UNIT-I

Contents
Hospital and its organization
Hospital pharmacy department and its organization
Adverse Drug Reaction
Community Pharmacy
 Hospital and its Organization
A Hospital is a health care unit consisting of medical, nursing staff and medical equipment
that provides treatment to patients in all aspects. All the peoples are well known about a
general hospital which provides primary treatment as well as an emergency treatment to
patients.
District hospitals have major facilities such as Intensive Care Unit (ICU), traumacentre,
rehabilitation hospitals, and children hospitals.
A hospital can be defined as a complex organization or an institution which offers health
and wellbeing of the people through diagnosis, treatment, prevention, rehabilitation, and
cure by a team of qualified staff and provides the facilities for education and research.
The qualified and trained staff includes physician, staff nurse, dieticians,
pharmacists,pathologists, radiologist, and anaesthetist, in a hospital.
Thus, the hospital is an institution which is scientifically, systematically and economically
organized for prevention, diagnosis, and therapy of diseases.
Health Care- Primary, Secondary and Tertiary

The prevention, diagnosis, and treatment of disease, injury, illness or physical and mental
impairment are collectively associated with human health.

The medical practitioners, nurses, psychologists, dentists, midwives, pharmacists are

professional healthcare provider.

They provide healthcare services such as preventive, curative and rehabilitative care. There
are three levels of care are primary care, secondary care, and tertiary care.

Primary Health Care (PHC)

These are the basic and first level of contact between individuals and families replace with in
the health system. The general and registered medical practitioners, the family physician,the
physiotherapist are the usual primary health care providers.
Various services are provided by Primary Health Care (PHC) such as immunization, basic curative care
services, maternal and child health services, prevention of common diseases or injuries. In addition,
health education, family planning, sufficient provision of food and nutrition and safe drinking water
are supplied.

In India, primary healthcare is provided through a network of Sub-centers and Primary Health
Centers in rural areas, whereas the family welfare centers provide such services in urban areas.

The healthcare service provider staff, in PHC, includes a medical officer, a staff nurse,the pharmacist,
and other supporting staff from paramedical background offer a service to every 30000 populations
in the plain area and 20,000 persons in tribal, hilly, and backward areas. Each PHCs has to supervise 6
Sub-centers.

The Sub-center made up of one Auxiliary Nurse Midwife and Multipurpose Health Worker that
provides a service to a population of 5000 in plain and 3000 persons in hilly and tribal areas.
Secondary Health Care (SHC)
In which patients from Primary Health Care are referred to specialists in higher hospitals for
treatment. Depending on the policies laid down by the National Health System, patients may
access these services through physician referral or self-referral. Cardiologists, urologists,
dermatologists, and other such specialists are referred to as

The secondary health care services such as acute care; short time-period stay for short but
serious illness in an emergency department of a hospital.

Some secondary care providers do not work in hospitals that are psychiatrists,

physiotherapists, respiratory therapists, speech therapists and so on. In India, the District
Hospitals and Community Health Centers are the best examples of Secondary Health Centers
in the public health system.
Tertiary Health Care (THC)
A third level service of the health system is referred as Tertiary Health Care. In this health
system, specialized consultative care is provided to the patient who is admitted into these
centers on referral from primary and secondary medical care. Tertiary Health Care Services
provide cancer management, cardiac surgery,

neurosurgery, and a host of complex medical, surgical interventions, and other major medical
complexities. Specialized Intensive Care Units (ICU), advanced various diagnostic support
services, and trained medical personnel are the key features of tertiary health care. Under
the public system in india, tertiary.

The comparison of primary, secondary and tertiary healthcare is given in the following table.
Classification of Hospitals
The hospitals are classified on the following basis
A) Clinically oriented B) Ownership and administrative control C) System on medicine
A) Clinically Oriented
The word Clinical denotes the diagnosis and treatment of a disease in a patient. Different
types of diseases require different modes and means of treatment with the right medication
at right time.
Broadly the hospitals are of different types on the basis of clinical oriented.
A. Based on Type of People
i. Maternity Hospital: These hospital concerns with specialization in caring for women
during pregnancy and childbirth. The gynecological services i.e. related to the female
reproductive system along with antenatal (during pregnancy) and neonatal (newborn
child) care.
ii. Paediatric Hospital: These hospital includes special medical care of infants, children,
adolescents up to the age of 18 years.
iii. General Hospital: It is a non-specialized hospital treating patients suffering from all
types of medical conditions.
B. Based on Anatomy / Physiology
i. ENT Hospitals: These hospitals concern with the diagnosis and treatment of disorders
including ears, nose, and throat. ENT doctors are also called Otolaryngologists.
ii. Eye Hospitals: These hospitals concern with the study and treatment of disorders, diseases
of the eye and surgery of the eye. A doctor of medicine specialized in diagnosis, treatment, and
services provider of eye and vision are called as Ophthalmologist.
iii. Kidney Hospitals: These hospitals concern with kidney transplantation and dialysis
services. The doctor specialized in this field is known as Nephrologist.
iv. Dental Hospitals: These hospitals particularly involve in the study, diagnosis, prevention,
treatment of diseases, and disorders of the oral cavity and teeth. The dental specialist provides
dental treatment and surgery of surrounding oral tissues is known as Dentist.
v. Heart Hospitals: These hospitals includes treatments related to the heart and lungs. Mostly
major surgery of the heart and lungs are done in these hospitals.
vi. Orthopedic Hospitals: These hospitals include surgery of fractured bones, deformities,
disorders of bones, spine diseases, and congenital disorders.
vii. Neurological Hospitals: These type of hospitals generally includes surgery of neurons
(Neurosurgery). These involves treatment, prevention diagnosis of the nervous system
C. Based on Diseases
• Tuberculosis hospitals
• Leprosy hospitals
• Cancer hospitals
• Mental hospitals
• Diabetes hospitals
• Rehabilitation based on anatomy/physiology
B) Ownership and Administrative Control basis of Classification
According to ownership and administrative control, the hospitals are classified as
a. State Government Controlled
a) i) General hospital ii) ESI (employee state insurance) hospital
b) i) Stanley hospital –Chennai ii) Osmania hospital –Hyderabad
c) i) Victoria hospital –Bengaluru
b. Private trusts Controlled
a) Ramachandra hospital –Chennai
b) KMC hospitals-Udupi and Mangaluru
c) Bombay hospitals –Mumbai
c. Municipality Corporation Panchayat Controlled
a) BMC hospital –Mumbai
b) KEM hospital –Mumbai
c) Chennai corporation hospital
d. Non-Government Controlled Religion Bodies Controlled
a) Hindu mission hospital –Chennai
b) Ramakrishna mission hospital –Chennai and Kolkata
c) Meenakshi mission hospital –Madurai
d) Christian medical college hospital –Vellore
e. Public Limited Controlled
a) Apollo hospital –Chennai
b) Wockhardt hospital-Bengaluru, Nagpur
c) Vijaya hospital- Chennai
f. Miscellaneous Basis of Classification
a. Based on Bed Numbers
i. Large hospitals–More than 1,000 beds
ii. Medium hospitals–500 to 1,000 beds
iii. Small hospitals–100 to 500 beds
iv. Very small hospitals–Less than 100 beds
b. Based on Costs
i. High cost or elite hospitals
ii. Low cost/budget hospitals
iii. Free hospitals
c. Miscellaneous Hospitals
Training hospitals (hospitals attached to medical and dental colleges)
Based on the System of Medicine Hospital
1. Ayurvedic System of Medicine
Ayurveda is a system of medicine that has a historical background in India. Current and
modernized practices initiated from the Ayurveda system of medicine which is traditional
complementary and alternative medicine globally.
2. Unani System of Medicine
The Unani system of medicine was introduced in India first time by the Arabs and Persians
around 11 th century. The effective and safe medicine alternative for other systemholds a
long and impressive record in India.
3. Naturopathy System of Medicine
Another alternative system of medicine in India is Naturopathy or Naturopathic medicine that
employs an array of pseudoscientific practices (beliefs and practices which are claimed to be
factual and scientific but are incompatible with scientific facts and technique) branded as
"natural", "non-invasive", and as promoting "self-healing". Naturopathy as the name indicates
the natural healing or self-healing.
4. Homeopathy

Homeopathy is a system of alternative medicine developed in 1796 by Samuel Hahnemann. He

developed this system of medicine for the cure of various critical diseases and health care of the
patient. The system of medicine is based on the principle of cure, a claim that a substance that
causes the symptoms of a disease in healthy people would cure similar symptoms in ill people.

