The PHIC Benchbook for Pharmacies

Objectives

• To develop standards, criteria and indicators for public and private pharmacies to ensure access, availability, affordability and safety of essential medicines

• To ensure good governance and transparency in medicines selection and rational use, procurement, allocation and re-imbursement of essential medicines.

• To provide a mechanism for ensuring quality systems and processes for safety in medicines management (storage, distribution and dispensing)

• To provide minimum benchmark for the accreditation of drug stores and pharmacies for medicines re-imbursement.

Methods of Development

• PHIC Benchbook• Competency standards

– Canada– Europe– America

• Key person Interviews• Focused group discussion• Pilot testing

Initial List of Standards and Criteria

• Client Rights and Organizational Ethics

• Client Care• Leadership and Management• Human Resource Management• Information Management• Safe Practice and Environment• Performance Improvement

Patient Rights and Organizational Ethics

STANDARD 1.1• The pharmacy as a matter of policy and practice must respect

and support client's rights and preferences.

CRITERIA• The pharmacy has written policies and procedures that

respect client's rights and preferences.• The pharmacy has information dissemination strategy that

explains the rights and responsibilities of clients within its facility.

• The pharmacists/pharmacy aide must be able to demonstrate how they respect client's rights and preferences.

Patient Rights and Organizational Ethics

STANDARD 1.2• The pharmacy as a matter of policy and practice provides

confidentiality, privacy and security within its facility.

CRITERIA• The pharmacy has written policies and procedures to ensure

confidentiality and privacy. • The pharmacy must have a system designed to ensure

confidentiality, privacy and security.• The pharmacy has a safe area for keeping client records and

prescriptions.

Client Care

STANDARD 2.1• The clients have physical access to the pharmacy that is

appropriate to their needs. CRITERIA• Signage are easily seen and recognized by clients to access the

pharmacy's services.• Entrances and exits to the pharmacy are free of obstruction

and other unsafe elements.• Alternative passageways for clients with special needs (e.g.

ramps) are available, clearly and prominently marked and free from obstruction.

Client Care

STANDARD 2.2• Clients are identified and receive prompt and timely attention

upon entry to the pharmacy. CRITERIA• The pharmacy has written policies on how to identify clients

and provide prompt and timely service. • The pharmacy ensures that clients are seen within the

acceptable waiting period as written in its policies.• Clients find the actual waiting time acceptable.

Client Care

STANDARD 2.3• The pharmacy as a matter of policy and practice has an appropriate

strategy to evaluate their clients' needs and characteristics and provide the appropriate products and services.

CRITERIA• The policies and procedures to determine the mix of pharmaceutical

products and services must be based on client’s characteristics, epidemiologic strategy.

• The pharmacy has a written policy on evaluating and ensuring the continuous availability of the products and services based on their clients' needs.

• Information on the mix of pharmaceutical products and services offered and their availability is strategically disseminated to clients.

Client Care

STANDARD 2.4• The pharmacy ensures that information on pharmaceutical

products is available inside the pharmacy and given to clients.

CRITERIA• There are available posters, flyers and other media devices inside

the pharmacy that informs the patient on how to take pharmaceutical products appropriately.

• The pharmacy staff reinforces the posted information by giving brief instruction to clients about the pharmaceutical products they are supposed to take.

• The clients of the pharmacy actually received medication counseling advice from the pharmacy staff about the pharmaceutical product they are supposed to take.

Client Care

STANDARD 2.5• The pharmacy staff has a standardized way to provide information

to their clients about the pharmaceutical products they are supposed to take.

CRITERIA• The pharmacy staff should provide pharmaceutical information

such as dose, frequency and duration of drug intake.• The pharmacy staff should provide information about the intended

effect and the possible side effects of the drugs.• The pharmacy staff should provide information on what to do in

case of side effects.• The pharmacy staff gave opportunity to the client to ask further

information about the pharmaceutical products they are supposed to take.

Client Care

STANDARD 2.6• The pharmacy as a matter of policy and practice monitors and

report adverse events due to intake of pharmaceutical products.

CRITERIA• The pharmacy must have a written policy on monitoring and

reporting of adverse events due to use/intake of pharmaceutical products.

