Beruflich Dokumente
Kultur Dokumente
A.
Pharmaceutical Communication
CREDIT 3
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Lecture Plan
A 2 Hour Lecture every week
A 15 Min review of previous lecture in every class
10 Lectures on Business Communication
7 Lectures on Pharmaceutical Communication
Total17 Regular Lectures
Lecture 15 & 16 will be Power-point Projection
1 Hour Class Test after Lecture 17 (Total Marks 20)
19th Lecture class will be a Presentation (Based on assigned topic for individual)
(Total Marks 15)
1st Mid
Introduction
Business Letters
Report Writing
Hr
6
4
4
2nd Mid
Practical Aspects of
BusCOM
Hospital Management
Handling Rx
Hr
6
2
4
Final
Industry
Hr
2
Communication
Industry Guidance
New Drug
2
2
Submission
Int. Marketing
Books Recommended
1. Lesikar's Basic Business Communication -Raymond V. Lesikar, John D. Pettit , Marie
Elizabeth Flatley
2. Essentials of Business Communication - Pal, Rajendra and Korlahalli, J. S.
3. Hospital Pharmacy William E. Hasan, 5th edition, Lea & Febiger, Philadelphia.
4. The Drugs Acts and Rules 1940 to 2006 Published in Gazzette of India, Pakistan, Dacca
and Bangladesh
5. Guidance for Industry - DGDA Ministry of Health and Family Welfare, Government of
Bangladesh
6. Dispensing of Medication Eric W. Martin 7th Edition Mack Publishing Company
7. Remington The Science and Practice of Pharmacy Lippincott Williams and Willkins 21st
Edition
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Lecture 1. Introduction
Line Up. Concept, objective, types (Upward, downward and horizontal) and Importance of Business
communication, Principles of effective communication, Barriers of communication (Wrong choice of media,
Physical, socio-cultural and semantic barriers)
Communication
Communication is the process by which information is transmitted between individuals and
organizations so that an understanding response results.
o Sending and receiving information through messages
o Once considered simply as response to a stimulus
o Now viewed as complex process __focuses on sender, receiver and the clarity of the
message
Objectives of Communication
Various objectives of Communication are :
1) Information: One of the most important objectives of communication is passing or
receiving information about a particular fact or circumstance.
2) Advice: Advice is an important objective of communication as it involves personal
opinions and is likely to be subjective. Advice is given to influence his/her opinion or
behavior.
3) Order: Order is an authoritative communication. The downward flow of information is
dominated by orders. Orders may be written or oral, general or specific, procedural or
operational, mandatory or discretionary.
4) Suggestion: Suggestion enjoys great advantage over other means of communication like
advice or order. Suggestion is supposed to be very mild and subtle form of communication.
5) Persuasion: It is an important objective of communication. In the office or the factory, the
lazy, the incompetent and the disgruntled workers have o be persuaded to do their work.
6) Education: Education is a very conscious process of communication. The main purpose of
education is to widen knowledge as well as to improve skills.
7) Warning: Warning is a forceful means of communication as it demands immediate action.
If employees do not abide by the norms of the organization, or violate the rules and
regulations, it may become necessary to warn them.
8) Raising Morale: Morale boosting is only possible through communication. High morale
results in better performance.
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Merits:
Expression and gestures makes communication very effective.
Very suitable for discussions.
Limitations
Unsuitable for large organizations.
Unsuitable for large gatherings.
Ineffective if the listener is not attentive.
Visual Communication: It encompasses gestures and facial expressions, tables, charts,
graphs, diagrams, posters, slides, film strips etc. It is suitable only to communicate
elementary and simple ideas, can be effective if used in combination with other media.
Audio-Visual Communication: It encompasses television and cinema films that combine
the visual impact with narration.
Computer based Communication: It includes e-mails, voice mails, cellular phones, fax etc.
Advantage:
The quickest means of communication.
The barrier of space is conquered.
Video-conferencing can replace personal meetings.
Storage and retrieval of permanent record had become easier.
Limitations:
Uncertain legal validity.
The virus malady.
Fear of undesirable leakage.
Non-verbal Communication
Non-verbal Communication is communication transmitted without the use of words.
Characteristics of non-verbal communication:
1) Verbal and non-verbal clues co-exist.
2) Body postures, gestures and dress suggestive of social status and education level.
3) Non-verbal clues are more reliable than verbal clues.
4) Non-verbal clues carry cultural biases.
5) It is necessary to interpret non-verbal clues in relation to their context.
KINESICS
Body Language -The study of body language is the most important aspect of non-verbal
communication. Body language includes facial expression, gestures, body movements,
posture, eye contact and touch.
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1. Facial Expression: Face is the index of the mind. A glance at someones face is enough to
give them clues about the subjects mental state.
2. Gestures: A gesture is a movement of the head, hands or legs to express an idea, feeling or
emotions.
3. Body Movements: Body movements refer to the positioning or movement of the body.
4. Posture: Posture means the way in which someone usually stands or sits or holds his
shoulders, neck and back.
5. Eye Contact: Eye contact is a very subtle aspect of body language. It regulates interaction.
6. Touch: Like gestures, touching is also one of the earliest methods of communication
among human beings.
Barriers to communication
Each communication must be transmitted through an appropriate medium. An unsuitable
medium is one of the biggest barriers to communication.
Physical Barriers:
Noise: Noise in a factory, external disturbance in telecom facilities, poor writing, bad
photocopies etc.
Time and Distance: It can also act as a barrier to communication.
Semantic Barriers:
Interpretation of Words: It is quite possible that the receiver of a message does not assign
the same meaning to a word as the transmitter had intended. This may lead to
miscommunication.
Words carry different meanings, shades or flavors to the transmitter and receiver.
To minimize semantic barriers, we should
o Use familiar words.
o Clarify the shades.
o As far as possible, use words with positive connotations.
Barriers caused by different comprehensions of reality are:
Abstracting means picking up few details and leaving out others.
Slanting means giving a particular bias or slant to the reality.
Inferring means drawing inferences from observation.
Socio-Psychological barriers:
Attitude and Opinions: We react favorable or are hostile according to our personal benefit.
Emotions: We cannot transmit nor receive anything correctly if our mind is agitated.
Closed Mind: We hold our opinion so rigidly that we just refuse to listen.
The Source of Communication: We react according to the trust we have in the source of
communication.
PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH
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Quickening of promotion
o Employer Benefit: Prompt & quick decision making and effective communication save
and earn a lot of money and a win-win situation maintained
Organizational Function of Communication
o Informing_ Sharing information, where 1st party takes the initiative to communicate,
gives message to the receiver that should be understandable and the 2 nd party should have
much interest.
o Controlling_ Regulate some activities and behavior of the other party, for eg.
Camera/other electronic product manuals have detail information about what to do/what
not to do.
o Persuading_ Influencing and convincing ability. Advertisements given in TV/other
electronic media tries to make others agree they thought.
o Co-ordinating_ Integration/co-operation/togetherness lack in PDB
Lecture 3. Introduction (Continues.)
