Pharmacy Licensure Exam Guidelines

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Questions and Answers

What is the primary goal of the Generic Law of 1988?

To encourage the extensive use of drugs with generic names (correct)

To limit the availability of all medications

To promote the use of brand-name drugs exclusively

To increase the cost of pharmaceutical products

Which act specifically addresses the prohibition of counterfeit drugs?

R.A.No. 9502

R.A.No. 8203 (correct)

R.A.No. 6715

R.A.No. 9165

Which of the following does the Comprehensive Dangerous Drugs Act of 2002 NOT address?

Funding for the development of new medications (correct)

Family and community participation in enforcement

Unlawful acts and penalties

Drugs classified as dangerous drugs

What is one of the objectives of the Food and Drug Administration Act of 2009?

To improve the regulatory capacity of the Bureau of Food and Drug Administration (D) Signup and view all the answers

Which act amended the Intellectual Property Code to facilitate access to cheaper medicines?

R.A.No. 9502 (C) Signup and view all the answers

How does the Dangerous Drugs Act contribute to drug enforcement?

It encourages family and community participation in enforcement (D) Signup and view all the answers

Which statement aligns with the goals of the Generic Law of 1988 regarding health professionals?

To emphasize the scientific basis for drug use (D) Signup and view all the answers

What is the primary purpose of the Foods, Drugs, Devices, and Cosmetics Act?

To ensure the safety and efficacy of foods and medical supplies. (C) Signup and view all the answers

What role does the Bureau of Food and Drugs play in relation to counterfeit drugs?

It administers and supervises the implementation of the law against counterfeit drugs (D) Signup and view all the answers

Which agency is empowered to enforce the provisions of the Foods, Drugs, Devices, and Cosmetics Act?

The Bureau of Food and Drugs. (D) Signup and view all the answers

What significant change does the Generic Law of 1988 promote?

The use of generic names for the identification of drugs. (C) Signup and view all the answers

What action can the Department of Health take against drugs and devices that are not safe or efficacious?

Withdraw them from the market if necessary. (B) Signup and view all the answers

Which of the following is NOT a responsibility outlined for the Department of Health under the Foods, Drugs, Devices, and Cosmetics Act?

Encouraging private companies to manufacture more drugs. (A) Signup and view all the answers

What is one of the aims of the policy declared by the Generic Law of 1988?

To facilitate the free availability of generic drugs to indigent patients. (B) Signup and view all the answers

What authority does the Bureau of Food and Drugs have according to the Foods, Drugs, Devices, and Cosmetics Act?

To administer and enforce laws related to food and drugs. (A) Signup and view all the answers

How does the Foods, Drugs, Devices, and Cosmetics Act ensure a pure and safe supply of cosmetics?

By mandating quality measures and ensuring compliance. (B) Signup and view all the answers

What is a requirement for an immunizing pharmacist to provide vaccination services?

Certificate of Current Employment in the Pharmaceutical Outlet (A) Signup and view all the answers

Which law regulates the practice of pharmacy and sets standards in the Philippines?

R.A.No. 5921 – The Pharmacy Law (A) Signup and view all the answers

Which of the following is NOT a requirement for the operation of vaccine products?

Annual Quality Control Audit (D) Signup and view all the answers

What must an immunizing pharmacist possess in addition to a valid certificate of training in vaccination?

Certificate of Basic Life Support Training (C) Signup and view all the answers

Which act was signed into law to address counterfeit drugs in the Philippines?

R.A.No. 8203 – Special Law on Counterfeit Drugs (A) Signup and view all the answers

Who is responsible for the administration of the Pharmacy Examination in the Philippines?

Board of Pharmacy (A) Signup and view all the answers

What should be included in the Standard Operating Procedures (SOPs) for vaccine handling?

Disposal methods (A) Signup and view all the answers

Which of the following laws is directed towards ensuring access to cheaper and quality medicines?

R.A.No. 9502 – Universally Accessible Cheaper and Quality Medicines Act (B) Signup and view all the answers

What is the principal responsibility of a pharmacist according to the code of ethics?

To ensure the well-being of the patient (A) Signup and view all the answers

How should a pharmacist treat patient confidentiality?

