Standards of Care for Long Term Care Pharmacy at Home

Welcome to the Standards of Care Section

Below, we outline the standards for Long Term Care (LTC) pharmacy as defined by the Centers for Medicare and Medicaid Services (CMS) and further explain for adaptation in the at-home care setting. These standards were originally developed by CMS in 2005 to establish performance and service criteria for LTC pharmacies. Any pharmacy operating within the LTC arena, including LTC Pharmacy at Home, must adhere to these standards to qualify as an LTC pharmacy and engage in any LTC contracts. These criteria represent the essential framework ensuring that pharmacies provide compliant, high-quality care to patients in their homes.

In addition to the CMS standards, there are specific Minimum Care Service Requirements that your pharmacy must meet to be considered an LTC pharmacy at home and to qualify for accreditation. These requirements focus on key aspects of patient care that are critical in the home setting:

  • Patient Qualification Review – Ensuring patients meet all criteria to qualify for LTC services at home.
  • Patient Care Coordination – Facilitating seamless coordination among all caregivers and healthcare providers.
  • Medication Dispensing Review – Conducting thorough reviews of all medications prior to dispensing to enhance safety and adherence.

For more details on these essential services and how they contribute to the accreditation process, visit the Minimum Care Services page.

a pharmacist holding a medicine

Standards of Care for Long Term Care Pharmacy at Home

Updated November 2024

Standard 1: Comprehensive Inventory and Inventory Capacity

Standards

Pharmacies must maintain a comprehensive inventory of formulary drugs commonly used in the long-term care setting. Additionally, they must provide a secure area for the physical storage of medications, ensuring compliance with federal and state regulations for controlled substances. However, this requirement does not extend beyond the standard inventory or security measures typically maintained in a pharmacy’s normal business operations.

How to Meet Comprehensive Inventory and Inventory Capacity Standards
  • Maintain availability of medications not typically stocked in retail pharmacies to meet individual patient needs, such as liquid formulations of medications usually provided as tablets or capsules, IV medications (e.g., antibiotics), and other specialized drugs.
  • Ensure sufficient stock to fulfill prescriptions and orders daily, with urgent orders delivered within four hours and new maintenance prescriptions filled within 24 hours.
  • Over-the-counter (OTC) medications must also be available and appropriately documented in the patient’s medical record.
Why Comprehensive Inventory and Inventory Capacity is Important
  • Meeting Unique Patient Needs
    Long-term care patients often require specialized medications not typically available in retail pharmacies. Ensuring the availability of such medications allows pharmacies to provide timely, effective care tailored to the complex health needs of this population.
  • Timely Medication Access
    Prompt access to medications is critical in the long-term care setting to prevent treatment delays that could lead to adverse health outcomes.
  • Comprehensive Care Coordination
    Stocking a full range of prescription and over-the-counter (OTC) medications supports holistic patient care. Including OTC medications in the patient’s medical record ensures all aspects of their treatment are documented, reducing the risk of drug interactions and improving overall care coordination.
  • Regulatory Compliance and Patient Safety
    Secure storage of medications, especially controlled substances, is mandated by federal and state laws to protect patient safety and prevent diversion. Adhering to these standards reflects a commitment to compliance and upholds trust in the pharmacy’s operations.
  • Supporting the Long-Term Care Model
    Long-term care patients often face unique challenges, such as limited mobility or complex care regimens. By maintaining a comprehensive inventory and capacity to fulfill these needs, pharmacies play a vital role in supporting the goals of long-term care: enhancing patient quality of life, reducing hospital readmissions, and ensuring safe medication management in the home or facility setting.

Standard 2: Pharmacy Operations and Prescription Orders

Standards

Pharmacies are required to provide the services of a dispensing pharmacist to ensure compliance with pharmacy practice standards for dispensing prescription medications to long-term care (LTC) residents. Pharmacies must have the necessary pharmacy software and systems to efficiently manage prescription drug ordering and processing.

