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| About Online and Mail-Order Pharmacies: What You Need to Know |
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| BENEFITS AND RISKS: Using an online or mail-order pharmacy (referred to below as online pharmacy) can save you a great deal of money and provide other benefits. However, there are also potential risks. BENEFITS:
RISKS:
To help protect you from risky websites, PharmacyChecker.com checks for you whether online pharmacies are licensed, offer security and privacy of your information, provide an address and phone number, require an original prescription and your medical information. It also finds out whether online pharmacies charge added fees and periodically updates prices to help you can find the lowest drug prices. In addition, PharmacyChecker.com maintains a list of Rogue Pharmacy Websites; sites that do not follow safe online pharmacy practices and from which we strongly recommend you never order. TYPES OF ONLINE AND MAIL-ORDER PHARMACIES: Online pharmacies, also called Internet pharmacies, are businesses that sell and market prescription drugs and other pharmacy products over the Internet and send them to consumers by mail. It is difficult to determine the total number of online pharmacies. In 2000, a FDA study found there are about 300-400 online pharmacies, about half of which are domestic. (Reference: http://www.fda.gov/ola/2002/drugimportation0725.html). Similarly, the National Association of Boards of Pharmacy has estimated there are 200 domestic online pharmacies. The American Medical Association has estimated that there are 400 sites that offer dispensing and online prescribing services, half of them foreign. The total number of websites selling drugs may be around 1000. Prescription Requirements Online pharmacies fall into different categories based on their prescription requirements:
Traditional Online Pharmacies Most legitimate online pharmacies require you to provide your original prescription -- the one obtained from an in-person examination with your doctor. Prices at online pharmacies that have a traditional prescription requirement are often lower than at online pharmacies that accept prescriptions based on remote consultations (as described below) or that require no prescription at all. Pharmacies in this category include major national chains, neighborhood pharmacies in the U.S. and Canada, and large mail-order prescription fulfillment centers. Most pharmacies with a traditional prescription requirement carry the full stock of prescription drugs you would find in your neighborhood pharmacy. Remote Consultation Online Pharmacies Some consumers wish to purchase prescription drugs without having to visit their physicians to obtain a prescription. There are online pharmacies, generally known as online consultation pharmacies, remote consulting pharmacies, or prescribing pharmacies, that work with physicians who review a patient’s self-reported medical history and then write a prescription if deemed appropriate. Often this is done for medications, often referred to as "Lifestyle" drugs, that are non-addictive and less likely to require physician monitoring. U.S. states have different laws on what constitutes a valid doctor-patient medical consultation. As an advisory, the American Medical Association and the U.S. Food and Drug Administration have issued statements asserting that remote consultations are a substandard medical practice when there is no prior doctor-patient relationship, one established by an in-person physical exam. Except where expressly permitted by law, the PharmacyChecker Verification Program will not approve remote consultation online pharmacies. No-Prescription Required Mail-order and Online Pharmacies Some websites will sell you prescription medication without requiring any prescription at all, a practice that is illegal in the United States, and regarded as dangerous. Other websites that offer to sell you drugs without a prescription pose as online pharmacies for the purpose of stealing your credit card information. Ordering from such sites is exceedingly risky to your health and could lead to unauthorized use of your credit card and/or identity theft. See our list of Rogue Online Pharmacies for more information. Range of Medications Sold By Online Pharmacies Not all online pharmacies sell the broad range of prescription drugs that you would expect to find in your neighborhood pharmacy. The product range of online pharmacies typically falls into one of the following categories:
THE PHARMACYCHECKER.COM VERIFICATION PROGRAM PharmacyChecker.com verifies information about three types of entities that participate in online pharmacy: 1) Pharmacies (retail, pet, and wholesalers), 2) Affiliate websites, and 3) Referral Sites. Pharmacies have a bricks and mortar presence (a walk-in pharmacy), in which the bricks and mortar pharmacy and the website are one and the same company, or operate under the same holding company. An Affiliate website does not have a bricks and mortar pharmacy presence but refers orders to a licensed pharmacy or links to another website on which a drug order is placed. An online pharmacy Referral site simply links to drug-selling websites on which the drug order is actually placed. Note that sometimes a pharmacy will provide the option to have your prescription filled by another licensed pharmacy in a different country so that you can take advantage of lower international prices, in which case they operate as both Pharmacy and Affiliate. All online pharmacies must have specific qualifications for approval in the PharmacyChecker Verification Program and to publish the PharmacyChecker.com seal on their websites. PharmacyChecker.com verifies the following qualifications:
The PharmacyCheckere.com Seal PharmacyChecker.com advises consumers to look for the PharmacyChecker.com seal (clickable image below and at http://www.pharmacychecker.com/sealprogram/choose.asp) before ordering prescription medication from a website, especially if the company is not generally well known. Websites are only authorized to publish the seal if they have met the criteria mentioned above. Just as important, to make sure a seal is valid, consumers should check that it links to a page hosted on www.pharmacychecker.com and provides a profile of the site. 
