PHARMACY PRACTICE

Hospital And Its Organization

 Hospital and its Organization

Definition of Hospital by WHO:

“The hospital is an integral part of social and medical organization.
Its function is to provide complete health care, both curative and
preventive for the population and whose outpatient services reach out to
the family and its home environment. The hospital is also centre for
training of health workers and for social research”
CLASSIFICATION OF HOSPITALS
I. Primary Hospitals
II. Secondary Hospitals
III. Tertiary Hospitals
 Primary Hospitals
➢Primary hospital is typically a hospital that contains less than 100 beds .
➢They are tasked with providing preventive care, minimal health care and
rehabilitation services.
➢They include general practitioners, physicians and physiotherapist.
➢The basic services provided by them are immunization, maternal and child
health services, curative care services and prevention of diseases are
provided by PHC.
➢The staff in PHC includes a medical officer, a staff nurse and paramedical
support staff.
 Secondary hospitals
➢Secondary hospitals are preferred with a medium size city, country or
district and contain more than 100 beds but less than 500.
➢They are responsible for providing complete health services and medical
education and also conduct research on regional basis.
➢These hospitals include cardiologists, urologists, dermatologists and other
such specialists.
➢The services are provided by medical specialists.
➢The services include acute care, short period stay in hospital emergency
department for brief but serious illness.
➢There may be providers who remain in contact but do not work in
hospitals such as psychiatrists, physiotherapists, respiratory therapists etc.
➢District hospitals and community health centres at the block level are the
examples of secondary hospitals
 Tertiary Hospitals
➢These are comprehensive or general hospitals of the city at national or provincial level
with the bed capacity exceeding 500.
➢They are responsible for providing specialist health services and play a vital role with
regard to medical education and scientific research and they also serve as a medical hub
providing care to multiple regions.
➢The Patients are admitted into these centres on a referral from primary or secondary
health professionals.
➢They offer personnel facility as well as facilities for advanced medical investigation
and treatment.
➢They provide advanced diagnostic support services, specialized intensive care and
special services such as neurosurgery, cancer management, cardiac surgery etc that
cannot be provided by primary and secondary health cent-res.
➢The examples of tertiary hospitals include medical colleges and advanced medical
research institutes.
CLASSIFICATION BASED ON CLINICAL AND NON CLINICAL BASIS

I. Clinical hospitals
This type of classification is based on the diagnosis and treatment of the disease. It
is further classified on the basis of specialty and length of stay.
1. Medicine- Medicine for general communicable diseases and specialized
medicines for psychiatric disorders ,tuberculosis, leprosy, asthma, cancer etc
2. Surgery- It is done for gynecologic, orthopedic and otolaryngologic patients.
3. Maternity — It deals with delivery cases.
4. Pediatric — They treat the diseases of children.
On the basis of length of stay they may provide
• short term stay i.e. less than 30 days ,
• long term stay i.e. more than 30 days in case of chronic disease and
• custodial stay i.e. meant for psychiatric and mentally retarded patients.
II. Non clinical hospitals
This type of classification is based on ownership of hospitals and is of
two types.
1. Public ownership: - They may be governed by —
a) Central government —These include railway hospitals and defense
hospitals, P.G Institute of Medical sciences at Pondicherry, lucknow
and Chandigarh, AllMS at New Delhi .
b) State government — Civil hospital at district head quarters
c) Local self government —These hospitals are under municipalities
like NDMC hospital in Delhi, AMC hospital in Ahmedabad
II. Private ownership :- They are run by following types of organization
a. Trusts-The board of trustees look into the affairs-Bombay hospital
(Mumbai),Jaslo Hospital (Mumbai).
b. Religious bodies:- Christian Medical College Hospital (Vellore
&Ludhiana),RamKrishan Mission Hospital (Calcutta).
c. Limited companies- They are under public limited companies,
where public subscribes to the shares eg . Apollo Hospital Ltd
(Chennai and Delhi),Mod Hospital (Delhi).
 ORGANISATION STRUCTURE OF A HOSPITAL

❖A hospital is mainly for the purpose of health care of the patients.

