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Dispensing I

The document outlines guidelines for dispensing medications in the Philippines based on prior laws. It discusses key terms like generic names, prescriptions, and dispensing. It also describes types of prescriptions and medications that either require a prescription from a medical practitioner or can be dispensed over-the-counter without one. The document provides details on ethical prescribing and dispensing practices as well as what constitutes unethical prescriptions.

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Ash M
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0% found this document useful (0 votes)
135 views74 pages

Dispensing I

The document outlines guidelines for dispensing medications in the Philippines based on prior laws. It discusses key terms like generic names, prescriptions, and dispensing. It also describes types of prescriptions and medications that either require a prescription from a medical practitioner or can be dispensed over-the-counter without one. The document provides details on ethical prescribing and dispensing practices as well as what constitutes unethical prescriptions.

Uploaded by

Ash M
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 74

2/18/2023

DISPENSING I & II

Maureen Allysandra Gamboa-Gulmatico

OUTLINE
I. Introduction
II. Dosing calculations and schedule
III. Extemporaneous compounding
IV. Medication review
V. Medication-related problems
VI. Medication error
VII. Adverse drug reaction

INTRODUCTION

1
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OUTLINE
▪ Definition of dispensing
▪ Prescription
▪ Components of prescription
▪ Types of prescriptions

DISPENSING
- defined as the act, by a validly registered
pharmacist, of filling a prescription or doctor’s order
on a patient’s chart
(DOH AO No. 63 s 1989)

DISPENSING
- a process of reading, checking, and interpretation of
prescription, preparing, packaging, labeling, record-
keeping, and sale or transfer of drugs and medicines
with or without a prescription or medication order
which process includes counseling and information
giving by or under supervision of a duly registered
and licensed pharmacist
- (RA 10918)

2
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PRESCRIPTION
- an order for medication issued by a physician,
dentist, veterinarian, or other properly licensed
medical practitioner

In hospital – it is termed medication order

Parts of a prescription
▪ Prescriber’s office Information (name, add, no.)
▪ Patient Information (name, add, No., age, sex, etc)
▪ Date when prescription was written

Parts of a prescription
▪ Superscription – Rx symbol or :recipe” which means “you take”
▪ Inscription –medication prescribed
▪ Subscription – dispensing instructions to the pharmacist
▪ Signature or signa – directions for the patient (to be placed on
the label)
▪ Licenses of the prescriber
▪ Other dispensing info (refill info, special labeling, other
instructions)

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10

TYPES OF PRESCRIPTION
1. Simple – orders with only one ingredient
2. Compounded – orders requiring mixing of ingredients
3. Polypharmacy – orders with ten or more than two
ingredients of the same therapeutic uses. Also called the
shotgun preparation

11

Parts of compounded prescriptions


1. Basis – chief, active ingredient
2. Adjuvant – used as assist to the basis
3. Corrective - qualifies the action of basis and the
adjuvant
4. Vehicle – added to dilute the active ingredients
processing the prescription order

12

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Magistral prescription
- Prescribed very often by the same doctor, of
the same ingredients and compounded by
the same pharmacist

13

Coded prescription/blind prescription


- Consist of words and symbols to represent
the names of the drugs.

14

Types of drugs in medication order


1. Stat order – single dose of medication
administered immediately
2. Single order – one time medication
3. Standing – medications routinely administered
until canceled by another order
4. PRN – medications given when necessary

15

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16

Concepts and Laws Governing Dispensing


in the Philippines
▪ A.O. 62 s. 1989
▪ Rules and Regulations to Implement Prescribing
Requirements under the Generics Act of 1988 (R.A. No. 6675)

▪ A.O. 63 s. 1989
▪ Guidelines for DISPENSING Based on Prior laws

17

Important terms
▪ Generic Name
▪ Identification of drugs and medicines by their
scientifically and internationally recognized active
ingredients or by their official names as determined
by BFAD.
▪ INN or USAN

18

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Important terms
▪ Prescription
▪ The written order and instruction of a validly registered authority for
the use of a specific drug product for a specific patient.
▪ This may also include the doctor’s order on the patient’s chart.

▪ Generic Prescribing
▪ Prescribing drugs or medicines using their generic names or generic
terminology

19

Important terms
▪ Dispensing
▪ The act by a registered pharmacist of filling the prescription or a
prescriber’s order.

▪ Generic Dispensing
▪ Dispensing the patient’s /buyer’s choice from among generic equivalent,
e.g. finished pharmaceutical products having the same active
ingredient(s), same dosage form and same strength as the prescribed
drug

20

Guidelines for Prescribing Based on Prior


laws
▪ Only validly registered medical, dental and veterinary
practitioner, whether in private or employed in private
institution, corporation or in government, are authorized to
prescribe drugs.

21

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▪ Generic name, shall be used in all prescriptions


▪ For drugs with a single active ingredient, the generic name of the
active ingredient shall be used in prescribing.
▪ For drugs with two or more active ingredients, the generic name as
determined by BFAD shall be used for prescribing

22

▪ The generic name must be written in full but the salt or


chemical form may be abbreviated
▪ Naproxen Na
▪ Oxacillin Na

▪ The Generic name of the drug must be clearly written on a


prescription immediately after the Rx symbol.

23

▪ In addition to the generic name, a brand name may also be


indicated, in such cases, the following shall observed
▪ If written on a prescription pad, the brand name enclosed in
parentheses shall be written below the generic name
▪ If written on a patient’s chart, the brand name enclosed in
parentheses shall be written after the generic name

24

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▪ One drug shall be prescribed on one prescription form.


(Amended)

25

Unethical prescriptions
▪ VIOLATIVE PRESCRIPTION
▪ Where the generic name is not written
▪ Where the generic name is not legible and a brand name is legibly
written
▪ When the brand name is indicated and instructions added ( such as
the phrase “no substitution”) which tend to obstruct, hinder or
prevent proper generic dispensing

26

Unethical prescriptions
▪ ERRONEOUS PRESCRIPTION
▪ Where the brand name precedes the generic name
▪ Where the generic is the one in parentheses
▪ Where the brand name is not in parentheses
▪ Where more than one product is prescribed on one prescription form

27

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Unethical prescriptions
▪ IMPOSSIBLE PRESCRIPTION
▪ When only the generic name is written but not legible
▪ When the generic name does not correspond to the brand name
▪ When both the generic and brand name are not legible
▪ When the drug product prescribed is not registered with the BFAD

28

Concepts and Laws Governing Dispensing


in the Philippines

▪ Guidelines for DISPENSING Based on Prior laws (A.O. 63)

29

Types of Medication Based on


Prescription Requirement
▪ Prescription drugs
▪ Aka Ethical/Legend Drugs
▪ These drugs can only be dispensed upon written order of a validly
registered practitioner.

