Community Pharmacy
Organization and structure of retail and wholesale drug store, types and design, Legal requirements for establishment and maintenance of a drug store, Dispensing of proprietary products, maintenance of records of retail
and wholesale drug store
Function of community pharmacy, Organization and structure of retail and wholesale drug store, Legal requirement for establishment, Maintenance of records
Pharmacy and therapeutic committee, PTC, Organization of PTC, Functions of PTC, Automatic stop order, Emergency drug list, ADR and safety monitoring, Role of Pharmacy and therapeutic committee
Function of community pharmacy, Organization and structure of retail and wholesale drug store, Legal requirement for establishment, Maintenance of records
Pharmacy and therapeutic committee, PTC, Organization of PTC, Functions of PTC, Automatic stop order, Emergency drug list, ADR and safety monitoring, Role of Pharmacy and therapeutic committee
Introduction to clinical pharmacy, Concept and Objectives of clinical pharmacy, Function and responsibilities of clinical pharmacist, Clinical Pharmacy services.
hospital formulary is developed under the guidance of pharmacy and therapeutic commitee of the hospital.pharmacist working in a hospital should play an important role in the preparation of the hospital formulary
Definition, Types of drug distribution systems, Dispensing of drugs to ambulatory (outdoor) patients, Distribution of controlled drug, Novel drug distribution methods
Objectives, scope, Organization and structure of retail and wholesale drug store, type and design, dispensing of proprietary products, legal requirements
Introduction to clinical pharmacy, Concept and Objectives of clinical pharmacy, Function and responsibilities of clinical pharmacist, Clinical Pharmacy services.
hospital formulary is developed under the guidance of pharmacy and therapeutic commitee of the hospital.pharmacist working in a hospital should play an important role in the preparation of the hospital formulary
Definition, Types of drug distribution systems, Dispensing of drugs to ambulatory (outdoor) patients, Distribution of controlled drug, Novel drug distribution methods
Objectives, scope, Organization and structure of retail and wholesale drug store, type and design, dispensing of proprietary products, legal requirements
Pharmacy Practice
Scope of pharmacy practice
Community Pharmacy
Scope of community pharmacy
Community pharmacy management
Selection of Pharmacy site
Objective
Legal requirements
Drug procurement
Drug storage and inventory control
Pharmacy Practice is the discipline of pharmacy which involves developing the professional roles of pharmacists. Pharmacy Practice offers practicing pharmacists in-depth useful reviews and research trials and surveys of new drugs and novel therapeutic approaches.
Community Pharmacy Ravinandan A P 7th Sem.pptxRavinandan A P
Community Pharmacy -
Introduction
Organization and structure of retail and wholesale drug store,
Types and design
Legal requirements for establishment and maintenance of a drug store
Dispensing of proprietary products
Maintenance of records of retail and wholesale drug store.
1) Layout and Physical Facilities For Medical Store
• Designing a Drug Store
• Location and Layout of the Hospital Pharmacy
• Layout
• Flow charts for Materials and Members
General Flow Chart Out Patients
General Flow Chart In Patients
General Flow Chart for Materials
• Selection of Site Space, Layout & Design For Community Pharmacy
• Plan an Ideal Retail and Whole sale Store
• Legal Requirements
General Licenses
Restricted Licenses
• Physical Facility
Personal and Floor space Requirement including Equipments
2) Staff
• Selection Of Staff
• Compensation
3) Receipt of drugs
• What is a Drug?
• Requisition, Supply and Receipt of Drugs
Drug request
Completing Stores Requisition/ Delivery (issue) Form
• Supply of Drugs from Medical Stores
Store Requisition / Delivery (issue) Form
Receipt of drugs at Dispensary
4) Disposal of Expired Drugs
5) Drug Safety
6) Unit dose dispensing
• What is UDD
• ADVANTAGES
7) Guidelines To Minimize Pilerage of Drugs
8) Hathi Committee Recommendation For Hospital Pharmacy
Community Pharmacy: Defined as a place where the medicines are stocked and dispensed to the patients or patient care givers under the supervision of a qualified and registered pharmacist upon the production of a prescription or when legally permitted without the prescription
Some of the points to be considered before starting a pharma franchise company FitwelPharma
Pharma franchise companies are many advantages to be a part of the Pharma franchise company. Also, it offers you a huge scope because of the greater demand for drugs. You should check the pharma company sales services and delivery period too.
