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COURSE CODE: PHR 207 Pharmaceutical Communication CREDIT 3

A. Introduction to Business Communication and Report Writing:

1. Introduction: 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)
2. Business Letters: Lay-out and kinds of business letters – Interview, Appointment,
acknowledgement, Claims, Orders, Grants, Promotion, Inquiries, Reply, Sales, Circular,
Complaints, Credit refusals, personal evaluations etc.
3. Fundamentals of Report Writing: Definition, characteristics and types of reports;
Interpreting findings, Organizing report information, Writing the report, Writing
references
4. Practical Aspects of Business Communication: Report writing, Public speaking,
Seminar, Presentation, Interviews, Group Discussion, Effective listening and Non-verbal
Communications (Body language, space, time), Correctness of communication
(Grammar, Spelling, Capitalization), Commercial terms and abbreviations; Handling
mail, filing and indexing

B. Applied Communication (Communication in Hospital settings)

1. Hospital Management: Patient Communication, Purchase & Inventory record keeping,


Vendors Dealing, Dispensing routine and record keeping, label symbols, procurement and
execution of order forms, Inspection of nursing drub cabinets, emergency boxes, and
night drug cabinets, patient admission and discharge forms; Clinical Drug literatures and
information resources.
2. Handling Prescriptions: Common abbreviations used for prescriptions, Controlled drug
prescriptions, checking and receiving prescriptions, consulting the prescriber,
compounding and checking finished prescriptions, Record keeping and pricing,
prescription ownership and refilling.

C. Industrial Communication (Communication in Pharmaceutical Industry and


Regulatory Affairs)

1. Communication in Industry: Head office personnel communication with Sales,


Distribution, Plant and MIS Team; Production and QC validation protocol &
interpretation of analytical data, Batch Manufacturing Record (BMR) for shifting duty
personnel.
2. Communication with Regulatory Body:
A. Guidance for Industry -Submission of Clinical Trial Application for Evaluating Safety
and Efficacy, Requirements for permission of New Drugs Approval, Post approval
changes in biological products, Preparation of the Quality Information for Drug
B. Submission for New Drug, Communication with DCC committee and Technical
Subcommittee for approval, Block list approval, Licensing authority of DGDA,
Inspection report for Pharmaceutical industry and retail outlets.
C. International Marketing and Trade Related Barriers: Communication for outsourcing
(contract manufacturing), technology transfer, Letter of Credit (LC) opening for
export and Import.

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 1


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 Hr 2nd Mid Hr Final Hr


Introduction 6 Practical Aspects of 6 Industry 2
BusCOM Communication
Business Letters 4 Hospital Management 2 Industry Guidance 2
Report Writing 4 Handling Rx 4 New Drug 2
Submission
Int. Marketing 2

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 21 st
Edition

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 2


A. Introduction to Business Communication and Report Writing
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.
PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 3
Different types of communications

A. Formal mode of communications


Downward Communication: Downward communication flows from a superior to the
subordinate staff. Its objectives are:—
· To give directions about some job.
· To explain policies and procedures.
· To convey assessment of performance.
· To explain the rationale of the job.
Its limitations are:—
· Under communication or over communication.
· Delay.
· Loss of information.
· Distortion.
· Resentment by subordinate staff.
To make it effective:—
· Managers should be adequately informed.
· Managers should be clear how much to communicate.
· Information should be passed on to the correct person.
Upward Communication: Upward communication moves from the subordinate staff to the
superiors. Its importance is:—
· Provides feedback to the superiors.
· Releases the pent up emotions of the subordinate staff.
PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 4
· Provides the superiors with useful suggestions.
· Promote harmony.
Its limitations are:—
· Employees are reluctant to express themselves.
· Employees fear that their criticism may be interpreted as a sign of their personal weakness.
· Great possibility of distortion.
· Bypassed superiors feel insulted.
· Resentment by subordinate staff.
To make it effective:—
· Superiors should take initiative to get close to the subordinate staff.
· Keep the lie of communication short.
Horizontal Communication:—
· It flows between people at the same level.
· It is important for promoting understanding and coordination among various people or
departments.
· It is carried on through face to face discussion, telephonic talk, periodical meetings &
memos.
Consensus:—
Consensus is the process of arriving at agreement through consultation.
B. Informal Communication:—
Grapevine:—
· It is an informal channel of communication.
· Primarily a channel of communication of horizontal communication, it can flow even
vertically and diagonally.
It is of 4 types:—
· Single strand: Flows like a chain.
· Gossip: One person tells everyone else.
· Probability: Information may move from anybody to anybody.
· Cluster: Moves through selected group.
Importance:—
· Emotional relief.
· Harmony and cohesiveness in the organization.
· Fast channel.
· Provides feedback

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Lecture 2. Introduction (Continues……)
Demerits:—
· Distortion of information.
· May transmit incomplete information.
· Travels with destructive swiftness.
· Keep an eye on rumor-managers.
· Use it primarily for feedback.
· Contradict rumors promptly.
Media of communication
Written Communication: It includes letters, circulars, memos, telegrams, reports, minutes,
forms and questionnaires, manuals etc.
Therefore, everything in written form falls in the area of written communication.
Merits:—
· Accurate
· Precise
· Permanent Record
· Legal Document
· Can reach a large number of people simultaneously.
· Helps to fix responsibility.
Limitations:—
· Time Consuming
· Expensive not in terms of postage but of the time of so many people.
· Quick clarification is not possible.
Oral Communication: Includes face to face conversation, conversation over the telephone,
interview, and group discussion.
Merits:—
· Saves time
· Saves money
· Immediate feedback
· Can be informal
· Immediate clarification
Limitations:—
· Not possible for distant people in the absence of mechanical devices.
· Unsuitable for lengthy messages.
· Message cannot be retained for long

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· No legal validity
· Greater chances of misunderstanding
· Not easy to fix responsibility
Face to Face Communication:—
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.

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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.
1. Facial Expression: Face is the index of the mind. A glance at someone’s face is enough to
give them clues about the subject’s 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:—

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· 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.
· Inattentiveness: We unconsciously become inattentive if communication contains new idea
or if we don’t like an idea.
· Faulty transmission: Part of the message is last in transmission and can also act as a
barrier.
· Poor Retention: Oral messages in particular are lost due to poor human retention.
· Status Consciousness: We are over-conscious of our lower or higher rank and do not
express ourselves candidly.
Importance of Effective Communication (Viewpoints of Employee & Employer Benefits)
o Employee Benefit
 Better application submitted
 Get more chances to call in interview
 Better face that interview
 More possibility of job opportunity
 Become a good communicator and earn more attractions
 Quickening of promotion
 More visible; Positive impact on career progression
 Becomes good Motivator, Efficient co-coordinator & Leader
 Ensure better customer service in a service oriented company
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 1 st party takes the initiative to communicate,
gives message to the receiver that should be understandable and the 2nd 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

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Lecture 3. Introduction (Continues….)

Characteristics affecting Human behavior

A. Cultural B. Social C. Personal D. Psychological

 Reference  Age  Motivation


 Culture
group  Occupation  Perception
 Sub-culture
 Family  Economic  Learning
 Social class
 Roles & condition  Beliefs &
status  Lifestyle attitude
 Personality

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.

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B. Social Factors
Social factors also impact the human behavior. The important social factors are: reference
groups, family, role and status.
• Reference Groups
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.

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• 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
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 person’s 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.

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 12


Lecture 4. Business Letters

Line Up. Lay-out and kinds of business letters – Interview, Appointment, acknowledgement, Claims, Orders,
Grants, Promotion, Inquiries, Reply, Sales, Circular, Complaints, Credit refusals, personal evaluations etc.

Business Letter is important when


 A permanent record is required.
 Formality is necessary.
 A message is sensitive.
 An organized, well-considered presentation is necessary.
THREE LEVELS OF LEARNING WRITING SKILLS
Learning how to write effective communication, can be described at three levels:
 Choosing the right words
 Constructing sentences
 Designing paragraphs
(1) Choosing the right words
A skilled writer should choose words such that the receiver gets the meaning in a precise
manner, without different interpretations. Following guidelines are useful:
(i) Searching words that the receiver understands
Adaptation is a process of simplifying; it is not as easy as it sounds because:
 Many individuals write at a more difficult level
 Writers know the subject better than the receiver
Extensive experience supports simplification.
(ii) Using familiar words
Familiar words enhance communication because they are easy to understand and absorb.
Human memory favors familiar words as it speeds up filing and storage! For example, use:
 “Show” in place of “demonstrate”
 “Use” instead of “utilize”
 “Try” for “endeavor”
(iii) Choosing short words
Short words communicate better; use:
 “Quit” in place of “terminate”
 “Agreed” in lieu of “accorded”
 “Last year” instead of “previous year”

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(iv) Using technical words with caution
Every field of specialization has words that have specific meaning in that field and should be
used when communicating with persons from the same area of specialization. They do not
communicate well with others and hence should be used with caution, if at all.
(2) Constructing sentences
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:
 “If” for “In the event that”
 “Like” for “Along the lines of”
 “To” for “With a view to”
(b) Avoiding round about ways of saying things
Round about ways of saying add words and verbosity to the sentences. Being direct makes it
simple, short and impressive.
(c) Avoiding repetition of words and phrases
Repeating words and phrases is very boring and should be excluded from ones‟ writing. Only
exception is when the writers want to emphasize something.
(iii) Determining emphasis in the construction of sentence
Short sentences emphasize content and long sentences dilute it although determining
emphasis in a sentence is largely a matter of judgement.
(iv)Using correct rules of grammar for sentence clarity
Rules of grammar have emerged as a result of some customs but mostly because they help
write logically and clearly. Students must know these rules of grammar to acquire effective
writing skills.
(v) Learning power of punctuation This is a group of distinctive signs that are used in
writing and every writer must learn them properly. Some of the uses change like fashion over
time and writers must remain updated on them. They add power to ones‟ expressions.

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(3) Designing paragraphs
Paragraphs form the third link that is critical to acquiring effective writing skills. Besides
words and sentences, they play a major role. Paragraph designing requires a clear thinking
and a systematic mind. Design of paragraphs has a direct impact on the layout and
presentation of the writing and contributes significantly in attracting and retaining readers‟
attention. A few guidelines are:
(i) Paragraphs should exhibit unity of idea or topic
Contents of a paragraph should relate to one idea (group of thoughts) or topic. However,
unity can vary and so can the size of a paragraph. Ideally, a good test for a paragraph is that it
should be possible to reduce the contents of a paragraph to one sentence or one statement. If
it is not possible, unity of the paragraph is likely to suffer.
(ii) Paragraphs should be kept short
A paragraph should consist of 8 to 9 lines only. Paragraphs larger than 10 lines should be
critically examined and „fat‟ cut off
 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.

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Lecture 5. Business Letters (Continues….)

TYPES OF WRITTEN COMMUNICATION


Written communication has a very large variety:
1 Letters
2 Memos
3 Telegrams
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 Letter
1. Short version usually not for external use. 1. A written form mainly for external use but
can be internal as well
2. Less formal 2. More formal
3. Most popular for office & library 3. News letters are like newspapers, policy
correspondence. statement/ code of conduct, reports, brochure,
flyers and posters.

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 16


IMPORTANCE OF BUSINESS LETTERS

(1) Role of Written Business Letters


Letter messaging is a significant form of business communication. It also constitutes the
major component of written communication and forms the backbone of a successful
enterprise. A good letter message:
 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)
 May refuse a request yet win respect
 May grant a request yet incur ill will

(2) Need for Written Business Letters


(i) Every business has to maintain contacts with suppliers, customers / prospects, government
agencies, employees, bankers, investors etc. Most often these happen through business letter.
(ii) Companies have to correspond with other enterprises for varied reasons:
 Placing orders for goods & services required from other firms
 Acknowledging and executing orders for other firms
 Granting credits to other parties
 Negotiating credits from other parties
 Securing credit facilities etc from banks
 Sending statement of accounts for debtors
 Receiving statement of accounts from suppliers etc
(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
 Providing a convenient and inexpensive means of communications without personal
contact
 Seeking or giving information
PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 17
 Furnishing evidence of transaction entered in to
 Providing a record for future reference

(ii) Secondary functions


 Creating goodwill for the company
 Making an impression as an efficient and reliable firm

(2) Objectives of Letter Messaging


More important ones are:
 Serves as a record for future use – copies can be sent to functionaries in different
locations for future reference
 Leaves a more durable impression on the receiver than an oral message
 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
 Forms authoritative, legal document for contracts and collaborations in business
 Is used for building goodwill, image and reputation.

TRADITIONAL CLASSIFICATIONS OF LETTERS


Letter messages have evolved over a long time. A traditional way of classifying these letters
in five different ways is as below:
(1) Classifying on the basis of nature of contact
(i) Personal letters
These are written to friends and relatives and follow informal and friendly style. They help:
 Exchange information
 Seek information
 Seek help, guidance or advice etc

(ii) Impersonal letters


These are usually business letters written in formal style. They are intended to exchange
communication among individual functionaries, firms and institutions.

(2) Classifying on the basis of approach


Three categories are:
PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 18
(i) Direct letters
In these letters, one comes direct to the point without any introductory remarks. Such
letters are useful for:
 Enquiries
 Quotations
 Orders
 Good news messages
 Offers of appointment
 Promotions
 Instructions for job

(ii) Indirect letters


Theme of such letters is not pleasant as they concern bad news like:
 Not being able to sanction the loan
 Cannot concede the claim preferred
 Not being able to accept the terms asked for

In such letters, there is always an introductory sentence that is intended to put the receiver
in a good frame of mind.

(iii) Persuasive letters


These are mainly sales letters where one has to think of an opening that catches readers‟
attention immediately and prompts him to read on. The message is aimed at persuading
readers to buy the product or acquire / experience the service offered.
(3) Classifying on the basis of types of communication
Four types are:
(i) Official letters
These are letters written to Government, semi-government and other statutory authorities
and are addressed formally.
(ii) Demi-official (DO) letters
These are also official letters but are addressed to a person by name. DO letters are
written if matter:
 Requires personal attention of the addressee
 Is of confidential nature
 Is urgent requiring immediate disposal / response
PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 19
(iii) Form letters
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
 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
 Collection of debts and dues
 Complaints
 Sales promotion
 Sales circulars
 Appointment of agencies etc

(5) Classifying on the basis of functions / departments of the firm


A few major functional heads are:
(i) Personnel letters
These are letters emanating from personnel / human resource department:
 Inviting applications for notified vacancies
 Calling for preliminary interviews
 Calling for written tests
 Calling for recruitment interviews
PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 20
 Sending offers of appointment
 Issuing circulars for training and development
 Issuing promotion, increment or bonus letters
 Issuing warning letters etc

(ii) Purchasing letters


These letters cover the correspondence for purchasing and other allied functions in materials
management, supply chain functions etc:
 Inviting tenders or quotations
 Placing orders for supplies and contracts for services & materials
 Sending reminders
 Sending complaint letters etc

(iii) Sales letters


These are letters pertaining to the marketing and sales activities of the firm:
 Advertising, publicity and marketing communication
 Marketing research and surveys of customers and competitors
 Sales circulars
 Giving and soliciting specific sales information etc

(iv) Accounting and finance letters


These letters may relate to:
 Account payable
 Account receivable
 Banking
 Investments etc

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Lecture 6. Fundamentals of Report Writing

Line Up. Definition, characteristics and types of reports; Interpreting findings, Organizing report information,
writing the report, writing references

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 informat ion
and have become integral part of modern information management for decision-making.
OBJECTIVES
After studying this unit, students shall be able to:

ring 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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LIMITATIONS OF WRITTEN REPORTS
A few major ones are:
1. No immediate feedback is available.
2. Lack of personal contact with the readers
3. Readers cannot ask questions by way of clarification
4. Text of the reports is not adjustable as is possible with oral reports
CLASSIFICATION OF REPORTS
Reports can be classified in several ways as under:
(1) Classifying on the basis of form of communication
 Oral reports
 Written reports
(2) Classifying on the basis of legality
 Informal (short) reports
 Formal (long) reports
Formal reports can be further subdivided:
 Statutory reports
 Non-statutory reports
(3) Classifying on the basis of frequency of issue
 Periodic reports (also called Routine reports)
 Special reports
(4) Classifying on the basis of functions
 Informative reports
 Interpretive reports (also called Analytical or Investigative reports)
(5) Classifying on the basis of nature of subject
 Problem determining reports
 Fact-finding reports
 Performance reports
 Technical reports
(6) Classifying on the basis of number of persons entrusted to draft reports
 Reports by individuals
 Reports by team
 Reports by committee or sub-committee

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CHARACTERISTICS OF GOOD BUSINESS REPORT
Following features stand out:
(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. Self-
interest 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

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 24


persons to throw up and use simple words and phrases for expressions. Reports should be free
of trite expressions, clichés and figures of speech.

PREPARING A WRITTEN REPORT


Written reports have emerged as very useful tools in decision-making in large organizations.
Usually some vital decisions are taken and if companies have to survive and grow in
competitive environments, quality and reliability of decisions must be world class. This
requires great care while preparing the written reports. Six important steps are:
 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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Lecture 7. Fundamentals of Report Writing (Continues….)

Ways to Organize Report Text Section


• By criteria or topics: This is the most common way. The main headings could be the
standards, factors, solutions, benefits…etc.
• By order of occurrence. “Progress reports,
• By order of location or space.
• By procedure or process.
• By order of importance or by alphabetization.
• By order of familiarity or simplicity.
• By sources.
• By problem solution.

Five Important Cautions


1. 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.
Components of a Business Report
1. Title Page:
– Name of the report
– Name, title and organization of the individual receiving the report
– Picture that is relevant to the report
– Authors name, title, and organization
– 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

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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.
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)
– Do not number this page
4. Introduction:
– Explain the purpose of the report
– Describe its background and significance
– Close the introduction by previewing the reports organization
5. Body/Results of study
– Discuss, analyze, and interpret the research findings
– Discuss proposed solution to the problem
– Arrange findings in logical sequence
– Use clear, descriptive headings as well as charts, graphs and pictures to emphasize
your points.
6. Conclusion and Recommendation
– Explain what the findings mean in relation to the original problem
– Use numbered recommendations that suggest actions for solving the problem
7. Bibliography and webliography
Writers tend to minimize the role of providing the necessary references in the bibliography. It
gives a very favorable impression of the team and highlights the efforts put in by them for the
in-depth study carried out. In the contemporary world, searching the web for seeking the
latest development on any subject has become very popular especially with management
students. The specific web sites consulted should get proper mention in the bibliography.

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Lecture 8. Practical Aspects of Business Communication

Line Up. Public speaking, Seminar Presentation, Interviews, Group Discussion, Effective listening and Non-
verbal Communications (Body language, space, time), Correctness of communication (Grammar, Spelling,
Capitalization), Negotiation Skills; Handling mail, filing and indexing, Media for communication, CRM

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 one’s 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 tape-
recording 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 one‟s speech, it may sound jarring and
monotonous. On the other hand, a few well-meaning shouts so as to throw your voice to the

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 28


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!
(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 haven’t fared much better.
Preparing Content: 3As
1. Analyze your AUDIENCE
 What are their names, titles, backgrounds, reasons for attending, etc…?
 What are their big concerns?
 What are their objectives, fears, hot buttons, and attitudes?
 What is their perception of you and your institution?
 What are their questions likely to be?
 What is personally at stake for them?
 How much detail do they need?
2. Define what ACTION you want them to take
 What action do you want the audience to take?
 Define it in terms of the audience.
 What will they feel, believe, and do after hearing your talk?
3. Arranging Your ARGUEMENT
 Shake hands with the audience.
 Get to the point.
 Present your theme.
 Develop your agenda point by point.
 Summarize and recommend.

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Important considerations
1. Eye Contact
 Never let them out of your sight.
 Looking them in the eye makes them feel that they are influencing what you say.
 Eye contact allows the presentation to approximate conversation—the audience feels
much more involved.
2. Voice
 Articulation
 Pronunciation
 Vocalized pauses
 Rate of speech
 Volume
 Pitch or tone
 Emphasis
3. Body Language (Things not to do)
 Stand immobile
 Use a single gesture repeatedly
 Examine or bite your fingernails
 Cross your arms in front of your chest
 Chew gum or eat candy
 Click or tap your pen, pencil or pointer
 Shuffle your notes unnecessarily
 Tighten your tie or otherwise play with your clothing

Interview Skills
The Do’s
• Dress appropriately for the industry. When in doubt, go conservative.
• Personal grooming and cleanliness should be impeccable. Keep cologne or perfume to a
minimum. Pay particular attention to hands and fingernails.
• 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.
• Maintain good eye contact during the interview.
• Sit still in your seat; avoid fidgeting and slouching.
PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 30
• Ask for clarification if you don’t understand a question; and be thorough in your
responses while being concise in your wording.
• Treat the interview seriously and show interest in the employer and the opportunity
presented and respond to questions in a positive manner.
• Evaluate the interviewer and the organization. An interview is a two-way street.
• Make sure you understand the employer’s next step in the hiring process; know when and
from whom you should expect to hear next.
Interview Don’ts
• Don’t make excuses. Take responsibility for your decisions and your actions.
• Don’t make negative comments about previous employers or supervisors (or others).
• Don’t give the impression you are only interested in salary.
• Don’t act as though you would take any job or are desperate for employment.
• Don’t chew gum or smell like smoke.
• Don’t take cell phone calls during an interview. If you carry a cell phone, turn it off
during the interview.

Business Negotiation Skills


“Negotiation involves two or more parties with competing or conflicting interests or needs,
working towards an agreement on how they will cooperate.” (Tillett, 1991)

12 Conflict Resolution Skills


1. Think Win/Win
2. Creative responses that transform problems into creative opportunities
3. Build empathy by using active listening to clarify understanding
4. Apply assertiveness strategies to attack the problem and not the person
5. Eliminate “power over” to build “power with” others
6. Manage emotions by expressing fear, anger, hurt, and frustration wisely to effect change
7. Name personal issues that cloud the picture
8. Map the conflict by defining issues of common needs and concerns
9. Design creative solutions together
10. Plan and apply effective negotiation strategies to reach agreement
11. Help conflicting parties move towards solution through mediation
12. Broaden perspectives to evaluate problems in a broader context

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Business Discussions (Brainstorming)
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:
 Expand creative thinking and identify issues or opportunities
 Identify possible causes of a problem and identify data collection requirements
 Identify possible solutions to a problem and see different points of view
5 Steps to Effective Brainstorming
1. Clearly define the topic to be brainstormed.
2. Aim to generate as many ideas as possible in 20-30 minutes.
3. Don't change, criticize or evaluate any idea.
4. Encourage each member to present as many ideas as possible.
5. Keep going until all ideas have been presented.
Evaluate Results
At the end of a successful brainstorming session you will have a long list of ideas. Now you
will need to separate the “jewels” from the “junk” and create a manageable list of feasible
ideas that are worthy of further investigation. Here's how:
 Clarify: Make sure everyone understands what each idea means.
 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.

The Leader's Role:


To successfully lead a brainstorming session it is often more effective to think of yourself as
facilitating rather than leading. This distinction is particularly important if you happen to hold
a leadership position in the company.
Here are some of the key responsibilities:
 Make sure the group is clear about the topic that is to be brainstormed and stimulate ideas
 Explain the rules and make sure they are followed
 Help phrase ideas clearly and write ideas down
 Don't let your extroverts dominate the discussion, solicit input from of quieter members
 Keep the discussion within the established time limit.

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Lecture 9. Practical Aspects of Business Communication (Continues ….)

Medias of Communication
Media Potential Target Advantage Disadvantage
Type
TV Mass media – Public Wide reach; High perceived Expensive;
can credibility; Audio and Programs not always
reach many visual; Good for simple on at convenient
people; messages and times; Not everyone has
High status slogans; Can help to TV; No room for
generate interaction unless
interest, awareness linked to a TV call in
and excitement show
Radio Same as above Public Medium to wide Reach; Relatively inexpensive
High status; Good for (compared to TV); Programs
simple messages and not always on at convenient
slogans; Can help to times; No room for
generate Interaction; Audio only, no
interest, awareness visual communication
and excitement
Newspap Same as above Literate People Can review and re-read as Requires literacy; Not as
er needed deep reach as TV or radio;
Publication depends
on the whim of editors
Websites Need to be Literate public; Global info can be Computers needed and may
/internet computer Specific list serves obtained, not only local or not be widespread; List
& literate and networks can regional; Youth becoming serves and websites require
blogs be set-up for computer savvy; someone to manage and
particular List-serves can be quite facilitate them
audiences/clients such inexpensive; Can establish and provide content as well
as the links as technical assistance
media directly to other sites; Can also
establish
pages on existing sites
Mobile Tremendous Specific publics, Growing reach, Text messages must
phones potential teenagers in especially in rural be short; Best if linked or
and text for 1 on- 1 particular areas; Low cost for text tied
messages communication messages; Highly popular to other
directly. communication
efforts
Posters No potential for General and Can deliver simple Requires visual and
feedback, unless specific publics messages and written literacy; Generally
widely slogans; Not necessarily better for
tested or if expensive and can simple messages and
produced often be produced slogans
together with in-house
communities
through
participatory
processes
Brochure No potential for General and Can deliver more Limited to specific
feedback, unless specific publics information than Distributions; Requires
widely posters, good for visual and
tested and instructional info; Don’t written literacy
produced have to be
PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 33
through expensively
participatory produced
workshops with
participants
Fact No potential for General Can be distributed limited to specific
sheets feedback audiences after meetings, in information for
and markets; Can also be specific topics –
flyers mailed; Cheap if done in single facts or tips
B&W on colored
paper; reviewed at leisure;
Inexpensive/cheap; Can be
produced in house through
desktop
publishing
Newslett No potential for General and Can deliver more Limited to specific
ers feedback unless specific publics information than posters Distributions; Requires
produced with and brochures; Not visual and
community necessarily expensive, can written literacy
input – then be done in-house; Good for
can be highly reporting on progress and
effective at achievements;
promoting local Credibility can be
innovations and high if produced by
activities community (people
particularly if like to see
local themselves in print);
people ‘report’ Can be produced in house
and write through
the news items desktop publishing
Instructio Feedback and Target audiences Can be paused for deeper Requires editing
nal video questioning can discussion and replayed as equipment and
be built Needed; Most communities software unless in camera
into the are likely to have at least taping is followed; Usually
presentation and one VCR; needs to be supported with
learning High status; Equipment is other printed materials; Can
getting be over-used when other
cheaper to use and methods may be more
purchase; Can record appropriate; More expensive
‘before’, costs up-front
‘during’ and ‘after’
steps in process; Can be
played back
immediately
Public Lots of potential Different Encourages group Only good for one off
presentati for audiences can be Formation; Helps to moments in a process; Need
ons & interaction and targeted directly publicize to be held when people are
communi participation general info; Generates available (nights, weekends);
ty local Don’t always attract
meetings, Ownership; Builds desired audience
service partnerships
clubs,
etc.
Power Can incorporate Good for more If well done, good for Requires computer
point feedback sophisticated marketing or skills and equipment
presentati audiences like selling ideas and generating to view, projectors;
ons service clubs and interest; Can be accessed Cannot
professionals, over the internet communicate large

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 34


civil servants amounts of detailed
information;
Requires electricity and
some amount of technical
savvy;
Projectors can be
expensive
Bumper Not General public Usually attractive; But not Message/slogan
stickers participatory at and specific all cars will needs to be kept
all audiences post them short and punchy
Billboard Same as above Best for one main message Very expensive;
or slogan; Fairly permanent People forget to
depending on duration notice after a while
posted
Highly visible
Diaries, Can be General publics Highly popular; Very expensive to
Calendar participatory if and specific Lots of information produce – particularly in
local audiences and tips can be color; People expect them
communities and included to be free; Limited to one-
audiences are year only, unless designed in
profiled such a way that tips/info
can be torn off and kept for
future reference (such as:
menu ideas, shopping tips,
etc.)
Promotio Participatory, to shoppers, moderately can be costly to
nal items the mothers, inexpensive; produce, although
such as extent that people consumers make a visible can be done in partnership
T-Shirts, like statement in the with
cups, them and use market small enterprise
aprons, them popular
caps,
shopping
bags, etc
Campaig Participatory to general public inexpensive to can generate a
n Slogan the generate, even free; slogan that is
competiti extent that people can help to unify all ultimately not usable
on get materials and or effective; require effective
involved. outputs organization and promotion
Goodwill Depending on the different if the right people not always available;
ambassad personality, they ambassadors can are committed, can have to work around
ors can be be identified for lend high status and their schedule;
(sports highly engaging different target credibility to a not always ‘reliable’;
figures, and audiences strategy and to its must be credible;
singers/c interactive and messages not always willing to work
elebrities, attract for free or for charity;
beauty high levels of may not actually
queens, community/audie believe or practice
personali nce the recommendations
ties) participation being promoted

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 35


Lecture 10. Practical Aspects of Business Communication (Continues…)

Customer Relationship Management (CRM)


CRM is “the development and maintenance of mutually beneficial long-term relationships
with strategically significant customers” (Buttle, 2000)

Understanding Customer Relationship Management (CRM)?


CRM is a business philosophy based on upon individual customers and customised products
and services supported by open lines of communication and feedback from the participating
firms that mutually benefit both buying and selling organisations. The buying and selling
firms enter into a “learning relationship”, with the customer being willing to collaborate with
the seller and grow as a loyal customer. In return,, the seller works to maximize the value of
the relationship for the customer’s benefit. In short, CRM provides selling organisations with
the platform to obtain a competitive advantage by embracing customer needs and building
value-driven long-term relationships.
Functions of Customer Relationship Management

The role of salespeople as relationship builders and promoters


o identifying potential customers and their needs;
o approaching key decision makers in the buying firm;
o negotiating and advancing dialogue and mutual trust;
o coordinating the cooperation between the customers and their company;
o encouraging the inter-organisational learning process;
PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 36
o contributing to constructive resolution of existing conflicts; and
o leading the customer relationship development team

Managing Customer Relationships


The global salesperson must be involved in the following activities in order to initiate,
develop and enhance the process that is aimed at building trust and commitment with the
customer.
Initiating the relationship
o Engage in strategic prospecting and qualifying;
o Gather and study pre-call information;
o Identify buying influences;
o Plan the initial sales call;
o Demonstrate an understanding of the customer’s needs;
o Identify opportunities to build a relationship; and
o Illustrate the value of a relationship with the customer
Developing the relationship
o Select an appropriate offering;
o Customise the relationship;
o Link the solutions with the customer’s needs;
o Discuss customer concerns;
o Summarize the solution to confirm benefits; and
o Secure commitment.
Enhancing the relationship
o Assess customer satisfaction;
o Take action to ensure satisfaction;
o Maintain open, two-way communication; and
o Work to add value and enhance mutual opportunities.
Relationship networks
The ultimate outcome of a successful CRM strategy is the creation of a unique company asset
known as a relationship network. A relationship network consists of the company and its
major customers with whom the company has established long and enduring business
relationships. The additional aspects of a global salesperson’s job are to:
o Manage customer value;
o Act as customer advocate; and
o Enhance customer loyalty and build a “health” and profitable network of relationships.

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 37


B. Communication in Hospital settings

Lecture 11. Hospital Management

The hospital is a complex organization and an institute which provides health to people
through complicated but specialized scientific equipment, and a team of trained staff
educated in the problems of modern medical science. The hospital pharmacy deals with the
supply of drugs, the filling of special prescriptions, with the manufacture of drugs. with the
storage and dispensing of narcotic and biological products, with the supply and storage of
ancillary products.

Figure: Departmental organization in a large hospital pharmacy operation

A. 1. Patient admission and discharge communications


Although each hospital introduces variations, the following is a step-by-step outline of the
procedure entailed in a decentralized unit-dose system:
o Upon admission to the hospital, the patient is entered into the system.
o Diagnosis, allergies and other pertinent data are entered on to the Patient Profile card.
o Direct copies of medication orders are sent to the pharmacist.
o The medications ordered are entered on to the Patient Profile card.

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 38


o Pharmacist checks medication order for allergies, drug –interactions, drug-laboratory test
effects and rationale of therapy.
o Dosage scheduled is coordinated with the nursing station.
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 patient’s 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

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 39


Minimize Barriers: Effective Communication Skills
 Proper environment
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 patient’s 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

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 40


 Route, dosage form, dosage and administration schedule
 Special directions for preparation, storage or administration
 Precautions to be observed while taking
 Common side effects, how to avoid or action required if they occur
 Techniques for self-monitoring of drug therapy
 Potential interactions or therapeutic contraindications
 Refills
 What to do if you miss a dose
 Any other information this patient may need to ensure safe use

A. 3. Dispensing routine and record keeping


Writing the Order: Medications should be given (with certain specified exceptions) only on
the written order of a qualified physician or other authorized prescriber. Allowable
exceptions to this rule (i.e., telephoned or verbal orders) should be put in written form
immediately and the prescriber should countersign the nurse’s or pharmacist’s signed record
of these orders within 48 (preferably 24) hours. Only a pharmacist or registered nurse should
accept such orders. Provision should be made to place physician’s order in the patient’s chart,
and a method for sending this information to the pharmacy should be developed. Prescribers
should specify the date and time medication orders are written. Medication orders should be
written legibly in ink and should include:
 Patient’s name and location (unless clearly indicated on the order sheet).
 Name (Generic) of medication.
 Dosage expressed in the metric system, except in instances where dosage must be
expressed otherwise (i.e., units, etc)
 Frequency of administration.
 Route of administration.
 Signature of the physician.
 Date and hour the order was written.
Any abbreviations used in medication orders should be agreed to and jointly adopted by the
medical, nursing, pharmacy, and medical records staff of the institution. Any questions
arising from a medication order, including the interpretation of an illegible order, should be
refer to the ordering physician. It is desirable for the pharmacist to make (appropriate) entries
in the patient’s medical chart pertinent to the patient’s drug therapy. Also, a duplicate record
of the entry can be maintained in the pharmacy profile. In computerized patient data systems,

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 41


each prescriber should be assigned a unique identifier; this number should be included in all
medication orders. Unauthorized personnel should not be able to gain access to the system.

Medication Order Sheets:


The pharmacist (except in emergency situations) must receive the physician’s original order
or a direct copy of the order before the drug is dispensed. This permits the pharmacist to
resolve questions or problems with drug order before the drug is dispensed and administered.
It also eliminates errors, which may arise when drug orders are transcribed onto another form
for use by the pharmacy. Several methods by which the pharmacy may receive physician’s
original orders or direct copies are:
3. Self-copying order forms. The physician’s order form is designed to make a direct copy
(carbon or NCR), which is sent to the pharmacy. This method provides the pharmacist
with a duplicate copy of the order and does not require special equipment. There are two
basic formats:
a. 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 physician’s order. Provision should be made to transmit physician’s 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 pharmacist’s 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.

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 42


A. 5. Inspection of nursing drug cabinets emergency boxes, and night drug cabinets
During such times as a hospital pharmacy may be unattended by a pharmacist, arrangements
must be made in advance by the director for the provision of drugs to the medical staff and
other authorized personnel of the hospital, by use of night cabinets or floor stock, or both, and
in emergency circumstances, by access to the pharmacy. A pharmacist must be available for
consultation during all absences; this protocol can be accomplished by telephone. If night
cabinets are used, the following should prevail: absence of a pharmacist, must be by locked
cabinets or other enclosures constructed and located outside of the pharmacy area, to which
only specifically authorized personnel may obtain access by key or combination, and which is
sufficiently secure to deny access to unauthorized persons by force or otherwise. The director
shall, in conjunction with the appropriate committee of the hospital, develop inventory
listings of those drugs to be included in such cabinets and shall ensure that:
a. Such drugs are available therein, properly labeled.
b. Only prepackaged drugs are available therein, in amounts sufficient for immediate
therapeutic requirements.
c. Whenever access to such cabinets shall have been gained, written physician’s orders and
proofs of use, if applicable, are provided.
d. Written policies and procedures are established to implement their requirements of this
subsection.

A. 6. Clinical Drug literatures and information resources


A pharmacist must be acquainted with Medline/Pubmed, Embase, Toxnet, PDR,
BP/USP/BNF, MIMS/QUIMP, MICROMEDEX, Access Medicine Drug Index, TGA,
RPhWORLD online or handling hard copies so as to upgrade himself with current drug-
disease-diagnosis updates.

A. 7. PHARMACY TECHNICIANS IN THE PHARMACEUTICAL SERVICES


 Receiving written prescriptions or requests for prescription refills from patients or their
caregivers
 Verifying that the information on the prescription is complete and accurate.
 Counting, weighing, measuring, and mixing the medication
 Preparing prescription labels and selecting the container
 Establishing and maintaining patient profiles
 Ordering and stocking prescription and over-the-counter medications

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 43


 Assisting with drug studies
 Taking prescriptions over the telephone
 Transferring prescriptions
 Tracking and reporting errors

Definitions:
1. “Order”: The direction for the drug, strength and frequency of administration as written
on the Doctor’s Order Sheet of the patient’s 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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Lecture 12. Handling Prescriptions

A prescription is a written, verbal, or electronic order from a practitioner or designated


agent to a pharmacist for a particular medication for a specific patient.

Who can write a prescription?


 Practitioners: Physicians, veterinarians, dentists, podiatrists
 Mid-level 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
 Legend drugs – expire 1 year from date issued
 Controlled drugs
 CIII-CV – expire 6 months from date issued
 CII – expire 7 days from date issued
 Ensures continual patient supervision
 Promotes patient follow - up
o Patient Name and Address
 Full first and last name: Middle initial may be helpful
 Full address
 DOB – not required, but will be helpful in further identifying the correct patient to
prevent medication errors
o Name of the drug
 Availability
 Cost
 A Drug - $10
 B Drug - $25
 C Drug - $45
 D drug – Full price
 Full payment
o Strength of the drug
 Be familiar with drugs and their various dosing strengths and dosage forms

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 45


 When in doubt, use references or call pharmacy for help
 Be familiar with dosing units and their corresponding abbreviations (Handout 4)
 Weight – based dosing
 Always convert patient weight to correct units (kg)
 Liquid medications
 One product may be available in a number of concentrations
 Be familiar with various product concentrations
 Indicate BOTH concentration and dose of medication
Example: Cephalexin suspension 125 mg/ 5 ml
1 teaspoon (5 ml) every 6 h 200 ml
o Quantity of the drug
 Prescribe only necessary quantity
 Write for specific quantities rather than time period (for example: dispense #30 vs.
dispense for 1 month)
 Calculate: quantity = frequency per day x treatment days
 Writing out “Dispense # X” is helpful
o Directions for use
 Write out in full English or use Latin abbreviations (Handout 5)
 Latin abbreviations – more convenient, more potential for mistakes
 Avoid Dangerous Abbreviations (Handout 3)
 Provide clear and specific directions
 Avoid “Take as Directed.”
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 drug’s 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 practitioner’s usual place of business
o Refills
 Refills are not required

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 46


 To avoid interrupting maintenance therapy, practitioners can authorize refills on a
written prescription
 Non-controlled substances - No limit to number of refills allowed. Use
Discretion.
 Refills authorized are valid only for life of the prescription – 1 year
 PRN – Refill as needed for 1 year

B. 2. Brief Description on Drug Packaging Insert Headings


 Composition Content of the unit
 Description Therapeutic category, Physical properties, Kinetic profile
 Mode of Action Discussion on therapeutic goal achievement
 Indication Disease and conditions where the drug is applicable.
 Dosage and Administration Unit dose measurement and time schedule
 Side Effect The unwanted/untoward effects of the drug
 Use in Pregnancy & Lactation
 Overdose Impact of consuming more than dosage guideline.
 Contra-indication The situation in which drug use is prohibited
 Precaution Warning statement
 Drug interaction Modification of the effect of one drug by another
 Pharmaceutical Precaution Doings/not doings to maintain integrity.
 Availability Commercial packing.