30

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Types of Medication Based on


Prescription Requirement
▪ Nonprescription drugs

▪ AKA Over-the-counter (OTC) Drugs


▪ These drugs may be dispensed even without a written order of a validly
registered physician, dentist or veterinarian in licensed drug outlets.

▪ When dispensing OTC drug without a doctor's prescription, the pharmacist


shall give the necessary information and direction for use of the drugs.

31

Dangerous drugs
▪ Uses YELLOW PRESCRIPTION / DDB
FORM

32

Schedule of Controlled Substances


SCHEDULE I
▪ high potential for abuse
▪ no currently accepted medical use
▪ lack of accepted safety for use of the drug or other
substance under medical supervision.

33

33

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Examples:
▪ Narcotics: Heroin
▪ Hallucinogens: LSD
▪ MDA ((3,4-methylenedioxyamphetamine), ),
▪ DOM (2,5-Dimethoxy-4-methylamphetamine)
▪ DMT (Dimethyltryptamine)
▪ DET (diethyltryptamine)
▪ mescaline, peyote, bufotenine, ibogaine,
psilocybin, phencyclidine

34

34

Schedule of Controlled Substances


SCHEDULE II
▪ high potential for abuse
▪ with currently accepted medical use
▪ Abuse of the drug or other substances may lead to severe
psychological or physical dependence.
▪ No prescription for a controlled substance in schedule II may be
refilled.

35

35

Examples:
▪ Morphine
▪ Cocaine
▪ Methylphenidate
▪ Laudanum
▪ Meperidine
▪ Short-Acting Barbiturates (Amobarbital, Pentobarbital,
Secobarbital)
▪ Fentanyl
▪ Methadone
▪ Oxycodone
▪ Hydromorphone
36

36

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Schedule of Controlled Substances


SCHEDULE III
▪ has a potential for abuse less than the drugs or other
substances in schedules I and II.
▪ has a currently accepted medical use
▪ Abuse of the drug or other substance may lead to moderate or
low physical dependence or high psychological dependence.

37

37

Schedule of Controlled Substances


SCHEDULE III
▪ Such prescriptions may not be filled or refilled more than six
months after the date thereof or be refilled more than five
times after the date of the prescription unless renewed by the
practitioner.

38

38

Examples:
▪ Anabolic Steroids
▪ Intermediate-Acting Barbiturates (Butarbital, Talbutal,
Aprobarbital, Metharbital)
▪ Buprenorphine
▪ Dihydrocodeine
▪ Ketamine
▪ Hydrocodone
▪ Codeine
▪ Marinol
▪ Paregoric
39

39

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Schedule of Controlled Substances


SCHEDULE IV
▪ has a low potential for abuse relative to the
drugs or other substances in schedule III.
▪ The drug or other substance has a currently
accepted medical use
▪ Abuse of the drug or other substance may lead to
limited physical dependence or psychological
dependence relative to the drugs or other
substances in schedule III.
▪ Control measures are similar to Schedule III.
Prescriptions for Schedule IV drugs may be
refilled up to five times within a six month period. 40

40

Examples:
▪ Benzodiazepines such as alprazolam (Xanax®),
chlordiazepoxide (Librium®), clonazepam
(Klonopin®) diazepam (Valium®), temazepam
(Restoril®)
▪ The benzodiazepine-like "Z-drugs": Zolpidem
(Ambien®), Zopiclone, Eszopiclone, and
Zaleplon (Sonata®);
▪ Long-acting barbiturates such as
phenobarbital;
41

41

Examples:
▪ Some partial agonist opioid analgesics, such as
pentazocine (Talwin®);
▪ The stimulant-like drug modafinil (sold in the
U.S. as Provigil®) as well as its (R)-enantiomer
armodafinil (sold in the U.S. as Nuvigil®);
▪ Antidiarrheal drugs, such as difenoxin, when
combined with atropine (Motofen)

42

42

14
2/18/2023

Schedule of Controlled Substances


SCHEDULE V
▪ has a low potential for abuse relative to the drugs or
other substances in schedule IV.
▪ The drug or other substance has a currently accepted
medical use in treatment in the United States.
▪ Abuse of the drug or other substance may lead to
limited physical dependence or psychological
dependence relative to the drugs or other substances
in schedule IV.
▪ No controlled substance in schedule V which is a drug
may be distributed or dispensed other than for a
medical purpose.
43

43

Examples:
▪ Cough suppressants containing small amounts of codeine (e.g.,
promethazine+codeine);
▪ Preparations containing small amounts of opium or diphenoxylate
(used to treat diarrhea);
▪ Pregabalin (Lyrica®), an anticonvulsant and pain modulator.

44

44

Recording of prescription
▪ NOTE: All Rx dispensed in the drugstore, botica or hospital
pharmacy shall be kept in file for 2 years and recorded in a
prescription book duly-registered by BFAD which shall be open
for inspection to Food and Drug Inspectors at any time during
business hours of the outlet. This prescription book shall be
kept for 2 years after the last entry.

45

15
2/18/2023

Additional Guidelines on Dispensing to Implement the Generics


Act of 1988

▪ Drugstores, Boticas, and Other Drug Outlets

▪ Inform the patient/buyer of all available drug products generically


equivalent to the one prescribed with their corresponding prices.
▪ The drug outlet shall not favor or suggest any particular product so
that the patient/buyer may fully and adequately exercise his option to
choose.

46

Additional Guidelines on Dispensing to Implement the Generics


Act of 1988

▪ Drugstores, Boticas, and Other Drug Outlets

▪ For this purpose, all drug outlets shall post in a conspicuous place in
their establishment a list of drug products using generic names with
their brand names, if any, and their corresponding current prices.
▪ A handbook or directory containing the above required information,
readily accessible to the patient/buyer shall be considered substantial
compliance.