Chemist and Pharmacies are the most important part of pharmaceutical distribution chain. They sell out medicine and drugs to patients at prescription of registered medical practitioner...
Quick Sccess Guide: Top 25 Questions Answered by the New FDA Q&A DraftAngela Carver
Supply chain businesses nationwide are rushing to implement operational changes in order to meet upcoming FDA Drug Supply Chain Security Act deadlines. This process has been a struggle for many due to the complexity of this legislation. Different business types must follow different portions of the rule in regards to reporting, registering and much more. The Food and Drug Administration released a new draft to answer some of the most frequently asked questions from third party logistics and wholesale distribution operations. This report is an update to a previously published 2014 draft. It is the intention of the FDA that these drafts are viewed together. This Q&A supplemental provides clarification based on the most frequently asked questions and comments received after the publication of the Annual Reporting draft guidance.
It is critical to clearly understand how these changes will affect your operation as any error in reporting or filing can result in significant penalties. Take advantage of these detailed tools provided by the FDA to ensure your operation is prepared before reported deadline dates. For more information on technologies to aid in pharmaceutical regulatory compliance contact Datex experts today at marketing@datexcorp.com or 800.933.2839 ext. 243.
How to start a wholesale pharmacy business in India? - Fossil RemediesFossil Remedies
If you are looking to start a wholesale pharmacy business in India then it is a one of the leading PCD Based Pharma Franchise Companies in India. Here you know the basic requirements to start a wholesale pharmacy business.
Need for Therapeutic Drug Monitoring, Factors to be considered during the Therapeutic Drug Monitoring, and Indian scenario for Therapeutic Drug Monitoring.
Drug distribution system in a hospital.pptxMangeshBansod2
Drug distribution system in a hospital
Dispensing of drugs to inpatients, types of drug distribution systems, charging policy and labelling, Dispensing of drugs to ambulatory patients, and Dispensing of controlled drugs.
Adverse drug reaction- Drug Interaction .pptxMangeshBansod2
Classifications - Excessive pharmacological effects, secondary pharmacological effects, idiosyncrasy, allergic drug reactions, genetically determined toxicity, toxicity following sudden withdrawal of drugs, Drug interaction- beneficial interactions, adverse interactions, and pharmacokinetic drug interactions, Methods for detecting drug interactions,
spontaneous case reports and record linkage studies, and Adverse drug reaction reporting and management.
2. Hospital Pharmacy and its Organisation.pptxMangeshBansod2
Hospital pharmacy and its organization
Definition, functions of hospital pharmacy, Organization structure, Location, Layout and staff requirements, and Responsibilities and
functions of hospital pharmacists.
Hospital and it’s organization
Definition, Classification of hospital- Primary, Secondary and Tertiary hospitals, Classification based on clinical and non- clinical basis, Organization Structure of a Hospital, and Medical staffs involved in the
hospital and their functions.
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
New Directions in Targeted Therapeutic Approaches for Older Adults With Mantl...i3 Health
i3 Health is pleased to make the speaker slides from this activity available for use as a non-accredited self-study or teaching resource.
This slide deck presented by Dr. Kami Maddocks, Professor-Clinical in the Division of Hematology and
Associate Division Director for Ambulatory Operations
The Ohio State University Comprehensive Cancer Center, will provide insight into new directions in targeted therapeutic approaches for older adults with mantle cell lymphoma.
STATEMENT OF NEED
Mantle cell lymphoma (MCL) is a rare, aggressive B-cell non-Hodgkin lymphoma (NHL) accounting for 5% to 7% of all lymphomas. Its prognosis ranges from indolent disease that does not require treatment for years to very aggressive disease, which is associated with poor survival (Silkenstedt et al, 2021). Typically, MCL is diagnosed at advanced stage and in older patients who cannot tolerate intensive therapy (NCCN, 2022). Although recent advances have slightly increased remission rates, recurrence and relapse remain very common, leading to a median overall survival between 3 and 6 years (LLS, 2021). Though there are several effective options, progress is still needed towards establishing an accepted frontline approach for MCL (Castellino et al, 2022). Treatment selection and management of MCL are complicated by the heterogeneity of prognosis, advanced age and comorbidities of patients, and lack of an established standard approach for treatment, making it vital that clinicians be familiar with the latest research and advances in this area. In this activity chaired by Michael Wang, MD, Professor in the Department of Lymphoma & Myeloma at MD Anderson Cancer Center, expert faculty will discuss prognostic factors informing treatment, the promising results of recent trials in new therapeutic approaches, and the implications of treatment resistance in therapeutic selection for MCL.
