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?

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

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

<p>R.A.No. 9502 (C)</p> Signup and view all the answers

How does the Dangerous Drugs Act contribute to drug enforcement?

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

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

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

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

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

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

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

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

<p>The Bureau of Food and Drugs. (D)</p> Signup and view all the answers

What significant change does the Generic Law of 1988 promote?

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

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

<p>Withdraw them from the market if necessary. (B)</p> 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?

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

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

<p>To facilitate the free availability of generic drugs to indigent patients. (B)</p> 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?

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

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

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

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

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

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

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

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

<p>Annual Quality Control Audit (D)</p> Signup and view all the answers

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

<p>Certificate of Basic Life Support Training (C)</p> Signup and view all the answers

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

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

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

<p>Board of Pharmacy (A)</p> Signup and view all the answers

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

<p>Disposal methods (A)</p> Signup and view all the answers

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

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

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

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

How should a pharmacist treat patient confidentiality?

<p>Maintain and respect confidentiality (D)</p> Signup and view all the answers

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

<p>To respect their abilities and collaborate closely (B)</p> Signup and view all the answers

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

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

The Code promotes the welfare of patients in what manner?

<p>In a caring and compassionate manner (A)</p> Signup and view all the answers

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

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

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

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

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

<p>Exposing patient information for personal benefits (A)</p> Signup and view all the answers

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

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

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

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

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

<p>Refer the patient to another pharmacist (C)</p> Signup and view all the answers

How should a pharmacist demonstrate respect for individual dignity?

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

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

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

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

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

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

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

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

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

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

<p>Integrity (C)</p> Signup and view all the answers

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

<p>Dedicate funds to research pharmaceutical companies (B)</p> Signup and view all the answers

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

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

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

<p>Philippine Medical Association (A)</p> Signup and view all the answers

What kind of scholarships does the PPhA provide?

<p>Scholarships for senior pharmacy students (D)</p> Signup and view all the answers

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

<p>Hosting an annual national convention (D)</p> Signup and view all the answers

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

<p>Since 1960 (A)</p> Signup and view all the answers

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

<p>Cash incentives (A)</p> Signup and view all the answers

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

<p>Licensure in a foreign country (A)</p> Signup and view all the answers

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

<p>Public health and regulatory (C)</p> Signup and view all the answers

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

<p>Failure to maintain good moral character (D)</p> Signup and view all the answers

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

<p>Business management (D)</p> Signup and view all the answers

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

<p>Proof of financial stability (B)</p> Signup and view all the answers

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

<p>Being of good moral character (A)</p> Signup and view all the answers

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

<p>300 hours (B)</p> Signup and view all the answers

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

<p>Proof of employment history (A)</p> Signup and view all the answers

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

<p>Beneficence (B)</p> Signup and view all the answers

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

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

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

<p>Establishing consistent client expectations (C)</p> Signup and view all the answers

Which statement accurately describes the principle of veracity?

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

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

<p>Justice (A)</p> Signup and view all the answers

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

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

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

<p>The power to act (B)</p> Signup and view all the answers

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

<p>Non-maleficence (D)</p> Signup and view all the answers

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

<p>Comprehensive Dangerous Drugs Act of 2002 (B)</p> Signup and view all the answers

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

<p>Food and Drug Administration Act of 2009 (D)</p> 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?

<p>Develop public awareness programs on drug safety (B)</p> 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?

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

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

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

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

<p>Minimizing duplication in medications (A)</p> Signup and view all the answers

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

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

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

<p>To each, according to effort (B)</p> Signup and view all the answers

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

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

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

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

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

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

What expectation do patients generally have regarding their healthcare providers?

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

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

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

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

<p>Certificates of Product Registration (D)</p> Signup and view all the answers

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

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

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

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

What primary responsibility do pharmacists have in promoting patient care?

