Professional Documents
Culture Documents
CHAPTER 5
MEDICATION RELATED PROBLEMS
Drug related problems - an event or circumstance involving drug therapy that
actually or potentially interferes with desired health outcomes; a patient problem that
is either caused by a drug or may be treated or prevented by a drug.
Drug therapy problems - is any undesirable event experienced by a patient which
involves, or is suspected to involve, drug therapy, and that interferes with achieving
the desired goals of therapy.
COMPONENTS:
1. Problem – undesirable event or risk of an event experience by the patient.
2. Drug therapy involved.
3. Relationship that exists between the patient and drug therapy.
a. Consequence of drug therapy.
b. Require the addition or modification of drug therapy.
CATERGORIES AND CAUSES OF DRUG RELATED PROBLEMS
There is no valid medical indication for the drug therapy at this time.
Multiple drug products are being used for a condition that requires single
drug therapy.
The medical condition is more appropriately treated with non-drug therapy
Drug therapy is being taken to treat an avoidable adverse reaction
associated with another medication.
Drug abuse, alcohol use, or smoking is causing the problem.
2. Wrong drug/ Ineffective drug
The drug product is not the most effective for the indication being treated.
The medical condition is refractory to the drug product.
The dosage form of the drug product is inappropriate.
The drug is not effective for the medical problem.
The drug product causes an undesirable reaction that is not dose related.
A safer drug product is required due to risk factors.
A drug interaction causes an undesirable reaction that is not dose-related.
The dosage regimen was administered or changed too rapidly.
The drug product causes an allergic reaction.
The drug product is contraindicated due to risk factors.
6. Inappropriate compliance
Noncompliance is defined as the patient's inability or unwillingness to take a
drug regimen that the practitioner has clinically judged to be appropriately indicated,
adequately efficacious, and able to produce the desired outcomes without any
harmful effects.
Example:
Consider a 57-year-old male patient who feels the medication he is taking for
his back pain is not being effective (acetaminophen 1000 mg three times
daily). This patient is taking a daily dose of 0.200 mg of levothyroxine (Synthroid)
to manage hypothyroidism. He is also taking 81 mg of enteric-coated aspirin
each morning as primary prevention of heart attack.]
CHAPTER 6
ADVERSE DRUG REACTION
Adverse drug reaction is an unwanted, undesirable effect of a medication that
occurs during usual clinical use.
Adverse drug reactions occur almost daily in health care institutions and can
adversely affect a patient’s quality of life, often causing considerable morbidity
and mortality.
Note Within these few definition I want the reader to only memorize WHO
meaning and make their own understanding for the rest.
ADE as “any untoward medical occurrence that may present during treatment with a
pharmaceutical product but which does not necessarily have a causal relationship with
this treatment”
ADR as “a response to a drug which is noxious and unintended and which occurs
at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for
the modification of physiologic function.”
WORLD HEALTH ORGANIZATION
ADR
An appreciably harmful or unpleasant reaction, caused by an intervention related
to the use of a medicinal product, which predicts hazard from future administration
and warrants prevention or specific treatment, or alteration of the dosage regimen, or
withdrawal of the product (Edwards).
Any unexpected, unintended, undesired, or excessive response to a drug that requires
discontinuing the drug (therapeutic or diagnostic), requires changing the drug therapy,
requires modifying the dose (except for minor dosage adjustments), necessitates
admission to a hospital, prolongs stay in a health care facility, necessitates supportive
treatment, significantly complicates diagnosis, negatively affects prognosis, or results in
temporary or permanent harm, disability or death (ASHP).
Harm is directly caused by a drug at normal doses (Edwards).
Unexpected Adverse Reaction
An "unexpected" adverse reaction is one, the nature or severity of which is not
consistent with information in the relevant source documents.
Serious Adverse Effect
Any untoward medical occurrence that at any dose results in death, requires hospital
admission or prolongation of existing hospital stay, results in persistent or significant
disability/incapacity, or is life- threatening (Edwards).
Signal
Reported information on a possible causal relation between an adverse event and a
drug, the relation being previously unknown or incompletely documented (Edwards).
Medication Error
Any preventable event that may cause or lead to inappropriate medication use or
patient harm while the medication is in the control of the health care professional,
patient, or consumer (NCC MERP).
Errors in the process of ordering or delivering a medication, regardless of whether
an injury occurred or the potential for injury was present (Bates).
Inappropriate use of a drug that may or may not result in harm (Nebeker).
Side Effect
Intended effect at normal doses related to the pharmacology of the drug.
Extension effect
Aka. excessive actions
Associated with the MOA/Pharmacological activity of the drug
Overdosage
Results from drug levels above the therapeutic levels
Pharmacovigilance
Science and activities relating to detection, assessment, understanding and
prevention of adverse effect and medication-related problems.