5. Allopathic System of Medicine

The Allopathy system of medicine is a commonly used system in the recent era for immediate
effect and cure of disease. Recent medical system which treats the symptoms and disease of
patients under treatment using drugs, radiations, and surgery. In 1842, C.F.S. Hahnemann was
the person who coined the term "Allopathy" to designate the usual practice of medicine
(Allopathy).
Functions of a Modern Hospital
1. To provide the means and methods by which medical staff can work together in groups with the
purpose of community and patient’s health care.
2. To reduce the incidences of disease through early detection and treatment.
3. To estimate the need for facilities, supplies, and equipment utilized in hospitals and evaluate to control
and maintenance of the hospital.
4. To provide a common link between the general public and policymakers.
5. To estimate the requirements for various departments and to recommend various policies to maintain
adequate and competent staff.
6. To stimulate the growth of medical sciences in which doctors and nurses receive their education and
training in large (teaching) hospitals.
7. To develop and maintain an effective system of retrieval of clinical administrative records and reports.
8. To increase the quality and standards of medical practice.
9. To provide facilities to continue the education of all the medical professionals.
10. To participate in various safety programmes of the hospitals.
11. To initiate, utilize and participate in research projects design for improvement of
patient care and other hospital services.
12. To participate in the financial planning for the working of the hospital.
Organization Structure and Administration of a Hospital
Hospital Pyramid: An Organizational Structure
Understanding the organizational structure of a hospital is important because it provides an
idea about the responsibility of every person for each area of the hospital.
• Hospital pharmacy is one of the most important department among several
departments of a hospital.
• Hospital pharmacy may be defined as that department of the hospital
which deals with procurement, storage, compounding, dispensing,
manufacturing, testing, packaging and distribution of drugs.
• It is also concerned with education and research in pharmaceutical services. A
hospital pharmacy is controlled by a professionally competent and a qualified
pharmacist.
Pharmaceutical services in a hospital comprises of the service rendered to the patient through
a number of activities
like
• Dispensing of drug
• Manufacture & distribution of medicament and products.
• Patient counseling service .
• Establishment and maintenance of Drug Information centre.
• Providing the therapeutic drug monitoring services.
• Maintaining liaison with medical staff, nursing staff and the patients themselves.
• Participate in teaching programme of nursing & pharmacy students.
• To maintain the nursing department & the central sterile supply unit in the hospital
• Maintenance of proper records of the drugs purchased & there distribution
Functions
• To provide & evaluate pharmaceutical services & thereby supporting the medical staff, with
due consideration of
the objectives & policies of the hospital .
• To estimate the requirements for the department and enforce the policies procedures for
the recruitment of time
adequate & Competent staff.
• To provide & Evaluate pharmaceutical services .
• To develop & maintain an effective system of clinical & administrative records & Reports.
• Draw a plan to for hospital pharmacy administration.
• To raise the quality of law & general standards of medical practices .
• It lowers the incidences of disease through early detection and treatment .
• To participate in the Financial plan for the operation of hospital .
• To participate in & put into practice, the safety programme of the hospital
• It keeps a record of each supply dispensed.
• It inspects the received items & maintains an inventory for the same.
• To maintain a satisfactory system of records & book-keeping for the above products.
• To do in house production of drugs, the buying of which from outside source is not prudent.
• To furnish information concerning medications to physicians, interns & nurses providing
specifications for the purchase of drugs, chemicals, biological etc.,
• Proper storage of drugs .
• Dispensing & sterilizing parental preparations which are manufactured hospital
Objective of hospital pharmacy

• To ensure the availability of right medication, at right time, in the right dose at the
minimum possible cost.
• To professionalize the functioning of pharmaceutical services in a hospital.
• To act as a counseling department for medical staff, nurses and for patient.
• To act as a data bank on drug utilization.
• To participate in research projects.
• To implement decisions of the pharmacy and therapeutics committee.
• To co-ordinate and co-operate with other departments of a hospital.
• To plan, organize and implement pharmacy policy procedures in keeping with
established policies of the hospitals.
Location and layout

• The hospital pharmacy should be located in hospital premises so that patients

and staff can easily approach it. In multi-storeyed building of a hospital, the
pharmacy should be preferably located on ground floor especially the
dispensing unit. It should be laid in such a way that there is a continuous flow
of men and materials.
• OP pharmacy should give a pleasant appearance and must have enough space
for seating of patients who have to wait for medicines. OPD’s waiting room
should give a professional look. It should have educative posters on health and
hygiene and light literature for reading.
• Space must be provided for routine manufacturing of stock solution, bulk
powders, ointments etc. The manufacturing room should be adjacent to the
pharmacy
• Medical stores of a pharmacy should be adjacent to the pharmacy itself or should be directly
concerned with pharmacy.
• Pharmacy receives materials from two sources:
1. Medical stores
2. Manufacturing division of the hospital.
• Pharmacy issues materials to in-patients and out-patients. The in-patients are served by
nursing stations who receive their materials from the pharmacy.
• The location & layout of a hospital pharmacy varies greatly between hospitals some are
centralized, with all of the pharmacy staff & equipment located in a single area of the
hospital and 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.
Facilities required in hospital pharmacy
• In smaller hospitals, with one pharmacist only, one room is required for pharmacy, having a
combination of dispensing, manufacturing, administrative and all other sections of complete
pharmaceutical service. For sterile products there should be a separate room or area.
• In large hospitals, with 200 or more beds, departmentalization of pharmacy activities is
required. A separate area is required for :-
Inpatient services and unit dose dispensing
Outpatient service
An office for the chief pharmacist
A compounding room
A store room
prepackaging &labelling room
sterile products room
A separate area for drug information services and space assigned on various nursing units for
unit dose drug administration.
 Floor space requirements

• 250 sq. feet is the minimum required area for any sized hospital. 10 sq. feet per bed in
100 bedded hospital. Floors of pharmacy should be smooth, easily washable and acid
resistant.

• In manufacturing sections, drains should be provided, walls should be smooth, painted

in light color. Wooden cabinets are laminated. Fluorescent lamps are placed above
prescription counter. Counter for Bunsen burner are also required.
• Equipments required in hospital pharmacy includes:
 Prescription case
 Drug stock cabinets with proper shelves and drawers.
 Sectional drawer cabinets with cupboards bases.
 Work tables and counters for routine dispensing.
 Sink with drain board.
 Cabinet to store mortar and pestles.
 Cabinet for glass utensils, flasks, funnels and beakers.
 Refrigerator of suitable capacity.
 Narcotics safe with individually locked drawers.
 Office desk with telephone connection and file cabinet.
 Dispensing window for nurses and outpatients.
 Personal requirements in hospital pharmacy
• No standard rules regarding the requirement of personnel for inpatient
pharmacy.
• Number of pharmacists required for a hospital are calculated on the basis of
workload, number of prescriptions received and dispensed and the number of
bed available. For a small hospital minimum 3 pharmacist are required. As the
number of bed increases, the number of pharmacist also increases.
• Pharmacist should possess adequate pharmacy qualification and experience. The
overall charge of the in-patient department should remain with the chief
pharmacist.
• If manufacturing of drugs is involved in pharmacy, adequate number of
technicians, assistants, peons etc. required.
REQUIREMENTS
ABILITIES REQUIRED FOR HOSPITAL PHARMACIST
• Technical Ability
• Ability to Develop a manufacturing section.
• Administrative Ability .
• Ability to control Inventory
• Ability to conduct & participate in Researches
• Ability to conduct Teaching programme
• Technical Ability: He should have thorough knowledge of basic sciences pharmacology,
toxicology, route of administration, stability etc:
• A hospital pharmacist must provide information regarding proper handling of drugs. As
hospital pharmacist is a part of medical team, he must gain confidence amongst his medical
colleagues through his technical competence, eg, by providing comparative evaluation of
various data on drug actions, dosage, toxicity and relative cost.
Ability to Develop a Manufacturing Section : Manufacturing within a hospital requires control over
supply, quality, equipment, and raw material cost.

