Chapter 1. Pharmacy © [.
PHARMACY ORIENTATION
Outline:
Introduction and orientation 1 the Professional of Pharmacy in relation to:
© Hospital Pharmacy
© Retail Pharmacy
© Industrial Pharmacy
* Forensic Pharmacy
* Pharmaceutical Education and rescarch etc
HARMACY —~ Introductio:
The word “Pharmacy” is derived from the Greek word “Pharmakon™ means medicine or drug.
Pharmacy is the science and technique of preparing, dispensing, and reviewing drugs and providing additional
clinical services. It is a health profession that links health seiences with pharmaceutical sciences and aims
to ensure the safe, effective, and affordable use of drugs. The professional practice is becoming more clinically
oriented as most of the drugs are now manufactured by pharmaceutical industries.
Definition:
* Pharmacy can be defined as the knowledge of identification, selection, pharmaceutical action,
preservation, combination, analysis and standardization of drugs and medicines.
* Pharmacy is the art and science of preparing, dispensing and proper
medicines,
* Pharmacy is the clinical health science that links medical sciences with chemistry and it is charged
with the discovery, production, disposal, safe and effective use, and control of medications and drugs,
Drug:
A substance intended for the use in diagnosis, cure, mitigation, treatment or prevention of disease.
(FDA)
ization of drugs and
The material may be:
© Natural
© Plant
© Animal
© Mineral
© Synthetic (aspirin)
© Semi-synthetic (ampicillins)
Scope:
1, Interpretation of prescription orders
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Compounding,
Labeling
|. Dispensing of drugs and devices
. Drug product selection and DURS
). Patient monitoring and interventions
/. Provision of information of medicines and devices
DIFFERENCE BETWEEN DRUG AND MEDICI
Drug Medicine
Definition | Substances which act on the body and | Substances that have definite form and
are used for prevention, diagnosis and | therapeutic use for treatment
treatment
Potency APIs /active potent compound Palatable form of drug
Amount Do not have definite form or dose Has definite form and dose
Compare All drugs are not medicines All medicines are drugs
Dosage form | No appropriate dosage form / vehicle | Have appropriate dosage form
Effects May have positive / negative effects | Usually have positive effects
Connotations | Associated with negative connotations | Associated with positive connotations
Source Natural, synthetic, semi-synthetic API + excipient
Example PCM Panadol (PCM 500 mg)
Naming of a Drug:
Description Example
Chemical Name | Indicate chemical structure of drug N-acetyl-para-aminophenol
Generic Name _| Given to compound during early investigation | Paracetamol
Official Name | Given to drug in official monograph Paracetamol (BP. 1998),
Acetaminophen (USP XXII)
Brand Name _| Name of drug in market Panadol (GSK), Paramol (Misr)
Erom Drug Substance to Pharmaceutical Preparation:
Active drug substance (active pharmaceutical ingredient - API)
Excipients (inactive pharmaceutical ingredients)
© Technological, biopharmaceutical and / oF stability reasons
© Diluents / fillers, binders, lubricants, disintegrant, coatings, preservatives and stabilizers,
colorants and flavorings
© Should always be stated in SPC (important in the case of allergies)
Pharmaceutical dosage form:
© Determines the physical frm of the final pharmaceutical preparation
© Isa drug delivery system which is formed by technological processing (drug formulation)
© Must reflect therapeutic intentions, route of administrations, dosing etc.
Pharmaceutical Preparation (PP)
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© Particular pharmaceutical product containing active and inactive pharmaceutical in
formulated into the particular dosage form.
© Packed and labelled appropriately
© Two major types of PP according the origin:
* Manufactured in large scales by pharmaceutical industry (original and generic preparations)
© Compounded individually in compounding pharmacies
Pharmacist:
A Pharmacist holds a Graduation in Doctor of Pharmacy (Pharm, D). Pharmacist is a person who
is Expert in medicines and a sole custodian of Medicines, right from manufacturing, testing, Clinical
administration & dispensing it safely to the patients. A Pharmacist cherish roles of different kinds, from
working in clinical pharmacy with direct interaction with patients alongside other medical staff to serving in
community pharmacy, he supervises Manufacturing units or Laboratories, A Drug expert aka Pharmacist can
review prescriptions and can suggest necessary dosage for the patients. In some developed countries, only a
pharmacist is at liberty to write prescriptions, Right man for the right job, obviously.