❖The most important division of a hospital is the functional department of
clinical services which needs supportive services like pharmacy and nursing
and administrative support of office.
❖The hospital should keep maintenance and safety.
❖The overall policies and control of the hospital is under the top management.
❖It is constituted by the governing body and the administrator.
❖The Chief Executive or Director of the hospital is the administrator.
❖The heads of all concerned department are responsible to the administrator.
❖A hospital is a multifaceted organization comprising many
committees, departments, types of personnel, and services.
❖It requires highly trained employees, efficient systems and controls,
necessary supplies, adequate equipment and facilities, and, of course,
physicians and patients.
❖It is a business as well as a caring, people-oriented institution and it
has a similar structure and hierarchy of authority as any large
business.
 A. Board of Trustees

✓The 'board of trustees," or governing board, operates the hospital in

trust for the community and has a fiduciary duty to protect the assets of
the hospital through efficient operation.
✓The trustees are responsible for establishing the hospital's mission and
establishing it by laws and strategic policies.
✓Trustees select the administrative leader of the hospital and delegate
the hospital's daily operations and budgeting to the appointed
executive.
 B. Executive Administration
➢The chief executive officer (CEO) reports to the governing board and
provides leadership in implementing the strategic goals and decisions set
by the Board.
➢The CEO also represents the hospital to the external environment and the
community.
➢ In these tasks, the CEO must coordinate the collective effort of the
hospital's personnel
 C. The Medical Staff
• The physician is the leader of the clinical team and the major agent working
on behalf of the patient.
• The physician's responsibility is to diagnose the patient's condition
accurately and to prescribe the best and most cost-effective treatment
plan.
• The medical staff is a formally organized self-governing unit within the
hospital, primarily comprised of physicians, but may also include other
doctoral level health care professionals such as dentists or psychologists
 D. Nursing Services

• Nursing services employees are responsible for carrying out the

treatment plan developed by the physician
• Nursing services, also called patient care services, is the largest
component of the hospital.
 E. Paramedical Department
They include laboratory.
i. Pathology department: The pathology department is one of largest
departments and has the responsibility for making tests and studies on
blood,sputum,feces,body fluids and tissues.
ii. Bacteriology department: concerned with studies about bacteria and their
toxins
iii. Biochemistry: chemistry of living organisms and of vital processes.
iv. Hematology laboratory: It is responsible for making hemoglobin
determinations, coagulation time studies, red and white cell counts and
special blood pathology studies for anemia and leukemia, etc
v. Parasitology laboratory: It studies the presence of parasites, the cyst and
ovasof the parasites that are found in the feces,
vi. Serology laboratory:lt does blood agglutination tests, Wassermann tests
 F. House Keeping Services
➢Good housekeeping reflects the image of hospital.
➢Head of house keeping department has good knowledge of quality of soaps,
detergents, cleaning agents, their use.
➢He also known to the principles of home economic and physical science.

Activity of house keeping department:

i. Cleaning of floor and wall with help of detergents and removal of dirt
wipes.
ii. Maintaining colors of doors, window and room.
iii. To change curtains of door and window.
iv. To prepare a room when a patient leaves room from hospital.
v. To perform linen services
 G. Clinical Support Services
➢The hospital pharmacy purchases and dispenses all the medications used to
treat patients in the hospital.
➢The pharmacist works directly with the medical staff in establishing a
formulary, the listing of drugs chosen to be included in the pharmacy.
H. Medical Record Keeping Service
The Purpose of medical record is:
i. It protects legal interest of hospital and patient.
ii. It provides data for research and education.
iii. It provides communication to another physician.
iv. It helps in administration and planning of the hospital.
v. It helps in treatment of patient in future.
 I. Administrative Support Services
➢Non-medical administrative services are necessary to the hospital's business
and physical plant management.
➢The CEO leads these administrative services and is directly responsible for
the day-to-day operations of the facility
➢Business services manages the hospital's admitting and discharge
functions, records charges to a patient's account, and handles accounts
receivables with third-party payers such as insurance companies.
➢The finance department advises the CEO on financial policy and long-range
planning.
➢Accounting is central to the hospital's financial business. Detailed and sound
accounting practices are fundamental to maintaining important
organizational statistics for administrative decision-making.
➢Admitting services is often where the patient first has contact with
the hospital.
➢The sensitivity and efficiency of this department can greatly influence
the patient's perception of the quality of care received.
➢The human resources department interacts with all departments in
the hospital to ensure the quality and motivation of personnel
working at the hospital.
➢Other important administrative and business functions may include
i. marketing and planning,
ii. public relations,
iii. plant and materials management,
iv. fund-raising, housekeeping, and
v. security.
HOSPITAL PHARMACY AND ITS
ORGANISATION
Definition
• The Hospital Pharmacy is a department in which competent and
legally qualified pharmacists procure/manufacture, store, compound,
check for quality, dispense, pack and distribute drugs to in-patients
and out-patients.
• It is a crucial department which caters the need of physicians, nurses,
technician and other staff members of Hospital.
 FUNCTIONS OF HOSPITAL PHARMACY
• Hospital Pharmacy Services offers both clinical service and operational
functions.
• Clinical service includes:
i. drug utilization
ii. providing patients with the proper medication and dosages at the right time at a
reasonable cost.
iii. Drug therapy selection and review screening for allergies,
iv. drug/drug interaction
v. food/drug interactions.
vi. A pharmacy and therapeutic committee controls drug therapy, drug information,
formulary service and antidote information
vii. Patient assistance programs are allowed in case of free medications for eligible
patients through major drug companies and various privately funded programs.
Operational Services include:
i. They include drug procurement, contracting and purchasing for special
drug orders; for example, chemotherapy drugs for cancer patients
ii. To provide drug packaging to decrease waste and ensure convenient
administration.
iii. To provide Unit-dosed drug distribution to prevent error.
iv. To provide a medication storage-ordering system to provide staff with 24-
hour accessibility to drugs for emergencies and first-dose medication.
v. To provide drug preparation that includes IV admixture and special
compounding.
vi. To plan, organize and direct policies and procedures in accordance with
established policies of the hospital.
vii. To assure Quality functions that include unit inspections for drug safety,
tracking of medication errors and adverse drug reactions
RESPONSIBILITIES AND FUNCTIONS OF HOSPITAL PHARMACIST
Hospital pharmacist is responsible for the following:
1. He should dispense drugs and medicines as per the prescriptions of the
hospital for out patients and inpatients.
2. Management of the stores which include:
a) He should purchase drugs and medicines and other allied stores as per the
recommendations of the pharmacy and therapeutics committee (PTC).
b) He should provide proper instructions for proper storage of such drugs and
medicines.
c) He should maintain proper records of the drugs purchased and the distribution
thereof.
d) He should keep control over the storage and dispensing of narcotic and biological
products.
e) He should maintain record of supply and storage of ancillary products and articles
required in the hospital.
3. He is responsible for manufacture and distribution of medicaments and
products such as transfusion fluids, tablets, capsules, ointments, stock mixtures
as per the hospitals formulary.
4.He is responsible for providing therapeutic drug monitoring services by
studying effects of various drugs administered to the inpatients.
5. Establishment and maintenance of drug information centre.
6. He should provide patient counseling service while supplying drugs especially
from the out-patient department.
7. He should maintain liasion with the medical staff, nursing staff and the
patients themselves.
8. He should maintain the nursing department and the central sterile supply
unit in the hospital.
9. He should participate in the teaching programmes of nursing and the
pharmacy students.
ORGANIZATION STRUCTURE OF A HOSPITAL PHARMACY
• The hospital pharmacy consists of various divisions like
i. compounding and dispensing
ii. manufacturing or production,
iii. quality control,
iv. central sterile supply,
v. research, education and training,
vi. administration and library.
❑The head of the pharmacy is the chief hospital pharmacist and is responsible
to the administrator.
❑The number of assistant Pharmacist in a hospital depends on the volume of
work, nature and scope of operations, staff strength and has to assist the
chief in matters relating to administration and overseeing and controlling the
various functions of the pharmacy.
❑The secretary and other office clerks assist the chief in all matters
 LOCATION AND LAYOUT
➢The location and layout of a hospital pharmacy varies greatly
between hospitals.
➢ Some are "centralized", with all of the pharmacy staff and
equipment located in a single area of the hospital and
➢others are "decentralized" meaning there is a main pharmacy in a
central location but there are also "mini-pharmacies", called
satellites, located throughout the hospital at key patient care units.
➢The layout of the pharmacy will depend on the size, needs, resources,
and focus of the hospital.
➢Hospital Pharmacy receives supply of materials either outside or
inside manufacturing unit.
➢Medicines are supplied to in-patient and out-patient according to
their need.
➢ The out-patient pharmacy should be well furnished to give suitable look.
➢ It should be provided with proper facilities for waiting patient.
➢ It should have educative or informative posters on health for reading to pass leisure time
of waiting.
 STAFF REQUIREMENTS
All members of pharmacy shall be competent, of good moral character and
mentally and physically fit to perform their duties acceptably
The list of personnel required in pharmacy is as follows:
i. Smaller hospitals required only one pharmacist who is usually sharing all
responsibilities of hospital pharmacy.
ii. In larger hospitals, more than one pharmacist is selected.
iii. Selection is on the basis of specialization in certain areas, may become
expert in one or more fields
iv. The no of pharmacy staff members are depends on
a. Number of beds in the hospital.
b. Scope of services In-patient and Out-patient.
c. Activities of Pharmacy, whether it is involved in manufacturing of drugs and
formulation.
v) The list of personnel required in hospital pharmacy as follows:
a) Director of Pharmacy

b) Associate Director QQualification- PG in Pharmacology with minimum experience

c) Two to three Assistant director

d) Chief Pharmacist- Graduate in Pharmacy

e) Assistant Chief Pharmacist- Diploma in Pharma RRegistered as Pharmacist in PCI

f) Staff Pharmacist- completing nursing courses.

