Abstract

Quality in specialty pharmacy goes beyond the right patient, drug, time, dose, and route. Specialty pharmacies are held to higher standards to ensure that they take a more active role in a patient’s care by offering a comprehensive support system. Although a major undertaking, obtaining accreditation can help ensure that superior standards and requirements are met. Accreditation is a process by which an impartial organization thoroughly reviews a company to validate that it is conducting business in a manner consistent with national standards. Of the different specialty pharmacy accrediting bodies, the majority focus on patient safety and continuous quality improvement. The accreditation process can be both time-consuming and challenging; however, its potential benefits include the following:■Accreditation illustrates the specialty pharmacy’s focus on patient safety and continuous quality improvement.■The process of accreditation helps the company and creates a return on investment. ■Accreditation illustrates the specialty pharmacy’s focus on patient safety and continuous quality improvement.■The process of accreditation helps the company and creates a return on investment. ■Identifying areas for improvement■Ensuring compliance with internal policies■Requiring evaluation of current processes to improve effectiveness■Creating a forward-thinking company culture■Assisting in prioritizing quality improvement initiatives■Providing a competitive advantage for business opportunities A specialty pharmacy that is accredited attracts potential customers, clients, and partners. Being accredited quickly lets all three know the specialty pharmacy meets the strict guidelines required by that organization. Accreditation also illustrates the specialty pharmacy’s high priority on both ensuring patient safety and improving processes. The benefits are not all external; many are recognized internally as well. The process of accreditation ultimately assists the company in running more efficiently, effectively, and safely. It creates a return on investment. If an organization is considering attaining accreditation, the first decision is to determine which accreditation to pursue. This decision should take into account multiple factors including, but not limited to, the area of pharmacy practice, the requirements of the accreditation, the availability of internal resources, and the value proposition for the organization. Many health care providers may be familiar with The Joint Commission hospital accreditation programs. A number of other accrediting bodies have specific programs related to specialty pharmacy. These include URAC, Accreditation Commission for Health Care, and Community Health Accreditation Program, as well as The Joint Commission. As the bar for quality and accountability in compounding continues to rise, specialty pharmacies that engage in significant compounding activities may also consider pursuing accreditation specific to this area. Organizations such as the Pharmacy Compounding Accreditation Board can provide an external validation that the pharmacy is performing in accordance with all national compounding standards. When deciding to pursue accreditation, strong leadership support is essential from the start. The company will also need to complete a thorough gap analysis to determine what resources and process improvements will be required to meet the standards. An important factor in the accreditation process is selecting the right cross-departmental team and creating a strong sense of teamwork. Additional key points to help ensure a successful accreditation visit include the following:■Start early! Allowing sufficient time for work on submissions is vital. A lead-in time of 6 months to 1 year may be reasonable, depending on the complexity of the accreditation.■Establish and communicate a clear and detailed project plan, including assignments, personnel responsible, and timelines.■Set regular status update meetings and adjust timelines and responsibilities as needed.■Ensure all policies and procedures are current.■Complete regular quality audits to compare submitted documents to the standards.■Use feedback from the accreditation organization to prepare for the onsite visit.■Educate staff on the importance of the accreditation and the details of the accreditation visit.

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