Cultur
B. Social
C. Personal
al affecting Human behavior
Characteristics
Refere
Age
nce
Occup
group
Culture
ation
PHARMACEUTICAL COMMUNICATION (PHR Family
207) WORLD UNIVERISTY OF BANGLADESH
SubEcono
culture
Roles
mic
&
conditi
D.
Psychologic
al
Motiva
tion
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Percep
tion
class
Lifestyl
e
Person
ality
g
Beliefs
&
attitud
e
Human behavior
A. Cultural Factors
Human behavior is deeply influenced by cultural factors such as: culture, subculture, and
social class.
Culture
Basically, culture is the part of every society and is the important cause of person wants and
behavior. The influence of culture on behavior varies from country to country therefore
marketers have to be very careful in analyzing the culture of different groups, regions or even
countries.
Subculture
Each culture contains different subcultures such as religions, nationalities, geographic
regions, racial groups etc. Marketers can use these groups by segmenting the market into
various small portions. For example marketers can design products according to the needs of
a particular geographic group.
Social Class
Every society possesses some form of social class which is important to the marketers
because the buying behavior of people in a given social class is similar. Here we should note
that social class is not only determined by income but there are various other factors as well
such as: wealth, education, occupation etc.
B. Social Factors
Social factors also impact the human behavior. The important social factors are: reference
groups, family, role and status.
Reference Groups
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Reference groups have potential in forming a person attitude or behavior. It also include
opinion leader (a person who influences other because of his special skill, knowledge or other
characteristics).
Family
Human behavior is strongly influenced by the member of a family. Therefore marketers are
trying to find the roles and influence of the husband, wife and children. Here we should note
that buying roles change with change in consumer lifestyles.
Roles and Status
Each person possesses different roles and status in the society depending upon the groups,
clubs, family, organization etc. to which he belongs. For example a woman is working in an
organization as finance manager. Now she is playing two roles, one of finance manager and
other of mother. Therefore her buying decisions will be influenced by her role and status.
C. Personal Factors
Personal factors can also affect the human behavior. Some of the important personal factors
that influence the buying behavior are: lifestyle, economic situation, occupation, age,
personality and self concept.
Age
Age and life-cycle have potential impact on the consumer buying behavior. It is obvious that
the consumers change the purchase of goods and services with the passage of time. Family
life-cycle consists of different stages such young singles, married couples, unmarried couples
etc which help marketers to develop appropriate products for each stage.
Occupation
The occupation of a person has significant impact on his behavior. For example a marketing
manager of an organization will try to purchase business suits, whereas a low level worker in
the same organization will purchase rugged work clothes.
Economic Situation
Consumer economic situation has great influence on his behavior. If the income and savings
of a customer is high then he will purchase more expensive products. On the other hand, a
person with low income and savings will purchase inexpensive products.
Lifestyle
Lifestyle refers to the way a person lives in a society and is expressed by the things in his/her
surroundings. It is determined by customer interests, opinions, activities etc and shapes his
whole pattern of acting and interacting in the world.
Personality
PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH
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Personality changes from person to person, time to time and place to place. It has different
characteristics such as: dominance, aggressiveness, self-confidence etc.
D. Psychological Factors
There are four important psychological factors affecting the human behavior. These are:
perception, motivation, learning, beliefs and attitudes.
Motivation
The motivation is the drive that leads the consumer towards buying a product or service. If
the motivation is high, meaning the need or perception of need is high, the individual will
actively seek to satisfy that need.
Perception
A persons meaningful experience of the surrounding world is called perception. There are
three different perceptual processes which are:
Selective attention (current need): Marketers try to attract the customer attention
Selective distortion (pre-set mind): Customers try to interpret the information in a way that
will support what the customers already believe
Selective retention (remembers good points about favorable brands): Marketers try to retain
information that supports their beliefs.
Beliefs and Attitudes
Beliefs are the way people think about a particular subject or product. An attitude is the
individual's consistently favorable or unfavorable evaluation, tendency or feeling about a
particular subject. These beliefs and attitudes shape the consumer's perception of the product.
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Formality is necessary.
A message is sensitive.
Constructing sentences
Designing paragraphs
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Length of the sentence is the most important feature of constructing sentences. In general,
sentences should be adapted to readers. Long sentences are hard to read and harder to absorb.
Short sentences enhance readability. A sentence should have 16 to 18 words, on the average.
Sometimes longer or shorter sentences may be justified. A few good suggestions are:
(i) Limiting content of a sentence
Limiting content of a sentence would reduce its length. However, it should not be overdone.
Too many short sentences make the reading choppy!
(ii) Economizing on words
Always look for shorter ways of saying things. A few suggestions are:
(a) Avoiding cluttering phrases
Go in for shorter expressions like:
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Large paragraphs are heavy and make reading dull and difficult
Short paragraphs appear well-organized and invite readers to read on with attention
Paragraph positioning enhances layout design. Suitable system of headings and subheadings
can further improve the attractiveness of the prose. These days printers use colour
schemes for titles etc to give come hither look to the readers.
(iii) Positioning topic sentence to advantage
Writers must become aware of the importance of positioning topic sentence in the design of a
paragraph. It can help in designing good paragraphs. However, where it should be placed in a
paragraph depends upon the writers plan:
(a) Placing topic sentence first
It is the best option and many firms have adopted it as a policy guideline.
(b) Placing topic sentence last
Here the beginning sentence in the paragraph serves as an introduction. The paragraph ends
with the topic statement that is the real content.
(c) Placing topic sentence in the middle
If topic sentence is placed in the middle of a paragraph, it dilutes the content. It is rarely used
but, in specific situations, it can impart the requisite impact.
(iv) Leaving unnecessary details out of the paragraph
This requires good visualization of the receiver. One can make the paragraph smarter by
omitting extraneous details. Much depends upon the writers judgment.
Lecture 5. Business Letters (Continues.)
TYPES OF WRITTEN COMMUNICATION
Written communication has a very large variety:
1 Letters
2 Memos
3 Telegrams
PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH
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4 Tele-printer messages
5 Short reports (Informal)
6 Long reports (Formal)
7 Proposals
8 Company profiles
9 Product profiles
10 Applicant profiles or resume/ writing
11 Abstracts or Summary writing
12 Reviews and Comments
13 Minutes of meetings etc
14 Research papers
Two popular forms letters and memos are detailed below:
Letters and Memos
Letters and memos are the most traditional written business communication. Letters are
commonly used to present official business information to other businesses, to individuals or
to outside business stakeholders. Memos are usually an internal written communication
format used to convey information to managers and employees. The three main types of
written communication in business include business letters, memoranda and reports. Modern
examples may extend to text messaging, social networking posts and multimedia business
presentations.
Memo/Letter
Memo
1. Short version usually not for external use.
Letter
1. A written form mainly for external use but
Can pacify an angry customer (and a bad letter can annoy a customer)
May sell a new product (or spoil the sale of an established product)
May collect debt without hurting customers feelings (or lose both money and customer)
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Placing orders for goods & services required from other firms
(iii) Letter messaging may be of less importance for small businesses but it is not dispensable.
In fact, a certain amount of letter writing is essential for day to day living in the modern
knowledge society.