To safeguard the marketplace, Google, Microsoft, and Yahoo! use the Verification Program to qualify online pharmacy advertisers for their search marketing programs. U.S. ONLINE PHARMACIES: Most U.S. prescription sales initiated by online pharmacies are with established national chain pharmacies or large pharmacy benefit management companies that carry a full range of drug products. There are also several U.S. remote consultation sites that offer only a limited number of "lifestyle" or "popular" prescription drugs. These sites are usually more expensive than local pharmacies or traditional online pharmacies. While seemingly numerous, many remote consultation sites are operated by the same companies but under different names and websites to market their products. U.S. Drug and Pharmacy Regulations In the U.S., the Food and Drug Administration (FDA), a division of the U.S. Department of Health and Human Services, is responsible for the regulation and safety of America's drug supply. New drug reviews, post-market surveillance, and drug recalls are carried out by the FDA. Pharmacies and pharmacists are regulated and licensed by the states. Pharmacy regulations differ a little from state-to-state but all require the presence and management of licensed pharmacist personnel, strict enforcement of safe dispensing practices and storage safety requirements. The regulation of controlled substances, drug products with stronger and addictive ingredients (discussed more below), is the responsibility of the Drug Enforcement Agency (DEA). Pharmacies must have a DEA-issued license to sell controlled substances. The National Association of Boards of Pharmacy (NABP) (www.nabp.org), the umbrella trade group for state pharmacy boards, created the Verified Internet Pharmacy Practice Site (VIPPS) program in 1999 responding to public concern over websites selling drugs without abiding by the laws applicable to neighborhood pharmacies. As of May 2008, there were only 15 VIPPS- certified pharmacies: Approximately half of these were pharmacy benefit management companies that operate online pharmacies that can only be used by their members. Other VIPPS members were national chain pharmacies, larger U.S. online pharmacies, and one specialty online pharmacy. The VIPPS program is open to Canadian pharmacies but none have become members. For people living in the U.S., the potential benefits of buying from a U.S. online pharmacy rather than a foreign online pharmacy often include:
If you do not have insurance, or your insurance does not cover the drugs you need , U.S. online pharmacies are almost always more expensive than their foreign counterparts — except for generic drugs and "lifestyle" drugs, such as Viagra. Click here for a list of online pharmacies verified by PharmacyChecker.com. FOREIGN ONLINE PHARMACIES: For a growing number of Americans who do not have health insurance, adequate drug coverage, or any drug coverage and seek lower drug prices, and for others looking for medications that are not available domestically, foreign online pharmacies are increasingly popular. As discussed in greater detail in this section, the U.S. government generally allows individuals to import medication for their own use up to a three-month supply, however it is technically illegal. If you are buying medication from a foreign country, you want to know that the dispensing source is regulated and licensed by the appropriate governing authority. For this reason, PharmacyChecker.com acts to verify the licenses of pharmacies in foreign countries. Just several years ago, most non-U.S. pharmacies selling prescription drugs to Americans were Canadian. Today, pharmacies in other countries, such as Australia, Fiji, India, Israel, New Zealand, and the United Kingdom play a larger role in meeting this demand. To better educate our visitors, many of whom are looking to foreign pharmacies for lower drug prices, below is an overview of the agencies that regulate drugs and pharmacies in some foreign countries. Prescription products shipped from countries other than Canada have been confiscated by the U.S. government more often than those shipped from a Canada. However, overall there have been very few confiscations since Fall 2006. CANADA Drug and Pharmacy Regulation in Canada Canada’s systems for regulating drug products are very similar to those in the United States. At the federal level, the Therapeutic Products Division - an agency of Health Canada that regulates Canada's drug supply - is Canada's counterpart to the U.S. Food and Drug Administration. All drug products sold in Canada must be approved by the Therapeutic Products Division. Pharmacies in Canada, on the other hand, are regulated by the provinces; a similar system to the U.S. in which states regulate pharmacies. To operate a pharmacy in Canada, the premises must be licensed by the provincial pharmacy board, managed by a licensed pharmacist, and meet stringent standards for the storage and disbursement of medication. Useful links:
Online Pharmacy Regulation in Canada: In 2003, the National Association of Pharmacy Regulatory Authorities (NAPRA), Canada's counterpart to the NABP, introduced the VIPPS program but, as of May 2008, there were no participating pharmacies. Click here for a listing of online pharmacies currently verified by PharmacyChecker.com, including Canadian sites. PharmacyChecker.com has published several interesting reports on price differences between the U.S. and Canada. These are found at http://www.pharmacychecker.com/News.asp. FOREIGN COUNTRIES OTHER THAN CANADA AUSTRALIA: In Australia drugs are regulated by the Therapeutic Goods Administration, Australia's counterpart to the U.S. Food and Drugs Administration. Australia uses the same standards as the European Union for the regulation of prescription drug products. Like in Canada and the United States, pharmacies are registered at the state/province level, and pharmacists must be registered in the states in which they practice. The state boards are incorporated in a federation called the Pharmaceutical Society of Australia that guides and proposes policies and standards for the safe practice of pharmacy. Over 80% of Australia’s pharmacies belong to an organization called the Pharmacy Guild of Australia. Its role is to support its pharmacy and pharmacist members on workplace issues and training. The Guild also negotiates on behalf of its members with the government and drug manufactures, wholesalers, and other organizations responsible for the provision of health products. Useful Links
INDIA: The Central Drugs Standards Control Organization (CDSCO), a division of the Indian Ministry of Health and Family Welfare, is responsible for drug approval and regulation, as well as for the licensure of pharmacies. CDSCO is responsible for approving new drugs for the Indian market, post-market surveillance, and enforcement actions to protect the Indian drug supply. Under the CDSCO, the Drugs Control Administration is responsible for regulating pharmacies. They do so through the State Drug Control Offices, also called Food and Drug Administration offices, which inspect and license pharmacies, and enforce the Pharmacy Act of 1940, which require pharmacies to meet rigorous safety standards. Pharmacies in India must comply with similar regulations as those in the U.S., such as having a licensed pharmacist on the premises during hours of operation, safe storage of drugs, particularly those with special requirements (such as insulin), and safeguarding of controlled substances. However, India's enforcement standards are generally lower than in the United States. While in many respects economically disadvantaged compared to the U.S. and countries of the European Union, India has a very large and highly sophisticated pharmaceutical industry. In fact, a sizable portion of the world’s pharmaceutical active ingredients are manufactured in India. These ingredients are then exported to other countries such as the U.S. and the EU for the manufacture of final drug products. Many drugs in India are manufactured in FDA-approved or inspected facilities. In fact, the U.S. Food and Drug Administration has inspected more drug manufacturing plants in India than any other country outside the U.S. However, the drug supply in India is not as strongly regulated as it is in the U.S. and some other economically developed countries, such as Canada and the United Kingdom. Consequently, it has a higher rate of counterfeit medication. Additionally, Americans may be uncomfortable with the fact that tablets sold in India are often unmarked, likely as a cost-saving measure, unlike pharmaceuticals in the U.S., which are generally marked. Useful Links
ISRAEL: The Pharmaceutical Division of the Israeli Ministry of Health regulates that country’s drug supply, pharmacists and pharmacies. Israel’s system for pharmaceutical regulation is strongly based on both U.S. and EU pharmaceutical regulations. Israeli regulations require that drugs approved for sale in that country must be manufactured using U.S. or EU standards for Good Manufacturing Practices (GMP) and USFDA or equivalent European Standards. Additionally, drugs approved for use in Israel are generally approved for use in the U.S. or EU. Pharmacies are licensed by the Israeli Ministry of Health. Under Israeli law, drug labels must be in Hebrew and English. Useful Links
