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Rules for Buying Prescription Drugs Online

Rules for Buying Prescription Drugs Online

It is pretty comfortable to buy prescription drugs online. No one knows what you are buying. Still, you have to beware of scams.

Buying drugs online is becoming very popular in the USA. Only a few mouse clicks give a customer access to hundreds of websites that sell prescription drugs and other medications so he does not have to go to the closest drug store.

A lot of representatives of this online business offer a convenient, hidden-from-all-seeing-eye and reliable way to purchase prescription drugs. And in most cases, buyers can use the service of such sites with the same amount of trust as if buying medications in an ordinary drug store nearby. Such e-commerce parties can include both well-known pharmacy networks and small drug stores that enhance the list of their services to local customers this way.

However, customers should be more careful if they refer to companies that sell services and medicines long-time banned in the real world. There are so-called “rogue sites” which are engaged in the sale of illegal drugs or approved drugs that do not comply with the sale procedure for such medications. For example, some companies offer their customers to fill out a short form before buying drugs online and withdraw their opportunity to consult a professional doctor face-to-face.

Dr. Jeffrey Shuren, the FDA’s associate commissioner for policy and planning, says, “Such practice leaves the customer alone with the medication purchased and deprives him of the opportunity to hear objective recommendations on how to take the drug, derived from a professional physician. The customer, therefore, takes his medicine at his own risk. Internet lets you forget about such trivialities”.

This situation can cause a lot of problems such as adverse interactions of different medications and poisoning of the body when taking expired or counterfeit drugs. As Dr. Shuren says, “Websites that offer a particular drug based on a short questionnaire filled out by a customer can cause further health problems. The patient is at risk to purchase a completely different drug and permanently lose his opportunity to improve his health without obtaining a competent and trustworthy consultation from a doctor concerning his diagnosis and drug contraindications”.

So far the FDA has received only a few reports of incidents associated with online drugs sale. However, the nature of these situations suggests a potential risk associated with the drug purchase based on a short questionnaire. For example, a 52-year-old resident of Illinois died from a heart attack after taking Viagra. He had recurrent pain in his chest, besides, his parents suffered from heart diseases. This incident happened last March. The purchase was made on a website after completing a short questionnaire. Although the cause of this man’s death cannot be linked to Viagra use, the FDA says that traditional communication between the patient and his doctor might have revealed his problems with the cardiovascular system and he could be appointed a required treatment.

The FDA inspects a big number of websites that sell drugs online and, supposedly, violate the law. The Department intends to initiate the procedure against violators under the law. The FDA has decided to check internet resources focusing on the delivery of new drugs that are not approved yet, frauds in the medical services and facts of prescription drugs sold without the required diagnosis.

Opening Perspective

A growing number of customers use internet to solve their health problems. A survey conducted by Cyber Dialogue Inc. has shown that health problems is the sixth most popular reason for using World Wide Web.

Still, it is unlikely that virtual pharmacies could wipe out the regular drug stores from the market – at least, in the nearest future. Researchers claim that over 2.97 million prescriptions were given out in 1999. Despite the fact that there are no reliable numbers of how many medications are sold online, the researchers believe that such a tendency will remain.

For some patients, buying medications online offers significant benefits compared to the visit to a ‘real’ pharmacy:
• People with disabilities and people who live far away from the nearest drug store get a big choice of medications online;
• There is an opportunity to choose the most suitable company that has the best sale offers among hundreds of others available online;
• There is a wide and easy-to-use choice of drugs;
• A customer has access to drug descriptions and reference material which is difficult to obtain in normal drug stores;
• The purchase and drug choice are hidden from the all-seeing eyes.

Buying drugs online also provides great opportunities for savings. Sometimes this statement is fairly justified. A survey conducted by Consumer Reports in autumn indicates that the use of online pharmacies can save up to 29% on the purchase of certain drugs. However, another survey conducted by the University of Pennsylvania in 1999 and published in Annals of Internal Medicine states that the average online price on Viagra and Propecia was 10% higher than in Philadelphia pharmacies.

In the next section of this survey, Dr. Bernard Bloom and Ronald Iannacone suggest that 37 out of 46 websites that sell drugs online either require their visitors to provide a doctor’s prescription or fill out the questionnaires. The remaining 9 sites hosted outside the USA require no prescription. The researches have also revealed that even though the sites with the questionnaires assure that the answers would be reviewed by a qualified medic it was impossible to check the qualification of a doctor, besides, patients could provide false information in order to get access to medications.