FUNCTIONS AND OBJECTIVES OF LETTER MESSAGING
(1) Functions of Letter Messaging
According to a reputed expert, L Gartside, followings are the primary and secondary
functions of letter writing:
(i) Primary functions
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Serves as a record for future use copies can be sent to functionaries in different
locations for future reference
Can reach anywhere in the firms hierarchy and even levels that are difficult to access
normally
Can be sent to different regions, countries and continents where oral or personal contacts
are difficult, thus widening firms reach and access
Exchange information
Seek information
Direct letters
In these letters, one comes direct to the point without any introductory remarks. Such
letters are useful for:
Enquiries
Quotations
Orders
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Offers of appointment
Promotions
Is of confidential nature
These are letters that are used for correspondence on routine and recurring issues. These are
usually preprinted as forms with suitable blanks and hence the name. These are used for:
Acknowledgement
Reminders
Interviews
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Notices
Appointments etc
Sometimes, various possible alternative responses are preprinted and the applicable
paragraph(s) are ticked. They lack personal touch but save effort and time.
(iv) Internal letters
These take the form of memos written among different functions and departments within an
organization. They are eminently suitable for internal communication.
(4) Classifying on the basis of subject of the letters
These may be one of the several types as below:
Enquiries
Orders
Credit information
Complaints
Sales promotion
Sales circulars
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Placing orders for supplies and contracts for services & materials
Sending reminders
Sales circulars
Account payable
Account receivable
Banking
Investments etc
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INTRODUCTION
Business Report is an impartial, objective, planned presentation of facts to one or more
persons for specific, significant business purpose. A report is a method of giving information
about something seen or investigated. It is a formal presentation and is written complete with
conclusions reached and recommendations made. It provides background material and
relevant information in decision-making and action-taking. It is rightly said that reports carry
information from those who have it to those who need it. They reflect flow of information
and have become integral part of modern information management for decision-making.
OBJECTIVES
After studying this unit, students shall be able to:
Grasp the role and importance of written reports in business
Classify business reports in several ways
Understand characteristics of good business reports
Appreciate the advantages and limitations of written reports
Become proficient in preparing written reports
Learn the preferred format for good written reports
IMPORTANCE OF BUSINESS REPORTS
Reports have become, over time, basic management tools for decision-making. These are
extremely important for firms that have grown in size. All the facts and figures cannot be
masterminded by one individual like a proprietor / entrepreneur does in a small enterprise.
For larger firms, reports are indispensable. They have emerged as a very good way of ensuring
participative management for better decision-making and carrying the business forward faster on
the path of growth and expansion.
ADVANTAGES OF WRITTEN REPORTS
Among other merits, following could be enumerated:
1. Provide record for both the parties sender and receiver
2. Provide a reference that can be distributed to all concerned
3. Writers have time to think and ponder before writing
4. Writers can change and chop the text several times before its submission
5. Receivers can go over the reports several times
6. Receivers can construct better response as they too have time to think and ponder
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Oral reports
Written reports
Statutory reports
Non-statutory reports
Special reports
Informative reports
Fact-finding reports
Performance reports
Technical reports
Reports by individuals
Reports by team
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(1) Accuracy of facts: Since reports are used for decision-making, inaccurate and unverified
facts can lead to disastrous results. It is said, What is worse than no information is wrong
information.
(2) Brevity: Difficult to define, it is also not possible to state it as a rule to be followed for
writing reports. Good reports are brief but brevity should not be achieved at the cost of clarity
nor should it be at the expense of completeness. Thus the reports should include everything
that is relevant yet be brief!
(3) Clarity: Clarity comes from orderly, systematic and clear thinking. Reports should be
skillfully divided in to short paragraphs, giving headings and inserting signposts to attract
attention and securing sustained interest of the readers who are indeed customers.
(4) Free from grammatical errors: Good reports are a good piece of composition presented
attractively and free of any grammatical error. If choice of words is faulty, construction of
sentences is confusing and design of paragraphs is dull, reports would find few readers. If
reports require too much of sorting out of data and sifting out the meanings before taking
decisions, it would always leave a lurking doubt in the decision makers mind. And if
decisions do not reflect the conviction of management, they are unlikely to be implemented
properly.
(5) Objectivity of recommendations: Recommendations should be objective and impartial.
These must be based on logical conclusions of the investigation, analysis and findings. Selfinterest of the individuals should not creep in directly or indirectly.
(6) Unity and Cohesion: If the writers are clear about the main purpose of the report, it gives
unity and cohesion to the report
(7) Precision: Reports avoid extraneous issues and are precise and incisive. Precision adds
value to the report.
(8) Reader-orientation: Reader orientation is customer orientation. Writers must always
keep the person(s) going to read the report in mind. Contents of reports to laypersons will be
different from the reports prepared and submitted to experts and specialists.
(9) Relevance: The facts and data should have a direct bearing on the main purpose of the
message intended. Nothing relevant should be skipped nor any irrelevant data be added to
make the report confusing. Exclusion of facts may make the report
incomplete and is likely to mislead.
(10) Simple language: Reports using simple, familiar words and direct construction of
sentences call for a greater understanding of the subject. Only a deep knowledge enables
persons to throw up and use simple words and phrases for expressions. Reports should be free
of trite expressions, clichs and figures of speech.
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Knowing the purpose of the report: This highlights the importance of crafting a good
title for the report. The wordings of the title of the report should cover the purpose in a
precise, concise and specific manner.
Visualizing the reader(s): Reports should adapt to the mental frame of the readers. If
report is meant for a larger group, the typical characteristics of the receivers must be
visualized and borne in mind while writing the report. In short, writers must have a
healthy love and respect for their readers report has to attract and sustain their attention
Choosing the ideas: After writing down the ideas, next step is to sequence them in some
logical and systematic way for making it easier for the readers to understand and grasp
the ideas.
Collecting all facts and data backing the ideas: Having collected all the relevant data,
writers must edit in terms of the most suitable sequencing of the ideas for influencing the
receivers. For ease of readability, all the data may not have to be put in the main body of
the report detailed tables, charts etc may be put in the appendices at the end of the
report.
Organizing ideas in the most effective manner: The order in which the ideas will be
presented is as important as the ideas themselves. The discipline of translating your
thoughts in to appropriate words and organizing these thoughts and words logically has
no equal in the intellectual training.
Writing, rewriting and rewriting: To revise any draft effectively, it should be read
objectively and with a fresh mind from the viewpoint of the readers. Writers must read
paragraph by paragraph and check the continuity of the ideas. Every word, figure and
image must be checked thoroughly.
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By criteria or topics: This is the most common way. The main headings could be the
standards, factors, solutions, benefitsetc.
By procedure or process.
By sources.
By problem solution.
Place the most important ideas (Criteria) in the highest degrees of heading,
considering report length, subject matter, and reader.
2.
Try to balance the sections as well as possible. For example, if section II.A, had 12
subheading and section II.B had no subheading, the proportion would be lopsided.
Then try to narrow the scope of heading II.A (by rewarding it and by rearranging
facts) and broaden II.B.
3.
Have at least two subheading if you divide any topic; for example, A.1 and A.2 never
ever only A.1.
4.
The number of section headings neither too many nor too few. Usually three to seven
main sections are desirable.
5.
Do not consider the report title as a section heading, and do not begin the first
sentence with exactly the same words as the heading.
