DISPENSING LEC LESSON 1: Dispensing Process, Reading & Interpreting the

Prescription and Other Medicine Orders

Dispensing

• Refers to the process of preparing and giving medicine to a named person on the basis
of a prescription.

• Involves the correct interpretation, accurate preparation and the labeling of medicine
for use by the patient

• Vital elements of the rational use of the medicines.

• It is the act by a validly registered pharmacist of filling a prescription or doctor’s order on

the patient’s chart. (AO 63 s.1989 – “Rules and Regulation to Implement Dispensing
Requirements under the Generics Act of 1988”)

Dispensing

Dispensing refers to the sum of processes performed by a pharmacist from reading,

validating, and interpreting prescriptions; preparing, packaging, labeling, record keeping,
dose calculations, counseling or giving information, in relation to the sale or transfer of
pharmaceutical products, with or without a prescription or medication order. (RA 10918)

GOOD DISPENSING PRACTICE

Ensures that the right drug, in the right dosage form indicated for the patient’s condition, is
delivered to the right patient, in the prescribed dosage and quantity with clear instructions
and in a package that maintains the potency and stability of the drug

Pharmacist

“Is an INDESPENSABLE provider of the medication EXPERTISE”

Pharmacist refers to a health professional who has been registered and issued a valid
Certificate of Registration (COR) and Professional Identification Card (PIC) by the PRC and
Professional Regulatory Board of Pharmacy (BOP). (RA 10918)

The World Health Assembly recognizes the key role of pharmacist in public health and the
use of medicines

Emphasizes responsibility to:

• Provide informed and objective advice on medicine and their use

• Promote the concept of pharmaceutical care

• Pharmacist can play a key role in helping people to make informed self-care choices

• Increasingly, people are managing a large proportion of their ailments without consulting
either a doctor or pharmacist:

• Instantaneous access to limitless data (thru internet) on all aspects of health and care
mean that people across the globe have the means to query decisions and challenge
medical opinion.

 • Growing empowerment is also influenced by greater levels of education Having

information is one thing but being able to understand it and utilize it is another (SELF-
MEDICATION)

10 STAR PHARMACISTS

1. CARE GIVER 6. TEACHER

2. DECISION MAKER 7. LIFE LONG LEARNER

3. COMMUNICATOR 8. RESEARCHER

4. LEADER 9. AGENTS FOR POSITIVE CHAGE

5. MANAGER 10. ENTREPRENEUR

1. Pharmaceutical Care Provider

• Must provide a patient-centered, outcomes-oriented practice of pharmacy.

• Pharmacist as a key member of the health care team, with responsibility for the
outcomes of medication therapy.

• Pharmaceutical care delivered by the pharmacist seeks to optimize patient outcomes,

and is the key to effective, rational and safe use of medicine.

• The pharmacist provides caring services. Whether these services are clinical, analytical,
technological or regulatory, the pharmacist must be comfortable interacting with
individuals & populations.

• Services must be of the highest quality.

2. Decision Maker

• The foundation of the pharmacist’s work must revolve around accurate decisions made
or taken regarding appropriate, efficacious, safe and cost-effective use of resources

• The Pharmacist must possess the ability to evaluate, synthesize data and information, and
decide upon the most appropriate course of action.

3. Researcher

• The pharmacist must be able to use the evidence base (e.g., scientific, pharmacy
practice, health system) effectively in order to advise on the rational use of medicines in
the healthcare team.

• As a researcher, the pharmacist is able to increase the accessibility of unbiased health

and medicines- related information for the public and other healthcare professionals.

4. Leader

• Whether the pharmacist finds itself in multidisciplinary (ex. team) caring situations or in
areas where other health care providers are in short supply or non- existent, he/she is
obligated to assume a leadership position in overall welfare of the community.

• Leadership involves compassion and empathy as well as vision and the ability to make
decisions, communicate, and manage effectively. A pharmacist whose leadership role is
to be recognized must have vision and the ability to lead.

 A. Transparency - Communicate any changes in company vision and values. Involve employees in the
decision making;

B. Communication C. Accessibility

D. Respect - Promoting a culture of respect and equality among physicians, nurses and allied-health
professionals is crucial to team building.

D. Trust - It fosters honest conversations and allows employees to openly express themselves.

5. Manager

• The pharmacist must effectively manage resources (human, physical and fiscal) and
information; he or she must also be comfortable being managed by others, whether an
employer or the manager/ leader of a health care team.

• More and more, information and its related technology will provide challenges to the
pharmacist as he/ she assumes greater responsibility for sharing information about
medicines & related products.

6. Teacher

• The pharmacist has the responsibility to assist with the education and training of future
generations of pharmacists. Participating as a teacher not only imparts knowledge to
others, it offers an opportunity for the practitioner to gain new knowledge and to fine-
tune existing skills.

• To assist with the education and training of future generations of pharmacist and the
general public.

• The teaching sessions are the best conducted (EXPERTISEvsCOMPETENCE)

7. Entrepreneur

The pharmacist must learn how to make market survey in the chosen area, plan, direct,
manage a new pharmacy business

The Pharmapreneur must possess and apply appropriate pharmaceutical sciences

knowledge perform pharmacist-directed patient care, solve problems and continue to learn
as the healthcare laws and policies change enhance patient care by creating new
outcomes improvements paradigms innovate new pharmacy business solutions that
enhance the patient experience and strengthen the business of community pharmacy.

8. Lifelong learner

• Pharmacist regularly update their knowledge and skills in order to keep up with the
current trends and issues- related to drug therapy management.

• The life-long process of active participation in learning activities that assists individuals in
developing and maintaining continuing competence, enhancing their professional
practice, and supporting achievements of their career goals”.

• The concepts, principles and commitment to life-long learning must begin with attending
pharmacy school and must be supported throughout the pharmacist's career
9. Communicator

• The pharmacist must provide a link between physicians and patients, and to other
healthcare professionals. The pharmacist must have a complete knowledge about the

 pharmaceuticals with recent updates and be confident while communicating with other
health care professionals and community member.

• Pharmacist must have effective patient counseling skills and it may help him/ her to
provide better pharmaceutical care to the community by identifying the patient’s
problem and requirements, ensuring the quality of patient life. Strong communication
skills will enable a pharmacist to establish the necessary rapport to build a trusting
relationship.

In the Philippines...

Poor communication (between pharmacists-patient, and pharmacists- other health care

providers) is considered among pharmacists perceived major batrriers in providing
pharmaceutical care (Agaceta et.al. 2014)

10. Agent of Positive

Change the pharmacist must be the lead in creating change in pharmacy practice to
improve patient care, pharmacy services and inter professional collaboration

THE WORD PHARMACIST STANDS FOR

P – PATIENCE

H – HONESTY

A – ALERTNESS

R – RESEARCH

M – MOTIVATOR

A – ADMINISTRATOR

C- COURAGEOUS

I – INTELLOGENT

S – STUDIOUS

T – THINKER

 DISPENSING LEC LESSON 2: Principles of Good Customer Service

“An effective communication with one type of patient may be totally inappropriate for
another. “

SERVICES ARE DISTINGUISHED BY THE FOLLOWING FEATURES:

• The customer is a participant in the service process.