• The pharmacy staff must be aware of the facility’s policy on monitoring and reporting adverse events.

• The pharmacy must show evidence of implementation of the policy on adverse event monitoring and reporting.

Leadership and Management

STANDARD 3.1• The provider organization’s management team provides leadership,

acts and assumes overall responsibility for the pharmacy’s operation and the quality of its services.

CRITERIA• The pharmacy has written policies and procedures manual that

contain its mission, vision and goals based on agreed-upon values.• The pharmacy leadership communicates its policies and procedures

to all levels of the workforce.• The leadership support activities that promote team building/good

working relationship and activities that reinforce its core values.

Leadership and Management

STANDARD 3.2• The organization’s management team ensures the presence of

effective working relationships with the pharmacy staff.

CRITERIA• The organizational structure as shown in the written policies and

procedures has clear lines of supervision and authority.• The facility has written policies and procedures for the leadership to

elicit feedback from its staff regarding its leadership and management process.

• The facility has documents of the staff's individual rating and performance.

• The leadership and management provide incentives for good performance and disincentives for poor performance.

Leadership and Management

STANDARD 3.3• The pharmacy management ensures that resources are

available to provide pharmaceutical products and major services are available.

CRITERIA• The leadership takes an active role designing and

implementing the delivery of health care services to the community.

• The leadership allocates resources for continuing professional development of staff necessary for the delivery of services.

• The leadership takes the lead in evaluating and improving the current services.

Human Resource Management

STANDARD 4.1 • The pharmacy staff is a mix of appropriately trained and

qualified pharmacy personnel to provide the services needed by the clients.

CRITERIA• The pharmacy has a written policy that defines the standard

qualifications and competencies of its staff.• There are written policies and procedures for monitoring

client needs and staff workload to ensure the adequacy of staff in terms of numbers or expertise.

• Staff number and skill mix are based on actual needs.

Human Resource Management

STANDARD 4.2 • The recruitment, selection, appointment and reappointment

procedures ensure appropriate qualification and competency of pharmacy staff.

CRITERIA• The pharmacy has written policies and procedures for

recruitment, selection and appointments that conform to regulatory requirements of Philippine FDA, Civil Service or Department of Labor and Employment.

• Selection and appointment and evidence of compliance with selection or appointment standards are documented.

• Relevant licenses are routinely monitored for renewal.

Human Resource Management

STANDARD 4.3• The pharmacy staff members are aware and responsible for

their role and how it contributes to the attainment providing quality services.

CRITERIA• The staff receives a written statement of their job description,

roles and responsibilities to the attainment of quality of services.

• The staff accountabilities and responsibilities are consistent with their qualifications, training and experience.

• All pharmacy staff providing service has documented evidence of appropriate training and experience.

Human Resource Management

STANDARD 4.4• There are relevant orientation, training and development

programs to meet the training needs of management and staff.

CRITERIA• There are written policies and procedures for orientation of

new management and staff. • The organization assesses the educational needs of

management and staff and identifies and/or provides resources to meet those needs.

• There is training and development program evaluation system.

Information Management

STANDARD 5.1 • Relevant, accurate, quantitative and qualitative data are collected

in a timely and efficient manner for improvement and delivery of products and client services.

CRITERIA• The operations manual define policies and procedures to determine

what, how and when data from pharmaceutical and administrative records are updated, aggregated and analyzed.

• The facility maintains records of client information and preference for products and services.

• The pharmacy management provides resources and opportunities to enable management and staff to use available data in their decision making and provision of products and services.

Information Management

STANDARD 5.2• The collection of data and reporting of information comply

with professional standards and regulatory requirements and support management decision making.

CRITERIA• The facility in its operations manual has a policy on how and

when to collect and submit reports as required by DOH, FDA and PHIC.

• The facility submits relevant reports to government units for public health purposes and policy making.

Information Management

STANDARD 5.3 • Client records are kept confidential and safe, and comply with

all relevant statutory requirements and codes of practice.

CRITERIA• The organization has written policies and procedures to

protect client records against destruction, tampering and unauthorized access or use.

