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Phase I
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is it safe? Goal:safety
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25-50 healthy people (non-blinded)
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|
Phase II
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does it work? Goal: safety, efficacy
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10-200 with disease (single-blinded)
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Phase III
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is it better? Goal: safety, efficacy
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200-1000 with disease (double-blinded)
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Phase IV Post-marketing surveillance (Pharmacovigilance)
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||
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A
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potential for error
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Ala pa naman
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B
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error did not reach patient
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Buti di umabot
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C
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error but no harm
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Char wala lang pala
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D
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error with monitoring
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Dapat i-monitor
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|
E
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error with Temporary reversible harm
|
temporarE / Eentervention
|
|
F
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error & hospitalization
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hosFital
|
|
G
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error with Permanent injury
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Grabe permanent
|
|
H
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error with near death
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nagHingalo
|
|
I
|
error with death
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Iyak
|
|
A - augmented
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predictable, dose-dependent, extension effect
|
|
B - bizarre
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Unpredictable, dose-independent,hypersensitivity rxns, idiosyncratic rxns
|
|
C - continuous
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long term effect related to drug, chronic use
|
|
D - delayed
|
manifested long after the exposure, carcinogenicity, teratogenicity
|
|
PREGNANCY RATINGS:
|
|
|
A - safe: human & animal
|
|
|
B - safe (human), unsafe (animal)
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|
|
C - no studies (human), unsafe (animal)
|
|
|
D - unsafe (human): beneifits>>>>risk (can use)
|
|
|
E - unsafe (human): risk>>>> benefits (cant use)
|
|
|
E - end of use
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From sudden termination, abruptly discontinued
|
|
F - failure of therapy
|
resistance, inappropriate use, patient tolerance, AMR
|
|
S1
|
retail dealer o exemp dd
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|
S2
|
prescriber in prescribing dd
|
|
S3
|
retail dealer of da & excempt da preparations
|
|
S4
|
wholesaler dealer of dd
|
|
S5I
|
Importer of da & exempt da preparations
|
|
S5C
|
compounder, producer, & manufacturer of da & excempt da preparations
|
|
S5E
|
Exporter of da & excempt da preparations
|
|
Systolic
|
diastolic
|
|
|
Normal
|
<120
|
<80
|
|
Pre-HTN
|
120-139
|
80-89
|
|
Stage 1 HTN
|
140-159
|
90-99
|
|
Stage 2 HTN
|
MT 160
|
MT 100
|
|
Wt(kg)/ht(m) X 2
|
wt(lbs)x703 / ht(in)x2
|
|
Underweight
|
<18.5
|
|
Normal weight
|
18.5 - 24.9
|
|
Overweight
|
25 - 29.9
|
|
Class I obesity
|
30 - 34.9
|
|
Class II obesity
|
35 - 39.9
|
|
Class III
|
MT 40
|
|
MEN
|
WOMEN
|
Risk
|
|
MT 40 inches
|
MT 35 inches
|
Cardiovascular & Metabolic disease
|
|
LT 0.85
|
LT 0.75
|
Excellent, less risk
|
|
1 or higher
|
1 or higher
|
increased risk
|
|
Moist heat
|
Protein coagulation
|
autoclave (121 C, 15 psi, 15-30mins)
|
|
Dry heat
|
Oxidation
|
Oven (160 C, 2-4hrs)
|
|
Membrane Filtration
|
physical separation
|
0.2 micron filter (for heat sensitive)
|
|
Gas
|
alkylation
|
ethylene Oxide (Carboxide, 10% EtO + 90% CO2)
|
|
Ionizing Radiation
|
DNA mutation
|
Gamma rays
|
|
RA 5921 / 10918 Pharmacy Law
|
RA 6675 Generics Act of 1988
|
|
RA 3720 Food, Drugs & Cosmetics Act
|
RA 8203 Special Law on Counterfeit Drugs
|
|
RA 6425 Dangerous Drugs Act of 1972
|
RA 4226 Hospital Licensure Act
|
|
