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CENTRO ESCOLAR UNIVERSITY
Manila, Malolos, Makati
School of Pharmacy
Dispensing, Compounding and Incompatibilities
with Adverse Drug Reaction
Name: ___________________________________________________________________
DISPENSING
Based from Administrative Order (A.O.) No. ___ series of 1989, otherwise known as “Rules and
Regulations to Implement ___________ Requirements under the Generics Act of _____ (R.A.
_________”:
DISPENSING – is the act by validly-registered ____________ of filling a prescription or doctor’s order on
a patient’ chart.
PRESCRIPTION
v From the Latin words prae which means _________; and _________ which means “I write”
v An order for medication issued by a licensed ___________, ____________, and _____________.
v Classification of Drugs Based on Prescription Requirements:
o Over-the-counter Drugs – do not need a prescription; the __________ is responsible in giving the
necessary information and direction for use of the drug.
o Prescription Drugs – also known as ______________ or _______________; can only be
dispensed when prescription is presented
o Dangerous Drugs – pharmaceutical products referring to either prohibited or regulated drugs
which require a special prescription form usually obtained from the Dangerous Drugs Board.
Ø 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
Ø __________ Drugs – include sedative-hypnotics and drugs which contain a salt derivative
of a salt of an isomer of amphetamine
Ø Requirements in Prescribing List A Drugs:
a. S-___ license of the __________
b. Special DDB prescription form (Form No. ______) must be used
c. Recording system
v TYPES OF PRESCRIPTION
o Based on the Number of Ingredients
§ Simple Prescription
§ Compound Prescription
§ Polypharmacal Prescription
o Compounded or Non-compounded Prescription
§ Distinct Portions of a Compounded Prescription
1. Basis/Base - ________; responsible for the therapeutic action
2. Adjuvant – aids or assist the ________
3. Corrective or __________ - qualifies the action of the base and the adjuvant
4. Vehicle – dilutes the active ingredient
o New or Refill Prescription
§ Partial Filling of Prescription – means dispensing ______ 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.
o Generic or Controlled Prescription
§ Generic Dispensing – means dispensing the patient’s/buyer’s choice from among generic
____________.
§ Dispensing of Controlled Drugs – partial filling is not allowed; dispensing must be done by
the ___________ who shall affix his/her signature on the prescription filled
§ Dispensing of 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.
v FORMS OF PRESCRIPTION ORDER
“Sacrifice is a part of life. It’s supposed to be.
It’s not something to regret. It’s something to aspire to.”
-Mitch Albom, The Five People You Meet in Heaven
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o Prescription Blanks
o Physician’s Order or Medication Sheet - orders for medications by an individual authorized to
prescribe and are intended for use in the institutional setting.
v PARTS OF A PRESCRIPTION
o Prescriber’s Information
o Patient’s Information
o Date of Prescribing
o Superscription – the _____ symbol; “you take”, “recipe”
o ____________ – includes the medication prescribed
o Subscription – dispensing direction to the ____________
o Transcription or _________ - direction to the patient; “let it be labelled”
o Refill, special labelling and/or other instructions
o ____________ Signature
v SOME IMPORTANT CONSIDERATIONS IN PROCESSING THE PRESCRIPTION ORDER ARE
AS FOLLOWS:
o Reading the Prescription – should be in ___________
§ If illegible or error has been made – consult another pharmacist or the prescriber
§ Never guess the meaning of an indistinct word or unrecognized abbreviation
Examples of abbreviation can be found on the last pages of this review material.
o Dating the Prescription – important in determining the appropriate ___________ and
________________
o Packaging – selection of the appropriate container should be based on:
a. The type, nature and quantity of medication to be dispensed; and
b. The mode of administration
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
o Recording and Filing the Prescription
§ Prescription Book – shall be kept for ______ years after the last entry (Sec. 2, A.O. No. ____
series of 1989)
§ Poison Book – shall be kept for _____ years after the last entry (Sec. 34, R.A. _______)
§ DD Book – shall be kept for _______ years after the last entry
o Refilling of Prescription
§ Instruction is provided by the ___________
§ For non-controlled substance – may be refilled to _________ after the prescription was written
v VIOLATIVE, ERRONEOUS AND IMPOSSIBLE PRESCRIPTIONS
o 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 which is legible is written
§ Where the brand name is indicated and instructions added (such as phrase “_____________”)
o ___________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**
**It was amended by Administrative Order No. ____ series of 1990.
o Impossible Prescription – SHALL ________ 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
“Sacrifice is a part of life. It’s supposed to be.