g) Non Professional trained pharmacy helper

h) Clerical help
COMMUNITY
PHARMACY
ORGANIZATION AND STRUCTURE OF RETAIL AND
WHOLESALE DRUG STORE
❖The main factor responsible for the success of a drug store its location and
proper layout design.
❖The main objectives of layout design are:
i. It should attract a large number of customers.
ii. It should increase the sale of a store.
iii. It should reduce the selling expenses to a minimum.
iv. It should provide the customer satisfaction.
v. It should have space for reserve for stock, office and resting place for the employees.
vi. It should have a proper entrance for coming goods.
vii. It should project a professional image and improve general appearance.
viii. It should minimize the movement of customers within the premises of the drug store.
❖A modern drug store
should fulfill all the
requirements in
schedule 'N' of the drug
and cosmetic rules,
1945.
❖To start a retail drug
store a minimum of 150
sq. meter area is
required
❖similarly to whole sale
drug store a minimum of
200 sq. meter area is
required.
 TYPES OF DRUG STORE
The different types of drug store are
classified as:
1. Traditional Drug Stores:
✓ These types of drug stores are
designed in such a manner that the
entire area of Drug store is exposed
to customers.
✓These drug stores have pleasing and
professional appearance and is
convenient for both workers and
customers
✓they provide opportunity for
maximum sales
✓but there are good chances of theft
in such design.
2. Personal Service Drug Stores:
✓ The whole of the area is not exposed to
the customer but the customer is required
to interact with the drug store personnel at
the service counter.
✓During the purchasing process the
customer demands an article and the
personnel provide the articles.
✓This design offer maximum facilities and
interaction between drug store employee
and the customers.
✓The success of any of the drug store
depends upon the convenience and
friendly service of the personnel at the
service counter.
3. Prescription Oriented Drug Store:
✓They provide a comfortable waiting area where the customers are
expected to wait while his prescription is proceeding.
✓In this design health related items, drugs and prescription
accessories are displayed in the vicinity
✓while orthopedic and surgical appliances are kept in a separate
room.
✓Cosmetics and gifts are arranged in a suitable area in the store of this
type.
4. Pharmaceutical Centre:
✓These types of stores sell medicines, convenience articles, orthopedic
and surgical appliances.
✓The store has sufficient floor space and is artistically decorated.
5. Super Drug store:
✓Super drug stores have a huge floor area ranging from 5,000 to 10000
with a square design.
✓Their customers have access to all-most-all the area in the drug store
and can inspect, handle and select articles themselves.
✓The design is on self service pattern except for the prescription
department where self service is not possible.
The legal requirements for the establishment of retail drug store
For retail sale two types of licenses are issued.
1. General licenses
2. Restricted licenses
General licenses:
✓General licenses are granted to persons who have the premises for the
business and who engage the services of a qualified person to supervise
the sale of drug store.
✓Licenses for retail sale of drugs other than those specified in schedule
C,CI and X are issued in form 20
✓for drug specified in C, Cl in form 21 and
✓for schedule X drugs in form 20F.
Condition for general licenses:
i. The licenses should be displayed in prominent place in a part of premises
open to the public.
ii. The licenses should comply with the provisions of drugs and cosmetics act
and rules there under in force.
iii. Any change in the qualified staff should be reported to the licensing
authority within one month.
iv. Precaution prescribed by the licensing authority for the storage of
schedule C and Cl drugs should be observed.
v. For the sale of additional categories of drugs listed in schedule C, Cl
excluding X the licensee must take prior permission of the licensing
authority.
Restricted licenses:
✓The licenses for the restricted sale of drug other than those specified in
schedule C, Cl and X are issued in form 20A
✓and those specified in schedule C and Cl but not in schedule X are issued in
form 21A.
Condition for restricted licenses:

i. The licensee must have adequate premises equipped with facilities for the
proper storage of drugs to which the licenses applies provided
ii. Licensee should be complying with the provisions rules there under in force.
iii. Drugs only purchased from a duly licensed dealer or manufacturer.
iv. The licenses can deal only in such drug as can be sold without the
supervision Of qualified person.
v. Drugs should be sold in their original container
MAINTENANCE OF RECORD OF RETAIL AND WHOLESALE DRUG STORE

