Building your own pharmacy is an exciting and daunting process. As you forge ahead, you must inevitably cut through some red tape to comply with the necessary laws and regulations governing the industry. These include:
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New HIPAA regulations
Newly stringent HIPAA laws (effective on September 23, 2013) mean that your pharmacy must now be constructed with privacy, security, and protection of patients' personal health information (PHI) as your first priorities. They affect the following areas:
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Breaches in security
The Department of Health And Human Services requires you to report ANY disallowed PHI disclosures unless the privacy rule permits them, not just those that pose significant risk to affected individuals as was previously true. Business associates and subcontractors must sign agreements that will be updated regularly, and remain fully compliant with the HIPAA Security rule.
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Patients' privacy requirements
Patients can now restrict who sees their PHI, and are allowed full access to their own files. However, the requirements also dictate that health professionals who need specific information in order to care for patients (or for other valid reasons) can still access it as needed.
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Safeguarding personal information
You must now control and restrict who can access devices and other storage media that contain patients' PHI. For this, you will need several layers of protection. Not only must you safeguard hardwired devices (computers) and other stationary means of access, but you must also protect devices that are portable, such as laptop computers.
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Centralize workstations
This will prevent unauthorized access, theft and tampering.
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Utilize lockable pharmacy shelving and fixtures
Devices and other means of access to patients' PHI should be securely locked at all times, with strict policies defining when workstations can be used.
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Require secure logins
Authorized personnel must login securely to access PHI.
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Establish audit trails
When electronic equipment is moved to another facility, reused or recycled, and audit trail should be established so that anyone not authorized will not have access to PHI, whether intentional or accidental. Further, policies should be established that specify when any media, electronic hardware, or other means of access to PHI should be moved, eliminated, or reused.
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Disability access requirements
Your new pharmacy's layout and design will also need to address accessibility requirements for disabled customers. The Americans with Disabilities Act requires that there be:
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Disabled parking
The number of spaces you provide will depend on the size of your store.
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At least one accessible entrance
Preferably the main entrance, clearly marked and ramped. Doorways here should be at least 32 inches wide.
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At least one accessible bathroom
At least one accessible bathroom per gender (as applicable) should be provided, with handrails, raised toilets, and lowered mirrors and sinks.
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At least one accessible checkout lane
At least one checkout lane should be at least 36 inches wide with part of the counter no more than 36 inches high, to provide easy access for customers in wheelchairs.
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Service counter(s)
Any service counters, such as the pharmacy counter, must also be at least partly lower to no more than 36 inches high for easy access.
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Wider aisles
When possible, your pharmacy shelving and fixtures layout should be positioned throughout the store so that aisles are at least 36 inches wide, for wheelchair access.
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Accessible merchandise
Pharmacy shelving that contains customer-accessed merchandise can be as much as six feet high, but when possible, duplicate merchandise should also be placed on lower shelving, to provide easy access for customers in wheelchairs.
Although it may seem overwhelming when you first confront these regulations, being in compliance with them will also help you serve your customers' best interests at all times.
