Manshrof Theory Part 1

Reference Guide For The
Foreign Pharmacy
Licensing Exam- Theory
toxicology
,physiology
calculations
rTlicrobiology
pharrTlaceutics
organic
cherTli~try
statistics
& calculus
health
care
delivery
rTledication
dispensing
pharrTlacy
adrTlinistration
health
care
econorTlics
rTledicin'al
cherTlistry
physical
pharrTlacy
biopharrTlaceutics
pharrTlacokinetic
pharrTlacology
therapeutics
rTlunology
herTlistry
natOrTl
biology
REFERENCE GUIDE
FOR THE FOREIGN
PHARMACY
LICENSING EXAM
?
THEORY
(VOLUME I)
MANAN H. SHROFF
www.phannacyexam.com
Refereneeifsmde for the Foreign Pharmacy

Licensing Exam -Theory
This bo~-i\not intended as a substitute for the advise of physicians. Students or readers must
consult tbeii physician about any existing problem. Do not use information in this book for any
kind of s@}.f.1heatment.Do not administer any dose of mentioned drugs in this book without
consulting your physician. This is only a review guide for the preparation of the Foreign Pharmacy
Licensing Exam (FPGEE )
The author is not responsible for any kind of misinterpreted, incorrect, or misleading
information or any typographical errors in this book. Any doubtful or questionable answers should
be checked in other available reference sources.
All rights reserved.
No part of this book may be reproduced or transmitted in any form or by any means, electronically
photocopying, recording, or otherwise, without prior written permission of the publisher.
RXEXAM is a registered trademark of Pharmacy Exam of Krishna Publications inc. Any unautho
rized use of this trade mark will be considered a violation of law.
NAPLEX and FPGEE are registered trademarks of the National Association of Boards of
Pharmacy (NABP). This reference guide is in no way authorized by or sponsored by NABP.
www.phannacyexam.oom
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Referellce,e.nide for the Foreign Pharmacy

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,Y~')KriStnan
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REFERENCE GUIDE;,~);',':
FOR THE FOREIGN)'"
PHARMACY
LICENSING EXAM .~')
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THEORY
(VOLUME I)
Dedicated To
Krishna
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Reference/GUide for the Foreign Pharmacy

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PREFACE:
I am very pleased to introduce this Reference Guide for the Foreign Pharmacy
Licensing Exam-Theory. After the overwhelming interest in the Reference Guide for Foreign
Pharmacy Licensing Exam-Second Edition, it encouraged me to write another short and comprehensi ve guide that would help the reader to prepare for and succeed at the FPGEE.
I tried my best to cover as much of the course as possible which is outlined in the FPGEE-syllabus.
I would still recommend that students give more attention to clinical pharmacology, pharmacy
management and pharmacoeconomics.
I hope my efforts will bring you much success.
Best of luck,
Manan H. Shroff
Reference-Guide for the Foreign Pharmacy

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TABLE OFCONTENTS
A
Pharmaceutical Services Management &

Social and Behavioral Sciences
:t( Pharmacy Law

~
~
;5..
-e;
Pharmacy Management
Pharmacoeconorrrics
~
U.S.HealthCare Delivery
stem
New Drug Approval
Clinical Drug Literature
-1)~.
.... ...... - .......
8
16
25
29
34
36
~.
~.
~
Organic/General Cherrristry
Natural Products
Cell Biology
Human Endocrine System
Microbiology and Pathology
Blood
Human Digestive System
Inborn Error Of Metabolism
Metabolism
40
51
55
58
62
64
68
73
75
C Pharmaceutical Sciences
1f:
)(.
~.
~
/'P(
~
26.-
Suspension and Emulsion

Pharmaceutical Additives
Rheology
Colloids
Solution of Electrolytes and
Concentration Expression
Pharmacokinetics
Kinetic Principles and Order of Reactions
Bioavailability and Bioequivalence
.
'.1 :"
: __
:~;
~ 1'.
". ..~.'"
~ ".~ i; i , '.
B Preclinical Sciences
,-.-
78
86
94
96
98
104
109
114
.~
Reference Glide for the Foreign Pharmacy

. ' " '. . -'. Krisrnan

',,-
..~.....
TABLE OF CONTENTS (Cont'~)

DNAandRNA
Vitamins and Their Sources
Teratogenic Drugs
TPN (Total Parenteral Nutrition)
Acid Base Disorder
Oral Contraceptive
Family planning _
Interpretation of Clinical Laboratory Tests
Anti-infective and Their Poteiitial Side Effects
.Renal Failure
Cystic fibrosis
Drugs and their side effects
~,
Biomedical Sciences
~
;;(
38.
39.
Accidental Poisoning and Antidotes

Statistics
.
Immunology \
Microorganisms and Drugs of Choice
Pharmacology
...J.
Questions
/~;
Answers
116
118
119
123
125
127
130
132
136
138
146
147
158
161
170
178
181
200
Reference Guide for the Foreign Pharmacy

Krisman
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PHARMACEUTICAL SERVICE MANAGEMENT-"

&
SOCIAL AND BEHAVIORAL SCIENCES
www.pharmacyexam.com
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I-Pharmacy Law
A
PURE FOOD AND DRUG ACT OF 1906
Congress passed this law in 1906 to protect peo le from unsanitary and poorl
f"
--
FOOD, DRUG AND COSMETIC ACT OF 1938
labeled fOQd.
....
This law suggests that no new drug can be marketed until proven safe by the FDA for public use.
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DURHAM HUMPHREY AMENDMENT OF 1951

I;
*
*
*
*
This law is also known as " Prescription DrugAmendment".
It diffe~ates
between prescription
and
0.4 drugs.
Jfo .>~ \
;:P-~(,.rk'
It also authorizes or&l2rescri tions and PLe
It suggests that ea~g

a prescription."
~
K'e
~r n'
. tion refills.
should be labeled" Caution: Federal law prohibits dispensing

-
without
9-~ve....
s
KEFAUVER HARRIS AMENDMENT OF 1962
It is also known as the ''Drug Efficacy Amendment".
This law indicates that n~w a
It also establishes Good Manufacturing
MEDICAL DEVICE AMENDMENT OF 1976
*
I
IT
roved drugs must be ~afe as well as ~eciv_e.

Practjye requir~ents.
'" This law passed in 1976, and ~s:

The classification of medical devices
Safery and efficacy of medical devices
O(?~
ORPHAN DRUG ACT OF 1983
This law was passed fO~' han druCgs

~s
that affect very few people). Congress
passed this act to prgvidetax relief and other Mt:'entives for the manufacturers to de~p
and
m-!!iet orphan drugs.

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DRUG PRICE COMPETITION

1984
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AND PATENT TERM RESTORATION
ACT OF
-=
'This law is also known asWaxman HatchAmendment.
'This law was passed to make g~c
'Thislaw also provides more incentive to innovative pharmaceutical com anies and encourages
---~
them to develop new dru s.
~dec\d~
\2
H
dru s m..Q!:..e
readily a~e
--=--
w' ~
to the public.
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aTe) w-
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NATIONAL DRUG CODE NUMBER (NDCl---"
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The NDC generally co~f
II
ill
The st four characters indicate the aIll-eof the manufacturer or distributor.

The middle four characters identify th
nd.stren tho
The last two characters identify the nackacre.
OVERTHECOUNTERDRUG
The FDA generally classifies drugs into three categories in final monograph.
Category I:
II
ill
Q...9..06.
(orc)
---
--
+ 2.
ten to eleven letters: 4 -+
,
~
It~cl~des ingredients ?ene~y considered safe, effective and not

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IDlJluran
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.
Category II: It includes ingredients that are not considered safe, effecti ve and are
misbranded.
Category ill: It includes ingredients for which ~ta are insufficient to rmit the
classification.
-
PATIENTPACKA~EINSERT
T~e FDA passed this law in 1970 that states certain dru .~e.
a Patient Packa e Insert ~
indicating the uses, risks and precautions of such dru s. The list of such drugs are :
LfMt\i"\j:
~'(I';'"
Isotretinoin..
~c.~
(.'"1
p pI)
~(,
*
*
pYl::O"'tANVt
,:)orl\~Y'.
Cf"\
D~L.
laJoJ.
ex.Ce~o\
d.os~
r~;
Ticlopidine
..:g cl~f,c....fB rUsi
U;) W<"<.r.- ~
fProgesterone
C
LEstrogen
Intrauterine device ( '(0,' Cr~t;",.~;\M.,:..)
-7f"'
CLi.ot.~
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I'D
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Oral contraceptives
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OBRAACT OF 1990
It is known as the mnibus Bud etReconciliationAct of 1990. Itr~es

that pharmacists must
o~rapatientcounse~g
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THE FDA EMPLOYS A TWO LETTER CODING SYSTEM FOR THERAPEUTIC

EQmvALENCEOFD~FERENTDRUGS
.
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AA:
T:
Topical drugs that meet bi
uivalence standards.
AB :
Drugs meeting the n~sary
bio~valence
BC :
Drugs in extended release dosage fQ!!Ilwith bhoeguivalence issut?s.
Drugs ~at are available in conventional dos_a e forms and have no

bioeqrnvaIepce prob~.
Topical drugs with bi~uivalence
r uirement.
issues.
x...
BX:
Drugs for which adequate information is not a~le
bi~uivalency.
to determine the
POISON PREVENTIONACT
Q.20~
-z:
* ~
This law was implemented to Erevent the death of children from accidental poisoning. This act was
passed in 1973. It indicates that all dispensed dru s must be required to be in a child proof
l4'rom this law are :
container. Drugsfexempt
(._. ~
I .v:
~
~
l:J "'_'t a.~-, -:
c...Ub
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'--
,*
*
Subljpgt!aldosage form of nitro! 1 cerine

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SubliJ.k,oual
and che~ble form ofIsosorbide dinitrate (less than 1Omg)
-Choles
amme powder
" "'a. r;.....fLo... &. ta.b.
i
....Methyl rednisolone tablets (less tpan 84 mg)
Mebendazole. tablets (less than 600 mg of drug)
011 t l
K Potassium supplements (unitdosef0rm)Vi'c:tbI\~~II.'dwt LJI'''fpeJ '11)'
0.0. J
om cin eth 1succina~_
. and granules not mo"rethan 8 gtJ!of drug)
Col~sti 01 in powder form
~
\of ~
.u..6p. .
,~omycin
ethyl succinate (tablets no more than 16 gm of drug)
Pancreli ase preparations ~ ta.-b,) wp. 0(' po wdex pcr.-n.
Prednisone (tablets no more than 105 mg) Beta 'C
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Oralcontrace tives
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~
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Not'+: (V"
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*
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*
*
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CONTROLLEDSUBSTANCEACT(~SA)
= Controlled
.
.
to ~'
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sc'ne.clula")
The attorney eneral of United state has auf1?~rityt<tplace a drug into one of the five ~
;::,Jo.
catego~es of schedule controlled drugs.
6) ~d d\.. Itetr o~
~ ~
Q~
~rom one. ~~
c\\(.o\ule.
0vV\.0~,
The controlled drug can be classified into five different classes accordin to the otential for abus~.
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5
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Substance Act
Drug EnforcementAdministration
:,g
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(~~
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e-:The potency of abuse of controlled drugs should be I > IT > ill > IV > V. Scheduh~iJhould be
G~20., considered the highest potential for abuse and schedukv)the lowest potential for abuse.
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SCHEDULE II CONTROLLED DRUGS
* ~
Cannot be r~ed
in any circumstances.
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The art:i;Ufilling of this class of drugs should be done within}2 hours of initial filling.
TheDEA22
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,,-orderformisreq@ed
,'
to order this class of drug. a.v,,t;JI ~ ~ .