RA 9165 Comprehensive Dangrous Drugs Act of 2002
|
RA 9275 Expanded Senior Citizens Act of 2003
|
|
AO 90 s. 1990 allowed more than 1 medication written in given prescription except Dangerous Drug prescription
|
|
|
AO 62 s. 1989 rules and regulations to implement PRESCRIBED requirements under RA 6675
|
|
|
AO 2012 - 0012 classifications/types of hospitals
|
|
|
RA 4226
|
PHILIPPINES Hospital Licensure Act
|
|
EO 49 s. 1993 Govt Hospital Procurement must follow only vol 1 of PNDF
|
|
|
AO 63 s. 1989 dispensing requirements under RA 6675
|
|
|
AO 55 labeling requirements under RA 6675
|
|
|
Prescription record Book
|
keep for 2 years
|
|
Dangerous drugs record Book
|
keep for 1 yr
|
|
Poison Book
|
keep for 5 years
|
|
Normal Prescription
|
valid for 1 month
|
|
keep in file for 1 yr
|
|
|
DD Prescription
|
limit for 1 month
|
|
antiCA limit for 3 months (ex: Morphine supply)
|
|
|
Yellow - kept by RPh
|
|
|
White - kept by physician
|
|
|
Green - kept by patient
|
|
list of alternative drugs prepared & periodically updated by the DOH on the basis of health conditions obtaining in the Philippines, as well as on the internationally accepted criteria
|
|
|
Core List
|
list of drug that meets the needs of majority of population
|
|
Complementary List
|
list of alternative drugs used when no response to the core list
|
|
organized structure pools together all healthcare professionals, the diagnostic & therapeutic facilities, equipment & supplies & the physical facilities into a coordinated system for delivering healthcare to the public
|
|
|
Public Health
|
prevention, mitigation of disease in the community
|
|
primordial - goes before the patient, changes soceity
|
|
|
Primary - prevent disease, no disease yet
|
|
|
secondary - early detection, treatment
|
|
|
tertiary - limit disability, rehab
|
|
|
Hospital Pharmacy
|
practice of pharmacy in hospital setting
|
|
Preparation & Delivery of a drug or device
|
|
|
PRESCRIPTION: written order & instruction from licensed prescriber to the pharmacist for specific patient
|
Valid for 1 month (28 days); keep in file for 1 yr
|
|
Superscription
|
Rx, recipe
|
|
Inscription
|
Drug and dosage
|
|
Subscription
|
direction to the RPh
|
|
Transcription
|
signa, direction to the patient
|
|
Erroneous
|
Violative
|
Impossible
|
|
brand nme precedes genric name
|
generic name is not indicated
|
generic name is written but NOT legible
|
|
X - (generic name)
|
generic name is NOT legible but brand name is legible
|
generic name does not correspond to brand name
|
|
brand name not in ()
|
Brand name is only indicated "NO SUBSTITUTION"
|
both generic and brand name are NOT legible
|
|
"Shall be filled"
|
"Shall not be filled"
|
product is not registered to FDA
|
|
dispense, report
|
don't dipense, report
|
"Shall not be filled"
|
|
don't dispense, report
|
|
Prescription / Ethical Drugs
|
dispense ONLY upon writtn order
|
|
For management or treatment of a condition or disease
|
|
|
Non-prescription / OTC Drugs
|
dispensed without written order
|
|
only for symptomatic relief at minor self-limiting ailments
|
|
Essential Drugs
|
satisfies healthcare needs of majority
|
|
conscientious, explicit & judicious use of concurrent best evidence in making decisions about the care of individuals
|
|
Case - conrol
|
retrospective study, info collected from the past
|
|
inexpensive, recall bias
|
|
|
Cohort
|
prospective/longitudinal study, no intervention
|
|
time consuming, expensive, less recall bias
|
|
|
Cross - sectional
|
survey at a single point in time
|
|
new + on-going cases
|
|
|
Randomized controlled
|
clinical trials, GOLD standard, experimental study, 2 or more treatments and placebo
|
|
costly,, time consuming, ethical considerations
|
|
Any untoward occurence during use of a drug, without without correlation
|
|
|
ADR
|
noxious and unintended, doses normally used
|
|
S/Es
|
Unintended effect at normal doses, related to pcol properties
|
|
Toxicity
|
noxious and unintended or intended, dose is higher than normal
|
|
ME
|
preventable but lead to cause harm while in control of a professional, patient
|
|
PROHIBITED drugs
|
|
|
opium & its derivatives
|
Heroin & Morphine
|
|
coca leaf & its derivatives
|
Cocaine
|
|
a & b Eucaine
|
|
|
Hallucinogenic drugs (Mescaline, Lysergic acid diethylamide)
|
|
|
Indian Hemp & its derivatives
|
|
|
other drugs (natural or synthetic) with physiological effects of narcotic drug
|
|
|
REGULATED drugs
|
|
|
Sleep-inducing sedatives
|
barbitals
|
|
any salt, isomer, or salt of isomer of Amphetamine
|
Benzedrine or Dexedrine
|
|
Hypnotic drugs
|
Methequalone
|
|
Respiratory rate
|
12-20 breathe/min
|
|
Number of breaths in 15 secs x 4
|
|
|
Heart Rate
|
60-100 BPM
|
|
number of pulse in 15 secs x 4
|
|
|
Temperature
|
37 C / 98.6 F
|
|
F = C (9/5) + 32
|
|
|
C = F-32 (5/9)
|
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