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The essential elements of a specialty pharmacy practice, including patient management and support, medication therapy management, fiscal management, and technology use. It emphasizes the importance of coordinated care, patient privacy, and quality improvement. Specialty pharmacy practices facilitate access to specialty medications, collaborate with healthcare providers, and provide comprehensive clinical management services.
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The ASHP Accreditation Standard for Specialty Pharmacy Practice reflects contemporary best practice for specialty pharmacy. The accreditation process is designed to be easy to understand, flexible, and consultative in nature and can be tailored to different models of care. The accreditation focuses on optimal care delivery through evaluation of: Effective patient care plans to achieve desired medication therapy outcomes Patient-specific assessments and optimal collection, use, and documentation of information Inclusion of specialty drug-specific assessment and disease state-specific assessment requirements Comprehensive review of the patient’s medication history and medication list prior to each fill Documentation of all pharmacy case management activities Patient consultation and education Quality metrics and quality improvement plans This standard combines the Center for Pharmacy Practice Accreditation (CPPA) standards^1 with the support of ASHP’s pharmacy expertise and accreditation history. Successful accreditation signifies to payers, patients, and other healthcare providers that the pharmacy provides an advanced level of high- quality, safe, and efficient patient care in a predictable and measurable way.
Specialty pharmacy generally revolves around the provision of 1) high cost medications with 2) special handling procedures and 3) requiring complex patient care.^2 Specialty pharmaceuticals have at least four of the following characteristics: 3 Typically high in cost ($600 or more per month) (^1) Version III, February 27, 2019; Standards used with permission of Center for Pharmacy Practice Accreditation (CPPA) (^2) Blaser DA, Lewtas AJ, et al. How to define specialty pharmaceuticals—a systematic review. Am J Pharm Benefits. 2010;2(6):371-380. (^3) Distribution Management Association’s Center for Healthcare Supply Chain Research. Specialty Pharmaceuticals Facts, Figures and Trends in Healthcare. 2012. http://www.hcsupplychainresearch.org/projects/pdfs/2012-SpecPharm-ExecSummary.pdf. Accessed December 31, 2012.
Involve complex treatment regimens that require ongoing clinical monitoring and patient education Have special handling, storage, or delivery requirements Are generally biologically derived and available in injectable, infusible, or oral form Are dispensed to treat individuals with chronic and/or rare diseases Frequently have limited or exclusive product availability and distribution Treat therapeutic categories such as oncology, autoimmune/immune, or inflammatory conditions marked by long-term or severe symptoms, side effects, or increased fatality Prescription medications continue to be among the fastest growing elements of healthcare spending,^4 and the growth of the specialty medication spend continues to outpace traditional medication growth. In 2017 the specialty medication spend was 43.4% of the total non-discounted spend in the US. The majority of new active substances launched in 2017 were considered orphan.^5 By 2022 the spending on specialty medications, including orphan and precision, is expected to reach nearly $450B.^6 Under the pharmacy and medical benefits, the members who use specialty medications account for a much greater percentage of healthcare costs. Given these factors, it is imperative that pharmacy practices help optimize the clinically appropriate use of specialty medications. The ASHP Standard for Specialty Pharmacy Practice is designed to create a consensus around the practice of specialty pharmacy and guide the accreditation process. Specialty pharmacy practice is defined as a pharmacy practice created:
1.1 The Specialty Pharmacy Practice has Appropriate Documents and Current Licensure
1.2 The Specialty Pharmacy Practice Has A) A Clear Organizational Structure Including a Mission Statement, B) A Policy and Procedure Process, and C) A Process for the Delegation of Organizational Oversight and Leadership to Allow for Safe and Effective