Target Audience
Hematology/oncology fellows, attending faculty, and other health care professionals involved in the treatment of patients with mantle cell lymphoma (MCL).
Learning Objectives
1.) Identify clinical and biological prognostic factors that can guide treatment decision making for older adults with MCL
2.) Evaluate emerging data on targeted therapeutic approaches for treatment-naive and relapsed/refractory MCL and their applicability to older adults
3.) Assess mechanisms of resistance to targeted therapies for MCL and their implications for treatment selection
The prostate is an exocrine gland of the male mammalian reproductive system
It is a walnut-sized gland that forms part of the male reproductive system and is located in front of the rectum and just below the urinary bladder
Function is to store and secrete a clear, slightly alkaline fluid that constitutes 10-30% of the volume of the seminal fluid that along with the spermatozoa, constitutes semen
A healthy human prostate measures (4cm-vertical, by 3cm-horizontal, 2cm ant-post ).
It surrounds the urethra just below the urinary bladder. It has anterior, median, posterior and two lateral lobes
It’s work is regulated by androgens which are responsible for male sex characteristics
Generalised disease of the prostate due to hormonal derangement which leads to non malignant enlargement of the gland (increase in the number of epithelial cells and stromal tissue)to cause compression of the urethra leading to symptoms (LUTS
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Ethanol (CH3CH2OH), or beverage alcohol, is a two-carbon alcohol
that is rapidly distributed in the body and brain. Ethanol alters many
neurochemical systems and has rewarding and addictive properties. It
is the oldest recreational drug and likely contributes to more morbidity,
mortality, and public health costs than all illicit drugs combined. The
5th edition of the Diagnostic and Statistical Manual of Mental Disorders
(DSM-5) integrates alcohol abuse and alcohol dependence into a single
disorder called alcohol use disorder (AUD), with mild, moderate,
and severe subclassifications (American Psychiatric Association, 2013).
In the DSM-5, all types of substance abuse and dependence have been
combined into a single substance use disorder (SUD) on a continuum
from mild to severe. A diagnosis of AUD requires that at least two of
the 11 DSM-5 behaviors be present within a 12-month period (mild
AUD: 2–3 criteria; moderate AUD: 4–5 criteria; severe AUD: 6–11 criteria).
The four main behavioral effects of AUD are impaired control over
drinking, negative social consequences, risky use, and altered physiological
effects (tolerance, withdrawal). This chapter presents an overview
of the prevalence and harmful consequences of AUD in the U.S.,
the systemic nature of the disease, neurocircuitry and stages of AUD,
comorbidities, fetal alcohol spectrum disorders, genetic risk factors, and
pharmacotherapies for AUD.
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These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
2. Introduction
Community pharmacy deals with compounding, counseling,
and dispensing of drugs to the patients.
The above responsibilities are dealt with care, accuracy, and
legality.
Community pharmacy also involves proper procurement,
storage, dispensing and documentation of medicines.
The community pharmacist is a qualified and pertinent
professional having good knowledge, skills and competence to
deliver the service to the community.
3. A community pharmacist should:
Have a good understanding of pharmaceutical care,
pharmacotherapy, and health promotion strategies,
Have good skills of communication with patients and
healthcare providers,
Maintain high standards with respect to products, services,
and communication, and Document everything in order.
Community pharmacy is a branch of pharmacy that deals
with varied areas of patient care, drug dispensing , and
advising patient on safe and rational use of drug.
5. Types and Design of Drug Stores
A modern drug store complies with the requirements of schedule “N” of
Drug and Cosmetics Rules . A drug store establishment needs a
minimum of 150 sq. feet area , whereas a wholesale drug store requires
a minimum of 200 sq. feet.