• Services are produced and consumed simultaneously
• Services are perishable.
• Service site location is dictated by the consumer.
• Economies of scale are difficult to achieve in services.
• Standardization of services is difficult.
• Services are labor-intensive.
• Output is difficult to measure.
• Most important, services are intangible. While there may be a tangible expression of
the service, in this case a prescription, the cognitive evaluations and judgment of the
pharmacist always will remain intangible.
• Managing and marketing services is “selling the invisible” (Beckwith, 1997).

TYPES OF VARIABILITY IN DEALING WITH CUSTOMER

1. Arrival - customers do not want service at times convenient for the company or in a
steady, predictable pattern,

2. Request variability - Customers’ desires are not standard,

3. Capability variability - customers’ own abilities to contribute to the service process vary
(e.g., a visually impaired patient who requires training on the use of a nebulizer

4. Effort variability - how much energy will the customer expend to facilitate the service
encounter

5. Subjective variability - customers vary in their opinion as to what it means to be treated

well - by:(Frei, 2006).

WHAT IS A GOOD CUSTOMER SERVICE?

• Delivering good customer service requires the following:
• Solving customer problems with no hassle
• Solving customer problems promptly
• Providing people who know what they are doing
• Providing people empowered to solve customer problems
• Treating people with dignity and empathy
• Correcting mistakes when they are made

(adapted from Karr and Blohowiak, 1997)

 SERVICE ENCOUNTER
The critical point in services is the service encounter.

The service encounter is the interaction between the service organization, the service
provider, and the customer. It is the familiar scene in the pharmacy where the patient drops
off and picks up the prescription, as well as being counseled.

STANDARDS FOR EVALUATING SERVICES

“If someone has a good experience at your place of work, they will tell at least three people,
while disgruntled customer will tell twelve people about an unpleasant experience with a
company.” - Orley Ray Wilson (1996) in “A Crash Course in Customer Recourse”

STANDARDS OF EVALUATING CUSTOMER SERVICE

The five dimensions are;

1. Reliability - the ability to perform the promised service dependably and accurately

2. Responsiveness - the willingness to help customers and provide prompt service

3. Assurance - the knowledge and courtesy of employees and their ability to convey
trust and confidence

4. Empathy - the caring, individualized attention provided to customers

5. Tangible - the appearance of physical facilities, equipment, personnel, and

communication materials

Of these five dimensions, reliability is most highly valued by consumers. Nothing fancy is
required; just do what you say you will do. - (Berry, Parasuraman, and Zeithaml, 1994)

MEASURING SERVICE QUALITY

Since services are for the most part intangible, customers use a psychological standard to
evaluate services and service quality

In services, quality is defined by the gap between the expectation for the service and the
perception of how it was delivered (Fig. 11-1)

SEVEN P’S OF SERVICE

1. Product

2. Price

3. Place

4. Promotion

5. Physical attributes

6. Process

7. People

 WHEN THINGS GO WRONG: SERVICE RECOVERY

“The customer doesn’t expect everything will go right all the time; the big test is what you do
when things go wrong ...

Occasional service failure is unavoidable.”

CATASTROPHIC PRESCRIPTION ERRORS

• Catastrophic errors are defined as causing severe damage to a patient that is not easily
reversed, for example, an error that results in a 4-day stay in a hospital or worse.
• As a practical matter, a successful response to a catastrophic medication error proceeds
through the following stages:

a. Signal detection.

b. Preparation and prevention.

c. Containment/damage limitation.

d. Recovery.

e. Learning.

NONCATASTROPHIC PRESCRIPTION ERRORS AND SERVICE FAILURES

- the damage is easily reversible

Examples include: technicians are rude, billings are late

5 elements for service recovery:

a. apology,

b. urgent reinstatement,

c. empathy,

d. symbolic atonement,

e. and follow-up

In a retail setting, the recommendations for service recovery include discount, correction,
manager/employee intervention, correction plus replacement, apology, refund, and store
credit

 INVALUABLE SKILLS FOR INTERACTION WITH CUSTOMERS

To win a customer over, you need to establish a rapport early on.

This can be done by letting them know you genuinely care and want to help

1. HAVE A GOOD ATTITUDE

- Service begins with attitude. 100% CUSTOMER SERVICE is 80% ATTITUDE and 20%
TECHNIQUE

- If you have a positive attitude, you will find being friendly and helpful comes naturally

2. MAKE A LASTING FIRST IMPRESSION

- Make and eye contact and smile. If you can’t help a customer right away, let them
know you will be with them as soon as possible, whatever you do, don’t ignore your
customer.

3. GO FOR THE QUICK FIX

- Customers don’t like to wait, esp. when they have a problem they need to solve

- A prompt partial solution is better than a full resolution that takes a long time

4. ALWAYS FOLLOW UP

- Keep the customer updated.

- If you promise to look into something, do so, and do it promptly

5. TALK THE TALK

- Make sure dialogue is as effective as possible

- Choose your WORDS CAREFULLY

- Choose a word that reflect a service attitude

Example:

- “May I help you?” vs “How may I help you?”

- “I apologize for the inconvenience”

- “I don’t know the answer right now, but I’d be happy to find out for you”

6. SHOW SOME EMPATHY

- Empathy is MORE than Sympathy

- It means understanding the needs of your customers

- No one likes having their questions met with an apathetic or rude response

 7. HEED CUSTOMER CRITICISM

- If customers constantly make the SAME complaints, it’s a sign that your service system
needs improvement

8. LET THEM DOWN EASILY

- If you have to decline a customer request to uphold a company policy, DO SO IN A

GENTLE WAY

- When possible, offer the customer an alternate solution

- Express your disappointment at not being able to meet the customer’s needs

- Ex. Discounts

- Purchasing Antibiotic without prescription

STANDARDS FOR FACE-TO-FACE CUSTOMER SERVICE

1. GREET CUSTOMERS WITH A SMILE AND EYE CONTACT

- Believe it or not, SMILING can make you relax and can positively influence

- your mood

- It is important to customers when greeting and speaking to them

2. NEVER IGNORE A CUSTOMER

- Acknowledge anyone who the pharmacist encounter

- Thank customers who have waited, no matter how long the wait

3. IT’S ALL IN THE NAME

- Customers feel important when you show that you remember them from a previous
visit to your work environment

- NOTE: Its always best to address a customer by their last name Mr._______ or
Ms.________) or Ma’am / Sir, unless the customer requests otherwise

4. ACTION SPEAKS LOUDER THAN WORDS

- When a customer asks for directions (location of a product), do not just point toward
the appropriate area, take the initiative to walk the customer to where he/ she needs
to go

- Same as with how to use some of the medical devices

 5. PEOPLE FIRST, PAPER SECOND

- Rather than answer customer’s question by handling them a brochure or information

card, take the time to personally help them.