Likelihood of ADR
2. Ethnicity and genetics
Genetic Polymorphism
N-acetyl Transferase
Fast Acetylators – Asians, Eskimos
Slow Acetylators – Caucasian, African-American
3. Age
Theophylline - Warfarin
Heparin - Digoxin
Anticonvulsant - Lithium
5. Sex
6. Concurrent medicines
Polypharmacy
8. Cytotoxic reaction
Quinidine
HIPS drugs (Analgesic Drugs)
10. Genetically determined enzyme deficiency
Hemolytic anemia
11. Dose of the drug
12. Alcohol and Cigarette
13. Error in self medication
TYPES OF ADR:
A. AUGMENTED TYPE A
B. BIZARRE TYPE B
C. CONTINUOUS TYPE C
D. DELAYED TYPE D
E. END OF USE TYPE E
F. FAILURE OF THERAPY TYPE F
A. AUGMENTED
DOSE-RELATED
Common
Related to the pharmacologic action of the drug
Exaggerated
Predictable
Low mortality
B. BIZARRE
NON-DOSE RELATED
Uncommon
Not related to the Pharmacologic action of drug
Unpredictable; High mortality
Hypersensitivity
unusual susceptibility
immune response to environmental antigens resulting in symptomatic reactions
upon secondary exposure to the same antigen (allergens)
Idiosyncrasy – unknown mechanism influenced by genetic and environmental factor.
TYPE OF IMMUNOLOGIC REACTIONS
C. CONTINUOUS
DOSE-RELATED AND TIME-RELATED; CHRONIC
Uncommon
Related to the cumulative
Drug resistance
A decrease in responsive of the invading microorganism to chemotherapeutic agents.
Tachyphylaxis
Correct by changing the dose “DRUG HOLIDAY”
SUBTYPE:
Addiction
Uncommon
Usually dose-related
Occurs or becomes apparent sometime after use of the drug
E. END OF USE
WITHDRAWAL
Uncommon
Occurs soon after withdrawal of the drug
F. FAILURE OF THERAPY
UNEXPECTED
Common
Dose related
Often caused by drug interaction
CHAPTER 7
SIDE EFFECTS, TOXICITY, AND INTERVENTION
Side effects are any effects caused by a drug other than the intended therapeutic effect
whether it is beneficial or harmful. It can be based on the same therapeutic effect of the
drug.
Sometimes called adverse effects. Any unwanted effects of a drug that are expected
to happen.
Example:
Atropine: Pre anaesthetic medication, Decreases secretion. As side effects, it causes
dryness of the mouth.
Codeine: Analgesic or cough suppressant. As side effect it leads to constipation. It
allows codeine to be used as an anti-diarrheal medication.
Minoxidil: Anterior vasodilator. First used as a treatment to hypertension and was
found to cause Hirsutism as a side effect. Side effect explains the use of topical
minoxidil in treating alcopecia.
SIDE EFFECTS:
a) Mild – digestive disturbances such as nausea, constipation, diarrhea; fatigue;
headaches; vague muscle aches; malaise; change in sleep patterns.
b) Moderate – rashes, visual disturbances, muscle tremor, difficulty with urination;
any perceptible change in mood or mental function, changes in blood
components, such as a temporary, reversible decrease in the white blood cell
count or in blood levels of some substances, such as glucose.
c) Severe – Life threatening; Liver failure, Abnormal heart rhythms, certain types
of allergic reactions that results in persistent or significant disability.
d) Lethal (Deadly) – drug reactions directly or indirectly cause death.
Talk to your healthcare provider about what side effects to look out for, and what
to do if you experience one of them;
Read the information that comes printed on your medicine labels so that you are
aware of the side effects associated with your medicines and know what to be on
the lookout for;
Ask if there are ways to prevent or manage drug side effects like taking a
medicine with food, or at bedtime;
Ask whether you can drink alcohol when using the medicine, as combining
alcohol with certain medicines can be dangerous;
Make sure your healthcare providers are aware of any allergies you have; and
Contact your healthcare professional if you experience any side effects.
Toxicity any toxic adverse effect that a chemical or physical agent might produce
within a living organism.
TYPES OF TOXIC STUDIES:
a) Acute toxicity – refers to those adverse effects occurring following oral or
dermal administration of a sing dose of a substance, or multiple doses given
within 24 hours, or an inhalation exposure of 4 hours.
b) Sub-acute toxicity – resembles acute toxicity except that the exposure
duration is greater, form several days to one month.
c) Subchronic toxicity – it is the toxic exposures repeated or spread over an
intermediate time range (1-3months).
d) Chronic toxicity – it is the exposure (either repeated or continuous) over a
long (greater than 3 months) period of time.
