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Pharmacy Board Exam45 min read
Pharmacy Practice & Laws
Drug Dispensing, Regulations & Patient Care in the Philippines
In This Section
1. Prescription Processing
Parts of a Prescription
Prescriber Information
- β’ Name and address
- β’ PRC license number
- β’ PTR number (Professional Tax Receipt)
- β’ S2 number (for dangerous drugs)
- β’ Signature
Patient Information
- β’ Full name
- β’ Age (especially for children/elderly)
- β’ Gender (if relevant to dosing)
- β’ Address (required for controlled drugs)
- β’ Date of prescription
Superscription
The Rx symbol (Recipe = "take thou") - traditionally placed at top left
Inscription
Drug name (generic/brand), strength/dosage form, quantity to dispense
Subscription
Dispensing directions to the pharmacist (e.g., "Dispense as written," "May substitute")
Signa (Sig)
Directions for the patient on how to take the medication
Common Latin Abbreviations
| Abbreviation | Latin | Meaning |
|---|---|---|
| ac | ante cibum | before meals |
| pc | post cibum | after meals |
| bid | bis in die | twice a day |
| tid | ter in die | three times a day |
| qid | quater in die | four times a day |
| hs | hora somni | at bedtime |
| prn | pro re nata | as needed |
| stat | statim | immediately |
| po | per os | by mouth |
| q4h | quaque 4 hora | every 4 hours |
Prescription Validity
- β’Regular prescriptions: Valid for 1 year from date of issuance
- β’Dangerous drugs (Schedule II): Valid for 3 days only
- β’Controlled substances: Cannot be refilled; new prescription required
- β’Antibiotics: Best dispensed promptly; check clinical appropriateness
2. Drug Dispensing
The Dispensing Process
1
Receive & Validate Prescription
Check completeness, authenticity, legality, prescriber authorization
2
Patient Profile Review
Check allergies, drug interactions, therapeutic duplications
3
Drug Preparation
Select correct drug, verify strength, count/measure accurately
4
Labeling
Patient name, drug name, strength, directions, warnings, pharmacy info
5
Final Check
Pharmacist verification before dispensing to patient
6
Patient Counseling
Explain medication use, side effects, storage, answer questions
Generic Substitution (RA 6675)
The Generics Act of 1988 mandates that prescriptions should use generic names. Pharmacists may substitute with generically equivalent products unless prescriber indicates "DAW" (Dispense As Written).
When Substitution is Allowed
- β’ Same active ingredient
- β’ Same strength and dosage form
- β’ Bioequivalent products
- β’ Patient consent obtained
When NOT to Substitute
- β’ "No substitution" or "DAW" written
- β’ Narrow therapeutic index drugs
- β’ Critical dose drugs
- β’ Patient refuses
Labeling Requirements
Required Information
- β’ Patient's name
- β’ Drug name (generic name required)
- β’ Strength and quantity
- β’ Directions for use
- β’ Prescriber's name
- β’ Pharmacy name and address
- β’ Date dispensed
- β’ Expiration date
Auxiliary Labels
- β’ "Shake well before use"
- β’ "Take with food"
- β’ "May cause drowsiness"
- β’ "Avoid sunlight"
- β’ "Refrigerate"
- β’ "For external use only"
- β’ "Keep out of reach of children"
3. Philippine Pharmacy Laws
Major Pharmacy-Related Laws
| Law | Title | Key Provisions |
|---|---|---|
| RA 10918 | Philippine Pharmacy Act of 2016 | Current pharmacy practice law; CPD requirements; scope of practice |
| RA 6675 | Generics Act of 1988 | Generic prescribing mandatory; generic name prominent on labels |
| RA 9502 | Universally Accessible Cheaper and Quality Medicines Act of 2008 | MDRP (maximum drug retail price); parallel importation; compulsory licensing |
| RA 9711 | Food and Drug Administration Act of 2009 | Created FDA; regulates drugs, food, cosmetics, devices |
| RA 9165 | Comprehensive Dangerous Drugs Act of 2002 | Drug schedules; PDEA; penalties for illegal drugs |
| RA 3720 | Food, Drug and Cosmetic Act | Original drug regulation law (amended by RA 9711) |
RA 10918: Philippine Pharmacy Act
Scope of Pharmacy Practice
- β’ Drug dispensing and compounding
- β’ Drug information services
- β’ Patient medication counseling
- β’ Pharmaceutical care
- β’ Drug manufacturing QC
- β’ Drug marketing and distribution
- β’ Clinical pharmacy services
Requirements for Practice
- β’ BS Pharmacy degree
- β’ Pass PLE (Pharmacist Licensure Exam)
- β’ Valid PRC license
- β’ CPD units (45 per 3-year period)
- β’ APID (for handling dangerous drugs)
Board of Pharmacy
Composed of a Chairman and 4 members appointed by the President. Supervises PLE, issues certificates of registration, and promulgates Code of Ethics.