Date submitted
2. Acknowledgement: In the compilation, analyses of data, facts etc for the preparation
of the report, the individuals or the team might have requested and received valuable
help and suggestions. It is a good practice to thank the persons individually or
collectively for the help extended by them for the completion of the report. The
acknowledgement should normally cover not more than half-full A-4 size word
processed page and should be signed by all the persons who have authored the report.
PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH
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3.
Executive summary: The term executive has been derived from its usage in USA
where executive are members of the top rung of the organization covering Chief
Executive Officer (CEO), Chief Operating Officer (COO), Chief Finance Officer
(CFO), Chief Information Officer (CIO) etc. This is an extremely important page and
must be written in very compelling language covering the main recommendations.
Executives read this page
3. Table of Contents:
Show the beginning page number of where each report heading appears in the report
Connect the page numbers and headings with spaced dots (leaders)
4. Introduction:
5. Body/Results of study
Use clear, descriptive headings as well as charts, graphs and pictures to emphasize
your points.
Use numbered recommendations that suggest actions for solving the problem
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A. Public Speaking
Everyone seems to be talking to every other person. It is human nature to be communicating,
negotiating and marketing all the time with the aim of persuading others to own point of
view. The sole purpose is to change the mind or way of thinking about a topic. Budding
managers / leaders must become aware of the role of different elements that go to make a
person an effective, persuasive speaker:
(1) Articulation: Everyone should have a basic appreciation how the speech mechanism
works in humans. He should be able to adjust the faculty of speech to suit the occasion.
(2) Pronunciation: The speaker should be able to pronounce each word clearly and avoid
slang to make a point. He should not slur the words and avoid speaking filler phrases like I
think or you know etc.
(3) Tone: One should avoid speaking in one tone, without varying it, as it will make the
speech very monotonous and dull. One should modulate ones voice to make it sound
interesting.
(4) Pitch: One should vary the wavelength and frequency of the voice. A good speaker keeps
the listeners on their toes by continually changing tone and pitch of voice. This precludes
speeches becoming boring.
(5) Speed of delivery: An effective speaker has a control on his pace of delivery. A speed of
150 to 200 words per minute is normal. A faster delivery may appear insincere and a lower
pace may sound like lecturing. It is possible to count words spoken per minute by taperecording the speech. A human brain can easily hear up to 400 words per minute. If speaker is
slow, listeners mind may wander away.
(6) Pauses: Pause in speech is a critical tool. When speakers want to highlight any word, a
pause just before that word would ensure that. If they want to emphasize the importance of a
word, a pause just before and after the word would do it effectively.
(7) Body language: The powerful language of gestures, sounds and expressions never tells a
lie and does not mislead those who have a deep knowledge of it. A proper posture is very
important saggy shoulders and cross-legged sitting postures will not appear to be honest.
(8) Volume: If one is screaming throughout ones speech, it may sound jarring and
monotonous. On the other hand, a few well-meaning shouts so as to throw your voice to the
last row, may energize a speech and electrify the situation. It can be an effective tool for
persuasion but should be used very carefully.
(9) Quality of voice: Quality of voice can be measured by the impact it has on the audience.
Everyone must try to keep the vocal quality high because it is what distinguishes one speaker
from another!
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(10) Variety in speaking: A seasoned speaker keeps varying the voice of delivery tone,
pitch, speed and volume, to make it sound interesting. Change should be brought in every 30
seconds or after every paragraph. Variety in speech delivery keeps the listeners locked in to it
as it sounds interesting. The speaker should let the words speak for themselves as listeners
reflect on them through his voice.
B. Presentation Skill
Speakers lack the skills and confidence to make effective presentations. We have all been
victims of speakers who put us to sleep. Despite knowing how ineffective many speakers are,
many of us have found that, despite the best intentions, we havent fared much better.
Preparing Content: 3As
1. Analyze your AUDIENCE
What are their names, titles, backgrounds, reasons for attending, etc?
What will they feel, believe, and do after hearing your talk?
Important considerations
1. Eye Contact
Looking them in the eye makes them feel that they are influencing what you say.
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2. Voice
Articulation
Pronunciation
Vocalized pauses
Rate of speech
Volume
Pitch or tone
Emphasis
Stand immobile
Interview Skills
The Dos
Arrive 10 minutes early. Know the exact time and location of your interview; know how
long it takes to get there, park, and find a restroom to freshen up.
Offer a firm handshake, make eye contact, and have a friendly expression when you are
greeted by the interviewer.
Ask for clarification if you dont understand a question; and be thorough in your
responses while being concise in your wording.
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Treat the interview seriously and show interest in the employer and the opportunity
presented and respond to questions in a positive manner.
Make sure you understand the employers next step in the hiring process; know when and
from whom you should expect to hear next.
Interview Donts
Dont make excuses. Take responsibility for your decisions and your actions.
Dont make negative comments about previous employers or supervisors (or others).
Dont act as though you would take any job or are desperate for employment.
Dont take cell phone calls during an interview. If you carry a cell phone, turn it off
during the interview.
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Brainstorming is a group discussion in which individuals use the free flow of ideas to
generate as many thoughts as possible within a defined period of time. Brainstorming is a
great tool to:
Categorize Ideas: Combine related ideas. Re-write your list or rearrange post-it notes.
TIP: If you want to group the ideas, an affinity diagramming process might be the best
way to proceed.
Rank Order Ideas: Ranking the brainstorming results helps to focus a team's efforts to
find workable solutions to the issue at hand.
Make sure the group is clear about the topic that is to be brainstormed and stimulate ideas
Don't let your extroverts dominate the discussion, solicit input from of quieter members
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Medias of Communication
Media
Type
TV
Potential
Target
Advantage
Disadvantage
Mass media
can
reach many
people;
High status
Public
Radio
Same as above
Public
Expensive;
Programs not always
on at convenient
times; Not everyone has
TV; No room for
interaction unless
linked to a TV call in
show
Relatively inexpensive
(compared to TV); Programs
not always on at convenient
times; No room for
Interaction; Audio only, no
visual communication
Newspap
er
Same as above
Literate People
Websites/
internet
&
blogs
Need to be
computer
literate
Literate public;
Specific list serves
and networks can
be set-up for
particular
audiences/clients such
as the
media directly
Mobile
phones
and text
messages
Tremendous
potential
for 1 on- 1
communication
directly.
Specific publics,
teenagers in
particular
Posters
No potential for
feedback, unless
widely
tested or if
produced
together with
communities
through
participatory
processes
No potential for
feedback, unless
widely
tested and
produced
through
participatory
workshops with
participants
No potential for
General and
specific publics
General and
specific publics
Limited to specific
Distributions; Requires
visual and
written literacy
General
Can be distributed
limited to specific
Brochure
Fact
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sheets
and
flyers
feedback
audiences
Newslett
ers
No potential for
feedback unless
produced with
community
input then
can be highly
effective at
promoting local
innovations and
activities
particularly if
local
people report
and write
the news items
Feedback and
questioning can
be built
into the
presentation and
learning
General and
specific publics
Lots of potential
for
interaction and
participation
Different
audiences can be
targeted directly
Can incorporate
feedback
Instructio
nal video
Public
presentati
ons &
communi
ty
meetings,
service
clubs,
etc.