47

▪ Dispensing partially filled prescription

▪ The partially filled prescription shall be returned to the buyer after


recording the partial filling in the prescription book.
▪ The drugstore that completes the filling of the prescription shall keep
the prescription in the file.

48

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Violation on the Part of Dispensers and


Outlets
▪ Imposing a particular brand or product on the buyer
▪ Inaccurate dispensing, i.e., dispensing a drug product which
does not meet the prescription as to a or all of the following:
active ingredient, dosage form, and strength

49

Violation on the Part of Dispensers and


Outlets
▪ Failure to record and keep prescriptions filled
▪ Failure to report to the nearest DOH office cases of violative,
erroneous or impossible prescriptions within three
months after receipt of such prescriptions

50

Review!

51

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Identify the parts of prescription

52

Identify the parts of prescription

1. Prescriber information
2. Patient information
3. Prescription date
4. Superscription/Take thou
5. Inscription – med prescribed
6. Subscription – instructions to RPh
7. Signa – instructions to patient
8. Special instructions

53

Determine the type of prescription

54

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Determine the type of prescription


▪ ERRONEOUS PRESCRIPTION

55

Determine the type of prescription

56

Determine the type of prescription


▪ VIOLATIVE PRESCRIPTION

57

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Determine the type of prescription

58

Determine the type of prescription


▪ IMPOSSIBLE PRESCRIPTION

59

Determine the type of prescription

60

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Determine the type of prescription


▪ IMPOSSIBLE PRESCRIPTION

61

DOSING CALCULATIONS AND SCHEDULE

62

OUTLINE
▪ Definition of terms
▪ Calculation equations

63

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POSOLOGY
▪ The science related to dose

DOSE
- The amount of drug given at a time, which may be repeated

64

Mode of Administration
▪ The complete description of the amount of the drug,
route of administration, frequency of administration
and duration of treatment.

65

Dose expression
✓ % solution 1 % solution means 1 g in 100 ml
✓ Proportion 1:1000 (1 g in 1000 ml) = 1 mg/ml.
✓ PPM is ‘parts per million’. 1 PPM means 1 part
(gm or ml) in 10,00,000 (grams or ml).

66

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Loading dose
▪ a single or few quickly repeated doses given in the
beginning to attain target concentration rapidly

67

Maintenance dose
▪ dose to be repeated at specified intervals after the attainment
of target Cpss so as to maintain the same by balancing
elimination

68

69

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Scheduled medications
▪ Include all maintenance doses administered according to a
standard, repeated cycle of frequency.
▪ Examples: Medications given q4h, QID, TID, BID, daily, weekly,
monthly, annually

70

Examples of standard administration time

71

Examples of standard administration time

72

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Time-critical scheduled medications


▪ Include where early or delayed administration of
maintenance doses of greater than 30 minutes before
or after the scheduled dose may cause harm or result in
substantial sub-optimal therapy or pharmacological
effect.

73

Non-time-critical scheduled medications


▪ Include those where early or delayed administration
within a specified range of either 1 or 2 hours should
not cause harm or result in substantial sub-optimal
therapy or pharmacological effect.

74

75

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Dosage calculations

76

Dosage calculations

77

Dosage calculations

78

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Sample problem # 1
The dose of a drug is 0.5mg/kg. What dose should be given a 6-
year-old child who weighs 44 lbs?

79

Sample problem # 1
The dose of a drug is 0.5mg/kg. What dose should be given a 6-
year-old child who weighs 44 lbs?

▪ 44 lbs is 19.95kg

▪ 0.5mg/1kg = x/19.95kg
▪ X=9.975mg~10mg

80

Sample problem # 2
▪ The doctor orders Benedryl (Diphenhydramine) 50 mg PO
every 6 hours PRN. Calculate the dose for a 4-year-old child
using Fried’s Rule.

81

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Sample problem # 2
▪ The doctor orders Benadryl (Diphenhydramine) 50 mg PO
every 6 hours PRN. Calculate the dose for a 4-year-old child
using Fried’s Rule.

▪ 4 years = 48 months
▪ 48/150*50 = 16mg

82

EXTEMPORANEOUS COMPOUNDING

83

OUTLINE
▪ Definition of terms
▪ Compounding facilities and equipment
▪ Ingredient standards
▪ General steps in compounding process
▪ Packaging, storage, and labeling
▪ Stability, expiration, and beyond-use dating

84

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EXTEMPORANEOUS COMPOUNDING
▪ preparation (mixing, assembling, altering,
packaging, and labeling of drug/drug-delivery
device) of drug product according to licensed
practitioner’s prescription and medication order,
to meet the unique individual patient’s need

85

Manufacturing
▪ Production, preparation, propagation, conversion,
and/or processing of a drug or device, either
directly or indirectly, through extraction from
substances of natural origin or independently
through means of chemical or biological synthesis.

86

Compounding facilities and equipment


- Pharmacies that engage in compounding should have a
designated area with adequate space for the orderly
placement of the equipment and materials used in
compounding activities.
- The pharmacist is also responsible for the proper
maintenance, cleanliness, and use of all equipment
involved in the compounding practice.

87

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Attire
▪ Personnel engaged in the
compounding of drugs
should wear clean clothing
appropriate to the operation
being performed.

88

Compounding guidelines
• General Chapter <795> Pharmaceutical Compounding—
Nonsterile Preparations
• General Chapter <797> Pharmaceutical Compounding—Sterile
Preparations
• General Chapter <800> Hazardous Drugs—Handling in
Healthcare Settings
• General Chapter <825> Radiopharmaceuticals—Preparation,
Compounding, Dispensing, and Repackaging

89

Ingredient standards
USP/NF: meets the minimum purity standards, conforms
to tolerances set by the United States Pharmacopeia /
National Formulary for contaminants dangerous to health

ACS reagent: High purity; conforms to minimum


specifications set by the Reagent Chemicals Committee of
the American Chemical Society

90

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Ingredient standards
CP (chemically pure): More refined than technical or
commercial grade but still of unknown quality

Technical/commercial: Indeterminate quality

91

General steps in compounding process


A. Preparatory
1. Judge the suitability of the prescription in terms of its safety
and intended use and the dose for the patient.
2. Perform calculations.
3. Select the proper equipment.
4. Don the proper attire and wash hands.
5. Clean the compounding area and the equipment.
6. Assemble all necessary materials and ingredients.