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

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

<p>Procedures for storage, handling, and disposal (A)</p> Signup and view all the answers

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

<p>To each, an equal share (B)</p> Signup and view all the answers

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

<p>Completion of a residency program (C)</p> Signup and view all the answers

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

<p>To respect individual dignity and confidentiality (D)</p> Signup and view all the answers

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

<p>Board of Pharmacy under the PRC (B)</p> Signup and view all the answers

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

<p>Adverse Events Following Immunization (AEFI) (D)</p> Signup and view all the answers

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

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

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

<p>Insanity deemed temporary (C)</p> Signup and view all the answers

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

<p>TOR in BS Pharmacy or equivalent (A)</p> Signup and view all the answers

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

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

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

<p>Patient's insurance details (B)</p> Signup and view all the answers

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

<p>Take an oath of profession (C)</p> Signup and view all the answers

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

<p>Medical reports indicating addiction to drugs (D)</p> Signup and view all the answers

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

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

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

<p>The exam is conducted biannually (C)</p> Signup and view all the answers

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

<p>Providing free samples of medications (D)</p> Signup and view all the answers

Flashcards

Vaccine Product Registration

Vaccine products must have a valid Certificate of Product Registration (CPR) issued by the FDA.

Immunizing Pharmacist Certification

Only PRC-BOP certified immunizing pharmacists can provide vaccinations in pharmacies.

Immunizing Pharmacist Requirements

Immunizing pharmacists require a certificate of employment, BLS training, and vaccination training certificates.

Pharmacy Law

The legal framework governing the practice of pharmacy in the Philippines, set by Republic Act 5921.

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Board of Pharmacy

The organization that administers and regulates pharmacy examinations and registrations in the Philippines.

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Standard Operating Procedures (SOPs)

Procedures for vaccine storage, handling, preparation, dispensing, administration, and disposal maintained by pharmacies.

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AEFI Monitoring

A procedure for monitoring, handling, and reporting of Adverse Events Following Immunization (AEFI).

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Patient Medication Profile

Pharmacies must maintain a record of a patient's previous medication usage and allergies.

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R.A. No. 3720

An act ensuring the safety and purity of foods, cosmetics, and drugs/devices.

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Bureau of Food and Drugs

Government agency responsible for enforcing laws related to food, drugs, and cosmetics.

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Food, Drugs, and Devices Act

Law mandating safety standards for food, cosmetics, and drugs/devices. It sets specific standards and measures and aims to ensure efficient usage.

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R.A. No. 6675

A law that promotes the use of generic drug names.

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Generic names

Common names for drugs, used instead of brand names, aiming for lower costs.

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National Drug Formulary

Official list of acceptable drugs.

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Rational use of drugs

Ensuring drugs are used effectively and safely, minimizing waste and side effects.

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Standards and quality measures

Specific requirements for the purity and safety of foods, drugs, and devices.

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Pharmacist's Primary Responsibility

The pharmacist's primary obligation is to prioritize the well-being of the individual patient.

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Professional Standards vs. Legal Requirements

Pharmacists adhere to ethical and professional standards that go beyond the minimum legal requirements.

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Patient's Well-being

Pharmacists place the patient's well-being at the center of their practice.

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Caring and Compassionate Manner

Pharmacists treat individuals with care and compassion.

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Serving the Community and Society

Pharmacists serve the needs of individuals, communities, and society as a whole, promoting health for all.

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Patient Confidentiality

Pharmacists respect patient privacy and uphold the confidentiality of patient records.

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Honesty, Integrity, and Professionalism

Pharmacists act with honesty, integrity, and professional conduct in their interactions with patients and healthcare professionals.

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Respect for Colleagues

Pharmacists value and respect the contributions of their colleagues and other healthcare professionals, collaborating to improve patient care.

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Generic Law of 1988

This law encourages the use of generic drugs by promoting a rational system for procuring and distributing them. It also emphasizes the scientific foundation for drug use to enhance health professionals' awareness of their therapeutic effectiveness.

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Counterfeit Drugs

Republic Act No. 8203 prohibits the production and distribution of fake medications, penalizes offenders, and assigns the Bureau of Food and Drugs to enforce its provisions.

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Dangerous Drugs Act of 2002

This law classifies drugs as dangerous, controlled precursors, or essential chemicals, defines unlawful acts and penalties, and outlines roles for government agencies, private sectors, and individuals in drug control.

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Universally Accessible Cheaper and Quality Medicine Act

Republic Act No. 9502 ensures affordable and high-quality medication by amending previous laws related to intellectual property, generic drugs, and pharmacy.

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Food and Drug Administration Act of 2009

This law focuses on strengthening the Bureau of Food and Drug Administration (FDA) by establishing testing labs, field offices, and upgrading equipment and human resources. It also aims to enhance FDA's regulatory capacity.

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Drug Safety

The Generic Law of 1988 promotes drug safety by minimizing duplication in medications and/or drugs with potentially adverse drug interactions.

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Drug Effectiveness

The Generic Law of 1988 encourages health professionals to be aware of the scientific basis of drug use, promoting better understanding of their therapeutic effectiveness.

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Regulation of Establishments and Products

The Food and Drug Administration Act of 2009 aims to enhance the FDA's administrative and technical capacity in overseeing establishments and products under its jurisdiction.

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Pharmacist's Objectivity

A pharmacist must prioritize factual information and unbiased decisions, even if it conflicts with personal opinions or financial interests.

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Individual's Well-being

A pharmacist's primary responsibility is to promote the health and safety of each person they serve, even above their own interests.

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Respect for Life Dignity

Pharmacists must treat all individuals with respect and avoid discriminatory practices, focusing on individual needs.

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Patient's Right to Choose

A pharmacist respects the patient's choices in their treatment plan, even if it differs from the pharmacist's own opinion.

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Confidentiality and Privacy

Pharmacists must protect patient information and avoid disclosing it without consent, unless legally required.

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Collaboration for Health

Pharmacists work with other healthcare professionals and agencies to improve health outcomes and address health challenges.

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Honesty and Integrity

Pharmacists must maintain ethical behavior and professional standards, avoiding actions that could compromise their judgment.

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Continuous Learning & Skill Development

Pharmacists are committed to staying up-to-date with the latest knowledge and skills to provide effective care.

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PPhA's role in healthcare

The Philippine Pharmacists Association (PPhA) aims to ensure pharmacy's recognition as an equal and distinct partner within the healthcare system.

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PPhA's policy involvement

PPhA actively contributes to the development and implementation of healthcare policies, standards, and programs at both the national and international levels.

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PPhA's unifying force

PPhA acts as a bridge, connecting various local pharmaceutical chapters, affiliate organizations, and networks with national and international healthcare organizations.

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PPhA's member benefits

PPhA prioritizes protecting the rights and promoting the well-being of its members.

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PPhA's professional development

PPhA encourages continuous professional growth and development for its members through opportunities like continuing professional education (CPE).

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PPhA's core values

PPhA's core values are solidarity, professionalism, integrity, competence, and social responsibility. These values guide their actions and decisions.

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PPhA's affiliate organizations

The PPhA has 9 affiliate organizations, representing various sectors within the pharmaceutical profession.

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PPhA's contributions to pharmacy practice

PPhA works to promote medication safety, enhance professional competency among its members, and provide ongoing professional development opportunities.

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Pharmacist's License

A certificate that permits an individual to practice pharmacy in the Philippines, granted after passing the licensure exam and meeting all qualifications.

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Who can take the Pharmacist Licensure Exam?

Only Filipino citizens, with good moral character, a BS Pharmacy degree from an accredited school and completing a 1200-hour internship are eligible.

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Internship Requirements

Pharmacists-in-training must complete at least 1200 hours in various settings like community, hospital, manufacturing, and public health.

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Republic Act No. 10918

This law governs the practice of pharmacy in the Philippines, outlining qualifications, licensing, and other regulations.

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Good Moral Character

A necessary requirement for pharmacists, reflecting honesty, integrity, and ethical conduct.

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Reciprocity

When the Philippines recognizes a foreign pharmacy license, allowing the holder to practice in the Philippines.

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Professional Ethics

A set of moral principles and values guiding pharmacists' decisions and actions to ensure patient safety and well-being.

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What are the requirements for a Pharmacy Practice Setting?

A pharmacy practice setting must meet specific requirements, including the display of the pharmacist's license, the proper handling of prescription drugs, and the maintenance of patient medication profiles.

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What are the requirements for opening a retail pharmacy outlet?

To open a retail pharmacy outlet, you need a valid License to Operate (LTO) issued by the FDA.

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What are the grounds for non-registration of a pharmacist?

A pharmacist might not be registered if they have been convicted of a crime involving moral turpitude, found guilty of immoral conduct, or medically proven to be addicted to drugs or alcohol.

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What are some grounds for license suspension or revocation?

A pharmacist's license can be suspended or revoked for various reasons, including immoral conduct, fraud or deceit, gross negligence, malpractice, or addiction.

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What is the purpose of the Professional Licensure Exam for Pharmacists (PLE)?

