GROUP PRESENTATION

PHARMACEUTICAL MANAGEMENT

MARKETING OF NON-PRESCRIPTION DRUGS

OTC DRUGS:-An OTC drug product is a Product marketed

for use by the consumer without the intervention of a health care professional.

PRESCRIPTION DRUGS:-A prescription drug product is a drug that can only be obtained with a prescription from an

appropriate health care practitioner.

PHASES OF OTC DRUG REVIEW

First phase of the OTC drug review?The first phase was accomplished by advisory review panels. The panels were charged with reviewing the ingredients in nonprescription drug products to determine whether these ingredients could be generally recognized as safe and effective for use in self-treatment. They are also reviewing claims and recommending appropriate labeling, including therapeutic indications, dosage instructions, and warnings about side effects and preventing misuse.

According to the terms of the review, the panels classified drug product in three categories as follows:

Category I: generally recognized as safe and effective for the claimed therapeutic indication;

Category II: not generally recognized as safe and effective for claimed indications;

Category III: insufficient data available to permit final classification

Second phase of the OTC drug Review?

The second phase of the OTC drug review is the agency’s review of ingredients in each class of drugs, based on the panel’s findings, on public comment, and on new data that may have become available. The agency, in turn, publishes its conclusions in the Federal Register in the form of a tentative final monograph. After publication of the tentative final monograph, a period of time is allotted for objections to the agency’s proposal or for requests to be submitted for a hearing before the Commissioner of FDA.

Third phase of the OTC drug review?The publication of final regulations in the form of drug monographs is the third and last phase of the review process. The monographs establish conditions under which certain OTC drug products are generally recognized as safe and effective.

FDA’s APPROVAL PROCESS OF OTC PRODUCTS

 The Food, Drug, and Cosmetic Act of 1938 was the first piece of legislation to require that drugs be cleared by the U.S. Food and Drug Administration before being marketing for human use. This act required that all new drugs be proved safe for human use before marketing, prohibited the sale of dangerous, contaminated or misbranded products, and mandated labeling specifications.

A new drug application (NDA) has been required for all new drug entities that have been introduced since the enactment of the Food, Drug, and Cosmetic Act. After an NDA is approved by the FDA, the drug product may be marketed only by the sponsor of the NDA. Additional manufacturers who wish to market similar products must seek approval to do so through submission of a separate NDA. In some cases, such as with generic medications, an abbreviated NDA may be submitted. NDAs are updated periodically to include post marketing information and minor label changes.

In 1951, the Durham-Humphrey amendments to the Food, Drug, and Cosmetic Act established the distinction between prescription and OTC drugs. For drugs that could not be labeled with sufficient instructions to allow safe, unsupervised use by consumers, these amendments allowed labeling directed to physicians and pharmacists instead of to consumers. Drugs with physician- and pharmacist-directed labeling were then available by prescription only.In 1962, the Kefauver-Harris amendments to the Food, Drug, and Cosmetic Act were passed, requiring that drug products be proved not only safe but also effective for their intended uses. Enactment of these amendments compelled the FDA to determine the effectiveness of more than 4,000 newer drug products, including more than 500 OTC products that had been marketed before the enactment of the amendments. The OTC Drug Review was begun in 1972 as an FDA-initiated scientific review of OTC product ingredients in use at that time to ensure that appropriate safety, effectiveness and labeling standards are met. This review process consists of three phases: an advisory panel review, creation of a tentative monograph and publication of a final monograph.

As a result of the initial OTC drug review findings, If OTC ingredients determined to be safe and effective for their intended uses subsequently the FDA approved these products for general use. And if found to be ineffective, these are considered to be unsafe.And the some cases required submission of additional data before safety and effectiveness could be established by FDA.

OTC DRUGS MARKETING

Two regulatory pathways exist for the legal marketing of such products:

NDA process.OTC Monographs.

“NDA PROCESS” “OTC MONOGRAPHS” Pre-marketing approval.

Confidential filling.

Drug products are specify.

May require a user fee.

Potential for marketing exclusivity.

Mandated FDA review timelines.

May require clinical studies.

Label comprehension

No pre-marketing approval.

Public process

Active ingredient –specific.

OTC drug category.

No user fees.

No marketing exclusivity

No mandated time lines.

May require clinical studies.

Label comprehension and actual use studies not required.

