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Online Pharmacies: Breach Ethical Principles

Student:      Jana Woods Kennedy

Faculty:      Dr. Roz Seymour

East Tennessee State University

Online Pharmacies: Breach Ethical Principles

Due to the popularity of the Internet, access to the delivery of health care is rapidly changing. The Internet is described as the world's largest computer network. In January 1995, there were approximately 4,852,000 people connected to the Internet (Pallen, 1995). There are thousands of health related topics available on the Internet. The American Association of Family Physicians stated that Email use alone has grown from as estimated 100,000 addresses in 1970 to over 100 million in 2000 (Kane & Sands, 1998). The Internet allows both communication and provision of services between patients and providers (Ferguson, 1998). The Internet has created countless opportunities for patients to access not only health-related information, but also products and services like online pharmacies. The Internet offers convenience and privacy for persons buying online products such as medications (Ferguson, 1998). It is the disabled, the elderly, and patients living in remote areas that via the Internet can more easily obtain information, products, and services that were previously acquired only with great difficulty (FDA, 2001). These Internet customers become easy targets for unethical and illegal online pharmacies (FDA, 2001). This paper addresses how some online pharmacies breach the ethical principles as well as laws that govern Internet services. The principles of nonmaleficence (or doing no harm) and beneficence (or doing good) will be examined in reference to the questionable practices of various online pharmacies. This paper also discusses the federal and state measures that are being established to help prevent the breaking of laws and the breach of such ethical principles as nonmaleficence. 

A Breach in Ethical Princip1es

The definition of online pharmacy is a legitimate pharmacy site on the Internet that provides consumers with a convenient and private way to obtain prescribed medications, sometimes at a more affordable price than regular pharmacies. Online pharmacies provide the elderly and persons in remote areas quick access and an easy and convenient way to purchase medications (FDA, 2001). Reputable Internet pharmacies allow patients to consult with a licensed pharmacist from the privacy of their homes. Legitimate online pharmacies only fill prescriptions prescribed by physicians and they use safe and legal medications (Henney & Shurren, 1999). 

The increase in access to health care services by individuals with home computers and access to the Internet has created an avenue for unscrupulous online pharmacy sites to easily breach both the legal and the ethical principles (FDA, 2001 ). Nonmaleficence (doing no harm) and beneficence (doing good) are ethical principles that some of these online pharmacies seem to ignore (Bradley-Popovich, 2000). For example, nonmaleficence is an ethical principle that is breached when an illegal pharmacy puts a patient at risk by sending out contaminated or counterfeit products. Nonmaleficence is also breached when the patient is sent the wrong product, an incorrect dosage, or possibly no product at all (FDA, 2001). 

Online pharmacies not only breach ethical principles that are considered essential in standard health care practice, they also break federal laws (FDA, 2001). The pharmacies that break laws and breach the ethical principle of nonmaleficence, are putting patients at risk for dangerous drug interactions and other serious health consequences, because many of them do not require the patient to have a prescription written by a physician (FDA, 2001). One other problem with illegal online pharmacies is that their products are not FDA approved (www.fda.gov/oc/buyonline/faqs.html). They sell products that are similar but not identical formulations of FDA approved products (FDA, 2001). The products are often not stored or distributed under the quality conditions required by the United States and therefore cannot be legally sold in the US (FDA, 2001). These drugs may be legal to sell in a foreign country, such as Mexico, but this does not make it legal to sell them in the US, even by the Internet (FDA, 2001). All of these factors add to a breach of the ethical principles of nonmaleficence (Bradley-Popovich, 2000). The principles of doing no harm is breached because patients lives are put in harms way by breaking the FDA rules and laws (FDA, 2001) to the benefit of illegal health service providers. 

The online pharmacies where the problems usually originate are the pharmacies that are not licensed by the National Association of Boards of Pharmacy (FDA, 2001). These online pharmacies usually offer to prescribe a drug for the first time without a physical exam, physician, or registered pharmacist involved in the process (www.fda.gov/co/buyonline.faqs.html). This is a direct ethical breach of nonmaleficence. Without a licensed provider prescribing the drug potential harm becomes an issue. Adding to this breach in ethics is the fact that many online pharmacies do not have access to a registered pharmacist to check medications and to answer patients' questions (FDA, 2001). 

The people affected for the most part by the use of technology for illegal and unethical practice include the disabled, the elderly, and patients living in remote areas of the country. However, everyone using the Internet could be adversely affected. The major players who run these illegitimate online pharmacies, often from Web sites originating in foreign countries such as Mexico, are talented enough to make the site appear to be associated with a legitimate pharmacy when in fact they are not legal in the US in accordance with FDA laws (FDA, 2001). Web sites that sell prescription drugs without a valid written prescription deny consumers the protection provided by an examination conducted by a licensed practitioner, again, breaches of nonmaleficence and beneficence (FDA, 2001). 