Power
point
presentati
ons
Target audiences
after meetings, in
markets; Can also be
mailed; Cheap if done in
B&W on colored
paper; reviewed at leisure;
Inexpensive/cheap; Can be
produced in house through
desktop
publishing
Can deliver more
information than posters
and brochures; Not
necessarily expensive, can
be done in-house; Good for
reporting on progress and
achievements;
Credibility can be
high if produced by
community (people
like to see
themselves in print);
Can be produced in house
through
desktop publishing
Can be paused for deeper
discussion and replayed as
Needed; Most communities
are likely to have at least
one VCR;
High status; Equipment is
getting
cheaper to use and
purchase; Can record
before,
during and after
steps in process; Can be
played back
immediately
Encourages group
Formation; Helps to
publicize
general info; Generates
local
Ownership; Builds
partnerships
information for
specific topics
single facts or tips
Requires computer
skills and equipment
to view, projectors;
Cannot
communicate large
amounts of detailed
information;
Requires electricity and
some amount of technical
savvy;
Projectors can be
Limited to specific
Distributions; Requires
visual and
written literacy
Requires editing
equipment and
software unless in camera
taping is followed; Usually
needs to be supported with
other printed materials; Can
be over-used when other
methods may be more
appropriate; More expensive
costs up-front
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Bumper
stickers
Billboard
Not
General public
participatory at and specific
all
audiences
Same as above
Diaries,
Calendar
Can be
General publics
participatory if
and specific
local
audiences
communities and
audiences
are
profiled
Promotio
nal items
such as
T-Shirts,
cups,
aprons,
caps,
shopping
bags, etc
Campaig
n Slogan
competiti
on
Participatory, to
shoppers,
the
mothers,
extent that people consumers
like
them and use
them
moderately
inexpensive;
make a visible
statement in the
market
popular
Participatory to
the
extent that people
get
involved.
Depending on the
personality, they
can be
highly engaging
and
interactive and
attract
high levels of
community/audie
nce
participation
inexpensive to
generate, even free;
can help to unify all
materials and
outputs
if the right people
are committed, can
lend high status and
credibility to a
strategy and to its
messages
Goodwill
ambassad
ors
(sports
figures,
singers/c
elebrities,
beauty
queens,
personali
ties)
general public
different
ambassadors can
be identified for
different target
audiences
expensive
Message/slogan
needs to be kept
short and punchy
Very expensive;
People forget to
notice after a while
Very expensive to
produce particularly in
color; People expect them
to be free; Limited to oneyear only, unless designed in
such a way that tips/info
can be torn off and kept for
future reference (such as:
menu ideas, shopping tips,
etc.)
can be costly to
produce, although
can be done in partnership
with
small enterprise
can generate a
slogan that is
ultimately not usable
or effective; require effective
organization and promotion
not always available;
have to work around
their schedule;
not always reliable;
must be credible;
not always willing to work
for free or for charity;
may not actually
believe or practice
the recommendations
being promoted
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o Pharmacy technician picks medication orders. Placing drugs in bins of Transfer card per
dosage schedule.
o Medication card is filled for particular dosage schedule delivery.
o Pharmacist checks card prior to release.
o The nurse administers the medication and makes appropriate entry on her medication
record.
o Upon returns to the pharmacy, the card is rechecked.
o Throughout the entire sequence, the pharmacist is available for consultation by the
doctors and nurses. In addition he is maintaining surveillance for discontinued orders.
A. 2. Patient Communication/Counseling
Patient counseling is defined as one-on-one interactive sessions designed to modify patient
knowledge and behavior. It also refers to the process whereby a pharmacist listens a patients
concern about his or her drug therapy and offers education appropriate for the patients need.
Importance of patient counseling:
o To promote adherence to medications and avoid treatment failure and future hospital
admissions
o Helps patients cope with their disease and any medication side effects that might occur
o Important to avoid potential drug interactions with OTC, herbal, and prescription
medications
Patient Counseling Process
The pharmacist should be aware of barriers to counseling
o Disease state: dementia, stroke
o Language: verify primary language
o Hearing/vision problems
o Environmental: noise, lack of privacy
o Educational level (reading ability)
o Patient motivation: disinterest in learning
o Lack of pharmacist training/time
Minimize Barriers: Effective Communication Skills
Proper environment
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o Private, quiet: Free of distractions, e.g., patient should have pain controlled; ask
patient to lower volume on the TV etc.
o Introduce yourself
Greet the patient
Explain your purpose
Ask the patients permission to counsel
Know your audience
o Educational level: tailor talk for understanding
o Use appropriate language
o Religious or ethnic beliefs (e.g. need to avoid blood products or specific foods)
Be specific
o Name of medication (brand/generic), dose, dosage form, schedule
o List precautions: e.g., use sunscreen, avoid milk
o How to administer (Sub-Q, PO, IM etc.)
o Special directions and precautions
o Necessary lab tests
Be selective
o Cover major / common side effects
o Cover major / common drug interactions
o Cover patient specific indication
o Emphasize benefits of medication
o What to do if dose(s) missed
o Duration of therapy
o Provide written information
o Summarize key points
Be sensitive/empathetic
o Listen to the patient
o Speak distinctly and clearly
o Return later if patient indisposed, not alert, distracted, has visitors etc.
Common Topics of Patient Counseling
Name (generic)
Intended use and expected action
Route, dosage form, dosage and administration schedule
PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH
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Orders for medications included among treatment orders. Use of this form allows the
physician to continue writing his orders on the chart as he has been accustomed in the
past, leaving all other details to hospital personnel.
b. Medication orders separated from other treatment orders on the order form. The
separation of drug orders makes it easier for the pharmacist to review the order sheet
2. Electromechanical Copying machines or similar devices may be used to produce and
exact copy of the physicians order. Provision should be made to transmit physicians orders
to the pharmacy in the event of mechanical failure.
3. Computerized Computer systems in which the physician enters orders into a computer,
which then stores and prints out the order in the pharmacy or elsewhere, are used in some
institutions. Any such system should provide for the pharmacists verification of any drug
orders entered into the system by anyone other than an authorized prescriber.
A.4. Vendors Dealing (for drug & other hospital equipment supply)
A hospital has long-term contracts with several suppliers for all of the hospital's requirements
of certain items at set prices. The contracts made have to run for years. The contracts have
clauses saying that the supplier will remain price competitive. The hospital's materials
manager learns that, by joining a group purchasing association for all of a large number of
items, the items covered by the long-term contract can be purchased at better prices. A
purchase pharmacists must be there to deal or negotiate for their prices and time for delivery.
A. 5. Inspection of nursing drug cabinets emergency boxes, and night drug cabinets
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Transferring prescriptions
Tracking and reporting errors
Definitions:
1. Order: The direction for the drug, strength and frequency of administration as written
on the Doctors Order Sheet of the patients Medical Record.
2. Prescription: The direction for the drug, strength, quantity, and frequency of
administration as written on a prescription blank by a doctor for dispensing by the Pharmacy.
3. Administer: The word administer is employed when a nurse or other properly
qualified individual gives medication to a patient, pursuant to the order of a qualified
practitioner.
