Legal

• Republic Act No. 5921 regulates the practice of pharmacy in the Philippines and sets standards for pharmaceutical education
• Objectives of the Act:

  • Standardization and regulation of pharmaceutical education
  • Examination for registration of pharmacy school graduates
  • Supervision, control, and regulation of pharmacy practice in the Philippines
• The Council of Pharmaceutical Education:

  • Composed of the Secretary of Education, Undersecretary of Health Services, Food and Drug Administrator, Chairman of the Board of Pharmacy, Dean of the College of Pharmacy, and a representative of a national pharmaceutical organization
  • Functions include promulgating rules for pharmaceutical education, accrediting colleges of pharmacy, and approving accreditation of pharmacies for internship
• The Board of Pharmacy:

  • Composed of a Chairman and two members appointed by the President
  • Qualifications for board members include being a Filipino citizen, a registered pharmacist with at least 10 years of experience, of good moral character, not a faculty member of a pharmacy school, and a member of a national pharmaceutical association
• Powers and duties of the Board of Pharmacy:

  • Examining pharmacy practice applicants
  • Issuing registration certificates
  • Reprimanding, suspending, or revoking registration certificates for specific grounds
  • Promulgating rules and regulations for pharmacy practice
  • Checking employment of qualified personnel in pharmaceutical establishments
  • Encouraging the development of botanical gardens for medicinal plants
• Grounds for reprimand, suspension, or revocation of registration certificate:

  • Conviction of violations
  • Immoral or dishonorable conduct
  • Fraud or deceit in registration acquisition
  • Negligence, incompetence, or malpractice
  • Acting as a dummy of an unqualified individual
  • Addiction, insanity, false advertising, violations of the Code of Ethics
• Administrative Investigation:

  • Conducted by all board members
  • Charges sustained by evidence may lead to reprimand, suspension, or revocation of registration
  • Suspension not exceeding six months
  • Reinstatement possible after exemplary conduct
• Procedure and rules for complaints and investigations:

  • Respondent entitled to answer complaints
  • Formal investigation with hearing dates set
  • Subpoena duces tecum may be issued
  • Proceedings recorded and resolved within ninety days
• Rights of respondent:

  • Entitled to be heard or represented by counsel
  • Speedy and public hearing
  • Confronting and cross-examining witnesses
  • Summoning and presenting witnesses
• Appeal process:

  • Decision becomes final after thirty days unless appealed to the President of the Philippines within that period
• Qualifications for board examination candidate:

  • Filipino citizen
  • Good moral character
  • Completion of Internship Program in prescription pharmacy, pharmaceutical manufacturing laboratory, and hospital pharmacy accredited by the Council of Pharmacy
• Internship program hours distribution:

  • Equal hours in a prescription pharmacy, a pharmaceutical manufacturing laboratory, and a hospital pharmacy accredited by the Council of Pharmacy
  • Remaining hours can be spent in any or all of the mentioned establishments at the candidate's choice
  • Each establishment must keep a separate record of pharmacy students undergoing internship and issue certificates for the hours
• Requirements for taking the exam:

  • Graduation with a Bachelor of Science in Pharmacy or an equivalent degree from a Council of Pharmaceutical Education accredited school, college, or university
  • Completion of a standard pharmacy course of at least five academic years
• • Pharmacy subjects: Botany and Pharmacognosy, General Pharmacy, Compounding and Dispensing, Physical and Manufacturing Pharmacy, Pharmacy Administration, Pharmaceutical Jurisprudence and Ethics
  • Practical examination includes Identification and Analysis of Drugs, Preparation of Official Pharmaceuticals, Compounding and Dispensing of Prescriptions, Manufacturing Pharmacy and Quality Control
• Scope of pharmacist examination:

  • Theoretical examination includes subjects in Chemistry, Biological Science, and Pharmacy
  • Chemistry subjects: General Inorganic Pharmaceutical and Physical Chemistry, Organic and Medical or Pharmaceutical Chemistry, Qualitative, Quantitative, and Drug Assaying
  • Biological Science subjects: Physiology Biochemistry, Microbiology and Public Health, Pharmacology and Toxicology
• Passing requirements:

  • General average of 75% or over in both theoretical and practical examinations
  • No ratings below 50% in more than 2 subjects in theoretical examinations
  • Candidates failing theoretical or practical exams can repeat only the failed portion in a re-examination
• Examination details:

  • Given twice a year in the City of Manila and environs
  • Examination fees: fifty pesos for each applicant, ten pesos for each certificate of registration after passing the exam
• Practice of Pharmacy:

  • Definition includes preparation, analysis, distribution, and sale of pharmaceutical products
  • Prerequisite: at least 21 years old, passed Board of Pharmacy exam, and holds a valid certificate of registration
  • Sales of medicine restricted to prescription drug stores or hospital pharmacies
  • Pharmacies must be under the supervision of a registered pharmacist at all times
• Pharmacists must record the date of each sale, name and address of the purchaser, name and quantity of the poison sold, and the purpose claimed for the purchase before delivering it
• No prescription containing a dangerous quantity of poison shall be filled without consulting the prescribing authority and verifying the prescription
• Pharmacists must inform the purchaser of the poisonous character of the substance before delivery
• Every box, bottle, or package containing a dangerous or poisonous drug must have a red label with the word "Poison" and a vignette of a skull and bones
• Poisons specified in the law cannot be sold to individuals under eighteen years of age, mentally deranged, under the influence of liquor, or addicted to opiates and habit-forming drugs
• Books recording the sale of poisons must be open for inspection by authorities and kept for at least five years
• Less violent poisons can be dispensed by pharmacists without a physician's prescription but must be recorded in a poison book
• Poisonous drugs must be kept in a locked cabinet in every pharmacy
• Drugs capable of provoking abortion or preventing conception can only be sold with a prescription from a licensed physician
• Pharmacists must record specific data in a register book for abortives and anti-conceptionals after filling a prescription containing such substances
• Potent drugs can only be dispensed by pharmacists upon the prescription of a licensed physician, dentist, or veterinarian
• Specific requirements for the opening and operation of drugstores and pharmacies must be followed according to the rules and regulations set by the Food and Drug Administration
• Penalties are imposed for violations of the Pharmacy Law, including fines and imprisonment for certain offenses
• The term "Pharmacy" refers to a place where drugs are sold at retail and prescriptions are compounded and dispensed
• The term "Drug" includes articles intended for use in disease prevention, affecting the structure or function of the body, but does not include devices or their components
• The term "Device" includes instruments or contrivances intended for use in disease prevention or affecting the body's structure or function
• The term "Poison" refers to substances capable of destroying life or seriously endangering health when applied externally or internally in moderate doses
• The Pharmacy Law was further amended by Executive Order No. 174 to strengthen the regulation of drugs and devices
• Título de la Ley: Esta Ley se conocerá como "Ley de Desarrollo Profesional Continuo de 2016"
• Declaración de Política: La política del Estado es promover y mejorar la práctica de las profesiones en el país. Para lograr esto, el Estado implementará medidas que mejoren continuamente la competencia de los profesionales de acuerdo con los estándares internacionales de práctica, asegurando así su contribución al bienestar general, crecimiento económico y desarrollo nacional
• • Acuerdo de Reconocimiento Mutuo de la ASEAN o ASEAN MRA: acuerdo regional basado en el reconocimiento mutuo de calificaciones, requisitos cumplidos, licencias y certificados otorgados, experiencia adquirida por profesionales, para mejorar la movilidad de los servicios profesionales dentro de la región
  • Competencia: habilidad que va más allá de la posesión de conocimientos y habilidades, que incluye competencia cognitiva, funcional, personal y ética
• • Programa de CPD: acreditado por la entidad técnica, que puede incluir conferencias, visitas de capacitación, que mejoran el conocimiento, habilidades y aprendizaje permanente multidisciplinario
  • Proveedor de CPD: acreditado por la entidad técnica para ofrecer actividades de aprendizaje
  • Formales: como requisitos de currículo
  • Informales: evaluaciones de la vida diaria
  • Aprendizaje: se espera que sea parte de un proceso de aprendizaje
  • Permanente: realizado a lo largo de la vida y cualificaciones