6. ALL’S WELL THAT ENDS WELL

- Last impressions are just as important as first ones

- Make customers leave or hang up the phone on a positive note

- Stay Friendly, maintain eye contact (If in person), and remember to say “

- Thank you!”

TAKE NOTE:

Remember to always ask customers before they leave the prescription counter if there are
any questions about their medications.

7. FOLLOW THE GOLDEN RULE

- Follow the golden rule as it relates to customer service

- “DO UNTO OTHERS AS YOU WOULD HAVE THEM DO TO YOU”

STANDARDS FOR TELEPHONE CUSTOMER SERVICE

- Many employees view the phone call as an interruption

- Something that should be dispensed as quickly as possible

REMEMBER: Telephone customers service is just as IMPORTANT as any other activity that you
might be engaging in on a day-to day basis.

THE FOLLOWING ARE TELEPHONE SERVICE PROBLEMS THE CALLER WISHES TO AVOID

a. Waiting while the phone rings continuously

b. Being greeted in a rude fashion

c. Being transferred to someone who is not available or to someone who cannot help
them

d. Being placed “oh hold” for a long period of time”

e. Getting the call transferred several times

GOOD CUSTOMER TELEPHONE SERVICE CONSIST OF THE FOLLOWING

1. ANSWER THE PHONE PROMPTLY

- The longer you let the phone ring, the more impatient the customer gets

- Answering the phone quickly shows your concern for the customer on the

- other hand and it also portrays you as efficient

 2. IDENTIFY YOURSELF AND THE PHARMACY NAME IMMEDIATELY

- It is the polite and professional way to answer the phone

- It confirms the customer that they have reached the number that they intended to
call

- IDENTIFY YOURSELF AND THE PHARMACY NAME IMMEDIATELY

- BE FRIENDLY Start with a helpful and friendly attitude

- When you’re on the phone, your voice always sounds exactly like your face looks

3. HAVE ALL THE RESOURCES AVAILABLE

- Being unprepared gives the impression that you don’t know what you are doing

- USE THE CALLER’S NAME - It shows that you are interested and attentive to him/ her

6. INDICATE YOUR REGRET WHEN APPLICABLE

- It is important to recognize when you should express regret, and do so in a genuine

manner

- Example: If the customer was disconnected from an earlier call

7. DON’T INTERRUPT

- It sends message that you are not polite or sensitive to what the customer needs

- It also implies that you are not listening / missing critical information

8. TRANSFER A CALL ONLY WHEN ABSOLUTELY NECESSARY

- Try to resolve the customer’s concern yourself

- If you need to transfer a call Explain the need to transfer

9. HANG UP GENTLY

- Let the customer hang up first then hang up the phone gently

10. SPEAK CLEARLY TO MAKE YOU UNDERSTOOD

- Speak slowly to make sure you are not misunderstood

11. GET AS MUCH INFORMATION AS QUICKLY AS POSSIBLE

- Request information as soon as possible

 DISPENSING LEC LESSON 3: ROLES OF PHARMACIST

1. Academic Pharmacist

• Focus on teaching, research and training of the upcoming pharmacist.

• Education motivates the professionals in the health care system

• From their basic education training and pre-registration training, students acquire a broad
understanding of the scientific principles and techniques of the pharmaceutical sciences
and the ability to keep pace throughout their careers with developments in medicine and
pharmacy.

• Their knowledge and expertise extent to all aspects of the preparation, distribution, action
and uses of medicines.

• Education Policy (PACOP)

2. Industrial pharmacist (Pharmaceutical Industry)

• Research and Development

– Contribute in research, and their expertise in formulation development is of particular

relevance to the biological of the active ingredient

• Manufacture and quality assurance

– (Good manufacturing Practice)

– Validation of various stages of production and the testing of products before release

 • Patent application and Drug Registration

– Pharmacist is ideally qualified to understand and collate the diverse information required
for patent and authorization submission

• Drug Information

– (knowledge and expertise to provide detailed information on medicines)

• Clinical trials and Post Marketing Surveillance

– Pharmacist has the knowledge of drugs and health care provision required to facilitate
collaboration between companies, health

– professionals and government in relation to clinical trials and surveillance

• Sales and marketing

– Can contribute to proper marketing practice related to health care and to the provision of
appropriate information to health professionals and public

– (labels of No Approved Therapeutic claims in food supplements in Tagalog version was

once prohibited due to the reason that public will tend to understand that products has no
benefits)

• Management

– The inclusion of pharmacist in all levels of management promotes an ethical approach

within management policies

3. Primary Care Pharmacist/ Prescribing Advisors

• They work on national health services organizations that are in charge of a range of local
health services.

• Their job is to ensure the best use of medicine and resources

4. Hospital Pharmacist

• Vital part of the health care team. Part of the team where the focus is firmly on patients.

• Manufacture of sterile medicines, managing the care of patients with all types of condition,
working in the dispensary, providing information on medicines for the whole hospital

• Takes part in planning and implementation of clinical trials

• Pharmacy and Therapeutics Committee (Pharmacist as secretary)

5. Community Pharmacists

• Health professionals most accessible to the public

• Work at the frontline of healthcare in cities, towns and villages across nation

• As a community pharmacist, job would be all about helping the public, assessing their
conditions and making decision about medicines they should take.
• They will be involved in dispensing medicines and offering patient advice and practical
help on keeping health.

 The main activities of community Pharmacist are:

• Processing of prescription • Responding to symptoms of minor

ailments
• Care of patient or clinical pharmacy
• Informing health care professionals and
• Monitoring of drug utilization= (DUR) the public
• Traditional and alternative medicine • Health promotion

6. Regulatory Control and Drug management

• Health and drug policy

• Management

– Responsible for drug management, which includes selection of essential drugs)

• Regulatory and Enforcement Agency-

– (FDA/ PDEA)

• Professional and Registration Authorities

• -BOP/ PRC

WHAT IF THE PHARMACIST IS NOT PRESENT DURING FDA VISIT?

 Pharmacy as a complete profession

Pharmacy a complete profession: Pharmacist reflect on every sector of society in the form of:

ARTISTS – designing s drug dosage form

LAWYER – having a fair knowledge of laws and legislation about the drug

ENGINEER – having sound technical knowledge

ENTREPRENEUR – with sound knowledge of management, accounting, marketing, and

counseling

HEALTH PROFESSIONAL – having a fair knowledge regarding health

Conclusion:

• Pharmacist is the first person of health care

system by playing various roles like academic
pharmacist, community pharmacist, clinical
phar macist, industrial phar macist, hospital
pharmacist veterinary pharmacist etc.