NEW ZEALAND: The drug supply of New Zealand is regulated by Medsafe, that country’s counterpart to the U.S. Food and Drug Administration. Medsafe determines which drugs will be used by citizens of New Zealand: it administers the application process for new drugs and is charged with post-market surveillance. Under the Medicines Amendment Act 2003, Medsafe is also responsible for issuing pharmacy licenses. Pharmacies in New Zealand are held to similar standards of practice as in Canada, the United Kingdom, and the United States. The Pharmaceutical Society of New Zealand is the professional pharmacist’s association. It provides education, training, and career development of pharmacists to achieve high standards of pharmacy practice. The Pharmacy Council is the national regulatory body for licensing pharmacists. Useful Links
SINGAPORE: Singapore is among the most economically developed countries, one with exceedingly strong regulations in all industry sectors, on a par with the United States, the United Kingdom, and the countries that comprise the European Union. It has very high pharmacy and pharmaceutical regulatory standards. Singapore is recognized by the World Health Organization Collaborating Centers in the areas of Transfusion Medicine, Drug Quality Assurance and Food Contaminants Monitoring. Pharmacies in Singapore are licensed at the national level by the Health Sciences Authority (HSA), a division of the Ministry of Health. As in the United States, pharmacies must meet stringent standards before licensure is granted. Pharmacies must be under the management of a licensed pharmacist registered with the Singapore Pharmacy Council. Among other requirements, safe dispensing equipment and storage facilities, requisite professional reference materials, and an adequate system for record keeping are all checked for legal compliance before a pharmacy is licensed in Singapore. The regulation of drug products in Singapore is the responsibility of the Therapeutics Products Division, which operates as part of the Health Sciences Authority. Only products licensed by the Health Products Regulation Group are approved for the market. The drug approval process takes nine months, unless the product is already approved in the United States, European Union, and Australia, in which case there is an expedited process. Useful Links
SOUTH AFRICA:
SWITZERLAND: The counterpart to the U.S. Food and Drug Administration in Switzerland is called Swiss Medic. All prescription drugs sold in the Swiss Market must first be approved as safe and effective by Swiss Medic, using a similarly rigorous review process to that used in the United States. Switzerland is also under the regulation of the European Medicine Agency (EMEA), and thus is required to meet the same standard for pharmaceutical safety as all countries in the European Union. Switzerland is comprised of regional government bodies called Cantons (like states in the U.S.). Cantons are responsible for licensing and regulating retail pharmacies in Switzerland. Useful Links
TURKEY: According to the World Health Organization, Turkey 's drug licensing standards closely resemble the countries of the European Union. However, unregistered generic products remain a problem in the rural and eastern region of the county, and PharmacyChecker has not permitted pharmacies from such areas to participate in its program. As guided by The Law of Pharmaceutics and Medical Products, drugs sold in Turkey must be approved by a division of the Ministry of Health, called Drugs and Pharmacy General Management, which is Turkey 's counterpart to the FDA. The process for drug approval is administered by the Advisory Commission For the Registration of Medicinal Products For Human Use, a Commission of the Ministry's Scientific Advisory Board. The Commission is comprised of pharmaceutical research experts, clinicians, a pharmaceutical technologist, a pharmacologist, and a Ministry of Health representative. Unlike in the United States a large majority drug products sold in Turkey are brand name, and most of those produced by well-known international manufacturers. In fact, with first class manufacturing facilities, Turkey has become a major player in the manufacture of generic drug products, and Turkey has the world's 15th largest pharmaceutical market. Under the The Pharmacists and Pharmacies Law, Turkey mandates, at the national level, that all pharmacies meet high standards of pharmacy practice, such as having a licensed pharmacist on the premises during hours of operation, safe storage of drugs, and a clean, sanitary area for dispensing. Useful Links
UNITED KINGDOM: Drug products sold in the UK are regulated by the Medical and Healthcare Products Regulatory Agency (MHRA) and the European Medicines Evaluation Agency (EMEA). The MHRA is the United Kingdom’s counterpart to the U.S. Food and Drug Administration and decides which drugs are safe and effective for citizens of the UK. The EMEA is in an agency of the European Union charged with evaluating the safety of new products for members of the EU. Drugs that are approved by the EMEA can be sold throughout the EU. On a national level, pharmacists and pharmacies are registered with and regulated by the Royal Pharmaceutical Society of Great Britain (RPSGB). Useful Links