Hospital pharmacist has to organise manufacturing function by doing proper cost-benefit analysis.
Although quality maintenance is essential because considerable quantities of drugs are required for
treatment of patients (out-door as well as in door).

Administrative Ability: Hospital pharmacist should be able to plan, organise and control various
functions of hospital pharmacy. He should prepare work schedule for his staff. He should frame various
policies and procedures to get the work done.

He should interact with his staff daily. Hospital pharmacist must maintain the legal and administrative
records properly. Where patients are charged for drugs the hospital pharmacist must develop charging
policies.

Chief pharmacist is usually responsible for interviewing, selecting and evaluating the staff members for
• Ability to Control Inventory: Chief pharmacist has to exercise his duties which are lying at
nursing stations, supply rooms etc. He has to communicate with supplier of drugs. He must
check the quality of drugs and other supplies.
• Ability to Conduct and Participate in Researches: The pharmacist is required to maintain
information of pharmaceutical journals. He must advise about new methods, preservation,
preparation and to improve efficacy of preparation. He must have the basic understanding
methods so that he can properly evaluate the research datas.
• Ability to Conduct Teaching Programmes: The pharmacy staff can act as trainers for the
nursing staff must prepare suitable teaching material for the nursing staff like proper storage
of drugs, proper use of drugs etc. Chief pharmacist is also responsible for the practical
training of pharmacy students. He should see that they must learn and have sufficient
professional skill.
Material management of a hospital
• Management is a process involving planning, organising, staffing and controlling any organisation.
• Hospital is a very complex organisation. So emphasis should be given on management of materials
in a hospital pharmacy. Financial management, human resource management and computer
application are the other aspects.
• Material management is a scientific technique, concerned with Planning, Organizing & Control
of flow of materials, from their initial purchase to destination.
Aim of material management