Maintain and respect confidentiality (D) Signup and view all the answers

What aspect does the code emphasize about the pharmacist's relationship with other health professionals?

To respect their abilities and collaborate closely (B) Signup and view all the answers

What duty is expected of a pharmacist in relation to professional competence?

To maintain current knowledge and continuously enhance professional competence (D) Signup and view all the answers

The Code promotes the welfare of patients in what manner?

In a caring and compassionate manner (A) Signup and view all the answers

What role does the pharmacist play in health care policy according to the Code?

They help in formulating and implementing health care policies (D) Signup and view all the answers

According to the FIP Code of Ethics, a profession is characterized by what?

Willingness to comply with ethics that exceed minimum legal standards (C) Signup and view all the answers

Which of the following is NOT a responsibility of a pharmacist according to the Code?

Exposing patient information for personal benefits (A) Signup and view all the answers

What is one obligation a pharmacist has regarding individual treatment options?

To promote the individual's right to freedom of choice of treatment (B) Signup and view all the answers

Which obligation emphasizes the need for pharmacists to maintain a high level of professional knowledge?

To ensure competency in pharmaceutical services provided (C) Signup and view all the answers

What should a pharmacist do in the event of a pharmacy closure?

Refer the patient to another pharmacist (C) Signup and view all the answers

How should a pharmacist demonstrate respect for individual dignity?

By showing respect to life dignity and avoiding discrimination (B) Signup and view all the answers

What is a key obligation for ensuring ethical judgment in pharmacy practice?

To act with honesty and integrity in professional relationships (A) Signup and view all the answers

What does the pharmacist pledge regarding the good of individuals versus personal interests?

To always put the good of the individual before personal or commercial interest (C) Signup and view all the answers

Which obligation focuses on cooperation among healthcare professionals for better health outcomes?

To cooperate with colleagues in promoting good health (C) Signup and view all the answers

What is an obligation that addresses how pharmacists manage patient information?

To safeguard individual information without consent or due cause (C) Signup and view all the answers

What is one of the core values of the Philippine Pharmacists Association?

Integrity (C) Signup and view all the answers

Which of the following is NOT a part of the PPhA's mission?

Dedicate funds to research pharmaceutical companies (B) Signup and view all the answers

What is the purpose of the Continuing Professional Education (CPE) seminars offered by the PPhA?

To keep practicing pharmacists updated on industry trends (B) Signup and view all the answers

Which organization is NOT listed as one of the nine affiliate organizations under PPhA?

Philippine Medical Association (A) Signup and view all the answers

What kind of scholarships does the PPhA provide?

Scholarships for senior pharmacy students (D) Signup and view all the answers

Which of the following is a key activity of the Philippine Pharmacists Association?

Hosting an annual national convention (D) Signup and view all the answers

How long has the PPhA been providing Continuing Professional Education (CPE)?

Since 1960 (A) Signup and view all the answers

What benefit does the PPhA provide to topnotchers in the Pharmacy Licensure Exam?

Cash incentives (A) Signup and view all the answers

Which requirement is NOT necessary for a candidate to qualify for the Professional Licensure Exam for Pharmacists?

Licensure in a foreign country (A) Signup and view all the answers

What component of the internship program requires the least number of hours?

Public health and regulatory (C) Signup and view all the answers

Which of the following would disqualify a candidate from taking the Professional Licensure Exam for Pharmacists?

Failure to maintain good moral character (D) Signup and view all the answers

Which area is NOT evaluated during the Professional Licensure Exam for Pharmacists?

Business management (D) Signup and view all the answers

Which document is NOT required for candidates to present when applying for the Professional Licensure Exam?

Proof of financial stability (B) Signup and view all the answers

For a foreign candidate to practice pharmacy in the Philippines, which condition is essential?

Being of good moral character (A) Signup and view all the answers

What is the maximum number of hours required for the community internship component?

300 hours (B) Signup and view all the answers

Which aspect is NOT associated with the requirements for the licensure exam reevaluation?

Proof of employment history (A) Signup and view all the answers

Which principle requires healthcare practitioners to maximize benefits while minimizing harm?

Beneficence (B) Signup and view all the answers

Which of the following best defines autonomy in the context of biomedical ethics?

