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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5739_Библиотеки_им_академика_М_И_Перельмана.pdf
Pharmacy Practice58
3. No prescription for a controlled substance in schedule II
may be refilled.
4. Controlled substances in schedule III or IV may not be
dispensed without a written or oral prescription in
conformity.
5. Such prescriptions may not be filled or refilled more than
6 months after the date thereof or be refilled more than
5 times after the date of the prescription unless renewed
by the practitioner.
6. No controlled substance in schedule V that is a drug may
be distributed or dispensed other than for a medical
purpose.
Prescriptions filled with controlled substances in schedule
II may be written in ink or indelible pencil and must be signed
by the practitioner issuing them. Prescriptions for narcotic
substances in schedules III, IV and V, must be kept in a separate
file. Registration of doctors who can prescribe: Doctors
(practitioners), in order to prescribe narcotics for or order
administered (dispensed) to their patients in the hospital, must
be licensed to practice under the laws of the State and must be
duly registered.
Schedules for Controlled SubstancesSchedules for Controlled Substances
Schedules for Controlled SubstancesSchedules for Controlled Substances
Schedules for Controlled Substances
1. Schedule I
a. The drug or other substance has a high potential for
abuse.
b. The drug or other substance has no currently accepted
medical use in treatment in the United States.
c. There is a lack of accepted safety for use of the drug or
other substance under medical supervision.
2. Schedule II
a. The drug or other substance has a high potential for
abuse.
b. The drug or other substance has recurrently accepted
medical use in treatment in the United States or a
currently accepted medical use with severe restrictions.
c. Abuse of the drug or other substances may lead to severe
psychological or physical dependence.
Drug Distribution System in Hospital 59
3. Schedule III
a. The drug or other substance has a potential for abuse less
than the drug or other substances in schedules I and II.
b. The drug or other substance has a currently accepted
medical use in treatment in the United States.
c. Abuse of the drug or other substances may lead to
moderate or low physical dependence or high psycho-
logical dependence.
4. Schedule IV
a. The drug or other substance has a low potential for abuse
relative to the drug or other substances in schedule III.
b. The drug or other substance has a currently accepted
medical use in treatment in the United States.
c. Abuse of the drug or other substances may lead to limited
physical dependence or psychological dependence
relative to the drugs or other substances in schedule III.
5. Schedule V
a. The drug or other substance has a low potential for abuse
relative to the drugs or other substances in schedule IV.
b. The drug or other substance has a currently accepted
medical use in treatment in the United States.
c. Abuse of the drug or other substances may lead to limited
physical dependence or psychological dependence
relative to the drugs or other substances in schedule IV.
ISOLISOL
ISOLISOL
ISOL
AA
AA
A
TED KEY POINTSTED KEY POINTS
TED KEY POINTSTED KEY POINTS
TED KEY POINTS
• One of the basic services provided by hospital pharmacy
department is drug distribution system fails into three
broad categories:
i. Ward-controlled system
ii. Pharmacy-controlled imprest-based system.
iii. Pharmacy-controlled patient issue system.
• In ward-controlled system the ward writes an order to
pharmacy for all drugs, it anticipates over a particular time
period for two or three days.
• The second category of pharmacy-controlled imprest-based
systems is commonly used. In such systems, a defined range
of drugs is available in each ward and is managed by
pharmacy staff.
Pharmacy Practice60
• The third category is the systems that are based on direct
patient issue. In these systems, the drugs are issued to the
patient rather than the ward can be classed as unit dose
systems. In the unit dose system is where each dose is
delivered by the pharmacy.
• Outpatient refers to patients not occupying beds in a
hospital or in clinics, health centers and other places where
outpatients usually go for health care. In short from the
outpatient department is known as OPD.
• Referred outpatient is referred directly to outpatient
department by his attending medical/dental practitioner
for specific treatment, other than an emergency treatment.
• Primary care is majority care. It describes a range of services
adequate for meeting the great majority of daily personal
health needs. This majority includes the need for prevention,
health maintenance and for evaluation and management of
various symptoms, problems and chronic aspects of disease.
• Ambulatory patient is able to walk and since outpatients,
receive primary health care and walk off, they are wrongly
called ambulatory patients. However, majority of the
outpatient are ambulatory.
• There are four systems for inpatient drug distribution
department:
i. Individual prescription order system
ii. Complete floor stock system
iii. Combinations of individual preseription order and floor
stock system
iv. Unit dose dispensing method.
• Individual prescription order system used in small and/or
private hospitals because of its economics consideration and
reduced manpower requirements.
• In “complete floor stock” system the nursing station
carries both “charge” and “non-charge” patient medication.
According to this system the drugs are stored at the nursing
station and are administered by a nurse according to the
chart order of the physician.