It’s not something to regret. It’s something to aspire to.”
-Mitch Albom, The Five People You Meet in Heaven
Page 3 of 9
EXTEMPORANEOUS PRESCRIPTION COMPOUNDING
PHARMACY COMPOUNDING – is defined as the preparation, ___________, assembling, packaging or
labelling of drug or device as a result of a practitioner’s ____________ or drug order.
• Includes fortifying or reducing the strength of an active ingredient in a dermatological preparation
• Reformulate adult dosage forms, such as tablets or capsules, into an oral suspension for pediatric
use, or IV admixture
Considerations in Extemporaneous Prescription Compounding
1. ____________ of the compounded preparation
2. Chemical and physical _____________ of the ingredients
3. The proper __________________
4. Special adjuvants or techniques
5. _____________________ required
INCOMPATIBILITIES
INCOMPATIBILITY means:
• Conflict, disagreement, differences in prescription;
• Problem which could arise during the compounding or dispensing of a prescription; and
• Interaction of two or more substances
• NOTE: Incompatibility is unintentional, but SOME ARE INTENTIONAL OR EXPECTED.
FORMS OF INCOMPATIBILITY:
1. Physical Incompatibilities
2. ______________ Incompatibilities
3. Therapeutic Incompatibilities
A. PHYSICAL INCOMPATIBILITIES – physical or chemical interaction between two or more ingredients
that leads to a visibly ____________ change.
Manifestations or Evidences of Physical Incompatibility
1. INCOMPLETE SOLUTION
• Forms of Incomplete Solution
o Insolubility – inability of the ________ material to dissolve in a particular solvent system.
Example: Camphor + Water (Remedy: _______________)
Gum + Alcohol (Remedy: _______________)
Iodine + Water (Remedy: _________________)
o Immiscibility – two or more liquids fail to mix with one another homogeneously.
Example: Cod liver oil + Water (Remedy: ___________________________)
1 mL Phenol + 10 mL Water (Remedy: _____________________)
2. PRECIPITATION – the solute which is originally dissolved in the solvent is thrown out of solution;
separation of the solute.
• Reasons of Precipitation
o Salting-out – concentrated solutions of electrolytes are mixed in prescription with solutions of
non-electrolytes
§ Electrolytes and non-electrolytes compete for the water molecules.
Example: KBr + Camphor water (Remedy:____________________________________)
o Change in the Solvent System
Example: NH4Cl + Camphor + Alcohol + Water (Remedy: ________________________)
o Change in Temperature (Endothermic/Exothermic Reactions)
§ Endothermic Reaction – absorbs heat from the surrounding; _______ temperature of the
solution; ___________ solubility
Example: NH4Cl + Water (Important Reminder: ______________________)
§ Exothermic Reaction – gives off heat to the surrounding; _________ temperature of the
solution; ___________ solubility, with the exception of _______________.
Example: Lime water is more soluble in cold water than in hot water.
Important Reminder: ________________________________________________
o Change in pH
Example: Phenobarbital Na + Syrup of Orange (Remedy: ________________________)
Codeine SO4 + NaOH (Remedy: ____________________________________)
3. LIQUEFACTION OF SOLID INGREDIENT – due to deliquescence, efflorescence and eutexia.
• Deliquescence – absorbs moisture and _________(NaCl)
• Efflorescence – release water of crystallization (Citric acid, atropine SO4, FeSO4, alum,
effervescent tablet)
• Eutexia – liquefaction of solids at _______ temperature, due to the lowering of their ________
points
“Sacrifice is a part of life. It’s supposed to be.
It’s not something to regret. It’s something to aspire to.”
-Mitch Albom, The Five People You Meet in Heaven
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o Exhibited by ASA, menthol, phenol, thymol, camphor, salol, and other aldehydes and ketones
Example: Lidocaine + Prilocaine → EMLA
o NOTE: Eutexia is NOT always to be expected in mixing eutectic compounds
Example: Salol: Acetanilide (1:2 = will not liquefy; 2:1 will liquefy)
Salol: MgCO3 (1:2 = will not liquefy; 2:1 will liquefy)
4. VAPORIZATION – also known as _________________; liberation of the ___________________
Example: Volatile oils, ketone, esters, NTG, aldehyde, alcohol
5. POLYMORPHISM – existence of one or more crystalline and/or amorphous form
Example: Cubic: _________ Tetragonal: __________
__________: Iodoform _________: Iodine
Monoclinic: __________ Triclinic: ____________
6. WATER LOSS – manifested by liquid dosage forms; reverse of _______________
Example: Emulsion (phase inversion in O/W emulsion)
Crumbling of ointments
B. CHEMICAL INCOMPATIBILITIES – reaction in which a visible change is NOT necessarily observed.
Chemical Reactions Involved in Chemical Incompatibility
1. OXIDATION-REDUCTION (REDOX)
• Oxidation – remember VILEORA, which means _______________________________________.