4. Dispense: The word dispense is employed when a pharmacist gives medication to a
nurse or other properly qualified individual in accord with the directions of a properly written
prescription.
5. Doctor: This term is herein employed to indicate and individual who has qualified for
and has received a number from the Drug Enforcement Agency.
6. Addict: Any individual who habitually uses any narcotic drug so as to endanger the public
morals, health, safety or welfare, or who is so far addicted to the use of narcotic drugs as to
have lost the power or self-control with reference to his addiction.
7. Administer: The direct application of a controlled substances to the body of a patient or
research subject by a practitioner or his agent or by the patient or research subject at the
direction and in the presence of the practitioner.
8. Controlled Substances: A drug or other substance, or immediate precursor, included in
schedule I, II, III, IV or V of Part B of this title. The term dose not includes distilled spirits,
wine, malt beverages or tobacco.
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practitioners:
nurse
practitioners,
physician
assistants,
optometrists,
pharmacists
B.1. Contents of the Prescription
Under Texas State Law, all prescriptions should have the following essential elements:
o Date of the order
Date the prescription is issued or written
Allows the determination of the life of the prescription to validate refills
Controlled drugs
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o Intended use of the drug, unless practitioner feels indication is not in best interest of
patient
Encouraged, seldom practiced
Helps confirm appropriateness of medication
Reminds patient of drugs purpose
Facilitates communication between health care providers
o Practitioner Name, Address, Telephone number
Validates prescription
Provides contact information to clarify any questions
Information based on practitioners usual place of business
o Refills
Refills are not required
To avoid interrupting maintenance therapy, practitioners can authorize refills on a
written prescription
PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH
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ii.
Topical: local effect, substance is applied directly where its action is desired.
a.
b.
c.
i.
ii.
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iii.
iv.
Parenteral: desired effect is systemic, substance is given by other routes than the digestive
tract.
a.
Intravenous (IV) (into a vein), e.g. many drugs, total parenteral nutrition
e.
Intra-thecal (into the spinal canal) is most commonly used for spinal anesthesia and
chemotherapy
h.
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Potential Problem
Preferred Term
U (unit)
Write unit
IU (international unit)
Mistaken as IV or 10
Q.D., Q.O.D.
zero
g (microgram)
Write mcg
H.S. (at bedtime or half Mistaken for either meaning:Write out half strength or
strength)
3 times weekly
D/C
at bedtime
Interpreted
subcutaneously
as
discontinueWrite discharge
A.S.,
A.D.,
A.U.
(Latin Mistaken for each other (A.S.Write out left ear or right
abbreviations for left, right, both for O.S., A.D. for O.D., A.U. forear or both ears
ears) O.S., O.D., O.U. (Latin O.U., Vise-versa)
eyes)
Lecture 13. Handling Prescriptions (Continues.)
B. 5. Controlled drug prescriptions
PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH
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Definition - a prescription drug whose use and distribution is tightly controlled because
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g. The compounder shall continually monitor the work of the employee and answer any
questions the employee may have concerning the SOPs.
Labeling
1. Products prepared in anticipation of a prescription prior to receiving a valid prescription
should not be prepared in an inordinate amount. A regularly used amount should be prepared
on the basis of a history of prescriptions filled by the pharmacy. These products shall be
labeled or documentation referenced with the following:
a. A complete list of ingredients or preparation name and reference or established name or
distinct common name
b. Dosage form
c. Strength
d. Preparation date
e. Name and address of compounder
f. Inactive ingredients
g. Batch or lot number
h. Assigned beyond-use date, based on published data, or appropriate testing, or USPNF
standards.
Storage conditions for these products shall be dictated by their composition and sterility, e.g.,
stored in a clean, dry place (defined temperature condition), in a refrigerator, or at controlled
room temperature.
2. The compounder shall examine the product for correct labeling after completion of the
compounding process.
3. The compounder's prescription label shall contain the following:
a. Patient's name
b. Prescriber's name
c. Name and address of compounder
d. Prescription number
e. Established name or distinct common name (cannot use trademarked name of a
manufactured product)
f. Strength
g. Statement of quantity
h. Directions for use
i. Date filled
j. Beyond-use date/storage, etc.
k. An appropriate designation that this is a compounded prescription
PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH
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4. The compounder shall label any excess compounded products so as to reference them to
the formula used, the assigned control number, and beyond-use date based on the
compounder's appropriate testing, published data, or USPNF standards.
Records and Report Keeping
a. The compounder shall maintain records, including but not limited to, the hard copy of the
prescription to indicate that the prescription is compounded.
b. The compounder shall keep adequate records of controlled drug substances (scheduled
drugs) used in compounding.
c. All records of all compounded products shall be kept for a period of time as set forth in the
laws or regulations. Such records shall be readily available for authorized inspection.
Prescription ownership and refilling.
When a prescription is written it is the property of the pre-scriber until he delivers it to the
patient, or to the druggist for the patient; it then ceases to be his and he has no legal right to
recall it. If the patient has the prescription it is his to do with as he chooses, and when it is
delivered to the druggist to be filled it becomes and remains the property of the druggist. The
patient cannot demand its return nor can the physician, and should a prescriber for any reason
wish to regain possession of one of his prescriptions that has been filled, he should remember
that he is to ask the druggist for the favor of its return and not, demand it. It is the same
proposition as if the doctor sent an order to a merchant to deliver to his servant a pair of
shoes. The merchant should retain the order as his evidence of the transaction. Of course, the
major object in the pharmacist retaining prescriptions is really that he may have them in case
it is necessary to have them refilled.
Preparation of orders
All controlled substances orders and records must be typed or written in ink or indelible
pencil and signed in ink or indelible pencil.
Telephone orders
A doctor may order a controlled drug by telephone in case of necessity. The nurse will write
the order on the doctor's order sheet, stating that it is a telephone order and will sign the
doctor's name and her own initials. The controlled drug may then be administered at once.
The order must then be signed by the doctor with either his signature or his initials within 24
hours.
Verbal orders
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A verbal order may be given by a doctor in an extreme emergency where time does not
permit writing the order. The nurse must write the order on the doctors order sheet. The
doctor must sign the order with either his signature or his initials within 24 hours.
Information on daily controlled drug administration sheet
The full information required on the Daily Controlled Drugs. Administration Sheet is as
follows:
1. Date.
2. Amount given.
3. Patients full name
4. Patients hospital number.
5. Name of doctor ordering.
6. Signature of nurse administering.
The following information is requested for auditing purposes and is not required by Federal
law:
1. Number of tablets or ml administered
2. Filing out inventory column (to be retained for Pharmacy).
Prescribing controlled drug in out-patient department
Prescriptions for Schedule II and other controlled substances drugs may be dispensed from
Pharmacy and must include the following information.
a. Patient s full name
b. Patients address or hospital number
c. Date
d. Name and strength of drug prescribed.
e. Quantity of drug to be dispensed
f. DEA number and signature of physician
g. Frequency and route of administration
The prescription must be written in ink or indelible pencil and shall not bear cross outs or
erasures. Discharge prescriptions for Schedule II drugs must be picked up by a registered
nurse.