Pharmacist might persue speciatization in almost every major disease management, like Cardiac
Pharmacist, Oncology Pharmacist, Pediatric, Ambulatory Care Pharmacist, Neuro Pharmacist, Pain
management, Diabetes, Hypertension or simply can work as a hospital Pharmacist to keep check on smooth
flow of Right medicines in Hospital.
Pharmacist provides counselling about Drug -Drug interactions, Drug-Food interactions, Drug-Body
interactions, he can work best to reduce possible side effects of medicines.
PHARMACIST - IMPORTANT PILLAR OF HEALTHCARE:
One may ask why presence of Qualified Pharmacist is so important? According to WHO & research
concluded by John Hopkins university, there are recorded average 2,50,000 Deaths only in USA annually due
to medication errors or due to misuse of Medicines, And God knows how many are sacrificing their lives in
developing countries like Pakistan duc to Medication errors. As | said earlier, Pharmacist is a sole custodian
of Medicines and only he can overcome these errors with his expertise. The role of a pharmacist in health care
system must be taken into consideration and implemented strongly. At the end of the day we all in healthcare
sector works for the betterment of our patients.
Pharmacy Education;
There are two types of courses studied in pharmacy, The courses include:
|, Presrequisite courses — Courses other than professional courses (Important for background
knowledge for professional pharmacy courses)
1. Physical sciences
I, Biological sciences
IH, — Mathematics, statistics, computer sciences ete.
2, Professional courses
1. Pharmaceutics
i. Physical Pharmacy
Dosage Form Science
Pharmaceutical Microbiology and Immunology
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iv. Industrial Pharmacy
¥. Biopharmaceuties and Pharmacokinetics
vi, Pharmaceutical Quality Control
vii. Pharmaceutical Technology
Ul, Pharmaceutical Chemistry
i. Organic Chemistry
ji, Biochemistry
iii, Analytical Chemistry
iv. Medicinal Chemistry
IH. Pharmacognosy
IV. Pharmacology and Toxicology
V. Microbiology and Public Health
VI. Pharmacy Practice
i, Mathematics and Biostatistics
i. Community, Social and Adm
Dispensing Pharmacy
iv. Computer and Its Applications in Pharmacy
v. Hospital Pharmacy
vi. Clinical Pharmacy
vii. Forensic Pharmacy
Pharmaceutical Marketing and Management
VII. Physiology, Anatomy and Histology, Pathology
ative Pharmacy
TYPES OF EDUCATION NECESSARY FOR A PHARMACIST:
© Basic sciences
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Clinical studies
Technical studies
Drug information and scientific knowledge
Economic knowledge
* Psychological and sociological understanding
AIMS OF MODERN PHARMACEUTICAL EDUCATION:
* Provide scientific background
© Provide professional skills and knowledge
© Provide business training
© Provide broad general education
Code of Ethics:
* Pharmacists are health professional who assist individuals in making the best use of medications
‘© This code states the principles fundamental roles and responsibilities of pharmacists
© The principles are:
© Pharmacists respect relationship between the patient and pharmacist and this occur by:
= Pharmacist has to maintain knowledge
Pharmacist asks for the consultation of colleagues
© Pharmacist promotes the good of every patient ina confidential manner by considering:
= Needs stated by the patient
= Needs defined by the health science
© Pharmacist respect autonomy and dignity of each patient
= Autonomy: A pharmacist promotes the rights of self-determination by encouraging
patient to participate in decisions about their health
Dignity: The pharmacist respects personal and cultural differences among patients,
Some Definitions:
* Pharmaceutics is the discipline of pharmacy that deals with all facets of the process of turning a new
chemical entity (NCE) into a safe and effective medication. Pharmaceutics is the science of dosage
form design, Pharmaceutics deals with the formulation of a pure drug substance into a dosage form.
* Pharmaceutical formulation, in pharmaceutics, is the process in which different chemical
substances, including the active drug, are combined to produce a final medicinal product. The word
formulation is often used in a way that includes dosage form.
+ Pharmaceutical manufacturing is the process of industrial-scale synthesis of pharmaceutical
drugs as part of the pharmaceutical industry. The process of drug manufacturing can be broken down
into a series of unit operations, such as milling, granulation, coating, tablet pressing, and others,
© Physical Pharmacy: This subject deals with application of physical chemical principles to problems
in the pharmaceutical sciences. Physical pharmacy is a fundamental course that leads to proper
understanding of subsequent courses in Pharmaceutics and pharmaceutical technology.