Right material,

in right quantities,

at right time,

at right price,

from right sources,

at a least cost.
Objective of material management
• To develop a system of supplies where by there will be an adequate stock of items required
but at the same time, it shouldn't be too much in quantity to avoid wastage. It should be
stored in a manner that, an item can be easily traceable or obtainable and distributed
according to the use.
• To ensure that the resources available are used most effectively and drugs for the stores
should be purchased at most economical price.
Procedure
To achieve these objectives, following procedures can be used,
1. To determine categories of stock required, estimate the quantity and quality of each item.
2. To procure the items of good quality from various sources at most economical prices.
3. To receive the items according to the quantity and quality specified and payments made
regularly.
4. Received items are stored properly so as to prevent deterioration during storage.
5. To develop a good control on inventory.
6. To develop a proper distribution system of drugs.
Store management
It is the function of receiving, storing & issuing of materials. Hospital materials require huge
investments. It is therefore necessary to ensure accuracy, preservation and safety of materials at all
stages of store management.
Function of store
A store branch is generally responsible for,
• Receipt of stores- to receive, check and inspect all supplies.
• Storage-To stock all materials properly to avoid damage and pilferage.
• Issue of materials-To issue materials against a requisition.
• Documentation- To maintain accurate records of materials received, issued and stored.
Inventory control
• It means stocking adequate number and kind of stores, so that the materials are available
whenever required and whatever required. Scientific inventory control results in optimal balance.
• The main function of the inventory control, is to provide maximum supply service, consistent
with maximum efficiency and optimum investment.
• Various inventory control techniques includes: ABC analysis, VED analysis, EOQ, Lead time, FSN
etc.
Finance management
• Financial management is a vital activity in any organization. It is the process of planning,
organizing, controlling and monitoring financial resources with a view to achieve
organizational goals and objectives.
• The financial management of pharmacies and health systems is a combination of the
traditional management of personnel and drug and supply costs with the management of the
total costs of care. It includes determining the consequences of less than optimal drug therapy,
improving drug therapy, and reengineering pharmacy departments and services across all
patient care settings to deliver optimal pharmacotherapy.
• In hospital pharmacy, managers are responsible for planning, organizing, and controlling
resources so that the organizations in which they are employed meet their goals.
• Pharmacist managers face many such decisions: how much inventory to carry, which sources
of supply to use, how to set prices, which third-party prescription plans to participate in,
which drugs to include on a formulary, whether a new disease management service will be
profitable, whether the hospital should open a pharmacist-managed hypertension clinic.
Goal of finance management
• The principal goal of financial management is to increase the value of the organization. A
major part of achieving this goal is making efficient use of financial resources.
• Pharmacies make the most efficient use of cash that is invested in inventories when they carry
the smallest amount of inventory necessary to meet consumer demand. Carrying larger
inventories is inefficient because it takes cash away from other, more productive uses.
Accounting of finance management
• A proper understanding of the tools and techniques of financial management requires a basic
working knowledge of accounting.
• Financial statements facilitate decision making in three areas.
1. First, financial statements provide information to decision makers. With this information,
decision makers can better assess the financial implications of various decisions they must
make. For example, bankers are decision makers. Before making loans, they will carefully
evaluate the financial statements submitted by applicants to decide whether they can repay
the loans. Managers are also decision makers. They use financial statements, for example,
to make pricing decisions, to help decide
whether to hire additional personnel, to decide whether to buy new equipment, and to decide
which services to offer.
2. Second, financial statements aid decision makers by reporting the results of past decisions.
The prudence of a banker’s past lending decisions will be reflected in his or her current
financial statements. Likewise, a manager who makes poor service and pricing decisions
will notice, on financial statements, a decrease in profits.
3. Finally, financial statements keep track of a range of financial items such as cash, debts,
and assets. Decision makers need this information to efficiently and effectively manage
their organizations.
• Financial statements provide decision makers with the following types of information:
a) Present financial status of the business. The balance sheet, or statement of financial
position, indicates what a business owns and what it owes at one point in time.
b) Past profit performance of the business. The income statement, also called the profit and
loss statement, indicates whether the business made a profit or suffered a loss over some
period of time.
c) Where the business is getting its cash and how it is spending it. This is found on the statement
of changes in financial position or the cash flow statement.
d) How the owners investment in the business has changed over some period of time.
Limitations of financial management
• Financial management is a tool that managers can use to better assess the financial implications
of decisions they face. Its use should be limited to deciding among potential courses of action
that will help the pharmacy to reach its goals. In most cases, it should not be used to decide
what those goals are, nor should most decisions be based solely on financial criteria.
• For example, a hospital pharmacy could decrease its expenses, and maintain its revenues, by
switching from unit-dose to multiple-dose drug distribution and by cutting out all clinical and
educational services. If the pharmacy’s decisions were based solely on financial criteria, a
financial analysis might show the advisability of this course of action.
• But a hospital pharmacy has a higher and more basic mission than to operate as cheaply and
profitably as possible. Its primary mission is to provide pharmaceutical services that improve
patient care.
• Unit-dose distribution and clinical and educational services substantially improve patient care.
Consequently, the decision of whether to offer them should not be made solely on the basis of
financial criteria.
Role of pharmacist in dispensing /supply of drugs
• One of the most important duties provided by the hospital pharmacist is the dispensing of
drugs after due verification of the prescription.
• Patient confidentiality shall be maintained at all times.
• Appropriate information shall be provided to the patient or the care giver and when possible,
understanding of this information should be checked.
• For all prescription handled by the pharmacy,
i. Patients details shall be checked and confirmed.
ii. Proper documentation shall be maintained.
• Assessment of the prescription should include but not be limited to assessment of whether
i. The prescription is legally valid
ii. The prescription includes an appropriate dosage form and appropriate route of
administration.
iii. Prescription is appropriate to the patients condition.
i. Duration of treatment is correct
ii. Prescription is compatible with other medications.
iii. Possibility of adverse drug reactions exist.
iv. Contraindicated.
v. Potential for misuse and inappropriate use of the medicines in prescription by patient exist.
Role of pharmacist for the promotion of rational drugs
• To promote rational use of drugs, the pharmacist shall involve himself in activities such as:
i. Preparation of formularies
ii. Critical assessment of promotional materials prepared by the drug companies.
iii. Updating the knowledge of drugs through continuing education programmes and also to
organize educational programmes for health professionals.
iv. Preparation and dissemination of patient information leaflets
Role of pharmacist in patient counselling
i. Name and description of drugs
ii. The dosage form, route of administration and duration of drug therapy.
iii. Intended use of the drug and expected action.
iv. Special directions and precautions for the drug.
v. Common side effects or interactions and therapeutic contraindications
vi. Techniques for self monitoring drug therapy
vii. Proper storage of the drugs
viii. Actions to be taken in case of missed dose.
• Pharmacies providing patient counselling shall have regard to the following:
i. Only Registered Pharmacist are involved in counselling.
ii. Patient information leaflets are provided.
iii. Proper documentation is made.
iv. Unnecessary counselling should be avoided.
v. Facilities are provided for confidential conversation and patient confidentiality is maintained.
Pharmacist role in health promotion
• The pharmacist should be involved in health promotion campaigns, on health topics.
Pharmacists should be involved in particularly drug related-topics (alcohol use, tobacco use,
poison prevention etc).
E. Pharmacists role in improving medication adherence
• Reviewing how patients are using medications can result in suggestions for changes in
medication, dosing, or additional therapies that improve patient adherence.
F. Pharmacists role in providing drug information
• To provide for in service education & training for pharmacists, pharmacy students and other
health care professionals
Role of pharmacist in managing pharmacy store
• Management of the stores which include: Purchase of drugs and medicines and other allied
stores as per the recommendations of the pharmacy and therapeutics committee(PTC).
• Providing instructions for proper storage of such drugs and medicines. Maintenance of proper
records of the drugs purchased and the distribution thereof. Storage and dispensing of
narcotic and biological products.
Indoor pharmacist responsibility
A. Central Dispensing Area
To ensure that all drugs are stored correctly
To check the accuracy of the dosages prepared especially of (a) intravenous admixtures and (b)
Unit doses.
To keep proper records and preparation of bills, if any
To co-ordinate the over all pharmaceutical needs of the “patient care” areas with the central
dispensing area.
To ensure that the established policies and procedures laid down are followed.
To communicate with all pharmacy staff regarding new developments in the area.
To maintain professional competence- Keep update with information regarding drugs in current
use in the hospital, with special reference to their side effects, drug interactions, therapeutic
efficacy etc., as well as their incompatibilities and stability.
B. Patient Care Areas (Wards, Operation Theatres and other departments of the hospital where
drug of special categories are used)
 To maintain a liasion with nurses who are involved in the drug administration.
 Reviewing of drug administration in each patient periodically to ensure that all doses are being
 Adverse drug reaction
The World Health Organization’s (WHO’s) original definition of an ADR was ‘a response to a
drug that is noxious and unintended and occurs at doses normally used in man for the
prophylaxis, diagnosis or therapy of disease, or for modification of physiological function.
Thus, this definition excludes overdose (accidental or intentional), drug abuse, treatment
failure and drug administration errors.
"FDA: For reporting purposes, FDA categorizes a serious adverse event (events relating to
drugs or devices) as one in which “the patient outcome is death, life-threatening (real risk of
dying), hospitalization (initial or prolonged), disability (significant, persistent, or permanent),
congenital anomaly, or required intervention to prevent permanent impairment or damage."
A side effect is defined by ASHP(American society of health-system pharmacists) as an
expected, well-known reaction resulting in little or no change in patient management (e.g.,
drowsiness or dry mouth due to administration of certain antihistamines or nausea
associated with the use of antineoplastic).
An ongoing ADR-monitoring and reporting program can provide benefits to the organization,
pharmacists, other health care professionals, and patient. These benefits include (but are not
limited to) the following,
 i)Providing an indirect measure of the quality of pharmaceutical care through identification of
preventable ADRs and anticipatory surveillance for high-risk drugs or patients.
(II) Complementing organizational risk management activities and efforts to minimize liability.
(III) Assessing the safety of drug therapies, especially recently approved drugs.
(IV) Measuring ADR incidence.
(V) Educating health care professionals and patients about drug effects and increasing their
level of awareness regarding ADRs.
(VI) Providing quality-assurance screening findings for use in drug-use evaluation programs.
(VII)Measuring the economic impact of ADR prevention as manifested through reduced
hospitalization, optimal and economical drug use, and minimized organizational liability.
• An adverse drug event (ADE) is a broader term and includes ‘any untoward medical
occurrence presenting during the administration of a drug’. Thus, an ADR can also be
considered as an ADE, but not all ADEs are ADRs
• adverse effects are usually detected by laboratory tests (e.g, bio-chemical, haematological,
immunological, radiological, pathological) or by clinical investigations (e.g. Gastrointestinal
endoscopy, cardiac catheterization), adverse reactions by their clinical manifestations
(symptoms and/or signs).
Classification scheme for adverse drug reactions:
I. Predictable: known pharmacology of a drug and are associated with high morbidity and
low mortality.
II. a) Side effects: Undesired effects (often self-limited) that are predictable based on the
pharmacologic action of the drug (e.g., tremor associated with betaagonist therapy).
III. b) Secondary effects: Undesired but not inevitable effects that are predictable based on
the pharmacological action of the drug (e.g., pseudo membranous colitis associated with
clindamycin therapy)
IV. C) Interactions: Interactions with other drugs, foods, or diseases that alter drug clearance
and Produce concentration-dependent effects (e.g. inhibition of metabolism of
cyclosporine by erythromycin) d) Toxicity: Undesired effects produced by elevated drug
doses (e.g., metabolic acidosis associated with salicylate overdose)
II. Unpredictable: Reactions are idiosyncratic, bizarre or novel responses that cannot be
predicted from the known pharmacology of a drug.
a) Intolerance: Exaggerated side effects after usual drug dosage or with usual therapeutic
drug Concentrations (e.g., tinnitus in the setting of therapeutic salicylate concentrations)
b) b) Allergic or pseudo allergic: Undesired effects of an allergic or apparently immune-
Mediated nature (e.g. urticaria Associated with penicillin therapy)
c) c) Idiosyncratic: Undesired and often severe effects that are not related to the known
pharmacologic action of the drug.
Risk factors for adverse drug reactions
Many factors can predispose a patient to the occurrence of ADRs. Patients who have one or
more of the following predisposing factors are at high risk of developing an ADR:
1. Polypharmacy
2. Extreme age (very young and very old)
3. Previous history of adverse drug reactions Impairment in the organs of clearance
4. Female
1. Polypharmacy: Patients on multiple drug therapy are more prone to develop an ADR either due
to alteration of drug effect through an interaction mechanism or by synergistic effect. The
amount of risk associated with multiple drug therapy increases with an increase in the number
of drugs administered.
2. Multiple and inter current diseases: Patients with multiple diseases are at increased risk of
developing an ADR due to multiple drug use for their diseases like congestive heart failure,
diabetes, and peripheral vascular, chronic pulmonary, rheumatological, hepatic, renal and
malignant diseases.
 Similarly, patients with impaired hepatic or renal status are also at high risk of developing an ADR
to drugs which are eliminated by these organs.
 For example, a patient with decreased renal function who is treated with aminoglycosides is at
increased risk of developing nephrotoxicity unless appropriate dose adjustments are made.
3. Age: Elderly and pediatric patients are more vulnerable to ADRs. Elderly patients are more
susceptible to ADRs due to the physiological changes (pharmacokinetic and pharmacodynamic)
which accompany ageing, and also because they often take many drugs for chronic and multiple
diseases.
 Paediatric patients may develop serious ADRs to some drugs since all children, especially
neonates, differ in their drug handling capacity compared to adults. An example of such a serious
reaction is the grey baby syndrome with chloramphenicol.
• The use of aspirin was restricted in those younger than 12 years after an association with Reye’s
syndrome (Reye's syndrome is a rare but serious condition that causes swelling in the liver and
brain, typically affecting children and teenagers after a viral infection, and is linked to aspirin
use) was found in epidemiological studies.

