PHA6129 LEC: Key Regulatory Issues in Health-System Pharmacy Practice

LAW

A legally binding requirement imposed by a legislative body

R.A. 5921

Pharmacy Law (updated)

R.A. 9165

Comprehensive Dangerous Drugs Act of 2002

REGULATION

Governmental order having the force of law

DOH

A.O. like the 2012-0012: which classifies different types of hospitals

FDA

like the 2020-0017, which are licensing requirements

DDB

A.O. which are pertinent for dangerous drugs

RULE

An authoritative recommendation meant to guide behaviors associated with specific, limited situations.

STANDARD

A statement that defines the performance expectations, structures, or processes that must be in place for an organization to provide safe and high-quality care, treatment, and services.

GUIDELINE

Voluntary guidance and direction to practitioners and other audiences based on consensus of professional judgment, expert opinion and documented evidence.

EXTERNAL INFLUENCES

1	Health-System Certification and Accreditation Programs
2	Federal and State Laws and Regulations
3	Nongovernmental Standards-Setting Entities
4	Pharmacy Professional Organizations

CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS)

To meet the terms of participation in governmental or private reimbursement programs

CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS)

• Works in partnership with the states to administer Medicaid, the Children’s Health Insurance Program (CHIP), and the Health Insurance Portability and  Accountability Act (HIPAA)

CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS)

Develops Conditions of Participation (COPs) that should be met to participate in the Medicare and Medicaid programs.

Medicare

Health insurance policy offered to the senior-citizen set, along with people under 65 who have certain disabilities.

Medicaid

Public assistance program based largely on financial need; it’s paid for with public funds collected through taxes

CHIP

Children’s Health Insurance Program

CHIP

Insurance program that provides low-cost health coverage to children in families that earn too much money to quality for Medicaid but not enough to buy private insurance

HIPAA

Health Insurance Portability and Accountability Act

HIPAA

Federal law that required the creation of national standards to protect sensitive patient health information from being disclosed without the patient’s consent or knowledge

PhilHealth

Created under Republic Act No. 10606 of 2012 (Amended RA 7875 – National Health Insurance Act of 1995)

PhilHealth

assumed the responsibility of administering the former Medicare program for government and private sector employees from the Government Service Insurance System (GSIS) in October 1997, from the Social Security System (SSS) in April 1998, and from the Overseas Workers Welfare Administration (OWWA) in March 2005.

Universal Healthcare

Republic Act No. 11223

ACCREDITATION

Acknowledges that a hospital or other health care organization has met or exceeded the requirements of an accrediting body

ACCREDITATION

The Joint Commission, Healthcare Facilities Accreditation Program (HFAP), National Integrated Accreditation for Healthcare Organizations (NIAHO)

Joint Commission International (formerly JCAHO)

• An independent, not-for-profit organization dedicated to improving the safety and quality of health care in organized health care settings

Joint Commission International (formerly JCAHO)

• Principal accrediting body for the operation of hospitals and other health care organizations

Joint Commission International (formerly JCAHO)

Sets continually evolving standards for acute care hospitals and other health care organizations

Joint Commission International (formerly JCAHO)

• Develops standards relevant to pharmacy

  • Medication management (how they dispense) 

  • Infection control

  • Patient care

  • Medical records

  • Safety and security

  • Education

  • Performance improvement

  • Environment of care (facilities)

• Developed National Patient Safety Goals (NPSGs) that address specific patient safety issues, some are medication related

Joint Commission International (formerly JCAHO)

Accreditation is for three years

JCI-Accredited Hospital in the Philippines

• Asian Hospital and Medical Center

• The Medical City

• St. Luke’s Medical Center (the ones both in Pasig and Clark)

• Makati Medical Center

Healthcare Facilities Accreditation Program (HFAP)

Principal accreditation agency for osteopathic medical colleges and health care facilities

Healthcare Facilities Accreditation Program (HFAP)

• Address all departments and functions including pharmacy services and medication use

• Accreditation is for three years

National Integrated Accreditation for Healthcare Organizations (NIAHO)

Integrates CMS CoPs with ISO 9001 Standards (global principles designed to provide assurance that quality in imbedded in supplier-customer relationships)

National Integrated Accreditation for Healthcare Organizations (NIAHO)

• Designed to facilitate the development and implementation of a Quality Management System (QMS) for health care organization

• Accreditation is for three years

FOOD AND DRUG ADMINISTRATION (FDA)

Responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation

FOOD AND DRUG ADMINISTRATION (FDA)

• Helping to speed innovations

• Helping the public to get accurate, science-based information

FOOD AND DRUG ADMINISTRATION (FDA)

Enforces the federal Food, Drug, and Cosmetic Act, sets labeling requirements for food, prescription and OTC drugs and cosmetics, sets standards for investigational drug studies and product approval, and regulates and oversees the manufacturing and marketing of drugs

FOOD AND DRUG ADMINISTRATION (FDA)

Republic Act 9711 of 2008 (BFAD to Food and Drug Administration)

DRUG ENFORCEMENT ADMINISTRATION (DEA)

Enforces provisions of the controlled substances act relating to the manufacture, distribution, and dispensing of legally produced controlled substances

DRUG ENFORCEMENT ADMINISTRATION (DEA)

• Investigates and prepares for the prosecution of those who violate controlled substances laws and regulations

DRUG ENFORCEMENT ADMINISTRATION (DEA)

Enforces the federal controlled substances laws and regulations

E.O. No. 218

Creation of Philippine Drug Enforcement Agency)

OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION(OSHA)

• Assure safe and healthful working conditions for working men and women; by providing research, information, education, and training in the field of occupational safety and health

OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION(OSHA)

• Conducts periodic workplace inspections to ensure workers are kept safe in their jobs

OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION(OSHA)

Pharmacy-related standards – workplace accidents and exposure to hazardous materials

Occupational Safety and Health Center

PHILIPPINE COUNTERPART of OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION(OSHA)

Occupational Safety and Health Center

EO No. 307 of 1987: Creation of _

NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY ANDHEALTH (NIOSH)

Conducting research and making recommendations for the prevention of work-related injury and illness

CENTERS FOR DISEASE CONTROL AND PREVENTION(CDC)

Dedicated to protecting the health and promoting quality of life through the prevention and control of disease, injury, and disability

CENTERS FOR DISEASE CONTROL AND PREVENTION(CDC)

Hand-hygiene, standard precautions, and other infection control issues

Inter-Agency Task Force on Emerging Infectious Diseases

PHILIPPINE COUNTERPART of CENTERS FOR DISEASE CONTROL AND PREVENTION(CDC)

OFFICE OF INSPECTOR GENERAL (OIG)

Protect the integrity of certain governmental programs, as well as, the health and welfare of the beneficiaries of those programs

ENVIRONMENTAL PROTECTION AGENCY (EPA)

Responsible for developing and enforcing regulations pertaining to environmental laws and issues

ENVIRONMENTAL PROTECTION AGENCY (EPA)

Enforces the Resource Conservation and Recovery Act (RCRA) which regulates the handling and disposal of hazardous (pharmaceutical) waste from the point of generation to final disposal

Department of Environment and Natural Resources (DENR)

PHILIPPINE COUNTERPART of ENVIRONMENTAL PROTECTION AGENCY (EPA)

Department of Environment and Natural Resources (DENR)

Implements the following:

Presidential Decree 1586 (Environmental Impact Statement System)

RA 6969 (Toxic Substances and Hazardous and Nuclear Waste Control Act of 1990)

RA 9003 (Ecological Solid Waste Management Act of 2000)

OFFICE FOR CIVIL RIGHTS (OCR)

Enforcing Civil Rights Act primarily dealing with human relations management – prohibiting discrimination in employment hiring, promotion, compensation and treatment of protected employee groups

Civil Service Commission/National Labor Relations Commission

PHILIPPINE COUNTERPART of OFFICE FOR CIVIL RIGHTS (OCR)

STATE BOARDS OF PHARMACY

Setting licensure requirements for individuals, pharmacies, and some health care organizations

STATE BOARDS OF PHARMACY

Establish and enforce the rules and regulations of the state’s pharmacy practice act and discipline pharmacists and pharmacies

STATE BOARDS OF PHARMACY

Enforce their state’s controlled substances act

The Board of Pharmaceutical Examiners

was created on January 26, 1903 by virtue of Public Act No. 597 under the Department of Interior. The members were appointed by the Commissioner of Public Health upon the advice and consent of the Board of Health.

