As an independent pharmacist, it can be exciting to realize the dream of opening your own pharmacy. It's a time of meeting with designers and even architects as you plan the layout and choose everything from pharmacy shelving and fixtures to flooring and lights.
Alternatively, you may already be in business and simply want a fresh new look, complete with new pharmacy shelving and fixtures.
Before you build or remodel, however, make sure you become familiar with building regulations associated with starting a pharmacy, especially related to new HIPAA laws concerning patient privacy.
How new HIPAA regulations affect your pharmacy's design
You must design your pharmacy's layout to be compliant with new HIPAA regulations. Specifically, you need to address:
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Privacy requirements
Patients have the right to restrict who sees their personal health information, also known as PHI. They are also allowed complete access to their own files. (Should health professionals need specific information to take care of patients or for other allowed reasons, they are still permitted access to PHI under the new regulations.)
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Breaches in security
Previously, HIPAA laws only required you to report security breaches only if they pose a significant risk to the individuals who were affected. With the new HIPAA laws, that has changed. The Department of Health and Human Services now requires that ANY unauthorized PHI disclosure will need to be reported unless it's permitted by the privacy rule. Subcontractors and business associates will need to sign agreements that will be updated regularly, with all abiding by the HIPAA Security rule completely.
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Physical safeguarding of information
When you build or redesign your pharmacy layout, you need to restrict and control who can access any devices that store patient health information. This includes electronic media or hardware such as laptops, which would normally be portable. However, to protect sensitive information, workstations should be centralized to prevent unauthorized access, tampering and theft. You should also implement policies that restrict when workstations can be used. Finally, establish policies that determine when any electronic hardware, media, or other components that allow access to PHI can be reused, eliminated, or moved.
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Audit trails
If electronic equipment is recycled, reused, or moved to another facility, establish an audit trail so that unauthorized personnel do not have access to PHI, whether accidental or intended.
Establishing your pharmacy layout with privacy and security as your first priority
While you will most certainly want to establish your pharmacy layout to make customers' shopping experience easier and more enjoyable, your first priority will be to protect patient information. Therefore, establish your pharmacy layout so that all workstations and other devices that allow access to PHI are kept in secure and controlled areas, such as behind the pharmacy counter and/or in a secure, locked pharmacy shelving fixture. Further restrict unauthorized access by implementing authentication measures with every login to access PHI.
Building regulations associated with starting a pharmacy
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Establishing a "clean space"
Finally, if your pharmacy prepares compounding sterile preparations (CSPs), the current USP(797) "Pharmaceutical Compounding -- Sterile Preparations" regulation states that the buffer area must now meet a minimum ISO 7 clean room standard, and the ante area must meet a minimum ISO 8 standard. (ISO stands for "International Organization for Standardization.) The primary engineering control (PEC; the piece of equipment such as a biological safety cabinet or laminar airflow where aseptic compounding activities take place) is generally located within the buffer area; the internal work within the equipment must equal ISO 5.
Plan to incorporate these requirements into your layout before you begin construction or remodeling, and you'll avoid unnecessary headaches during the process.
