Professional Documents
Culture Documents
Perception of Individuals
Our perception of the message is also
influenced by our perception of the
individual sending the message, because
we tend to be influenced by a person’s
3. PERSONAL BARRIERS – include: low self- cultural background, status, and age
confidence, shyness, dysfunctional, internal These perceptions are further influenced by
monologue, lack of objectivity. [Cultural any bias we have or stereotypes we hold of
differences, discomfort in sensitive situations certain groups of individuals
and conflicting values to health practice] STEREOTYPES
4. POTENTIAL PHARMACIST-RELATED PERSONAL People who are mentally ill do not comply
BARRIERS – include: low self-confidence, with their medication regimens
shyness, dysfunction internal monologue, lack Nurses always complain about pharmacists
of objectivity, cultural difference, discomfort in Elderly people can’t hear well and always
sensitive situation, and negative perception talk too much
about the value of patient interaction People who talk slow are lazy
5. ADMINISTRATIVE BARRIERS – such a Women with red hair have a temper
management may view the lack of money Example:
compensated for communication as a reason Patients may perceive you as an
not to communicate, More money is made by uncaring, busy person who is
prescribing medication, not caring for patient concerned only with filling prescriptions
(PROFIT-ORIENTED) and taking their money
These stereotypes influence what they may ago, her son had developed a minor
say to you and how they may listen to you. bacterial infection and received an
If they perceive you as a professional, they antibiotic
will listen to what you tell them about their The mother stopped giving her baby the
medications antibiotic after 4 days of therapy (rather
than necessary 10 days) because it
Sharing the Same Perception appeared that the infection was cured
One key to preventing misunderstanding is When you asked her why she stopped the
try to understand and share the antibiotic, the mother stated that she was
perceptions of other individuals. just following the directions on the
Many times, using “ lay language” which is prescription label: “Take one-half
familiar to patients, rather than medical teaspoonful three times a day for infection
terminology, which is familiar only to health until all gone.” The mother stated that she
care professionals, can enhance gave medication until the infection was “all
understanding gone”
Determine the patient’s past experience Unfortunately, the intended message was
with medications or with the particular that the antibiotic should have been given
drugs may also be helpful. until the liquid was all gone
Patients who have positive experiences In this example, the mother understood the
previously may be more willing to take the words on the label, but she put them into a
medication. different context and thus derived a
However, if their past experiences have different meaning from the one intended
been bad, they may be reluctant to even
begin taking the medication. The social context also influences how messages
are received and interpreted.
Advice Pharmacists should follow when The type of relationship that patients have with you
Communicating with People of Different determines the level of acceptance that the
Background patients have regarding the information provided.
Learn as much as you can about the
patient’s background including beliefs Research has shown that if patients perceive
about taking medications pharmacist to be credible. Unbiased providers of
View diversity as an opportunity. With a little useful information, they will listen and retain more
patience and the right attitude, you will be information about their medication.
amazed at the opportunities that crop up
to help one another. If they perceived pharmacist to be trustworthy and
Do not condescend. Patronizing behavior is honest, they will be more willing to approach
not appreciated and is recognized as such pharmacist for assistance.
in any culture
Talk about your differences. To improve the communication process, we must
Misunderstanding will often take root when remember that people assign meanings to
people from differing background do not messages based on their background, values and
talk to one another experiences
Be willingly to talk openly and with
constructive attitude. MODES OF COMMUNICATION
a. Verbal communication – through words
MISUNDERSTANDING – How to prevent b. Visual communication – through pictures or
misunderstanding? printed materials
c. Kinesthetic communication – through body
Case Scenario language
A 9-month-old baby is admitted to the d. Interpersonal communication – through
hospital with a severe infection. You, the social interaction
pharmacist, speak with the mother upon e. Intrapersonal communication – within our
admission and learn that about 1 week self
INTERPERSONAL – person-person spontaneous Allows workers from different cultures to work
communication [speaking or writing] together as a group
INTERPRETIVE – one-way receptive communication Worldwide marketing campaign
[listening, reading, viewing] An increase in international business
PRESENTATIONAL – one-way, drafted, edited, In pharmacy, to provide proper dispensing and
productive communication [speaking/writing] patient counseling to achieve optimum
therapeutic outcomes
OTHER TYPES OF COMMUNICATION
a. Small group communication – CULTURE COMPETENCE
communication between and among PhilPSP:”...must be able to relate and
members of a team who meet for a communicate with people of diverse
common purpose or goal (classrooms, values, beliefs, background and
workplace) expectations in carrying out his/her
b. Organizational communication – important roles as medication expert”
communication with and among large, Acknowledge the uniqueness of each
extended groups client/ patient
c. Mass communication – communication to Deliver quality, effective unbiased care
a large audience via some mediated regardless of age, gender, ethnicity/ race,
channel such as television, radio, internet, religion, socio-economic status and other
newspaper demographic identifiers
d. Public communication – communication in
which one person gives a speech to large CULTURE RELATIVISM
audience in person (aka Public speaking) Cultures are unique and must be
evaluated, judge, and helped according
FACTORS INFLUENCING COMMUNICATION to their own values and standards
Prevention of:
1. Cultural Blindness – inability to be familiar with
or cognize (Know/understand) the culture of
others.