The types and designs of drug stores are:
Pharmaceutical Centre: This centre keeps the medicine mostly of
prescription type along with convenience goods and orthopaedic and
surgical applications. The store is well decorated with good atmosphere
and uncluttered (not in use) floor space is the hallmark of the
pharmaceutical centre. Separate room for orthopaedic and surgical
appliances is provided.
Prescription-Oriented Drug Store and Design: Comfortable waiting
area should be provided. Health related items, including drugs, home -
healthcare appliances and supplies, and prescription accessories
should be displayed near the vicinity. Separate room should be
provided for orthopaedic and surgical appliances . Cosmetics should be
displayed in other area of drug store.
6. Types and Design of Drug Stores
Traditional Drug Store and Design: Major objective is to disperse
customers and expose them to all areas of drug store. A drug store having
pleasing appearance, professional atmosphere, and convenience for
employees and customer provides opportunity for maximum sale at
minimum expense. Surveillance for shoplifters should be considered as a
major objective.
Super Drug Store and Design: The store should be 5,000 - 10,000 sq. ft.
with a square design. Traffic control is a major objective rather than traffic
dispersal design, which is in self -service style and all the items one can get
in such drug store. Maximum sale at minimum cost is achieved.
Personal Service Drug Stores: In this type of design, the whole area is not
exposed to the customer but the customer is required to interact with the
drug store personnel at the service counter. During the purchasing process
the customer demands an article and the personnel provides it.
This service and design facilitates maximum interaction between the drug
store employee and the customers. The success of such drug store
depends upon the convenience and friendly service of the personnel at the
service counter.
7. Legal Requirements for Retail or Wholesale Drug
Store
Licenses:
General Licenses: These licenses are granted to an individual having
premises for the business and who may employ or may himself be a
qualified person to supervise the sale of a drug store. Form 20 deals with
license for retail sale of drug store , other than those specified in schedule
C, C1,and X. For drug specified in schedule C, C1 excluding those specified
in Schedule X is governed through for m 21 and for Schedule X in 20F.
The conditions applicable for general licenses are:
○ The owner should display the license in a prominent place within the
premises allowing public to see.
○ The license should fulfill at the provisions of Drug and Cosmetics Act and
Rules.
○ Any change in the staff should be brought in the knowledge of the Licensing
Authority within a month.
○ Schedule C and C1 drugs should be stored as per the precautions prescribed
by the Licensing Authority.
○ The owner should take permission fro m the License Authority for the sale of
additional categories of drug listed in Schedule C and C1, excluding X.
8. Legal Requirements for Retail or Wholesale Drug
Store
Restricted Licenses: These licenses are granted for the restricted sale of
drugs other than those specified in Schedule C , C1, and X and those
specified in Schedule C and C1, excluding X are governed by the form 20A
and 21A , respectively. The conditions for restricted licenses are:
○ The drug should be sold in its original container.
○ The license should fulfill all the provision s of Drugs and Cosmetics
Acts and Rules.
○ The drug should be purchased from a duly licensed dealer.
○ The licenser should bear premises equipped with required storage
facilities for drug.
Minimum Qualifications: The minimum qualification for starting a
wholesale drug store is matriculation with four years‟ experience in selling
of drugs in a chemist shop on salary basis or Diploma in Pharmacy and also
should be Registered Pharmacist with the State Pharmacy Council. The
minimum qualification to get registered with State Pharmacy Council is
Diploma in Pharmacy from a recognized institution.
A person who has sufficient capital and is interested to start a drug store,
can also do so by appointing a „Registered Pharmacist‟ on whole time
basis.
9. Legal Requirements for Retail or Wholesale Drug
Store
Minimum Space: Though, there is no minimum prescribed area mentioned
in the Drugs and Cosmetics Act and Rules, 1945, the minimum desirable
area to open a new retail as well as wholesale drug store is 10 sq. metres.
However, the minimum desirable area to open a new combined wholesale
and retail drug store is 15 sq. metres.
Store Arrangements: There should be a sufficient number of racks to store
drugs and pharmaceutical preparations. For storage of antibiotics, vitamin
products, vaccine, sera, and enzymatic preparations , which are required to
be stored at a temperature between 2-8°C, a refrigerator is necessary.
10. If the analysis indicates that a new pharmacy should be established, the
pharmacist should consider the following factors:
Organization: The pharmacist may choose from three widely recognised forms of
legal organization for the drug store enterprise.