The ability to decide and act upon one’s decisions (A) Signup and view all the answers

What aspect of the pharmacist's professional behavior is reinforced by possessing a code of ethics?

Establishing consistent client expectations (C) Signup and view all the answers

Which statement accurately describes the principle of veracity?

It emphasizes truth-telling between patients and healthcare providers. (D) Signup and view all the answers

Which principle outlines the importance of fairness and entitlements in healthcare?

Justice (A) Signup and view all the answers

What is the primary focus of the ethical principle of confidentiality?

To foster trust between healthcare professionals and patients (B) Signup and view all the answers

What essential element of autonomy allows individuals to implement their decisions?

The power to act (B) Signup and view all the answers

To which principle does the phrase 'first, do no harm' relate?

Non-maleficence (D) Signup and view all the answers

Which act provides a framework for the involvement of families and schools in drug enforcement?

Comprehensive Dangerous Drugs Act of 2002 (B) Signup and view all the answers

Which of the following acts addresses the regulatory improvements for the Bureau of Food and Drug Administration?

Food and Drug Administration Act of 2009 (D) Signup and view all the answers

What is one of the responsibilities of the Dangerous Drugs Board as outlined in the Comprehensive Dangerous Drugs Act of 2002?

Develop public awareness programs on drug safety (B) Signup and view all the answers

What is one of the objectives of R.A.No. 9502, the Universally Accessible Cheaper and Quality Medicine Act?

To provide access to cheaper and quality medicines (D) Signup and view all the answers

Which statement best describes the role of the Bureau of Food and Drugs in relation to counterfeit drugs?

It administers and supervises the implementation of the Special Law on Counterfeit Drugs. (A) Signup and view all the answers

What aspect of drug safety does the Generic Law of 1988 specifically address?

Minimizing duplication in medications (A) Signup and view all the answers

Which law allows for the appropriation of funds to combat counterfeit drugs?

R.A.No. 8203 – Special Law on Counterfeit Drugs (C) Signup and view all the answers

What is the concept of distributive justice that allocates resources based on an individual's effort?

To each, according to effort (B) Signup and view all the answers

What does role fidelity require of healthcare professionals in relation to their patients?

To act in ways that consistently demonstrate loyalty (A) Signup and view all the answers

What is a requirement for a pharmacist to provide vaccination services in pharmacies?

Certificate of Training in Vaccination issued by PRC-BOP (B) Signup and view all the answers

Which of the following statements best describes informed consent in clinical settings?

It requires full disclosure of benefits and risks in writing. (A) Signup and view all the answers

What expectation do patients generally have regarding their healthcare providers?

That they will only be treated by providers of their choice (C) Signup and view all the answers

Which of the following laws emphasizes standardization and regulation of pharmacy education in the Philippines?

R.A.No. 5921 – The Pharmacy Law (B) Signup and view all the answers

What type of documents must vaccine products have issued by the FDA?

Certificates of Product Registration (D) Signup and view all the answers

What is the role of a Code of Ethics in a professional setting?

To serve as a comprehensive guideline for behavior within the profession (B) Signup and view all the answers

Which act provides the regulation of counterfeit drugs in the Philippines?

R.A.No. 8203 – Special Law on Counterfeit Drugs (D) Signup and view all the answers

What primary responsibility do pharmacists have in promoting patient care?

To ensure rational use of drugs and safety in medication (D) Signup and view all the answers

What is included in the Standard Operating Procedures (SOPs) for vaccine management?

Procedures for storage, handling, and disposal (A) Signup and view all the answers

Which principle of distributive justice emphasizes an equal share for all individuals?

To each, an equal share (B) Signup and view all the answers

Which of the following is NOT a requirement for obtaining a Certificate of Registration to practice pharmacy?

Completion of a residency program (C) Signup and view all the answers

What is a crucial aspect of the pharmacist's ethical obligation towards patient dignity?

To respect individual dignity and confidentiality (D) Signup and view all the answers

Who has the authority to administer the Pharmacy Examination in the Philippines?

Board of Pharmacy under the PRC (B) Signup and view all the answers

What must be monitored and reported as part of the vaccine dispensing process?

