Creating a Structure of Compliance

July 2014 - Vol.11 No. 7 - Page #1

Maintaining perpetual regulatory compliance in the hospital pharmacy can represent a challenging but attainable goal for pharmacy directors. Striking a positive balance between realistic operations and regulatory expectations can be a significant portion of the pharmacy director’s workload, yet there are many ways to approach this concept. Regardless of your approach, the physical model that perhaps most exemplifies stability in this regard is the tripod construct. Universally recognized as a symbol of strength and stability, the three legs of the tripod supporting safe and compliant pharmacy practices tend to fall into three broad categories:

  • Implementation of appropriate technology, automation, and engineering controls
  • Creation and establishment of comprehensive policies and procedures (P&Ps)
  • Development and enforcement of proper training and competency assessment

There are many resources available for accomplishing the first two legs above, including numerous past articles in Pharmacy Purchasing & Products. As an example, look to page 18 of this issue for an article on pharmacy renovation that includes the proper selection of engineering controls. Likewise, we encourage you to reach out to us if there has been a past article that addressed your own needs. We would be happy to arrange for you to speak with the author about how to address specific challenges. 

The third leg of the tripod is often the most difficult to sustain. Ensuring effective training and ongoing competency is essential for the other legs to remain strong, so this is an area that PP&P seeks to support on a continual basis. Performing site visits and networking with colleagues can be helpful in finding successful tactics, but there are also several other resources. Consider providing your staff with online training courses such as those offered by Critical Point (, or other focused training materials, such as ASHP’s ToolKit for insourcing sterile IV compounding ( 

Should the scope of certain training requirements exceed the abilities of your staff, a consultant may be deemed necessary. Seasoned consulting professionals who have managed numerous and varying pharmacy operations can customize appropriate trainingand validation programs to help gain and maintain regulatory compliance. 

To maintain the integrity of this tripod of compliance, no one leg may be deemed more or less important than the others, as focusing solely on one or two aspects of compliance will weaken the entire structure. PP&P is here to help fortify all three legs and foster a perpetual confidence in your pharmacy operation.

All the best,

R. Mitchell Halvorsen


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