First phase of the OTC drug review?The first phase was accomplished byadvisory review panels. The panels werecharged with reviewing the ingredients innonprescription drug products to determinewhether these ingredients could be generallyrecognized as safe and effective for use inself-treatment. They are also reviewing claimsand recommending appropriate labeling,including therapeutic indications, dosageinstructions, and warnings about side effectsand preventing misuse.
According to the terms of the review, the panelsclassified drug product in three categories as follows:Category I: generally recognized as safe and effectivefor the claimed therapeutic indication;Category II: not generally recognized as safe andeffective for claimed indications;Category III: insufficient data available to permit finalclassification
Second phase of the OTC drug Review?The second phase of the OTC drug review is theagency’s review of ingredients in each class ofdrugs, based on the panel’s findings, on publiccomment, and on new data that may have becomeavailable. The agency, in turn, publishes its conclusionsin the Federal Register in the form of a tentative finalmonograph. After publication of the tentative finalmonograph, a period of time is allotted for objections tothe agency’s proposal or for requests to be submitted fora hearing before the Commissioner of FDA.
Third phase of the OTC drug review?The publication of final regulations in the form ofdrug monographs is the third and last phase of thereview process. The monographs establishconditions under which certain OTC drug productsare generally recognized as safe and effective.
The Food, Drug, and Cosmetic Act of 1938 was the first pieceof legislation to require that drugs be cleared by the U.S.Food and Drug Administration before being marketing forhuman use. This act required that all new drugs be provedsafe for human use before marketing, prohibited the sale ofdangerous, contaminated or misbranded products, andmandated labeling specifications.A new drug application (NDA) has been required for all newdrug entities that have been introduced since the enactmentof the Food, Drug, and Cosmetic Act. After an NDA isapproved by the FDA, the drug product may be marketed onlyby the sponsor of the NDA. Additional manufacturers whowish to market similar products must seek approval to do sothrough submission of a separate NDA. In some cases, suchas with generic medications, an abbreviated NDA may besubmitted. NDAs are updated periodically to include postmarketing information and minor label changes.
between prescription and OTC drugs. For drugs that could not belabeled with sufficient instructions to allow safe, unsuperviseduse by consumers, these amendments allowed labeling directedto physicians and pharmacists instead of to consumers. Drugswith physician- and pharmacist-directed labeling were thenavailable by prescription only.In 1962, the Kefauver-Harris amendments to the Food, Drug, andCosmetic Act were passed, requiring that drug products beproved not only safe but also effective for their intended uses.Enactment of these amendments compelled the FDA to determinethe effectiveness of more than 4,000 newer drugproducts, including more than 500 OTC products that had beenmarketed before the enactment of the amendments. The OTCDrug Review was begun in 1972 as an FDA-initiated scientificreview of OTC product ingredients in use at that time to ensurethat appropriate safety, effectiveness and labeling standards aremet. This review process consists of three phases: an advisorypanel review, creation of a tentative monograph and publicationof a final monograph.
As a result of the initial OTC drug reviewfindings, If OTC ingredients determined to besafe and effective for their intended usessubsequently the FDA approved theseproducts for general use.And if found to be ineffective, these areconsidered to be unsafe.And the some cases required submission ofadditional data before safety andeffectiveness could be established by FDA.
Two regulatory pathways exist for the legalmarketing of such products:NDA process.OTC Monographs.
“NDA PROCESS” “OTC MONOGRAPHS” Pre-marketing approval. No pre-marketing approval. Confidential filling. Public process Active ingredient –specific. Drug products are specify. OTC drug category. May require a user fee. No user fees. Potential for marketing exclusivity. No marketing exclusivity Mandated FDA review No mandated time lines. timelines. May require clinical studies. May require clinical studies. Label comprehension and actual use studies not required. Label comprehension
Purchase and use of OTC drugs without full knowledge is notonly a waste of resources for all stakeholders but can beharmful for consumers. Creating awareness of rational druguse is only possible through continued public education witha broad vision of good health and wellbeing of the society. Indeveloped economies, the four A’s of marketing has beenaddressed fairly which is:Product ------ AppropriatenessPrice --------- AffordabilityPlace ---------- Accessibility, andPromotion ---- Accountability for the promises madeBut in Pakistan the accessibility and awareness is still on alower side especially for OTC drugs.
health care consumers. The availability of over-the-counter medications makes it possible forconsumers to treat numerous ailments without thesupervision of a health care professional. Many ofthe medications now available without aprescription were previously classified asprescription-only products.The U.S. Food and Drug Administration haveprocedures in place that allows prescriptionproducts to be reclassified as over-the-countermedications if certain criteria are met. Reclassifiedproducts have had clinical and economic effects onthe U.S. health care system and have led toconcerns among health care professionals. Patienteducation and counseling are particularly importantto promote safe and effective use of over-the-counter products.
POSSIBLE BENEFITS:-1. Increased access.2. Decreased frequency of visits tophysicians, 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 diagnosis2. Delay in obtaining needed therapy3. Use of suboptimal therapy4. Drug resistance5. Increased costs to patients6. Failure to follow label instructions (Adverseeffects, Drug interactions)7. Perceived loss of control by physicians
Over-The-Counter counseling refers toa pharmacists full working knowledge of Over-the-counter (OTC) drugs as well as initiating anassessment of the patients self-care concernsand drug-related needs.OTC counseling patients about self-care andnon-prescription drugs does not follow the sameformat as for prescription drugs. What is alsoimportant is that a pharmacist should assesswhether the patient has any underlyingconditions as to avoid any drug-releaseinteractions.
The pharmacist plays a key role in ensuring that thebalance of OTC use tips toward benefit rather than risk.Who better to serve as the “learned intermediary” tohelp patients understand and apply health information?The pharmacist is available at the point of purchase tohelp the patient select an appropriate OTCproduct, suggest non pharmacologic therapy, or referthe patient to a physician when necessary.Pharmacists are trained to help patients determine whenand how to treat themselves; when to see a physician;when diagnostic tests are appropriate; and when to useemergency health care services. As an extension ofpharmaceutical care, pharmacists can counsel patientson the appropriate use of OTC products, therebymaximizing the benefits and reducing the risks.
Effective non-prescription drug counseling requires athorough description of patients symptoms. Beforeadvice can be given, the PHARMACIST will needknowledge on the nature, severity and extenuatingcircumstances surrounding those symptoms. Aswell, other aspects of the patients health e.g. otherdiseases, drugs, contraindications, allergies, must beexamined. This information-gathering" stage is mostimportant.
PHARMACIST must be able to give information to thepatient so products are used both safely and effectively.When providing care to patients involving over thecounter medications, it is necessary to perform anadequate mini-assessment of the client’s problem,consisting of:Properly identifying the person who will be using theproduct 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 thecomplaint;Asking about whether the client has any medicationallergies; and,Asking whether the client has consulted a health careprofessional 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 previousappropriate 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 mayrecommend an appropriate product or course of action,including non-drug measures.
If you recommend a non-prescription drug product, youshould discuss:Directions for use;Expected outcomes of therapy, including a time-framefor a response;Common adverse effects and precautions;Correct storage; and,When to seek medical attention.Ideally, you should document nonprescription drug useon the client’s medication profile. This is especiallyimportant for clients who have a medical conditionand/or are taking prescription medication.