• Additionally, children can be exposed to more adverse effects because of the heightened
probability of dosing errors and the relative lack of evidence for both safety and efficacy.

4. Drug characteristics: Some drugs are highly toxic in nature and patients who are treated with
these agents are at an increased risk of ADRs. For example, nausea and vomiting is a common
ADR seen in patients treated with cytotoxic anti-cancer drugs.

Also, patients who are treated with drugs which have a narrow therapeutic range such as digoxin
and gentamicin are more susceptible, as a slight increase in the serum concentration of these
drugs may result in toxicity.
[Link]: Women are reported to be more susceptible to ADRs than men, for a number of
reasons: physiological, pharmacokinetic, pharmacodynamic and hormonal. Chloramphenicol-
induced aplastic anaemia and phenylbutazone-induced agranulocytosis are twice and thrice as
common in women as in men, respectively.
[Link] and genetic factors: It is evident that ADRs are more common in genetically
predisposed individuals. For example, patients who are deficient in glucose-6-phosphate
dehydrogenase (G6PD) are at higher risk of developing haemolysis due to primaquine than
those who are not. Race and genetic polymorphism may account for alterations in handling of
drugs and their end organ effects.
7. Sex : Women may be more susceptible to ADRs, but they also receive more drugs than men.
In addition, there are particular adverse reactions that appear to be more common in women.
For example, impairment of concentration and psychiatric adverse events associated with the
antimalarial mefloquine are more common in females.
8. Ethnicity: Ethnicity has also been linked to susceptibility to ADRs, because of inherited traits
of metabolism. For example, CYP2C9 alleles associated with poor metabolism occur more
frequently in white individuals compared with black individuals. This has a potential effect on
warfarin metabolism and increases the risk of toxicity
• Examples of ADRs linked to ethnicity include the increased risk of angioedema with the use
of angiotensin-converting enzyme inhibitors in black patients

• the increased propensity of white and black patients to experience central nervous system
ADRs associated with mefloquine compared with patients of Chinese or Japanese origin and
differences in the pharmacokinetics of rosuvastatin in Asian patients, which may expose
them to an increased risk of myopathy.

9. Pharmacogenetics the study of genetic variations that inluence individuals’ responses to

drugs.

10. Porphyrias: The porphyrias are a heterogeneous group of mainly autosomal dominant
inherited disorders of haem biosynthesis, leading to excess porphyrin production. Patients with
acute porphyrias may have life threatening attacks precipitated by commonly prescribed drugs.
[Link] reactions
 Mechanisms of Type A ADRs
a) Pharmaceutical causes: example of a formulation factor being important for the risk of
adverse reaction is doxycycline. Brands containing the hydrochloride salt have been
associated with high frequency of oesophageal stricture and ulcers in patients lying down
or who do not take the medicine with an adequate amount of water.
• The problem was avoided when the manufacturer introduced a formulation containing
doxycycline carragenate resin instead of the corrosive hydrochloride.
b) Pharmacokinetic causes:
Alterations in the absorption, distribution, metabolism and elimination of drugs may alter drug
effects by changing the concentration of drug present at the site of action.
c) Pharmacodynamic causes: Increased sensitivity of target tissues or organs may predispose a
person to ADRs.
Drug receptor This inter variability between different individuals can greatly affect the drug
effect when the drug acts through these specific receptors.
Diseases: An example is an asthmatic patient who develops bronchoconstriction while taking
nonselective beta blockers such as propranolol.
 Mechanisms of Type B ADRs
[Link] causes: The main sources for the pharmaceutical causes of type B reactions
include decomposition of the active ingredient, effects of the nondrug excipients (additives,
preservatives, colouring and solubilising agents) and synthetic by-products of active
constituents. In most cases, the use of decomposed drug products may result in therapeutic
failure. Deaths have been reported due to decomposition of paraldehyde to acetaldehyde and
its subsequent oxidation to acetic acid.
2. Pharmacokinetic causes: Although changes in pharmacokinetic parameters such as
absorption, distribution, metabolism and excretion may theoretically lead to type B reactions.
3. Pharmacodynamic causes: Many factors including age, sex, body weight, medical condition
and drug therapy influence the end response of a patient to an administered drug.
[Link] causes for abnormal responses or idiosyncrasy The deficiency of G6PD results in
haemolysis, accompanied by a fall in haemoglobin level, fever and the formation of dark urine.
haemolysis in patients with G6PD deficiency, and these include primaquine, sulphones,
sulphonamides, chloramphenicol, quinine and quinidine. Other genetically determined ADRs
include methhaemoglobinemia (nitrates), porphyria (sulphonamides and barbiturates)
malignant hyperthermia (halothane and suxamethonium),
[Link] reasons for abnormal response : Refer table 5.3
 Classification of adverse drug reactions
• Classification systems for ADRs are useful for educational purposes, for those working within
a regulatory environment and for clarifying thinking on the avoidance and management of
ADRs.
• Rawlins–Thompson classification The Rawlins–Thompson system of classification divides
ADRs into two main groups: type A and type B (Rawlins, 1981).
[Link]-A (Augmented): Commonest (up to 70%)-Dose dependent, severity increases with
dose. Preventable in most part by slow introduction of low dosages.
• Predictable by the pharmacological mechanisms, e.g., hypotension by beta-blockers,
hypoglycemia caused by insulin or oral hypoglycemic, or NSAID induced gastric ulcers.
[Link]-B (Bizarre): Rare, idiosyncratic, genetically determined, unpredictable, mechanisms are
unknown, Serious, can be fatal; unrelated to the dose, e.g., hepatitis caused by halothane,
aplastic anaemia caused by chloramphenicol, neuroleptic malignant syndrome caused by
some anesthetics and antipsychotics.
The DoTS system, The DoTS classification is based on dose relatedness, timing and patient
susceptibility (Aronson and Ferner, 2003). In contrast with the Rawlins–Thompson
classification, which is defined only by the properties of the drug and the reaction, the DoTS
classification provides a useful template to examine the various factors that both describe a
reaction and influence an individual patient’s susceptibility.

In the DoTS system reactions are divided into toxic effects (effects related to the use of drugs
outside of their usual therapeutic dosage), collateral effects (effects occurring within the
normal therapeutic use of the drug) and hyper susceptibility reactions (reactions occurring in
sub therapeutic doses in susceptible patients).
3. Type-C (Continuous drug use) Dose-related and time-related (Chronic): Occurs as a result of
continuous drug use. May be irreversible, unexpected, unpredictable, e.g., dementia by anticholinergic
medication.

4. Type-D (Delayed) or Time-related: Delayed occurrence of ADRs, even after the cessation of treatment
e.g, corneal opacities after thioridazine, ophthalmopathy after chloroquine, or pulmonary/peritoneal
fibrosis by methyserzide.