1.3 The Specialty Pharmacy Practice Describes the Scope of Specialty Pharmacy Services
1.4 The specialty Pharmacy Practice Defines and Manages Internal and External
1.5 The Specialty Pharmacy Practice has Appropriate Professional and Support Staff to
1.6 The Specialty Pharmacy Practice Maintains a Structure to Ensure Appropriate Fiscal
1.7 The Specialty Pharmacy Practice has Protocols for Medication Procurement, Storage, Preparation, and Distribution for Medication Integrity and Safe and Timely
1.8 The Specialty Pharmacy Practice has an Appropriate Environment to Maintain
1.9 The Specialty Pharmacy Practice Uses Systems and Technology that Support Safe
1.10 The Specialty Pharmacy Practice Uses Information Systems and Technology for
1.11 Specialty Pharmacy Practice Information Systems Provide Access to Appropriate Evidence-Based References and Clinical Decision Support Programs that Facilitate the
1.12 The Specialty Pharmacy Practice Supports the Interoperability of Information
1.13 The Specialty Pharmacy Practice Ensures The Integrity, Security, and Privacy of
1.14 The Specialty Pharmacy Practice Maintains Policies and Procedures to Ensure
1.15 The Specialty Pharmacy Practice has a Contingency Plan in Order to Maintain
2.1 The Specialty Pharmacy Practice Provides Comprehensive Benefits Investigation, Prior Authorization Assistance, And Benefits Coordination on Behalf of The Patients it
2.2 The Specialty Pharmacy Practice Implements Mechanisms to Support Patient Safety
2.3 The Specialty Pharmacy Practice Facilitates Patient Access to Care Through the
3.1 The Specialty Pharmacy Practice Facilitates Coordinated Patient Management
3.2 The Specialty Pharmacy Practice Communicates with Healthcare Providers to
3.3 The Specialty Pharmacy Practice Maintains Internal Policies And Procedures for
3.4 The Specialty Pharmacy Practice Maintains A Comprehensive Patient Profile For All
3.5 The Specialty Pharmacy Practice Provides Patient-Centered Consultation and
3.6 The Specialty Pharmacy Practice Provides and Monitors Pharmacy Patient Case
3.7 The Specialty Pharmacy Practice Modifies Patient Case Management Based on
3.8 The Specialty Pharmacy Practice Evaluates and Documents Competency and Facilitates Continuing Professional Development of Staff Involved in Patient Care
3.9 The Specialty Pharmacy Practice Maintains Consistent Procedures for Patient
3.10 The Specialty Pharmacy Practice Prohibits the Use of Refill Protocols Whereby
4.1 The Specialty Pharmacy Practice Reports and Evaluates Quality Outcomes and Quality Metrics to Assess the Effectiveness of Patient Care Services and Promote
4.2 The Specialty Pharmacy Practice Implements Continuous Quality Improvement
1.1 The specialty pharmacy practice has appropriate documents and current licensure required of the specialty pharmacy practice. NARRATIVE: It is expected for accreditation that the patient care, dispensing services, and support services provided by the specialty pharmacy practice and as described in their Scope of Services demonstrate compliance with applicable state and national regulatory requirements and/or standards established by a recognized organization appropriate for the services provided. The specialty pharmacy practice may or may not have a legal department or outside legal counsel to ensure necessary legal and regulatory compliance including resolution of conflict between state and federal laws and regulations. In order to provide pharmacy services beyond the borders of a pharmacy’s home state, out-of-state licensure and additional documentation may be applicable. Dispensing, wholesaling, infusion service provision and nursing services require individualized licensure with practice-specific oversight guiding individual practice authority. Maintaining an adequate and well-trained workforce is essential for high quality patient care and to reduce organizational risk. Regarding the staff of the specialty pharmacy practice, all pharmacists and nurses are licensed or registered and all technicians are licensed, registered, and/or certified, as required by state regulations. The specialty pharmacy practice has mechanisms for ensuring that all pharmacists and technicians are in good standing in all states where they are licensed/registered/ certified through verification of licensure, registration, certifications and continuing education requirements. 1.1.1 The pharmacy practice has a written code of conduct demonstrating the practice’s commitment to provision of ethical care and services. NARRATIVE:
The specialty pharmacy implements sales and marketing practices, through policy implementation, orientation, and training of sales and marketing personnel, that support the practice’s expectations of its staff and professional pharmacy partners to act in an ethical and compliant manner. 1.1.2 The specialty pharmacy practice has a Compliance Program. NARRATIVE: The specialty pharmacy practice has a written compliance program implemented for the entire organization. The program includes the following elements:
The specialty pharmacy practice has appropriate staff management procedures to support overall operations and patient care. Effective staff management also aligns the roles of employees within the overall specialty pharmacy practice and assists in maintaining the integrity and consistency of the operations and patient care services. The specialty pharmacy practice has the following elements for effective staff management:
patient collections and accounting, billing units associated with specialty medications, and third-party audits to ensure financial integrity and timely access of medications for patients. 1.7 The specialty pharmacy practice has protocols for medication procurement, storage, preparation, and distribution for medication integrity and safe and timely delivery. NARRATIVE: Specialty pharmaceuticals routinely have specific handling requirements necessary for medication potency and integrity at the point of administration by the patient. Even in the absence of these special handling requirements, the significant costs associated with specialty medications require the specialty pharmacy practice to have the ability to reconcile delivery of medication to the patient. Because of the high percentage of specialty medication delivered via mail or courier service, diligence is exercised by the specialty pharmacy practice to protect and ensure safe delivery of medications to the patient. These policies and procedures include supply chain, storage, medication preparation, inventory control and delivery. The specific areas are the following: Supply chain: Due to the costs associated with specialty pharmacy therapy and the increasing risks associated with tertiary or “grey” market suppliers, specialty and non-specialty pharmaceuticals are sourced from licensed (minimum) and accredited (desired) distributors, wholesalers or manufacturers to ensure patient safety. This includes all branded and generic medications provided to patients under the care of the pharmacy provider. It is the responsibility of the applicant pharmacy to ensure that the specialty pharmacy practice stays current with established regulatory requirements governing supply chain and medication provision. The specialty pharmacy should ensure it has processes to prevent the dispensing of medications that have been adulterated, misbranded, are/or suspected of being counterfeit or fraudulent. Medication products should be visually inspected upon receipt and put into inventory. Additionally, inventory control should detect theft or diversion, and include investigating and reporting suspicious events to the appropriate agency, if warranted. Storage: Specialty pharmaceuticals have specific storage requirements and frequent requirements for inventory reporting. The specialty pharmacy practice ensures that medications are stored appropriately and pursuant to manufacturer requirements. The specialty pharmacy practice also demonstrates ability to identify storage temperatures, humidity conditions and have procedures for continuous temperature and humidity monitoring and detection of variances and excursions, as well as addressing ambient refrigerator or freezer storage conditions. Storage refers to both the act of medication storage and the ability to accurately reconcile medication inventory stored within the pharmacy location. The specialty pharmacy practice has mechanisms to track inventory levels and provide reporting via a reliable inventory tracking tool for internal auditing and reporting requirements. Appropriate physical storage conditions are ensured from the point of receipt from the medication source, storage at the pharmacy level, medication preparation at the site of dispensing, and throughout the delivery process of providing medication to the patient.
