Generally-speaking, regulatory compliance can be defined as adhering or conforming to a rule, standard, regulation, or law. In the healthcare setting, regulatory compliance has additional layers of complexity baked in that also include professional and ethical matters, given the nature of the services rendered in these fields.
Pharmacy regulatory compliance encompasses all pharmaceutical activities – everything from drug ordering/medication procurement, inventory management, billing practices for private and government payers, and drug security to medication and patient safety measures, prescription fraud monitoring, and professional credentialing. Virtually each task pharmacy professionals perform in any pharmaceutical setting is governed by rules, norms, standards, or laws that demand unwavering compliance. Any discovered non-compliance has the potential to cause major financial and operational setbacks to organizations of all sizes. What also complicates companies’ ability to consistently adhere to all rules and regulations is the reality that compliance itself is a moving target – governing agencies, oversight and advisory boards in charge of making and enforcing the laws can be slow to create accountability structures. Couple that with swiftly changing markets requiring new laws and rules to quickly supplant old ones…this is the genesis for why a healthy compliance program is a must. Making a commitment to fostering a culture of compliance from the start and investing in dedicated resources to ensure programmatic integrity saves companies a great deal of heartache and enables them to focus on their mission of providing high quality patient care.
Whether stand-alone independent retail pharmacies or pharmacies embedded in a Level 1 Trauma Center, pharmacy entities assume a great deal of responsibility for numerous state and federal regulatory and accreditation requirements. Traversing the maze of laws and regulations seems overwhelming and can be both time-consuming and expensive. Let us help you focus on what your business model’s individualized compliance needs are so you can build a strong foundation for optimizing operational performance and productivity.