The Board of Pharmaceutical Examiners

PHILIPPINE COUNTERPART of STATE BOARDS OF PHARMACY

Republic Act No. 5921

An Act to Regulate the Practice and Setting Standards of Pharmaceutical Education in the Philippines and Other Purposes

Nongovernmental, standards-setting organization that advances public health by ensuring the quality of medicines, food ingredients, and other health care products, promoting the safe and proper use of medications, and verifying ingredients in dietary supplements

Mildred B. Oliveros

OIC of PRC

Anthony Aldrin C. Santiago

Member of PRC

Adeline C. Royo

Second Member of PRC

UNITED STATES PHARMACOPEIA (USP)

Nongovernmental, standards-setting organization that advances public health by ensuring the quality of medicines, food ingredients, and other health care products, promoting the safe and proper use of medications, and verifying ingredients in dietary supplements

NATIONAL FIRE PROTECTION ASSOCIATION (NFPA)

Reduce the worldwide burden of fire and other hazards on the quality of life providing and advocating consensus codes and standards, research, training and education

NATIONAL FIRE PROTECTION ASSOCIATION (NFPA)

Pharmacies store large number of flammable materials

INSTITUTE OF MEDICINE (IOM) OF THE NATIONAL ACADEMIES

Provides a vital service by working outside the framework of government to ensure scientifically informed analysis and independent guidance

PHARMACY PROFESSIONAL ORGANIZATIONS

Established standards of practice, guidelines, and codes for their specialty

AMERICAN COLLEGE OF CLINICAL PHARMACY (ACCP)

Provides leadership, education, advocacy, and resources enabling clinical pharmacists to achieve excellence in practice and research

AMERICAN PHARMACISTS ASSOCIATION (APA)

Provides information, education, and advocacy to empower its members to improve medication use and advance patient care

Philippine Association of Colleges of Pharmacy, Inc. (PACOP) - 1976

Philippine Pharmacists Association (PPhA) - 1920

PHILIPPINE COUNTERPART of AMERICAN PHARMACISTS ASSOCIATION (APA)

AMERICAN SOCIETY OF CONSULTANT PHARMACISTS (ASCP)

Representing senior care pharmacists

AMERICAN SOCIETY OF CONSULTANT PHARMACISTS (ASCP)

Providing resources to optimum provision of pharmaceutical care to patients residing in health-system and residential settings

AMERICAN SOCIETY OF HEALTH SYSTEM PHARMACISTS(ASHP)

Adopted professional policy positions, statements, and guidelines that foster improvement in pharmacy practice and patient care

AMERICAN SOCIETY OF HEALTH SYSTEM PHARMACISTS(ASHP)

Represent a consensus of professional judgment, expert opinion, and documented evidence

AMERICAN SOCIETY OF HEALTH SYSTEM PHARMACISTS(ASHP)

• Accrediting body for practice sites that conduct pharmacy residency programs and technician training programs

• Develops standards to improve medication use and enhance patient safety

Philippine Society of Hospital Pharmacists (1962)

PHILIPPINE COUNTERPART of AMERICAN SOCIETY OF CONSULTANT PHARMACISTS

(ASCP)

INTERNAL INFLUENCES

1	Pharmacy and Therapeutics (P&T) Committee and Medical Executive Committee
2	Infection control, quality/performance improvement, safety committees and IRB
3	Organization and Department Standards

PHARMACY AND THERAPEUTICS (P&T) / MEDICAL EXECUTIVE COMMITTEE

Provide oversight and approval of standards of performance for the organization and each department

ORGANIZATION AND DEPARTMENT STANDARDS

• Ensure compliance and quality of care

• Pharmacy assessments should include compliance with their organization and department standards

BY LAWS, RULES, REGULATIONS, POLICIES AND PROCEDURES

Pharmacy department policies and procedures must be consistent with the organization’s requirements and should be developed with the input of pharmacists and support staff

COMPETENCE ASSESSMENT AND PERFORMANCE EVALUATION PROGRAMS

Competent – have the skills, knowledge, and ability to perform a job according to defined expectations

The Joint Commission defines the competencies that are required and how they will be assessed, use appropriately qualified individuals to assess competence, assess competence at defined intervals, and take action when a person does not meet the competency requirements.

PERFORMANCE IMPROVEMENT PROGRAMS

• Improve processes related to care, treatment, and services

• Contain elements of quality control and quality improvement

• Monitoring performance and collecting data

• Aggregating and analyzing data

• Analyzing undesirable patterns and trends in performance

• Identifying and managing sentinel events

• Using information from data analysis, to identify and prioritize opportunities for improvement

• Improve performance by taking action on improvement opportunities