Potential buyers still have the opportunity to use sites considered legal and law-friendly by the FDA’s experts. Many of them sell Viagra, Propecia (medication for pattern baldness treatment) and Xenical (medication for obesity treatment). Other sites hosted abroad offer drugs for cheaper price than in the USA, however, they may differ from the sites approved in the USA or offer expired drugs. Other sites are either fraud or simply offer drugs without a prescription. Such websites can be built in almost any state or even country where there is a phone line.

Many people believe that the country should introduce new law to deal with fraudsters. According to republican Ron Klink (D-PA) who is lobbying the adoption of such a law, “today websites that sell drugs online are not obliged in any way to report their activities”. Customers have no access to information about the site, they do not know whether online pharmacy is licensed to sell drugs or not, whether professional doctors work for such sites or not. Customers don’t even know whether the site is registered or not. According to a draft law, such sites will be required to inform their customers about the name, address and telephone number of the company that owns the site, names of pharmacists and doctors who are working for this company and indicate in which state the pharmaceutical company, pharmacists and doctors were licensed.

Some representatives of this industry are against the adoption of the legislative act proposed by the Republicans. They prompt their opinion by saying that the current legal system provides enough opportunities to check the activities of such companies. Mary Ann Wagner, vice president of pharmacy regulatory affairs at the National Association of Chain Drug Stores, says, “The presence of existing regulatory mechanisms is quite enough. And they all are working”.

Online Sales Monitoring

The question whether the prospective legislation can deal with the regulations in this sphere remains unanswered. At this stage, the regulators are working on a new strategy dividing the power between various regulators at regional and federal levels. State medical boards regulate medical practice while state pharmacological boards control the pharmaceutical industry. The FDA and the Federal Trade Commission ensure that drug sellers legalize their products. Many authorities (such as the U.S. Consumer Society and the Postal Service) enforce regulations regarding the delivery of goods.

The FDA ensures the safety, effectiveness and compliance of the production of medications as well as a part of the drug prescription process. Dr. Shuren says, “Drug sale without a prescription is the violation of law regulating the sale of food, drugs and cosmetics. Thus the FDA has all rights to deal with companies that fail to meet this requirement”. She also adds that the FDA has more chances to make responsible decisions about the regulation because state regulators often cannot enforce implementation of the law outside a particular state. In case a company is no longer capable of doing its activity in this state, it has potential to work in 49 other states. If the federal agency prohibits the operation of a website, it will be no longer active in the USA.

In July, the FDA announced a cooperation of regional regulatory authorities to deal with illegal online sales of drugs without a prescription. The FDA signed an agreement with the National Association of Boards of Pharmacy and the Federation of State Medical Boards who are willing to cooperate and ensure the legacy of online transactions of drug sales in the USA.

Despite the fact that the practice of regulating such transactions is pretty new, last year the FDA had successful experience in applying penalties to such sites. For example, Lei-Home Access Care, a company in California, was selling home blood tests to detect HIV over the internet in 1996-1997. Not only these tests had not been approved, but their results were fabricated by the company’s employees who got blood samples from patients. After carrying out an extensive investigation, the FDA closed this site, and its owner, Lawrence Greene, was sentenced to 5 years in prison.

The Federal Trade Commission (FTC) announced a campaign called “Operation Cure.All” in July. It was aimed at prohibiting the sales of drugs advertised as the cure for all diseases. As the result of this two-year campaign, about 800 sites and newsgroups of Usenet network which contained questionable deals were identified.

Judy Bernstein, the director of the FTC’s Bureau of Consumer Protection, describes the situation as follows, “Miracle cure-all has found a fertile ground even though people, apparently, are tired to laugh over it”. According to her, “consumers spend millions of dollars on fraudulent and quack products”.

Four companies agreed to meet the FTC’s requirements within the framework of this program, including the shutdown of sites that advertised the medication for arthritis treatment which was obtained from beef fat as well as other drugs capable, as they claimed, to cure cancer and AIDS and reduce blood pressure. The FDA is closely working with the FTC within the “Operation Cure.All” program and uses its own regulatory mechanisms, for example, sending out alerts with requirement to remove untruthful advertising from the sites.