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Con tr 0II
edIId rugs:~
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II'
y\c.\> P I q......---
1
2
3
4
5
6
7
I 8
9
10
11
12
13
14
15
16
17
18
~G.\l6 nJ..,-o,
r
coca'I"e
Ritalin
Dexedrine
Adderall
Ms Contin
Concerta
Oxycontin
Oxy IR
MS IR
Roxanol ,
Roxicet
Percocet
Demerol
Dilaudid
Dolo h!ne
Duragesic
RMS unisert
Percodan
Tylox
=
=
-
=
=
=
\-
=
=
=
=
=
=
=
=
=
c-:
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CJ
~ -----
ccti.a.~V>'
'.
De.I<.e.chlv\~'''\t: ~'\k:s
~.
L ~
D L ,c.:.t. ~
~'Cy\~
DextrqampheUmrnne~
~
Amphetamine + Dextroamphetamine
{
Morphpe sulfate _ .:
I
. Meth i henidate~ ~ 0..\\6 l'Ul.bf ~ + 6... ~

. 6xycodon .
Oxycadone
MOrp~e sulfate
Morphine sulfate
Ox ~APAP-"
~<:1e.J;,"<:'
(u ' \>N' .......Q)
Ox cO,done APAP '-") ~.p\Aj'\'1.- Me ridine
Hydromorphone
- Methadgn QJIb ~bf'
Fentanyl ~
~orphille sulfate
O~codone~+ Aspirin
xycodone -nAPAP
(e.--
--
CL-:j(6: ~
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or
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---
a:
1 Hje;-~~
Dc'o:t
e. (Jf;t'\ Aitel'\.'G:.:w
Meth 1 henidate _) tt
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AD't'.D
............
)
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DISPENSING OF
cm CIV and
CV, DRUGS
nt-i"Ur
rc;
"'Cannot be refilled ~fCthan five times. ;:,"1'\ b
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sr~ ~
~r
~~I~
"""'V\..~.
\,"~'HI'
Cannot be filled for the prescQI2!!..0nolder thtlfl ix months
Do not re.gmre any DEA 222 form to fill the order.
--
~--
Controlled illdrugs:
*
*
*
*
*
Lortab
T lenol # 3
FioricetlC~ine
Fiorinal / Codeine
Vicoflin
at, 61::; ---")
=
=
=
=
=
700
Talwin
TalwinNX
Talacen
Talwin compound
Darvon
Darvon compound
Darvocet
Equanil
Librimn
Valimn
Serax
Tranxene
Dalmane
Klonopin
Ativan
Prosom
Restoril
Halcion
Xanax
Ambien
Cylert
#"
Cd
~~~b~I'W
Controlled IV drugs:-')
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
*
~bodone
+ APAP
Acetaininophen + C
e
Butalbi
+APAP+ Caffeine + Codeine
Butalbital + Aspirin + Caffeine + Cod~ine
Hydrqcodone
=
=
=
=
=
=
=
=
=
=
=
=
=
=
=
=
=
=
=
=
=
----
Pentazocine
Pentazocine + Naloxone
Pentazocine + APAP
LYentazocine + Aspirin
'Propoxyphcnc
Propoxyphene + Aspirin
Propoxyphene + APAP
';Meprobamate
Chlordiazepoxide
Diazepam
Oxazepam
Clorazepate
F1urazepam~
ao~pam
Lorazepam
Estazolam
~pam~
Triazolam
AI razolam
I
Zolpidem
Pemoline -'}
deLls'.
Gi. 16(,
01<0.. '2o~.cL.NL ..",tt
5lp pke.n.obcvJo J,J, -'l W
p'
A~e,k"\ ~ I~
Ii'jf'-a.c.t:V(
tk60 r
Controlled V drugs:
*
*
Buprenex
Lomotil
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Buprenorphine
Diphenoxylate
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EMERGENCY
DISPENSING OF Cll DRUGS REQUIRES

0iiJ:!:
CERTAIN CONDITIONS
The dispensing quantity of the drug should be ~
The prescriRtionsis immediately reduced to a written grescription

by the pharmacist
----- with complete
information abC!utthe ordering physician's n<llle,~s,
DEAand jhOne
number.
to cover em~q~ency situations.,.
........
c1 ~
*
~
The prescriber must s~!!Qa written rescription within ~ffrom

prescription.
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1-""
pY'.&~
~ve
c:
lV~
"'"" ~s
FAXINGOFCllDRUGS
~
~o..c.e .. J\u.A~n""2o....l-
0('01
~.-;
an authorized emergency
d'
rof" ~
d,lS\>eK\.'!.
~"-'2~'~
'?-U ~"'.... Ol.
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A pharmacist can fill the crr prescription by using afax prescri12tio under the condition that before
dispensing of the drug,one must receive the ori . al rescription. The faxing of ell prescriptions
should be considered the ori&nal crr prescription onl ,und,Erthe follo~g conditions:
When a prescription is faxed by a prescriber that needs to be compounded and administered to a

patient viill, g:., I.M. or intrasp~al infusi9n.
LT
c..
\-~
When a prescription is faxed by pre~criber for,a p~nt
Me~adone can be used for pai~ as well as for treatment of drug detoxific~t!0n.A phann!cy no~
regijtered with the DEA narco~
cannot dispense Methadone for treatment of drug! .
detoxification.
. THE FILING METHOD FOR CONTROLLED
QmUlle for crr

Se nd file for cm, CN and CV
Thirdfilefornoncontrolledsubstances
,-C f')
liv~g in long-term care(m~i${
SUBSTANCES
(UN\sched..J....
~~c.~~~)
O~forcrr
S~~
file for em. CN . CV and non-cQ!!!rolled substances
.Qo.~ -\e.,.. ~<.2')s,t~d,
t.....'t'e.J ,VJ(' ~ \t.... loVJCA. n' -
C.b'Y
(.(
",.~tLe.;;~
~9N\
':9
Af\
13
I ~
O1\e 'I$.h
~e
for Cll,cm, CN and CV with the condition that all IJ.!,N and V should be previously
marked
with red inkonfa~ of the prescription, so that it can be easily differentiated from CIl
Seco d eofnon-contr lledsubstance.
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DESTRUCTION
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1\
~I.)U'-ce
~o~oJ(.
'DEA
\..Uol ~
OF CONTROLLED
~ol'l"V'\
~f\
01. It..
c . $
is,
co.ul~
rlL
.A~
Sw~.
~-~
lOb:
DRUGS
The request to destroy controlled substances should be done on a ~~~~~
If the institution has a past history of v~ low drug abuse, the DEA may authorize registrant to
destroy the drug without a DEA representative.
~\
OR
The dru
that needs to be destrQy~d can be forwarded to a state
e cy.
OR
The drugs that needs to be destroyed can be forward~d to a DEA field offic~.
<V,.r-
*
*
. The theft of
__
en dru
(1S
should be irnrriediately reported to a DEA office or 10~cal:;;;o.J;==
A report of theft must be made on a ~A
106 form.
/
DEA 222 ORDER FORM
This form must be used to order only CI and Cllldrugs.
Each order form contains three copi~s. Copy I, Copy IT and Copy
There are ten lines on each order form. Only one item can be entered on one lin . For ea~ item,
one must include name of the drug (Ritalin), the dosage form of the drug (tablet) and the volume or
unit of the drug in ea
ontainer (# 100).
(-\J.J.. p~~
)
Co
should be kept by the ~rson
to the supplier, {j,;'
~
-:::.-
m.
tirP\
fillin
out the DEA formYCopy I and IT. should be submitted
--
..- .... \
0..1'-"'"
ThtG!!IPli~ecords
the date and quantity shipped to the purchaser on Copy I and IT. Co
IT is
sent to the lmAby su neraiid Co I should be kep.t.by.supplier for his own record. Any partial
supply of the drug must be filled by supplier within 60 days from the order date.
Upon receiving the order form from the supplier, the p.!lfchaser must rec~.9- all the receiyed
items on the appropriate line with date received.
14
Krisman

-26(<.-1'0 CHECK VALIDITY OF

~
EANUMBER
-==-
- -
2. -
f')l\A?-
1 ~
The DEA numb~r is nin characters consistipg of two ett ~followed by seven n
bers.
The flrst letter generally gives an idea about the f~gi;tr~If

person is a )2rescriberthen it would
begin with anA or ~; if it is a mid-level prescriber then it would begin with
Ifit is a distributor
then it would begin with a P or R.
-(~.,1
~ er(" e')
the last name of ~--stran
.The second letter is usually th~f
*
*
Toverif
aDEAnumber
Add the first, third and fifth

number
of the DEAnumber.
,
~
II
L -4- l...j
+6
Add the second, fourth and six n~er
III
Add the resultant sums of en) to (1).
The final most ri

number.
I-+S
-r-5
of the DEA number and tllultiply by two. ---'> "1.t
-=-
t number of this sum should ~

-e
with the ninth di .t of the provider DEA
, rf:
ckd<I"'LA~t
-~ 0
For example, Dr. Ayan Shroff with DEA # BS 243578
an be verified by:
The first letter "~is
II
The second letter should be th~~f

be "S')n this case.
III
Now
Now
Now
Now
* J!f
The numbe ~ 1fuefinal most right number of sum) should :r:p.at<2.h

the last number of the DEA
number BS 2435786, and therefore the provided DEA number is valid.
indicated pre.~r.
theta tnam~f
pre~er,
-
therefore it should
adding the first, third and fifth digits of given DEA number will give us 2 + 3 + 7 = 12.
adding the second, fourth and six digits of given DEA number will give us 4 + 5 + 8 = 17.
multiply the resultant sum of second, fourth and sixth digits by "2' (17 X 2.= 34)
add this sum to the sum of the first, third and fifth digits of the DEA number # 12 + 34 = 46.
15

({ /"<. l~_>\ . I r
(0 ~\~ ~ J ~.f
..v ~ ~
):
k..~
LtPIYVV
Krisman
\I;:' .\ J b_,'
cv..J
')0)
-lJ ~
~-Pharmacy
Management
~u.~~ -s n Q..j' . ~ pVt'ce, PY-Odu..Cf/~\~a.\
l","
pro~
Co
u.:>Lo
*
A
coFunctions o~atios in financi~ analysis: The~e

a few important ratios that indicate the
tprofitability, efficiency and overall financial ~tions
of a pharmacy.
~
L \ ~ L, l ;;t~
c/-c;<:I
W C S>' CV\.('(.ed ~S~~
~'
Ratios indicating profitability:
vv 0:
sd:~J,/
(N
1.
Net
Net
Net
Net
2.
3.
4.
profit
profit
profit
profit
to
to
to
to
To W ('\\
To-t..J \,;,.1,;
net sales (NP:NS)

net worth (NP:NW)
total assets (NP:TA)
inventory (NP:IN)
~\
1.
Net profit to net sales (NP:NS): It can be calculated by dividing net profit by net sales. It is
expressed as a percentage. The normal ratio lies between 3 to 70/,: )~ ('oi..o ",t.,) S'I en ~~
~
,:;~\
\~
d"0clP~~':i
b.&(MS.
2.
~\
Net profit to net worth CNP:NW): It can be calculated by dividing net profit by net worth. It
~ is considered e bes among other ratios for calculating pmfitabili~e
ratio lies between 20 to
': '2dI,~
25 %. A 15% is acceptable for older pharmacies and 40% is JfJm,fJIe for ne~ phannacies. ,\;:,-,\
".
~ .....\C
'J t
s~
pSwtrru:<.<j
"6
~~
.-..c1: pYO~
vU': ~
YIiL
jn~t:.M.e~
Net profit to totarassets CNP:TA): It is normally calculated by dividing net profit by total
assets. The normal acceptable ratio lies between 10 to %,' 15%
pkAAl'N' . ~,:)
~C!I'~
w,.-l P II..AA
-'>!r:~
~o"(
Net rofit to invento

:IN : It can be@alculated by dividing net profit by inventories. It
is a good indicator of both I mfttabilit: and.Jl.ticiency.The normal acceptable ratio lies between
$0.21 to $0.27. "1t (s ~l
&t"..0 \~~GV\."""'''(~''''
s s. 'f~ s.cJ.v. ~ i>\vlA..fo' 'C'
4.
~:7~
Ratio indicating
1.
2.
3.
4.
5.
6.
Inventory turnover rate (IN :TOR)

Net sales to inventory (NS:IN)
Net sales to networking capital (NS:NWC)
Net sales to net worth (NS:NW)
Account receivable collection time (AJR cr)
Accounts payable remittance type (AlP RT)
c..;.e~n\.:::J
; & ~~
'liWetl
(dy
:M
QUo
~J1~
::::.Heo.l\,::"'/::,,.1?- ...
\'Y~/.
v.
"'/)1~
;v='Se..
,..
na.-p
r'lr.o~
ventol)' turnover rate: It is normally calculated by dividing the cost of goods sold by the
average of beginning and ending inventory. The inventory turnover rate should be 4 as a minimum,
with a target of 6 or hi he~.~ Ca -'t a-~1~o~
s:'cL CC<.h\ 6t C:J. w-~;Jjd b<.t a.diM:
#A
t,)J:
CV ~
t - L-
1\--
'\;M\)
.
efficiency:
'"
OM..u,J
r#
af: ~
\"
~ ...~"1&tt.,~~~",-~
~II..
v
't,("",,--...~~ -"-
\a;~I~
~~
G
'>UJ"'-'
Net sales to inventory: It can be calculated by dividing net sales by net inventory. The ratio
normally ranges from 6 to 9.
-t\u. w.cd: vaJJ.JJl. ~cr ~ ra.tw 'N<);.;l'd ~ t,~.'" ~r}A..-
\' ~ \ ~ h...s,'c.. acco~
-oLov-bl, - ~
~~
"(Jstr,.,.
~~~e.t1:-L:a.be
-1 ~P;",
""
l~+- (J uJYI1lA'S e.q~

