What are OTC drugs?
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Over-the-counter (OTC) drugs
• OTC drugs are drugs that have been found to
be safe and appropriate for use without the
supervision of a health care professional such
as a physician, and they can be purchased by
consumers without a prescription.
• Example of OTC drugs:
• 1.Panadol tablet (analgesic),
• 2.antidandruff shampoos (coal tar),
3.antiseptic vaginal wash.
OTC drugs generally have these
characteristics
1.Their benefits outweigh their risks.
• i.e, list of Benefit > list of dangerous effect.
2.The potential for misuse and abuse is low.
• i.e no severe side effect or danger if patient
takes an overdose of the drug or if he gets used
to take the drug on daily basis, such as
acetaminophen capsules 500mg to be taken up
to 2 caps three times daily (unless hepatic
illness).
• 3. Consumer can use them for self-diagnosed
conditions.
• If patient suffers from headache or back pain
he could buy and use respectively:
• A. panadol or ibuprofen caplets safely .
• B. menthol or capsaicin cream for topical
application.
• If the patient suffers diarrhea he could use
• A. loperamide (1 brand name: Imodium) and
B. bismuth subsalicylate (2 brand names:
Kaopectate, Pepto-Bismol
• If the patient suffers from cold and flu he could
use
Tylenol cold
• If the patient suffers from allergy he could use
• Benadryl( diphenhydramine first generation
antihistamine)
• claritin (loratidine ,a second generation
antihistamine)
4. They should be adequately labeled.
• All nonprescription, over-the-counter (OTC) medicine labels
have detailed usage and warning information so consumers
can properly choose and use the products. Eg:
• Active Ingredient. Therapeutic substance in product;
amount of active ingredient per unit.
• Uses. Symptoms or diseases the product will treat or
prevent.
• Warnings. When not to use the product; conditions that
may require advice from a doctor before taking the product;
possible interactions or side effects; when to stop taking the
product and when to contact a doctor; if you are pregnant or
breastfeeding seek guidance from a health care professional;
keep product out of children’s reach.
• Inactive Ingredients. Substances such as colors or flavors.
• Purpose. Product action or category (such as antihistamine,
antacid, or cough suppressant.
• Directions. Specific age categories, how much to take(dose), how
to take(route of administration), and how often (frequency)and
how long to take(duration).
• Other Information. How to store the product properly and
required information about certain ingredients (such as the
amount of calcium, potassium, or sodium the product contains)
• The expiration date, when applicable (date after which you
should not use the product).
• Lot or batch code (manufacturer information to help identify the
product).
• Name and address of manufacturer, packer, or distributor.
• Net quantity of contents (how much of the product is in each
package).
• What to do if an overdose occurs.
• 5.Health practitioners are not needed for
the safe and effective use of the product.
• Why?
• Because The labeling of the drug contains
warnings and the more common drug
interaction.
What Are The requirements for OTC
drug?
1. Standards for safety and efficacy (GRASE)
2.Good Manufacturing Practices (GMPs inspections)
3. Labeling under CFR (code of federal regulations)
• For a drug to be accepted by the FDA to
be an OTC product, some steps are to be
taken.
• An application is made by the
manufacturer to the FDA:
• The drug is approved either as an NDA
(New Drug Application) or fulfils an OTC
monograph…
• This is to be discussed in the
following…..
It is required that all new OTC drugs
obtain an NDA (New Drug Application)
before being marketed and sold. The FDA
reviews all NDAs to ensure that:
• The drug is safe and efficacious and
helps cure the problem for which a patient
would take it, if taken as directed
• The benefits of taking the drug outweigh
the dangers of taking it
• The drug’s packaging/package insert
contains appropriate information
However, some older drugs are exempt
from having to obtain an NDA,
because they’re “generally recognized
as safe and effective” (GRASE,
GRAS/E or GRAS/GRAE). These
drugs have been on the market for
many years and the “safe and
effective” rating is, of course,
dependent on a user taking the drug as
directed. Even aspirin, for example, is
not safe if consumed to excess.
Safety & Effectiveness
Standards for OTC Products
FDA state that consumers must be able to:
1.Self-diagnose
2.Self-treat
3.Self-manage
Which can be assessed through:
1.Label comprehension studies
2. Actual use studies
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How OTC drugs are approved
• These drugs are sometimes approved under
applications like new prescription drugs
(NDA), i.e new drug application
• but more often they are legally marketed
without an application, by following a
regulation called an OTC drug monograph.