92

General steps in compounding process


B. Compounding
7. Compound the prescription according the formulary record or
the prescription

C. Final check
8. Check as indicated, the weight variation, adequacy of mixing,
clarity, odor, color, consistency, and pH.
9. Enter the information in the compounding log.
10. Label the prescription.

93

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General steps in compounding process


D. Sign-off
11. Sign and date the prescription, affirming that all the indicated
procedures were carried out.

E. Clean-up
12. Clean and store all equipment.
13. Clean the compounding area.

94

Packaging, storage, and labeling


- To help maintain potency of the stored drug, packaging
materials should not interact physically or chemically with the
preparation.
- In general, compounding chemicals should be stored in tightly
closed, light-resistant containers at room temperature; some
chemicals, however, require refrigeration.
- Temperature requirements for storage of substances are
detailed in the appropriate USP/NF monographs.

95

Packaging, storage, and labeling


- Labeling should be done according to regulations. Usually,
labeling information includes the:
a. Generic or chemical names of the active ingredients
b. Strength or quantity
c. Pharmacy lot number
d. Beyond-use date
e. Any special storage requirements

96

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97

an economical means of providing


presentation, protection,
preservation, identification,
Packaging information, containment,
convenience, and compliance for a
drug product

98

Properties of packaging
▪ Protect the contents from environmental hazards

99

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Properties of packaging
▪ Protect the contents from environmental hazards
▪ Protects the content from mechanical hazards

100

Properties of packaging
▪ Protect the contents from environmental hazards
▪ Protects the content from mechanical hazards
▪ They must not add or permit loss to its contents

101

Properties of packaging
▪ Protect the contents from environmental hazards
▪ Protects the content from mechanical hazards
▪ They must not add or permit loss to its contents
▪ Must have a pharmaceutically elegant appearance
▪ Must be convenient and easy to use by the patient
▪ Must be cheap and economical
▪ Must not react with the content
▪ Must be biodegradable

102

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“that which holds the article


and is or may be in direct
Container contact with the article.”
- USP

103

TYPES OF PACKAGING
PRIMARY PACKAGING
▪ the material that first envelops the
product and holds it. This usually is
the smallest unit of distribution or use
and is the package which is in direct
contact with the contents.
Examples: Ampoules, Vials, Containers,
Dosing dropper, Closures (plastic,
metal), Syringe, Strip package, Blister
packaging.

104

TYPES OF PACKAGING
SECONDARY PACKAGING
▪ is outside the primary packaging – used to
group primary packages together.
Example: Paper and boards, Cartons,
Corrugated fibers, Box

105

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TYPES OF PACKAGING
TERTIARY PACKAGING
• is used for bulk handling , warehouse
storage and transport shipping.
The most common form is a palletized unit
load that packs tightly into containers.

106

Classification of Containers

107

Well-closed container

According to Tight container

protection
ability Hermetic container

Light-resistant container

108

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According to
quantity held Single-unit Multiple-unit
container container

109

Glass Plastic Metal Rubber Paper


&
Board

Packaging materials

110

GLASS

Type General Description Uses Test


I Highly Resistant Borosilicate For parenteral use Powdered glass
Glass test
II Treated Soda Lime Glass For parenteral use Water attack test
III Soda Lime Glass For parenteral use Powdered glass
test
NP General-Purpose Soda Lime Other products except Powdered glass
Glass parenteral use test

111

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Advantages of glass
▪ They are hygienic and suitable for sterilization
▪ They are relatively non-reactive (depending on the grade
chosen)
▪ It can accept a variety of closures
▪ They can be used on highspeed packaging lines
▪ They are transparent.
▪ They have good protection power.
▪ They can be easily labeled.

112

Disadvantages of glass
▪ It is relatively heavy
▪ Glass is fragile so easily broken.
▪ Release alkali to aqueous preparation

113

PLASTIC
A wide range of solid composite materials which are
largely organic, usually based upon synthetic resins or
upon modified polymers of natural origin and possessing
appreciable mechanical strength.

At a suitable stage in their manufacturing, most plastics


can be cast, molded or polymerized directly into shape.

114

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Thermoset

Types of
Plastics
Thermoplastic

115

Advantages
▪ Lightness
▪ Resistance to impact
Plastic ▪ Versatility in design and
consumer acceptance

116

Disadvantages
PERMEABILITY – process of solution and
diffusion with the penetrant dissolving in
the plastic on the one side and diffusing on
the other side
Plastic LEACHING – used to describe movement of
components of a container into the
contents
SORPTION - term used to indicate the
binding of molecules to polymer materials

117

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▪ Aluminum, tin, or steel


Metal ▪ Used in vial caps, ointment
tubes, aerosol cans

118

Rubber

▪ Excellent material for


forming seals, used to form
closures such as bungs for
vials or in similar
applications such as gaskets
in aerosol cans

119

Advantages
▪ Good resealing
▪ Good fragmentation
▪ Good coring
Natural
Disadvantages
rubber ▪ Poor ageing
▪ Moisture and gas permeation
▪ Cannot be sterilized by
autoclave

120

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▪ Polyisoprene - obtained by polymerization


of a hydrocarbon of formula known as
isoprene which is produced from
petroleum products.
▪ Butyl - co-polymerization of isobutylene
Synthetic and isoprene which come from petroleum
▪ Nitrile - This elastomer is a copolymer of
rubber acrylonitrile and butadiene.
▪ Silicone – rubber-like material composed
of silicone-itself a polymer-containing
silicon together with carbon, hydrogen
and oxygen

121

Advantages
▪ Stable at high temperature
▪ Resistance to oxidation and
Synthetic permeation

rubber
Disadvantages
▪ More prone to fragmentation
▪ Complex formulation

122

Paper

▪ Rarely used as primary


packaging, but rather used as
secondary packaging
▪ Increases display area,
provides protection

123

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Safety packaging
Child-Resistant Container
▪ one that is difficult for most children under 5
years of age to open or gain access to the
contents or obtain a harmful amount of the
contents
▪ based on the principle that a young child is
unlikely to coordinate two or more actions to
achieve a successful opening

124

Safety packaging
Tamper-Resistant Container
▪ uses an indication or barrier to entry that is distinctive by
design, or must employ an identifying characteristic which if
breached or missing can reasonably be expected to provide
visible evidence to consumers that tampering has occurred