B.3. Routs of Drug Administration


Enteral: desired effect is systemic (non-local), substance is given via the digestive tract
i. By mouth (orally), many drugs as tablets, capsules, or drops
ii. Rectally, various drugs in suppository or enema form.

Topical: local effect, substance is applied directly where its action is desired.
a. Epicutaneous (application onto the skin).
b. Intradermal (into the skin itself)
c. Subcutaneous (under the skin), e.g. insulin.
i. Eye drops (onto the conjunctiva), e.g. antibiotics for conjunctivitis
ii. Ear drops - such as antibiotics and corticosteroids for otitis externa
iii. Inhalation/Intra-nasal (through the nose) e.g. decongestant nasal sprays to be
taken up along the respiratory tract e.g. inhalational anesthetics.
PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 47
iv. Intra-vaginal or Vaginal suppositories are commonly used to treat gynecological
ailments, including vaginal infections such as candidiasis.
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
b. Intra-arterial (into an artery), e.g. vasodilator drugs in the treatment of vasospasm
and thrombolytic drugs for treatment of embolism
c. Intramuscular (into a muscle), e.g. many vaccines, antibiotics, and long-term
psychoactive agents. Recreationally the colloquial term 'muscling' is used.
d. Intra-cardiac (into the heart), e.g. adrenaline during cardiopulmonary resuscitation
(no longer commonly performed)
e. Intra-thecal (into the spinal canal) is most commonly used for spinal anesthesia and
chemotherapy
f. Intra-peritoneal (infusion or injection into the peritoneum) e.g. peritoneal dialysis
g. Intra-vesical infusion is into the urinary bladder
h. Intra-vitreal through the eye
B.4. Common abbreviations used for prescriptions
o a.c. = before meals (from "ante cibum," before meals)
o ad lib: use as much as one desires (from "ad libitum")
o b.i.d. = twice a day
o t.i.d. = three times a day (from "ter in die," 3 times a day)
o caps = capsules
o da or daw = dispense as written
o g (or gm or GM) = gram, gtt. = drops (from "guttae," drops), h. = hour, mg =
milligram, ml = milliliter
o p.c. = after meals (from "post cibum," after meals)
o p.o. = by mouth, orally (from "per os," by mouth)
o p.r.n. = when necessary (from "pro re nata," for an occasion that has arisen, as
circumstances require, as needed)
o q.d. = once a day (from "quaque die," once a day)
o q.i.d. = four times a day (from "quater in die," 4 times a day)
o q.h. = every hour, q.2h. = every 2 hours, q.3h. = every 3 hours

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 48


List of dangerous abbreviations, acronyms, and symbols

Abbreviation Potential Problem Preferred Term

U (unit) Mistaken as zero, four, or cc Write “unit”

IU (international unit) Mistaken as IV or 10 Write “international unit”

Q.D., Q.O.D. Mistaken for each other. Write “daily” and “every
Period after Q and O after Q other day”
can be mistaken for “I”

Trailing zero and lack of leading Decimal point missed Never write a zero by itself
zero after a decimal point,
and always use a zero
before a decimal point

MS, MSO4, MgSO4 Confused for one another Write “morphine sulfate”
or “magnesium sulfate”

µg (microgram) Mistaken for mg (milligram) Write “mcg”

H.S. (at bedtime or half – Mistaken for either meaning: Write out “half – strength”
strength) Also mistaken for every hour or “at bedtime”

T.I.W (three times a week) Mistaken for three times a Write “three times weekly”
day or twice weekly or “3 times weekly”

S.C. or S.Q. (subcutaneous) Mistaken for SL for Write “Sub-Q” or “subQ”


sublingual or “5 every” or “subcutaneously”

D/C Interpreted as discontinue Write “discharge”


whatever medication follows
(typically discharge meds)

c.c. Mistaken for U (units) when Write “ml” for milliliters


poorly written

A.S., A.D., A.U. (Latin Mistaken for each other (A.S. Write out “left ear” or
abbreviations for left, right, both for O.S., A.D. for O.D., A.U. “right ear” or “both ears”
ears) O.S., O.D., O.U. (Latin for O.U., Vise-versa) Write out “left eye” or
abbreviations for left, right, both “right eye” or “both eyes”
eyes)

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 49


Lecture 13. Handling Prescriptions (Continues….)

B. 5. Controlled drug prescriptions


 Definition - a prescription drug whose use and distribution is tightly controlled because
of its abuse potential or risk
 Regulation is more strict
 Federal law and State law regulate the storage, use, and disposal of controlled substances
 Controlled drugs are divided into Schedules according to abuse potential
 Schedule I (C-I) – Highest abuse risk. No safe medical use in U.S. Examples: heroin,
marijuana, LSD, PCP, and crack cocaine.
 Schedule II (C-II) – High abuse risk but have safe and accepted medical use. Examples:
morphine, oxycodone, methylphenidate, dextroamphetamine.
 Schedule III (C-III) – Abuse risk less than C-II and safe and accepted medical use.
Examples: Acetaminophen/Codeine (Tylenol #3), acetaminophen/hydrocodone
(Vicodin), propoxyphene (Darvon).
 Schedule IV (C-IV) – Abuse risk less than C-III and safe and accepted medical use.
Examples: diazepam (Valium), alprazolam (Xanax), phenobarbital, chloral hydrate.
 Schedule V (C-V) – Abuse risk less than C-IV and safe and accepted medical use.
Mainly consist of preparations containing limited quantities of certain stimulant and
narcotic drugs for antitussive and antidiarrheal purposes.

Checking and receiving prescriptions


In dispensing of controlled substances, the following requirements should be considered with
prescriptions:
1. Except when dispensed
2. Drugs may be dispensed on the oral prescription in an emergency situation.
3. Prescription shall be retained in conformity with the requirements of this law.
4. No prescription for a controlled substance in Schedule II may be refilled.
5. Controlled substances in Schedule III or IV may not be dispensed without a written or oral
prescription in conformity.
6. Such prescriptions may not be filled or refilled more than 6 months after the date thereof or
be refilled more than 5 times after the date of the prescription unless renewed by the
practitioner.
7. No controlled substance in Schedule V that is a drug may be distributed or dispensed other
than for a medical purpose.

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 50


Prescriptions filled with controlled substances in Schedule II may be written in ink or
indelible pencil and must be signed by the practitioner issuing them. Prescriptions for
narcotic substances in Schedules III, IV and V, must be kept in a separate file.

Consulting the prescriber


It is in the additional role of managing medication therapy, in collaboration with prescribers,
that pharmacists can now make a vital contribution to patient care. To do so, the role of the
pharmacist needs to be redefined and re-orientated. The traditional relationship between the
doctor as prescriber, and pharmacist as dispenser, is no longer appropriate to ensure safety,
effectiveness and adherence to therapy. Pharmacists need to pay more attention to patient-
centered, outcomes-focused care to optimize the safe and effective use of medicines.
Dispensing is, and must remain, a responsibility of the pharmacy profession, but prescribing
and dispensing should not be done by the same person. By taking direct responsibility for
individual patients' medication-related needs, pharmacists can make a unique contribution to
the outcome of medication therapy and to their patients' quality of life.

