How do I appropriately conduct a risk assessment?

UPDATED:The College has developed a risk assessment template, along with a companion guide and two examples (1% hydrocortisone powder in 1% clotrimazole cream and progesterone 400 mg suppositories) to help registrants understand what to document, reference, and consider when conducting a risk assessment. Use of the OCP template is optional, as how a pharmacy chooses to document risk assessments is at the discretion of the non-sterile compounding supervisor. 

Every pharmacy that offers non-sterile compounding services must meet or exceed the minimum requirements set out in the NAPRA Model Standards for Pharmacy Compounding of Non-Sterile Preparations (elsewhere referred to as “the standards”). 

The steps for conducting a risk assessment are described in Section 4 of the standards. In brief, there are three levels of requirements (A, B, and C), defined in section 8 (page 12) of the standards. These correlate to the compounded preparations’ associated risk and their complexity. The level of requirements the pharmacy needs to have in place depends on which non-sterile preparations are compounded, their complexity, how frequently they are compounded, at what concentration and in what amounts. Cumulative risk (of all compounded preparations) must be taken into account. Both risk to the preparation and risk to personnel must be considered and mitigated by adequate protection measures. 

A risk assessment must be completed for each compounded preparation, taking into account every ingredient (e.g., drug, active pharmaceutical ingredient [API]) used. 

A risk assessment should be conducted with appropriate resources. Safety data sheets and other applicable references should be consulted. The rationale for compounding and any risk mitigation strategies should be documented. Policies and procedures that ensure safety for personnel must be in place and documented as well. 

If there is uncertainty on the risk level to assign, go with the higher standard. Quality patient care and safety of all personnel should always be the top priority. 

Refer to Sections 4 and 8 of the  NAPRA Guidance Document for Pharmacy Compounding of Non-Sterile Preparations. Note that where the guidance document uses the language of “should,” it may be acceptable to meet the required standard using other technologies, techniques, materials and procedures than those suggested only if they have been proven to be equivalent or superior to those described in the guidance document.