Adverse Events Following Immunization (AEFI) (D) Signup and view all the answers

What must a successful candidate achieve in the Professional Licensure Exam for Pharmacist to qualify?

A general weighted average of at least 75% (A) Signup and view all the answers

Which of the following is NOT a ground for reprimand, suspension or revocation of a pharmacist's license?

Insanity deemed temporary (C) Signup and view all the answers

What document must be certified true for a candidate applying for the Licensure Exam?

TOR in BS Pharmacy or equivalent (A) Signup and view all the answers

Which statement accurately describes the requirements for opening a retail pharmaceutical outlet?

A valid License to Operate must be issued by the FDA (D) Signup and view all the answers

In the record books of prescription, which detail is NOT typically required?

Patient's insurance details (B) Signup and view all the answers

What action must all successful applicants of the Licensure Exam for Pharmacists undertake?

Take an oath of profession (C) Signup and view all the answers

Which condition leads to non-registration of successful examinees by the Board?

Medical reports indicating addiction to drugs (D) Signup and view all the answers

What is a requirement for a pharmacist when handling prescription medications?

A clearly labeled prescription label must be affixed (D) Signup and view all the answers

Which of the following remains true regarding the timing of the Professional Licensure Exam?

The exam is conducted biannually (C) Signup and view all the answers

Which of the following criteria does NOT apply when reviewing a pharmacist's professional conduct?

Providing free samples of medications (D) Signup and view all the answers

Study Notes

Regulation of Pharmacy Practice

Professional Licensure Exam for Pharmacist:
- A certification test to evaluate candidate knowledge and skills for licensed pharmacist practice.
- Assesses competency in pharmaceutical sciences, pharmacology, patient care, and professional ethics.

Qualification for the Licensure Exam

A citizen of the Philippines:
- Required for the licensure exam.
Good moral character:
- A requirement for the exam
Internship experience of at least 1200 hours:
- Community (300 hours)
- Hospital (300 hours)
- Institutional (120 hours)
- Public health and regulatory (180 hours)
- Manufacturing (300 hours).
Bachelor of Science degree from accredited school:
- Essential qualification
At least 21 years of age:
- A legal requirement.
Passed the corresponding examination given by the Board of Pharmacy:
- Successfully passed a qualifying exam.
Valid certificate of registration issued by the Pharmacy Board:
- Required documentation from the board.
Requirements based on IRR of RA No. 10918:
- Citizenship of the Philippines or foreign country with reciprocity policy.
- Good moral character and reputation.
- Graduate of BS Pharmacy or its equivalent from a recognized HEI.
- Completed an internship program approved by the Board.
- Follows guidelines promulgated by the associations and the CHED (Commission on Higher Education)

Documentary Requirements

Original and photocopy of PSA issued birth certificate:
Original and photocopy of PSA issued marriage certificate (for married female):
Certification of Good Moral Character: Issued by barangay, church, school, or employer.
NBI clearance:
Certified true copy of TOR (Transcript of Records): In the BS Pharmacy or equivalent degree from the Philippines or foreign country, duly recognized by CHED.
Certificate of Completion of internship: Duly signed by the dean/program head of the school.

Licensure Examination Process

PLE given twice a year:
- Scheduled examination periods are twice a year.
General weighted average of 75%:
- Required passing score for all subjects
No rating lower than 50% in any subject:
- Minimum passing score per subject.
Report of ratings:
- Board submits ratings to PRC within 3 working days.
Oath of Profession:
- Required by all successful candidates before practicing pharmacy.

Grounds for reprimand, suspension, or revocation of license (based on RA 5921)

Immoral or dishonorable conduct:
Fraud or deceit in the acquisition of the certificate of registration:
Gross negligence, ignorance, or incompetence:
- Negligence in clinical practice leading to harm.
Malpractice:
- Aiding or abetting criminal abortion or sex crimes through dispensing or selling abortive or sex drugs.
Acting as a dummy of an alien:
- Illegal.
Addiction to habit-forming drugs:
- Addiction resulting in professional incompetence.
Insanity:
- Mental illness rendering someone incompetent.
Violation of the Code of Ethics:

Grounds for Non-Registration

Convicted of an offense involving moral turpitude:
- A serious crime.
Summarily adjudged guilty of misrepresentation or falsification:
- Falsification of documents.
Found guilty of immoral conduct or dishonorable conduct:
Addicted to drug or alcohol:
- Addiction causing professional incompetence.
Declared of unsound mind:
- A legal determination of mental incapacity.