For various reasons it is very important to maintain various legal, financial and
professional records in a community pharmacy.
Type of records required in a community pharmacy may be classified as following:
(1) Legal records (registers):
➢According to federal and state law, the pharmacy owner (manager) is responsible for
maintenance of accurate up-to-date records of specific classes of drugs and poisons
according to Drugs and Cosmetic Act 1940.
➢Under Rules 1945 and The Poison Act 1919, the pharmacist is responsible for
maintaining accurate records related to acquisition and disposition of certain drugs
that are supposed to be subject to possible misuse or abuse.
➢According to law it is required to maintain a record on the distribution of poison and
hazardous substances.
➢Improperly maintained or incomplete records can bring legal action and penalties.
(2) Patients records:

➢To include patients drug histories those type of records are maintained.
➢The format of records may vary according to basic ideas of establishing a
record.
➢Records may be based on family unit basis that allows the pharmacist to
monitor the drug usage of each member of family.
➢These records also serve in economic purposes, as source of information for
insurance claims and for income tax deduction of the patients.
3. Financial records:
✓Properly collected and organized accounting data serves various important
uses as
i. Serves as a basic tool for efficient management and measuring its effect.
ii. For making sound decisions regarding future money needs, inventory
requirement, personnel matters and expansion of facilities.
iii. In - evaluation of past operations, controlling current operations and
providing information for planning and forecasting.
iv. Analyzing revenues and expenses & Measuring return on investment.
v. Providing the required information to potential granters credit and loans as
well as to federal, state, and local governmental agencies regarding income
and business taxes.
vi. Helping to ensure a profitable operation
 DISPENSING OF PROPRIETARY PRODUCTS
Patent or Proprietary medicine is defined as "'a drug which is a remedy or
prescription presented in a form ready for internal or external administration
of human beings or animals and which is not included in the current edition of
the Indian Pharmacopoeia or any other Pharmacopoeia authorized in this
behalf by the Central Government after consultation with the Drugs Technical
Advisory Board“.
➢Proprietary medicines are now a days available in ever increasing numbers.
➢Hence traditional compounding of medicines has lost its importance except in
hospital where physician may prescribe compounded prescriptions but to a
very limited extent.
➢This means that pharmacists should pay greater attention to dispensing of
proprietary medicines.
➢The number of proprietary medicines available in the market covers a very
wide range of therapeutic categories of drugs.
➢Generally proprietary medicines are having similar nomenclature that makes
the pharmacist's job much difficult.
➢Pharmacist should understand the wishes of the prescriber and must avoid
chances of confusion, error etc., while dispensing proprietary medicines and
must make use of computer programs and software in resolving such
problems.
The process of dispensing includes:
a)receiving a prescription
b) ascertaining the authority of the prescriber to prescribe.
c) obtaining any supplementary information to enable:
• the patient to be properly identified so the medicine is dispensed to the person for
whom it is intended,
• the medicine to be dispensed safely
d) determining the prescriber's intentions as to the patient's medicine,
including the dosing instructions
e) reviewing the medication history and other relevant patient information
f) entering the prescription details on the pharmacy computer and recording
any other aspect of the dispensing according to the requirements of the law
g) generating a label for the dispensed medicine and a repeat authorization
where required
h) selecting or preparing the product intended by the prescriber
i) clearly labelling the container of the medicine with the directions for its use as
intended by the prescriber along with any other information that facilitates its
proper, safe and effective use
j) using a barcode scanner (where packaging includes a barcode) to verify the
selection of the correct product for the patient
k) carefully checking and re-checking all dispensing for accuracy and
completeness
l) counseling the patient, or the patient's agent, sufficiently to allow a proper
understanding of all the information by the patient to use the medicine safely
m) ensuring that the entire dispensing process has been carried out according to
good pharmacy practice, and accepting that responsibility by placing his or her
initials or signature in the prescription records of the pharmacy and any other place
according to relevant legislation
ADVERSE DRUG
REACTIONS
 Definition
World health organization defines Adverse Drug Reaction as: "Any response to a
drug which is noxious, unintended and occurs at doses used in man for
prophylaxis, diagnosis or therapy. “