Reporting the Ethical Offenders

These types of unethical practices often go underreported and the FDA believes the occurrence of these problems will only increase (FDA, 2001). It is estimated that some 41 million Americans will use online pharmacies over the next 4 years (FDA, 2001). The 2001 congressional budget is expected to include new federal requirements for all Internet pharmacies (Fleming, 2000). New civil penalties for the illegal sale of pharmaceuticals will be put in place and more authority will be given to federal agencies to prosecute offenders (Fleming, 2000). There is also a new federal public educational campaign that is being organizedthrough the World Health Organization (WHO) and the FDA to educate citizens about the potential dangers of buying prescription drugs online (WHO, 2001). 

The American Pharmaceutical Association along with several states are already looking at new and better ways to regulate online pharmaceutical practice Fleming, 2000). Fifteen states have issued temporary restraining orders against Internet pharmacies selling drugs illegally (Arizona, California, Colorado, Connecticut, Illinois, Michigan, Kansas, Nevada, New Jersey, Nevada, Ohio, Texas, Washington, Wisconsin, and Wyoming (Fleming" 2000). 

In 2000, the Clinton Administration established a new federal requirement to enable consumers to identify legitimate Internet pharmacy sites (Fleming, 2000). According to this new requirement, providers have to demonstrate to the FDA that they comply with federal and state laws before receiving approval to operate and this designation will be documented at the Web site. Sites operating without doing so will face government sanctions (Fleming, 2000). Other Congressional safeguards to protect patients from injuries resulting from unsafe and counterfeit drugs were enacted long before the development of the Internet (Henney & Shurren, 1999). However, the sale of drugs on the Internet makes it easy to bypass this Congressional risk-management system (Henney & Shurren, 1999). Several federal agencies including the FDA and the US Customs Service" detain illegal products when they enter the country (Henney & Shurren, 1999).

The FDA posts at its Web site the names of several illegal drugs it has detained. However, the absence of a particular product or business from the detention list does not indicate that importation of their product is legal or that the FDA has not detained their products (Henney & Shurren, 1999). The FDA always tries to work with foreign governments to prosecute the seller in these cases, this includes online pharmacies (Henney & Shurren, 1999). 

The World Health Organization and the FDA are collaborating on developing a guide entitled Medical Products and the Internet (WHO, 2001). In addition to providing tips on finding reliable health and medical information on the Internet, the guide will provide advice to consumers about buying medical products online. In May 1998, the 51st World Health Assembly requested that the Director-General of the World Health Organization develop a guide on medical products and the Internet (WHO, 2001). The guide is intended to serve as a model for member states who can adapt it into locally meaningful advice for Internet users, to help them obtain reliable, independent, and comparable information on medicinal products while ethical principles are practiced appropriately. This guide was developed in consultation with drug regulatory authorities, drug information experts, consumer organizations, and the pharmaceutical industry .It is a model guide, designed to be translated into national languages and modified as the local situation may require (WHO, 2001). It is the hope of the FDA that educating Internet users by adding information guides to their site concerning online pharmacies, will make the reporting of illegitimate online pharmacies easier and help to alleviate unethical practices of breaching the principles of nonmaleficence and beneficence. Educating the consumer to properly report offenders will make it easier to locate online pharmacies in violation of the Federal Food, Drug and Cosmetic Act (FDA, 2001). 

The proper education of Internet users, about laws governing online pharmacies, is paramount in this process. The FDA wants all Internet online pharmacy users to understand the laws that are already in place. F or example, as a general matter it is illegal to import an unapproved drug into the US (FDA, 2001). There are exceptions to this rule in cases of serious conditions but patients must be granted special privileges (FDA, 2001). It is also important to know that it is illegal for anyone, including a foreign pharmacy, to ship prescription drugs, not approved by the FDA, into the US even though the drug may be legal to sell in the originating country (FDA, 2001). The FDA also wants consumers to know that Congress: a) requires that drugs be tested, b) test results must be reviewed by the FDA, and c) the formulation must be approved by the FDA (FDA, 2001). Understanding and observing these rules will also increase the likelihood of discovering breaches of ethics such as nonmaleficence and beneficence. An extremely important point for Internet users to remember is that products with similar but not identical formulations passed as FDA approved products, and products not made under the quality standards required by US law or labeled according to US requirements cannot be legally sold in the US (FDA, 2001). Also, prescription drugs, available from a foreign pharmacy, that are products that the FDA has not approved, and products not stored or distributed under the quality conditions required in the US cannot be legally sold in and/or online in the US (FDA, 2001). 

Conclusion