Pharmacy Establishment Requirements
Drug Retail Outlet (Drugstore)
- β’ LTO from FDA
- β’ Registered pharmacist in charge
- β’ Proper storage facilities
- β’ Adequate floor space
- β’ Prescription file maintenance
Hospital Pharmacy
- β’ Chief pharmacist supervision
- β’ 24/7 operation (larger hospitals)
- β’ Formulary system
- β’ Drug information services
- β’ Sterile compounding (if applicable)
4. Controlled Substances (RA 9165)
Drug Schedules
Schedule I - Prohibited Drugs
No accepted medical use. High potential for abuse.
- β’ Heroin, LSD, MDMA (Ecstasy), Methamphetamine (shabu)
- β’ Cannabis/Marijuana (unless for research)
- β’ Cannot be prescribed legally
Schedule II - Dangerous Drugs with Medical Use
High abuse potential but accepted medical use with severe restrictions.
- β’ Morphine, Fentanyl, Oxycodone, Methadone
- β’ Amphetamines (for ADHD)
- β’ S2 prescription required (special prescription form)
- β’ Valid for 3 days only; no refills
Schedule III - Moderate Abuse Potential
- β’ Combination products with limited narcotic quantities
- β’ Codeine combinations (e.g., co-codamol)
- β’ Ketamine, Anabolic steroids
Schedule IV - Low Abuse Potential
- β’ Benzodiazepines (Diazepam, Alprazolam, Lorazepam)
- β’ Zolpidem, Zopiclone (hypnotics)
- β’ Phenobarbital
- β’ Regular prescription but monitored
S2 Prescription Requirements
Prescriber Requirements
- β’ Valid S2 license from PDEA
- β’ Use official S2 prescription form
- β’ Written in ink, no erasures
- β’ Maximum 3-day supply (acute)
- β’ Patient's complete address
Pharmacist Requirements
- β’ Verify S2 license of prescriber
- β’ Record in S2 logbook
- β’ Retain prescription copy
- β’ Submit quarterly reports to PDEA
- β’ Secure storage of S2 drugs
PDEA (Philippine Drug Enforcement Agency)
The lead agency responsible for dangerous drug enforcement. Oversees:
- β’ S2 license issuance and monitoring
- β’ Drug enforcement operations
- β’ Import/export permits for controlled drugs
- β’ Coordination with international agencies
5. Drug Regulation & FDA
FDA Philippines Functions
Created by RA 9711, the Food and Drug Administration ensures the safety, efficacy, and quality of health products in the Philippines.
Regulatory Functions
- β’ Drug registration (CPR issuance)
- β’ Establishment licensing (LTO)
- β’ GMP certification
- β’ Import/export permits
- β’ Product quality surveillance
- β’ Adverse event monitoring
Products Regulated
- β’ Drugs and medicines
- β’ Biologics and vaccines
- β’ Medical devices
- β’ Food products
- β’ Cosmetics
- β’ Household hazardous substances
Drug Registration Process
Certificate of Product Registration (CPR)
Required before any drug can be marketed/sold in the Philippines. Valid for 5 years, renewable.
License to Operate (LTO)
Required for manufacturers, importers, distributors, retailers. Renewed annually.
GMP Certificate
Good Manufacturing Practice certification for drug manufacturers. Based on PIC/S guidelines.
Maximum Drug Retail Price (MDRP)
Under RA 9502, the government can impose price ceilings on essential medicines.
- Covered drugs: Initially 21 molecules for common diseases
- Price reduction: Up to 50% from original prices
- Enforcement: FDA monitors compliance; penalties for violators
- Goal: Make essential medicines affordable to Filipinos
6. Patient Counseling
Key Counseling Points
What to Cover
- βDrug name (generic & brand)
- βPurpose/indication
- βHow to take (dose, frequency, duration)
- βExpected benefits
- βCommon side effects
- βDrug-drug/drug-food interactions
- βStorage requirements
- βWhat to do if dose is missed
Communication Tips
- β’ Use simple, non-technical language
- β’ Speak in Filipino/local dialect if needed
- β’ Use teach-back method
- β’ Provide written instructions
- β’ Encourage questions
- β’ Ensure privacy during counseling
- β’ Consider health literacy level
- β’ Document counseling provided
Special Populations
Pediatric Patients
- β’ Counsel the parent/caregiver
- β’ Emphasize accurate dosing (use measuring devices)
- β’ Palatability issuesβmixing with food/drink
- β’ Storage away from children
- β’ Age-appropriate dosage forms
Geriatric Patients
- β’ Speak slowly and clearly
- β’ Use large-print labels if needed
- β’ Simplify regimens (pill organizers)
- β’ Address polypharmacy concerns
- β’ Consider cognitive impairment
Pregnant/Lactating Women
- β’ Confirm pregnancy status before dispensing
- β’ Check FDA pregnancy categories
- β’ Warn about teratogenic drugs
- β’ Advise on breastfeeding safety
Patients with Chronic Disease
- β’ Emphasize adherence importance
- β’ Discuss long-term therapy goals
- β’ Monitor for drug-disease interactions
- β’ Refill reminder systems
Medication Therapy Management (MTM)
A patient-centered approach optimizing therapeutic outcomes through comprehensive medication review.
Components
- β’ Medication therapy review
- β’ Personal medication record
- β’ Medication-related action plan
- β’ Intervention and referral
- β’ Documentation and follow-up
Goals
- β’ Improve therapeutic outcomes
- β’ Reduce adverse events
- β’ Enhance patient adherence
- β’ Decrease healthcare costs
- β’ Empower patient self-management
7. Drug Interactions & Safety
Types of Drug Interactions
Pharmacokinetic
One drug alters ADME of another
- Absorption: Antacids reduce tetracycline absorption
- Distribution: Warfarin displaced by aspirin from albumin
- Metabolism: CYP450 induction/inhibition
- Excretion: Probenecid inhibits penicillin secretion
Pharmacodynamic
Drugs with similar/opposing effects
- Synergism: Ξ²-blocker + thiazide for hypertension
- Antagonism: Ξ²-agonist vs Ξ²-blocker
- Additive: CNS depressants + alcohol
- Potentiation: Sildenafil + nitrates (dangerous!)
CYP450 Interactions
CYP450 Inhibitors
Increase substrate drug levels
- β’ Ketoconazole, Itraconazole
- β’ Erythromycin, Clarithromycin
- β’ Grapefruit juice
- β’ Cimetidine
- β’ Fluoxetine, Paroxetine
CYP450 Inducers
Decrease substrate drug levels
- β’ Rifampin (potent inducer)
- β’ Phenytoin, Carbamazepine
- β’ St. John's Wort
- β’ Phenobarbital
- β’ Chronic alcohol
Drug-Food Interactions
| Drug | Food/Beverage | Effect |
|---|---|---|
| Warfarin | Vitamin K-rich foods (leafy greens) | Reduced anticoagulant effect |
| MAOIs | Tyramine-rich foods (aged cheese) | Hypertensive crisis |
| Tetracycline | Dairy products | Decreased absorption |
| Statins (some) | Grapefruit juice | Increased drug levels (myopathy risk) |
| Alendronate | Any food | Decreased absorption (take fasting) |
Adverse Drug Reactions (ADR)
Type A (Augmented)
- β’ Predictable, dose-related
- β’ Common (80% of ADRs)
- β’ Exaggerated pharmacological effect
- β’ Example: Hypoglycemia from insulin
Type B (Bizarre)
- β’ Unpredictable, not dose-related
- β’ Less common but more serious
- β’ Allergic/idiosyncratic reactions
- β’ Example: Penicillin anaphylaxis
Pharmacovigilance
Pharmacists should report suspected ADRs to FDA through the ADR reporting system. This is mandatory for serious/unexpected reactions.
8. Pharmacy Management & Ethics
Inventory Management
FEFO/FIFO Principle
- FEFO: First Expiry, First Out (preferred)
- FIFO: First In, First Out
- β’ Minimizes expiry waste
- β’ Stock rotation essential
- β’ Check expiry dates regularly
Stock Control
- β’ Minimum/maximum stock levels
- β’ Reorder point calculation
- β’ ABC analysis (high-value items)
- β’ VEN analysis (vital/essential/non-essential)
- β’ Cycle counting vs. physical inventory
Record Keeping
- β’Prescription file: Retain for at least 2 years (longer for controlled substances)
- β’S2 logbook: Daily record of dangerous drug transactions
- β’Purchase records: Invoices, receipts from suppliers
- β’Temperature logs: Refrigerator monitoring for cold-chain drugs
- β’Adverse event reports: Documentation of patient reactions
Code of Ethics
The Code of Ethics for Pharmacists (promulgated by the Board of Pharmacy) guides professional conduct.
Duties to Patients
- β’ Prioritize patient welfare
- β’ Maintain confidentiality
- β’ Provide accurate drug information
- β’ Refer when necessary
Professional Duties
- β’ Maintain competence (CPD)
- β’ Uphold professional standards
- β’ Collaborate with healthcare team
- β’ Avoid conflicts of interest
Continuing Professional Development (CPD)
Requirements
- β’ 45 CPD units per 3-year cycle
- β’ Mandatory for license renewal
- β’ CPD provider accreditation by PRC
- β’ Online and face-to-face options
CPD Activities
- β’ Seminars and conferences
- β’ Postgraduate courses
- β’ Self-directed learning
- β’ Research and publication
- β’ Professional practice
Key Takeaways
- βKnow prescription parts: superscription (Rx), inscription, subscription, signa
- βRA 6675 mandates generic prescribing; substitution allowed unless "DAW"
- βRA 9165: Schedule I (prohibited), Schedule II (S2 rx required, valid 3 days)
- βFDA issues CPR (product registration) and LTO (establishment license)
- βRA 10918: Current pharmacy practice law; 45 CPD units per 3 years
- βPatient counseling covers: drug name, purpose, dosing, side effects, interactions
- βCYP450 inhibitors increase drug levels; inducers decrease drug levels
- βFEFO (First Expiry, First Out) minimizes expired drug waste