OTC drug monograph
• Dictionnary meaning:
• A monograph is a work of writing upon a single
subject, usually by a single author. It is often a
scholarly essay ,it may be released in the manner
of a book or journal article.
• An OTC drug monograph is a kind of "recipe
book" covering acceptable ingredients, doses,
formulations, labeling, and testing.
• The monographs state the requirements for OTC
drug categories including which ingredients can
be used and their intended use. Acne
medications, psoriasis treatments and sunscreens
are just some of the OTC products covered by
monographs.
• It tells
• 1. kind of ingredients that may be used to treat
certain diseases or conditions without a
prescription
• 2.the appropriate dose and
• 3. instructions for use.
• OTC products that meet a monograph’s
requirements may be marketed without FDA ( food
and drug administratio) review.
• OTC products that don’t fit under an existing
monograph must be approved under an application
like the applications for prescription products (New
drug application).
New Drug application
The NDA application is the vehicle through
which drug sponsors formally propose that
the FDA approve a new pharmaceutical for
sale and marketing in the U.S.
The data gathered during the animal studies
and human clinical trials of an Investigational
New Drug (IND) become part of the NDA.
The Goals of the NDA
• The NDA process types are:
• 1. direct- OTC
• 2. Rx- OTC switch
• Rx-to-OTC (prescription to OTC )switch
• The process of transferring FDA-approved
prescription medications to nonprescription,
over-the-counter (OTC) status is known as “Rxto-OTC switch.”
• Advantages:
• This process provides consumers with
convenient, cost-effective access to safe and
effective medicines without the required
assistance of a healthcare provider.
• When an ingredient is first introduced as an OTC
medicine, it typically has been marketed by a
manufacturer as a prescription medicine first.
• Then, after a sufficient amount of time has passed
to enable the manufacturer to gather appropriate
scientific information on the product, the
manufacturer may elect to submit a new drug
application to FDA, so that it may be considered
for OTC status.
• FDA experts review the application and determine
if that product has a high enough safety profile
and if labeling can be developed so that the
medicine can be marketed safely and effectively
as an OTC medicine. Example of OTC switched
drug: Benadryl (antihistamine).
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•
•
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• How does the switch process impact the
healthcare system ?
The Rx-to-OTC switch process has a positive
impact on the U.S. healthcare system process by
driving down overall healthcare costs. How?
1.Saving the fee for the doctor’s visit,
2. travel costs, and
3.time off from work.
• Who determines when a prescription medicine
should be switched to OTC status?
• 1.Technically, anyone could submit a Citizen’s Petition
to FDA to switch a product from Rx to OTC status.
• 2.However, the holder of the approved new drug
application (NDA)—the company that developed the
drug for prescription use—knows the most about the
drug and is in the best position to determine whether
and under what circumstances it would be
appropriate to request a switch.
• What does FDA need to consider before it can
approve a switch?
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•
•
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FDA must look at:
1.The safety and effectiveness of the product,
2.The benefit-to-risk ratio, and
3.Whether the labeling can be written in such a way that
consumers can use the products safely without the
intervention of a healthcare provider.
•
Behind the counter (BTC) class of drugs
• BTC class of drugs, are referring to a category of medicines
available without a prescription, but only in pharmacies or
through a pharmacist. Under this system, some
nonprescription medicines would not be available in other
convenient retail outlets, such as grocery stores without a
pharmacy. Examples of BTC drugs: pseudoephedrine and
plan B ( contraceptive).
• Pharmacists are health professionals who assist
individuals in making the best use of medications.
• This Code, prepared and supported by
pharmacists, is intended to state publicly the
principles that form the fundamental basis of the
roles and responsibilities of pharmacists.
• These principles, based on moral obligations and
virtues, are established to guide pharmacists in
relationships with patients, health professionals,
and society.
I. A pharmacist respects the covenantal relationship
between the patient and pharmacist
• Considering the patient-pharmacist relationship as
a covenant means that a pharmacist has moral
obligations in response to the gift of trust received
from society.
• In return for this gift, a pharmacist promises
1.to help individuals achieve optimum benefit from
their medications,
2. to be committed to their welfare,
3.and to maintain their trust.