125

Tamper-resistant
packaging

Strip foil pack


Foil pouch Blister pack

126

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Tamper-resistant
packaging

Bottle seal Shrink seal Breakable cap

127

Tamper-resistant
packaging

Tape seal

Sealed carton

128

Tamper-resistant
packaging

Sealed tube

Aerosol container

129

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Tamper-resistant
packaging

Shrink wrap

Film wrap

130

Other Container
Materials
▪ Liner
▪ Coils
▪ Desiccant
▪ Package insert

131

STORAGE TEMPERATURES

132

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Stability, expiration, and beyond-use dating


Stability: extent to which a dosage form retains, within specified
limits and throughout its period of storage and use, the same
properties and characteristics that it possessed at the time of its
preparation.
Beyond-use date: a date placed on a prescription by a pharmacy
noting when the prescription should no longer be used.
Expiration date: a point at which a manufacturer can no longer
guarantee the strength or safety of the medication.

133

Records and reports


1. Formulation records
2. Compounding records
3. SOPs
4. Ingredients records

134

MEDICATION REVIEW

135

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OUTLINE
▪ Definition
▪ Importance of medication review
▪ Categories of medication review
▪ Steps in conducting medication review

136

MEDICATION REVIEW
- it is an authorized, structured, ongoing review of
prescribing, dispensing, and use of medication.
- also referred to as Drug Utilization Evaluation (DUE) or
Medication Utilization Evaluation (MUE)

137

Importance of medication review


1. Helps to understand, interpret, evaluate, and improve
the prescribing, administration, and use of medications.
2. Permits a more efficient use of insufficient health care
resources.
3. Pharmacists play a key role in this process because of
their expertise in the area of medication therapy
management

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Importance of medication review


4. DURs afford the pharmacist the opportunity to identify trends
in prescribing within groups of patients such as asthma or
diabetes.
5. Pharmacist can then, in collaboration with other members of
the health care team, initiate action to improve drug therapy as:
- Prevent the use of unnecessary or inappropriate drug therapy,
- Prevent adverse drug reactions,
- Improve overall drug effectiveness.

139

Importance of medication review


6. DURs serve as means of
- Improving the quality of patient care
- Enhancing therapeutic outcomes
- Reducing inappropriate pharmaceutical expenditures, thus
reducing overall health care costs

140

Categories of medication review


1. Prospective – evaluation of a patient’s therapy before
medication is dispensed.
2. Concurrent – ongoing monitoring of drug therapy during
treatment.
3. Retrospective – review of therapy after the patient has
received the medication.

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Steps in conducting a drug use evaluation


1. Determine optimal use.
2. Measure actual use.
3. Evaluate.
4. Intervene.
5. Evaluate the medication review program.
6. Report the DUR findings.

142

MEDICATION-RELATED PROBLEMS

143

OUTLINE
▪ Definition
▪ Examples of medication-related problems
▪ How to prevent medication-related problems

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MEDICATION-RELATED PROBLEMS
▪ A medication-related problem is anything involving drug
therapy that interferes with (or has the potential to interfere
with) the desired outcome for a patient

145

Examples of medication-related problems


- Untreated conditions
- Drug use without an indication
- Improper drug selection
- Dose too low
- Dose too high
- Adverse drug reactions (side effects)
- Drug interactions
- Failure to receive medications

146

How to prevent medication-related problems


1. Communicate effectively with health care providers about
medications.
2. Designate a medication manager.
3. Keep a medication list.
4. Consult with a doctor or pharmacist before taking over-the-
counter medication, alcohol or herbal supplements along with
prescription drugs.
5. Use common sense when using medications.
6. Obtain medication refills in a timely manner.

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MEDICATION ERROR

148

OUTLINE
▪ Definition
▪ Medication use process
▪ Types of medication error
▪ Dispensing errors
▪ Sound alike-look alike drugs (SALADs)
▪ High alert medications (HAMs)

149

MEDICATION ERROR
▪ A medication error is any preventable event that may
cause or lead to inappropriate medication use or patient
harm while the medication is in control of the health
care professional, patient, or consumer
(National Coordinating Council for Medication Error
Reporting and Prevention, NCCMERP)

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151

152

Medication use process


1. Prescribing
2. Transcribing/documenting
3. Dispensing
4. Administering
5. Monitoring

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154

4 types of medication error


1. Knowledge-based error: can be related to any type of
knowledge, general, specific, or expert.
2. Rule-based error: can further be categorized as (a) the
misapplication of a good rule or the failure to apply a good
rule; and (b) the application of a bad rule.
3. Action-based errors: the performance of an action that
was not what was intended.
4. Memory-based error: occur when something is forgotten

155

Medication error: Dispensing


▪ A dispensing error is a discrepancy between a
prescription and the medicine that the pharmacy
delivers to the patient or distributes to the ward based
on this prescription, including the dispensing of a
medicine with inferior pharmaceutical or informational
quality.

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10 strategies in minimizing dispensing errors


1. Ensure correct entry of the prescription.
2. Confirm that the prescription is correct and complete.
3. Beware of look-alike, soundalike drugs.
4. Be careful with zeros and abbreviations.
5. Organize the workplace

157

10 strategies in minimizing dispensing errors


6. Reduce distraction when possible.
7. Focus on reducing stress and balancing heavy
workloads.
8. Take the time to store drugs properly.
9. Thoroughly check all prescriptions.
10. Always provide thorough patient counseling.