• Dispensing of charge floor stock drugs are those for which
the patient is charged for every single dose administered
to him.
Drug Distribution System in Hospital 61
• Dispensing of non-charge floor stock drugs are the
medicaments that are placed at the nursing station for the
use of all patients on the floor.
• Combinations of individual drug order and floor stock
system are used in those hospitals where patients pay for
their hospitalization and the hospitals use the individual
prescription order system as their primary means of
dispensing but have several drugs in the floor stock.
• In unit dose dispensing the multiples of single dose admini-
stration of medication are prepared by the pharmacists who
are ready for administration to a particular patient.
• An equitable price for drugs should be charged to all
categories of patients and it should be kept in mind to
protect the hospital financial interests.
• Charging policies can be categorized under several systems
like:
i. A per diem drug charge or all inclusive or no special rate
ii. A part-inclusive rate
iii. The professional fee concept
iv. Break-even point pricing
v. A cost-plus rate system
• A drug label refers to all the pieces of printed information
included with any dietary supplement, over-the-counter
medicine, or prescription drug.
• Label means a display of written, printed or graphic matter
upon immediate container or the wrapper of a drug package.
• The label contains:
i. The name of preparation
ii. Strength and dosage form
iii. Dosage form
iv. Quantity
v. Instructions for the use
vi. Precautions and warnings
vii. Registration number
viii. Batch number
ix. Manufacturing and expiry date
x. Price
xi. Name and address of manufacturer
Pharmacy Practice62
• Ambulatory refers to patients not occupying beds in
hospitals or other in patient settings, and to care given in
physicians’ offices, clinics, health centers.
• Ambulatory patient load into three categories—emergency,
referral or tertiary care and primary care.
• Controlled drugs are drug or other substance that is tightly
controlled by the government because it may be abused or
cause addiction, e.g. opioids, stimulants, depressants,
hallucinogens, and anabolic steroids.
PRAPRA
PRAPRA
PRA
CTICE QUESTIONSCTICE QUESTIONS
CTICE QUESTIONSCTICE QUESTIONS
CTICE QUESTIONS
VV
VV
V
erer
erer
er
y Shory Shor
y Shory Shor
y Shor
t Answer Tt Answer T
t Answer Tt Answer T
t Answer T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. What do you understand by drug basket system?
2. What do you mean by term “Inpatient”?
3. What are the advantages of unit dose dispensing system?
4. Enlist types of free floor stock system.
5. Define ambulatory patient.
ShorShor
ShorShor
Shor
t Answer Tt Answer T
t Answer Tt Answer T
t Answer T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. Write in detail about any two drug dispensing systems with
its advantages and disadvantages.
2. Discuss about drug dispensing system in ambulatory
patients.
3. Explain in detail the dispensing of controlled drugs.
4. Write a note on charge floor stock drug system.
5. What are the advantages and disadvantages of individual
prescription order system?
6. Write the advantages of unit dose dispensing system.
7. Explain distribution of narcotic substances.
LL
LL
L
ong Answer Tong Answer T
ong Answer Tong Answer T
ong Answer T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. Explain in detail about drug distribution methods for
inpatients.
2. Write a note on individual prescription order and floor stock
system.
3. Describe dispensing of drugs to ambulatory patients.
4. Discuss in detail about schedule for controlled substances.
Drug Distribution System in Hospital 63
Objective TObjective T
Objective TObjective T
Objective T
ype Questionsype Questions
ype Questionsype Questions
ype Questions
1. Floor stock drugs are classified into:
A. 2 parts B. 3 parts
C. 5 parts D. 6 parts
2. CUDD and DUDD stands for__________ and ___________
respectively.
3. Drug labeling and packaging rules were introduced in:
A. 1986 B. 1990
C. 1981 D. 1992
4. A _______ means a display of written, printed or graphic
matter upon immediate container or the wrapper of a drug
package.
5. Schedule for controlled substances do not include:
A. Schedule VI B. Schedule III
C. Schedule I D. Schedule II
AnswersAnswers
AnswersAnswers
Answers
1. A 2. Centralised unit dose drug distribution and decentra-
lized unit dose drug distribution
3. A 4. Label 5. A
DEFINITIONDEFINITION
DEFINITIONDEFINITION
DEFINITION
Hospital formulary is defined as a list of drugs used in the
hospital. The hospital formulary should be revised continuously
and it reflects the current clinical judgment of the medical staff.
The formulary provides for obtaining, prescribing, dispensing
and administering both the branded and generic drugs.
“Hospital Formulary is a continually revised compilation of
pharmaceuticals including important ancillary information that
reflects the current clinical judgment of the medical staff”.
The hospital formulary system is a method whereby the
medical staff of a hospital with the help of pharmacy and
therapeutic committee selects and evaluate medical agents and
their dosage form which are considered to be most useful in
the patient care. The hospital formulary system provides the
information for procuring, prescribing, dispensing and
administration of drugs under brand/generic names.