II. A pharmacist promotes the good of every patient
in a caring, compassionate, and confidential manner.
• A pharmacist places concern for the well-being
of the patient at the center of professional
practice. In doing so, a pharmacist
• 1.considers needs stated by the patient .
• 2.A pharmacist is dedicated to protecting the
dignity of the patient.
• 3.With a caring attitude and a compassionate
spirit, a pharmacist focuses on serving the
patient in a private and confidential manner.
III. A pharmacist respects the autonomy
(independence) and dignity of each patient
• A pharmacist promotes the right of self determination and recognizes individual selfworth by encouraging patients to participate in
decisions about their health.
• A pharmacist communicates with patients in terms
that are understandable.
• In all cases, a pharmacist respects personal and
cultural differences among patients.
IV. A pharmacist acts with honesty and integrity
in professional relationships.
• A pharmacist has a duty to tell the truth and
to act with conviction of conscience.
• A pharmacist avoids discriminatory practices,
behavior or work conditions that impair
professional judgment, and actions that
compromise dedication to the best interests
of patients.
V. A pharmacist maintains professional competence.
• A pharmacist has a duty to maintain
knowledge and abilities as new medications,
devices, and technologies become available
and as health information advances.
VI. A pharmacist respects the values and abilities
of colleagues and other health professionals
• When appropriate, a pharmacist asks for the
consultation of colleagues or other health
professionals or refers the patient.
• A pharmacist acknowledges that colleagues
and other health professionals may differ in
the beliefs and values they apply to the care of
the patient.
VII. A pharmacist serves individual, community,
and societal needs
• The primary obligation of a pharmacist is to
serve individual patients.
• However, the obligations of a pharmacist may
at times extend beyond the individual to the
community and society.
• In these situations, the pharmacist recognizes
the responsibilities that accompany these
obligations and acts accordingly.
VIII. A pharmacist seeks justice in the distribution
of health resources
• When health resources are allocated
(changing in place), a pharmacist is fair and
equitable, balancing the needs of patients and
society.
* adopted by the membership of the American
Pharmacists Association October 27, 1994
Pharmacist Duties and Responsibilities
• Pharmacists play a vital role in the health care system
through the medicine and information they provide.
• Responsibilities of Retail Pharmacist:
• 1.Compounding
• Compounding refers to the process of mixing
ingredients by hand to create medication.
• This is usually done by a machine or a pharmaceutical
company, but pharmacists will be expected to
compound medications from time to time. They will
learn how to safely mix medication during training.
• Eg: zinc olive cream for dermatitis, salicylic acid cream
for rough skin and corns , ichtamol ointment for pus.
• 2.Customer Service
• Customer service is one of the primary duties of a
pharmacist.
• The pharmacist must do the following:
• A)greet all customers (receiving well),
• B)obtain prescription medication,
• C)handle payment and
• D) answer any questions that the customer has.
• E)In addition to discussing prescription medication,
pharmacists help customers choose over-thecounter medication and may provide information
about diet, exercise and instrument use .
• 3.Record Keeping
• Pharmacists must maintain up-to-date and
accurate records for all patients.
• Most pharmacists use a computer program to
enter their client's confidential medical
information.( name, age, average weight,
medical condition , previous reported allergies
and sensitivity of patient, date of fill and refill of
prescription)
• 4.Ordering
• The pharmacist must maintain a fully-stocked
pharmacy. That will need to order medication,
drugs, pill bottles and other supplies.
• A pharmacist will also review new products and
medications.
• A pharmacist must order narcotic and take full
responsibility of sending an order letter to the
supplier by himself including his signature and
license number
• 5. Teaching
• Some pharmacists teach in pharmacy colleges or
collaborate as consultants for a medical team.
• Others may supervise pharmacy interns or
students in field work.
• Teaching may be a small part of the pharmacist's
position, but ensuring new pharmacists are well
trained and aware of their responsibilities and
professional ethics is a major duty for
pharmacists who teach.
• 6.Open discussion arrangement with customers
and neighbors
• The pharmacist should get talent in gathering
customers and patient sharing talks about
specific sickness like diabetes and inform them
about the new medications, their correct use,
their side effect and the critical situation they
may suffer during their chronic illness and how to
get over it.
Hospital Pharmacist
• Hospital pharmacists work in a hospital pharmacy
service, primarily within the public sector.