• All pharmacists working in different fields of

profession are directly or indirectly related to
nation’s health.

• Finally, pharmacists are responsible for ensuring

that “Right drug to right patient at the right time in
a right dose through right route on right way”. So
that Pharmacist is an integral part of health care
system.

THE OATH OF A PHARMACIST

• At this time, I vow to devote my professional life to the service of all humankind through the
profession of pharmacy.

• I will consider the welfare of humanity and relief of human suffering my primary concerns.

• I will apply my knowledge, experience, and skills to the best of my ability to assure optimal
drug therapy outcomes for the patients I serve.

• I will keep abreast of developments and maintain professional competency in my

profession of pharmacy.

• I will maintain the highest principles of moral, ethical, and legal conduct.

• I will embrace and advocate change in the profession of pharmacy that improves patient
care.

• I take these vows voluntarily with the full realization of the responsibility with which

• I am entrusted by the public.

CODE OF ETHICS FOR PHARMACISTS

• A pharmacist respects the covenantal relationship between the patient and pharmacist.

• A pharmacist promotes the good of every patient in a caring, compassionate, and

confidential manner.

• A pharmacist respects the autonomy and dignity of each patient.

• A pharmacist acts with honesty and integrity in professional relationships.

• A pharmacist maintains professional competence.

• A pharmacist respects the values and abilities of colleagues and other health professionals.

• A pharmacist serves individual, community, and societal needs.

• A pharmacist seeks justice in the distribution of health resources.

 DISPENSING LEC LESSON 4: VERBAL AND NON-VERBAL COMMUNICATION SKILLS FOR

PHARMACIST
VERBAL COMMUNICATION SKILLS

Essential verbal communication skills include the ability to LISTEN, UNDERSTAND and RESPOND
to what people say (active listening) and the ability to interpret nonverbal communication
and respond in a way that encourages continued interaction (evaluation

Active listening
• It is a way of listening closely to what a person has to say.
• It is done by giving the person your full attention. You show interest and appreciation for
his thoughts and concerns. You commit to him by letting him speak without interrupting.
• AL lets you show your respect, support, and concern for the other person.
• AL promotes trust between you and the other person. You become a companion as you
listen to his views.

Hearing vs. Listening

Hearing – We hear a series of words being spoken by

our clients.

Attention – We provide the necessary time and

silence for the client to convey what they need to.

Comprehension – To break down what is heard by us

to figure out what the client perceives as important

Awareness – Recognition and realization of what is

heard and providing paraphrasing as needed

Empathizing – Acknowledging the client that we

understand them and their story. Showing caring and
compassion for what is important to the client.

Factors that Impact Listening (Communication Habits)

In addition to communication barriers, some communication habits can interfere with your
ability to listen well

1.Multitasking- to do things at once (it evident to patients that they don ‘t has your full
attention.

2.Planning ahead to what you will say next- planning next point (Interrupting)

3.Jumping to conclusion before patients have completed their messages (only hearing parts
of messages)

4.Selective listening- Focusing only on content (listening with ears only but not understanding)
5.Judging the person or the message as it is being conveyed

 6.Faking interest and perception

7.Communicating in stereotypes ways.

Verbal Language

Reflecting the language of the patient will help build rapport Usual: avoid MEDICAL JARGON
and terminology

Gives clear assurance that messages are communicated clearly.

However, some patients may be knowledgeable about their condition or medicine, using
layman ‘s terms may send out signals that you are not listening, or that you do not respect
the patient ‘s knowledge

Appropriate Verbal Communication

Problems in Establishing Helping

Relationships

T h e r e a r e c o u n t l e s s s o u rc e s o f
problems in interpersonal
communication between Pharmacist
and Patients.

However, certain pharmacist attitudes

and behaviors are practically
damaging in establishing helping
relationships with patients.

These includes:

¤ Stereotyping ¤ Depersonalizing ¤ Controlling behaviors

Stereotyping – what image comes to mind when you think of:

- An elderly patient

- AIDS patient

- Dying patient

- Non-compliant patient

- Patient with Welfare Assistance

- Hypochondriacal patient

- Psychiatric patient

If you hold certain stereotypes of patients, you may fail to listen without judgement.

- I already know what he is going to say

- She is the type that never really wants help

 Depersonalizing – Be careful…

- Delivering a canned speech “a rigid communication format of a pharmacist

monologue rather than pharmacist-patient dialogue”

- Perceiving the patient as a case of number

- Impersonal; focus on the disease rather than the patient, focus on narrow clinical
rather than broader personal issues

- Communication with third parties instead of patient

Controlling

- Authoritarian style: You are the authority; patients are told what they should do and
what they should not do

- Decisions are made, often very little input from the patient on preference, desires, or
concerns about treatment.

- You don’t make room for the patient’s message or feedback

Listening Well - Listening well involves understanding both the content of the information
being provided and the feeling being conveyed.

Skills that are useful in effective listening include:

¤ Summarizing

¤ Paraphrasing

¤ Empathic responding

―Reflection of feelingǁ statements that are verbally convey your understanding of the
essence or emotional meaning of another person ‘s communication. In addition, non-verbal
communication that shows caring and attention to the patient

Barriers to Communication
• A lack of skill and understanding of the structure of discussion

• Inadequate knowledge of other communication skills

• Lack of insights into other people ‘s communication difficulties.

• A lack of inclination to communicate with patients (lack of confidence, concerns

related to confidentiality)

• Personal Barriers: tiredness or stress, personality differences

• Language barriers: Diverse dialects, culture and literacy

• Organizational barriers: lack of time, pressure of work and interruptions

 A. Physical barriers
o Large countertops and display areas behind which many pharmacist work
o Windows with security bars and protective glass
o Drive-through windows that isolate the pharmacist from the patients
o Elevated pharmacy work area that accentuates the pharmacist ‘s position of
authority and places the patient in inferior position.
o Communication with patients in bed (hospital setting)- patients in bed are easily
intimidated by people standing over them.

B. Lack of Privacy
o Common communication barrier
o Do not discuss or debate non-specific or specific patient data or health care issues in
public areas such as hallways, walkways, elevators, cafeterias, libraries and parking
lots
o Do not discuss patient-specific information with family or friends.

C. The Telephone
o Speak clearly, listen carefully, be organized and state the fact clearly and calmly
o Those initiating the phone conversation should identify themselves by name and state
the purpose of the call.

Blocking Behaviors

When professionals find it difficult to move away from medical concerns regarding the
patient in order to deal with “psychological issues”, and struggle to adopt a more
negotiating and partnership style.