2. Cultural Bias – the firm position or stance that
one’s own values and beliefs must govern the
situation
3. Cultural imposition – inclination to impose
beliefs, values, and patterns of behavior on
clients from another culture.
4. Cultural pain – suffering, discomfort, or being
INTERCULTURAL COMMUNICATION – refers to
greatly offended by an individual or group that
effective communication between people,
shows a lack of sensitivity toward another’s
workers, patients with different cultural
cultural experiences.
backgrounds
Techniques to Address Multicultural Issues
Culture Differences [Why does culture differs?]
Be aware of personal attitudes and
History
perceptions and multicultural issues
Educational background
Make concessions to cultural preferences
Social background
and customs
Ethnic
Recognize poor literacy/ health literacy
Religion
skills
Ecology
Communicate in an understandable
Technology
language
Be aware of nonverbal language
Need for Intercultural Communication
Be assertive and empathetic
Success of any international business
Treat each patient as an individual
Encourage feedback
Involve family as needed but focus on the
patient
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
e. Indications
The indication(s) stated in the labeling
materials shall include only the FDA-
approved clinical use(s) of the drug
product.
c. Pharmacologic Category f. Dosage and Mode of Administration
The pharmacologic category shall be The label shall contain full information
as determined by FDA, taking into on the product's recommended
consideration current acceptable dosage, including the (i) initial or
standards for therapeutic categories loading dose, (ii) optimal use or usual
Ex: Antihemorroid drugs, Penicillin dose, (iii) frequency interval, (iv)
Antibiotics, Analgesics, Anti-acne duration of treatment, (v) dosage
drugs, NSAIDs, etc. adjustment, and other pertinent
d. Formulation/Composition aspects of drug therapy, if applicable
The label shall state the name and g. Contraindications, Precautions, Warnings
strength of all APIs present per unit dose The label shall contain full information
of the product, which shall be arranged regarding the contraindication(s) of the
in decreasing pharmacologic activity, drug product, as well as the
or if having more or less similar precaution(s) to be observed in its
pharmacologic activity, in decreasing administration and use
potency and strength The label shall include warning
The generic name of the API shall be statements, as required and/or
stated in fulI (including salts and esters, specified by FDA (e.g. "Flammable," "For
if any) and correlated to the active external use only," "Keep out of reach of
moiety, when applicable. The name of children"). Other specific additional
the API shall be in accordance with its instructions shall be issued by FDA in
INN; for herbal medicines and appropriate regulations.
traditionally-used herbal products, the h. Interactions
official Philippine Pharmacopoeia The label shall include drug-drug, drug-
name shall be used, or as determined food, drug-laboratory testing
by FDA interactions, as well as other relevant
Alcohol, when present in the product interactions, if applicable.
shall also be indicated, expressed as a i. Adverse Drug Reaction(s)
percentage (%). The name "alcohol" The label shall include detailed
without qualification shall mean ethyl information on adverse drug reaction(s)
alcohol. for a drug product arranged by system
The coloring, antimicrobial, and organ class.
antioxidant agents, and preservatives
j. Overdose and Treatment rendered less legible than other
The label shall include signs and required labeling information.