Purchase and use of OTC drugs without full knowledge is not only a waste of resources for all stakeholders but can be harmful for consumers. Creating awareness of rational drug use is only possible through continued public education with a broad vision of good health and wellbeing of the society. In developed economies, the four A’s of marketing has been addressed fairly which is: Product ------ Appropriateness Price --------- Affordability Place ---------- Accessibility, and Promotion ---- Accountability for the promises made

But in Pakistan the accessibility and awareness is still on a lower side especially for OTC drugs.

ROLE OF SELF-MEDICATION (OTC)

Self-care is becoming increasingly popular among health care consumers. The availability of over-the-counter medications makes it possible for consumers to treat numerous ailments without the supervision of a health care professional. Many of the medications now available without a prescription were previously classified as prescription-only products. The U.S. Food and Drug Administration have procedures in place that allows prescription products to be reclassified as over-the-counter medications if certain criteria are met. Reclassified products have had clinical and economic effects on the U.S. health care system and have led to concerns among health care professionals. Patient education and counseling are particularly important to promote safe and effective use of over-the-counter products.

BENEFITS AND RISKS OF OTC

POSSIBLE BENEFITS:-

1. Increased access.2. Decreased frequency of visits to physicians, leading to lower healthcare costs. 3. Improved education of consumers. 4. Increased autonomy of patients. 5. Decreased cost to third party players.

POSSIBLE RISKS:-

1. Inaccurate diagnosis 2. Delay in obtaining needed therapy 3. Use of suboptimal therapy 4. Drug resistance 5. Increased costs to patients 6. Failure to follow label instructions (Adverse effects, Drug interactions) 7. Perceived loss of control by physicians

PHARMACIST’S ROLE IN OTC DRUG PRODUCTS

Over-The-Counter counseling refers to a pharmacist's full working knowledge of Over-the-counter (OTC) drugs as well as initiating an assessment of the patient's self-care concerns and drug-related needs. OTC counseling patients about self-care and non-prescription drugs does not follow the same format as for prescription drugs. What is also important is that a pharmacist should assess whether the patient has any underlying conditions as to avoid any drug-release interactions.

The pharmacist plays a key role in ensuring that the balance of OTC use tips toward benefit rather than risk. Who better to serve as the “learned intermediary” to help patients understand and apply health information? The pharmacist is available at the point of purchase to help the patient select an appropriate OTC product, suggest non pharmacologic therapy, or refer the patient to a physician when necessary. Pharmacists are trained to help patients determine when and how to treat themselves; when to see a physician; when diagnostic tests are appropriate; and when to use emergency health care services. As an extension of pharmaceutical care, pharmacists can counsel patients on the appropriate use of OTC products, thereby maximizing the benefits and reducing the risks.

Effective non-prescription drug counseling requires a thorough description of patient's symptoms. Before advice can be given, the PHARMACIST will need knowledge on the nature, severity and extenuating circumstances surrounding those symptoms. As well, other aspects of the patient's health e.g. other diseases, drugs, contraindications, allergies, must be examined. This information-gathering" stage is most important.

When non-prescription drugs are indicated, the PHARMACIST must be able to give information to the patient so products are used both safely and effectively. When providing care to patients involving over the counter medications, it is necessary to perform an adequate mini-assessment of the client’s problem, consisting of:Properly identifying the person who will be using the product and determining their approximate age;Inquiring about any current medical conditions;Asking about current non-prescription drug use, including herbal products;Asking about current prescription drug use;Inquiring about the symptoms and duration of the complaint;Asking about whether the client has any medication allergies; and,Asking whether the client has consulted a health care professional about the problem.

You should refer the client for medical attention if:Their condition is potentially severe,They are uncertain about their symptoms,Their self-diagnosis is likely incorrect,The condition has not responded to previous appropriate therapy, orThey have other risk factors that should be assessed.When you have assessed the client and the problem, and feel that a referral is not necessary, you may recommend an appropriate product or course of action, including non-drug measures.

If you recommend a non-prescription drug product, you should discuss:Directions for use;Expected outcomes of therapy, including a time-frame for a response;Common adverse effects and precautions;Correct storage; and,When to seek medical attention.

Ideally, you should document nonprescription drug use on the client’s medication profile. This is especially important for clients who have a medical condition and/or are taking prescription medication.