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Written by Teresa Jaworski - Subject Matter Expert, QPharma
Using the Internet to purchase items has become a very popular and convenient way of acquiring things we need without leaving the comfort of our homes. In addition, the Internet allows us to browse many different websites quickly so that we can compare costs and buy products at the most affordable prices.
However, when purchasing medications online, we should be very cautious. You could purchase a drug that is not safe and put your health at risk. Many websites that sell medications online are not US state-licensed pharmacies or are not pharmacies at all. Therefore you run the risk of purchasing counterfeit medicines that contain dangerous ingredients; are not manufactured according to standards; contain the incorrect dosage of ingredients; are contaminated; are not labeled, stored or shipped properly; or have expired. Counterfeit drugs are illegal!
The FDA issued a draft guidance document dated July 2009, Draft Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting, which will provide guidance for pharmaceutical manufacturers in using inks, pigments, flavors, and other physical-chemical identifiers (PCIDs) when making a drug product in solid oral dosage forms. The use of PCIDs will make it more difficult to counterfeit a drug thus making it easier to identify a genuine version of the drug. According to an FDA News Release dated July 13, 2009, “Drug counterfeiting is a serious public health concern,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “We look forward to working with industry to help ensure that consumers are not exposed to products containing unknown, ineffective, or harmful ingredients.”
A PCID is a substance or combination of substances with a unique physical or chemical property used to identify and validate a drug product. According to FDA, a substance used as a PCID should not adversely affect the identity, strength, quality, purity, potency, or bioavailability of the drug product. The PCID can often be detected by wholesalers or pharmacists however, in some cases an analytical instrument may be necessary to detect the PCID in order to determine if the drug products are genuine.
The FDA expects that most of the impending PCID ingredients are already being used as food additives, colorants, or other types of inactive ingredients and have already been established as safe. FDA recommends using the lowest amount of PCID that allows for identification of the product and recommends that the PCID be a substance with no medicinal effect. Refer to the draft guidance document located at www.fda.gov for additional information.
In a recent FDA News Release, the FDA warned consumers about a potentially harmful product, “Generic Tamiflu. The product did not contain Tamiflu’s active ingredient, Oseltamivir, but Cloxacillin, an ingredient in the same class of antibiotics as Penicillin.” FDA warned that using this product could result in an allergic reaction for patients that are allergic to penicillin including “a sudden, potentially life-threatening reaction called anaphylaxis, with symptoms that include difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness, or a rapid or weak pulse.”
Upon learning of the so called “Generic Tamiflu”, FDA purchased a package of the product without a prescription from a website that claimed to be an online drugstore. The “Generic Tamiflu” was received in a postmarked package from India. The product was stored in two blister packages with foil-backing labeled “Oseltamivir Phosphate 75mg. Capsules TM-FLU Capsules” and “Manufactured by: TRYDRUGS Pharmaceuticals PVT. LTD.” An FDA-approved generic drug for the prescription drug “Tamiflu” does not exist.
In another FDA News Release, dated January 25, 2010, the FDA warned consumers about a counterfeit version of the weight-loss drug Alli being sold at online auction sites over the Internet. FDA indicated that this counterfeit product was unsafe and illegal. “Alli is an FDA-approved, over-the-counter weight-loss drug that contains Orlistat as its active ingredient. The counterfeit version of Alli does not contain Orlistat; instead it is made with varying amounts of Sibutramine, a stimulant drug.” Laboratory testing completed by FDA determined that the dosing directions specified a dosage of three times the usual daily dose of Sibutramine, which could result in elevated blood pressure, stroke, and heart attack for people with a history of cardiovascular disease. Additionally, healthy people taking this product could suffer anxiety, nausea, heart palpitations, racing heart, insomnia, and small increases in blood pressure.
FDA continuously monitors the Internet and even makes purchases so they can test the drug products to verify product authenticity. However, consumers need to protect themselves as well by knowing how to recognize a genuine internet pharmacy. A genuine internet pharmacy will be licensed by the U.S. Board of Pharmacy and will follow the relevant laws and regulations. In addition, the National Association of Boards of Pharmacy Verified Internet Pharmacy Sites Seal (VIPPS Seal) provides a seal of approval to pharmacy sites that meet state license requirements. A pharmacy that carries this seal can be found at www.vipps.info.
Using the Internet to purchase items has become a very popular and convenient way of acquiring things we need without leaving the comfort of our homes. In addition, the Internet allows us to browse many different websites quickly so that we can compare costs and buy products at the most affordable prices.
However, when purchasing medications online, we should be very cautious. You could purchase a drug that is not safe and put your health at risk. Many websites that sell medications online are not US state-licensed pharmacies or are not pharmacies at all. Therefore you run the risk of purchasing counterfeit medicines that contain dangerous ingredients; are not manufactured according to standards; contain the incorrect dosage of ingredients; are contaminated; are not labeled, stored or shipped properly; or have expired. Counterfeit drugs are illegal!
The FDA issued a draft guidance document dated July 2009, Draft Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting, which will provide guidance for pharmaceutical manufacturers in using inks, pigments, flavors, and other physical-chemical identifiers (PCIDs) when making a drug product in solid oral dosage forms. The use of PCIDs will make it more difficult to counterfeit a drug thus making it easier to identify a genuine version of the drug. According to an FDA News Release dated July 13, 2009, “Drug counterfeiting is a serious public health concern,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “We look forward to working with industry to help ensure that consumers are not exposed to products containing unknown, ineffective, or harmful ingredients.”
A PCID is a substance or combination of substances with a unique physical or chemical property used to identify and validate a drug product. According to FDA, a substance used as a PCID should not adversely affect the identity, strength, quality, purity, potency, or bioavailability of the drug product. The PCID can often be detected by wholesalers or pharmacists however, in some cases an analytical instrument may be necessary to detect the PCID in order to determine if the drug products are genuine.
The FDA expects that most of the impending PCID ingredients are already being used as food additives, colorants, or other types of inactive ingredients and have already been established as safe. FDA recommends using the lowest amount of PCID that allows for identification of the product and recommends that the PCID be a substance with no medicinal effect. Refer to the draft guidance document located at www.fda.gov for additional information.
In a recent FDA News Release, the FDA warned consumers about a potentially harmful product, “Generic Tamiflu. The product did not contain Tamiflu’s active ingredient, Oseltamivir, but Cloxacillin, an ingredient in the same class of antibiotics as Penicillin.” FDA warned that using this product could result in an allergic reaction for patients that are allergic to penicillin including “a sudden, potentially life-threatening reaction called anaphylaxis, with symptoms that include difficulty breathing, chest tightness, swelling of the throat or tongue, hives, dizziness, loss of consciousness, or a rapid or weak pulse.”
Upon learning of the so called “Generic Tamiflu”, FDA purchased a package of the product without a prescription from a website that claimed to be an online drugstore. The “Generic Tamiflu” was received in a postmarked package from India. The product was stored in two blister packages with foil-backing labeled “Oseltamivir Phosphate 75mg. Capsules TM-FLU Capsules” and “Manufactured by: TRYDRUGS Pharmaceuticals PVT. LTD.” An FDA-approved generic drug for the prescription drug “Tamiflu” does not exist.
In another FDA News Release, dated January 25, 2010, the FDA warned consumers about a counterfeit version of the weight-loss drug Alli being sold at online auction sites over the Internet. FDA indicated that this counterfeit product was unsafe and illegal. “Alli is an FDA-approved, over-the-counter weight-loss drug that contains Orlistat as its active ingredient. The counterfeit version of Alli does not contain Orlistat; instead it is made with varying amounts of Sibutramine, a stimulant drug.” Laboratory testing completed by FDA determined that the dosing directions specified a dosage of three times the usual daily dose of Sibutramine, which could result in elevated blood pressure, stroke, and heart attack for people with a history of cardiovascular disease. Additionally, healthy people taking this product could suffer anxiety, nausea, heart palpitations, racing heart, insomnia, and small increases in blood pressure.
FDA continuously monitors the Internet and even makes purchases so they can test the drug products to verify product authenticity. However, consumers need to protect themselves as well by knowing how to recognize a genuine internet pharmacy. A genuine internet pharmacy will be licensed by the U.S. Board of Pharmacy and will follow the relevant laws and regulations. In addition, the National Association of Boards of Pharmacy Verified Internet Pharmacy Sites Seal (VIPPS Seal) provides a seal of approval to pharmacy sites that meet state license requirements. A pharmacy that carries this seal can be found at www.vipps.info.
Personal Shopping is just like an occupation where you get lots of suggestion. Now days online shopping is become more interesting. There are lots of website which provide online shopping services.
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