© ‘Physicochemical principles of pharmacy’ (physical pharmacy or pharmaceutics) comprises
the study of drug formulations and their design, manufacture, and delivery to the body. The
definition now extends to the targeting of drugs and delivery systems to specific sites in the
body, the fabrication of nanoparticles and the design of delivery devices.
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© Physical pharmacy integrates knowledge of mathematics, physics and chemistry and
them to the pharmaceutical dosage form development.
© It focuses on the theories behind the phenomena needed for dosage form design,
© Enable the pharmacist to make rational decisions on scientific basis concerning the art and
technology of solutions, suspensions, emulsions, ete,
© Physical pharmacy provides the basis for understanding the chemical and physical phenomena
that govern the in vivo and in vitro actions of pharmaceutical products.
Dosage Form:
Dosage forms are the means by which drug molecules are delivered into site of action within the body.
The need for dosage forms:
1. Accurate dose
2. Protection e.g. coated tablets, sealed ampules
3. Protection from gastric juice
4. Masking taste and odor
5. Placement of drugs within body tissues
6. Sustained release medication
7. Controlled release medication
8. Optimal drug action
9. Insertion of drugs into body cavities (rectal, vaginal)
10. Use of desired vehicle for insoluble drugs
Solid dosage Liquid dosage Semi solid dosage
T forms .
Unitdosage Bulk Biphasic Monophasic Internal External
forms |
T eas 7
‘Suspension intemal femal Ointment
Tablets me s
Serene Liniments pastes.
Powders Syrups Lotions. delies.
Pills: pas internal f= Extornal Elixirs Gargies
oC a et
seenerene s enon on Sprays Suppositones
a Dentitrice Eye lotions = Pessaries
Snutts Eye drops
‘Ear powgers: Nasal drops
RANCHES OF PHARMA‘
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Industrial Pharmacy Drug Sales and Marketing { ]
© Drug Wholesales ‘+ Hospital Pharmacy
© Journalism Clinical Pharmacy
© Marketing * Forensic Pharmacy
© Nuclear Pharmacy © Government Services
‘© Medical Communications © Community Pharmacy
Retail Pharmacy Other Ser
Introdu
¢ The pharmaceutical industry is responsible for the production of drugs, ensuring that they are safe
effective and of high quality,
* Pharmacist applies all the scientific knowledge & skill during production, storage and distribution
© Services provided by the phi
information & monitor
macist in different departments of the industry are research, medical
Products safety, regularity affairs, medical script writing, manufacturin
quality control, supplies, management any other departments.
Definition:
«l control
* The branch of pharmacy, which deals with fo
tion, manufacturers, analysis, storage
of pharmaceutical dosage forms, is called industrial pharmacy
¢ Inbrief industrial pharmacy can be de
cd as, “Its the processing of drugs from the source up-to the
finished product and (o provide quality assure product (o the professionals as well as the consumer
Operations Include:
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It includes basic unit operation like , milling, drying, lyophilization, Filtration & com
Which leads to the preparation of liquid, solid, semi-solid dosage form and also injectable.
Industrial Pharmacist:
Pharmacist who is related to industry is called industrial pharmacist. He has various jobs in industry,
some are executive i.e.:
. Production Incharge
. Factory Incharge
. Production Manager
|. Sales Manager
Pepe
And some junior executive is also working there i.e.
|. Production Pharmacist
. Analyst (QC)
. Assistant Pharmacist
|. Documentary Pharmacist
. Research Pharmacist
Research & Development (R & D):
ween
Formulation
Reformulation
Drug-excipient Compatil
Testing
Determine proper route of administration of drug
Product's stability including the proper packaging material
Innovations
lity
Production:
Conversion of raw materials to finished products
‘Supervises the operation, GMP must be observed, involved in planning production.
Raw Material + Production Procedure ~ Finished Products
With manufacturing facilities, engaged in production operations
CODOSOee
Quality Control:
© Qualitative / quantitative checks of RM, intermediate and finished products
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Tests are performed on products
Assay — determine the % purity of active ingredient
2. HOSPITAL PHARMACY:
Introduction;
The function of a hospital is to provide health care to the patient. In its organizational structure,
consists of many departments which are coordinated in their work and their common task is to provide health
care facilities to the patient, In these departments, one is Hospital Pharmacy.