Adverse drug reactions are due to following reasons, accordingly they are
classified:
1.Excessive therapeutic effects
2. Secondary pharmacological effects
3. Idiosyncrasy
4. Allergic reactions
5.Genetic make up of the patients
6.Sudden drug withdrawal
7.Drug interactions
 Excessive pharmacological effects
i. It generally appears due to over dosage of a drug.
▪ This is particularly troublesome with cardioactive, hypotensive,
hypoglycemia and central nervous system depressive agents,
▪ For example, hypotensive agent used in hypertension , in excess dose
cause profound hypotension
ii. It may also appear at usual therapeutic dose in certain conditions.
▪ Hepatocellular dysfunction, as in several hepatitis or advanced cirrhosis, can reduce the
clearance of drugs like Phenytoin, Theophylline and Warfarin.
▪ A reduction in hepatic blood flow, as in heart failure, can reduce the hepatic clearance of
drugs for e.g. propranolol, morphine and pethidine.
▪ Reduced production of plasma proteins (for e.g. albumin) by the liver in cirrhosis can
lead to reduced protein binding of drugs.
▪ Age of patients like neonates, infants and elderly must know during administration of
drugs.
 Secondary pharmacological effects
➢Any effects which are associated with a drug besides the desired effects are
called as Secondary Pharmacological effects.
➢This are also called as Type-A (Predictable) adverse drug reaction which is
based on Pharmacological properties.
➢For example, antihistamines are prescribed for their antiallergic skin
reactions or for their antinausea effects, but they also produce drowsiness
due to central nervous system depression(secondary pharmacological effects).
➢ This action may be little importance for patients lying on bed but it may have
disastrous consequences if a patient is motor driver.
 Idiosyncrasy
➢The term Idiosyncrasy is used for unusual, unexpected drug effect
which cannot be readily explained or predicted.
➢It also includes drug induced foetal abnormalities such as phocomelia
developing in offspring of mother exposed to thalidomide.
➢Thalidomide develops as potential teratogenecity if given to mothers
during initial period of gestation when the limb buds are formed.
 Allergic Reactions
➢The term allergy is an adverse response to a foreign substance resulting
from previous exposure to that substance.
➢They are usually referred to as an over-reaction of the immune system and
these reactions may damaging, uncomfortable, or occasionally fatal.
➢Mechanism of allergic drug reaction can be explained on immunological
basis.
➢Drug or its metabolite combines with circulating plasma protein to form
antigen.
➢When an individual comes in contact with such antigen, antibody formation
takes place.
➢such individual when re-exposed to the same drug, antigen reacts with the
antibodies and liberates the mediators of allergic reaction from mast cell.
➢e.g. kinins, histamine, serotonins and prostaglandins.
 Genetically Determined Toxicity
➢In case of patients with special genotype or genetic make up , there is
increase in chance of drug toxicity.
Examples:
i. Individual with pseudocholinestrase deficiency is highly susceptible to
succinylcholine. They may develop paralysis and often apnoea.
ii. Many drugs are detoxified in liver by acetylation. The ability of acetylation
of many drugs in liver is variable in individuals, slow acetylators have greater
risk of toxicity for some drugs like isoniazide, procainamide, hydrallazine,
phenelzine and dapsone.
Hereditary Conditions Drug Causing Toxicity

Pseudocholinesterase deficiency Succinyl choline

Porphyria Barbiturates, Sulphonamides

Glaucoma Corticosteroids

Methaemoglobinemia Phenacetin, salicylates

 Toxicity following drug withdrawal
➢Tolerance occurs after prolong use of variety of drugs narcotic analgesics, hypnotics,
ethyl alcohol, some hypotensive agents (clonidine) and corticosteroid drugs.
➢Sudden withdrawal of such drugs shows severe adverse effects.
➢In patients habituated to central nervous depressants such as ethyl alcohol,
barbiturates and some benzodiazepines, withdrawal of the usual dose may produce
marked agitation, tachycardia, confusion, delirium and convulsions.
➢clonidine is used in hypertension but it sudden withdrawal may cause severe
hypertension.
➢Long term of corticosteroid therapy is less common because it may be cause atrophy
of recipient's adrenal glands.
➢Therefore, sudden withdrawal can precipitate an acute adrenal crisis ( Addison's
disease) in which the patients become profoundly weak, hypertensive and are
collapsed.
➢Such circumstances can be avoided by gradual removal of the corticosteroid over a
period of weeks depending upon the length of time they have been consumed.
 DRUG INTERACTIONS

✓Now-a-days many drugs are used in combination to get prompt relief.