Demonstrated if there is reluctance to ask about the social and emotional impact of
problems on the patient and family

Tendencies: increases patient ‘s distress, take up too much time, and threaten our own
emotional survival

From health professionals

▪ Offering advice and reassurance too soon in the discussion

▪ Explaining distress as “normal”

▪ Considering physical aspects only

▪ Changing the topic

▪ Jollying patients along

From patients (reasons)

▪ A belief that nothing can be done

▪ They do not want to burden the healthcare professional

▪ They do not want to seem pathetic

▪ They feel uncomfortable

▪ They worry

 ▪ Written Communication Skills

Pharmacist must be able to accurately and effectively document patient information in the
patient medical record, document patient information in pharmacy medication profiles and
other pharmacy record and correspond with patients and other health care professionals.

Guidelines for Writing Medical record notes:

¤ Use black ink

¤ Write clearly and legibly

¤ Label notes with specific descriptive headings

¤ Provide the dates and the time on the notes

¤ Document the facts and avoid making unsubstantiated judgments.

¤ Organize the information using SOAP or freestyle format

¤ Sign the note with name and title.

¨ Remember, effective professional writing is about your audience and

its needs, accuracy, clarity, concision, correctness, and credibility or confidence in the
author

Strategies for Developing Strong Professional Writing Skills

Five general tips to improving one ‘s writing as a professional:

1. Accept the following truth: There are now two writers in your head—general and
professional.

2. Invest in planning time.

3. Develop and use trusted colleagues as proofreaders.

4. Let the document sit before sending it.

5. Adequacy can be a sufficient standard

ASSERTIVENESS

A style of response that focuses on resolving conflicts in relationship in an atmosphere of

mutual respect

To be assertive, each person must be able to directly and honestly convey

“this is what I think”

“This is how I feel about the situation”

“This is what I want to happen”

“This is what I am willing to doǁ”

This type of communication allows people to stand up for their own rights or what they
believe in without infringing on the rights of others. You also attempt to understand the
other‘s point of view even when there is disagreement.

The focus is on problem solving rather than turning the conflict into a

“Win/lose” situation that damages the relationship.

 Assertiveness skills require in relating to PATIENTS

¨ Willingness to initiate communication

¨ Encouraging patients to be more assertive with you

¨ Appropriate response to angry patients

¨ Empathic response

¨ Turn criticism into useful feedback

¨ Do not transmit messages through a third party.

Assertiveness skills require in relating to PHYSICIANS

¨ No need for anger or apology

¨ Always introduce yourself

¨ Apologizing makes you seem insecure and unassertive

¨ Do no put the physician “on the spot”

¨ Prepare your recommendation and keep current references “in reserve”

¨ Do not expect a “pat on the back”

Observation and Assessment

¨ Effective two-way communication requires continual observation and assessment of how

the other person is communicating.

¨ Body language and gestures provide important clues for the pharmacist, as well as the
patient and health care provider.

Empathy and Effective Communication

EMPATHY has many positive effects on a pharmacist ‘s relationships with patients. It helps
patients:

n Come to trust you as someone who cares about their welfare.

n Understand their own feelings more clearly.

n To alleviate the patient’s sense of isolation, this often accompanies an illness experience.

n Facilitate the patient ‘s own problem-solving ability

 Nonverbal Aspects of Empathy

Do a number if things nonverbally to convey interest and concern:

• Establishing eye contact while taking to patients
• Leaning toward them slightly with no physical barriers
• Having relaxed posture
• Head nods and encouragements to talk
• Tone of voice
• Establishing a sense of privacy by coming out from behind the counter
• Conveying that you have time to listen
• Sensitivity to patients’ non-verbal cues (feeling, tone of voice, facial expression and
body posture)

Tone of the voice “how you say it, matters”

- Refers to how the character of your message comes through in your words, both
written and spoken.

- It is not about what you say, but rather the way that you say it, and the impression it
makes on the patient who hears you.

NON-VERBAL COMMUNICATION
• Involves all aspects of communication other than spoken or written words, including
facial expression, eye contact, body position, touching, and voice characteristics.

• Consists of meaning conveyed through body language and facial expression

• Involves a complete mix of behaviors, psychological responses, and environmental

interaction through which we consciously or unconsciously relate to another person

• Approximately 55% to 95% of all communication can be attributed to nonverbal

sources

 • Sit or stand at eye level, maintain eye contact, and use a focused body posture to
convey interest and attentiveness.

• Sitting or standing at eye contact or lower projects a nonthreatening, equalizing

body position that facilitates open communication.

• Be physically close enough to the patient, family members or health care

professionals for clear and comprehensible communication but do not intrude on the
other person’s personal space.

• Invasion of personal space induces discomfort and may be perceived as physical

threatening; in either case, communication is compromised.

• Certain gestures and postures provide clues regarding the other person’s feeling.

• (BUT NOT THE SAME TO ALL)

IMPORTANCE OF NON-VERBAL COMMUNICATION

Nonverbal communications are important for three reasons:

• They mirror innermost thoughts and feelings

• It is difficult, and almost impossible to “fake” during an interpersonal interaction

• Congruence between verbal and non-verbal messages: your non-verbal

communication MUST BE CONSISTENT with your verbal communication or people will
be suspicious of the intended meaning of your message

Elements of Non-Verbal Communication

• The manner in which you use your arms, legs, hands, head, face, and torso may have
a dramatic impact on the messages that you send.

• It should reflect interest, empathy sincerity, respect

• In general, individuals from various societies use different body movements to

communicate certain message

Non-verbal communication can:

¤ Supplement spoken communication;

¤ Reinforce or substitute a spoken message:

¤ Undermine communication: for example, when non- verbal cues contradict spoken words

Body Language

Body language is a complex interplay of factors including:

Position: how we position our bodies (folding arms or inclining the head) and where we
position ourselves in relation to others;

Facial expression: smiles, frowns and raised eyebrows;

 Eye contact: whether we look at others, and how we do it

(staring; looking away, sideways or over someone’s shoulder);

Touch: how and where we touch ourselves, others, and

objects (spectacles, clothing or pens);

Physical reactions: perspiring, blushing or breathing rapidly.

Why do we need Effective Communication Skills?

• To establish the necessary rapport to building a trusting relationship

• To ensure an effective exchange of information necessary to understand patient’s

need and provide tailored counseling.

• To achieve improved adherence with medication use

• To increased satisfaction and improve relationship

• Fewer unaddressed ADEs

• Improved patient trust in Pharmacist’s advice and education

Key Points

• Verbal communication includes the written and spoken word

• Non-verbal communication includes facial expressions, eye contact and posture

• Body language can enhance or detract from communication with patients

• Observing patients’ body language can provide important cues to how they are
feeling

• It is important to reflect on verbal and non-verbal communication skills and how these
affect relationships with patients

 Effective Interview Skills for Pharmacist

Interviewing

- Interviewing is an important component of the disease management process.