Overdose the toxic effect refers to the direct cell damaging action of the drug
often when used at high dose. All drugs are toxic in overdose.
Overdose can be:
1) Absolute – acute high dose of the drug is administered as in suicidal attempt
or by accident.
2) Relative – the therapeutic dose of the drug is used but it may turn out toxic
because of underlying abnormalities in the patient.
Example:
a) Paracetamol at a dose of 4g/ day therapeutic dose can lead to fulminant
liver failure in a patient suffering from alcohol liver disease.
b) When Gentamicin is given to a patient with pre-existing renal impairment,
ototoxicity is more likely to occur.
Interventions:
A. Gastrointestinal decontamination
Activated charcoal – universal antidote (for the majority of poisons)
Substances not absorbed by activated charcoal: caustics, heavy
metals (lead, zinc, mercury), hydrocarbons, iron preparations,
lithium, toxic alcohols.
Gastric lavage – (tube through oral or nasal) using saline solution to flush
out poison in the stomach followed sanction of gastric contents. Indicated
if substances were consumed within 1 hour.
Cathartics – emptying of the bowels (purgative) that causes catharsis.
Commonly known as laxatives. Magnesium sulphate, magnesium citrate,
sorbitol.
Whole bowel irrigation – same as gastric lavage. But can be taken by
tube or orally. GoLYTELY, CoLyte orally or gastric tube.
B. Hemodialysis – filtration of blood. Can correct fluid and electrolyte
imbalances.
C. Charcoal hemoperfusion – filtering blood through cartilage containing activated
charcoal.
Advantage – faster than hemodialysis.
Disadvantage – cannot correct fluid and electrolyte imbalance.
CHAPTER 8
PHYSICAL INCOMPATIBILITIES
Incompatibility
A condition arising from chemical reaction that changes the original composition
of a substance.
Change of chemical properties of a pharmaceutical dosage forms.
Immediate incompatibility – interaction take place immediately after
compounding.
Delayed incompatibility – Take place in a period of time.
3. THERAPEUTIC INCOMPATIBILITY
b. Immiscibility
Two or more liquids fail to mix with one another homogeneously.
Incomplete mixing, Addition of surfactant with unsuitable
concentration, False time of addition, Unsuitable for a type of
emulsion, Presence of microorganism, and temperature.
Emulsions
Cod liver oil + Water
Remedy: Add emulsifying agent
1ml Phenol + 10ml Water
Remedy: Use co solvent or glycerine drop by drop
CASTER OIL EMULSION
Caster oil + Water
Remedy: Have a emulsifying agent
Caster oil + Acacia + Water
2. Precipitation
The solute which is originally dissolved in the solvent is thrown out of the
solution.
A substance is generally precipitated from its solution in one solvent in which it is
insoluble when added to a solution.
CAUSES:
a. Salting-out/Dehydration
Concentrated solutions of electrolytes are mixed in prescription in
solutions of non-electrolytes.
Occurs with liquids aside from solids where the less soluble component is
pushed out of the solutions
Non-electrolyte + Water
KBr + Camphor water
Remedy: Dispense them separately
Acacia mucilage + NaCl = decrease Acacia
Remedy: Decrease acacia content
[Water + Gum acacia] + ethanol
Remedy: Dispense them separately
c. Change in temperature
Endothermic reaction
Absorbs heat from the surroundings
Increased temperature of the solution increased solubility
NH4Cl + Water
Reminder: Have to store in hot environment
KI and Boric Acid
Reminder: Have to store in hot environment
Exothermic reaction
Gives heat to the surroundings
The increasing the temperature decreases the solubility of the
solute.
Lime water/Ca(OH)2 is more soluble in cold preparation than
in hot water
d. Change in PH
Phenobarbital Na + Syrup of Orange
Remedy: Change syrup of orage to simple syrup
3. Liquefacation of solid infredient
a. Efflorescent – There is a release of water or crystallization
Na2SO4 . 10H2O
CaSO4
CuSO4
NaCO3
FeSo4
Atropine SO4
Alum
Citric Acid
b. Deliquescence – Upon absorbing moisture there is liquefaction
NaOH
KOH
CaCl2
MgCl2
FeCl3
NaNO3
NH4Cl
c. Hygroscopic – Absorbs moisture but does not liquefy (DRYING AGENT)
NaCl
Sucrose
CaO
CuO
d. Eutexia
MONOCLINIC SUCROSE
TRICLINIC BORIC ACID
TETRAGONAL UREA
RHOMBIC IODINE
RHOMBIC NaCl
HEXAGONAL IODOFORM