Medication recalls, outdated and returned medications: The specialty pharmacy practice has systems, policies, and procedures in place to appropriately manage medication recalls, outdated drugs, and returned medications. If the specialty pharmacy practice participates in a drug take-back program, it complies with applicable regulations as well as established policy and protocol. Medication preparation: During the process of medication preparation, storage and labeling, refrigerated medications are at risk of exposure to excessive temperatures if preventative safeguards are not in place. Generally, refrigerated medications should be at room temperature for a limited time, consistent with good handling practices, during medication preparation and labeling procedures. Pharmacy staff is protected from exposure to hazardous medications and other materials used in the preparation of the specialty medications. Medication delivery: Medication delivery represents the largest threat to overall medication stability as temperatures can vary widely based on different courier options. The threat of temperature fluctuation is greater for refrigerated medications but also exists for non-refrigerated medications. The specialty pharmacy practice ensures that medications are shipped by the most appropriate method to accommodate the storage requirements of the therapeutic agent being provided to the patient. While disposable temperature sensors and non-pharmacy-based packaging suppliers exist, it is the responsibility of the pharmacy to ensure that internal procedures are developed and appropriate for medication delivery including routine and seasonal temperature monitoring. The specialty pharmacy practice has internal policies and procedures to ensure that internal packaging protocols are appropriate for temperature integrity of packaged medications. Medications are packaged and shipped by an appropriate courier to ensure that the medication is maintained within the manufacturer’s or USP storage requirements while in transit through receipt of the package by the patient or patient caregiver. Hazardous Medications: The practice has procedures for handling, storage, preparation, and delivery of hazardous medications, including other hazardous materials and access to Safety Data Sheets. 1.8 The specialty pharmacy practice has an appropriate environment to maintain patient privacy and deliver patient care services. NARRATIVE: The specialty pharmacy practice provides patient care services in a setting that maintains privacy and confidentiality and provides the pharmacy staff access to relevant patient information. The specialty pharmacy practice has a procedure to make pharmacy staff members aware of privacy requirements and takes measures to secure patient information and protect patient privacy and confidentiality. The specialty pharmacy practice ensures that patients receive services, including services delivered telephonically, in a space that provides the level of privacy which reduces noise and visibility and is
The pharmacy practice has a system that reduces alert fatigue and provides the most clinically relevant information to the pharmacist regarding the patient’s medication therapy. In addition, the pharmacy practice ensures that this clinical information is available at the point of care, at the location where counseling occurs, and to the pharmacist who is performing the counseling. 1.11 Specialty pharmacy practice information systems provide access to appropriate evidence- based references and clinical decision support programs that facilitate the delivery of patient care services. NARRATIVE: Pharmacy information systems provide access to clinical decision support programs that include current drug interaction and adherence screening methodologies for guidance in up-to-date clinical decision- making efforts. The specialty pharmacy practice ensures that the software is readily available and routinely updated to assist the pharmacy staff in effective clinical decision-making. The specialty pharmacy practice establishes expectations for utilization of the most current references and the primary literature in the provision of patient care services. GOAL: The specialty pharmacy practice implements clinical decision support programs, as described by the Agency for Healthcare Research and Quality (AHRQ)^10 , that aid in guiding evidence-based decision- making. 1.12 The specialty pharmacy practice supports the interoperability^11 of information systems. NARRATIVE: Patient care is improved through the sharing of patient information among patient care providers. The specialty pharmacy practice implements strategies to facilitate the foundational exchange of medical and medication information. The exchange or transmission of data occurs via fax or telephone or other appropriate method and the practice is able to accept e-prescribing transmissions. This exchange is primarily for the purpose of sharing information between and among appropriate healthcare providers. GOAL: The specialty pharmacy practice explores strategies for and takes steps to implement technology to electronically interface with other healthcare entities to exchange and make use of information by means of electronic health records (EHR). 1.13 The specialty pharmacy practice ensures the integrity, security, and privacy of patient information and other data. (^10) References: What is Clinical Decision Support? Available at: http://www.himss.org/library/clinical-decision-support. Accessed 3/27/2018. Clinical Decision Support (CDS). AHRQ. Available at: https://healthit.ahrq.gov/ahrq-funded-projects/current-health-it-priorities/clinical- decision-support-cds. Accessed 3/27/2018. Clinical Decision Support (CDS), Chapter 1: “Approaching Decision Support in Medication Management”, Section 1 – Introduction. AHRQ. Available at: https://healthit.ahrq.gov/ahrq-funded-projects/current-health-it- priorities/clinical-decision-support-cds/chapter- 1 - approaching-clinical-decision/section- 1 - introduction. Accessed 3/27/2018. (^11) Interoperability means the ability of health information systems to work together within and across organizational boundaries in order to advance the effective delivery of healthcare for individuals and communities. Reference: www.himss.org/library/interoperability- standards/what-is. Accessed 3/27/