(http://www.pharmacytimes.com)

158

Sound alike-Look alike drugs (SALADs)


- Medications that are visually similar in physical appearance or
packaging
- Name of the medications that have spelling similarities
Ex.
▪ Clotrimazole-Co-trimoxazole
▪ Dopamine-Dobutamine

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160

High-alert mediations (HAMs)


- Drugs that bear a heightened risk of causing significant patient
harm when they are used in error.
Ex. Adrenergic agents, anticoagulants, narcotics, sedatives,
hypoglycemics

161

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How to prevent error


▪ Double checking the drug (dispensing/administering)
▪ (Pharmacist) Contacting the prescribers in case of any
clarification regarding the prescription (DO NOT ASSUME)
▪ Becoming familiar with LASA medications
▪ Separating LASA medications from one another
▪ Using Tall Man Lettering
▪ Installing warning system to staff – Computer alerts or
warnings on stock bottle

163

Separating SALADs

TALL MAN Lettering

Cautionary labels

164

ADVERSE DRUG REACTION

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OUTLINE
▪ Definition of terms
▪ Risk factors of ADR
▪ Classification of ADR
▪ Drug interactions
▪ Classification of drug interaction

166

ADVERSE DRUG REACTION


▪ a response to a drug that is noxious and unintended and
occurs at doses normally used in man for the
prophylaxis, diagnosis or therapy of disease or
modification of physiologic function”.
(World Health Organization)

167

Adverse drug event


▪ Any untoward medical occurrence that may be present
during treatment with a medicine but does not
necessarily have a causal relationship with this
treatment, that is, an adverse outcome that occurs
while the patient is taking the medicine but is not, or
not necessarily, attributable to it

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Risk factors for ADR


1. Age: Very young, very old
2. Concurrent medicines
3. Duration of Therapy
4. Gender: Females = Inc. risks
5. Co-morbidities
6. Narrow Therapeutic Index Drugs
7. Ethnicity

169

TYPES OF ADR

170

TYPE A: AUGMENTED
KEY NOTES!! SUBTYPES
✓Dose-Dependent A. EXTENSION EFFECTS
✓Predictable B. ADVERSE EFFECTS
✓Common
✓Reproducible

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TYPE A: AUGMENTED

EXTENSION
SIDE EFFECTS
EFFECTS
Benzodiazepine → SEDATION Morphine → CONSTIPATION
Glibenclamide → HYPOGLYCEMIA ACE Inhibitors → COUGH
Warfarin → BLEEDING Minoxidil → HYPERTRICHOSIS
Antibiotics → DIARRHEA Thiazide → HYPERGLYCEMIA and
Furosemide → HYPOKALEMIA HYPERURICEMIA

172

TYPE B: BIZZARE
• SUBTYPES

KEY NOTES! A. IDIOSYNCRATIC


✓NOT dose related B. HYPERSENSITIVITY RXN
• Type 1 : Anaphylactic/Immediate
✓Unpredictable • Type 2 : Cytotoxic
✓RARE • Type 3 : Immune complex
✓Unknown Mechanism • Type 4 : Delayed
✓SERIOUS and FATAL -

173

TYPE B: BIZZARE
A. IDIOSYNCRATIC
Malignant Hyperthermia Steven-Johnsons Syndrome
• Succinylcholine • CArbamazepine
• Halothane • Phenytoin
• Sevoflurane • Sulfonamides

Hemolytic Anemia
• G6PD + Antimalarials
• G6PD + Sulfonamides

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TYPE B: BIZZARE

B.HYPERSENSITIVITY
Type 1: Anaphylactic/Immediate
• Penicillins → Anaphylaxis
• Clindamycin → Pseudomembranous colitis

Type 2: Cytotoxic
• Methyldopa → Hemolytic Anemia
• Chloramphenicol → Aplastic Anemia

175

TYPE B: BIZZARE
B.HYPERSENSITIVITY

Type 3: Immune Complex Type 4: Delayed or Cell


• Blood Dyscrasia mediated
• Arthus Reaction • Tuberculin Skin Test
• Systemic Lupus erythematosus • Morbiliform Rash
• Steven Johnsons Syndrome • Contact Dermatitis

176

TYPE C: CONTINUOUS
KEY NOTES! Addiction – PERSON TAKES THE DRUG
COMPULSIVELY
✓DOSE related EX: MARIJUANA, OPIATES

✓TIME dependent Dependence


– Physical Dependence - ABSTINENCE FROM DRUG
✓↑Duration = ↑Risk PRODUCES PHYSIOLOGICAL SYMPTOMS (BODY)
– Psychological Dependence - CRAVING AND COMPULSIVE
DRUG-SEEKING BEHAVIOR (MIND)
EX: BZD, CAFFEINE, COCAINE

Tolerance – REDUCED EFFECT WITH REPEATED


USED OF THE DRUG
EX: NICOTINE
-

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TYPE D: DELAYED
KEY NOTES!
✓ TIME dependent
• Carcinogenicity Teratogenicity
– Antineoplastics - CBZ
– Heterocyclic Amines - PHENYTOIN
– Aromatic - STREPTOMYCIN
Hydrocarbons - TETRACYCLINE
– Nitrosamines - THALIDOMIDE
– Aflatoxin - ISOTRETINOIN

178

179

TYPE E: END OF USE


KEY NOTES! ➢Opiate Withdrawal → Opioids
✓UNCOMMON ➢Rebound Insomnia → BZD
✓WITHDRAWAL ➢Rebound Hypertension → Clonidine
➢Adrenal Crisis → Corticosteroids
➢Rhinitis Medicamentosa → Nasal decongestant-

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TYPE F: FAILURE OF EFFICACY


KEY NOTES! ➢Drug-drug Interactions
✓ unexpected failure of efficacy ➢Use Of Counterfeit Drugs
✓ Common ➢Drug Instability
✓ dose-related ➢Patient’s Non-compliance
➢Wrong Route Of Administration
➢Drug Resistance
➢Expired Drugs
-

181

NCOMPATIBILITIES
- problem which could arise during the compounding or
dispensing of a prescription
- arises during, before or after drug administration
- interaction of two or more substances

❖ Physical
❖ Chemical
❖ Therapeutic

182

PHYSICAL INCOMPATIBILITIES
V – aporization
L – oss of water
L – iquefaction
I – ncomplete Sol’n
P – recipitation
P – olymophism
-

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Physical
incompatibilities I. Vaporization
❑ a.k.a VOLATILIZATION
e.g. Nitroglycerin
(MONDAY SICKNESS)

II. Precipitation
❑ Salting Out
e.g. Spirits + SALT
Aromatic Water + SALT
Camphor + Water

184

Physical
incompatibilities
III. Incomplete Sol’n
❑ insolubility/immiscibility
e.g. Gum/Pectin + ROH
Resin/Oil + H2O

IV. Loss of Water


• emulsion (phase inversion in o/w
emulsions)
• suspensions & solutions
(increased potency)

185

V. Liquefaction
❑ Eutexia ❑ Efflorescence
✓Camphor ✓Citric acid
✓Aspirin ✓Atropine
✓Alum
✓Menthol
✓Fe Sulfate
✓Phenol
❑Deliquescent ❑Hygroscopic
✓ NaCl ✓ Silica Gel