Unincorporated Sole Proprietorships: The business enterprise owned and
managed by an unincorporated sole proprietor is not considered in law as a
separate legal entity; rather, the owner and the enterprise are considered one.
Partnerships: Partnership arrangements and incorporation are mechanisms that
may be used to broaden the financial or talent base for an enterprise and also may
serve to spread the risk. As to liability, a partnership may be described as an
association of sole proprietors, because at law the partnership is not considered
separate from those who compose it.
Corporations: Co-ownership also may be affected through a more formal
organization known as the corporation, which i s a separate legal entity, created by
the expressed authority of the state.
Site Selection: The factors such as population in the trading area, distribution of
income among the population, type of industry, and the competitive climate have
been cited as being important for site selection.
Capital: Planning and assembling the capital requirements for a new pharmacy are
predicted on careful evaluation of projected sales volume, breadth and depth of
inventory requirements, and estimated operating expenses. The amount of capital
required for the operation of a successful pharmacy is a function of its productivity.
11. Documents Required to Open a Retail Drug
Store
A license is required to sell, stock, exhibit for sale, or distribute drugs. In
order to open a retail drug store in any state, the following documents
are needed for a new license:
Application (in duplicate) on Form 19 of the Drugs and Cosmetics Rules,
1945. One copy is for biological drugs and the other is for non-biological
drugs.
A fee of `1500 per licence (total `3000) to be deposited in State Bank of
India/Government Treasury under specific head for grant of a retail sale
licence.
The following documents should be carried with the qualified person while
submission of the fee:
An attested copy of Diploma in Pharmacy from any institution duly
recognized by Pharmacy Council of India,
An attested copy of registration certificate issued by State Pharmacy
Council,
An attested copy of matriculation certificate, and Affidavit from the
qualified person in case he/she is an employee of a drug store.
12. Documents Required to Open a Retail Drug
Store
Affidavit on non -judicial stamp paper, duly attested by a first class
magistrate by each partner in case of partnership concern or by the
proprietor in case of proprietorship concern.
A map of the retail drug store duly signed by proprietor/partners of firm.
Rent receipt in case of rented premises or an affidavit to that effect if the
person is the owner of the premises.
A copy of the partnership deed in case of partnership concern.
Refrigerator purchase receipt.
The licence is valid for a period of five years. It is required to be renewed
for next five years before its expiry.
Pharmacy Council of India is planning to make it mandatory to wear a
white coat bearing the name of the registered pharmacist who is running
the retail pharmacy.
13. Maintenance of Drug Store
A drug store can be maintained as follows:
Proper Drug Storage: Drugs are stored in an especially designed secure
area or space in a building so as to:
Avoid contamination or deterioration,
Avoid disfiguration of labels,
Maintain integrity of packaging and guarantee quality and potency of
drugs during shelf-life,
Prevent or reduce pilferage, theft or losses, and
Prevent infestation of pests and vermin.
Storage Environment: It should possess:
Adequate temperature,
Sufficient lighting,
Clean conditions,
Humidity control facilities,
Cold storage facilities, and
Adequate shelving to ensure integrity of the stored drugs.
14. Maintenance of Drug Store
Arrangement of Drugs on Shelves
Shelves should be made of steel or treated wood.
Shelves should be strong and robust.
Drugs should be arranged in alphabetical order of their generic names.
Each dosage form of drug should be arranged in separate and distinct
areas.
Sufficient empty space should demarcate one drug or dosage form
from another.
Most recently received drugs should be placed behind old stock on the
shelf except where new drugs have shorter expiration dates.
The environment should be kept clean.
Lids should be placed properly on tins at the time of closing the shop.
Drugs should be kept in a dry place protected from light and heat.
Liquids should be stored in a pallet on the floor or on the lowest shelf.
The store should be cleaned daily and mopped atleast once a week.
15. Maintenance of Drug Store
Storeroom
A well-arranged store enables easy identification of drugs and saves
time when picking a drug from the shelves.
Drugs should be put on the shelves in alphabetical order
corresponding to the essential drug list. This helps to remove drugs
quickly and makes for easy inventory control.