to a third party. As with other delegated functions, delegation documentation is regularly reviewed for compliance and delegation relationships are fully disclosed, as needed. The specialty pharmacy practice conducts benefits coordination when providing BI and PA assistance services by coordinating information and involvement of the prescriber, other healthcare providers, and other sources of assistance, whenever possible. A major benefits coordination service provided by the specialty pharmacy practice to patients is identifying various sources of financial assistance (manufacturer-sponsored copay cards, manufacturer product assistance, and foundational assistance) and enrolling patients on their behalf after they authorize the service. The outcome of BI and PA services and benefits coordination (especially patient financial assistance) is communicated to the prescriber by an appropriate method of communication as a means of fostering collaborative patient management. 2.2 The specialty pharmacy practice implements mechanisms to support patient safety and compliance with manufacturer and payer requirements. NARRATIVE: Specialty pharmacy practice represents an area of pharmacy practice in which establishing relationships with pharmaceutical manufacturers and payers are integral for gaining/retaining access to specialty pharmaceuticals, providing care to patients, and facilitating patient safety from the time an order is initiated and for the duration of therapy. Specialty medications frequently have restricted distribution networks and require data reporting to manufacturers on dispensing volumes, inventory levels, and patient load. Payer reporting may include call center metrics, formulary and pharmacist interventions, copay compliance, patient adherence and persistence rates, plan cost avoidance, and other dispensing metrics. Manufacturers provide patient support services through reimbursement HUBS. The registration of patients with these HUB services and the integration of specialty pharmacy practice services with existing HUB services, when appropriate, are frequently required to ensure patient access to manufacturer-sponsored medication financial assistance. In addition, Risk Evaluation and Mitigation Systems (REMS) requirements are integrated into the specialty pharmacy practice in order to support manufacturers in maximizing patient medication safety. Data reporting is a critical component of specialty pharmacy. Data reporting is frequently required pursuant to inclusion in third-party payer contracts as a mechanism to support quality metrics, cost avoidance, and other measures to support specialty pharmacy network inclusion. Data reporting to pharmaceutical manufacturers is often required in order to gain access to limited distribution pharmaceuticals. Specialty pharmacy practices may be compensated for this and other non-dispensing- related activities as part of product/manufacturer-specific fee-for-service agreements. Specialty pharmacy practices can best meet these reporting requirements by having data/ information systems with the capabilities and capacity to generate and support such reporting.
2.3 The specialty pharmacy practice facilitates patient access to care through the transparent provision of financial information to the patient and prescriber. NARRATIVE: Patient acceptance of and long-term compliance with therapeutic regimens are critical for positive therapeutic outcomes from specialty medication therapies. Through a collaborative, patient-centric approach to patient enrollment and financial assessment and education, specialty pharmacists are uniquely qualified to enhance patient adherence and drive improved overall outcomes. As in Standard 2.1, prescribers are increasingly dependent on specialty pharmacy practices to provide support for their patients through benefits investigation (BI) and prior authorization (PA) services. Through these arrangements, the prescriber is often insulated from the true cost of therapy at the patient level and may be unaware of the overall cost of therapy when alternate therapy exists. Enrollment of patients in manufacturer-sponsored copay assistance programs and the selection of a preferred pharmacy provider shields patients from the true cost of care, and patients are often undereducated about the financial implications of therapy initiation. Manufacturer-sponsored programs often reduce or eliminate deductible phases of coverage, significant coinsurance, and specialty tier copay structures. These programs also protect the patient from adverse formulary agent selection, which could potentially lead to higher out-of-pocket costs if the patient were fully responsible for the costs of therapy. The collaborative approach to patient access to care through the transparent provision of financial information is multi-factorial and includes the following: