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Module 4-notes

This document provides an overview of dispensing, prescription, and labeling regulations in the Philippines, particularly under the Philippine Pharmacy Act of 2016 (RA 10918) and the Generics Act of 1988 (RA 6675). It details the roles of prescribers and pharmacists, the types of medications (OTC, RX, and dangerous drugs), and the necessary components and classifications of prescriptions. Additionally, it outlines the procedures for processing prescriptions, including pricing, labeling, and record-keeping requirements.

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kennethstar313
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0% found this document useful (0 votes)
5 views

Module 4-notes

This document provides an overview of dispensing, prescription, and labeling regulations in the Philippines, particularly under the Philippine Pharmacy Act of 2016 (RA 10918) and the Generics Act of 1988 (RA 6675). It details the roles of prescribers and pharmacists, the types of medications (OTC, RX, and dangerous drugs), and the necessary components and classifications of prescriptions. Additionally, it outlines the procedures for processing prescriptions, including pricing, labeling, and record-keeping requirements.

Uploaded by

kennethstar313
Copyright
© © All Rights Reserved
Available Formats
Download as PDF, TXT or read online on Scribd
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Module 4- Overview on Dispensing, Prescription and Labeling

A drug is a substance that is used to provide mitigation, cure, treatment, prevention or diagnosis of a
disease.

It is basically given to a patient by a prescriber through a written order called the prescription which is
then handed over to the pharmacist

Dispensing Guidelines as to RA 10918 and RA 6675

The Philippine Pharmacy Act of 2016 or RA 10918 stipulates the following:

• Section 30 : Dispensing/Sale of Pharmaceutical Products

• Available through a retail drug outlet duly licensed by the FDA.

• Rx drugs and pharmacist-only OTC medications shall be dispensed only by a duly registered
and licensed pharmacist.

• Manufacturers and distributors are authorized to sell their products only to duly licensed
pharmaceutical outlets.

• Section 33 : Filling and Partial Filling of Prescription

• All prescriptions and pharmacist-only OTC medicines shall be filled, compounded and
dispensed only by a registered and licensed pharmacist. Completely filled prescriptions
should be surrendered to the pharmacist for recording.

• Partial filling of prescription less than the total quantity indicated in the prescription shall be
allowed. It is the responsibility of the pharmacist dispensing the last quantity completing
the prescription to keep the prescription according to proper prescription recording
guidelines.

• Administrative Order No. 63 s. of 1989, “Rules and Regulations to Implement Dispensing


Requirements under the Generics Act of 1988 (RA 6675),” defines Dispensing as the act by a validly-
registered pharmacist of filling a prescription or a doctor’s order on the patient’s chart.

The Prescription and Medication Order

George Urdang- First person to study the prescription of today


The term prescription originated from the two Latin words
“prae” meaning before “scribe” meaning I write

What is a prescription?

 An order for medication written by a physician, dentist or other licensed medical practitioner
and given to the patient for presentation to the pharmacist
 It contains a specific medication and dosage to be administered to a particular patient at a
specified time.
 It is written by a pharmacist in pursuant to the telephone dictation of the physician.
 A finished product, a drug or mixture of drugs compounded and dispensed by the pharmacist
pursuant to the instructions of a prescriber.
 Prescriptions are orders for medications, nondrug products and services that are written by a
licensed practitioner or midlevel practitioner who is authorized by law to prescribe.
 The prescription serves as the professional relationship among the physician, pharmacist and
patient
 The prescription serves as a vehicle for communication from the prescriber to the pharmacist
about the needs of the patient.
 A formula written on a piece of paper called a prescription blank

Types of Medication based on Prescription Requirement

COMPARISON OF THE 3 DRUGS IN TERMS OF PRESCRIPTION REQUIRED

DRUG OTC RX DRUG Dangerous drug


Prescription required none Ordinary Yellow
prescription prescription
Number of copies none One Three-ph, dr., & pt
Ways of identifying No Rx sign With Rx sign and add’l With Rx sign and add’l
label requiring label requiring
prescription prescription and List A
Recording required No Prescription book Dangerous drug book
Filing of prescription No 2 years 1 year
Note: for poison drug – the prescription should be kept for 5 years and recorded in poison book.

Nonprescription drugs
 Over-the-counter drugs
 Are pharmaceutical products or drug preparations that can be dispensed even without the
written order of a validly registered licensed physician, dentist or veterinarian, for the use of
consumers for the prevention or symptomatic relief of minor or self-limiting ailments
 Examples
 Biogesic for fever
 Solmux for cough
 Neozep for colds
 Gaviscon for hyperacidity
 Imodium for diarrhea
Prescription drugs
 Ethical or Legend drugs
 Are pharmaceutical products or drug preparations that are to be dispensed only upon written
order of a validly registered physician, dentist or veterinarian for the management or treatment
of a condition or disease
 Examples
o Lifezar for hypertension
o Glumet for diabetes
o Lipitor for hyperlipidemia
o Colchicine for gout
o Amoxil for bacterial infection
Dangerous drugs
 Are pharmaceutical products referring to either prohibited or regulated drugs which require a
special prescription form usually obtained from the Dangerous Drugs Board.
 List A Drugs
o Prohibited Drugs- include opium and its active components and derivatives; coca leaf
and its derivatives; hallucinogenic drugs; and other preparations containing
physiological effects of a narcotic drug
o Example- Morphine Codeine Fentanyl Hydrocodone Pethidine
o Regulated Drugs- include sedative-hypnotics and drugs which contain a salt derivative
of a salt of an isomer of amphetamine
o Example- Amphetamine Chloral hydrate Pentothal Methamphetamine
Etchlorvynol
 List B Drugs
 drugs requiring strict precautions in their use; the prescriber must write clearly “List B” after
the Rx symbol but before the generic name.
 Example Amiodarone Clonazepam Dexamethasone Lithium carbonate
Warfarin

Classifications of Prescription
1. Based on the Number of Ingredients
2. Compounded or Non-compounded Prescription
3. New or Refill prescription
4. Generic or Controlled Prescription

Based on the Number of Ingredients


Simple Prescription- A prescription containing a single ingredient only.
Compound Prescription- A prescription containing a two ingredients.
Polypharmacal Prescription – Also called as a “shotgun” prescription containing more than two
ingredients.

Compounded or Non-compounded Prescription


Compounded – Requires mixing of one or more ingredients including one or more active medicaments
with one or more excipients, vehicles or other adjuncts to make the product.
Distinct Portions of a Compounded Prescription:
 Basis/Base
 Adjuvant
 Corrective or Corregent
 Vehicle
Noncompounded – Prescription order which does not require mixing of two or more ingredients to
obtain a finished product.
New or Refill Prescription
New – original prescription order filled the first time
Refill – any repeat filling of an original prescription order
Partial Filling of Prescription – means dispensing less than the number of units prescribed.
The following shall be written on the face of the prescription in partial filling:
1. The date of partial filling
2. The quantity served and the balance of the prescription unserved
3. Name and address of the drugstore
Partially filled prescription must be returned to the buyer after recording the partial filling in the
prescription book.
Drugstore that completes the filling of prescription shall keep it on file.

Generic or Controlled Prescription


Generic Dispensing – means dispensing the patient’s/buyer’s choice from among generic equivalents
Dispensing of Controlled Drugs
Dispensing must be done by the pharmacist who shall affix his/her signature on the prescription filled.
1. Requirements in Dispensing List A Drugs (partial filling is NOT allowed):
2. S-2 license of the physician
3. Special DDB prescription form (Form No. 1-72) must be used
4. Recording system

OTHER TYPES OF PRESCRIPTION


Magistral Rx- A prescription that is very often prescribed by the same doctor, of the same ingredients
and compounded by the same pharmacist
Coded Rx- A prescription containing words or symbols to represent the name of drugs, it is also known
as “blind prescription”

Parts of Prescription

Prescriber’s Information It usually contains the name of the physician or dentist, his specialty,
clinic address, contact number and clinic hours

Patient’s Information It contains pertinent information about the patient such as the
name, address, sex, age and weight and sometimes BSA

Date Prescriptions are dated at the time they are written and also when
they are received and filled in the pharmacy.

Superscription The Rx symbol is a Latin verb “recipe” meaning “take though” or


“you take”

Historians believed that this symbol originated from the sign of


Jupiter employed by ancients in requesting aid for healing

Inscription The medication prescribed

It is the body or principal part of the prescription order


Subscription Dispensing directions to the pharmacist

It contains directions to the pharmacist for preparing and labeling


the prescription

It usually contains the quantity of the medication to be dispensed

Transcription Directions for the patients

It is also known as “signature” or “signa” meaning “mark though” or


“let it be labeled”

The instructions are usually written using abbreviated forms of


English or Latin terms

Refill Information If refill information is not supplied, it is generally assumed that no


refills are authorized

Prescriber’s Signature and License Numbers

It contains the signature of the prescriber as well as the doctor’s


license number to practice his profession, PTR number, and
sometimes S2 number

Understanding the prescription and medication order


 A complete understanding of all information contained in a prescription or medication order is
required.
 Each piece of information should be appropriate and consistent with the remaining information.

The pharmacist should read the entire prescription or medication order carefully to determine the
prescriber’s intent by interpreting the following information:
1. The name and address of both patient and the prescriber
2. The patient’s disease or condition requiring treatment
3. The reason the order is indicated, relative to the medical need of the patient
4. The name of the product, the quantity prescribed and instructions for use
5. All terminology including units of measure and Latin abbreviations

Evaluating the appropriateness of the prescription and medication order


 Complete information is required on the prescription or medication order to provide the necessary
information to allow the pharmacist to evaluate the appropriateness of the order.
 When the order is incomplete, the pharmacist must obtain the required information from either the
patient or the prescriber.
 The following should be considered during evaluation:
 The patient’s disease or condition requiring treatment
 The patient’s allergies or hypersensitivities
 The pharmacological or biological action of the prescribed product
 The prescribed route of administration
 Whether the prescribed product might result in a drug interaction
 Whether the dose, dosage form and dosage regimen are safe and likely to meet the needs
of the patient
 Whether the patient will have any difficulties adhering to the regimen and the potential
impact on the therapeutic outcome desired
 Whether the total quantity of medication prescribed is sufficient to allow proper completion
of a course of therapy
 Whether a physical or chemical incompatibility might result
 Whether a licensed practitioner, acting in the course and scope of practice, issued the
prescription in good faith, for a legitimate medical purpose

Processing the Prescription Order

1. Receiving the Rx
 It is desirable that the patient presents the prescription order directly to the pharmacist
 Greet properly and ask politely what you can do for the patient
2. Reading and Checking
 Upon receiving the prescription, it should first be read completely and carefully.
 Try to answer the following questions:
Is the prescription legal?
Who is it for?
What is the name of the medication?
What are the instructions for the patients?
What quantity is to be dispensed?

Types of Incorrect Prescriptions: Violative, Erroneous and Impossible


Violative Prescriptions
 SHALL NOT BE FILLED; SHALL BE KEPT AND RECORDED
 Where generic name is not written
 Where the generic name is not legible and a brand name is legible written
 Where the brand name is indicated and instructions added (such as phrase “no substitution”)
Erroneous Prescription
 SHALL BE FILLED; SHALL BE KEPT AND RECORDED
 Where the brand name precedes the generic name
 Where the generic name is the one in parenthesis
 Where the brand name is not in parenthesis
 Where more than one drug product is prescribed on one prescription form (amended, allowed
already)
Impossible Prescription
 SHALL NOT BE FILLED; SHALL BE KEPT AND RECORDED
 When only the generic name is written but it is not legible
 When the generic name does not correspond to the brand name
 When both the generic name and the brand name are not legible
 When the drug product prescribed is not registered with the FDA
3. Pricing
 Each pharmacy/drugstore should have a method for pricing the prescription that is applied
consistently by each pharmacist and it should be established to ensure the profitable operation
of the department.
The charge applied to the prescription must cover the following:
 Cost of ingredients
 The time of the pharmacist and auxiliary personnel involved
 Cost of inventory maintenance and other operational costs of the department
 A reasonable margin of profit/investment

Percent Mark Up
 SP = Cost of ingredients + (cost x % mark-up)
 The desired percent mark-up is taken of the cost of the ingredients to obtain the prescription
price
 The percentage mark-up applied varies depending on the cost of the ingredients:
 A lower % mark-up for prescription items with higher cost
 A higher % mark-up for prescription items with lower cost
Example:
A pharmacist bought a bottle of syrup for P37.50. At what price must the syrup be sold to have a profit
of 50% on the selling price?

Percent Mark Up Plus a Minimum Fee


 In this method, both a percent mark-up and a minimum fee are added to the cost of the
ingredients.
 SP = Cost of ingredients + (cost x % mark-up) + minimum fee
Example:
If the cost of the drug is P4.00 and the pharmacist applies a 40% mark-up and a minimum fee of P2.25,
what would be the selling price of the prescription?

4. Numbering and Dating

 It is a legal requirement to number the prescription order and to place the same number on the
label.
 Dating of the prescription on the date filled is also a legal requirement, it is different from the
date the prescription was made.
5. Labeling
 Labeling is primarily indicated for drug products which are not in their original containers and
transferred to another container.
 The label represents the professionalism of the dispensing pharmacist
 It should be neat, attractive and legible

The prescription label should contain the following information:


 Name and address of the pharmacy
 Date of dispensing
 Prescription number
 Prescriber’s name
 Patient’s name
The prescription label should contain the following information:
 Name and strength of the medication
 Directions for use
 Manufacturer’s lot number and expiration date
 Auxiliary and cautionary labels
 Name and initials of the dispensing pharmacist

6. Preparing
 The pharmacist should decide on the exact procedure to be followed in dispensing or
compounding the ingredients.
7. Packaging
 In filling a prescription, the pharmacist may select from a variety of containers.
 Selection is primarily based on the type and quantity of medication and the method of its
use.
 Prescription containers must protect the contents from air, moisture, light, loss of drug and
entrance of contaminants.
Types of Containers
— Round vials
— Prescription bottles
— Wide-mouth bottles
— Dropper bottles
— Application bottles
— Ointments jars and collapsible tubes
— Sifter-top containers
— Hinged-lid or slide boxes
— Aerosol containers
8. Rechecking
 Every prescription filled should be rechecked to avoid any errors.
 If another pharmacist is available, he should ask the other pharmacist to help in checking the
prescription.

 Rechecking should be done at least 3 to 4 times


o Before getting from the shelf
o While preparing the product
o When returning the container
o Before dispensing the medication
9. Delivering and Patient Counseling
 The pharmacist should give the prescription directly to the patient and instruct the patient on
what to do with the prescription
 The pharmacist should reinforce the information that the patient already is aware of, call
attention to any auxiliary labeling instructions and provide further information with the filled
prescription.
10. Recording and Filing
 The prescription should be recorded in prescription books and other books where the filled
prescription should be recorded.
 The prescription are then filed and maintained by the pharmacy.
o Prescription drugs – 2 years
o Dangerous drugs – 1 year
o Poisonous drugs – 5 years
o Abortive drugs – 5 years
11. Labeling Requirements
Based on FDA As mandated in RA 10918…

Section 36. Label of Dispensed Medicines.


Upon every box, bottle, or package of medicines compounded or dispensed by a registered and
licensed pharmacist based on prescription, there shall be pasted, affixed, or imprinted a seal or label
bearing, among others, the name of patient and generic name of drug; brand name, if any, strength,
expiry date, directions for use; and name and address of pharmacy, name of the doctor, the
dispensing pharmacist and other requirements prescribed…
Auxiliary labels containing special pharmacist’s instructions for the patient shall be required...

Auxiliary Labels

Shake Well
Required on all liquid disperse systems like suspensions and emulsions
Keep in the Refrigerator, Do Not Freeze
Required for products that are physically and chemically unstable at room temperature, it is
recommended for parenteral products that have been manipulated and which are not being used
immediately especially those that do not contain a preservative
Do Not Use After _____
Required on all manipulated parenteral products, reconstituted antibiotics and liquids, compounded and
other products known to be unstable
External Use Only
Recommended on products intended to be used externally, especially those that are potentially
dangerous when ingested
May Cause Drowsiness
Recommended for products that cause significant drowsiness like antihistamines, sedative-hypnotic
agents, narcotics and others
Do Not Drink Alcohol
Required for products that give a disulfiram-like reactions such as disulfiram, metronidazole and
chlorpropamide
Avoid Sun Exposure
Required on products that cause photosensitivity reactions like tetracyclines, sulphonamides and
thiazides
Take with Food
Recommended for drugs that cause stomach upset like erythromycin, NSAIDs and aspirin
Take on Empty Stomach
Recommended for drugs that have decreased absorption or increased destruction in the stomach when
taken with food like tetracycline and ampicillin
Take with Plenty of Water
Recommend for sulfonamides to decrease the likelihood of crystalluria, for expectorants to enhance
viscosity reduction of bronchial secretions, for bulk laxatives to increase stool bulk and decrease the
likelihood of compaction, and for irritating drugs like potassium supplements, chloral hydrate, certain
antibiotics, and theophylline products
Finish all this Medication
Recommended as a compliance aid for antibiotics and when a specific time course is not given in the
directions for use
Do Not Take with Dairy Products, Antacids…
Required for products that can be inactivated or destroyed due to the presence of metals in dairy
products and antacids like tetracycline and enteric-coated tablets
May Cause Discoloration of Urine or Feces
Recommended for products that discolour urine or feces like rifampin, ferrous preparations,
phenazopyridine
This Prescription Maybe Refilled _____
Times An optional label informing the patient of the number of refills, which is now often printed
directly on the prescription label
Keep Out of Reach of Children
May be used for any drug product containers most especially those drug containers without safety
closures
Protect from Light
Required for parenteral products that are photosensitive like sodium nitroprusside, furosemide etc., it is
especially important when the immediate container is not amber or opaque
Cancer Chemotherapy, Dispose of Properly
Required for containers of cytotoxic drug products

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