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COVID-19 Guidance - Personal Protective Equipement (PPE) for compounding

Page last updated on March 24, 2020, at 3:30 p.m. MT.

Background

The Alberta College of Pharmacy (ACP) is currently working with Alberta Health, the Alberta Pharmacists Association (RxA), and others to address the needs of our regulated members to access personal protective equipment (PPE).

As PPE availability becomes limited, it is critical that compounders use conservation measures to minimize waste and maximize efficiencies, while maintaining quality of compounded sterile preparations and ensuring patient safety. Pharmacists and pharmacy technicians must critically evaluate the information and, using their professional and clinical judgment, make decisions that best fit their practice site.  

Pharmacists and pharmacy technicians should assess the urgency and criticality of the products being compounded and consider if it is appropriate to collaborate with the prescriber to consider another medication or dosage form if available. 

Risk based discretion must be exercised.  This includes developing appropriate temporary policies and procedures that specify conservation measures, alternative work practices, training, monitoring.

Conserve garb and PPE

Pharmacy personnel must continue to wear garb and PPE for all sterile compounding activities.  Without garb and PPE, an immediate-use BUD must be assigned to the nonhazardous compounded sterile preparation (CSP). Hazardous CSPs do not qualify for an immediate-use BUD.

Reuse of garb and PPE may increase the risk of microbial contamination of the CSP and the environment. Pharmacy teams should carefully consider the impact on the CSP and the environment and implement risk-mitigating strategies to help ensure quality CSPs. Engineering controls are essential and must remain in effect to minimize the risk of contamination to the CSP and the environment.

The United States Pharmacopeia (USP) recommends the following:

  • Facilities should prioritize conservation of garb.
  • Prioritize availability of sterile gloves above other garb for sterile compounding activities because direct contact contamination is the highest risk to the CSP.
  • Inventory your supply of garb and PPE to prepare and implement a temporary garbing action plan. Ensure staff are properly trained to implement changes in garbing procedures. Check with suppliers on expected availability and investigate alternative suppliers.
  • Limit staff entering controlled areas.
    • Schedule staff to maximize compounding time and limit the number of compounders per day or shift. Modify work practices to limit personnel entering controlled areas and maximize use of staging areas, pass-throughs and cart exchanges. 
    • If necessary, establish and document deviations from existing Standard Operating Procedures (SOPs).

Reuse of masks

Ideally, masks and other single-use PPE should NEVER BE REUSED.  The United States Pharmacopeia (USP) states the following:

  • Reuse of face masks is not recommended because of the risk of introducing microbial bioburden from used masks.

If reusing a mask becomes a necessity, consider the following strategies:

  • Ensure each compounder has their own mask. Do NOT share masks.
  • Each mask should be labeled with the compounder’s initials and stored in a small, labeled, paper bag.
  • Replace the storage bag each time after the mask is used to reduce the possibility of more contamination.
  • If your sink is on the clean side of the line of demarcation, then put on your mask in normal garbing order.
  • If your sink is located on the outside of the anteroom or the segregated compounding area, then put on your mask after you wash your hands and use alcohol-based hand rub after donning your “dirty” mask.
  • Do NOT touch mask once it is donned until task completion.
  • The amount of times a mask can be worn is made by using judgment based on
    • the condition of the mask (it must cover the bridge of the nose to under the chin with no gaps);
    • if the mask is visibly soiled or gets wet; and
    • the handling technique (when donning only touch the masks ties, avoiding the body of the mask other than adjustable nose bridge).
  • Only essential conversations are allowed during compounding. Consider implementing additional measures to limit conversations.

Shortages of garb used for sterile non-hazardous compounding

  • Use clean, washable, dedicated non-disposable garments (e.g., gowns, lab coats), preferably made of low-linting or low shedding material. Any non-disposable garment must be closed up to the neck and closed down to the knee, have long sleeves and no collar. If available, wear sleeve covers which are one-time use only and can be sterile or non-sterile. Don sleeve covers prior to donning sterile gloves.
  • Non-disposable gowns may be reused for up to one week. When reusing gowns, consider the following points:
    • Minimize the number of personnel entering controlled area.
    • Add non-sterile or sterile sleeves when wearing a reused gown.
    • Discard the gown if it becomes visibly soiled.
    • Do not reuse shoe covers. In the event of a shoe cover shortage, implement a dedicated shoe policy.
  • Preferably, wash garments after each shift or sooner when visibly soiled. Garments should be made for cleanrooms (low-linting), and then a laundering, drying, folding, packaging, and distribution process must be in place to ensure these garments are properly washed and do not become contaminated when they are returned. For safety reasons, garments should not be brought home to be laundered. If this process cannot be followed, launderable garb should not be purchased.
  • Retain and reuse disposable gowns as long as they are intact and not visibly soiled. Preferably, discard used disposable gowns at the end of each compounding day.
  • Store garments in a manner that minimizes contamination.
  • Remove garments slowly to reduce movement of particles from skin side of garment into the environment.
  • Maintain garments inside of classified area or within the perimeter of the segregated compounding area (SCA).

Shortages of PPE used for sterile hazardous compounding

  • Prioritize gowns, ASTM approved sterile gloves and shoe covers for preparing antineoplastic agents in Table of the NIOSH list.
  • PPE must not be reused when compounding antineoplastic drugs in Table of the NIOSH list.
  • Do NOT reuse PPE that was used for hazardous compounding or for cleaning.
  • Do not reuse shoe covers. In the event of a shoe cover shortage implement a dedicated shoe policy and don one pair of ASTM approved shoe covers.

If facilities are not able to obtain garb or PPE

  • Adopt a risk-based approach and limit anticipatory compounding.
  • Use the shortest feasible beyond-use dates (BUDs) while giving consideration to the type of garb mitigation strategy used, avoiding drug shortages, and maintaining patient access to essential medications.
  • Where feasible, increase cleaning and disinfecting frequency.
  • Consider increasing frequency of surface sampling to weekly, at the end of day in the primary engineering control. If you perform high risk compounding, you must use a media that supports the growth of fungi to determine effectiveness of cleaning procedures and work practices.
  • If any changes are needed, promptly re-evaluate garbing procedure, personnel conduct and cleaning to remediate and consider assigning shorter BUDs.

 

For more information, please review the following article.