' t,t~ /;~' t, -z: to t j
fLV"'.A.. ~
"..J:
~.
16
r .J~.
Krisman

~
3.
oock .
~;W(~!>e.ts>=
~~t~cK"V\.-d
lC
C,oxY-e.n.t cus~
- Cur'
\;.obi \~b
Net sales to networkin~pital: The networking capital tuff{6~eris computed by dividing net sales
by net working capital. Networking capital assets is current assets minus current liabilities. Th~L
d\.. normal ratio range is 4 to 8. Ratios greater th.a'il8are considered ina9%illate capitali~atio~
overtrading. A value belo~indicates unde ailing or too much ca , italization.
.
~;--:!'-Ie,
L0<::>..-t;R.:::.
t~w o...1Se
U"
'/
L0>...b;Ll~ .
c;.- toW
Net sales to net worth: This is normally calculated by dividing net sales by net worth. Net
~orth is normally exp~sse~ by t~tal asseti minu~ to~al ~abilities 2.The ~onnal.ratio range
ISfrom 3 to 8. Greater ~ 8 ISconsidered un er capitalization and 0 ertrading while belo 3
indicates-dun ertradin g.
~
ill
.
4.
5.
-------
::.0 ~~
e-
t("o~
AccountSeIva~
collection time: It is normally calculated by dividing year end accounts receiv(- able by mean credit sales per day. This ratio is a direct measure of efficient credit management. o};, ~\
,
Normally, a 0 a collection period is a reasonable target.
AIR
Year end account receivable

Mean credit l~ per day
f~(',.s
-;/~~.
Accounuiayafi1remittance time: This is normally calculated by dividing year end accounts

payabledividedbymeancreditp~~eperdaYJ
Ro-c~
cJ1_~ a..CCo~
~
6.
NP
'(t:..~,
Year end account payable

Mean credit urchase per day
'l'"
le.~~"rL..Q~k.
O~'t--COM..~
'2\.
btJJ
0..6'
r-::...~
~
-
*
(S9IY@Wueasures a harrn.a~ 's ability to meet c rrent liabiliti~ with moderate change in
the com osition 0 urrent assets
Ratio indicating liquidity and solvency:
1.
Acid test ratio :=. ~...c.U.d
2.
3.
Current ratio
Inventoryto net working capital (IN:NWC)
@..2Z.,
.JM,
<>.::'0:-~
'1 R'::::
SW""'-
.j..
oj Oaoh Sr.a..CCoi.,Lr'\
--
tta.
r-e.cei V'O.(:).
v : \ ,\l;t:.io
wo--\:)
J:'-""
11.
Y"
wl''ret bb~
_
1
Acid test ratio: It is also known as uick ratio. It is normally calculated by dividing the sum
of ~ash and accounts receivable by .the current.liabili~Whe
normal ra& is l:l:(~ctf~~
'rctt..'o ~ Cl $.v..C.cess~ ~k~
M. \ \ \ ~~
o.Lu.u.JtIM. Poa1~I Y\~
p c..bjt. [i i i"ClI> 1. e.cc r~:t
4
Current ratio: It is calculat by dividing cUf,~asset.s by current liabilities. The ~nimurl!
.. >..
standard value ist::1.
Cu..ffC.,f'I.,;t ,4..~~-!..l!
-'> \t\..cL.cle. C,M\.-...i o..Uo~
~\
J~~'
&.
1.
2.
~.
r-./
L,~\t;..iA
H.~.Hl
lr'lve.tov"Cf
pT-
Inventory to networking capital: It is calculated by dividingrr::e~ninventor{b~'kwc. Mean 0

invento .s the average of the beginning and ending inventorW~r the accounting period~
ratio is an incilrectlD:easureofli uidi and solvency.~ '(\D-C~
-.Jck- d.~~ v-o:t.Q
'lA.__
o ,..-.Jf c;r cJ t:;:
t-.
3.
...J.
N wc.~
~o
\)Ji\.0J\.~reJ.
Q~
?~'"
'0 ~
c.,..,('f~
~U: .'
\V\.d.:c.cvtu-40lo\",)~~~~~)
tv.
(i) X
:\
~vc.Jo( u
17) ~o:,J
sJ.e - ~
.':.)&V\C~ ~rsQ.
17
Krisman

/.'
A high ratio indicates 10 liquidity and too muc inventory. A ratio of 8,Q! is a reasonable target.
Ratio indicatinglflnancia:
1.
Total liabilities t ~CDworth (r :NW)

Founded debt t~~J working capital (FD:NWC)
Fixed assets to~t~
(FA:NW)
2.
3.
1.
7
}f~\t
4f
'
position:
Tot~ liabilities to net@

This ratio can be calculated by dividing total liabilities by net
worth. It is expressed as a pe~age.
t is the most d.iJ:ectmeasure of the financial p~
of the pharmacy. A ratio of 50% or owe is acceptable.
~
~.'
.~.
GL405
:rJc
II~
2.
Roundeddebt to net working capital: It is normally calculated by dividing long term liabilitiesby net
working ca ital. It is also expressed as a ~rcentage. ~ng ~rm liabilitie~ed
as liabilities
\;Ll.,b'II;~,/xtendin
onger tharibne y~~. The normal acceptable value of a ratio is 20 to 2~.
/j
3.
:{ ~c.:..o.t.J
S{4---
Jet
I&ixedassets to net worth: This is calculated by dividing ~preciated fixed assets by

worth. It
helps to identify overinvestment in fixed assets.Ahi
v~ indicates overinvestmeiitin fixed
assets while a low alue indicates there is a need for remodeling. The target value would be 20%
or less.
-
d?
(if),.J Demand
and Price Elasticity
Elastic demand: If the relative change in r~~

be defined as elastic demand.
Inelastic demand: If the relative ch~ge In reyenue is less than the relatiyej; __
h_an=__ ~ ...
it is known as inelastic demand or price inelasticity.
Unitan' elasticity: When the relative change in price and re~e

elasticity.
-
Coefficient of elasticity: The coefficient of elasticity can be calculated by the following

formula:
r,\e. pnc.e :Y\~tL:5
where
~.
(: Q.4-11 .
is gre~?r than the relative change in rice, it will

:;0,::-
<
are equal, it is defined as unitary
= coefficient
-- Q = the relative
E
p
~\\3
of elasticity
change in uanti
xpressed as a percentage
the relative change in nc expressed as a percentage
or example, if we reduce the price forTolnaftate cream from $3 to $2.80 and this will increase
the sale offolnaftate tubes from 55 to 85 tubes, what would be the coefficient of elasticity?
18
Krisman

~'..,
Q = The relative change in quantity as a percentage
= (135-100) = 35%
, ~
15-4%
= 85 x 100/55 = (~)
1"':>
~
*
J~\
--
= The relative change

= (100-93) = 7~
= QIP
= 35/7
""2. ~I
..J...)'..J
= 2.8 x 100/3 = (93%)
in rice as a percentage
=5
A coefficient of over olJnormally indicates an increase in't-evenue, whereas a coefficient

below one eflects a oss ince price reduction does not quite increase the sales of
<i,.l.,.-merchandise. When E = 1. it is a unitary elasticity.
-
o-,:?~.
z: D ('~
Ll..S~ 're..vi~
~
\IJ><.
.
DUR (Drug Utilization
s 's
dec\~~ to '4Yo~ 1k.. ~~
0 QR~ \",-str~
Ro~
~ ~ lr"?- L:>
~
DUR: It is the process of quantitatively and systematically reviewing prescription claims S
data to evaluate the appropriateness of druz therapy.
1>~ ~ )
c;,,~ ~.\Y,(Hu1.~CA"".:it.)
, d.~ ~ov.tReview)~()\v<...
~ o."", ..,''oJ.o..-to-c
\N-.-
It is normally divided into following subcategories:
G;
Q,~ .. f...
(JJ.-
Prospective DUR
Retrospective DUR
(b
cC~
1.-
- L~
k 3';
l/-.
("I':
..v
~ ~-...:j
tfv.. ~.
~l
.
t
.. .A..D
t4 ~
Jscl.....=J)
ros ective DUR: This type of DUR study is normally don e

or at he time of
dlsellsln,"& the c4:ug,e.g. dispensing drugs to a patient at-;;Y retail pharmacy-store,
;;v/d.&Vt~u.~L.~
Js. ~
~D.A
C '::>,Ia{ite 'd,du.o..\"\e're.
.. ).
rRetrospective DUR: This type of DUR study is normally don after dispensing the drug.
e.g. review of drug utilization for a patient admitted to a hospital for sulfa hy~rsensiti~ity.
zr-
Q.'2..'-t~
~\
Advantages
of DUR:
./;;....
\J ~..f hi
p~
'1.
G:-'~
It helps to identify the physician's prescriQ,ing ~nd the patient's dru~ ug!izatio:Q.pattern.
ItjJ' ~~~
2.
the dru therWJ1roce.,ss by e~~g
previously occurring medica' on regimen
problems.
~
j~
SO-:'-.
I"'C'",
'~'-;:>~,RG(Dia ..~nosis Related Groups)
'-"',f,
. ..y ~1\2::..N<!,- ""~
... -
-'-.t\
'I
C. rv--uJ
.....DRG: It is known as diag~~~ ...