Domestic Regulation of the Industry

In addition to efforts made by regulators, industry trade unions and associations also strenuously fight against their dishonest colleagues. The National Association of Boards of Pharmacy (NABP) unveiled its plans to start a campaign in favour of Verified Internet Pharmacy Practice Sites (VIPPS). This program is aimed to provide customers with accurate and reliable information about the status of players who sell drugs in the online market.

VIPPS is a voluntary certification program for companies. Sufficiently rigorous selection of companies includes, among other things, the following criteria:
• availability and compliance with all the licenses under state law;
• need to publicize information about the drug, scheduled for advertising, on the VIPPS site;
• permission to allow proper inspection by NABP (if they have good reasons for this);
• adding VIPPS logo linked to the program’s website to your site;

According to the program’s co-workers, this program is especially helpful for elderly patients. Kevin Kinkade, the chairman of the NABP Executive Committee, says, “It is the older generation that becomes the target for dishonest dealers. VIPPS will mainly help those customers who want to make sure that the drug they are buying is made by a legal manufacturer”. Three companies, drugstore.com, Merck-Medco Rx Services, and PlanetRx.com, are currently authorized by VIPPS.

The American Medical Association (AMA) drafted rules for doctors engaged in online drug sales during the annual conference in June 1999. Although this project has not been approved yet, AMA’s officials say they will start to check whether doctors who prescribe drugs over the internet follow the minimum safety standards, including the requirement for examination of the patient to provide a diagnosis or at least health check him for possible problems.

Many of those working in this industry support AMA’s initiatives. Martin Hirsch, public affairs director for Roche Laboratories Inc. (it produces Xenical), says, “The relationship between patient and his doctor is critically important. We support any initiatives that ensure that this relationship continues”.

Even with the introduction of various regulatory actions, it is still difficult to control the illegal internet drug sales. Mr. Wagner (the National Association of Chain Drug Stores) says, “Even if the FDA, the state boards and other regulators will continue to do their jobs, it will be difficult to stay on top of illegal companies because of customer’s low awareness of the issue”.

The FDA plans to increase public awareness with educational campaigns that will inform consumers about the risks for their health, economy and law when selling or buying medications online. Such campaigns will also inform doctors and drug manufacturers. The similar outreach is conducted by other private and federal groups.

FDA’s Shuren says, “Customers must be aware of the risks of purchasing drugs online. The public also must know that there is a severe penalty for illegal sales of drugs over the internet. Even a couple of highly publicized cases can send a powerful message that such illegal websites won’t be tolerated”.

How Online Sales Work

In general, the mechanism of legal online drug stores operation can be described as follows:

• Users create an account submitting their credit card and health insurance information. This particular pharmacy is licensed to sell medications within the state and other states, if an out-of-state license is necessary.

• After creating an account, users have to submit a valid prescription by fax or email, or doctors can call it in.

• Some online drug stores send medications from a central spot. Others allow their customers to pick the drug up at a local pharmacy. The medications usually are delivered within 3 days, often for no shipping charge. A lot of online pharmacies can deliver your order overnight for an extra fee.

• Such websites usually have a mechanism for buyers to ask the pharmacist questions, either through email or a toll-free number.

What Customers Can Do

How can customers distinguish legitimate websites with hundreds of online pharmacies in business, especially when there are thousands of professional-looking sites that promise unbelievable discounts or a minimum of hassles? It is so easy to set up a website nowadays.

According to Dr. Shuren, medical officer in FDA’s Office of Policy, Planning and Legislation, “Customers should be cautions. They should use the same experience they use when purchasing products online from any business. They should search for a reliable dealer. They can get recommendations from their friends. In general, they should check and recheck the place out”.

FDA offers the following tips to customers who purchase drugs online:

• Check whether the website is approved and licensed by the NABP (visit the site at www.nabp.net, or call 847-698-6227).

• Do not purchase from sites that offer to sell a prescription medication for the first time without a visit to a physician, without a legal prescription, or sell medications not approved by the FDA.

• Do not do business with websites that don’t provide opportunities to consult a registered pharmacist.

• Avoid making purchases from websites that do not give their contact information, address in the USA and phone number to contact in case there is a problem.



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