- Process of interviewing goes beyond asking a series of pre-planned questions in a

certain order.

Components of an Effective Interview

¨ Listening

¨ Probing

¨ Asking sensitive questions

¨ Use of silence

¨ Establishing rapport

Interview and Assessment

¨ Educational Diagnosis Sequence

¨ Asses the patient needs to know

¨ Assess what the patient already knows

¨ Identify information gap

¨ Assess the patient’s ability to learn

¨ Determine the best way to instruct the patient

¨ Determine the best time to instruct the patient

¨ After instruction, assess whether learning occurred

Listening Technique for the Patient Interview Process

Listening is an ability which effectively enhances the communication process.

Listening techniques for the patient interview process:

¨ Stop talking. You can’t listen while you are talking

¨ Get rid of distraction

¨ Use eye contact to show you are listening

¨ React to ideas rather than the person

¨ Read nonverbal messages

¨ Provide feedback to clarify the messages. This shows that you listen and are trying to
understand.

 Probing

¨ Is the use of questions to elicit needed information from patients or to help clarify their
problems or concerns

¨ Probing skills

¨ Organization of questions

¤ Introduce questions and explain purpose

¤ Proceed from less to more personal

¤ Proceed from general to specific

¤ Group together by topic

¨ Phrasing of questions

¨ Several things should be considered before asking questions

¤ The phrasing of the question (“What” or “How”)

NOTE: Avoid “why” type questions as they may imply criticism

o For example (people might become defensive is asked:)
o “Why did you miss doses of medications?” instead “what causes you to miss dosed of
medication”
o It is usually better to use “what” or “how” type of questions

¤ Timing of the question

¤ Avoid leading questions

These questions strongly imply an expected answer

o Ex. “You don’t usually forget to take the medication, do you?”

¤ Balance open-ended, close-ended and mirror questions

¤ Avoid double-barreled questions

¤ Questions should be tactful and should avoid unnecessary prying

n Several questions are succession may leave the patient with a sense of being interrogated
and, therefore, may raise the level of defensiveness.

n The patient should be allowed to finish answering the current question before proceeding
to the next one.

 Asking Sensitive Questions

¨ Before asking, let the patient know that the behaviors or problems you are asking bout are
common.

¨ Ask whether the situation has ever occurred then ask about the current situation

¨ Use of simple, clear –cut questions and a matter –of- fact manner is critical.

¨ Embed more threatening topics among less threatening topics.

¨ It may help to discuss the reason why you are asking a particular question.

Use of Silence

¨ Learn to treat ―pausesǁ as a necessary part of the counseling process.

¨ Many times, the patient needs time to think about or react to the information you have
provided or the interview with unnecessary talk.

¨ “Talk ratio” should be in favor of the person being interviewed.

Starting the Interview

¨ You should start the interview by greeting patients by name

¨ Introducing yourself to patients if you do not know them. This helps establish rapport with the
patients

¨ State the purpose of the interviews

¨ Outline what will happen during the interview and put the patient at ease.

¤ The purpose of the interview should be stated in terms of the benefit to the patient

¤ The amount of time needed

¤ The subjects to be covered

¤ And the final outcome should be mentioned so the patient has a clear understanding of
the process

 Tips to Conduct a More Efficient Patient Interview

¨ Avoid making recommendation during the information-gathering phases of the interview.

Such recommendations prevent the patient from giving you all needed information and can
interfere with your ability to grasp the big picture of patient need.

¨ Similarly, do not jump to conclusions or rapid solutions without hearing all of the facts.

¨ Do not shift from one subjects to another until each subjects has been followed through

¨ Guide the interview using a combination of open ended closed ended questions.

¨ Similarly, keep your goals clearly in mind, but do not let them dominate how you go about
the interview.

• Determine the patient’s ability to learn specific information in order to guide you in your
presentation of the material. Reading ability, language, proficiency, and vision or hearing
impairment all would influence the techniques you use in interviewing and counseling a
patient.

• Maintain objectivity by not allowing the Patient’s attitude, beliefs, or prejudices to influence
your thinking.

• Be aware of the patient’s nonverbal messages.

• Depending on your relationship with patient, move from less personal to more personal
topics. This may remove some of the patient’s initial defensiveness.

• Note taking should be as brief as possible.

 DISPENSING 1 (LABORATORY): PRELIM POST ACTIVITY DISCUSSION ACTIVITY 1-2

PHARMACY PERSONNEL (RA 10918)

• Pharmacist

- refers to a health professional who has been registered and issued a valid Certificate
of Registration (COR) and Professional Identification Card (PIC) by the PRC and the
Professional Regulatory Board of Pharmacy;

- All pharmacists are expected to abide by current standards such as the Philippine
Practice Standards for Pharmacists, Good Laboratory Practice, Good Distribution
Practice, Good Manufacturing Practice and Good Clinical Practice, which are
deemed vital in the performance of their roles and functions in different practice
areas.

HANDLING OF PHARMACEUTICAL PRODUCTS BY PERSON OTHER THAN A PHARMACIST

• For the purpose of this section, persons handling pharmaceutical products, other than the
pharmacist, which shall include:

• pharmacy owners who are non-pharmacists,

• medical representatives or professional service representatives,

• pharmacy support personnel,

• pharmacy technicians,

• pharmacy assistants,

• pharmacy aides,

NOTE: persons who assist pharmacists in any part of a pharmacy operation, or any other
person performing functions involved in the handling of pharmaceutical products, shall be
duly certified by appropriate government agencies after undergoing an accredited training
program. No person, except pharmacy graduates, shall be allowed to render such services
without undergoing a comprehensive standardized training program: Provided, That the job
description is defined in the implementing rules and regulations of this Act.

PHARMACY PERSONNEL

Pharmacy technicians

• refer to persons who assist in compounding and dispensing of medicines in community,

hospital, institutional and industrial settings or engaged in other activities under the
supervision of the pharmacist as described in Section 39, Article IV of this Act;

Pharmacy assistants

• refer to persons who assist the pharmacists in different aspects of pharmacy operation
based on established standard operating procedures and processes, with a minimum
degree of independence or decision making and may have supervised interaction with
patients;

 Pharmacy aides

• refer to persons who assist the pharmacists in the different aspects of pharmacy operation
based on established standard operating procedures and processes, with very minimal
degree of independence or decision making and without direct interaction with patients;

Medical representative or professional service representative

• refers to one who represents any duly authorized manufacturer, distributor, trade r, and
wholesaler of pharmaceutical products and whose primary duty is to promote their products
to duly licensed health professionals;

DISPENSING

• refers to the sum of processes performed by a pharmacist from reading, validating, and
interpreting prescriptions; preparing; packaging; labeling; record keeping: dose calculations;
and counseling or giving information, in relation to the sale or transfer of pharmaceutical
products, with or without a prescription or medication order;