o Dehydrogenation
o Triggered by oxygen, light, metals
o Manifests as change in color
o Example: Ascorbic acid, epinephrine
• Reduction – remember VDGEROA, which means ______________________________________.
o Hydrogenation
o Example: Tollen’s test
2. ACID-BASE REACTIONS (General Reaction: _____________________________________)
• Precipitation
o Example: Ca(OH)2 + CO2 → CaCO3↓ + H2O
• Evolution of Gas – facilitates effervescence
o Effervescence is desired to mask salty and bitter-tasting drugs
o Chemical reaction involved: C6H8O7(aq) + 3NaHCO3(aq) → 3H2O(l) + 3CO2(g) + Na3C6H5O7(aq)
3. _________________ – the most common type of incompatibility
• It involves water as the solvent
• The most common mechanism of drug degradation
• Example: Susceptible groups of the following groups:
o Lactams (penicillins, cephalosporins)
o Esters (local anesthetics)
o Amides (local anesthetics)
o Imines (benzodiazepines, barbiturates)
4. _________________ - interaction of drug with solvent other than water
5. PHOTOCHEMICAL DEGRADATION (PHOTOOXIDATION; PHOTOLYSIS)
• Degradation by light
• Manifests as a change in color
• Example: Nifedipine, nitroprusside, riboflavin, phenothiazines, adriamycin, cisplatin, amphotericin B
6. RACEMIZATION – the optically active form of drug is converted into its enantiomorph, continues until
50% of original drug is converted to its optically inactive mixture
• Product: ___________ Mixture – contains equal amounts of dextro (__) and levo (__) isomers.
• Example: Thalidomide (R – for morning sickness; S – teratogenic)
Naproxen (Active form – NSAID; Inactive – Hepatotoxic)
7. GELATINIZATION – gel or gelatin formation
• Example: Acacia + ___________ salts
8. CEMENTATION – cake formation
• Example: Acacia + ___________ salts
9. EXPLOSIVE MIXTURE – reducing agent (RA) + oxidizing agent (OA)
• Example: sugar + KMnO4; glycerine + KMnO4
10. POLYMERIZATION – formation of 5-OH-methylfurfural from _______________
C. THERAPEUTIC INCOMPATIBILITIES – undesirable pharmacological interaction between two or more
ingredients
Manifestations or Evidences of Therapeutic Incompatibility
1. IMPROPER DOSES
• Overdosage
o Excessive amounts taken at one time
o Doses repeated at too frequent intervals
“Sacrifice is a part of life. It’s supposed to be.
It’s not something to regret. It’s something to aspire to.”
-Mitch Albom, The Five People You Meet in Heaven
Page 5 of 9
o Milligram instead of microgram
o Dose dumping from __________________ formulation
• Underdosage
o Administration of very small doses
o Doses given at less frequent intervals
o Milligram instead of gram
o Tinctures instead of fluidextracts
2. SYNERGISTIC AND ANTAGONISTIC COMBINATION
• Synergistic Combination – drugs with ______ pharmacologic action; intentional or unintentional
• Antagonistic Combination – drugs with ________ pharmacologic action; may be acceptable or
not
3. WRONG DRUG
• Trademark error or ineffective generic name – SALADs
• Improperly formulated dosage – physical and chemical incompatibilities
• Dosage form error – ophthalmic ointment instead of topical gel
• Improper use – Buccal/SL tablets are swallowed
4. CONTRAINDICATED DRUG
• Examples: Hypertensives – NO to vasoconstrictors
Asthmatics – NO to penicillins, ASA
Patients with ulcer – NO to steroids
Anemics – NO to chloramphenicol
5. FORMATION OF TOXIC COMPOUNDS – may result from chemical incompatibility
6. REDUCTION OR DELAY IN THERAPEUTIC EFFECTIVENESS
• May be due to chemical reaction or physical change
• Failure to comply instructions for proper storage and administration of the product
SPECIAL TOPIC FOR THERAPEUTIC INCOMPATIBILITY: DRUG INTERACTIONS
TERMINOLOGIES:
Precipitant Drug – also known as ______________; the drug, chemical or food causing interaction
Object Drug – drug affected by the interaction
NOTE: Drug interaction may be beneficial or adverse:
Beneficial – employed in the treatment of toxicity
Adverse – when it results to alteration of the pharmacokinetic parameters of pharmacodynamic
properties of drugs
Classification of Drug Interaction:
A. DRUG – DRUG INTERACTION
1. Pharmaceutic Interactions
• 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
• Example: Phenytoin Na will precipitate in acidic pH
Aminophylline (basic pH) should not be mixed with epinephrine which decomposes at
alkaline pH
2. Pharmacokinetic Interactions
• Pharmacokinetics: “What the _________ does to the __________”
• ADME is altered by the precipitant drug
• Manifestations:
a. Alteration in Absorption (A)
o Alteration of pH
§ Antacid + Bisacodyl (Effect: _______________________________________________)
§ Antacid + Ketoconazole (Effect: ____________________________________________)