✓Sometimes these may interact together and cause adverse reactions.
✓The identification of common reactions to a specific drug often requires 10 to
20 years of experience in therapeutic use.
✓Even then some problems may not be recognized as being drug related.
✓Drug interaction refers to modification of response to one drug by
another when they are administered simultaneously or in quick
succession.
✓The modification is mostly quantitative, i.e. the response is either
increased or decreased in intensity,
✓but sometimes it is qualitative, i.e. an abnormal or a different type of
response is produced.
✓The possibility of drug interaction arises whenever a patient
concurrently receives more than one drug, and the chances increase
with the number of drugs taken.
 Pharmacokinetic Drug Interaction
➢These interactions are those in which ADME properties of the Object drug
are altered by the precipitant and hence such interactions are also called as
ADME interactions“.
➢These are classified as:
1) Absorption Interactions
2) Distribution Interactions
3) Metabolism Interactions
4) Excretion Interactions
 Absorption Interactions
➢Absorption interactions are those where the absorption of the object drug
is altered.
➢The net effect of such an interaction is:
i. Faster or slower drug absorption.
ii. More or less complete drug absorption.
➢Major mechanisms of absorption interactions are
1. Complexation and adsorption.
2. Alteration in GI pH.
3. Alteration in gut motility.
4. Inhibition of GI enzymes.
5.Alteration of GI micro flora.
6.Malabsorption syndrome
 Distribution Interactions-
➢Primarily due to displacement of one drug from its binding sites on plasma
proteins by another drug.
➢Drugs highly bound to plasma proteins that have a relatively small voIume of
distribution like oral anticoagulants, sulfonylureas, certain NSAIDs and anti.
epileptics are particularly liable to displacement interactions
➢The drug which is in unbound form is active while portion which is in bound
form woks as temporary storage.
➢ When the drug is displaced by the other drug or chemical the unbound form
of the active drug becomes more leading to toxic level in the blood and
presenting as toxicity.
 Metabolism Interactions
➢ Metabolism interactions are those where the metabolism of the
object drug is altered.
➢Mechanisms of metabolism interactions include:
i. Enzyme Inhibition: It will decrease rate of metabolism. It is the most
significant interaction in comparison to other interactions and can be fatal.
ii. Enzyme Induction: It will increased rate of metabolism.
 Excretion Interactions :
➢Interactions involving excretions are important mostly in case of
drugs actively secreted by tubular transport mechanisms.
➢The alteration of urinary pH alters the process of reabsorption of the
drug leading to increase or decrease in excretion.

Eg: Alkalization of urine increases the excretion of barbiturates.

