Oversight | Federal and state regulatory | Professional Org.

Pharmacy Oversight

• Supervise and monitor pharmacy practice to ensure compliance with standards and regulations.

• Medication is properly prepared, handled, dispensed, and documented safely and legally.

How Pharmacy oversight protects patients and employees

• The patient is given the right medicine, the right amount, and told the right time to take the medicine.

• Patient safety: Someone checks your medicine for harmful side effects.

• Accurate records and documentation.

Food and Drug Administration (FDA)

• US Dep. of Health and Human Services.

• Protects public health, ensuring safety and efficacy

• Security of human and Vet. drugs

• Security of biological products, medical devices, food supply, cosmetics, and tobacco products.

Drug Enforcement Administration (DEA)

• U.S. Dep. of Justice

• Enforces the Controlled Substances Act (Ranks drugs using Schedules)

• Recordkeeping and Security

• Compliance and audits

• Pharmacy DEA registrations

Occupational Safety and Health Administration (OSHA)

• U.S. Dep. of Labor

• Sets and enforces safety standards for healthy working conditions for employees

Federal Trade Commission (FTC)

• Independent U.S. Agency

• Protects consumers and enforces antitrust laws to stop unfair business practices

Centers for Disease Control and Prevention (CDC)

• Department of Health and Human Services

• Protects public health, prevents chronic and infectious diseases, and manages medication.

• Vaccination campaigns and focuses on education about many health-related issues.

• Makes recommendations, not regulations.

U.S. Pharmacopeial Convention (USP)

• Non-profit organization

• Established quality standards for FDA-approved drugs.

• National formulary (USP-NF)

• Publishes important info on dietary supplements, homeopathic products, and sterile/non-sterile compounding standards.

National Board of Pharmacy

• The only professional program representing all 50 states’ BOPs

• Model State Pharmacy Act and Model Rules: a reference model for state regulation.

• Digital Pharmacy Accreditation (VIPPS): Identifies legitimate Pharmacies

American Pharmacists Association

• Collective voice of pharmacists, techs, and students

• Provides education and resources

• Collaborative development of workplace standards and support for proper med. use and patient support.

American Society of Health-System Pharmacists (ASHP)

• Accreditation of Pharmacy Programs

• Drug Shortage management: tracks shortages

• Practice Standards

• Education and professional development

National Council for Prescription Drug Programs (NCPDP)

• Not-for-profit Org.

• Issues unique 7-digit provider numbers that pharmacies or providers use for electronic record transmissions.

• Similar to National provider number (NPI), issued by CMS for government reimbursement

State Board of Pharmacy (BOPs)

• Work with state departments of health and advise state legislators on pharmacy practice.

• Oversee inspection of new pharmacies and maintains data base of all active pharmacist licenses.

• Laws and regulations vary by state

• Each state has their own drug enforcement agency that works with the DEA.

Joint Commission

• Non-government, Non-Profit professional healthcare association

• Set high standards for hospitals and other institutions

• Rigorous facility inspections for approval process of official accreditation