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?

2.Good Manufacturing Practices (GMPs inspections)

3. Labeling under CFR (code of federal regulations)

1. Standards for safety and efficacy (GRASE)

• 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 & EffectivenessStandards for OTC Products

FDA state that consumers must be able to:

1.Self-diagnose2.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

• Are to provide enough information to permit FDA reviewers to reach the following key decisions:

• 1. Whether the drug is safe and effective in its proposed use(s), and

• 2. whether the benefits of the drug outweigh the risks. • 3. Whether the drug's proposed labeling (package

insert) is appropriate, and what it should contain. • 4.Whether the methods used in manufacturing the

drug and the controls used to maintain the drug quality are adequate to preserve the drug identity, strength, quality, and purity.

• The documentation required in an NDA is supposed to tell the drug's whole story, including

• 1. how it is manufactured, processed and packaged.

• 2-what the ingredients of the drug are,• 3. how the drug behaves in the body • 4. what happened during the clinical tests, and • 5. the results of the animal studies,• 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 “Rx-to-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).

• 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?

• 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).

Code of Ethics for Pharmacists

• 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 self-worth 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-the-counter 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 detail-

oriented 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