Physical incompatibilities

186

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VI. Polymorphism
❑C hloramphenicol
❑A spirin
❑T heobroma
❑S ulfanilamide

Physical incompatibilities
Physical incompatibilities

187

CHEMICAL INCOMPATIBILITIES
1. Oxidation 7.Evolution of Gas
2. Reduction 8. Cementation
3. Hydrolysis 9. Gelatinization
4. Solvolysis 10.Polymerization
5. Racemization
11.Photoxidation
6. Explosion

188

I. Oxidation
❑ ascorbic acid
❑ Epinephrine
II. Reduction
❑Tollen’s Test
III. Hydrolysis
❑ Beta lactams
❑ Esters
❑ Amides
Chemical incompatibilities

189

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IV. Solvolysis
❑ Phenytoin Na
V. Racemization
❑ Levo →Dextro
VI. Explosion
❑ KMnO4 + Glycerin
❑ KMnO4 + Sugar
VII. Evolution of Gas
❑ Effervescent tablets
❑ PAS
Chemical incompatibilities

190

Racemization
• The conversion of one enantiomer to a racemate
• Example: Epinephrine – the l-enantiomer is
approximately 15-20x more active than d-
enantiomer
– Other drugs: bupivacaine, albuterol, levalbuterol,
omeprazole, and esomeprazole

191

VIII. Cementation
❑ Acacia + Bismuth IX. Gelatinization
❑ Acacia +Iron salts
X. Polymerization
❑ Dextrose → 5-OH methylfurfural

XI. Photoxidation
❑ Cisplatin ❑ Iron
❑ Adriamycin ❑ Nitroprusside
❑ Nifedipine
Chemical incompatibilities
192

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Methods of Correction
Modify the order of mixing Omission of an ingredient of
Change in the kind or little or no therapeutic value
concentration of solvent Change of dosage form
Change the form of ingredient Dispensing separately
Adjustment of the volume of Compounding by special
the prescription technique
Addition of therapeutically Proper storage
inactive substance/s

193

THERAPEUTIC INCOMPATIBILITIES
Undesirable pharmacological interaction
between two or more ingredients that leads to:
➢ potentiation of the therapeutic effects of the ingredients
➢ destruction of the effectiveness of one or more
of the ingredients
➢ occurrence of a toxic manifestation within the
patient

194

RUG
NTERACTION
❖ Drug-food
❖ Drug- laboratory
❖ Drug-drug

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PRECIPITANT DRUG
one that causes the interaction

OBJECT DRUG
one that is affected in the interaction

196

CLINICAL SIGNIFICANCE
ESTABLISHED ⎯ supported by well-proven clinical studies

⎯very likely but might not be proven


PROBABLE
clinically
⎯ might occur and some data
SUSPECTED
might be available
POSSIBLE ⎯ could occur and limited data are available
⎯ doubtful
UNLIKELY ⎯no good evidence of an altered clinical
effect is available
-

197

A. DRUG-FOOD INTERACTION

• CNS Depressants + Caffeine • INH + Histamine-Rich Foods


→Antagonism → Flushing

• Warfarin + Green Leafy Vegetables • Bisacodyl + Milk


→Antagonism → Alteration of pH

• Tetracycline + Dairy Products • ASA + Caffeine


→ dec absorption →alteration in pH → inc absorption

• MAOI + Tyramine-Rich Foods


→ dec metabolism of NE

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A. DRUG-FOOD INTERACTION
Increased by food Decreased by food
Griseofulvin Captopril
Acarbose Isoniazid
Metoprolol Penicillamine
Itraconazole Penicillins
Theophylline Erythromycin stearate
Tetracycline
Alendronate
Quinolones -

199

B. DRUG-LABORATORY TEST INTERACTION


1.Penicillin, Chloramphenicol, Vit. C, INH, Streptomycin
- glucose in Urine (Benedict’s test)
- false (+) result

2. Chlordiazepoxide
- thyroid function test (I131)
- false (-) result

3.Rifampicin (red-orange), Vit.B12 (intense yellow),


Chloroquine (brown)
- urinalysis
- change in color
-

200

C. DRUG-DRUG INTERACTION
❖Pharmacokinetic

1. ALTERED GIT ABSORPTION


a. Altered pH
b. Altered bacterial flora
c. Formation of drug chelates or complexes
d. Drug induced mucosal damage and altered GIT motility
2. DISPLACED PROTEIN BINDING (Distribution)
3. ALTERED METABOLISM
a. Enzyme Induction
b. Enzyme Inhibition
4. ALTERED RENAL EXCRETION
a. Alteration of Urinary pH
b. Alteration of Active Transport
-

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C. DRUG-DRUG INTERACTION
❖Pharmacokinetic

1. ALTERED GIT ABSORPTION


a. Altered pH
ANTACID + BISACODYL
ANTACID + KETOCONAZOLE(DEC. K)
ANTACID + SALICYLATES (DEC. S)
b. Altered bacterial flora
ANTIBIOTICS + DIGOXIN
c. Formation of drug chelates or complexes
TETRACYCLINE/ FLUOROQUINOLONES/ PENICILLAMINE + METAL
CHOLESTYRAMINE + DIGOXIN/ WARFARIN
SUCRALFATE + LEVOTHYROXINE (DEC T A)

202

C. DRUG-DRUG INTERACTION
❖Pharmacokinetic

1. ALTERED GIT ABSORPTION


d. Drug induced mucosal damage and altered GIT motility
• Gastric Emptying Rate & GE Time
ATROPINE + ANTACID (INC ANT A)
ATROPINE + AMPHETAMINE (DEC AMP A)
• Increased GI Motility
• CATHARTIC + ANY DRUG (DEC DRUG A)
• Adsorption of the Drug
• ADSORBENT + ANY DRUG (DEC DRUG A)
• Interruption of Enterohepatic Circulation
• ANTIBIOTICS + OCP

203

C. DRUG-DRUG INTERACTION
❖Pharmacokinetic

2. DISPLACED PROTEIN BINDING (Distribution)

WARFARIN + PHENYLBUTAZONE (HEMORRHAGE)