5. Type-E (End of dose): Sudden Withdrawal reactions. Occurs typically with the depressant drugs, e.g.,
hypertension and restlessness in opiate abstainer, seizures on alcohol or benzodiazepines withdrawal;
first dose hypotension caused by alpha-blockers (Prazosin) or ACE inhibitors.

6. Type-F (Failure of therapy): Results from the ineffective treatment (previously excluded from analysis
according to WHO definition), e.g., accelerated hypertension because of inefficient control. If adverse
drug reactions are considered as any other medical illness and approached in the same way, then many
questions would appear like:
 Methods of monitoring adverse drug reactions
Case reports The publication of single case reports, or case series, of ADRs in medical literature
is an important means of detecting new and serious reactions; especially Type B reactions.
Their importance is on the decline with reactions; especially Type B reactions. their importance
is on the decline with the emergence of spontaneous reporting systems. e.g. : Halothane
induced hepatitis.
Case–control studies compare the extent of drug usage in a group of patients who have
experienced the adverse event with the extent of usage among a matched control group who
are similar in potentially confounding factors, but have not experienced the event. By
comparing the prevalence of drug taking between the groups, it may be possible to identify
whether significantly more people who experienced the event also took a particular drug.
Examples of associations that have been established by case– control studies are Reye’s
syndrome and aspirin, and the relationship between maternal diethylstilboestrol ingestion and
vaginal adenocarcinoma in female offspring.
Spontaneous ADR Reporting- which is a system whereby any suspected ADRs are voluntarily
notified by health professionals, pharmaceutical companies and other stakeholders to a central

authority (Central Drugs Standard Control Organization -CDSCO in India).

 Prescription Event Monitoring- represents a method which is hybrid of spontaneous

reporting with aspects of formal epidemiological studies.

 Systematic methods- public health surveillance data such as death registries are used to
identify patterns of reactions that might be associated with drug use.

Randomized Controlled Trials- These studies involve patients divided into two groups
randomly into exposed and the other not exposed, so that the outcomes can be compared.
Adverse drug reaction-Causality assessment: Causality assessment is the method by which an
association is evaluated between a drug and a suspected reaction.
It assesses the relationship between a drug treatment and the occurrence of an adverse event.
It is an important tool which is used in pharmacovigilance programmes for evaluating
suspected ADR reports for assessing the safety of drugs for use & for regulatory purposes also.
This assessment may be undertaken by clinicians,academics, pharmaceutical industry, and
regulators.
Causality assessment can be done by treating health professionals as a tool for decision
making regarding a drug treatment & by regulators as a help in signal detection and aid in risk-
benefit decisions regarding medicines.
Algorithms, structured tools specifically designed for the identification of an ADR, should
theoretically make a more objective decision on causality.
The objective causal assessments are based on four basic principles-temporal eligibility,
dechallenge and outcome, rechallenge and outcome, and confounding factors
Spontaneous reporting Pharmacovigilance uses multiple methods, but this chapter will mainly
cover spontaneous reporting systems. Spontaneous reporting systems collect data about
suspected ADRs in a central database.
Cases are not collected in a systematic manner, but accumulate through reports submitted
spontaneously by people who make a connection between a drug and a suspected drug-
induced event. In the UK, the spontaneous reporting scheme is the Yellow Card Scheme.
Signal detection A signal is described as a possible causal relationship between an adverse
event and a drug which was previously unknown.
Using statistical approaches, run automatically by computer systems, databases of
spontaneous reports are scanned for ‘drug-adverse event pairs’ that are disproportionately
present within the database as a whole.
Record linkage system Here the records from different sources such as general practice and
hospital records, pharmacy records dental records, certificated cause of death patients records
etc are linked and analyzed. Such linkage becomes quite useful when seeking long term effects
of drug use (e.g. : possible increased occurrence of malignancy or of mental retardation in
individuals in individual's pregnancy.)
Yellow Card Scheme The UK’s Yellow Card Scheme, now operated by the MHRA, was established
in 1964 following the thalidomide tragedy. All healthcare professionals are encouraged to submit
reports of suspected ADRs using a Yellow Card (found in the British National Formulary), online
([Link] or via an application for mobile phones. It is not necessary to
confirm an association between the medicine and the event; a suspicion is sufficient for a report
to be submitted.
The MHRA requests that all serious suspected ADRS to established drugs are reported, but for
newer drugs, all suspected ADRs should be reported, even minor events.
Newer drugs under intensive surveillance are identified with an inverted black triangle symbol ( ▼)
in product information, including both Summaries of Product Characteristics (SPCs) and patient
information leaflets (PILs), and standard prescribing texts.
Black triangle status is generally maintained for at least 2 years, but the period varies, depending
on how much information is obtained about a product’s continued safety.
Community pharmacists are particularly encouraged to report suspected ADRs to over-the-
counter medicines and herbal products, as they are providers of these and people are most likely
to inform them of any problems encountered.
All information from Yellow Card reports is entered into a database, and the suspected reactions
are categorised using the internationally accepted Medical Dictionary for Regulatory Affairs
(MedDRA.
Direct patient reporting It is important to recognize that a patient is frequently the first person
to suspect an ADR, and given there is no requirement for causality to be confirmed in order to
submit a report about a suspected ADR, patients are capable of doing so themselves.
Published case reports In addition to reporting via the Yellow Card Scheme, practitioners may
also report individual cases in the literature, especially when the event is previously unknown
or unpredictable. As seen with thalidomide and practolol, astute and vigilant clinicians
submitting case reports to the medical press has been of importance in drug safety.
Cohort studies are prospective pharmacoepidemiological studies that monitor a large group of
patients who are taking a particular drug over a period of time. Ideally such studies compare
the incidence of a particular adverse event in two groups of patients: those taking the drug of
interest and another group, matched for all important characteristics except the use of the
drug.
Example cohort study conducted in Denmark followed women aged 15–49 years with no
history of thrombotic disease from January 2001 to December 2009 to determine the
proportion who developed a deep vein thrombosis in those who used oral contraception
compared with those who did not .This study found the relative risk of developing a deep vein
thrombosis associated with oral contraception.
Patient questionnaires Self administered questionnaires can be used for outpatients regularly
attending clinics, though they pose a risk of recall biases. They have helped to detect many
unsuspected adverse reactions. Ex: as headache and weakness in arms and legs due to
metformin. They are also used to show absence of effects.
ADR Monitoring and Reporting in India
The goal is to provide a clear and detailed picture of the ADR monitoring system highlighting its
strengths and weaknesses along with its key features. It was observed that the Central Drugs
Standard Control Organization (CDSCO) is regulating the safety, efficacy and quality of
pharmaceutical products having more than two hundred Adverse Drug Monitoring Centers
(AMCs) operational nationwide.
Within the Pharmacovigilance Programme of India (PvPI), these centers report ADRs to
National Coordination Centers (NCC) at the Indian Pharmacopoeia Commission (IPC) located in
Ghaziabad .
While electronics software called Vigiflow owned by World Health Organization Uppsala
Monitoring Centre (WHO UMC) plays a crucial role in reporting the ADRs to NCC by AMCs.
India contributes to global ADR monitoring through its national program and WHO
collaboration.
• DR Reporting Approaches
• What to report?
• These are considered as the adverse drug events which should be
• reported to the nearer hospital or reporting centres.33
• Death and deadly events.
• If patients get hospitalized due to drug’s adverse reaction.
• Fetal abnormality due to certain drug.
• If physician consider any particular health event as a harmful
• event.
• If the drugs lacking efficacy.
• Any drug action which is suspected.
• When to report?
• Any spontaneous events needed to be reported within 10 days.
• Any adverse drug event which is suspected needs to be reported
• as soon as possible.
• Unfortunate death due to adverse reaction should be reported
• immediately.
• Other adverse drug reactions should be reported within one
• week.
• Any adverse drug reactions which are non-serious should be
• reported within 30 days.
• Reporting delay leads to create more problems. So, as far as
• possible immediate reporting considered as ideal decision
Who can report?
Health care professionals are priorities for reporting adverse drug
reaction monitoring. Such as
Health professionals, physician.
Pharmacist.
Dentist.
The citizen of India also can report adverse drug reaction if it
happens due to some specific drug and medical devices.35
How to report?
There is a form called “Suspected Adverse Drug Reaction
Reporting Form” available for healthcare professionals. (Given in
“adverse drug reaction monitoring in India)
The for which is available for consumers is “Medicines Side Effect
Reporting Form” (given in “adverse drug reaction monitoring in
India
 Drug Interaction

Drug interaction refers as modification of response to one drug by another when they are
administered simultaneously or in case of quick successful therapy and in conditions like poly
pharmacy When a drug is used in conjunction with particular drug,foods, herbs, or other
medications, or when it is used to treat particular medical conditions, the way the drug acts in
the body changes.