Dispensing controlled drugs for home use
Occasionally patients who require drugs for use at home are discharged from the hospital or
released from The Emergency Ward during hours when the Pharmacy is closed. Whenever
possible, a prescription signed by a member of the staff who has a License to practice
medicine and a DEA number should be obtained. A staff physician whose DEA number is
PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH
Page 54
issued to an outside office should use his own prescription blank. If this is not available, then
he must insert his office address on the hospital prescription blank. This will permit the patent
or his relative to purchase the drugs at an outside pharmacy. If no physician is available, or
during hours when the local pharmacies are closed, the following procedure is allowed.
Access to pharmacy during off hours whenever any drug is not available from floor
supplies or night cabinets, and such drug is required to treat the immediate needs of a patient
whose health would otherwise be jeopardized; such drug may be obtained from the pharmacy
in accordance with the requirements of this section. One supervisory registered professional
nurse and only one in any given eight-hour shift is responsible for removing drugs therefrom.
The responsible nurse, in times of emergency, may delegate this duty to another nurse. The
responsible nurse must be designated by position, in writing, by the appropriate committee of
the hospital and, prior to being permitted to obtain access to the pharmacy, shall receive
thorough education and training in the proper methods of access, removal of drugs, and
records and procedures required. Such education and training must be given by the director of
pharmacy, who shall require, at a minimum, the following records and procedures:
a. Removal of any drug from the pharmacy by an authorized nurse must be recorded on a
suitable form showing patient name, room number, and name of drug, strength, amount, date,
time, and signature of nurse.
b. Such form must be left with the container from which the drug was removed, both placed
conspicuously so that it will be found by a pharmacist and checked properly and promptly;
or, in the case of a unit dose, place an additional dose of the drug, or the box, on the form.
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Salesmans Action
Prospect's Action
Find/Qualify/Classify/Categorize/Grade
Preparation
Analyze/Study/Set Objective/Plan
Approach
Presentation
Interest
Find out needs/ Buying Motives,
Response Handling
Present Benefits
Listen to the responses/ reactions,
Understands
Buying signals
PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH
Page 56
Closing
Post-call analysis
Need/wants Will
benefits
Environmental Conditions
Diagnostics Availability
Restrictions
Facilities requirements
Equipment Requirements
Process Requirements
System Limits
Documentation
Validation Protocol
Validation Report
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Reason for Revision At the end of each SOP, a space is provided to list the reasons why
the SOP is changed, along with the date.
Also production pharmacists ensures areas and equipment are visually clean after following a
validated cleaning procedure and ready for use as per SOP and only validated equipment is
used and the asset number recorded on the BMR batch manufacturing record, that equipment
calibrations have been performed as per SOPs, documentation / materials are checked as per
SOP and ensures during Sign-on process, declaration of area, keeping of Log books as per
SOPs and authorization of Batch Manufacturing records
C. Drug Master File
DMF is a document prepared by a pharmaceutical manufacturer and submitted solely at its
discretion to the appropriate regulatory authority in the intended drug market. There is no
regulatory requirement to file a DMF. However, the document provides the regulatory
authority with confidential, detailed information about facilities, processes, or articles used in
the manufacturing, processing, packaging, and storing of one or more human drugs.
Typically, a DMF is filed when two or more firms work in partnership on developing or
manufacturing a drug product. The DMF filing allows a firm to protect its intellectual
property from its partner while complying with regulatory requirements for disclosure of
processing details.
Interpretation of QC analytical data
Quality Control (QC) is an important task in the pharmaceutical industry. It not only protects
the manufacturer against compensation claims, but also guarantees the patient a safe and
effective product. QC measurements include stability testing of the drug formulation,
dissolution testing and analysis of raw materials and synthesis products. Pharmaceutical
quality control testing is usually a matter of repetitive testing of samples of APIs or of a
limited number of pharmaceutical products. Quality control laboratories may perform some
or all quality control activities, e.g. sampling, testing of APIs, excipients, packaging materials
and/ or pharmaceutical products, stability testing, testing against specifications and
investigative testing. For the quality of a medicine sample to be correctly assessed:
The submission of a sample of an API, excipient or pharmaceutical product or a suspected
counterfeit material to the laboratory, selected in accordance with national requirements,
should be accompanied by a statement of the reason why the analysis has been requested.
The analysis should be correctly planned and meticulously executed.
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The results should be competently evaluated to determine whether the sample complies with
the specifications or other relevant criteria.
Important QC parameters and definitions
Acceptance criterion for an analytical result: Predefined and documented indicators by
which a result is considered to be within the limit(s) or to exceed the limit(s) indicated in the
specification.
Accuracy: The degree of agreement of test results with the true value or the closeness of the
results obtained by the procedure to the true value.
Active pharmaceutical ingredient (API): Any substance or mixture of substances intended to
be used in the manufacture of a pharmaceutical dosage form and that, when so used, becomes
an active ingredient of that pharmaceutical dosage form. Such substances are intended to
furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation,
treatment, or prevention of disease or to affect the structure and function of the body.
Analytical test report: An analytical test report usually includes a description of the test
procedure(s) employed, results of the analysis, discussion and conclusions and/or
recommendations for one or more samples submitted for testing.
Analytical worksheet: A printed form, an analytical workbook or electronic means (erecords) for recording information about the sample, as well as reagents and solvents used,
test procedure applied, calculations made, results and any other relevant information or
comments.
Batch (or lot): A defined quantity of starting material, packaging material or product
processed in a single process or series of processes so that it is expected to be homogeneous.
It may sometimes be necessary to divide a batch into a number of sub-batches which are later
brought together to form a final homogeneous batch. In the case of terminal sterilization the
batch size is determined by the capacity of the autoclave. In continuous manufacture the
batch should correspond to a defined fraction of the production, characterized by its intended
homogeneity. The batch size can be defined either as a fixed quantity or as the amount
produced in a fixed time interval.
Batch number (or lot number): A distinctive combination of numbers and/or letters which
uniquely identifies a batch on the labels, its batch records and corresponding certificates of
analysis.
Calibration: The set of operations that establish, under specified conditions, the relationship
between values indicated by an instrument or system for measuring (especially weighing),
recording and controlling, or the values represented by a material measure, and the
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corresponding known values of a reference standard. Limits for acceptance of the results of
measuring should be established.
Certificate of analysis: The list of test procedures applied to a particular sample with the
results obtained and the acceptance criteria applied. It indicates whether or not the sample
complies with the specification.
Compliance testing: Analysis of active pharmaceutical ingredients (APIs), pharmaceutical
excipients, packaging material or pharmaceutical products according to the requirements of a
pharmacopoeial monograph or a specification in an approved marketing authorization.
Control sample: A sample used for testing the continued accuracy and precision of the
procedure. It should have a matrix similar to that of the samples to be analyzed. It has an
assigned value with its associated uncertainty.
Design qualification (DQ): Documented collection of activities that define the functional and
operational specifications of the instrument and criteria for selection of the vendor, based on
the intended purpose of the instrument.
Good manufacturing practice(s) (GMP): That part of quality assurance which ensures that
pharmaceutical products are consistently produced and controlled to the quality standards
appropriate to their intended use and as required by the marketing authorization.