§ Antacid + Salicylates (Effect: ______________________________________________)
o Complex Formation
§ Tetracycline + Metal-containing drugs (Effect: _____________________________________)
§ Fluoroquinolones + Metal-containing drugs (Effect: _________________________________)
§ Penicillamine + Metal-containing drugs (Effect: ____________________________________)
o Decreased Gastric Emptying Rate
§ Atropine + Antacid (Effect: ___________________________________________________)
§ Atropine + Amphetamine (Effect: _______________________________________________)
o Increased Gastric Emptying Rate
§ Nicotine + Antacid (Effect: ____________________________________________________)
o Increased GI Motility
§ Cathartic + Any Drug (Effect: __________________________________________________)
o Adsorption of the Drug
“Sacrifice is a part of life. It’s supposed to be.
It’s not something to regret. It’s something to aspire to.”
-Mitch Albom, The Five People You Meet in Heaven
Page 6 of 9
§ Cholestyramine + Digoxin (Effect: ______________________________________________)
§ Colestipol + Vitamin K (Effect: _________________________________________________)
o Interruption of Enterohepatic Circulation
§ Antibiotics + OCP (Effect: _____________________________________________________)
o Inhibition of GI Microbial Flora
§ Antibiotics + Digoxin (Effect: ___________________________________________________)
b. Alteration in Distribution (D)
o Displacement from Protein Binding Sites
§ Warfarin + Phenylbutazone = ______________________
§ Glibenclamide + Phenylbutazone = __________________
§ OHA + ASA = ___________________
c. Alteration in Metabolism (M)
o Enzyme Inducers – stimulate the metabolism of other drugs taken concomitantly; decrease the
pharmacologic action of the __________ drug.
o Enzyme Inhibitors – decrease the rate of the object drug metabolism
ENZYME INDUCERS (CROPGPSC) ENZYME INHIBITORS (MEDVICKGA)
Carbamazepine; Chronic Alcoholism Metronidazole
Rifampicin Disulfiram; Diltiazem; Diphenhydramine
Omeprazole Verapamil; Valproic acid
Phenytoin Isoniazid; Indinavir
Griseofulvin Chloramphenicol; Cimetidine; Ciprofloxacin
Phenobarbital Ketoconazole
St. John’s Wort Grapefruit Juice
Cigarette Smoking Acute Alcoholism
d. Alteration in Excretion (E)
o Alteration of Urinary pH
§ ASA + NaHCO3 (Effect: _____________________________________________)
o Alteration of Active Transport
§ Probenecid + Penicillin (Effect:_______________________________________)
§ Probenecid + Indomethacin (Effect: ___________________________________)
§ NSAIDs + Lithium salts (Effect:________________________________________)
§ Quinidine + Digoxin (Effect: __________________________________________)
§ Amiodarone + Digoxin (Effect: __________________________________________)
§ Corticosteroids + ASA (Effect: _________________________________________)
3. Pharmacodynamic Interactions
• Pharmacodynamics: “What the _________ does to the __________”
• Explains the mechanisms of action and pharmacologic effects of drugs
• Types:
a. Additive Effects (1 + 1 = 2) – response is EQUAL to the combined effects of individual drugs
o Alcohol + Barbiturates = _______________________________________
o Alcohol + Antihistamines = _____________________________________
o Alcohol + Chlorpropramide = ___________________________________
o Flecainide + Verapamil = ______________________________________
b. Synergism (1 + 1 = 3) – response is GREATER THAN the combined effects of the individual
drugs
o Co-trimoxazole ( _____________ + ______________ = ___________________________)
c. Potentiation (0 + 1 = 2) – a drug WITH NO INHERENT ACTIVITY WILL ENHANCE the effect of
another drug
o Amoxicillin + Clavulanic acid = _______________________________
o Ampicillin + Sulbactam = ___________________________________
o Piperacillin + Tazobactam = _________________________________
o Levodopa + Carbidopa = ____________________________________
d. Antagonism (1 + 1 = 0) – drug inhibits the effect of one another
o Phenoxybenzamine + Catecholamines = ________________________
o Warfarin + Vitamin K = ______________________________________
o Heparin + Protamine SO4 = __________________________________
o Opioids + Naloxone = _______________________________________
o Benzodiazepine + Flumazenil = ________________________________
o Atropine + Neostigmine = _____________________________________
B. DRUG – FOOD INTERACTION
• CNS Depressants + Caffeine (_____________)
• Warfarin + Green Leafy Vegetables (______________)
• Tetracycline + Dairy Products (______________)
• MAOI + Tyramine-rich Foods (______________)
• ASA + Caffeine (__________________)
• Amphetamine + Vitamin C (___________________)
“Sacrifice is a part of life. It’s supposed to be.
