Page 26 - Security Today, March 2020

Creating a Standardized Platform
Pharmaceutical industry seeks national security regulations that meet strict compliance requirements
By Lisa Ciappetta
The pharmaceutical industry is highly regulated. Companies must comply with state board of phar- macy security specifications and, in some cases, federal mandates, including HIPAA.1 As an add- ed twist, each state may adopt their own security specifications, often results in a lengthy list of additional chal- lenges for national companies.
These standards are crucial because the formulary at each lo- cation is expensive and prone to theft. If it is not stored properly, specialty and infusion drugs that experience out-of-range tem- peratures—even for a short period of time—may threaten the lives of patients.
Security Compliance Standards
To further complicate matters, security and regulatory compliance standards are constantly evolving. For example, USP Chapter 797, which provides procedures and requirements for compounding
sterile preparations to prevent harm to patients that could result from contamination, is continually adding more security-related requirements. Providers must be aware of these protocols and mandates to maintain compliance at their facilities. Additionally, security systems today must be able to provide an audit trail that shows a secure environment is being consistently maintained.
The following case study details the steps one of the largest providers of home and alternate treatment site infusion services took to secure its facilities, assets and employees when it was faced with a change to its security processes and procedures that resulted from becoming an independently owned organization.
With a staff of nearly 2,000 clinical experts—including special- ly trained infusion nurses, infusion pharmacists and registered di- etitians—the company treats patients of all ages with a wide range of acute and chronic conditions. It operates hundreds of infusion pharmacies and alternate treatment sites across the country.
Previously, as part of a larger organization, all security was
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HEALTHCARE SECURITY
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