Pharmacy Practice Setting Requirements

Affixing RPh:
- After the registered pharmacist's name.
Indication of information:
- Required for prescriptions.
Display of Certification of Registration:
- Required evidence of registration.
Sales of medicine, pharmaceuticals, drugs, devices:
Markings and inhibition to the sale of drug samples:
Pharmacist required & compensation:
- Required for practice and payment.
Display of certificate required:
- Showing required certificates.
Responsibility for quality of Pharmaceutical Products:
Filling and refilling of prescription:
Label of dispensed medicine:
Record books of prescription:
- Medication profile recording.
Name of prescriber:
Name and address of patient:
Product name:
Dosage strength and form:
Quantity of drug dispensed:
Initials of pharmacists:
Others as may be prescribed:
Requirements for Opening and Operation:
- Retail Pharmaceutical Outlet or Establishment.
Handling of Pharmaceutical Products:
- By persons other than a Pharmacist.
Administration of Adult Vaccines:
- Proper administration procedure.

A. Pharmaceutical Outlet

Valid License to Operate (LTO) issued by FDA:
Vaccine products with valid Certificates of Product Registration (CPR) issued by FDA:
Maintaining patient medication profile/record:
Standard Operating Procedures (SOPs):
- For vaccine storage, handling, preparation, dispensing, administration, and disposal.
Procedure monitoring, handling and reporting of adverse effects (AEFI):

B. Immunizing Pharmacist

Only PRC-BOP certified immunizing pharmacists:
- Allowed to provide vaccination services in pharmacies.
Certificate of Current Employment:
- In the Pharmaceutical Outlet.
Valid Certificate in Basic Life Support Training:
Valid Certificate of Training in Vaccination Issued by PRC-BOP:

Legal Control of Pharmacy Profession in the Philippines

Must be a registered pharmacist (RPh):
- Required for practice.
Administration of Pharmacy Examination and granting of registration:
Vested in the Board of Pharmacy which falls under the PRC.

Laws Governing the Practice of Pharmacy

R.A. No. 5921 – The Pharmacy Law:
R.A. No. 10918 – Revised Pharmacy Law:
R.A. No. 3720 – The Foods, Drugs, Devices, and Cosmetics Act:
R.A. No. 6675 – The Generics Law of 1988:
R.A. No. 8203 – Special Law on Counterfeit Drugs:
R.A. No. 9165 – The Comprehensive Dangerous Drugs Act of 2002:
R.A. No. 9502 – Universally Accessible Cheaper and Quality Medicines Act of 2008:
R.A. No. 9711 – Food and Drug Administration Act of 2009:

B. Ethical Control of Pharmacy Profession

Code of Ethics:
- More efficient decision-making process.
- Provides guidelines for directing professional behavior
Professional Characteristics:
- Specialized body of knowledge.
- Specific attitudes affecting professional behavior
- Existence of social sanction
- Desire to be professional
- An oath of allegiance and code of ethics.

Universal Principles of Biomedical Ethics

Autonomy:
- Ability to decide and implement personal decisions free from coercion constraint.
- Ability to decide.
- Power to act upon the decisions.
Veracity:
- Truthfulness in practitioner-patient interactions.
Beneficence:
- Actions aimed at benefiting others / preventing harm and promoting good.
Non-maleficence:
- Treating the sick in a way that is beneficial and not harmful
- Minimizing harm while maximizing good.
Confidentiality:
- Respect for patient privacy an important trust aspect that patients have in health care professionals
Justice:
- Concepts of fairness and equal treatment.
- Procedural justice: necessary in disputes.
- Distributive Justice: providing health care.
Role Fidelity:
- Following the role’s constraints and demonstrating loyalty
Informed Consent:
- Providing patients with complete information before clinical trials, medication, or surgery.
Patient Rights:
- Expecting knowledge and experience of clinicians, responsive providers, and numerous treatment choices

Code of Ethics

Carefully formulated system:
- Principles or rules of practice for professionals.