Medication interactions may alter a drug's effects or have unanticipated effects on the body.
There are detrimental therapeutic effects when one drug(the offender) alters the
concentration of another drug(the sufferer)

15% of elderly people in the U.S. routinely use five or more prescription drugs or dietary
supplements, and 36% are at risk of a serious drug-drug interaction.
 REASON FOR DRUG INTERACTION

When two (or more) drugs, or a drug and a food, drink, or supplement, join, a drug interaction
happens. Additionally, taking a medication while dealing with a particular medical situation
can lead to a drug combination. for instance, taking a nasal decongestant while having
elevated blood pressure is an example of how a drug interaction can alter how a drug works or
have unintended negative effects.

The two drugs involved in interaction are:

OBJECT DRUG: The drug for which the effect is altered (increased or decreased) is called as the
object drug. Example: warfarin, fluoroquinolones, antiepileptic drugs.

PRECIPITANT DRUG: The drug that provokes the interaction is named as the precipitant drug.
Example: Non-steroidal inflammatory drugs, antibiotics, rifampin.
RECENT DRUG WITHDRAWAL FROM MARKET:
i. Thioridazine, a common antipsychotic from the phenothiazine family, was extensively used
to treat schizophrenia and psychosis but was discontinued globally in 2005 due to its severe
cardiac arrhythmia- causing potential.
ii. The weight-loss medication lorcaserin, The hypothalamus, a part of the brain that is known
to regulate appetite, contains a form of serotonin receptor called the 5-HT2C receptor, which is
how it suppresses appetite. Due to an elevated risk of cancer it was authorized in 2012 and
taken off the market in the United States in 2020.
iii. Ranitidine, Due to its carcinogenic nature, ranitidine was taken off the market in the United
States as well as Australia and the European Union in April 2020. In a population study
conducted across the country in 2022, it was discovered that ranitidine significantly increased
the chance of developing liver, lung, gastric, and pancreatic cancer by 22%, 17%, 26%, and
35%, respectively.
Iv The European Medicines Agency recommended in March 2018 that Flupirtine's acting non-
opioid analgesic marketing authorizations be revoked due to the continued occurrence of
severe liver injury cases, including liver failure.
 Based on clinical importance, drug interaction can be classified as:

i. Beneficial Drug Interaction: Few drugs have positive impacts when they interact with other drugs.
Some of these advantages include potentiation or synergisms. Some drugs are purposefully used to
increase the effects of other drugs or to lessen their undesirable effects.

ii. Examples include the combinations of sulpha methaxozole and trimethoprim as well as carbidopa
and levodopa. There are numerous formulations on the market that make use of these
advantageous effects, including combinations of B. blockers and diuretics and estrogens and
progestogens as powerful antibiotics and contraceptives.

Adverse interactions: When two or more drugs are taken at the same time, they may have an impact
on one another that either intensifies or lessens the effect that would have been created by any one of
the drugs taken alone. The encounter is typically referred to as antagonistic when the intensity is
reduced. As an illustration, consider rashes, jaundice, anaemia, a drop in white blood cells, and kidney
injury.
 PHARMACOKINETIC DRUG INTERACTIONS
Pharmacokinetic interactions are those that can affect the processes by which drugs are
absorbed, distributed, metabolized and excreted.
Drug absorption interactions
(a) Effects of changes in gastrointestinal pH: Certain drugs require an acid stomach pH for
absorption. Others require the basic pH of the intestines. Any modification in the pH could
change this absorption. In the case of antacids, an increase in pH can inhibit the absorption of
other drugs suchas zalcitabine (absorption can be decreased by 25%), tipranavir (25%) and
amprenavir (up to 35%).However, this occurs less often than an increase in pH causes an
increase in absorption. In this case,a gap of two to four hours between taking the two drugs is
usually sufficient to avoid the interaction.
Adsorption chelation and other complexing mechanisms:
The presence of di- or trivalent cations can cause the chelation of certain drugs, making them
harder to absorb. This interaction frequently occurs between drugs such as tetracycline or the
fluoroquinolones and dairy products (due to the presence of Ca++). Binding with proteins.
Some drugs such as sucralfate binds to proteins, especially if they have a high bioavailability.
[Link] in gastrointestinal motility: For ex. Propantheline, slows down gastric emptying
and decreases paracetamol (acetaminophen) absorption; metoclopramide, on the other hand,
has the opposite impact; see "Paracetamol (Acetaminophen)+Domperidone or
metoclopramide,". The overall quantity of drug absorbed is unaffected.

(d) Induction or inhibition of drug transporter proteins: Drug transporter proteins, which
eject drugs that have diffused across the gut lining back into the gut, restrict the oral
bioavailability of some medications.

EX. Digoxin is a substrate of P-glycoprotein, which is currently the most well-studied drug
transporter. rifampicin that activate this protein, may decrease the bioavailability of digoxin.

(e) Malabsorption caused by drugs: The result is that many medications, such as digoxin and
methotrexate, have their digestion impaired.
II. Drug distribution interactions

(a) Protein-binding interactions: After ingestion, drugs travel in the blood, either dissolved or bound to
plasma proteins like albumin. Only unbound drugs are active. Strongly bound drugs, like dicoumarol, act as
inactive reservoirs.

Digoxin, can attach to the heart muscle tissue. Binding affects drug action, metabolism, and excretion,
especially in low-extraction drugs.

(b) Induction or inhibition of drug transporter proteins: Drug transporters like P-glycoprotein limit drug
entry into tissues like the brain. They actively remove drugs from cells. Inhibiting these proteins can increase
drug levels in the brain, potentially boosting effects or causing more side effects.

III. Drug Metabolism: Drug metabolism changes, mainly via cytochrome P450 (CYP) enzymes, can alter drug
effects. Inhibitors like clarithromycin increase drug levels, raising side effect risks. Ritonavir boosts HIV drugs
by inhibiting CYP3A. Inducers like carbamazepine lower drug levels, reducing effectiveness, such as with oral
contraceptives, increasing pregnancy risk.
•Object drug is the drug whose effect
is altered by the interaction.
•Precipitant drug is the drug that
causes the interaction, changing the
effect of the object drug.
Basically, the precipitant drug acts on
the object drug, either increasing or
decreasing its action.
(a) Genetic factors in drug metabolism: Genetic differences affect drug metabolism, especially
in cytochrome P450 enzymes. For example, some people have a low-activity CYP2D6
variant, making them poor metabolizers. This genetic trait influences how well they process
certain drugs.
(b) Knowing which CYP450 isoenzyme metabolizes a drug helps predict interactions.
Cyclosporine is metabolized by CYP3A4. Rifampicin induces CYP3A4, lowering cyclosporine
levels, while ketoconazole inhibits it, raising cyclosporine levels.
IV. Drug excretion interactions
Changes in urinary pH affect drug reabsorption. Only non-ionized, lipid-soluble drugs can pass
back into the body from urine. Alkaline urine increases loss of acidic drugs, while acidic urine
increases loss of basic drugs. Drug interactions can also inhibit pumps like ABCB11, reducing
reabsorption and increasing drug elimination in urine.
(b) Changes in active renal tubular excretion: Drugs using the same renal transporters can
compete for excretion. Probenecid reduces penicillin elimination by inhibiting organic anion
transporters (OATs). It may also affect ABC transporters like P-glycoprotein, altering renal drug
elimination and potentially causing side effects.
Changes in renal blood flow: Renal vasodilatory prostaglandin synthesis contributes to the regulation of blood flow

through the kidney. The renal excretion of some medications may be decreased if the synthesis of these

prostaglandins is blocked.