FILLING

• refers to the act of dispensing or providing medicines in accordance with a prescription or

medication order

• Pharmaceutical establishments - refer to entities licensed by appropriate government

agencies, and which are involved in the manufacture, importation, exportation, repacking,
and distribution of pharmaceutical products to pharmaceutical outlets;

• Pharmaceutical outlets - refer to entities licensed by appropriate government agencies,

and which are involved in compounding and/or dispensing and selling of pharmaceutical
products directly to patients or end-users;

PHARMACEUTICAL PRODUCTS

• refer to drugs, medicines, biologicals, pharmaceutical and biopharmaceutical products/

specialties, veterinary products, veterinary biologist and veterinary medicinal products;

CLASSIFICATION OF MEDICATIONS

A. Dangerous drug s refers to those listed in the:

1. Schedules annexed to the 1961 Single Convention on Narcotic Drugs, as amended

by the 1972 Protocol;

2. Schedules annexed to the 1971 Single Convention on Psychotropic Substances; and

3. Annex of Republic Act No. 9165, otherwise known as the "Comprehensive Dangerous
Drugs Act of 2002", and its amendments:

B. Over-the-counter (OTC) medicines - refer to medicines used for symptomatic rehef of

minor ailments and which may be dispensed without a prescription;

 C. Pharmacist-only OTC medicines - refer to over-the counter medicines classified by

appropriate government agencies to be obtained only from a licensed pharmacist, with
mandatory pharmacist's advice on their selection and proper use;

D. Prescription/Ethical medicines - refer to medicines which can only be dispensed by a

pharmacist to a patient, upon the presentation of a valid prescription from a physician,
dentist, or veterinarian and for which a pharmacist's advice is necessary;

E. High-alert medications - are drugs that bear a heightened risk of causing significant
patient harm when they are used in error. Although mistakes may or may not be more
common with these drugs, the consequences of an error are clearly more devastating to
patients.
o specific high-alert medications
o The following list of specific high- alert medications come from the ISMP. The
Institute for Safe Medication Practice (ISMP)
o magnesium sulfate injection
o methotrexate, oral, non- oncologic use
o opium tincture
o oxytocin, IV
o nitroprusside sodium for injection
o potassium chloride for injection concentrate
o potassium phosphates injection
o promethazine, IV
o vasopressin, IV or intraosseous

F. Adult vaccines - refer to cervical cancer, flu (influenza), pneumococcal, other pre-
exposure prophylactic vaccines to be administered to patients aged eighteen (18) years
and above, and such other vaccines as may be defined by the Department of Health
(DOH) in an administrative issuance;

G. Food/Dietary supplements - refer to processed food products intended to supplement

the diet that bears or contains one (1) or more of the following dietary ingredients:
vitamins, minerals, herbs, or other botanicals, amino acids, and dietary substances to
increase the total daily intake in amounts conforming to the latest Philippine-
recommended energy and nutrient intakes or internationally agreed minimum daily
requirements. It usually is in the form of capsules, tablets, liquids, gels, powders, or pills
and not represented for use as a conventional food or as the sole item of a meal or diet
or replacement of drugs and medicines, as defined under Republic Act No. 9711;

 H. Health supplement - refers to any product that is used to maintain, enhance and improve
the healthy function of the human body and contains one (1) or more or a combination
of the following:

(1) herbal fatty adds, enzymes, probiotics, and other bioactive substances; and

(2) substances derived from natural sources, including animal, plant, mineral, and botanical
materials in the form of extracts, isolates, concentrates, metabolites, synthetic sources of
substances mentioned in (1) and (2). It is presented in dosage forms or in small unit doses
such as capsules, tablets, powder, liquids and it shall not include any sterile preparations (i.e.
injectable, eye drops);

I. Household remedies refer to any preparation containing pharmaceutical substances of

common or ordinary use to relieve common physical ailments and which may be
dispensed without a medical prescription in original packages, bottles or containers, of
which the nomenclature has been duly approved by the FDA

J. Medical device - refers to any instrument, apparatus, implement, machine, appliance,

implant, in vitro reagent or calibrator, software, material or other similar or related article
intended by the manufacturer to be used alone, or in combination, for human beings, for
one (1) or more of the specific purposes of: diagnosis, prevention, monitoring, treatment,
or alleviation of disease; diagnosis, monitoring, treatment, or alleviation of or
compensation for an injury; investigation, replacement, modification or support of the
anatomy of a physiological process; supporting or sustaining life; preventing infection;
control of conception; disinfection of medical devices; and providing information for
medical or diagnostic purposes by means of in vitro examination of specimens derived
from the human body.

K. Physician's samples - refer to medicines given to health professionals for promotional

purposes only;

• Pharmaceutical products given or intended to be given free to any health professional by

a manufacturer or distributor or its professional service representative as part of its program or
promotion shall not be sold to any pharmaceutical outlet or the consuming public. The
statement "Sample, Not for Sale", or its equivalent, shall appear conspicuously on the primary
and secondary' packaging of the drug or combination products (medical device and drug)
classified as drug according to the primary intended mode of action to be given. It shall be
unlawful to remove, erase, deface or mark the original labels of samples.

 CATEGORY A — PHARMACEUTICAL ESTABLISHMENTS/OUTLETS

• where the direct and immediate control and supervision of a duly registered find licensed
pharmacist is required, per establishment, whether in-store or on the, including:

1. Pharmaceutical establishments/outlets selling or otherwise making available to the

consuming public prescription/ethical medicines, combination products (medical
device and drugs) classified as drugs according to the primary intended mode of
action, pharmacist-only OTC medicine, whether owned by the government or by a
private person or firm, whether sold at wholesale or retail;

2. E establishment involved in the manufacture, importation, exportation, distribution,

and sale of combination products (medical device and drugs) classified as drugs
according to the primary intended mode of action;

3. Departments/D visions/U nits of pharmaceutical laboratories, pharmaceutical

manufacturing laboratories, or other 23 establishments with processes involving the
preparation, manufacture, assay, regulation, product research and development,
quality control, repacking, importation, exportation, distribution, sale or transfer of
pharmaceutical products in quantities greatly in excess of single therapeutic doses;
and

4. Government units, including local government, city, first to third class municipal
health units, nongovernment organizations and/or associations involved in the
procurement, distribution, dispensing and storage of pharmaceutical products;

CATEGORY B – PHARMACEUTICAL ESTABLISHMENTS/OUTLETS

• where the supervision and oversight of a duly registered and licensed pharmacist is
required under pertinent provisions of law, including:

1. Retail outlets selling household remedies and OTC drugs as differentiated from the
pharmacist-only OTC medicines;

2. Satellite institutional pharmacies providing medicines solely to employees of their

respective companies or the employees' qualified dependents, or both; or members
of a duly registered organization or institution;
3. Fourth, fifth and sixth class municipal health units involved in the procurement,
distribution, dispensing, and storage of pharmaceutical products;

4. Institutions providing telepharmacy services; and

5. Nontraditional outlets of pharmaceutical products:

Provided, that no prescription medicines and pharmacist-only OTC medicines are

sold.