• They are experts in the field of medicines and are
not only responsible for the dispensing of
prescriptions but also the purchase, manufacture
and quality testing of all medicines used in a
hospital.
• Pharmacists work closely with medical and nursing
staff to ensure that patients receive the best
treatment. They also provide help and advice to
patients in all aspects of their medicines.
• The role of a hospital pharmacist can extend
outside the hospital with responsibility for
medicines in health centers, nursing homes,
hospices and general practitioners' (GP)
surgeries.
• Certificate requirements for hospital
pharmacist:
• 1. Pharm D program
• 2. Hospital pharmacy residency program
Responsibilities of Hospital Pharmacist:
• Hospital pharmacists have multiple duties and
responsibilities.
• 1. Making sure medications ordered by
prescribers (physician, dentists, surgeon)are
available for patients.
• 2. When an order is written, it is reviewed by a
pharmacist. The pharmacist takes into account
the patient’s height, weight, allergies, diagnosis
and other medications .
• 3. Pharmacists supervise the preparation of the
intravenous fluids and drug products, paying
attention to :
• 1.the concentration of the medication in the
intravenous fluids .
• 2.making sure of incompatibility between
medication not allowing their mixture in the same
bag .
• Pharmacists are also responsible for the
preparation of specialty fluids, like intravenous
nutrition and cancer chemotherapy.
• 4. Pharmacists work in several intensive care
areas, including
• 1-the Neonatal Intensive Care Unit, where the
sickest newborn babies receive care.
• 2-There are pharmacists that go on rounds
with some patient-care teams, such as the
nutrition, pain management and cancer
teams. Because These pharmacists help
choose, dose and monitor the drugs to be used
on patients covered by those teams.
• 5. Pharmacists are involved in education.
Pharmacists not only help educate the
patients and families, but also give lectures to
physicians, nurses and other pharmacists
about medicines and their appropriate use.
• 6. Another major emphasis is research.
Pharmacists are involved in designing human
studies and making sure they are carried out
in accordance with the applicable laws, rules
and regulations.
• Typical Pharmacist Traits :
• To be a good pharmacist:
• ·You should have a good memory and enjoy
learning about new medicines and treatments.
• ·You should also be trustworthy and detailoriented and have good communication skills.
• Also, you should have good problem solving
abilities to help or guide patients through
proper medication regiment or treatment.
Patient’s Bill of Right
• Effective health care requires collaboration
between patients, pharmacists and other
health
care
professionals.
Honest
communication, respect for personal and
professional values, and sensitivity to
differences are integral to providing patient
care. Pharmacists must ensure a health care
ethic that respects the role of patients in
decision making about treatment choices and
other aspects of their care.
• The California Board of Pharmacy encourages
health care providers to tailor this bill of rights
to their patient community by translating
and/or simplifying the language of this
document as may be necessary to ensure that
patients and their families understand their
rights and responsibilities .
• l. The patient has the right to considerate and
respectful care.
• 2. The patient has the right to and is
encouraged to obtain from pharmacists and
other direct caregivers relevant, current, and
understandable information concerning their
medication therapy and treatment.
• 3. The patient is entitled to the opportunity to
discuss and request information related to
their specific drug therapy, the possible
adverse side effects and drug interactions
• 4. The patient has the right to make decisions
about the plan of care prior to and during the
course of treatment and to refuse a
recommended treatment or plan of care.
• 5.The patient has the right to expect that all
communication, discussion ,and patient
counseling will be conducted so as to protect each
patients privacy.
• 6. The patient has the right to expect that all
records and discussion pertaining to his/her drug
therapy will be treated as confidential by the
pharmacist, and the patient has the right to
expect that the pharmacist will emphasize the
confidentiality of patient information to any other
parties entitled to review the patient's
information and records.
• 7. Patients have a right to competent counseling
from the pharmacist to help them understand
their medications and use them correctly.
• The collaborative nature of health care requires
that patients or their families participate in their
care. The effectiveness of patient care and
patient satisfaction with the course of drug
therapy will depend, in part, on the patient
fulfilling certain responsibilities. Patients are
responsible for providing information about their
medications as well as a history of their drug and
food allergies.
• To participate effectively in decision making,
patients must be encouraged to take
responsibility for requesting information or
clarification about the drugs they are taking
when they do not fully understand their
instructions.
• Good Luck