METHODS FOR DETECTING ADVERSE DRUG
EFFECTS
➢No drug is absolutely safe.
➢By the time, a drug is introduced in the market, most of
pharmacological effects are known.
➢Adverse effects resulting from excessive pharmacological activity are
well documented.
➢But unpredictable adverse effects are not identified, until it has been
subjected to much more widespread use.
➢So as to detect the unpredictable adverse drug reactions different
approaches are used
The various methods are given below
i. Cohort studies: This is used when groups of drugs receivers are studied to evaluate
outcomes after drug exposure.
✓ It is used when detection of events occur with frequency of more than 1 in 500 exposed.
✓It involves short term and long term clinical trials and post marketing surveillance of
established and new drugs
ii. Spontaneous case reports: It is common method of arousing suspicion about drug related
diseases.
✓A prescriber suspects that a condition arising in a patient may be drug related.
✓He therefore reports either in a letter to the medical journal or to the manufacturer of
drug.
✓By this means other prescribers are altered to the possibility of drug-disease relationship.
"Spontaneous Reporting Agencies" are set up to collect and collate such case reports.
✓Although the resulting information collected gives no idea of the frequency with which a
given event is caused by a drug, it indicates that a number of prescribers feel that the
event is possibly drug related
iii. Vital statistics and record linkage studies: The details of cause of
death (as recorded on death certificate) or of hospitalization (as
recorded on discharge letter) are routinely collected and analyzed. It
gives an early morning of epidemic of drug related disease, Record
related studies can be used to great effects in search for drug induced
disease.
iv. Case control studies: This used when patients with suspected drug
induced disease are compared With a reference population.
 STEPS INVOLVED IN ADR MONITORING
I. Identifying adverse drug reaction (ADR).
II. Assessing causality between drug and suspected reaction by using
various algorithms.
III. Documentation of ADR in patient’s medical records.
IV. Reporting serious ADRs to pharmacovigilance centers /ADR
regulating authorities
➢An ADR‐monitoring and reporting program should include the following features:
1. The program should establish
a) An ongoing and concurrent surveillance system based on the reporting of
suspected ADRs by pharmacists,physicians, nurses, or patients.
b) A prospective (before drug therapy)surveillance system for high‐risk drugs or
patients with a high risk for ADR.
c) A concurrent surveillance system for monitoring alerting orders , abrupt
discontinuation or decreases in dosage of a drug,
2. Prescribers, caregivers, and patients should be notified regarding
suspected ADRs.
3. Information regarding suspected ADRs should be reported to the
pharmacy for complete data collection.
4. High‐risk patients should be identified and monitored. High‐risk patients
include pediatric patients, geriatric patients,patients with organ failure
(e.g., hepatic or renal failure), and patients receiving multiple drugs.
5. Drugs likely to Drugs likely to cause ADRs (“high‐risk” drugs) should be
identified, and their use should be monitored. Examples of drugs that may be
considered as high risk include aminoglycosides, amphotericin, antineoplastics,
corticosteroids, digoxin, heparin, lidocaine, phenytoin, theophylline,
thrombolytic agents, and warfarin.
6. The cause(s) of each suspected ADR should be evaluated on the basis of the
patient’s medical and medication history, the circumstances of the adverse
event, and a literature review
7. A method for ranking ADRs by severity should be established.
8. A description of each suspected ADR and the outcomes from the event
should be documented in the patient’s medical record.
.9. Serious or unexpected ADRs should be reported to the Food and Drug
Administration (FDA) or the drug’s manufacturer (or both).
10. All ADR reports should be reviewed and evaluated by a designated
multidisciplinary committee (e.g., a pharmacy and therapeutics committee).
11. ADR ‐report information should be disseminated to health care
professional staff members for educational purposes. Good topics for medical
staff education include preventing ADRs and appropriate and effective care for
patients who experience ADRs.
12. Educational programs can be conducted as morning “report”discussions,
newsletters, “grand rounds” presentations, algorithms for treatment, and
multidisciplinary reviews of drug‐use evaluations. Patient confidentiality
should be preserved.
 Management
➢Rapid action is sometimes important because of the serious nature of a
suspected adverse drug reaction, for example anaphylactic shock.
➢Emergency treatment and withdrawal of all medicines is occasionally
essential, in which case cautious reintroduction of essential medicines should
be considered.
➢If several medicines could be causative, the non‐essential medicines should
be withdrawn first, preferably one at a time, depending on the severity of the
reaction. If the reaction is likely to be dose related, dose reduction should be
considered.
➢The patient should be observed during withdrawal. The waiting period will
vary, depending on the rate of elimination of the drug from the body and the
type of pathology.
➢If the patient cannot manage without a medicine that has caused an adverse
reaction, provide symptomatic relief while continuing the essential
treatment.
➢However, when treating an adverse drug reaction, it is important not to
introduce more medicines than are essential. Always have a clear
therapeutic objective in mind, do not treat for longer than is necessary.
➢The investigation and identification of an adverse drug reaction still depends
Largely on circumstantial evidence and the clinical skills of the attending
physician.
 REPORTING
Following are the main centers at the FDA that are involved with
evaluating the safety and efficacy of drug and efficacy of drugs.
I. The largest center is the center for drug evaluation and research
(CDER) which oversees both prescription and non prescription over
the counter (OTC) drugs.

In 2002, computerized data base designed to support FDA’S post

marketing safety program for drugs and therapeutics biological products.
II. The center for biological evaluation and research (CBER), ensures the
safety and efficacy of blood products, Vaccines, biological therapeutics,
Gene therapy, medical devices and tests, banked human tissue and
cellular products.

III. The center for food safety and applied nutrition(CFSAN) established
the CFSAN adverse events reporting system (CAERS) in 2002
✓The CAERS provides a monitoring system to identify potentially
serious problem secondary to non ‐FDA‐approved herbs, minerals,
vitamins, dietary supplements,and other substances.
IV. The National vaccine adverse event reporting system (VAERS) is co
administered by the FDA and the centers for disease control and
prevention (CDC).
Although vaccines protect many people from dangerous diseases they
do have the potential to cause adverse effects.
The VAERS depends on voluntary reporting by health professionals to :
a.identify rare adverse reaction not detected in pre‐ licensing studies
b.monitor for Increased in already known reactions
c.identify risk factors or pre existing conditions that promote reactions
d. identify particular vaccines lots with unusually high rates or unusual
type of events.