Installation qualification (IQ): The performance of tests to ensure that the analytical
equipment used in a laboratory is correctly installed and operates in accordance with
established specifications.
Manufacturer: A company that carries out operations such as production, packaging, testing,
repackaging, labeling and/or relabeling of pharmaceuticals.
Marketing authorization (product license, registration certificate): A legal document issued
by the competent medicines regulatory authority that authorizes the marketing or free
distribution of a pharmaceutical product in the respective country after evaluation for safety,
efficacy and quality. In terms of quality it establishes inter alia the detailed composition and
formulation of the pharmaceutical product and the quality requirements for the product and
its ingredients. It also includes details of packaging, labeling, storage conditions, shelf-life
and approved conditions of use.
Operational qualification (OQ): Documented verification that the analytical equipment
performs as intended over all anticipated operating ranges.
Performance qualification (PQ): Documented verification that the analytical equipment
operates consistently and gives reproducibility within the defined specifications and
parameters for prolonged periods.
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Reference substance (or standard): An authenticated, uniform material that is intended for
use in specified chemical and physical tests, in which its properties are compared with those
of the product under examination, and which possesses a degree of purity adequate for its
intended use.
Secondary reference substance (or standard): A substance whose characteristics are
assigned and/or calibrated by comparison with a primary reference substance. The extent of
characterization and testing of a secondary reference substance may be less
Specification: A list of detailed requirements (acceptance criteria for the prescribed test
procedures) with which the substance or pharmaceutical product has to conform to ensure
suitable quality.
System suitability test: A test which is performed to ensure that the analytical procedure
fulfills the acceptance criteria which had been established during the validation of the
procedure. This test is performed before starting the analytical procedure and is to be repeated
regularly, as appropriate, throughout the analytical run to ensure that the systems
performance is acceptable at the time of the test.
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and the reason for discontinuation of the study or non-pursuit of the new drug application.
Any expected serious adverse event (SAE) occurring during a clinical trial should be
communicated promptly (within 24 hours and not more than in 14 calendar days) by the
Sponsor to the Licensing Authority and to the other Investigator(s) participating in the study.
NOTE: Submit two hard copies and two soft copies i.e. CDs (PDF format).
Hard copies: It must be well labeled with document number, name of the firm, date of
submission etc. Number of volumes to be labeled as Volume No. / Total number of volumes
e.g. if there are five volumes, volume three will be labeled as Volume: 3/5.
Soft Copies: They must be well labeled with document number, name of the firm, date of
submission etc. Scanned copies of signed document like test reports are acceptable as soft
copies rest of the documents should be in PDF format. The table of content under each head
should be linked to the files (s) or relevant document for easy tracking in CDs. The table of
content should be hyper-linked to the main document to facilitate the review process.
Manufacturer should preserve/maintain one hard copy and soft copy of submitted documents
in his safe custody for any future reference, if required.
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Unani medicines manufacturing industries and numerous pharmacies distributed all over
the country. According to the information of the Directorate General of Drug
Administration (DGDA) of Bangladesh website, DGDA has offices of Drug
Superintendent only in 34 districts (out of 64 districts) all over the country. The Drug
Administration does not have Drug Superintendent even in every district let alone every
Upazila. It is impossible to control the production and marketing of drugs with this less
manpower all over the country. As a result, Drug Administration does not have strict
controlling power on pharmaceutical industries and retail and wholesale pharmacies. Yet
its a matter of hope that the present Govt. has taken initiative recently and DGDA is on
the process for the recruitment of Drug Supers and Drug Inspectors. According to the
available information, the Govt. is not going to appoint Drug Super in any Upazila.
Without Drug Super in Upazila level, it would not be possible to control the drugs strictly.
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The level of economic development in target market (for example, in remote regions
of Africa there would be no mains electricity on which to run TVs or radios).
The availability of other local resources to assist promotional campaign will also need
to be investigated (for example, sales people or local advertising expertise).
Local laws may not allow specific content or references to be made in adverts (for
example, it is not acceptable to show naked legs in adverts displayed in Muslim
countries).
And of course a lot depends upon the purpose of the international campaign in the
first place.
Levels of literacy and the availability of education for the national population.
The similarity or diversity of beliefs, religion, morality and values in the target nation.
The similarity or diversity of beliefs, religion, morality and values in the target nation.
The family and the roles of those within it are factors to take into account.
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It is beneficial where wages tend to be low, since staffing costs will be comparatively
low.
Where there are many languages, you'll need trained sales personnel that can convey
your message in specific tongues (see culture above).
The sales force will need to be supported. Commercial administration staff will have
to take care of sales enquiries, send out product literature and samples, and make
quotations - often online.
You'll need to invest time and effort in recruiting, motivating, organizing and training
a local sales force. Recruits will need to know about products and markets, language
and culture, the location of target segments, customer buyer behavior - and that's just
the beginning.
Where business etiquette varies from culture to culture, you'll need to train your
people in what to expect - or recruit salesmen from the local market.
When considering press advertising try to anticipate the levels of literacy within the
nation in question. Where literacy levels are lower, perhaps you could use a more
visual campaign.
What is the split between regional and national press in your target market?
What types of television channels are available? Are they HDD, digital, analogue,
satellite, cable, via the telephone, via a broadband or ADSL connection?
Is there space on the suitable TV channels when we want it, or at a price that we can
afford?
What is the behavior of the target population in relation to cinema? For example,
Cinema is tremendously popular in India.
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Radio has similar issues as TV and press. Which stations do your target groups listen
to - news, sports or music? Is there space available with the most suitable stations?
Web-based marketing using your own domestic site, or one developed specifically for
the target market. Chinese websites are very different to Western sites. They are very
busy and every single space is filled with images and text. Affiliate or pay-per-click
advertising may be available.
So, to finish, this lesson aimed to summarize the key options and issues that face the
international marketer when dealing with marketing communications and media
choices in international markets. Of course it is by no means conclusive.
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documentary requirement etc. The amendment can be affected if all the concerned parties that
are the importer, the exporter, the issuing and the negotiating bank agreed to do so. For an
amendment the importer must request the opening bank in writing duly supported by revised
indent or proforma invoice. The issuing bank then informs the other parties over the matter.
Receipt and scrutiny of documents
The nest step of opening an LC is to wait for shipment followed by negotiation documents
from the bank abroad. Generally the negotiating bank sends the following documents:
1. Commercial invoice
2. Draft or bill of exchange.
3. Bill of lading.
4. Marine insurance policy
Besides the following documents is auxiliary1. Packing list or mill specification
2. Certificate of origin
3. Inspection or survey certificate
4. Quality control certificate
The negotiating bank pay the exporter if the documents are found ok and debit the local
banks account maintained with them.
Scrutiny of the documents
After receiving the documents from abroad the local bank immediately check the documents
about whether the strictly according to the terms and conditions of the LC. Examining the
documents generally includes the following points
1. Completeness of the documents
2. Consistency of the documents with each other
3. Compliance with custom of ICC.
Retirement
If all the above formalities are met, the local banks take necessary steps to close the LC and
issue cost memo to the importer who pays accordingly.
N.B. Trade related barriers, outsourcing, technology transfer will be discussed in detail in
PHR 605
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