COUNTERFEIT MEDICATION Counterfeit medication is a global problem and the risks that you can be hurt by them are greater if you are buying drugs through the Internet from developing countries and/or those with poor regulations. Counterfeit medicines include those with wrong ingredients, no active or insufficient active ingredients, dangerous ingredients, as well as those with the right ingredients but fake packaging. For more detailed information on counterfeit medication see the following document published by the World Health Organization: http://www.who.int/mediacentre/factsheets/fs275/en/. U.S. LAWS ON IMPORTING DRUGS: IMPORTS ARE PERMITTED BUT NOT TECHNICALLY LEGAL Importing prescription medication into the U.S. by individuals for personal use is technically illegal. In practice, however, Americans who import medicine for private use by either taking it across the border or having it mailed to them are not typically prevented from doing so. More specifically, the FDA recognizes that the task of monitoring all drug imports is more than it can handle and offers guidelines for its government officials to use discretion in allowing imports. In accordance with these guidelines and those relating to purchasing drugs online, imports are usually allowed if the shipment 1) is for personal use only, 2) does not exceed a 90-day supply, and 3) does not include controlled substances. For detailed information on this policy see the FDA Coverage of Personal Importations policy at http://www.fda.gov/ora/compliance_ref/rpm/chapter9/ch9-2.html. The above policy has allowed pharmacies in Canada, to a lesser degree in Mexico, and increasingly pharmacies in other countries as well, to mail drugs to U.S. citizens. While it happens infrequently, drug shipments are sometimes seized by U.S. Customs. In these cases you will usually be informed that your drug order has been seized. There is a greater prevalence of drug import seizures from non-Canadian countries, especially from less developed countries, but generally confiscations are rare. Controlled Substances While the practice is illegal, some U.S. and foreign online pharmacies sell controlled substances to consumers who don't have a prescription. Americans with a valid prescription may legally order controlled substances from a licensed U.S. online pharmacy. However, shipments of controlled substances from outside the U.S. are not treated by U.S. Customs in the same way as shipments of common prescription drugs. The most reputable Canadian and other non-U.S. online pharmacies will not market or sell controlled substances to Americans. The PharmacyChecker.com Verification Program does not grant membership to non-U.S. pharmacies that sell controlled substances to Americans. More information on U.S. drug laws is available from the U.S. Food and Drug Administration: U.S. Food and Drug Administration: www.fda.gov. Multiple Countries: Different Pharmaceutical Regulation Systems The growth in demand for lower cost prescription drugs among Americans, and the supply problems faced by Canadian international pharmacies, largely a product of restrictive selling practices of drug companies, has led to an increasing number of countries entering the industry. While the FDA usually does not prevent Americans from importing medication for personal use, consumers should use their best judgment in determining from which countries they feel most comfortable ordering medications. The information below might be useful in determining from which countries you are willing to purchase medication. Countries with the most advanced and safe systems for regulating pharmaceuticals possess the following: 1) An agency that approves drugs for the national market through a:
2) National laws and standards for labeling of drug products and distribution. 3) A national system and/or state/provisional systems for regulating pharmacies that:
A Note on Intellectual Property Rights Countries have different laws for protecting the intellectual property rights of drug companies. For example, the United States allows the sponsor of a new drug to have exclusive sales and marketing rights for that product for 20 years. After that time, other companies may manufacture, market, and sell a generic version of that drug. Other countries might only protect the patent of a new drug for 10, 5, or no years at all. Some international online pharmacies sell generic versions of drugs that are still under patents in the U.S. and, therefore not available for sale in the U.S. As such, these products are viewed as unauthorized drugs by the U.S. Food and Drug Administration. For information from the U.S. Food and Drug Administration on patents see www.fda.gov/cder/ob/faqs.htm. To find out more about intellectual property rights go to the website of the World Intellectual Property Organization at www.wipo.gov. |
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