The increase in serum lithium observed with some NSAIDs, as described in "Lithium+NSAIDs," is an interaction for

which this is the proposed cause.

Biliary excretion and the entero-hepatic shunt: Many medications are eliminated in the liver, either unaltered or

conjugated (for example, as the glucuronide to increase their water solubility). Some of the conjugates are

converted by the gut bacteria to the parent compound and then reabsorbed. This recycling process lengthens the

time the drug remains in the body, but if an antibacterial is present, the drug is not recycled and is lost more

rapidly. This may help to explain the infrequent failure of hormonal contraceptives that can result from taking
PHARMACODYNAMIC DRUG INTERACTION
Drug-drug interactions (DDIs) occur when one drug alters the effect of another. These can be
pharmacokinetic (PK), involving changes in absorption, distribution, metabolism, or
elimination, or pharmacodynamic (PD), where one drug affects the pharmacological action of
another. PD interactions are often .described as additive, synergistic, or antagonistic.
Additive or synergistic effect:
• PD DDIs are typically divided into synergistic, additive, or antagonistic categories, despite the
fact that these words are frequently misused. The overall effect of a drug combination is
equivalent to the sum of the pharmacological effects of each individual agent, according to the
additivity idea.
Antagonistic or synergistic effect:
• A drug combination is said to be synergistic when its overall impact is greater than additive;
antagonistic when it is less so. PD DDIs may be applied in a beneficial or harmful manner, with
or without intention.
• A response the body has to two or more drugs that interact negatively with one another.
Drug antagonists may stop or reduce the effectiveness of one or more medicines. For instance,
when fluoroquinolones and erythromycin are combined, QT (electrical activity that occurs
between the Q and T waves which shows electrical activity of heart) delay may happen.
 Community Pharmacy

Community Pharmacy is defined largely to comprise all privately owned establishments involved in the performance of the
functions in varying degrees to serve the society’s need for pharmaceutical products and related services. Community
pharmacy is the branch of a pharmacy responsible to serves the different kinds of patient care and dispensing of medicines and
counseling the patient on the drug safety and rational use of drugs. The leading responsibilities of a community pharmacy are
compounding, advising, and distributing drugs to the patients. The community pharmacy provides the services with very care,
accuracy, and legality along with the appropriate procurement, storage, distribution, and documentation of medicines. The
community pharmacist should possess relevant educational qualifications, skills, and proficiency to provide professional
service to the community

A community pharmacist should have the following qualities:

1. Sound experience in pharmaceutical care and health promotion.

2. Good communication skills with patients and other healthcare providers.

3. Continue to maintain a high grade of standard in the development of products, services, and

communication.

4. Record to maintain documentation of dispensing of all orders.

Ideal Plan of Drug Store and Dispensing Unit
Ideal drug store should possess the following plan to execute properly:
1. Supervision and control of material handling and transportation.
2. Proper designing of suitable work locations.
3. Allocation of suitable locations as production centers and service centers.
4. Minimized the movement of workers at the production center and wherever it required.
5. Minimized the waiting time of the semi-furnished product.
6. Improvement in the methodology of work so there can reduce the production cycle in terms of
times.
7. Flexibility to change the design of products for their future expansions.
A good layout permits the supply of the materials through the plant at the desired speed with a lower
cost. Following are the general layouts for the retail and wholesale pharmacy store for efficient
functioning.
Types of Layout for Community Pharmacy
There are mainly following types of layouts:
1. Process Layout:
It is also known as functional layout and is categorized by keeping similar machines/operational tools at one
location. The arrangement is like a separate department, in which, a particular class of machine or operational
tool doing a particular type of work or process e.g. cutting machines may be placed under the cutting
department.
Advantages:
1. Better utilization of resources.
2. Greater flexibility.
3. Better supervision ultimately leads to better production.
4. While doing such arrangements, there may require a smaller number of machines or other resources
thereby resulting in reduced capital.
5. Disadvantages:
1. In pharmaceutical and chemical industries, the functional layout type may not be possible due to the
sequential performance/operation of many of the units/sectors
2. Product Layout:

This type of layout is also called a straight-line layout and is required to standardize in beginning according to the
manufacturing process of a particular product. Using such product layout design, the product can be manufactured
in large quantities by repetitive operation.
Advantages:
1. Fewer space requirements for the same volume of production.
2. Smooth and continuous workflow.
3. Processing of work is quick and smooth.
4. Floor space can be properly utilized.
5. Less in-process inventory.
6. The cost of material handling can be reduced by using conveyors.
7. Manufacturing time is reduced and the manufacturing cycle can be speeded up. This type of layout is more
suitable for Pharmaceutical Industries.
• 3. Combination Layout:

• In this layout, they use a combination of both functional and product layouts for more advantages.

• A combination of process and product layout combines the advantages of both types of layouts. The layout
should be well-organized by keeping the handling of material at a minimum level. While there requires suitable
layout planning to keep the cost of product minimum.

• Legal Requirements for Establishment and Maintenance of Drug Store

• Requirements for the Establishments of Drug Store

• General License: Granted to the person who has a premise for business and who engages the services of a
qualified person to supervise the sale of drugs.

•  The license for the retail sale of drugs other than the ones mentioned in schedules C, C1, and X was issued
in form 20. For drugs specified in Schedule C and C1 in form 21. Schedule X drugs in form 20F. Restricted
License: The licenses for the restricted sale of drugs other than those specified in Schedule C, C1, and X are
issued in the form [Link] specified in Schedule C and C1 but not in schedule X are issued in form 21A.
Requirements for the Maintenance of Records of Drug Stores
1. Legal Records:
According to the Federal State Law, up-to-date and proper records should be maintained according to the Drugs
and Cosmetics act 1940, Rules 1945, and Poison act 1919 for the maintenance of records of the distribution of
poisonous substances.
2. Patients Records:
 Patient’s drug history.
 Information on all kinds of and amounts of drugs taken by average patients.
3. Financial Records
Financial records need to maintain for the following purposes:
 For evaluation of records, past operations, forecasting needs, and controlling the needs.
 Analyzing revenues and expenses.
 Measuring return on investment.
 Help ensure profitable operations.
Dispensing of Proprietary Products
• Dispensing is the main part of pharmacy practice in which the distributor/pharmacist takes the required order of
medicine from a physician on the prescription and accordingly supplies the medicines for the treatment of the
patients. Following are the general patterns follow for the dispensing of the proprietary products.
The layout of Dispensing Procedure:
Receiving the order of proprietary drug- like Amlodipine. Check whether this order was received correctly.
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Keep the received order at the side and check for expiry date and storage conditions.
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Keep the received order in the proper dispensary shelf or drawer. The location of the shelf for the received order
should not be confused with other available stock.
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Receive the order (Amlodipine) of prescription and locate the medicine for dispensing. During locating of medicine,
dispenser should check the medicine for correctness because there may be similarly sounding medicine next to it e.g.
amitriptyline.
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Identify and pick the correct medicine. Check the medicine strength and quantity as per the order received from a
physician.
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Label and dispense the medicine. Before dispensing of medicine, check the label; and instructions are given on the
label and same to be instructed to patients.
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