re ated ",groups. It helps c t down healthcare cost. It is a
choice of payment for most third paItYpayers. The reimbur~em~nt under DRG is~
Q
i considered prospectiv~eimbursement.
cJ" > [. ,-,,!,.J>V
..
61
~~~
~\:)Ii\.
(<l.\()(,~')
Under this payment method, medical problems are classified and the amount to treat each
~
particular disease is tre-calculated. e.g. Mr. Mehta is admitted to Adecare hospital for
coronary bypass surgery.
19
d.e... .
Krisman

..
Under DRG, the cost (including surgery, patient's stay in hospital and medications) for this
particular medical problem is $6500. Third party insurance companies are going to pay only
$6500 to Adecare hospital regardless of the service provided.
'# This will discourage a hospital from keeping a patient for a prolonged period of time.
Now, if the actual cost to treat Mr. Mehta's medical condition comes to $7200, thenAdecare
hospital has to ay the difference ($700) from its own ocket. Similarly, if the
actual cost comes $5300, Adecare hospital will make an additional
ofit,
~.
G;>.-
_*
Retrospective
Q- ~~
and Prospective payment systems G.

~
Qd..vtvt\cc ~
SvLvl'ceo
tLt ~
vu.t
"l
'-tS +- '2. L( b
+ G. '14- f
'
ban pfov,ol~J yRi dL Y"~ bLfY'o.t!ft!.- .;
r::---. Prospective reimbursement! A form of reimbursement in which a healthcare service

e:
'"
p~ovider is paid in advance e.g. payillg a health-insurance comp~ny fixed amounts every
month.(~;l(u\ ~p're..\'Y\.i.Wrf\
0-b\~}\ c- P fr ;';;';-crl').')
, .
Gt 19\ ~~~"
~o~ P't) ~ SlN/iu ~
SR/uJice. ~@r~ll\<rtk..
RetrospectivelellTIbursement: A form of reimbursement in which a healthcare service
p~r
is paid@submittina
a claim, ~g3ubmitting medicaid cla~s, after dis.pensing /
drugs.
- (
\\o<;~{tc& evt ~~
dU.~
.
Q.2'-t4
e-: ~
~~
Medicare and Medicaid
P~
\/\..~CR..o.
xvr1I
Medicare:
It is title 18 of the Social Security Act. It was enacted in 1965.
G)
It is a federal program. signed to provide suppl~tal
healthcare coverage for the elderl
*
and some permanentl .2Clisabledpatients.
* Crt'}> It isunded and administ~by
the federal government. It consists of two parts:
PartAandPartB.
'~- -,-',...-~..,.."
v
,j(,
)(..u"-'v / ~
(;-d
,.....
* ~ Medicare does not cO$r any outpatient rescti.Jign dru .
----
co- 'L~(:zr)
.~_ ,.z: v
t Medicare Part A ~
t'
Q.!Jw/'~~
*
*
*
Co v(X$
\\o'>P~J..~;\,
.'
h.os?ito!:zcj ~ & l~- ~
" .
C9JV-
tw:.....~.
CD
The hospital in~ance is mandatory. It also covers nursing home service, home health
services and hM'oltal services.
)k~overage
and benefits of Part A are very limited,
It also includes cost-sharing provi io~s.
~7CttJ. C? ,v:....
/' --J; ~~
..LP ,
Q.'2'tt.{
~,
c;.,,,'~'(,1:
Medicare Part B:~
~(}
lr".
Q-oy
Doc:tn..
c..-
~0-
0/L:;;1
*
*
*
C)..24-l-l
8o~
Part B coverage is optional.

It covers medic,&land sur .cal services.
. t.:Part B coverage includes an annual deductible and coinsurance . .-u:L.- G4""<-,:::c: 0> ::..".,.o -~ p. . q,;~.
_ A./,., U'" t..','
C
!
~J
f\~B
~~
~?~~
.;
~r(7fY\
pt.
20
Krisman

XIX
'
H.~J:
t::k. oO~~yy\.ud::
lD ~
l.
2.
3.
4.
5.
indi ent patients.

(? Ct1'J" --
Medicaid benefits are more comprehensive than medicare benefits.

O.1-4~
Medicaid services include:
.
\ \:s
,., -
Inpatient and outpatient hos ital services

Lab and X-ra services
Ph_ sician se ices
Skilled Nursing Facility services
Home Healthcare services
Health Blief Model (HBM)
?t.'::.
# It is a joint federal and state government program that provides healthcare coverage for
o/.,.s>D....:L..
~~~
i'
poor and medicall
It is funded and administered by the federa and state zovemments and administered by
8governments
uE~~r direct su
.. n of th fed:::.al government.
wd ~
Medicaid: It is title 19 of the Social Security Act. or ~
-?
Q.
'n!Nlo
It was first pro osed b Rode I tock and later

.fied b Becker. According to this model,
the authors have hypothesized that people generally do not en age in preventive healthcare
practices o~ articilfatein health detection and screening,.programs unless they view themselves
\
erable d/or hav~certain kinds of health relevant roblems.
t
E\l<po~d
--r, Y'isk'
cI.
~~
There are three cate ories of behaviQ.r related to healthcare, these include:
l.
Health behavior
illness behavior
Sick-role behavior
2.
3.
Health behavior: It is defined as any activity undertaken by an individual who believes

~
himself or herself to be hea~y, for the u ose of preven .n illness.
*
*
*
*
*
Weight reduction screening program

Exercise program
Stress reduction
Regular self-examination for breast or testicular cancer
Change in diet to reduce fat or cholesterol consumption
illness behavior: It is defined as any activity undertaken by an individual who believes hel
sh~be
ill.
"?'
~~
*
*
Dis~ing
health roblems with a famil member, friend or ph~ist
Making an appointment to see physician
21
Krisman

*
*
Se~ng
to dete
Experimenting wi
Sick-role behavior: It is defined as an activit undertaken by an individual who on siders
themselves tt01?e)ill@who have been dia nose !)by a health professional ~s beinj ill..;
~
*
*
*
*
Following medical.advice
Taking medication as prescribed
~Selecti
g an appropriate <?I product
.>ft Sta ing horne from w ,rk or ~ol
Compliance and Factors affecting compliance
CC
~~C omp I'lance: I'd
"ill' s w mgness an d:==~
,
tIS e fime d as patient
mnatlVe clor t aki ng me diications
(Yand supporting the healthcare provider for tre~nt
of his/her disea~e,
Factors affecting compliance:
*
Age
*
Cost of medication
*
Disease (psychiatric)
*--- Satisfaction with care
*
Side effects of prescribed
*Belief
~
*
*
*
*
*
*
*
*
medication
in efficacy of treatment
Education
Satisfaction of care
Frequency of administration
Multiple drug therapies
Family size
, Duration of therapy
npleasant taste of medication
Kn~ledge of the disease
D~
G~
*
J"
c"..-/
,,,~
Important Dermition~
t\{.J.~
1z: .p. I:L,
- { -
AAC (Actual Acquisition Cost): The actual price paid b

and cash discounts,
.[" AWP (Average
q\y
WholesaJ.~
AwP~ l5i'.) ,q 0P-' '5""" wo.Jcl
OJMAu.J.
to
ublished'~
0..
EAC (Estimated Acquisition Cost): The third's

harmacles for a particular drug product.
..-...-
price" of a particular drug product.

0..
JJ o~ ell) (W)v,pJ '() ~
estimate 01 the rice paid by
~
'te.ivvvb....rsevne.rJ: o-t a.pr("lC;~
22
Krisman

MAC (Maximum Allowable Cost): The maximum amount that will be. paid b t4ird party
{t pharmacy for a particular product.
*
*
Jt
Capitation: A ros ective form of rei

e in which pharmacy receives a specific
amount of mone~or
each patient who is eligible to receive prescrip~
regardless of service provided.
Cdinsurance: It is one type of ~o~~~~diiI!l~an~in which patients

of1all o~s incurred. ~~\
C'.;LV"\\
~
.
Co a ent: It is one type of cost shari cr Ian'

ount each time a service is provide ."1ts~:
@Oud c"pa-v ~~~
ay a specified percentage
which the patient has t~ pay a f~

~
s.,;1" Ie C.<D~
~ v.. Co~~
r _~Yu.::.
2:;1<7 o!.-..4~~ ,pro
Co~!9ar br::J &~~.~
Deductible: It is one type of cost sharin~ pla~in which a patient has to .pay a~ pecifie~
Q ~~
amount during a specific period of time eford benefits are aid QYthird party. ~ __ C.r~' ~.f
-~.,
wq')(
k") ~
c...
'1 t6":
%.i reto;j .."t
'OJ"
COMMUNICATION
-'
Interpersonal communication is a common but com lex ractice that is essential in dealing
with patients and other healthcare providers.
The communication is normally divided into two subcategories:
1.
Verbal communication
Nonverbal communication
-3l
t:.~
-_.
A.
Verbal communication: When sender transmits or conveys a message to another person by

means of vocalized Ian a e.
Verbal communication is com osed of the following components:
1.
The sender: One who transmits a message to another person.
2.
The message: It is an el~t
3.
The receiver: One who receives a message from sender.
~ sWot ht
4.
that is transmitted from one person to other person.
CP~d
Feedback: It is the process of replYi~sender

message by receiver.
according to understanding of se~
~~~~
5. .
B' ers The interfe~~?ce that affects the receiving, sending and transmitting of message, e.g. loud
noise or telephone rings in the background
,c
I yt.':
n\_
~c ~
t to r ,
~
2.
cL. 1:
23

.Licensing Exam -Theory
.
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LXNonverbal communication: The art of communication that does not require vocalized
lanzua es or the writ en word to convey messages.
-
.-/
B.
r--"
The following are elements of nonverbal communication:
1.
Kinesics
Proxernics
2.
1.
Kinesics: The manner in which one uses his/her arms, l~,

a message to the receiver is defined as nesics.
Examples of kinesics:
1.
Varied eye contact

@ax=W posture
Slight lean toward the othemerson
~-;;=dy position
Frontanial appearance
.
mf
bl
A ppropnate, co orta e g~s->
2.
3.
4.
5.
6.
-fx
h~,
head and face to convey
"",.6 ~tr
' \'lJ.I ~,"';J,.'

j '"
<,
I/,.;:.
V,
QJI\
L.cko-..
t-fd'la.-W-
Proxernics: The d~stance between two interactive people puts more em hasis on content of
communication, and it is defined as proxemics.
www.pharmacyexamcom
24
Reference
Guide
Licensing
Exam
{die
for the Foreign

-Theory
Pharmacy
. (.',~
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ct. s s ccl~cJ) ~v.,

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h~t::C
3- Pharma~oeconomics
m.oM-'I pro\ll'd.e ('...,-fte-he-l\..$fY<-. ~~
~~~
'V
Pharmacoeconomics:
It is define2 as "the description and anal ys~ of th costs of drug therapy to
healthcare systems and socie _." Phafuiacoeconomic research idE!@.es, m~s,
and compares
the costs and conse uences of pharmaceutical
roducts and services.
----
~p-==
Phannac
onomi methodolocie include cost minimization, cost effectiveness, cost benefit, cost
of illness, cost utility, and decision analysis.
A.
1.
2.
3.
4.
5.
6.
7.
Direct cost
Indirect cost
Fixed cost
Variable cost
Average cost
Marginal cost
Opportunity cost
0#~ '(e.5.c>wCe
1.
..! ~)c.'..w;
If money is exchanged for the use of a resource,
Direct cost: It involves a transfer o~.