• Only authorized persons have access to the client records.• The facility staff protects records from tampering, alteration,

pilferage and unauthorized duplication.

Safe Practice and Environment

STANDARD 6.1 • The facility’s structural plan and layout provide a safe and

effective physical environment of drug storage, dispensing and client care consistent with regulatory requirements.

CRITERIA• The building plans comply with structural, technical and safety

standards as defined by professional and regulatory agencies.• Electrical, water supply and waste disposal comply with

structural and safety standards as defined by professional and regulatory agencies.

Safe Practice and Environment

STANDARD 6.2• The pharmacy practice safe and efficient storage and handling of

pharmaceutical products based on technical specifications, safety standards.

CRITERIA• The pharmacy has written policies and procedures on safe and efficient

storage and handling of pharmaceutical products based on technical specifications, safety standards.

• The pharmacy staff members are aware about the policies on safe and efficient storage and handling of pharmaceutical products based on technical specifications, safety standards.

• The facility appropriately safe and efficient storage and handling of pharmaceutical products based on technical specifications, safety standards.

Safe Practice and Environment

STANDARD 6.3• The pharmacy has a system to monitor and crosscheck the

expiry of the pharmaceutical products it stores and dispense.

• CRITERIA• The pharmacy has written policies and procedures on the

system of monitoring the expiry of the products it stores and dispense.

• The pharmacy staff members are aware about the policies and procedures on the system of monitoring the expiry of the products it stores and dispense.

• The pharmacy staff members crosscheck the expiry of every product it dispenses to clients.

Safe Practice and Environment

STANDARD 6.4• The pharmacy staff practices safe and efficient operation of medical

devices, equipment and supplies based on technical specifications, safety and regulatory standards.

CRITERIA• There are written policies and procedures for handling, use and

management of pharmaceutical equipment and instruments based on their technical specifications.

• The manual of operations of pharmaceutical equipment and instruments based on their technical specifications is readily available to pharmacy staff.

• The pharmacy staff is aware of the basic operations and simple troubleshooting of pharmaceutical equipment and instruments.

Safe Practice and Environment

STANDARD 6.5• The pharmacy facility is prepared to address fire, earthquake,

flood and other natural and man-made disasters.

CRITERIA• The pharmacy has written policies and procedures on address

fire, earthquake, flood and other natural and man-made disasters.

• The pharmacy staff is aware of what to do in terms of fire, earthquake, flood and other natural and man-made disasters.

• The pharmacy conducts regular simulation exercises like fire drill annually.

Safe Practice and Environment

STANDARD 6.6• The facility routinely collects and evaluates the safety and

adequacy of the pharmacy’s physical environment.

CRITERIA• The pharmacy must have a policy to evaluate and identify

risks or hazards in its facility.• Risks related to the physical structure are routinely identified,

assessed and appropriately addressed.• Accidents and incidents involving clients and staff are

regularly monitored, investigated and prevented from recurring based on policies and procedures.

Performance Improvement

STANDARD 7.1 • The pharmacy has a planned systematic approach to continuous

quality improvement that includes performance measurement, assessment and improvement.

CRITERIA• The facility has written policies and guidelines on how to implement

continuous quality improvement that includes performance measurement, assessment and improvement.

• The continuous quality improvement program must target improvement in the structures, processes and outcomes of client care.

• The implementation of the continuous quality improvement program must be documented for appropriate reporting.

Performance Improvement

STANDARD 7.2• The standard processes and performance of client service that

must be measured are designed collaboratively based on scientific standards and client preferences.

CRITERIA• The operations manual must contain policies and procedures on

how to define the standard processes and performance of care that must be measured.

• The clients' preference must have been considered in the development of these standards.

• These standards for the processes and performance of care must be disseminated to all staff and when appropriate to clients.

Performance Improvement

STANDARD 7.3• The organization provides a better care and service as a result

of continuous quality improvement activities.

CRITERIA• The facility must have documents showing improvement of

the structures and processes of care.• The facility must have good outcomes in terms of client

satisfaction.• The facility must have good outcomes in terms of the

community health status.

Next Steps

• Presentation to stakeholders