How to Meet Pharmacy Operations and Prescription Orders Standards
  • Ensure Pharmacy Software Readiness
    • Invest in pharmacy software capable of processing both electronic and written prescriptions seamlessly.
    • Regularly update software to stay compliant with evolving industry standards and regulations.
    • Train staff to use the software effectively to reduce processing errors and delays.
  • Develop and Maintain Comprehensive Policies and Procedures
    • Create a tailored policy and procedure manual specific to your pharmacy’s operations. Include:
      • Prescription receipt and processing workflows.
      • Delivery protocols, including timelines for routine and urgent deliveries.
      • Detailed instructions for ordering and handling controlled substances.
    • Use available resources, such as sample policies from associations, as a starting point, but customize them to reflect your pharmacy’s unique needs.
    • Review and update policies regularly to ensure they meet current compliance standards.
Why Pharmacy Operations and Prescription Orders Are Necessary
  • Ensuring Compliance with LTC Standards
    Long-term care settings require specialized pharmacy operations to meet the unique needs of residents. By adhering to pharmacy practice standards, pharmacies ensure that prescriptions are dispensed safely and appropriately, aligning with the regulatory and clinical requirements of the LTC population.
  • Facilitating Efficient Prescription Processing
    LTC pharmacies often handle high volumes of complex prescriptions. Pharmacy software capable of accepting and processing both electronic and written prescriptions streamlines operations, reduces errors, and ensures timely delivery of medications, which is critical for patient safety and adherence.
  • Establishing Standardized Workflows
    Clear policies and procedures are essential for ensuring consistency and reliability in pharmacy operations.
a female pharmacist helping an elder with medicines
medicine aisle

Standard 3: Special, Compliance Packaging

Standards

Pharmacies must have the capability to provide medications in specialized compliance packaging formats commonly required in long-term care settings. This includes options such as Unit of Use Packaging, Bingo Cards, Pouch Packs, or other compliance packaging formats. Pharmacies must have access to the necessary supplies, equipment, and arrangements with vendors to provide these packaging options, including labels, auxiliary labels, and packaging machines.

How to Meet Specialized, Compliance Packaging Standards
  • Compliance Packaging Standards
    • All maintenance medications must be provided in compliance packaging, typically for a 30-day supply or less.
    • Oral solids, except for medications required to remain in their original containers, must be dispensed in compliance packaging.
  • Available Packaging Options
    • Punch or Bingo Cards.
    • Multi-dose cards (containing multiple medications in each bubble).
    • Pouch or Pillow Packs, with options for single or multiple medications per package.
  • Special Considerations for Non-Oral Medications
    • Products that are not oral solids, such as insulin, creams, ointments, and ophthalmic solutions, may need to be dispensed in supplies exceeding 30 days, depending on patient needs and medication stability.
Why Special Packaging is Necessary
  • Enhanced Medication Adherence: Special packaging simplifies medication administration, reducing errors for caregivers and patients.
  • Improved Safety: Compliance packaging minimizes the risk of dosing errors, particularly in LTC at home settings where patients often experience polypharmacy.
  • Customized Solutions: Tailored packaging options address the unique needs of LTC patients.
  • Regulatory Compliance: Meeting packaging standards is critical for LTC pharmacies to align with state and federal guidelines, as well as contractual obligations with LTC’s level of service.
  • Operational Efficiency: Utilizing standardized packaging formats streamlines pharmacy operations and supports effective medication delivery systems.

Standard 4: IV Medications

Standards

Pharmacies must have the capability to provide IV medications to long-term care patients as prescribed by qualified medical professionals. This may require access to specialized facilities, such as a clean room, for the preparation of IV prescriptions. Pharmacies may also have access to or arrangements with vendors to supply the necessary equipment and supplies, as well as personnel trained in IV medication preparation and administration.

How to Meet IV Medication Standards
  • Flexibility Through Subcontracting or In-House Capabilities
    Pharmacies can meet this requirement by:
    • Subcontracting or arranging services with another pharmacy, a hospital, a home infusion provider, or a specialized IV services pharmacy.
    • Preparing IV medications in-house, which may include:
      • Using prepackaged products that do not require preparation in a clean room.
      • Installing a clean hood or establishing a clean room within the pharmacy to prepare IV medications on-site.
Why IV Medication Capability is Necessary
  • Critical for Complex Care Needs
    Many LTC patients require IV medications for acute treatments, such as antibiotics, hydration, or pain management, which are vital for maintaining their health and avoiding hospitalizations.
  • Ensuring Patient Safety and Compliance Access to specialized facilities or vendors ensures IV medications are prepared and delivered in compliance with stringent safety and regulatory standards.
hand holding medicinal tablets
a man and a woman pharmacists sorting medicines

Standard 5: Compounding / Alternative Forms of Drug Composition

Standards

Pharmacies must have the capability to provide specialized drug delivery formulations tailored to the unique needs of long-term care patients. For patients unable to swallow or ingest medications through conventional routes, pharmacies must be able to modify drug forms, such as splitting or crushing tablets, or preparing suspensions, gels, or other alternative formulations to ensure effective medication administration.

