Last year, USP 800 became an official monograph within the USP. Being a sub-1000 chapter, it is not a mere suggestion. Pharmacies and State Boards of Pharmacy now have to consider how to best implement the new requirements surrounding Hazardous Drugs (HDs)
While USP Chapter 800 primarily was drafted with compounding pharmacies in mind, the chapter applies to all pharmacies, and many pharmacies are scrambling to put appropriate policies and procedures into place to address these requirements. Today we will take a brief look at some of the things that should be addressed by a non-compounding pharmacy as well as those things that do not apply and can be largely ignored.
Identification of a Pharmacy’s HDs
The first thing a pharmacy has to consider is which HDs they actually use. It is extremely unlikely that any given pharmacy will not stock and dispense at least a few HDs. In order to identify which drugs to target, look to Centers for Disease Control. The CDC maintains a document that lists current HDs. Each pharmacy should review the list and identify the medications they dispense.
Once identified, the pharmacy should create a mechanism to identify these medications. Using a colored dot or sticker is a good way to alert employees that the medication is subject to the HD Policy and may require special handling.
Personal Protective Equipment (PPE)
The pharmacy needs to address the standard precautions employees should take when working with HDs. USP 800 allows the pharmacy to do an assessment of the risk for each drug based on
- The Type of HD (e.g., antineoplastic, non-antineoplastic, reproductive risk only)
- Dosage form
- Risk of exposure
- Packaging
- Manipulation required
Based on this, many or possibly all drugs would fall into a low-risk category requiring minimal PPE. It is always a good idea to wear chemo (nitrile) gloves when doing non-destructive or non-invasive manipulations like counting the HD. Some items may be formulated in such a way as to minimize most risk (e.g. a film-coated tablet). The policy can exempt products like this from PPE requirements based on this assessment. Likewise, the policy should cover cleaning and any additional PPE requirements for more advanced manipulations short of compounding like breaking tablets in half for a patient or dealing with broken tablets in a bottle.
Receiving, Storage and Containment
USP Chapter 800 goes to great length to outline the containment requirements for HDs. These are rather onerous, but the good news is that for most non-compounding pharmacies that do not perform manipulations on HD products, the pharmacy’s policy can simplify storage requirement to some variation of HDs will be stored alongside other non-HD substances. Likewise, the receipt of HDs is less challenging in the case of a non-compounding pharmacy. The policy can simply state that HDs will be unpacked in an area that is neutral/normal or negative pressure relative to the surrounding areas. In other words, probably where you already check your orders in. Finally, the check-in area should have access to a spill-kit and appropriate PPE in the case damaged a package is received
One area where USP 800 is confusing is with respect to unpacking HDs. USP 800 Section 10 states unequivocally:
PPE, including chemotherapy gloves, must be worn when unpacking HDs.
But as mentioned above, many or even all of the items being received at non-compounding pharmacies will be stored alongside non-HDs and most would be exempted from PPE by assessment when non-destructive or non-invasive manipulations like counting were done. In other words, the same item that needs to be unpacked with gloves would be retrieved from the shelf and counted without the requirements of PPE like gloves. Contradictory and annoying verbiage. For the time being, my State Board of Pharmacy is sticking with the thou shalt wear gloves when unpacking stance. I hope USP 800 clarifies this in the future. Wearing gloves is not onerous, but the reasoning is non-existent.
The only other thing that likely needs to be addressed by this part of your policy would be receipt of a damaged HD container. Fortunately, wholesalers already ship these in separate ziplock bags (Per USP 800 specifications) for this very reason, and your policy already has a spill kit kept in the receiving area.
Say YES to the SDS
Every pharmacy should already have a policy on Safety Data Sheets. This also needs to appear in the HD policy. A good source for free online Safety Data Sheets is http://www.msdsprovider.com. The service is free but requires an account. The pharmacy can either print out and store SDS documents on site in a binder or they can make them available online by providing access information to employees.
Training and Medical Survalience.
A good HD policy should cover training required for each employee that may work with HDs. In addition, the policy needs to cover the legal implications of exposure to Personnel of reproductive capacity. A good policy should document that each employee is aware that
- They are aware of the risks
- They can correctly identify when to use and how to use PPE
- They can understand that they can opt out of working with HDs if, for example, they may soon be, are, or may be pregnant or nursing.
All of this information should be documented in the employee’s HR folder.
The other potentially costly requirement listed in USP 800 is Medical Survalience. A compounding pharmacy requiring engineering controls like negative pressure rooms and exposure control measures should set up some sort of medical screening to ensure both effectiveness of engineering controls and compliance with PPE usage. There are a lot of unknowns in implementing such a program as there is not a lot of clinical literature to provide guidelines. USP 800 does not offer any real guidance in the implementation of these measures.
Fortunately for the non-compounding pharmacy, the HDs commonly used and the overall risk associated with common HDs do not provide a compelling argument to implement this type of procedure; there are no engineering controls to be validated. A policy could state that a Medical Surveillance program is not currently warranted based upon the limited scope of HDs and the absence of invasive or destructive manipulations, but the need will be evaluated on an annual basis.
What else?
There are several other items that would be included in a good HD policy, but this article cannot write your policy for you. Familiarize yourself with USP 800 and use or modify your current procedures as the basis of your policy. While you can purchase template policies, I would discourage this practice. No two pharmacies are alike, and simply copying someone’s policy and using it as your own will generally not bode well when the pharmacy inspector comes by to review this with you.
If you don’t have an HD policy, now is the time to create it. If you do have an HD policy, perhaps you should pull it out and review it for completeness.