Hospital pharmacy ean be defined in two ways on the basis of its services ie. Departmental Services
and Professional Services,
A department or service in hospital under the direction of competent pharmacist, Pharmacists work
with physicians, nurses, patient and other hospital personnel, From hospital pharmacy all medications are
supplied to nursing units, Pharmacist is an important part of the health care team,
Professional Services:
Pubepe
Participation in edueatio
rograms for patient, nurse & medical staff
. Poison control center activities
Drug information centre
Preparation of patient drug use profile
. Parenteral nutrition program
. Communicating new drug information to hospital personnel
. Dispensing and research of radiopharmaceuticals
Activities / Responsibilities:
‘Compounding, provides stock medication, performs moderate scale manufacturing (dermatological,
TPN)
Responsibility to inspect the pharmaceutical supply
The filling and labeling of all drug containers used in various wards
Responsible for Drug control system in hospital
Responsible for the professional care of the patient regarding drug use
Manager of hospital pharmacy
Part of PTC, managing Drug Information Service
Monitoring of drug therapy
Knowledge Required:
Hospital pharmacist must be knowledgeable on:
© Dnugs and their action
© Pharmaceutical Manufacturing Program
© Control procedure regarding
* QC (prep of TPN / admixtures)
+ Dnig distribution throughout the hospital
© Research activities both medical and pharmaceutical
© Teaching Techniques (in-service training programs)
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© Pharmacy administration in hosp
ROUTINE SERVICES SPECIAL SERVICES
Siocking of drugs and allied substances Participation in education, poison control activity, drug
information center, research activity
Dispensing to in-and out- Patients on prescription | Preparation of parenleral nutrition and
radiopharmaceuticals
‘Supply of the drugs to nursing station Dispensing of parenteral nutrition and
radiopharmaceuticals
Bulk manufacturing / compounding Preparation of patient drug use profiles:
S.CLINICAL PHARMACY;
© Recent wation in Pharmacy Practice (1970)
* Patient — oriented profession
Definition:
The branch of pharmacy which deals with patient care with particular emphasis (special practice) on
drug therapy is called clinical pharmacy.
It is also called “Patient-oriented Pharmacy”, so it includes not only the dispensing or administration of
required medications but also advice the patient on the proper use of all medications. Clinical pharmacy can
also be practiced in community as well as in hospital.
Activities:
© Makes rounds with doctor, maintains patient histories, monitors drug therapy, advises patient on drug
use, side effects, and drug interactions, ADR's
Direct patient involvement (conducting admissions, discharge, interviews)
Drug Utilization Reviews, education to improve drug's use
US: Doctors write Rx: pharmacists prescribe the medicine
Important that clinical Pharmacist is familiar with different lab tests and interpretation of results
Associated with decreased hospital mortality rates, decreased drug cost, decreased length of stay of
patient
‘© Pharmaccutical care ~ optimal use of medications to achieve specific outcomes that improve a patients
‘quality of life
© Counseling and Guidance to Patient
© Drug Monitoring Evaluation
Patient-Oriented Pharmacist Considers:
© Knowledge of Drugs
+ Drug Information skills
* Communication Skills
Previously: Physician “> Patient ++ Pharmacist
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Interaction
Now: Physician "Pharmacist (Dur) "4 patient
x
Barriers to Clinical Pharmacy Practice:
Lack of interest of top management
Higher costs
Other professionals are unhappy
Lack of incentive for pharmacist
Lack of training / specializing areas to develop expertise
PHARMACY PRACTICE TRANSITION
Figure 1. Time line of the five stages of major change in pharmacy practice
Marketing:
Product managers
Set policies / targets for the sales team
Sales:
© Contact prescribers regarding company’s products
© Explain products in detail
Drug Establishment:
© Manufactures, imports, repacks, distributes pharmaceuticals
Drug Trader:
© Registered owner of drug product
© Procures the RM and packaging components
* Provides production monograph, QC standard, procedures
a
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© Subeontracts a manufacturing lab
Drug Distributor / Importer:
‘* Imports RM, active ingredients, finished product for its own use or for wholesale distribution
Drug Distributor / Exporter:
+ Exports RM, active ingredients, finished product to other countries
Drug Distributor / Wholesale:
* Procures RM, active ingredients, finished product from local establishment for local distribution on
whole sale basis
© Important part of distributive scheme, provides mechanism to obtain various products manufactured
by different labs from single agency.
Less hazards in stock handling, record keeping and bill paying for the retailer