UNIT 4: Regulation of Pharmacy Practice

• What is the title of UNIT IV in the study material?


  Regulation of Pharmacy Practice
• What does PLE stand for in the context of pharmacy?


  Professional Licensure Examination
• What degree must one graduate with to qualify for the Licensure Examination?

  Bachelor of Science in Pharmacy
• Why is good moral character a requirement for the Licensure Examination?


  It ensures that candidates uphold ethical standards in pharmacy practice.
• How many hours of internship are required for the Licensure Examination?


  At least 1200 hours
• What are the components of the required internship program?


  • Community: 300 hours
  • Hospital: 300 hours
  • Institutional: 120 hours
  • Social and Administrative: 180 hours
  • Manufacturing: 300 hours
• What is the citizenship requirement for the Licensure Examination?


  Must be a citizen of the Philippines or a foreign country with reciprocity.
• What is the significance of the internship program being approved by the Board?


  It ensures that the internship meets the standards set for pharmacy education.
• How many modules are included in the Pharmacy Licensure Examination?


  Six modules
• What is the structure of the Pharmacy Licensure Examination over the two days?


  • Day 1:
  • Pharmaceutical Chemistry (20%)
  • Pharmacognosy (15%)
  • Practice of Pharmacy (17.5%)
  • Day 2:
  • Pharmacology-Pharmacokinetics (15%)
  • Pharmaceutics (17.5%)
  • Quality Assurance and Quality Control (15%)
• What is the total duration of the Pharmacy Licensure Examination?


  Two days
• What is the minimum General Weighted Average (GWA) required to pass the licensure examination?


  75%
• What happens if an applicant fails the exam three times?


  They must attend a refresher program before retaking the exam.
• What is the age requirement to engage in the practice of pharmacy in the Philippines?


  At least 21 years of age
• What document must a candidate hold to practice pharmacy after passing the exam?

  A valid certificate of registration
• What are the documentary requirements for the Licensure Examination?

  • Original and photocopy of PSA birth certificate
  • Original and photocopy of PSA marriage certificate (if applicable)
  • Certification of Good Moral Character
  • NBI clearance
  • Certified true copy of TOR in BS Pharmacy
  • Certificate of Completion of internship program
• How often is the PLE conducted?


  Twice a year
• What is the purpose of the Report of Rating submitted by the board?


  To inform the PRC of the ratings obtained by each candidate.
• What must successful candidates do before entering the pharmacy profession?

  Take their oath of profession
• What are the grounds for reprimand, suspension, or revocation of a pharmacy license?

  1. Immoral or dishonorable conduct
  2. Fraud or deceit in obtaining registration
  3. Gross negligence or incompetence
  4. Malpractice
  5. Acting as a dummy for an unqualified person
  6. Addiction to substances
  7. Insanity
  8. Violations of the Code of Ethics
• What are the grounds for non-registration of a successful examinee?


  1. Convicted of an offense involving moral turpitude
  2. Misrepresentation or falsification of documents
  3. Immoral or dishonorable conduct
  4. Medically proven addiction to drugs or alcohol
  5. Declared of unsound mind
• What are the requirements for pharmacy practice settings?

  • Affixing RPh after a pharmacist's name
  • Indicating COR number and validity
  • Displaying Certification of Registration
  • Maintaining patient medication profiles
  • Responsibility for quality of pharmaceutical products
• What are the requirements for opening and operating a retail pharmaceutical outlet?

  1. Valid License to Operate (LTO) from the FDA
  2. Valid Certificates of Product Registration for vaccines
  3. Maintain patient medication profiles
  4. Standard Operating Procedures for vaccine handling
  5. Procedure for monitoring and reporting AEFI
• Who can provide vaccination services in pharmacies?

  Only PRC-BOP certified immunizing pharmacists
• What are the requirements for an immunizing pharmacist?


  1. Certificate of Current Employment
  2. Valid Certificate in Basic Life Support Training
  3. Valid Certificate of Training in Vaccination issued by PRC-BOP
• What are the basic categories of legal principles affecting pharmacy practice?

  1. Statutory Law
  2. Regulatory Law
  3. Common Law
• What is statutory law in the context of pharmacy practice?


  It refers to laws passed by legislative bodies that dictate behavior and set penalties.
• What is regulatory law?


  These are laws enacted by government agencies that enforce rules affecting pharmacy practice.
• What does common law refer to?

  It refers to laws that have evolved through judicial decisions over time.