it is defmedas direct cost-> cP>h ~
ve1.a1J to
_,
2.
3.
4.
Fixed cost: It does not ch~ue with increas~ or decreasqin

C depreciation of a plant and equipment, ct.JI'Y\ i(\\s~
X -:J..Or~c,..:.o1:c,..
~
s.u.ppL
oumut, e.g. an employee's

c;, -:;ts .
Variable cost: It does vary or change with a change in(volumeiof au

cost of goods sold
Q.sr ~
~~~
G!
fbr
~"f
C1
rr-:;'':-,
~Iw..
v-oJ, .tr~)
salary, or
cJ
ut, e.g sales cornrrJrsion and

,r.1-e'/ WOo es , 'S.uf1-~
Average cost: It is the resources consumed per unit of IUtpUt.1t can be calc
~~
J,..w,
b."
c-wt(l-uk)
total cost by volume or quantity of o~.tput.

6.
c.,st
I'
"..,.t~
S4J\...1I'1C.~
aY
,$
~l
I ~~.)bfl.d
.
id
Indir ect cost: I toes
d
not m..YQ..Y.e
'!lly !ll~ney. tIS unpg; resource comrmtment, e.g. unpm
assis1:a!!cefrom a family m~mber.
r.C~r:-
5.
prol/lolt./fY"o~cQ.
,.... L
ated by dividing
-toW (p~
V J:.. <r( Q.JJ.a.lr:~Roul: [-'vlv
./
Marginal cost\,!t is defined as the change in total cost of producing one additional ~nit o~ output
~
tf?ar
Lot~ Ctost~ a,Qi b..~
InexeJ~l
C-Dbr: o.dd~ '
<tb...J:,t c.,,l:.
a.
c.,,!:
1-
"-O~
CUtQ...
r.k .~ ~ ex~
clUlP'./-Jj" 8c;'nrl,'r.A
'-'j
t-s
tU". ,;,
~cvrJ
fO
~Yl
to ~~
re.k.-VaJ ~
~-?\~NY
1o-J:,;:t.
-n.. ~
o>'Jt a1~
~1''A9
i;1,J.-
~~:J
LUrtJ:
1'It!-t~
C1
to proV'ide
1:0 :Utot~
ICe.-
vei~~
pYhpo~
dd.:.~
Q.
or a.
a.<l
1J u41oui-put
0..
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Reference Guide for the Foreign Pharmacy.

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Opportunity cost: It is defined as the amount that a resource could earjiin its highest valued
<0,
: _
7.
"*
Wtemative us~ It is the be~sure

(bst-, ~
D~
fa resQ!!rce.#
Sv..pE;:ft'5. ~
Cost ~
Pharmacoeconomic
of the v
Jo
o~~
~rOVt'ot~
te.
ovl.f~'
Methodologies:
Methodology
Cost measurement
Outcome unit
1.
Cost-benefit
Dollar
Dollar
2.
Cost-effectiveness
Dollar
Units such as blood pressure,

mm Hg, blood glucose
3.
Cost-minimization
Dollar
Assume to be equivalent in
comparative groups
4.
Cost-utility
Dollar
Quality-Adjusted Life Year

(QALY)
~
.
(i)
Cost-benefit analysis (CBA): It is a basic tool
t helps to .
. rocessintheJ1~tbcaI~Drogr~.l~
e
'
~~
b(. OfP'
~~l.
C
I
iA$..
FrOGI(~
s:
YlOYI.-
~tt
C.CV\A..
@TheoutcomemeasureisindoUar(f"tt:.,
QCc..u..(<..~r <N"I\ +L poro
~ ~ Gr".~
"
P'r0
<o..wvC>,sl-u:1C\../.:)
0
tic.k.tu:atlll..
&~~
..:...t [)~
ve the ecision\-making
1:0~
~CJ..
\o\e.:L~':)\~J\;)
e:Jl
i Heal
~soYt
~(~
tR
teoJ:
pro~("<.UVI".~
~\
that ~~
"cw...
This study calc. res ~f the possible benefits that may occur from the program. All the benefits
=-.
must be expressed in dollar value.
Disadvantage:
-z: IN..+
It is very ~t
to assign do~ues
may improve a patient's life.
,,--.1
~ >1.,_.; ;-; [;
to non-financial benefits, e.g. benefits of the program that
Example: By using cost-benefit anal sis, find out which of the following drugs is sociall beneficial
or acce table?
Variable
.$
:;.
trOlY"
Drug A
DrugB
800
200
300
200
500
500
600
50
100
'") ..o,..u..u".,L.
;..c". ;;.l:; ,J:~
Acquisition cost
Administration cost
';:-'L..--<' Of~;.A..--) Monitoring cost
Adverse effects cost
Days at work
Extra months of life
o
500
1000
26
Krisman

we need to calculate B/C ~enefit/C;W
To find out which drug is ~~,
Total cost associated with Drug A therapy: 1500

Total benefits associated with Drug A therapy: 10QP
B/C
= 1000/1500 = 0.667
Total cost associated with Drug B therapy: 750

Total benefits associated with Drug B therapy: 1500
B/C
= 15001750 = 2
IfB/C < 1, the drug will no be beneficial for soci~ty.

IfB/C =1, the cost and benefit will be same.
IfB/C> 1, the drug will be beneficial for society.
*
*
*
*
In the above example, Drus B .s m~o.;.;,re"""b,","e.,.,n~ial

to society compared to DrugA.
2 ~ost-effeCti';~~~alYSiS
(CEA): This technique is used to make a decision to s~

tive intervention from th, availablealternative~
~t
per-- ~
~ostc
,
((, ,,&rThe'
:. \; J.P..;,
JerC-
W~\~<Lcho.-.t.::
ut measure of this type of study
,iJ.tA...
IS
_::-
&..f0A-L7) -tj.j.. V' -
ealtluelated.me.asll!e
the
s,
b b,(-I~'~~
~ii~
rather than a financuil.
\...S..> \..
d!
.'
_
C,
or
el;tlJ:..'vmu-!.
\)
e.g. blood pressure, mm Hg, or blood glucosb\y

~G.-l
.1,
..'
r
~~
o.l c-.st.~
I'""'"'-"f~
tU.L ~
/;,1 (Jor if) ~- ;
Cost-minimization analysis (cMAiIt
is defined as when two or more' teitfnh~rttm:e
~t tI.. C',?s.t- - .~~
oJ
3.
--
41(J\,.\'
My(,
examined and assumed to be equivalent in terms of a given outcome. ~t

associated with eac~ c....
~
intervention may be examined and com ared e.~ the comparison of cost of two ca-channel ~
mg,
VJVIA."~
t:
bl~s
which
~~cessfully produce similar blood p~es_sure_
red,!ctiop. patterns in a selected
group of patients. CtJtfl.~cA~y,.......
s...~c..u,.
'bt
~..e. ca 'v'aJe..,J. ~rc ~.. T:". va..L.u.\.:wi '
<:;.E./~,H?_.. cw.. nA
'vol.e.i ~ &'0,,/::-!,AM.. CPA r: ~
('~.:'
(0!1.dI'
-1c.(.L{...
-.....1.
_\..>\
A. ...
l
w./{
/I V4
'-_r.
v~
4.
Costntilli;y analy:sis (CUA): It is an economic t'Oolthat measures th outcome of the program

in terms of guality and quantto/ of life.
C E ;i)
HRQOL has a very l~g~ Q.at3J2~se.This dat _se is prepared either by :rsonal interviews,
bytelephonein~ie..wj),0fbypostalsurve
- --J s.JI a.ci(A.-.is.\'"'.,.-...,i,.';"",} obS..vv~
(tfu<~
...u
~*
~:)
.'
CJ""l
r>
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CY
_.. '~
~
Personal interviews, telephone interviews and postal surveys are de,fined standardized
questionnaires. or instruments ofHR OLJ tteL>L S.t~
dl ~
~
. Co---:
+-,
L
3f,,~
t~
Ct~~-
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27
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Krisman

U)General Health Status Instruments: They normally evaluate health-related information

applicable to all ages, races, s~xes and sociceconomic
background.
J~
~~~~~-=~~.
General Health Status Instruments normally concentrate on four ke health conce ts:
1.
Physicalfunctionisg
Social ~
functiomng
Mental health
General health perceptions
2.
3.
4.
%'~
*
.
is the most commonly used General Health Status Instrument.
Disease-Spec!!ic~ealth-Statu~Instruments:
::::(
ob PSJ
fur
They normally focus on the effect of a