symptoms of overdose, as well as The caution statement, "Foods, Drugs,
possible treatment. Devices, and Cosmetics Act prohibits
k. Storage Condition(s) dispensing without prescription." shall
The label shall indicate appropriate always be included in the package
storage condition(s) and special insert, unit carton, primary label except
instructions for handling of the drug blister pack, foil strip, and small
product. containers of prescription drug
Special labeling instructions shall be products. In addition, for products
added for drug products with the classified as Dangerous Drug as per
following properties: Republic Act No. 9165, the caution
Properties Special Labeling Instructions statement shall be followed by an
Cannot tolerate refrigeration “Do not refrigerate or freeze”
additional statement as specified by
Cannot tolerate freezing “Do not freeze”
Light-sensitive “Protect from light” the Philippine Drug Enforcement
Cannot tolerate excessive “Store and transport not Agency (PDEA).
heat, e.g. suppositories above 30°C p. ADR Reporting Statement
Hygroscopic “Store in dry conditions”
For the product information sheet and
l. Pack Size or Net Content
the unit carton or primary label except
The unit carton shall indicate the pack
blister pack, foil strip, and small
size of the drug product expressed in
containers of products intended to be
terms of the number of units in the pack
sold without a unit carton, the statement
or the volume of each unit, e.g. 60 mL
“For suspected adverse drug reaction,
(for liquids), 10 blister packs x 10 tablets
report to the FIIA: www.fda.gov.ph" shall
(for tablets), 100 tablets, 12 sachets x 5
appear. In addition, a statement
g, etc.; Provided, that in case of drug
instructing the patient to seek medical
products for reconstitution for oral
attention immediately at the first sign of
administration, the pack size shall
any adverse drug reaction shall
reflect the volume of the product as
appear.
reconstituted.
The MAH may also include a reporting
For the primary label excluding blisters
statement for their own
and foil strips, the net content of the
pharmacovigilance system
product, stating the total
q. Registration Number
amount/quantity/number of the
The label shall indicate the registration
dosage form in a given container shall
number assigned by FDA to the
be expressed in metric units, e.g. 60 mL
product, which is denoted by a
(for liquids), 5 g (for sachets)
combination of letters and/or numbers.
m. Name and Address of MAH
r. Batch Number and Lot Number
The label shall state the name and full
The label shall indicate the product's
address of the MAH of the drug
batch number; provided, that if the
product.
entire batch is marketed by one drug
n. Name and Address of Manufacturer
establishment, only the batch number
The label shall state the name of the
shall be indicated. However, if a batch
manufacturer and full address of the
is divided into lots marketed by different
specific manufacturing site of the drug
drug establishments, the lot number
product as determined by FDA.
and corresponding batch number shall
o. Rx Symbol and Caution Statement
be indicated.
The labeling materials of prescription
s. Expiration Date and Date of Manufacture
drug products shall always include the
The label shall bear the month and year
Rx symbol, which shall be prominently
of the product's manufacturing and
displayed. The Rx symbol may be
expiration date either in letters or words
allowed to be over-printed or
and numbers, or in numbers alone; if
superimposed, provided, that such will
expressed in numbers alone, the year
not result in the obliteration by or being
shall be stated completely in order to
distinguish it from the month; and if the Directly below the generic class name
day is specified, the month shall be but still inside the generic outline box
spelled out, as shown below: are the individual components
June 2007 or Jun 2007 (including excipients) with the
06/2007 corresponding mEq/L or mmol/L
03 June 2007 or 03 Jun 2007 enumerated in the order of decreasing
Unless a certain day of the month is pharmacologic activity
specified, the last day of the stated Where one or more substances are
month shall be deemed as the date of amino acids and/or proteins, the total
the product's expiration/manufacturing amount of nitrogen in the volume of
date fluid in the container shall be reflected
For products reconstituted prior to use The osmolality, such as "hypotonic" or
and those which can be administered "hypertonic"; and the pH value or range
multiple times (e.g. suspensions), the (where applicable) of the solution shall
label shall include the period of be indicated
guaranteed safety, efficacy, and 3. Products for External Use
quality of the reconstituted preparation For products that are intended for
after first opening at a given storage external use, the statement "For external
condition(s). use only'' shall appear on all labeling
materials, rendered in capital letters
Special Labelling – In addition to the minimum against a red background or printed in
mandatory requirements mentioned, the following red font.