The PLE is a national examination that assesses a candidate's knowledge and skills to ensure they meet the required standards for practicing pharmacy.

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What is the 'Oath of Profession' for pharmacists?

Successful candidates in the PLE must take an oath before entering the practice of pharmacy.

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What are the requirements for a candidate to pass the PLE?

A candidate needs a general weighted average of 75%, with no score lower than 50% in any subject.

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What are some requirements for dispensing medicine?

Dispensing medicine requires precise labeling, proper record-keeping, and accurate patient information.

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What is the role of the Board of Pharmacy (BOP)?

The BOP regulates and oversees the practice of pharmacy in the Philippines, including issuing licenses, conducting examinations, and enforcing ethical standards.

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What are the roles of the FDA and CHED in pharmacy?

The FDA regulates the safety and quality of pharmaceuticals, while CHED recognizes and accredits institutions of higher learning in pharmacy.

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What is a CPR?

A Certificate of Product Registration is a document issued by the FDA to confirm a vaccine product meets safety and quality standards.

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What is an Immunizing Pharmacist?

A pharmacist certified by the PRC-BOP to administer vaccinations.

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What are SOPs?

Standard Operating Procedures are detailed steps for storing, handling, preparing, dispensing, administering, and disposing of vaccines.

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What is an AEFI?

An Adverse Event Following Immunization is any health problem occurring after vaccination.

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What is the Pharmacy Law?

Republic Act No. 5921 governs the practice of pharmacy in the Philippines, setting standards and regulations.

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What is the Board of Pharmacy?

The Board of Pharmacy, under the PRC, regulates pharmacy practice, administers exams, and grants licenses.

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Who governs pharmacy practice in the Philippines?

Several key laws govern pharmacy practice, including R.A. 5921 (Pharmacy Law), R.A. 10918 (Revised Pharmacy Law), and the Food and Drug Administration Act.

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What are the requirements for a pharmacist to practice in the Philippines?

A registered pharmacist (RPh) must have a BS Pharmacy degree from an accredited school, pass the licensure exam, and complete a 1200-hour internship.

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Autonomy

The right to make your own decisions without being controlled by others. It involves the ability to decide and the power to act on those decisions.

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Veracity

The principle of truth-telling, both for the patient and the healthcare professional. Patients must be truthful for proper care, and practitioners must disclose information so patients can make informed decisions.

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Beneficence

Doing good for others, especially in healthcare. It means preventing harm, removing harm, and actively promoting good.

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Non-maleficence

The principle of 'do no harm.' Healthcare professionals must strive to minimize harm and maximize benefits for their patients.

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Confidentiality

Keeping patient information private and secure. It's based on the trust patients have in healthcare professionals.

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Justice

Fairness and equity in healthcare. It means providing equal access to resources and treatments, ensuring fair treatment for everyone.

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What are some universal ethical principles in biomedical ethics?

Common ethical principles in biomedical ethics include autonomy, veracity, beneficence, non-maleficence, confidentiality, and justice. These principles help guide the ethical decision-making process in healthcare.

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What are the professional characteristics that contribute to strong ethical control in pharmacy?

A profession exhibits characteristics like specialized knowledge, specific attitudes, social sanctions, a desire for professionalism, and a code of ethics. These factors contribute to ethical standards and behavior in the field.

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Distributive Justice

A concept in healthcare ethics that deals with fair allocation of resources and benefits. It includes principles like equality, need, effort, contribution, merit, and ability to pay.

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Role Fidelity

A principle in biomedical ethics where healthcare professionals act in ways that demonstrate loyalty to their patients. It's about fulfilling the promises and responsibilities of their role.

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Informed Consent

A fundamental principle in biomedical ethics that requires patients to be fully informed about potential benefits and risks before making decisions about their care.

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Patient's Rights

These are the rights patients have when receiving healthcare, including choosing their doctors, treatments, and hospitals, and having their wishes respected.

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Code of Ethics

A set of principles or rules that guide the practice of a particular profession. It provides ethical standards for professionals to follow.

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Pharmacist's Role in Healthcare

Pharmacists are healthcare professionals who play a crucial role in ensuring medication safety, providing patient education, and promoting rational drug use.

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Board of Pharmacy (BOP)

The regulatory body for pharmacy practice in the Philippines. It oversees licensing, examinations, and ethical standards for pharmacists.

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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:
  • 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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