even though the effective date of the new, higher standards isn’t for another 18 months (July 2018), you need to use the time now to prepare. How?
First, start with a comprehensive review of the (34 page) NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings for 2016. In the document, providers can find the drug name, comments, and a links to key information.
Second, review Table 5 of the document, which is on pages 32-34. This chart gets into the specifics of why type of Personal Protective Equipment (PPE) you need to have for employees at each stage in the process, beginning with receiving, then continuing through normal handling, compounding, administration through various methods, disposal and cleaning.
PPE necessary, depending on the activity, includes double chemotherapy gloves, protective gown, eye/face protection, respiratory protection and ventilated engineering control.
Third, while many practice may have a “spill kit” for handling biohazards and/or chemical hazards (e.g., mercury), it may be necessary to specifically create and set aside a kit related to these hazardous drugs.
Remember, OSHA inspectors (and, heaven forbid if anything were to happen, plaintiff attorneys) are not just looking for boxes on a checklist. They will want to know that your staff has been trained, and that they have acknowledged and retained the training provided. This goes hand in hand with the OSHA HAZCOM (or Hazard Communication) Standard.
As hopefully you are aware, in updating HAZCOM, several years ago OSHA transitioned from the familiar Material Safety Data Sheet (MSDS) to now follow the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS), and adopted the universal and standardized Safety Data Sheets (SDS). At the very minimum, you should check your policy handling books to assure that you have these new documents, because while they are nearly identical to the ANSI Standard 16 section MSDS there are a few modifications.
While many of these SDS documents and even the NIOSH document is available online, this is one instance where a practice may want to go through the process of assembling paper copies in a readily accessible binder. Why? Because in an emergency situation, speed matters.
Healthcare is truly one of the most highly regulated industries on many levels. This is just another one you need to know about and add to your continuous New Year’s Resolutions list.