It’s not something to regret. It’s something to aspire to.”
-Mitch Albom, The Five People You Meet in Heaven
Page 7 of 9
INCREASED BY FOOD (GAMIT) DECREASED BY FOOD (CAQPIPET)
Griseofulvin (high fat-containing foods) Captopril
Acarbose Alendronate
Metoprolol Quinolones
Itraconazole Penicillamine
Theophylline (high fat-containing foods) Isoniazid
Penicillins
Erythromycin stearate
Tetracycline
C. DRUG – LABORATORY INTERACTION
• Penicillins, Chloramphenicol, Vitamin C, INH, Streptomycin
o Glucose in Benedict’s Solution
o False positive result
• Rifampicin (______________), Vitamin B2 (_______________), Chloroquine (_______________)
o Urinalysis (change in color)
• Daptomycin with two recombinant thromboplastin reagents
o Falsely prolonged patient thromboplastin time/INR
ADVERSE DRUG REACTION (ADR)
ADVERSE DRUG EVENT (ADE) VS. ADVERSE DRUG REACTION (ADR)
ADVERSE DRUG EVENT (ADE) ADVERSE DRUG REACTION (ADR)
o An injury resulting from the use of a drug o Response to a drugs that is __________
o Includes BOTH preventable (human errors, and ___________, and that occurs at
such as medication errors) and doses ___________ used in humans for
unpreventable (ADR) reaction the prophylaxis, diagnosis or therapy.
THEREFORE: ADR IS A CASE TYPE OF ADE.
Terms related to ADR:
SIDE EFFECT – expected and known effect of a drug that is NOT the intended therapeutic outcome.
ALLERGY – an ADR mediated by immune response.
CLASSIFICATION OF ADVERSE DRUG REACTION (ADR)
1. Type A (_________________)
• Common, _______________
• Dose related and result directly from the pharmacological action of the drug
• Extension effect, of drug’s pharmacologic action
• Side effect, toxicity or overdose
• Can be due to drug-drug interaction and drug-food interaction
• Examples: OHA - _________________________
Diazepam - _____________________
Loop Diuretics - __________________
Anticoagulants - __________________
Antihistamines - __________________
Narcotics - ______________________
Paracetamol Overdose - ___________
2. Type B (__________________)
• Uncommon, _______________, more serious than type A
• Not dose-dependent
• Unrelated to drug’s pharmacologic action
• Often serious and fatal
• May be influenced by genetics and environmental factors
• Type B ADRs include:
a. Idiosyncracy – genetically-determined reactions
o Antipsychotic agents - __________________
o Vancomycin (pseudoallergic) - _________________________
o Sulfonamides, Phenytoin, Carbamazepine - ________________________
o G6PD + Antimalarials or Sulfonamides - ___________________________
b. Immunologic or _______________ - immune responses to environmental antigens resulting
in symptomatic reactions upon secondary exposure to the same antigen, more commonly
referred to as _______________.
Types of Immunologic Reactions:
“Sacrifice is a part of life. It’s supposed to be.
It’s not something to regret. It’s something to aspire to.”