The rule of First In First Out (FIFO) should be applied always. So, the
drugs received first should be used first, except in cases when the new
stock has shorter expiration date than the old one. In this regard, the
principle of First Expire First Out (FEFO) should be applied.
To have access to drugs with shorter expiration dates first, they should
be put in front of the shelves.
Those with longer expiration dates should be placed behind those with
shorter expiration dates.
16. Maintenance of Drug Store
Dispensary
A daily drug use record should be maintained in the dispensary.
A table for dispensing drugs should be provided.
The dispensing table should not be overcrowded.
The documents should be arranged in an orderly manner on the table, away
from the dispensing area.
After use each tablet counter should be cleaned and placed within easy reach
to the table.
Dispensing of wrong drugs should be avoided by arranging drugs on the table
in alphabetical order so that the drug being dispensed is not confused with
another.
The drug containers from which drugs are not being dispensed should always
be closed to prevent spillage or dispensing the wrong drug.
It must be ensured that drugs stored in a drug store remain preserved during their
storage. There should not be any damage due to high temperature or exposure to
sunlight.
The drugs are to be stored as per the prescribed conditions of their storage. The
drugs stored in a drug store should be arranged in such a way that they are easily
traceable (whenever required). It can be done: According to the manufacturers,
According to the pharmacological action, and Alphabetically.
17. Maintenance of Drug Store
Storage and Maintenance
Drugs should be stored under condition that prevent contamination and
as far as possible, deterioration.
“Well closed container” precautions should be taken in relation to the
effects of the atmosphere, moisture, heat and light.
“Protected from moisture” means that the product should be “stored in
air tight container”.
“Protected from light” means that the product should be stored either in
a container made of material that absorbs light sufficiently to protect
the contents from change induced by such light.
Temperature requirement will be:
○ In a deep freeze (–15°C),
○ In a refrigerator (–2°C to 8°C),
○ Cold or cool (–8°C to 15°C), and
○ Room temperature (–15°C to 25°C).
18. Maintenance of Drug Store
Look-alike and sound-alike drugs should be stored separately.
Temperature should be maintained between 59 -86°F for non -refrigerated
medications. W here refrigeration is necessary, a “Medications Only”
refrigerator should be used and temperature should be maintained
between 36-46°F.
On daily basis check, the proper temperature should be verified and
documented. All multiple-dose injectable medications should be initialed
and have the date of first entry recorded on the label. Multiple dose vials
remain potent until manufacturer‟s date on the vial. The medication stock
should be monthly rotated employing a FIFO (First In/First Out) process.
19. Dispensing of Proprietary Products
Patent or proprietary medicine is a drug that behaves as a remedy or
prescription dispensed in a form given through internal or external route in
human beings or animals and presently excluded in the edition of the
Indian Pharmacopoeia or any other Pharmacopoeia authorized by the
Central Government after consultation with the Drugs Technical Advisory
Board.
Availability of proprietary medicines is increasing day by day. Henceforth,
traditional compounding of medicines is not practised more often except in
hospitals where physicians prescribe compounded prescriptions in limited
cases. So the pharmacists focus more in dispensing of proprietary
medicines. The proprietary medicines available in the market expand to a
wide range of therapeutic categories of drugs.
Mostly, the proprietary medicines have identical nomenclature that
presents difficulty for pharmacists. The pharmacist should clearly
understand the wishes of the prescriber, should not have any confusion,
and should avoid errors during the dispensing of proprietary medicines.
Computer programmes and software a used to resolve such problems.
20. Principles
To facilitate the compounders in spontaneous preparation of powders and
capsules, the following principles are laid down:
Packaging: The packaging of powders and capsules is done on the basis
of formulation:
Bulk Powders for External Use: Packing of these powders should be
done either as bulk oral powders or as powder-shaker with a sifter top.
Bulk Oral Powders: These powders need to be packaged in an air -tight
glass or plastic jar. It is advised to avoid exposure of bulk oral powders to
moisture as this may form a thick mass of product favoring microbial
growth.
Individual Unit Dose Powders: After preparation these powders are
kept flap to flap and secured using a rubber band. The whole set of
powders is put in a tough cardboard container and labeled before
dispensing the preparation to the patient.
Preparations with effervescent or deliquescent ingredients should be
packed in an air tight container (e.g., an ointment jar).