• A pharmacist working in a Category A establishment may be allowed to simultaneously

work or render pharmacy services in Category B establishments, the maximum number of
hours of which shall be determined, in accordance with such guidelines 24 as may be
established therefor by the Board, in coordination with the FDA, and other agencies,
establishments, institutions, and regulatory bodies.

DISPLAY OF CERTIFICATE OF REGISTRATION

• It shall be the duty of every pharmacist engaged in the practice, whether in private or
under the employ of another, to display the original copy of one's COR in a prominent and
conspicuous place in the drug establishment in which one is employed in a professional
capacity as pharmacist. When employed in establishments under Category B, as defined in
Section 31 of this Act, the duplicate copy of the pharmacist's COR shall also be displayed
therein. No pharmacist shall knowingly allow the COR to be displayed in an establishment
where one is not actually employed as a professional pharmacist.

DISPENSING/ SALE OF PHARMACEUTICAL PRODUCTS.

• No pharmaceutical product, of whatever nature and kind, shall be compounded,

dispensed, sold or resold, or otherwise be made available to the consuming public, except
through a retail drug outlet duly licensed by the FDA. Prescription drugs and pharmacist-only
OTC medicines shall be dispensed only by a duly registered and licensed 22 pharmacists,
except in emergency cases, where the services of a registered and licensed pharmacist are
not available: Provided, that a report shall be made to the supervising pharmacist within
twenty-four (24) hours after the occurrence of the emergency so that product recording in
the prescription books can be done.

DISPENSING/ SALE OF PHARMACEUTICAL PRODUCTS.

• Establishments/ outlets which are required to employ and/or retain and maintain the
professional services of duly registered and licensed pharmacists shall be classified as follows;

REQUIREMENTS FOR OPENING A DRUGSTORE

FDA CIRCULAR 2014-028

FDA CIRCULAR 2014-028

 • Guidelines on the Implementation of New Rules and Regulation on Licensing of Retail

Outlet for Non – Prescription Drugs (RONPDs) following Administrative Order No. 2014-0034,
dated 13 October 2014

+++

FDA CIRCULAR 2014-025

EDPMS

• The e-EDPMS refers to Electronic Essential Drug Price Monitoring System which was created
by the DOH to support the establishment of an efficient and effective system and
procedures for collecting price and inventories of essential drugs and other drugs stated in
RA 9502.

• The intent is for the DOH and DTI to monitor essential drug prices as well as stocks of
medicines in the local market and detect practices such as overpricing and non-
compliance to efforts of the DOH to regulate excessive price of drugs such as the GMAP &
the MDRP. It also aims to educate consumers on prevailing market prices of essential drugs to
enable them to make informed choices.

STANDARD OPERATING PROCEDURE (SOP)

• according to FDA Philippines is a document that describes “how to perform” various

routine operations that contains step by step instructions. It is written by the individuals who
perform the operation and who share some aspects of the operation. SOP is needed to
guide personnel when and why to perform a task, and what is the scope of the task. The SOP
must undergo series of reviews and approvals before it can be imposed. Individuals who can
be knowledgeable to review the procedure and who can be higher up in the hierarchy of
the department are the possible reviewers and can approve the tentative manual.

• OBJECTIVE – describes purpose of the goal and aim.

• SCOPE – up to what extend can be the task performed

• RESPONSIBILITY – who can be involved in performing the task.

• PROCEDURE – the step by step action of doing a task

• QUALITY RECORDS – how to do records and uphold them

• FORMS – to where the records are written (Optional)

• END OF DOCUMENT – can be used to place additional information and rationale

 GPS COORDINATES

CAPA

FDA CIRCULAR 2018-013

RMP (RISK MANAGEMENT PLAN)

• a detailed description of the risk management

System

 • RISK MANAGEMENT SYSTEM

- A set of pharmacovigilance activities and

interventions designed to identify, characterize,
prevent or minimize risks relating to medicinal
products including the assessment of the
effectiveness of those activities and interventions

RISK

• Event that has a probability of occurring

• Could have either a positive or negative impact

to the lifecycle of a medicinal product

• May have one or more causes

• One or more impacts (cost, schedule, or

performance)

• All drug products assume some elements of risk

1. INTRODUCTION

• Internal Environment – sets the basis on how risks are viewed and addressed

• Risk Management Approach – overall risk management approach (processes, personnel

involved, periodic reporting and monthly procedures to be performed

• Risk Management Objectives – ensure the safety, efficacy, and quality of drug products
they engage with in order to protect public health; comply with regulations of FDA

• Data Lock point - timeframe to which the RMP is expected to be valid

2. RISK IDENTIFICATION

- Identification and assessment of risks that

events that may adversely affect the set
objectives

3.RISK MINIMIZATION

- For each priority risks, indicate the corresponding risk

minimization plans. These plans may

include policies and procedures to ensure the

identified risks are prevented and/or minimized to an
acceptable level

4. RISK COMMUNICATION

• Communication system of drugstore to:

a. Internally

b. FDA

c. Consumers and HCP d

d. Other relevant stakeholders

 5. RISK MONITORING AND MANAGEMENT EVALUATION

• Periodic monitoring of identified risks

• Criteria where evaluation is needed

• When RMP revision is required

MAXIMUM DRUG RETAIL PRICES (MDRP)

• is a government intervention to the pharmaceutical industry to set a

maximum amount of drug prices in retailing, so that no other prices shall
top the allowed margin of price.

GOVERNMENT MEDIATED ACCESS PRICES (GMAP),

• also known as ADVISORY COUNCIL PRICE REGULATION RESOLUTION

2009-001, is a mediated action made by the government to convince drug
companies to lower the prices of their products that can be acceptable in
the budget of the consumers. Almost all drugs inclusive in this were slashed
into half of the original prices.

FDA REQUIREMENTS FOR PHARMACY & HOSPITALS DURING INSPECTION

FDA REQUIREMENTS FOR PHARMACY & HOSPITALS

• 1. Calibrated Digital Thermo-Hygrometer with certificate

• 2. Prescription Book

• 3. Senior Citizen Record Book

• 4. PWD Record Book

• 5. Generics Menu Card

• 6. GMAP/MDRP set

• 7. Generic Posters

• 8. Generic Dispensing Flowchart

• 9. FDA Health Information Tarps

• 10. Pharmacy Organizational Chart

• 11. Tablet Counting Tray

• 12. Graduated Cylinder

• 13. Laboratory Gown

• 14. Philippine Practice Standard for Pharmacists

• 15. information Education and Communication (IEC)