How to Meet Compounding / Alternative Drug Composition Standards
  • Establish In-House Compounding Capabilities for Basic
    Modifications/Compounds
    • Equip the pharmacy with tools and materials for basic compounding, such as tablet splitters, crushers, and suspension equipment.
    • Train pharmacists and technicians on proper compounding techniques and regulatory requirements.
    • Implement workflows to ensure quality control and accurate documentation for all compounded medications.
  • Subcontract with a Compounding Pharmacy
    • Partner with a compounding pharmacy or provider specializing in alternative drug formulations.
    • Ensure that subcontracted providers meet all regulatory and safety requirements.
    • Maintain clear agreements outlining roles, responsibilities, and quality expectations.
Why Compounding / Alternative Forms Are Necessary
  • Enhances Patient-Centered Care
    Many long-term care patients have unique needs that prevent them from taking medications in standard forms. Compounding ensures these patients can safely and effectively receive their prescribed treatments.
  • Supports Medication Adherence
    Providing medications in a form that is easier for patients to take reduces barriers to adherence, improving therapeutic outcomes.

Standard 6: Pharmacist On-Call Service

Standards

Pharmacies must provide 24/7/365 on-call service with a qualified pharmacist available to handle after-hours calls and ensure medication dispensing during emergencies, holidays, and outside normal operating hours. This is a critical requirement to meet the urgent needs of LTC patients and caregivers.

How to Meet Pharmacist On-Call Service Standards
  • Availability of Pharmacy Services
    A pharmacist must be accessible to patients, caregivers, and providers 24 hours a day, 365 days a year, to address medication-related inquiries or urgent needs.
  • After-Hours Communication
    The pharmacy must have a dedicated phone service to manage after-hours calls, ensuring they are answered promptly and appropriately.
  • Flexible On-Call Arrangements Pharmacist availability can be achieved through:
    • Employing on-call pharmacists, though this may involve higher costs.
    • Subcontracting with a backup pharmacy or pharmacy network to handle after-hours medication dispensing and emergencies.
Why 24/7 Pharmacist On-Call Service is Necessary
  • Immediate Access to Expertise
    Long-term care patients often face urgent or complex medication needs that require immediate consultation with a qualified pharmacist.
  • Supports Emergency Medication Needs
    Providing after-hours dispensing ensures that patients receive critical medications without delay, preventing health complications.
  • Fulfills Regulatory and Contractual Requirements
    Many LTC contracts and regulations mandate 24/7/365 pharmacist availability, making compliance essential for maintaining contracts.
a medical staff inserting a dextrose to a patient's arm
a medical professional writing while a patient is watching

Standard 7: Delivery Service

Standards

Pharmacies must provide reliable delivery services to ensure medications reach long-term care patients safely, securely, and in a timely manner. Delivery services must accommodate both routine and emergency needs, with flexible arrangements tailored to patient, caregiver, and facility requirements. Secure exchange systems and proper delivery documentation are critical for compliance and patient safety.

How to Meet Delivery Service Requirements Standards
  • Routine and Emergency Deliveries
    • Routine deliveries should occur at least once per month, with additional deliveries as needed for medication changes or urgent needs.
    • Patients recently discharged from a hospital or facility may require more frequent deliveries (e.g., every 7 or 14 days).
  • Delivery Documentation
    • All deliveries must include proof of delivery, such as:
      • A photo of the package delivered to the home.
      • A signed receipt or manifest from the caregiver, family member, or patient.
      • Documentation can be captured electronically or on paper.
    • Patients or caregivers must be educated during onboarding about delivery processes and what actions to take if no one is available to receive the delivery.
  • Delivery Execution
    • Deliveries can be handled by:
      • The pharmacy directly.
      • A courier service.
    • Pharmacies must ensure timely and secure delivery of medications.
Why Delivery Services Are Necessary
  • Ensures Timely Access to Medications
    Routine and emergency delivery services help ensure that patients receive their medications at the right time and dose, reducing the risk of treatment interruptions.
  • Supports High-Risk Patients
    Frequent deliveries for patients with complex or changing medication regimens, such as those recently discharged, promote adherence and safety.
  • Enhances Patient and Caregiver Confidence Reliable delivery services reassure patients and caregivers that their needs will be met promptly and consistently.