Compounding
Compounding involves the preparation, mixing, assembling, packaging, and labeling of a
drug or device in accordance with a licensed practitioner's prescription under an initiative
based on the practitioner/patient/pharmacist/compounder relationship in the course of
professional practice. The compounder shall be responsible for the following:
• Certifying all prescription orders;
• Approving or rejecting all components, drug product containers, closures, in-process
materials, and labeling;
• Preparing and reviewing all compounding records to assure that errors have not occurred in
the compounding process;
Following things that a compounding pharmacist needs to train:
a. All employees involved in pharmaceutical compounding shall read and become familiar
with Pharmaceutical Compounding—Nonsterile Preparations, Pharmaceutical
Compounding—Sterile Preparations.
b. All employees shall read and become familiar with each of the procedures related to
compounding, including those involving the facility, equipment, and personnel, actual
compounding, evaluation, packaging, storage, and dispensing.
c. The compounder shall meet with employees to review their work and answer any questions
the employees may have concerning SOPs.

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 51


d. The compounder shall demonstrate the procedures for the employee, and will observe and
guide the employee throughout the procedure. The employee will then repeat the procedure
without any assistance from, but under the supervision of, the pharmacist.
e. When the employee has demonstrated to the compounder a verbal and functional
knowledge of the procedure, then and only then, will the employee be permitted to perform
the procedure without supervision.
f. When the compounder is satisfied with the employee’s knowledge and proficiency, the
compounder will sign off on the documentation records to show that both the employee and
the compounder agree.
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 USP–NF
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

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 52


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
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 USP–NF 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.

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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
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 doctor’s 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. Patient’s full name
4. Patient’s 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. Patient’s address or hospital number
c. Date
d. Name and strength of drug prescribed.
e. Quantity of drug to be dispensed

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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
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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C. Communication in Pharmaceutical Industry and Regulatory Affairs

Lecture 14. Communication in Industry

Line up: Head office personnel communication with Sales, Distribution, Plant and MIS Team; Production and
QC validation protocol & interpretation of analytical data, Batch Manufacturing Record (BMR) for shifting duty
personnel.

Head office personnel communication (PMD activities)


Currently pharmacists are engaged in Product Management Department (PMD), Medical
Services Department (MSD), Sales Promotion/Medical Promotion, Clinical Services,
Training for field forces, and International Marketing (IM) departments.
A. Sales & Marketing coordination
Sales and marketing coordinators directly supervise and coordinate the activities planned by
sales and marketing executives. Their roles vary according to need and are therefore very
diverse. Coordinators in some firms have entry-level responsibilities that resemble those of
an office clerk. Other coordinators have duties more closely resembling those of a marketing
manager. In general, coordinators implement the plans and strategies developed by senior
management. They may be responsible for generating presentations and proposals, providing
database management, coordinating photography, putting together trade show displays, and
compiling sales and inventory reports. They also may help with surveys, web page design,
newsletters, and promotions. In addition, coordinators may assist sales representatives by
providing pre-sale, post-sale, and contract support.
B. Marketing-Plant coordination
Marketing plant coordinators need to be in close contact with production and product
developments in certain issues like sales forecast, packaging materials design, regulatory
issues like block list approval. They need to have a close contact with commercial department
for the same issues because they need to arrange raw materials, packaging materials from
local or distant sources.
C. Pharmacist in sales
In many countries of the developed world (such as, Japan, USA, Canada, etc.), Pharmacists
are working as Medical Representatives/Sales team with highly paid salary for the promotion
of drugs to the physicians. Our Pharmacists consider this job as a prestigious issue and they
don’t have interest to engage themselves for such kind of jobs. Considering the present job
crisis of Pharmacists in Bangladesh as well as considering the world scenario, Bangladeshi
Pharmacists should engulf these job areas omitting the traditional job trend in our country.
PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 56
They can enjoy this job opportunity as they are best suited for those positions than the
professionals working from any other disciplines.

Steps in a Sales Call to Customer


Call Steps Salesman’s Action Prospect's Action
Prospecting Find/Qualify/Classify/Categorize/Grade

Preparation Analyze/Study/Set Objective/Plan

Approach Secure access/Gain attention/Awake Willing to see/ to listen


Interest
Presentation Find out needs/ Buying Motives, Wants/ will benefit
Present Benefits
Response Handling Listen to the responses/ reactions, Understands
Buying signals
Closing Ask for the commitment/order Need/wants Will
benefits
Post-call analysis Follow through/ evaluation

Communication in Production Plant


A. Production and QC validation protocol
Most of the Pharmacists are currently working in the manufacturing of pharmaceutical
finished drugs. They need to have good interviewing skills to thoroughly understand the
system and get the information. Communication skill is important at two key points:
 Research prior to writing protocols
 Preparing validation documents
.Following type of information usually reflected by these documents:
 Data on operating the system
 Application Data instrumental
 Functions to be performed by the system
 Interface with other systems
 Environmental Conditions
 Diagnostics Availability
 Tests and calibrations
 Restrictions

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 Facilities requirements
 Equipment Requirements
 Process Requirements
 System Limits

Documentation
 Validation Master Plan
 Qualification Master Plan
 GMP Risk Analysis
 Validation Protocol
 Test protocol (including specification)
 Validation Report
 Summary of Deviations / Issues

B. Following SOPs and BMR for shifting duty personnel


SOP provides guidance on the validation planning process and the purpose and minimum
content requirements for a Validation Plan (VP). Validation standard operating procedures
are written to provide explicit instruction on how to achieve the standards for those
responsible for writing and executing master validation plans for drug, drug-device
combination, diagnostic, pharmaceutical biotechnology, and bulk pharmaceutical chemicals
products. Included is the ready-to-use template so that one can immediately save time and
expense without missing any critical elements.
SOP Format
All SOPs have been uniformly designed and formatted. Information common to all SOPs is
described below.
First Page
Company Name — At the top of each SOP, a box is provided to enter company name.
SOP Number — Each SOP is assigned a unique number that appears at the upper-left corner
of each page.
Title — The title of each SOP appears at the top of the first two pages below the SOP
number. The title describes the subject of the SOP.
Date — Each SOP is assigned an effective date at the top of the page, to the right of the SOP
number. The date describes the month, day, and year of implementation.
Author — Each SOP is assigned a space to provide the author name, title, and the
department, along with signatures and dates.
PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 58
Checked by — Each SOP is assigned a space to provide the name, title, and the department
of the person responsible for checking the contents of the SOP requiring the signature and
date.
Approved By — Each page of the SOP provides a space for the signature of the quality
assurance or manager approving the SOP to prevent unauthorized changes.
Revisions — At the end of each page is the revisions box. This box documents the revision
number, section, pages, initials, and date.
Other Pages
Subject — Each SOP begins with the subject to provide key description of the SOP.
Purpose — Each SOP is supported with reasons, describing the purpose.
Responsibility — The space for responsibility clearly identifies who has to follow the
procedures and who is responsible for the overall compliance with the SOP.
Procedure — Following the purpose statement are the individual steps of the SOP, arranged
in logical order to make the SOP easy to perform.
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 SOP’s, documentation / materials are checked as per
SOP and ensures during Sign-on process, declaration of area, keeping of Log books as per
SOP’s 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.

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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.
• 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 (e-
records) 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.

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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
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.

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 61


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.
Pharmaceutical excipient: A substance, other than the active pharmaceutical ingredient
(API), which has been appropriately evaluated for safety and is included in a medicines
delivery system to:
— aid in the processing of the medicines delivery system during its manufacture;
— protect, support or enhance stability, bioavailability or patient acceptability;
— assist in pharmaceutical product identification; or
— enhance any other attribute of the overall safety and effectiveness of the medicine during
its storage or use.
Pharmaceutical product: Any material or product intended for human or veterinary use,
presented in its finished dosage form or as a starting material for use in such a dosage form,
which is subject to control by pharmaceutical legislation in the exporting state and/or the
importing state.
Precision: The degree of agreement among individual results when the procedure is applied
repeatedly to multiple samplings of a homogeneous sample. Precision, usually expressed as
relative standard deviation, may be considered at three levels: repeatability (precision under
the same operating conditions over a short period of time), intermediate precision (within
laboratory variations — different days, different analysts or different equipment) and
reproducibility (precision between laboratories).
Primary reference substance (or standard): A substance that is widely acknowledged to
possess the appropriate qualities within a specified context, and whose assigned content is
accepted without requiring comparison with another chemical substance.