particular disease on atients. It requests detailed inform(!tion about effects of a djse~e and ('
treatment on atients.
~.~} -1;..1 ~"t{
c.~.
~~_..w.
~--'jQJW\.~
?'(o\'.).~\
tU
t-~~o..b;\;5& ~.
\~\o~t.-
Psychometrics(It is normally defin

~~~valuatea~sofanindividual)
\oJ. on
~*
.. -~
,jt-;r., .
J
,tf*v
'"
\V_
~f
s~"",e.J:
I~
re-~~
w.w:.t
~ \(\sVw..'rl'lvt. tf~ ~~/::;&.<"'~"",,)Dt..
as the sgence of usin standardized tests or scales to

\n...~~~
CVJ.a.!&.()~
~.
l.lH_.,ksCa..v:l tk..Ps..:f.J...,~
(clos-; _.t
(0.
~
lLrr.x.rf..
I( Reliabili
and validi are the most important ps chometric ro Eies that mus! be
poss~ed
by each and every standardized test or scale.
~
c: L;.
1eliabili .sa \ easure of co .isteri.~y~dre~a'ta
.. of meas~n~
while alidi " a measure
t5J)\ of a~y,
ontent validity, construct validity an Jriterion vali~tyJ, are types ,o~validation.
-- (
({i) (1rv..~e..k
(cJ.;.'vU'9,J:. v' ~:,l
Ire.,... ~
o-.v/
u
()
~0
.o-L,DecisionAnalysis: A systematic approach to decision-mak:iI;g under the conqition of ~c~ty
t
is defined as decision analysis. ~ ~s
~ cle6:s'icJh._ ~e--..s. tc.> d~
\Ik C\.." .~ k.:o
~ 'fred.Lc:t ~ V~
oP ecJ-Ch opt;.;~ &. IN-. ~\.
tf~
or~\tJ
I
..::ar::=!
~
(
),
k::
cL!c..61~
$1 Sa:1
~
Decision analysis h~s the decision maker tb
Y'A<t\
Q
'~t
U '
"y
ri!.SI
3.~~~~~ ~~~~
o~
1.
Identify the available option when faced with a decision.
2.
Predict the,{conse.,quences or outcomes'lof each 0 tion. (t4

-I_ \
I
"
~
'"
. "E'..
- I lor:'"
"I"
a..\IW-.
e bY~
rY"""'"
-Il
r'CN.1 e{\.~
e."o...kcJ:<.~
....,.."
3.
..,
P'(!c-tt-
. .
ck~ ~ I
\..A..Oo
k"A..
Wft.,
0 ()cHl
,';J1 ~r ~ J~
~
.)
cr ~
Determine the value of each outcome.
28
Oh..
Krisman

l?
>,
"
kos?\t~ot~
4-Healthc~re Delivery System

-.:; f.- h~
~ l4ea_H~ ~
e~~~-
The major healthcare activities in the United States are consolidated with the De artment of Heal~
and Human Services HHS' . One of the principal components of this department is Healthcare
FinancingAdministration CPA. It is charged with the responsibilities of administering Medicare
and Medicaid.
'
--
In the U.S., patients may get he

system.
A.
B.
e tices through one of the following healthcare delivery

~
Managed Care System

Long Term Care System
Hospital Pharmacy System
Retail Pharmacy System
C.
D.
C;P~a...:d W.
Managed Care System:
p'f'G.~
-----~
lPPG-P')
The principal corn onent or segment of the Managed Care System i HM .also known as Health
M '
ance Organization. It is a private or non,Qrofitentity which provid
asic healthcare
~
services to enrolles for a fixed amount on preRa ment basis, and provide additional~. 1
.
supplemental services for additional payIDe '. \-\ 0..0 ~ ex~~\V(..
~
tiO;;oa:~ .. "lev-.
----~
HMO is also described as an organized system of healthcare that is capable ofbrin~g togethe all
the';;cessarycomponentsofahealthcaresxstem~~
~~
'.0 -:>s;) ~@PO~"v..:><A ltr,,-~~.~
>f.l.
ee,)1:h..
1- ~
1.
- (s'<""~
2.
3.
/r.;.
There are thr~ important characteristics of an HMO;

,.
~
b too..:c.lUh\C1u.. (""~
r~
~s') ~Mo ~
Sit yv\\Y\. ~
pa..ck""
Membership is volun!illJ'. ?'I"'~
~
~.,
"'~
~
a
D~
,,",'
-'
~ 100A\.A.~':v~ b '-'Lvo:J b e, i:Q
~ 0~
ole. {c;t, .
They offe -.f...QIJ1 rehensi~, basi~ and sup leme~ health maintenance and treatment service .
e '.
Each mel)1berhas to p~
r;:--;-------
ed amount of monthly fees regardless of the service provided.

So:
An HMO is subdivided into the following categories:
l.
Staff Model HMO

Group Model HMO
Independent PracticeAssociation (IPA)
2.
3.
'i" :;.x.;....
G. 6 '-16
~
r'
&
c

",t
@ k.,.;. r per"""(
H,aliI:
p,:.~
t "r i'rov;k "vaM.51
ir'\cUV\,
p-Ya.~~~tc s.wt-6!tp~u:~t
prov,olul .
,-J&.
SeJL\I/Ceb(~:~l'"om
(f ~3
Q..b4{,n .
fu:~
0;0
1~
to
67-~Haf;J
(alJ
- L.::;;It is the fastest growin

e of HMO. In this type of HMO, an org~tion
c15'ntractsindividual
phy'sicians to provide service on a discounted fee-for-service basis plus pfttfit sJ;;ring.
CD,
oWr\/b...t
no.
t~~t-
~~,~!Ci)~~
P~SI~&ffi2q~@~.~p
Preferred Provider Or2anizatiori!,d~
s~es
Independent Practice Association: (T pA
D<W
~
~V'lCe rroviJers(ex:: l...bof'"tor.'ci
~.141-;Z- ~
IpA
.,
3. ~
~~
5i &..
They co~tract directly with I ewell

tablished h sician groups to pr v'
members for capitation fees or a fee-for -service.( f ~s)
~o..K~~~
CD~~\~)?\vv-..""-A.~~,ce
..;\.;;j
*.ros.'fX~~
u:
~cJ-
2. \Yt'GrOUPMOdelHMO:@~'~
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~s
s:H
~)
l~
~
1P
It is similar in function IPA, however the members of this type of organization use PhYiciJan
who are not directly under contract with HMO. When aJP,emberuses a noncontracting
physicians, he or she will not;~
a full reimbursement ~edical
expense
e-. ~
kvu~-~7 \n.vle
W ~~u.')
@ ~ _;:[,er: \ ~~.!.~
Long Term Care System:
P'3S t?~\ t!. c...::3
=-"
It is defined as healthcare or health related services that require medical, nu!"Singor supportive care
for 'Oor more da~
-~
Long Term Care institutions normally include the following:

Nursing Homes
ECF
(ex:-t~W \.A.H.
SNF (sKI' ltd
N()"'(S'-~
~~C\~'\ie.s
~c.:.~)
.1
Hospital Extended Care Units
:I
Psychiatric Hospitals
4.
'-
Chronic Diseases Hospitals

Facilities for the Mentall Retarded
Half-Way houses
--'l?'L\
Krisman

Nursing Homes:
It is defined as a nonhos ital institution which provides ~sin

and other health and~ial r~
supp-ortiveservices to the chronically ill and the elderly. They are subdivided into three different
~
~
categories:
1.
rI)~~
2.
3.
Extended Care Facilities (ECF)

Skilled Nursing Facilities (SNF)
Intermediate Care Facilities (ICF)
1.
ECF (Extended Care Facilities):
It was used in the earl
A nursing home has to ~t
rt1
ears of the Medicare program.

certain criJeria in order to be certified as an extended care facility.
~
~.
* "ff
(J)VIt/ ~Vft\/
Medicare covers only up to 100 da s ofinostLhospital extended care services.
*
2.
SNF (Skilled Nursing Facilities):
It is a nursing home that ~ts the r~

Medicare and Medicaid programs.
3.
Intermediate
An Intermediate Care Facility is defin~~ :

recognized under the M~aid program
which is licensed under state laws to provide health related care and services to individual who
require institution c~ due to their~andp~sic
con~s.
4.
Care Facilities (ICF): _
*
1.
2.
or the conditions fo
~--_./ both
J-
<l..-t'/q...,-~
irift:Gtt;
C!!!:": ~
~OSPital
\-IG$tt....t {!/f ~
----~
U,j;;;
It is a defined as care provided to patients who have asse

ough the acute sta e of their
illness, but who are still unstable and may require several months of further hospital care.
~
Hospital Healthcare
emen
--
System:
;;a",
0 S 12-
Generally, a hospjtal is classified in terms of the physical makeup and quantitative nature of
services proVided.
--
~-==:::---,,-~assifiedby:
Type of service
Length of stay
31
Krisman

3.
4.
Ownership
Bed capacity
A.
Type of service:
It is normally divided into two subcategories:
l.
2.
General hospital
ospital (Cancer, Psychiatric or Pediatric)
B.
Length of stay:
It is also divided into two different categories:
l.
~term
hospitals
Long-term hospitals
2.
ChQtl7term hospitals: The average length of stay is le~ than 3 da s~

n term hospitals: The average length of stay is mor.> than 30 da s.
C.
Type of ownership:
Hospitals are also classified by the type of ownership and usually gQy~nt
or non-government,
e.g. Federal, State or County hospitals, individual, partnership OF$-corporations.
eJ/c._('L..
-
D.
Bed capacity:
Hospitals are also classified according to their bed capacity.
l.
Under 50 beds
50-99 beds
100-199 beds
200- 299 beds
300-399 beds
400-499 beds
500 beds and over
(D
2.
3.
4.
5.
6.
7.
G
*
6)
Retail Pharmacies:
They are also considered one of the important cO!!!p'onen!s&{ the healthcare delivery system.;
However, health related services are primarily limited to dispensing medications and patient C!:J
~
counseling, e.g. Rite Aid, Giant, and CVS pharmacy.
- -
-~~~
32

Krisman
They can be subdivided into three categories:
1.
2.
3.
Chain-retail pharmacy services, e.g. CVS and RiteAid pharmacy

Individually owned pharmacies
Mail order pharmacies
33
Krisman

;vDA
5-New Drug Awroval
*
No new drug can be legally marketed in the U.S. without approval by the FDA.
The innovator company must submit an _.

otice of Claimed Inve~tigational Exemption for a
New Drug) for approval.After an appro ~
v ofJND from the FDA, the manufacturer may then
conduct clinical studies of its investigational new drug.
The ~uires
1.
2.
3.
4.
The name of the drug ,/

Its composition v
Methods of manufacturing and quality control /
Information from preclinical investigations regarding pharmacological,
toxicological evaluation.
The FDA may answer within 30 d s from the date the IND is filled. If the FDA approves
the JND, the innovator company may start human clinical testing of the new drug.
The testing proceeds through three different phases:
1.
Phase I clinical trial

Phase ITclinical trial
Phase III clinical trial
2.
3.
't4-U:F~
,Je.-w d~
the man!lfacturer to submit the following information:
pharmacokinetic, and
S-t*
Phas !trial:
This phase involves a small number of subjects for study of the drug's tog city, bioavailabi}ity,
metabolism, elimination and pharmacolo .cal action of the drug.'
-
Initially, a number of subjects receive .'

once safety of the new drug is assured.
Phase IT trial: The new drug is now tested on a!imited numger of atients who actually suffer
from the disease for which the new drug is claimed for.
Phase ITclinical trial helps to de rmine the efficacy of the drug and dosa e at which efficacy may
occur.
*
O (32.
drug. ) ~~
06
....-.,~,-
G)
rPhase
,-
Ct./~./'
illtrial: This trial involves hundreds or thousands of atients. The study is often
conducted at a physician's
conduct studies.
iL ~. ~~
L6
The purpose of phase I clinical trial is to detec the adverse ete.cts of the new
"~~
c..,...cLk ~ (!.M~
tri~ ~ -1k ~
lM- ~A>
( W
10';..11 ,tw
office or hospitals that have contracted with the manufacturer to
~..cro/~ct ~l!~O~
~,.../.>
r-O'r ~
~ p~
d.u..c
:-
'
r"f'.
.,;;;;;;;;:~~
()Z~
'f~
sq
Krisman

A Double Blind Study is normally conducted in this phase. It is a type of study in which the
nature of the drug is concealed from patients as well as attending physicians. In this type of
study, one group of patients receive the testing drug and the other group of patients receive
the placebo; the result of both groups is then compared to find out the true effectiveness of
the drug.
ev>d (eI""\
-=-
eJ.
1'J.,1-
.~.,
o--n
4- If the phase ill studies are favorable, the drug sponsor's may submit an ND