shall be required to appear on the label of specific 4. Supplements (Multivitamin/Mineral Herbal
product types: Products with Non-vitamin/Mineral Herbal
1. Parenteral Medications Components)
For parenteral products, the following Multivitamins, consisting of at least three
additional information shall be required: vitamins, and minerals, consisting of at
A statement of the least three mineral ingredients, shall
recommended mode of have the following additional
administration such as "IV", "IM” requirements:
or "SC", etc., as the case may The generic name adopted for
be. multivitamin-containing
Where the product consists of a products shall be "Multivitamins";
concentrated solution for for multi-mineral-containing
injection, a direction not to products the official name shall
administer the solution undiluted be "Minerals".
and a direction to dilute the For multivitamin and/or multi-
solution with the specified mineral preparations containing
diluent to the appropriate at least three herbal ingredients,
volume before use shall be the generic class name of the
stated. herbal ingredients shall be
2. Fluid Replacement Products "Herbs"
For fluid replacement products which For multivitamin products with
follow the standard formulations non-vitamin components (i.e.
contained in the current edition of the mineral or herbal ingredient), or
official compendium, the multi-mineral products with
nomenclature to be adopted as the nonmineral components (i.e.
generic class name shall be determined vitamin or herbal ingredient), or
by FDA multiherbal products with non-
For fluid replacement products not herbal components (i.e. vitamin
included in any official compendium, or mineral ingredient) the term
FDA shall determine the generic class "Multivitamins" or "Minerals" or
name "Herbs", respectively, shall first be
stated
6. Foreign donations of pharmaceutical products
7. Products that require special handling (e.g.
products that require cold-chain
management, pre-filled syringes)
5. Drugs under Maximum Drug Retail Price (MDRP) 8. Low volume of importation
Control
On the label of the minimum pack and *A Generic Labeling Exemption (GLE) application
the outer presentation of drugs listed shall be concurrently submitted by applicant
under Section I of Executive Order No. companies with their application for drug product
821 and other drugs as determined by registration, except for low volume of importation
the Secretary of Health, the following which shall be requested yearly. A letter stating the
statement shall be required to appear grounds for which the GLE is requested, as well as
in red background or red font: sample labels shall be included in the application.
For low volume of importation, in addition to the
letter a market forecast for the period applied for
6. Unique Global Product Identification Number shall be included.
SANCTIONS
Appropriate administrative charges and/or
imposition of administrative sanctions such
as, but not limited to, imposition of fines,
suspension, cancellation or revocation of
any license, permit or registration issued by
FDA.
EXEMPTIONS
1. Drug products manufactured for export
2. Veterinary drug products
3. If the container or primary pack containing the
product is enclosed in a transparent covering
and the particulars which are required to be set
on the label on the container or primary pack
are clearly visible through transparent
covering, the transparent covering is
exempted
4. Products that are compounded by a
pharmacist
5. Investigational drugs
RESPONSIBLE SELF-MEDICATION
The practice whereby individuals treat
Self-Care their ailments and conditions with
According to WHO, it is what people do for medicines which are approved and
themselves to establish and maintain available without prescription, and
health, prevent and deal with illness. It is a which are safe and effective when
broad concept encompassing: used as directed
Hygiene (general and personal) It requires that:
Nutrition (type and quality of food Medicines used are of proven
eaten) safety, quality and efficacy
Lifestyle (sporting activities, leisure, Medicines used are those
etc.) indicated for conditions that are
Environmental factors (living self-recognizable and for some
conditions, social habits, etc.) chronic or recurrent conditions
Socioeconomics factors (income Medicines should be specifically
level, cultural beliefs, etc.) designed for the purpose, and will
Self-medication require appropriate dose and dosage
Self-care is a broad concept which forms.
encompasses any action you take for your COMMON MINOR AILMENTS
Acne Dizziness Prickly heat
physical, mental and emotional health. It Body aches and Fever Minor skin
can include: pain bacterial infection
Treatment for a minor illness with Common allergy Flatulence Scabies
Colds Hemorrhoid Sore eyes
minimal supervision from a Cough Minor fungal Sore throat
healthcare professional infections
Taking a healthy, well-balanced Constipation Hyperacidity Obesity and
overweight
diet
Dandruff Indigestion Worm infestation
Exercising regularly Dehydration Insect bites
Finding appropriate methods to Diaper rash Lice infestation
relax after a stressful event Diarrhea Motion sickness
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