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 62


Qualification of equipment: Action of proving and documenting that any analytical
equipment complies with the required specifications and performs suitably for its intended
purpose.
Quality control: All measures taken, including the setting of specifications, sampling, testing
and analytical clearance, to ensure that raw materials, intermediates, packaging materials and
finished pharmaceutical products conform with established specifications for identity,
strength, purity and other characteristics.
Quality unit(s): An organizational unit, independent of production, which fulfills both quality
assurance and quality control responsibilities. This can be in the form of separate quality
assurance and quality control or a single individual or group, depending on the size and
structure of the organization.
Reference material: Material sufficiently homogeneous and stable with respect to one or
more specified properties, which has been established to be fi t for its intended use in a
measurement process.
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 system’s
performance is acceptable at the time of the test.

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C. Communication in Pharmaceutical Industry and Regulatory Affairs

Lecture 15. Communication with Regulatory Body

Guidance for Industry -Submission of Clinical Trial Application for Evaluating Safety and Efficacy,
Requirements for permission of New Drugs Approval, Post approval changes in biological products, Preparation
of the Quality Information for Drug

Guidance for Industry


Submission of Clinical Trial Application to DGDA for Evaluating Safety and Efficacy
All new vaccine and biological products first time produced in Bangladesh from novel seed
materials must undergo clinical trials in Bangladesh. Sponsors are required to submit a status
report on the clinical trial to the Licensing Authority at the prescribed periodicity. The
summary report should provide a brief description of the study, the number of patients
exposed to the drug, dose and duration of exposure, details of adverse drug reactions, if any,
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. CD’s (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 CD’s. 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.

N.B. Detail of guidance will be provided based on personal interest

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C. Communication in Pharmaceutical Industry and Regulatory Affairs

Lecture 16. Communication with Regulatory Body

Line up: Submission for New Drug, Communication with DCC committee and Technical Subcommittee for
approval, Block list approval, Licensing authority of DGDA, Inspection report for Pharmaceutical industry and
retail outlets.

 Power Point Projection

Inspection report for Pharmaceutical industry and retail outlets


Directorate General of Drug Administration of Bangladesh has great lack of manpower
for the monitoring of drug production in large numbers of Allopathic, Ayurvedic, and
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
it’s 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.

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 65


C. Communication in Pharmaceutical Industry and Regulatory Affairs

Lecture 17. Communication with Regulatory Body (Continues…)

Line Up: International Marketing and Trade Related Barriers: Communication for outsourcing (contract
manufacturing), technology transfer, Letter of Credit (LC) opening for export and Import.

International Marketing Communications (Promotion)

Media Choices for International Marketing


Marketing communications in international markets needs to be conducted with care. This
lesson will consider some of the key issues that are to take into account when promoting
products or services in overseas markets. There will be influences upon media choice,
cultural issues to be considered, as well as the media choices themselves - personal selling,
advertising, and others.

Influences upon International Media Choice.


There are a number of factors that will impact upon choice and availability of media such as:
 The nature and level of competition for channels in target market.
 Whether or not there is a rich variety of media in your target market.
 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.

Cultural Issues and International Marketing Communications.


There are a whole range of cultural issues that international marketers need to consider when
communicating with target audiences in different cultures.
Language will always be a challenge. One cannot use a single language for an international
campaign. For example, there are between six and twelve main regional variations of the
Chinese languages, with the most popular being Mandarin (c 850 Million), followed by Wu

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 66


(c. 90 million), Min (c. 70 million) and Cantonese (c. 70 million). India has 22 languages
including Assamese, Bengali, Bodo, Dogri, Gujarati, Hindi, Punjabi, and Tamil to name but a
few. Of course language choice could affect branding choices, and the names of products and
services.
Design, symbolism and aesthetics sometimes do not transcend international boundaries. For
example Japanese aesthetics sometimes focus upon taste and beauty. Also look at Japanese
cars from the front - they have a smiling face.
The manner in which people present themselves in terms of dress and appearance changes
from culture to culture. For example in Maori culture, dress plays a central role with
everyday clothing differing greatly from ceremonial costume. Whereas in Western business-
culture the standard 'uniform' tends to be a conservative collar and tie.
Other factors that need to be considered in relation to international marketing
communications (Promotion) include:
 The work ethic of employees and customers to be targeted by media.
 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.

Media Choices in International Marketing.


Personal Selling in International Marketing.
Personal selling has a number of pros and cons:
 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.
 There is a dilemma as to whether to place expatriate employees into your international
target market, or to recruit locally. Local is best!

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 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.

Advertising in International Marketing.


Advertising has a number of pros and cons:
 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.
 Which language(s) is the press written in?
 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?
 Which TV channels do our target segments watch?
 Is there space on the suitable TV channels when we want it, or at a price that we can
afford?
 Where visual communication is paramount, are there suitable poster locations?
 What is the behavior of the target population in relation to cinema? For example,
Cinema is tremendously popular in India.
 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?

Other Media Choices in International Marketing.


Other potential media would include:
 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.
 International tradeshows, trade missions, sponsorship (for example international
sporting events), Public Relations (for example oil companies) and a variety of other
international marketing communications are available to the international marketer.
 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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Opening Letter of Credit in Bangladesh – Rules & Regulation

Definition of Letter of Credit


A Letter of Credit (LC) is a document issued by your bank that essentially acts as an
irrevocable guarantee of payment to a beneficiary. This means that if you do not perform
your obligations, your bank pays. The letter of credit can also be the source of repayment of
the transaction meaning that the exporter will get paid with the redemption of the letter of
credit.

Opening of LC
Generally a bank open an LC only on behalf on their own customer maintaining account with
them and are know to be participating in the trade. Payments in retirement of the bill are
received by the bank by debiting the party’s account or by a crossed check from other bank.

Application for LC
For opening of LC, a client is required to fill a prescribed application from provided by the
bank. The application must be supported by the following papers –
1. Indent issued by the indenting agent or proforma invoice issued by the foreign suppliers.
2. Marine insurance cover note issued by an approved insurance in favor of the bank
covering the unusual marine risks.
3. IMP form duly signed.
4. IRC form duly renewed.
In the LC application form the client signed an agreement with the following clauses:
1. Bank will have the pledge of documents and goods covered by the credit.
2. The credit will be paid back to the bank on maturity of the draft by the applicant.
3. The LC will be governed by the ICC brochure no. 500.

Additional Requirement
Depending on the specific provision in the underlying sale contract it may be necessary to
incorporate the following terms.
1. Who will pay the charges of the bank, buyer or seller?
2. Whether short form of Bill of Lading (B/L) is acceptable?
3. Whether is case of balk importer, charter party B/L is acceptable or not?
4. Where shipment by a charter party is allowed, the following clause must be stipulated
in the letter of credit –

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 69


a) Shipping documents must include copy of charter party agreement.
b) B/L must be signed named carrier or his authorized agent.
If the LC application and supporting documents are found in order, the bank proceeds to
assess the financial position and credit worthiness of the importer, market demand for the
goods to be imported. An LC margin is retained keeping in view the bank customer
relationship, past performance and post shipment financing arrangement. However the
margin must commensurate with the minimum margin requirement set by Bangladesh Bank.
The charges must be realized in cash or by debiting the account of the customer.

Transmission of LC
If all the necessaries are met, then the LC form is signed two authorized officer of LC
department whose specimen signatures are available at the correspondent bank abroad. If the
LC is a Full Mail one, then the original LC form accompanied by a copy of it is mailed to the
correspondent bank abroad via a reliable currier service.

If the correspondent bank abroad is not the negotiating bank, a third copy is sent to the
negotiating bank. The correspondent bank or reimbursement bank abroad honor the claim of
negotiating bank on the basis of 3rd mailed copy of LC.

Amendment of LC
After opening of LC sometimes its necessary to alter the original terms and condition. These
amendments may involve (i) change in unit price, (ii) extension in validity of LC, (iii)
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 auxiliary-

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1. 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
bank’s 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

PHARMACEUTICAL COMMUNICATION (PHR 207) WORLD UNIVERISTY OF BANGLADESH Page 71

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