GLIBENCLAMIDE + PHENYLBUTAZONE (HYPOGLYCEMIA)
OHA + ASA (HYPOGLYCEMIA)
BILIRUBIN + SALICYLATES(KERNICTERUS)

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C. DRUG-DRUG INTERACTION
❖Pharmacokinetic
3. ALTERED METABOLISM
Enzyme Inducers Enzyme Inhibitors
Phenobarbital Metronidazole
Phenytoin Allopurinol
Rifampicin Grape fruit Juice
Isonizaid
Carbamazepine
Cimetidine
Chronic Alcoholism Disulfiram
Charcoal boiled Food Acute alcoholism
St John’s Wort Chloramphenicol
Ketoconazole
Erythromycin
Valproic acid

205

206

• ACUTE ALCOHOL • CLARITHROMYCIN


• VERAPAMIL • CIPROFLOXACIN
• PHENYLBUTAZONE • CHLORAMPHENICOL
• FLUCONAZOLE • CIMETIDINE
• METYL KETO • DISULFIRAM
• ITRACONAZOLE • ENOXACIN
• INDINAVIR • ALLOPURINOL
• ERYTHROMYCIN • DILTIAZEM

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C. DRUG-DRUG INTERACTION
❖Pharmacokinetic
4. ALTERED RENAL EXCRETION
Interaction Example Effect
1. Glomerular METHYLXANTHINES Rapid renal
Filtration Rate excretion
2. Active Tubular PROBENECID (-) ACTIVE
Secretion TUBULAR
SECRETION
3. Alteration of ASA + NaHCO3 Increase
Urine pH excretion

208

C. DRUG-DRUG INTERACTION
❖Pharmacodynamic

1. ADDITIVE
INTERACTION EFFECT
ROH + Barbiturates SEDATION
ROH + Antihistamine
ROH + CNS Depressants
ROH + Chloral Hydrate

Aminoglycoside + Loop Diuretic OTOTOXICITY

Flecainide + Verapamil negative inotropic &


chronotropic
- effects

209

C. DRUG-DRUG INTERACTION
❖Pharmacodynamic

2. SYNERGISTIC
INTERACTION EFFECT
Sufamethoxazole + INC. Bactericidal
Trimethoprim Activity

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C. DRUG-DRUG INTERACTION
❖Pharmacodynamic

3. POTENTIATION
INTERACTION BRAND NAME
Amoxicillin + Clavulanic Acid AUGMENTIN
Ampicillin + Sulbactam UNASYN
Piperacillin + Tazobactam PIPTAZ
Levodopa + Carbidopa SINEMET

211

C. DRUG-DRUG INTERACTION
❖Pharmacodynamic

4. ANTAGONISM

INTERACTION
Phenoxybenzamine + Catecholamines
Warfarin + Vit K
BZD + Flumazenil
Atropine + Neostigmine

212

C. DRUG-DRUG INTERACTION
❖Pharmaceutical

✓ caused by a chemical or physical


incompatibility when two or more drugs are
mixed together
✓ occurs when drugs are mixed
inappropriately in syringes or infusion
fluids prior to administration

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C. DRUG-DRUG INTERACTION
❖Pharmaceutical
FLUID INCOMPATIBILITY
AMINO ACID Do not add any drug to amino acid
fluids. These fluids may degrade
acidifiable drugs.
BLOOD Do not add any drug to blood.
Its capacity prevents recognition
of drug incompatibility.

SODIUM CHLORIDE Do not add amphotericin.

SODIUM BICARBONATE CaCl2, Ca gluconate,


Vancomycin, Insulin,

214

OTHER ESSENTIAL
INTERACTIONS
SUBX A SUBX B EFFECT
AMINO GLYCOSIDE LOOP DIURETIC ➢ Nephrotoxicity
➢ Ototoxicity
BETA BLOCKERS INSULIN ➢ Masking of
Hypoglycemic
effect
PRAZOSIN ➢ Inc “First Dose”
Phenomenon
THIAZIDES DIGITALIS ➢ Inc toxicity of
Digitalis
because of lox
K levels -

215

MEDICATION COUNSELING

216

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Paracetamol
▪ Use: best for fever and pain, and it lasts for 4 to 6 hours. It is
also good for minor sprains and aches.
▪ Side effects: If you take more than eight extra-strength pills in
two days, and have more than seven drinks a week, it might
cause liver damage. People with pre-existing liver condition,
and drink alcohol regularly, should consult the physicians.
▪ Caution: Keep in mind that it's easy to use too much by taking
two or more medicines with paracetamol, like Neozep, Bioflu,
or Alaxan.

217

Ibuprofen
▪ Use: best for menstrual cramps, fever, sprains, and joint pain
that linked to osteoarthritis. It lasts for 4 to 6 hours.
▪ Side effects: It might cause gas, bloating, stomach pain,
heartburn, dizziness, and constipation. Prolonged use can
cause ulcers, elevated blood pressure, kidney, and liver
damage, and in rare cases, stroke or heart attack.
▪ Caution: If you have pre-existing heart or kidney disease, have
hypertension, diabetes, ulcers, or bleeding problems, and take
diuretics, consult the physician.

218

Aspirin
▪ Use: It is best for fever, pain, and inflammation. There is evidence that
at low doses (80 mg) daily can prevent heart attack and stroke, but
you should make sure to check with your doctor if aspirin is right for
you. High doses relieve pain, but experts prefer the other choices.
▪ Side effects: It might cause stomach pain, heartburn, dizziness, and
constipation. Prolonged use can cause ulcers, kidney and liver
damage.
▪ Caution: If you have diabetes, bleeding disorder such as hemophilia,
or pre-existing liver or stomach condition, or if you are taking
corticosteroids such as prednisone, or blood pressure medication,
consult your physician.

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Always read drug labels carefully.


Learn about the warnings for all the drugs you take.
Keep medications in their original containers so that you can easily identify
them.
Ask your doctor what you need to avoid when you are prescribed a new
medication. Ask about food, beverages, dietary supplements, and other drugs.
Check with your doctor or pharmacist before taking an OTC drug if you are
taking any prescription medications.
Use one pharmacy for all of your drug needs.
Keep all of your health care professionals informed about everything that
you take.
Keep a record of all prescription drugs, OTC drugs, and dietary supplements
(including herbs) that you take. Try to keep this list with you at all times, but
especially when you go on any medical appointment.

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