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Frequently Asked Questions |
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When it comes to taking medicine, you play an important role in ensuring your safety—and the safety of those you care for. By partnering with health professionals involved in your care, you can help them determine which medicines are most appropriate for you or your dependents. Partnering also helps your health care professionals teach you how to take these medicines safely.
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In this section, you'll learn how to reduce your risks of medication safety problems at key points in your care:
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* At your doctor's visit
* When you fill your prescription
* When you take your medicine
* After you take your medicine
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Who plays a role in medicine safety?
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* Pharmaceutical companies that develop, test, and produce medicines
* Regulatory agencies that approve the use of medicines
* Health care professionals who prescribe medicines
* Pharmacists who dispense and provide counsel regarding your medicine
* Patients and care givers who take medicines or give medicines to those they care for
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What is involved in approving a medicine?
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All medicines have benefits as well as risks. Before any new medicine is approved by regulatory agencies , it undergoes extensive testing—usually in several thousand people. The goal of this testing is to determine how safe and effective the medicine is—and to show that its benefits outweigh the known risks. A medicine is approved for use by appropriate patients only when its benefits have been adequately shown to outweigh the risks for its intended use in those patients.
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Which are OTC, Restricted OTC & Prescription Medicines?
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(OTC) Over-the-counter drugs are medicines that may be sold directly to a consumer without a prescription from a health care professional, as compared to prescription drugs which may only be sold to consumers possessing a valid prescription. In many countries, OTC drugs are selected by a regulatory agency to ensure that they are ingredients that are safe and effective when used without a physician's care. As a general rule, over-the-counter drugs have to be primarily used to treat a condition that does not require the direct supervision of a doctor and must be proven to be reasonably safe and well-tolerated. OTC drugs are usually also required to have little or no abuse potential. One of the oldest OTC drugs is aspirin. The OTC products must be labelled in such a way so as to educate consumers about their medications. These labels comply to a standard format and are intended to be easy for typical consumers to understand. These include information on the product's active ingredient(s), indications and purpose, safety warnings, directions for use, and inactive ingredients. Restricted OTC drugs are those products having over-the-counter status but simultaneously subject to other restrictions on sale. While these products are legally classified as OTC drugs, these are stored & displayed for sale only from the registered pharmacy employing a registered pharmacist. Such items may be unavailable in grocery stores etc. that stock other non-restricted OTC medications. Regulations detailing the establishments where drugs may be sold, who is authorized to dispense them, and whether a prescription is required vary considerably from country to country. Various forms of Emergency contraception, although considered as OTC for women aged 17 or over, these are prescriptions for younger women In India, although there is no official list of either of the above categories, yet these can be derived by going through the various provisions & Schedules to the Drugs & Cosmetic Act 1945 of India. All those medicines containing ingredients not specified in Schedule H, not listed as new drug, are not Narcotics and psychotropic drugs can be classified as restricted OTC drugs whereas those containing the ingredients of above categories are prescription drugs. Medicines which are neither restricted OTC nor prescription and are included in the Schedule K are OTC drugs.
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Which are Generic, Patented or Branded Medicines etc?
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A generic drug is a drug which is produced and distributed without patent protection.
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When a pharmaceutical company first markets a drug, it is usually under a patent that allows only the pharmaceutical company that developed the drug to sell it exclusively. Once the patent protection accorded to the original developer have expired, many equivalent drugs containing the same active ingredients as that of the original patented formulation manufactured by many companies appears in the market. Such formulations are called Generics and these may or may not have specific Brand name signifying the company manufacturing or distributing it. Generics are considered identical in dose, strength, route of administration, safety, efficacy, and intended use and are also identical or within an acceptable bioequivalence range to that of patented formulation. Generic drugs can be legally produced for drugs where:
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| * The patent has expired,
* The Generic company certifies the brand company's patents are either invalid or unenforceable in countries where a patent(s) is/are not in force The expiration of a patent removes the monopoly of the patent holder on drug sales. When generic products become available, the market competition leads to substantially lower prices for both the original brand name product and the generic forms. The principal reason for the relatively low price of generic medicines is that Generic manufacturers do not bear the burden of proving the safety and efficacy of the drugs through clinical trials since these trials have already been conducted by the patented company. Companies incur fewer costs in creating the generic drug, and are therefore able to maintain profitability at a lower cost to consumers. The costs of these generic drugs are so low that many developing countries can easily afford them. Many of the drugs introduced by generic manufacturers have already been on the market for a decade or more, and may already be well-known to patients and providers (although often under their branded/Patented name).
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For as long as a drug patent lasts, a brand/patented name company enjoys a period of“market exclusivity” or monopoly in which the company is able to set the price of the drug at a level which maximizes profitability. This price often greatly exceeds the production costs of the drug, which can enable the drug company to make a significant profit on their investment in research and development, thus enabling them to fund the research and development of new medicines which most generic companies cannot afford to do. With multiple firms producing the generic version of a drug the profit-maximizing price generally falls to the ongoing cost of producing the drug, which is usually much lower than the monopoly price. Having more generic-drug options means more cost-savings to consumers.
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In the early years of pharma industry when the patent act was not enforced in India, the medicines were mainly classified as Pharmacopial Medicines or Proprietary medicines. Pharmacopial medicines are those whose ingredients and dosage form is specified in Pharmacopoeia of India or of any other country and which are sold by the name as mentioned in pharmacopoeia. For example, if a tablet (dosage form),contains Paracetamol (Ingredient) and distributed as Paracetamol Tablet IP, it is called Pharmacopial medicines. If the same Paracetamol tablet IP as stated above is sold under Brand-A, it is called proprietary medicines.
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Your role in medicine safety continues after you take your medication home from the pharmacy. Each time you take your medicine—or give medicine to someone you care for—you are playing a key role in ensuring your safety and the safety of those in your care.
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Take your medicine (or, as a care giver, give it to the patient) exactly as directed:
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| * Read the directions and special instructions on your medicine, every time you take it
* Follow the directions on the label along with any other instructions from your health care team
* Do notchange the dosage without talking to your doctor first
* Store the medicine according to any instructions provided, and be sure to keep it out of the reach of children and pets.
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"Report any side effects to your doctor or another health care professional right away."
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One of the most important things you can do to keep you and those you care for safe is to promptly recognize and report any problems that might be related to the medication. Here's how:
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* Report any side effects to your doctor or another health care professional right away. For side effects that seem severe, such as difficulty breathing, extreme dizziness, or a very bad rash, contact emergency services
* For parents and care givers: Download these helpful guides to learn more about medication safety for children and seniors.
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Your pharmacist is a valuable partner in your care. To help keep you and your family safe, always take these steps when filling a prescription for yourself or someone you care for
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| * Make sure you have the right medicine and dosage—and that you understand how to take the medicine—before leaving the pharmacy
* Find out the active ingredient of any non prescription medicine—and avoid taking more than one kind of medicine containing that ingredient .
* Ask your pharmacist to explain anything that is unclear.
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