Unit Dose Capsules: For packing and dispensing of these capsules,
glass or plastic tablet bottle having a child-resistant closure is preferred.
21. Discard Dates: Manufacturing of proprietary powders and capsules are
done in special environments to provide a long shelf-life. In case of
extemporaneous preparations, the compounder should consider
several points while deciding the expiry for a product , e.g., stability of
the ingredients in the preparation and the vulnerability of the
preparation to microbial attack. A general rule states an expiry of up to
three months for any preparation, although every preparation should be
dealt as an individual formulation.
As the term expiry is misunderstood by the patients, hence shelf-life
should be indicated on the label of extemporaneously compounded
preparation and replace the expiry term with discard after followed by
a definite date and/or time.
22. Labeling: Along with the standard requirements for the labeling of
extemporaneous preparations, the points stated below should be
considered:
Bulk oral powders, individual unit dose powders, and bulk powders
for external use are moisture-sensitive. Hence , a caution saying „
Store in a dry place ‟ is mandatory on their label.
Any preparation intended for external use (like bulk powders for
external use) should bear an additional caution „For external use
only‟ on their label.
Likewise, dusting powders also need a caution on their label, stating
„Not to be applied to open wounds or raw weeping surface.
23. Maintenance of Records of Retail and Wholesale Drug Store
For various legal, financial, and professional reasons, the maintenance of
records in the drug store is becoming increasingly important. The types of
records required may be classified as:
Records required by law regarding the acquisition and disposition of
drugs,
Records regarding patient utilization of drugs, and
Records regarding the past and present financial status of the pharmacy.
Management's role in this function is to identify the specific records
required, develop systems for keeping them, and delegate the
responsibility for day -to-day record keeping to capable personnel.
24. Types of Records
Types of records that should be maintained in a drug store are as follows:
Legal Records: According to Federal and State law, the pharmacy owner
or manager is charged with maintaining accurate up -to-date records on
specific classes of drugs and poisons. Under the provisions of the Federal
Controlled Substances Act of 1970, the pharmacist is required t o maintain
accurate records related to the acquisition and disposition of certain drugs
that are deemed to be subject to possible misuse or abuse. Improperly
maintained or incomplete records can bring legal action and penalties.
Advantage: Abuse and misuse of drugs do not take place.
Patient’s Records: In recent years, many pharmacists have broadened
their record - keeping activities to include patient drug histories. Although
the form of patient record varies with time, the basic idea is to establish a
record (usually on a family-unit basis) that allows the pharmacist to
monitor the drug usage of each member of the family, since there is a
need of drug history for every individual and to reduce the problems
associated with drug interactions and individual idiosyncrasies to drugs. In
addition, these records also may serve economic purposes, as sources of
information for insurance claims and for income tax deductions of the
patient.
25. Providing the required information to potential granters of credit and
loans as well as to Federal, State, and Local governmental agencies
regarding income and business taxes.
Helping to ensure a profitable operation.
Advantages
Efficient management of drug store,
Requirement of inventory,
Helps in making good decisions for future money requirements,
Investment returns,
Analysis of financial statements,
Ensures profits to the drug store,
Checks out the past and current financial position, i.e., revenues and
expenses of drug store,
Less time-consuming process than the journals,
Accounts are proper and accurate,
Labour economy,
Statistical records of sales, i.e., total sales information of various areas, and
Some account books are not needed to maintain, i.e., cheque no., the
payment date, etc., as these are recorded in the purchase book itself.
26. Advantages
Patient compliance.
In case of insurance claims and income tax deductions to patient, it serves
as an information source.
It provides information regarding the number of patients visiting the drug
store. This facilitates to know the drug store business, and also the
relationship between pharmacist and patient.
Financial Records: Properly collected and organized accounting data serves
various important uses and are of value to the pharmacy owner in the following
ways:
Providing the basic tools for efficient management and measuring its effect.
Making sound decisions regarding future cash needs, inventory
requirements, personnel matters, and expansion of facilities.
Evaluating past operations, controlling current operations, and providing
information for planning and forecasting.
Analyzing revenues and expenses.
Measuring return on investment.
Providing the required information to potential granters of credit and loans as
well as to Federal, State, and Local governmental agencies regarding
income and business taxes.
Helping to ensure a profitable operation.