Philippine Pharmacists Association Code of Ethics

Preamble:
- Pharmacists assist individuals, promoting good health and rational drug use for a better quality of life.
Ethical principles:
Placing patient well-being as central to practice
Promoting individual welfare in a caring and compassionate manner
Supporting the needs of the individual, community, and society.
Respecting patient rights and confidentiality.
Acting with honesty, integrity, and professionalism in all relationships.
Respecting abilities, and contributions from colleagues and other health professionals in ensuring better patient care and maintaining competency
Coordinating with government and other health professionals to shape health care policies and programs which benefit society.

FIP Code of Ethics

1. Obligations Pharmacist: Prime responsibility is individual (before personal or commercial interest); be objective and support individual access to effective treatment.
2. Obligations Pharmacist: Show the same dedication to all; respect life, avoid discrimination, treat each individual with respect and regard to their personal circumstances.
3. Obligations Pharmacist: Respect individual choice, do not disseminate identifying information without consent/proper cause.
4. Obligations Pharmacist: Respect and safeguard the individual without consent or cause; cooperate with colleagues and other professionals.
5. Obligations Pharmacist: Act with honesty and integrity in professional relationships; avoid practices and working conditions that could impair professional judgement.
6. Obligations Pharmacist: Serves individual, community, and society; recognize responsibilities involved to serve individuals and society (with large-scale implications)
7. Obligations Pharmacist: Maintain and develop professional knowledge and skills; update accordingly with pharmaceutical developments.
8. Obligations Pharmacist: Pharmacy to serve the community by handling disputes or closure by informing and referring patients.

Oath of a Pharmacist

Professional life to serve humanity: devotion and service to all humankind.
Welfares of humanity: relief from suffering and humanity's primary concern.
Skills, knowledge, experiences to ensure optimal drug therapies: to serve patients to the best understanding of medicine through skill, knowledge and experience.
Develop professional competency: being current with developments and maintaining competence.
Maintain principles: upholding high morals, ethical and legal conduct.
I take the vows voluntarily and entrusted by public.
Advocate change for improved patient care.

Pharmaceutical Organization

Purpose:
- Attainment of goals and objectives for pharmacy profession upliftment
- Enhancing Pharmacy services and better delivering patient care.
- Acts as the collective voice of members, setting standards.
- The different organizations are established at international, national, and local levels for specialization.
The Philippine Pharmacists Association (PPhA):
- A national organization accredited by PRC and SEC.
- 2008: Former Philippine Pharmaceutical Association.
- Located in Manila.
- Established in 1920.
- Has affiliate organizations.
- Has a vision of total Filipino well-being and partnership with healthcare professionals.
- Functions include upholding and enhancing pharmacy, advocating equal partnership, participating in health policies and programs, uniting pharmaceutical chapters/organizations, safeguarding member rights, and promoting professional growth.
- Holds a national convention and provides cash incentives for top performers on the Pharmacy Licensure Exam
Other Organizations:
- PAPPI: Pharmacists in Pharmaceutical Industry.
- PSHP: Society of Hospital Pharmacists.
- PACOP: Association of Colleges of Pharmacy.
- DOHLP: Department of Health League of Pharmacists.
- IPAP: Institutional Pharmacists Association of the Philippines. – FJCPPHA: Federation of Junior Chapters of the PPhA.
- YPG: Young Pharmacists Group Philippines.
- DSAP Drugstore Association of the Philippines – FAPA: Federation of Asian Pharmaceutical Associations.
- AASP: Asian Association of Schools of Pharmacy.
- FIP: International Pharmaceutical Federation.
PPhA programs:
- Maintaining medication safety through programs.
- Continuing professional education programs (CPE) since 1960 to keep pharmacists updated., with seminars available
- Scholarship for pharmacy students.

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Explore the essential qualifications and requirements for becoming a licensed pharmacist in the Philippines. This quiz covers various aspects like internship experience, educational background, and ethical standards necessary for the licensure exam. Test your knowledge on the regulatory framework surrounding pharmacy practice.