'to the FDA.
AnQcontains
on an IND.
By law the FDA has 180 days to review anNDAand to answer~e.~pp.n.M>r'scompan .
Phase IV trial: It is also known as ostmarketin surveillance.
Once the new~g~pplication

has been a roved, the innovator company may legally distribute
the drug in interstate commerce.
Manufacturers must maintain and keep adequate postmarket:iJ:.!g

report and records.
Manufacturers must submit any new information regarding a drug's safety and effi~y
-=
serious drug interactions to the FDA.
The importance of postmarketing surveillance:
1.
To com~a
2.
a complete report including the drug's ~ety and e ~acy which has been noted
---------'>~cJ
_I
~)
ik~
t.O ~
hjtI...t.,
~
LA.
...-_
or any
drug's safety and e ectiveness in a vast range or group of patients.
--~~~--~
--
5.- -
To find out the Ion -term as ects of to~~ty and adverse effects of the ~g.
35
/'

d--~O
-':;>
Krisman
~'(',
c:..~L,-o
~-Clinical
Drug Literature
It is defined as an extensive, heterogenous collection of resources which provide information about

drugs.
Drug information sources can be classified into three important categories:

Primary literature
Secondary literature
Tertiary literature ~~
(i)
0.
5c
Q-{~'j
---'>
CV\
g.,~
tU- ~~
ko/! do\ifruJz
e.J:Al ~
~~%8:::c..X1 ~i
slip ~
~ -t -
ci.
.\) CL
0.. ,..l,'_ a
~\_
~'i]
'2.t.;o
- .\r
J.~ C'Jk.~~"-'\'~<
~~.j.t ~ ex~"
Primary literature: Articles appearing in pharmaceutical and medical journals

have the most
~
ac~te health related information. They are classified as primary literature .
\~tCu.r s: '~
L
Li'\A..
---u' 0<f' .__A"~
(t.II.,\. \<rr~
~ov.rCe..!.~'>..::':l~'
...
current and
w o rie
i
Advantage:
1.
The most current and accurate health related .
Disadvantages:
1.
Pharmacists, pharmacy students, and physicians have the least contact with these type of
resources.
~<W
~:')lU'n~~&
DY'~ topic., r~6~'
pe-uO~@
\\os~;W p~)\lSr"'~ST
Secondary literature: It represents two types of resources:
1.
Indexin..g(qiblio~c)
Abstracting
2.
* \~.
"X' They represent the ~ost
*
1.
2.
3.
4.
rary. -
Several considerations should be applied before selecting secondary sources:

.: ~."..AJ.Y'.>'J
Lagtime~tk
~v.J W. pw6~c~?
~
cJ:At
~~
Coverage of literature
Selectivity of indexing and abstracting
Co~
G.1Cl'O-ik ~-raJ.
.. mvestment
/~\
fli ~lib
ex nsive
0 terant
.X
Q..w\
oAt.tk
V->
~Jf'\;,)~ ~~~
J.nn ~_"'_
~~
.
~o-r ~rj -.
'oW:J.h'
La2 time: It is defined as time elapsed between documents published in journals versus when it
was abstracted or indexed. The article with a prolonged la time may ac pdated or current
~
~
info~tion.
------
36
Krisman

~tkS~i~~bCU~o.\
--
CCD.Yera2.eof literature~
eJectivi
ofindexin
-----.... and abstractin
: One should pay close

........-..
attention when selecting secondary literature from journals, e.g. pharmac.r~ted

are less likely to provide article information on cardiac or neurosurgery.
io~als
Advantage:
1.
More current and u~
Disadvantages:
1.
Less current and updated information compared to primary literature.

Vea exp,ensive.
The dru . formation is availabldi!! different sources. e.g.<rom

standard rint,
aIm to or microfiche. These v~
sources may have, different cost It is therefore very
im ortant to ~te
individual needs at the practice site and purchase ccordingly.
@
2.
~ tk90t"~1 tL. ScW\.u-
.,p~.i ~&~~b
~~
information com ared to terti~
\r"\toY"~
,?'(ovldeJ.
\.
literature.
*
l.
2.
*
1.
2.
Disadvantages:
'.
4~~
\w..~
~h
Q~t
Lack of current and updated information .....:'l

.2. r'..,
U
,~
The author may interpret incorrectly from the primary ~source and. may provide macC.tll:ate p..u-t..A~
information.
Classification of Drug Information Sources:

A
01fl?se
C~ta.b~\~S,\~,'\t~~.,.tbli~
( Parenteral) e ~ ~'>
o..Jv"f\I":~~
v])
te"L...,..:a.w...
:
t)
e"
":.:.-\
Drug manufacture
J ~
HandboC?kofInj~ledrugs
2.Kitj.s Guide to ParenteJ!1lAd.mixture~
/5
~TriSset(>
s..tJ,\l15 <rb~lA.~
B
- Poison information resources
~y'YYUA.tCLW
1.
2.
3.
4.
Index Nominum
Matriandale:The Extra Pharmacopoeia
US
iction~
of Drugs Names
USP Dictionary of Drugs Names
I
\Nw..GJ
1.
2.
DreiJbach' s Handbook of Poisoning'

. Clinical Toxi..2!.ogyof Commercial
Products
outside of USA Q. 3.2..~
sto.tL
d.a
\'1lV('I\(.
G. 9,.3
E
l.
2.
~) ~ ~'-4
\;.
..v..'1
I;-\~,",,,,ol<""'~
_ x.;J
I"> r
o- ~<)..c,t-)
37
G---~"5~
Krisman

0._ '2 SI.
c
1.
.
Sid effectsofdrugs
\livestigational
~'J
3.
4.
5.
G>~eO-~.(fDIS)
6.
(o..O..~ ~
"TextbookofADR
(. f" f'\e.~.la/~
!(
-e~ b.-" (~p~~
Adverse effects
In..d.vc
drugs
&wt-LLl-e(.
Therapeutic orientated references

/;"
. .Th
I
I
Y(I\.~I.
A Pipeline
@ li )lj.tid elr 11.
'rug Facts and Comparisons
;s. I t<>}(.I
tttgdc~ ~
~
Matriandale: The Extra Pharmocopoeia
v o..voJo.\:!t. ~ u..sf\l~ ~~v<. '40'(~ cJoouX
UJ:.p
c-utsiJ.e.
~O"
-r:r:
L
Drug orientated references
..$
...:::-CJc~
I"
Merck~ual
Applied Thera utics
Clinical Pharmac and Therapeutics
Cancer Chemotherapy Handbook
(~urc-f"
Dispensin~orienta
1.
USP-~"
2.
3.
Merck Index
~emington
------===0.
.::,[
+
'I
2.
3.
4.
I.lsA
G
Drugs
Jl.L..aJ..'~.
.'
Facts and Comparisons

Handbook of Nonprescription
Bluebook
Red book
1<.
. ~~)
ed references
"'~~v...Jd
/C v- _ )J. ~J
):.
r -
38
[ PRECLINICAL SCIENCES
39
po
Krisman

7-Organic/General Chemistry
*
Organic chemistry is the chemistry of the compound carbon.

Atomic orbitals: The region in space where an electron is likely to be found is called an
orbital. There are different kinds of orbitals. They have different sizes, shapes and electron
occupancies.
The orbital at the lowest energy level is known as 'Is orbital. It is a s~

with its center
at the atomic nucelous and therefore has less tlectron density and morelst~ility.
The next higher energy level orbital is@'. It is larger than the "Is" orbital. Following
these there are ~
orbitals of equal energy calle 2p 'orbitals. They are dumbbell-shaped.
They are known as "2px", "2py" and "2pz".
Electron configuration (Pauli exclusion principal):
According to Pauli, only two electrons can occupy any atomic orbital, and they must have
opposite spins.
Hybrid orbitals
Bond angle
Shape
Example
SP hybridization
180
linear
BeCl2
SP2 hybridization
120
Trigonial
BF3
SP3 hybridization
109.5
Tetrahedral
CH4
Polarity of bonds:
Normally, two nuclei share the electrons in covalent bonds, however many times the
electron cloud is denser at one atom than the other, depending on the electron withdrawal
power of the atom. This will make o~the
bondJ.elati~
neg~tive and the other
end relatively positive; such a bond is said to be polar and possess polarity.
EB
Example:
H --
e
F
We can expect cov ent bonds to possess polarit when joined atoms have different
tendencies to attract electron. Below is the list of electronegative elements; fluorine (F)
posseses the highest electronegativity.
F> 0 > CI, N > Br > C, H
40
. Krisman

Polarity of molecules:
.~
-ve..
A molecule is co~~ered to be~if

the center of ne ative char e does not coincide with
the ce~
of positive charge. Molecules like H2' N2, O2, Cl2 and Br2 have zero dipo~
movement and are considered to be nonpolarJ
CH3CI has the dipole movement of 1.86 D, whereas CCl4 has the dipole movement~.
Both molecules have a similar tetrahedral structure, however, in carbon tetrachloride
(CCI4) dipole movement is exactly opposite to one another,
~_
CI
tl
/C",,-H
H
Methy!Chloride
8 = 1.86 D
Carbon tetrachloride
8=OD
Isomer: : tifferent comp _undsthat represent the ~

molecular formula but possess different
molecule structure, an
ysical and emical characteristics are defined as isomer.
p ~-
<J)
--
Example: Ethyl alcohol and dimethyl ether. They both have the same molecular formula
(C2 H6 0), however they are completely different compounds in aspects of
physical and chemical properties.
Ethyl alcohol
2.
H-C-O-C-H
H-C-C-O-H
1.
Dimethy lether
Boiling point = 24 C
Does not react with Na metal
1.
Boiling point = 78 C
Reacts with Na metal
2.
Stereoisomers: Compounds that are different from each other"nly in the ~

atoms are
oriented in space are called stereoisomers. Unlike isomers, they diller littl~ in structure and
therefore there is very little difference in physical and chemical properties of the two
structures.
--
------
--
--::;!'
41
Krisman

Stereoisomers can be further divided into two different categories:
1.
Enantiomers
Diastereomers
2.
1.
Enantiomers:
enantiomers.
2.
Diastereoisomers:
diastereomers.
Chiral: Molecules that are not su
Configuration: The arrangement of atoms that characterize a particular stereoisomer is called

its configuration.
Stereoisomers that are mirror ima_gesof each other are defined as
Stereoisomers that are not mirror ima~es of each other are defined as
osable on their mirror images are defined as chiral.
Geometric isomer: The particular kind of diastereomers that owe their existence to
hindered rotation about double bonds are called geometric isomers. They are normally
prefixed by "cis" (on the same side) and "trans" (across).
---C~
rc0
II
*
*
H~~
II
(-------xC
H~~
~H
Cis 2-Butene
Cis = same side
Trans 2-Butene
Trans = across
There is an interesting characteristic about the above two model.@iSomerof2-Butene

is '
(less stable)than the trans isomer of 2-Butene. The reason behind this is that methyl groups
are well separated in trans isomer, however they are closel enoug,h i cis position to cause
crowding and instability.
Confi urational isomers: They are interconverted by inversion' at the chiral enter.
CQ!L..- ational isomers: They are interconverted by rotation about single bonds.
Geometric isomers: They are interconverted by rotation about double bonds.
.-
IUPAC Rules:
-1.
Select the parent structure as th onges continuous chain. In numbering the parent carbon
chain, start at whichever end results in the use of the lowest number.
42
"f"pl''Pnce Guide for the Foreign Pharmacy

-":r1lI!iing Exam -Theory
Krisman
_- CH3"CHi" CHi" CH- CH3
CH3
correct name = 2 methylpentane

wrong name = 4 methylpentane
If the same alkayl group occurs more than once as a side chain, indicate this by the prefix
di, tri tetra etc.
CH3
I
CT-T-CH-CH-C-CH
e.g.
~"'3
CH3
CH3
2,2,4-trimethylpentane
If there are several different alkayl groups attached to the parent chain, name them in
alphahe ical order.
H
e.g.
CH-
CH3
'-I
C-
CH
/
C~
C-
I'L
C-
CH
3
CH
25
ca,
2-ethyl-4-isopropyl-3-methylpentane
4.
If there is a presence of a double bond in the parent chain, designate its position by the
number of the first doubly bonded carbon encountered when numbering from the
end of chain nearest the double bonds.