The first hospital formulary in India was published in 1968
by the Department of Pharmacy, CMC, Vellore. The first
hospital formulary for the development of government hospital
teachings was published in 1997 at Government Medical
College, Trivandrum.
The need for hospital formulary
• The increasing number of new drugs manufactured and
marketed by drug companies.
• Increasing complexity of untoward effects of modern potent
drugs.
Hospital Formulary
6
Hospital Formulary 65
• Newer sales promotion strategies of pharmaceutical
industry.
• The public interest in getting possible health care at lowest
possible cost.
Advantages of hospital formulary
• It provides the practitioner with approved and efficacious
medicines to treat disease.
• Hospital formulary reduces the inventory cost of the drugs.
It regulates the number of medicines by improving the
procurement and inventory management.
• It improves the quality assurance and easier dispensing.
• It gives stress on medicine information and focused on
patient’s education efforts.
• It removes the irrational combinations of drugs and also
improves adverse drug reaction management.
Disadvantages of hospital formulary
• The hospital formulary system deprives the physician of the
right and prerogative to prescribing and obtained the brand
of his choice.
• The system may sometimes permit the pharmacist to act as
the sole judge to which the brands of the drugs to be
purchased and dispensed.
FORMULFORMUL
FORMULFORMUL
FORMUL
ARAR
ARAR
AR
Y CONTENTSY CONTENTS
Y CONTENTSY CONTENTS
Y CONTENTS
The formulary should consist of three main parts:
1. Information on hospital policies and procedures con-
cerning drugs.
2. Drug products listing
3. Special information
1. Information on hospital policies and procedures con-
cerning drugs
a. Categories of drugs, e.g. formulary drugs, non formulary
drugs, etc.
b. Brief description of the PTC including its membership,
responsibilities and operation.
c. Hospital regulations about prescribing, dispensing and
administration of drugs including writing of drug orders,
Pharmacy Practice66
verbal drug orders, automatic stop orders, self adminis-
tration of drugs by patients.
d. Pharmacy operating procedures such as prescription
labeling, handling of drug information request and
outpatient prescription policies.
e. Information on using the formulary: It includes how
formulary entries are arranged and the information
contained in each entry.
2. Drug products listing
a. Formulary item entries:
i. Alphabetically by generic name
ii. Alphabetically within therapeutic class
b. Type of information
i. Generic name of the product
ii. Dosage form, strength, packaging
iii. Active ingredients
iv. Adult/pediatric dose
v. Route of administration, cost, etc.
c. Indexes to the drug products listing:
i. Generic name/brand name
ii. Therapeutic/pharmacological index
3. Special information
a. Hospital approved abbreviations
b. Rules for calculating pediatric dosages
c. List of sugar free drugs
d. Metric conversion tables
e. Poison control information
f. Table of drug interactions
PREPPREP
PREPPREP
PREP
ARAARA
ARAARA
ARA
TION OF HOSPITTION OF HOSPIT
TION OF HOSPITTION OF HOSPIT
TION OF HOSPIT
AL FORMULAL FORMUL
AL FORMULAL FORMUL
AL FORMUL
ARAR
ARAR
AR
YY
YY
Y
Preparation of a hospital formulary is a principal responsibility
of the pharmacy and therapeutic committee. However, it is also
rests primarily on the chief pharmacist service, etc. The
committee is free to make necessary decisions, regarding the
material to be included in the formulary and pharmacist
undertaken the production of the formulary that is compiling
and printing, etc.
Hospital Formulary 67
The physical appearance and structure of the formulary is
important influence on its use. The formulary should be
visually pleasing, easily readable and should appear pro-
fessional. A typical formulary must have the following
composition:
• Introduction
i. List of abbreviations
ii. List of drugs used in the formulary
• Basic information on each drug
i. Efficacy for the treatment of specific conditions
ii. Safety profile of the item
iii. Interaction profile
iv. Adverse effects
v. Pharmacokinetic profile
vi. Availability of the item
vii. Available dosage form
viii. Cost
ix. Acceptability to patients
• Supplementary information on each drug
i. Storage guidelines
ii. Patient counselling information
iii. Labelling information
iv. Brand names and prices
• Prescribing and dispensing guidelines
i. Principles of prescription writing
ii. Reporting of ADR
iii. Prevention of ADR
• General drug use and advice
i. Use of IV drugs
ii. Special situations like pregnancy, breastfeeding, liver/
kidney diseases
iii. Poisoning information and antidotes
iv. Treatment of snakebites and insect bites
• Miscellaneous section
i. Children’s dose
ii. Renal adjustments
iii. Metric units
iv. Diagnostic aids