Standard 8: Miscellaneous Reports, Forms, and Prescription Ordering Supplies

Standards

Pharmacies must provide the necessary reports, forms, and prescription ordering supplies to support the delivery of quality pharmacy care. These materials assist patients, caregivers, and providers in managing medications effectively and ensuring compliance with best practices.

How to Meet Miscellaneous Reports, Forms, and Prescription Ordering Supplies Standards
  • Develop and Standardize Forms and Reports
    • Create templates for commonly required forms, including medication instructions, health monitoring tools, and ordering guides.
    • Regularly update templates to align with regulatory and operational requirements.
  • Educate Patients and Caregivers
    • Train patients, families, and caregivers on how to use provided forms and tools effectively.
    • Offer written or digital instructions and follow up to ensure understanding.
  • Collaborate with Families
    • Work closely with families to understand their needs and customize forms and reports accordingly.
  • Ensure Compliance with Controlled Substance Regulations
    • Provide secure, easy-to-use forms for controlled substance tracking.
    • Educate caregivers and patients on legal and safety requirements for managing these medications.
Why Miscellaneous Reports, Forms, and Prescription Ordering Supplies Are Necessary
  • Supports Medication Adherence
    Clear and accessible materials help patients and caregivers follow complex medication regimens, reducing errors and improving health outcomes.
  • Improves Patient Safety
    Providing specific instructions for medication administration ensures medications are used correctly and safely.
  • Enhances Monitoring and Management
    Tools for tracking health metrics enable better management of chronic conditions, providing critical data for healthcare providers.
a pharmacist holding a medicine while talking to someone through phone
a medical staff handing a emergencies medical kit to a patient

Standard 9: Emergency Boxes and Log Books

Standards

For Long-Term Care Pharmacy at Home Services, emergency boxes and log books are typically not required unless specific state laws dictate otherwise. The National Council for Prescription Drug Programs (NCPDP) defines the Level of Service Code (418-DI) value of “7” as “Medical at home with special pharmacy services identical to Long Term Care beneficiaries except for emergency kits.”

How to Meet Emergency Boxes and Log Books Standards
  • Emergency Boxes
    • Not Required for Long-Term Care Pharmacy at Home
      • Emergency medication kits (e-kits) are generally not necessary for LTC Pharmacy at Home services unless mandated by state law.
      • Pharmacies should confirm state-specific requirements to ensure compliance.
    • Special Considerations
      • If the pharmacy is viewed as an LTC provider under state regulations, it may need to supply e-kits.
      • Pharmacies must ensure they are prepared to meet these requirements if applicable, including establishing protocols for emergency supply management and compliance.
  • Emergency Log Books
    • Not Required for LTC Pharmacy at Home
      • Since emergency boxes are not typically required for LTC Pharmacy at Home, log books for tracking and charging medications from emergency stock are also unnecessary.
    • State-Specific Requirements
      • If state laws necessitate the provision of e-kits, pharmacies must establish a system for logging medication usage, charges, and maintaining comprehensive records of resident medication orders and administration.
How to Address Emergency Supply Needs if Required
  • Assess State Law Requirements
    • Research and document state-specific mandates regarding e-kits and emergency supply management.
  • Prepare for E-Kit Management
    • If e-kits are required, implement both facility-based and at-home procedures for:
      • Maintaining and replenishing emergency stock.
      • Logging and charging for medications used from emergency supplies.
      • Recording medication orders and administration in compliance with state and federal laws.
Why This Approach is Necessary
  • Ensures Compliance
    Understanding and adhering to state-specific requirements protects the pharmacy from potential regulatory issues.
  • Supports Quality Care
    If emergency supplies are required, having a clear and compliant system in place ensures patients receive timely access to critical medications.