-Mitch Albom, The Five People You Meet in Heaven
Page 8 of 9
o Type I (Immediate or Anaphylatic Immune Response)
§ Most common category of allergic reaction
§ IgE mediated
§ Examples: Anaphylaxis from penicillins; hay fever; asthma (NSAIDs + ASA); urticaria
(___________)
o Type II (Cytotoxic Reactions)
§ IgG or IgM mediated
§ Blood dyscrasias: disorder of cell components of the blood (Hemolytic anemia, aplastic
anemia, thrombocytopenia)
§ Examples: Methyldopa - ___________________
Chloramphenicol - _______________
Aspirin/Ibuprofen - _______________
Blood transfusion reactions
o Type III (Immune Complex)
§ Examples: Serum sickness
HIPPS – SLE
o Type IV (Delayed, Cell-mediated)
§ Delayed reactions (from weeks – months)
§ T-cell mediated
§ Examples: Tuberculin Skin Test (ROA: _____)
Poison Ivy (urushiol) - ___________________
Tissue/Organ Rejection
3. Type C (_______________)
• Uncommon
• Dose- and time-related
• Associated with the cumulative dose of the drug
• Subtypes:
o Addiction – condition where a person takes a drug compulsively, despite potential harm to
himself, or his desire to stop.
§ Examples: Marijuana, Opiates,
o Dependence – compulsion to take the drug repeatedly and experiences unpleasant symptoms
if discontinued
§ Examples: Benzodiazepines, Caffeine, Steroids
o Tolerance - ________ dose, same response
§ Example: Nicotine
o Tachyphylaxis – repeated administration, ________ effectiveness
4. Type D (______________)
• Rare, delayed in onset
• Usually dose-related
• Subtypes:
o Carcinogenicity – ability of any substance to cause or induce ____________
§ Examples: Antineoplastic agents
Aromatic hydrocarbons (___________)
Heterocyclic amines
Aflatoxins
Nitrosamines
o Teratogenicity – ability of any substance to cause congenital malformations or birth defects;
the risk of teratogenesis is highest during the _________ trimester of pregnancy
§ Teratogens include:
a. Vitamin A Derivatives – isotretinoin, tretinoin, etretinate (heart and brain abnormality)
b. Phenytoin – fetal hydantoin syndrome (craniofacial defect)
c. Valproic acid/Carbamazepine – neural tube defects (Prevention: Give Vitamin ____)
d. ACEIs – ________ dysgenesis
e. Thalidomide – phocomelia (Current use: ______________)
f. Lithium – Ebstein’s Anomaly (problem in ______________)
g. Methimazole – aplasia cutis (absence of ______; first trimester of pregnancy)
h. Warfarin – fetal warfarin syndrome (characterized by nasaly hypoplasia and depressed
nasal bridge; first trimester of pregnancy)
i. Antineoplastics – embryocidal
j. Alcohol – fetal alcohol syndrome
k. Streptomycin – _____ nerve defect
l. Tetracyclines – discoloration (__________) and defects of teeth and altered bone
growth
m. Estrogens and Androgens – may cause serious genital tract malformations
§ Pregnancy Categories include:
“Sacrifice is a part of life. It’s supposed to be.
It’s not something to regret. It’s something to aspire to.”
-Mitch Albom, The Five People You Meet in Heaven
Page 9 of 9
a. Category A – no evidence of risk to fetus
b. Category B - animal studies have failed to demonstrate risk and there are no adequate
and well-controlled studies in pregnant women
c. Category C – animal studies have shown adverse effects, no adequate well-controlled
studies in human
d. Category D – positive evidence of human fetal risk but benefits may warrant use
e. Category X – positive evidence of human fetal risk and risks outweigh the benefits
5. Type E (_________________)
• Uncommon
• Withdrawal symptoms
• Examples: Opiate withdrawal
Clonidine - _______________
Steroids – adrenal insufficiency (_______________________)
Oxymetazoline - ___________________________ (rebound congestion)
6. Type F (_______________________)
• Common; dose-related
• Therapeutic failure due to the following:
o Lack of efficacy
o Poor patient compliance
o Counterfeit drugs
o Drug interactions
o Antimicrobial resistance
o Inappropriate use/wrong route of administration
o Underdosing
o Manufacturing errors/toxic excipients
o Expired drugs
NOTHING FOLLOWS-----
Prepared by:
Crisfel Rosario del Mundo, MSc, RPh
“Sacrifice is a part of life. It’s supposed to be.
It’s not something to regret. It’s something to aspire to.”
-Mitch Albom, The Five People You Meet in Heaven