e.g.
CH-322CH-CH=CH
correct name = l-butene

incorrect name = 4-butene
A.
Different types of bondine:
1.
2.
3.
4.
Ion-ion bonds
Dipole-dipole bonds
Van der walls forces
Ion-dipole bonds
43
Krisman

1.
Ion-ion bonds: It is described as the attraction between the opposite charges on a ~and
an an
2.
Dipole-dipole bonds: It is described as the attraction between positive end of one.'pol a

molecule and the negative end of anothe olar olecule. In hydrogen chloride, the r~afively
positive hydrogen of one molecule is attracted to the relatively negative chloride of another.
-=:>
c- +::>
The most powerful of these dipole-dipole bonds is the hydrogen bond. In this type of bond,
a hydrogen atom serves as a ridge between two electronegative atoms (F, N, 0), holding
one y a covalent bond and the other by electrostatic attraction.
----
,.-example: H-- F--------H-
<,
Hydrogen bond (covalent bond)

F
Hydrogen bond (electrostatic attraction)
The
en
f a hydrogen bond purely depends on the electronegativity of other atoms.
The mor el~ctronegative the power of a QIIl, the more theipowerful hydro en bond will be
formed. This electrostatic attraction has a strength of 5 Kca1Jmole which is weaker than
covalent bond (50 to 100 Kcallmole)
3.
Van-der walls forces: It is the attraction between the oppositely charged ends of momentary, ~_ed_d~i ,--o_l_e:-s
_in_n_e_i_~h_b_or_i_n~g_n_o~npolar
compounds. The Van-der walls forces have a
very short range and normally seen between surfaces of molecules. These forces are present
~---among all molecules.
(+-+-+-)
(-+-+-+)
4.
(b
Ion-dipole bonds: It is described as the attr~n

of a positive ion for the negative e~d of a
polar solvent molecule, and of a negative ion for the positive end of a polar solvent molecule .
.
~-
'
Specification of configuration Rand S:
It was first proposed by R.S. Cahn, Sir Christopher Ingold and V. Prelog.
The four atoms attached to the chiral center are all different, and priority depends on the
tomic n~ber
the atom with the higher number having higher priority.
~-
When specifying configuration of a molecule, we should visualize the molecule oriented so

that the ligand of the lowest priority is directly away from us.
44
Krisman

Br
Cl
S isomer
R isomer
I> Br >Cl > H
r-
.!.
Y9< Try to arrange other ligands in order of highest priority to least riority in a clo_ck s
direction; this type of configuration is known as
'configuration. When we arrange
counte clockwise, it would be known as'S' configuration.
For above example, 'H' atom has the lowest atomic number and therefore has the lowest
priority; so we should move away hydrogen atom from us. Now, we need to arrange ligand
of the highest priority to the least priority in clockwise direction, this will give us 'R'
configuration. When the same ligands have arranged in counterclockwise, it will give us
'S' configuration.
Sequence rule for Rand S configurations:
1.
If the four atoms attached to the chiral center are all different, r>riori depends on the
Grtornic number the atom with the highef\ilUmber getting higher priority. If two atoms are
isotopes of the same element, the atom of higher mass number has the higher priority.
T~
H-
Chiral center
C -SOH
I
Chloroiodoethanoic
acid
In Chloroiodoethanoic
2.
If the relative priority of two groups cannot be determined by rule 1, one should compare
the next atom in the group.
acid, the sequence is I, Cl, S, H.
---
Cl-ICH
~~
I
-C-CH
I
Cl
Sec-butylchloride
45
Krisman

In sec-butylchloride, two atoms are attached to the chiral center are themselves carbon,
however in methyl (CH3) groups the second atoms are H, H, H. In ethyl groups (C2Hs)' they
are C, H, H. Since c~n
has a higheriatornic number compared'to hy~en,
C2HShas the
higher priority over CH3 The sequence should be Cl, C2Hs' CH3, H.
3.
When there is a double or triple bond, both atoms are considered to be dupli~ted
triplicated. Therefore;
H H
C = A equals
C =A equals
I
-CH = CH2
or
C-
C- C-C
C-A
FOrexample, in glyceraldehyde the OH group has the highest priority of all since has the highest
atmoic number among all.
~
C=O
where C
I
C-O
equals
H-C-OH
I
C
I
C~OH
Now, between CHO and CH20H; 0, 0, H of -CHO takes priority over 0, H, H of -CH20H.
The sequence should be OH,~,
CH20H, H
For example, in l-amino-2methyl-l-phenylpropane,

the C, C, C of phenyl takes priority
over the C, C, H of isopropyl, but not over N, which has a higher atomic number. The
sequence should be NH2, C6Hs' C3H7 and H
---
@- f -
CH (CH3)2
NH2
l-amino-z-methyl-I phenylpropane
D
eso compound: It is one whose molecules are superimposable on their mirror images
e '-::> ugh they contain chiral centers. It can be easily identified by the fact that one half
of olecule is the mi 0 .mage of the other half. Meso compound is optically inactive.
#
www.ptbalrm~l!X.lnn.com
.:.
------
46
Krisman

C~
CI
CI
CH3
~compound
E
SNI and SN2 Reaction Summary: SNI and SN2 reactions are characteristics
They play an important role in organic chemistry.
SN1 reactlO~ are c haractenze

. db
y:
1.
2.
3.
4. ~
First order kinetic

Rac
zation
Rearrangement
The reactivity sequence is
6.
Example:
The react" .
CH3
Tert-butyl
~ carbon)
H-W
H
Isopropyl
(2 carbon)
3 carbon
2 carbon
SN2 reactions are characterized by:
H-C-W
I
I
Ethyl
..,
= When
= When
4. ~
R OCOCF3
CH-C-W>CH-C-W>CH-C-W>
1.
2.
3.
---"7)
CH3
Nl),j)~b
-'
e of a compound:
CH3
;-,~.:;\
r t: -'
Methyl
(1 carbon)
central carbon is attached with three other carbons.

central carbon is attached with two other carbons.
Second order kinetic

Complete stereo6hemical inversion
IX
Absence of rearranzement
The reactivity sequence is CH3W >
--
Example:
R-Br
www.pharmacyexam.com.
+ Cl
-->~
R- CI
+ Br
47
Krisman

The reactivity sequence of a compound in SN2:

H
I
H-C-W
1.
Ethyl
(10 carbon)
Isopropyl
(2 carbon)
>CH-C-W
CH3
Tertbutyl
(3 carbon)
-Cis and Trans Isomers (Z and E configuration) : The particular~.!

diastereomers
that owe their existence to hindered rotation about double bond are called geometric
- ----isomers
...-. .
CH-C-W
CH3
>CH-C-W>
Methyl
CH3
----------------
?f The
an ement of atoms that characterize a particular stereoisomer is called its

- confi uration.
In Cis 2-Butene, methyl groups are on the same side of the molecule, whereas in Trans 2Butene, methyl groups are on opposite sides of a molecule.
Cis 2-Butene
Cis = same side
Trans 2-Butene
Trans = across
(Examples of cis and trans 2-Butene)

Z and E isomers: The specification of Z and E isomers can be explained as follows:
~
/J"o...
In order to specify, we need to find out the group of higher riority (higher\atomic number)
on the one carbon atom and the group of higher priority on the other carbon atom.
www.phmmacyexam.com
48
Krisman

CH3
CH3
~/
~/
.r
H
C
II
II
>:
Br
CI
CI
I-bromo-I chloropropene
/'"
Br
I-bromo-lchloropropene
CH3 > H
Br > Cl therefore
Gisomer
CH3 > H
CI < Br
therefore
E~somer
Effects of substituent groups: Sulfonation of toluene generally yields ortho and para
toluene sulfonic acid. Meta isomers of this compounds are very difficult to obtain. This can
be explained by the effects of substituents.
The substituent groups that offer ortho and para isomers of the parent compound are
called ortho-para directors.
Gi .~So(Ortho_para
*
*
*
*
*
*
*
Br
CI
OH
- OCo
-.-
~A~
directo!U->j
( ott,
C..,t"\1,
NHCocHg
CH~R
~3
:!iHCOC~
Sulfonation of Toluene:
~
CH3
S03H
CH3
)
S03H.
Toluene
(
*
Para Toluene
Sulfonic acid
@~jtl
~
Ortho Toluene
Sulfonic acid
This will explain why the sulfonation of toluene yields ortho and para isomers; since the
methyl group present in the ring is a ortho-para director.
49
Krisman

The substituent groups that offer meta isomers are know as meta-director.
:J
eta-directors
*
*
*
*
*
*
-S03H soH
-CN
-COOH
Cc. R
Co
Nitration of benzaldehyde:
CHO
CHO
Nitration
Benzaldehyde
>
~NO
M-Nitrobenzaldehyde
In the above example, nitration of benzaldehyde will yield meta nitro benzaldehyde because
the CHO group present in the ring is a meta director.
50

Manshrof Theory Part 1

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Reference Guide For The

Refereneeifsmde for the Foreign Pharmacy

..... " ...J

Referellce,e.nide for the Foreign Pharmacy

.--, '~d~-- <lH;~~~l~'.

Reference/GUide for the Foreign Pharmacy

Reference-Guide for the Foreign Pharmacy

Pharmaceutical Services Management &

:t( Pharmacy Law

Suspension and Emulsion

Reference Glide for the Foreign Pharmacy

. ' " '. . -'. Krisrnan

TABLE OF CONTENTS (Cont'~)

Accidental Poisoning and Antidotes

Reference Guide for the Foreign Pharmacy

PHARMACEUTICAL SERVICE MANAGEMENT-"

Reference Guide for the Foreign Pharmacy

PURE FOOD AND DRUG ACT OF 1906

FOOD, DRUG AND COSMETIC ACT OF 1938

DURHAM HUMPHREY AMENDMENT OF 1951

This law is also known as " Prescription DrugAmendment".

It suggests that ea~g

should be labeled" Caution: Federal law prohibits dispensing

It is also known as the ''Drug Efficacy Amendment".

This law indicates that n~w a

It also establishes Good Manufacturing

MEDICAL DEVICE AMENDMENT OF 1976

roved drugs must be ~afe as well as ~eciv_e.

'" This law passed in 1976, and ~s:

ORPHAN DRUG ACT OF 1983

This law was passed fO~' han druCgs

Reference Guide for the Foreign Pharmacy

DRUG PRICE COMPETITION

AND PATENT TERM RESTORATION

'This law is also known asWaxman HatchAmendment.

'This law was passed to make g~c

NATIONAL DRUG CODE NUMBER (NDCl---"

G_\ 18 ...,J, 1"

The NDC generally co~f

The st four characters indicate the aIll-eof the manufacturer or distributor.

ten to eleven letters: 4 -+

It~cl~des ingredients ?ene~y considered safe, effective and not

It is known as the mnibus Bud etReconciliationAct of 1990. Itr~es

THE FDA EMPLOYS A TWO LETTER CODING SYSTEM FOR THERAPEUTIC

0., ;\.. ~f.

Topical drugs that meet bi

Drugs meeting the n~sary

Drugs in extended release dosage fQ!!Ilwith bhoeguivalence issut?s.

Drugs ~at are available in conventional dos_a e forms and have no

Topical drugs with bi~uivalence

Subljpgt!aldosage form of nitro! 1 cerine

s:hoJ.c\ oe, o.t

Reference Guide for the Foreign Pharmacy

SCHEDULE II CONTROLLED DRUGS

to order this class of drug. a.v,,t;JI ~ ~ .

. Meth i henidate~ ~ 0..\\6 l'Ul.bf ~ + 6... ~

Reference Guide for the Foreign Pharmacy

Cannot be filled for the prescQI2!!..0nolder thtlfl ix months

Do not re.gmre any DEA 222 form to fill the order.

at, 61::; ---")

01<0.. '2o~.cL.NL ..",tt

5lp pke.n.obcvJo J,J, -'l W

Reference Guide for the Foreign Pharmacy

DISPENSING OF Cll DRUGS REQUIRES