Bioethics

Pharmacy and the Internet

Technology has always had an impact upon pharmacy and mostly in a beneficial way; and especially if we consider the sub-discipline of Pharmacognosy, which is the study of drugs from natural resources (biological origin). The extraction of substances from plants that have medicinal and/or pharmacological properties is age old and require chemical and technological processes. The most current technology that is has had an impact on the practice of pharmacy is the internet that has presented us with ethical concerns. It is to be duly noted that these ethical concerns are perhaps not new, but rather the internet has added a new layer of ethical concern that is becoming more widely pervasive with the mundane accessibility to the internet.

Having practiced Pharmacy before the internet, when there were just typewriters and paper claim forms for services rendered, there has always been a plethora of ethical concerns for pharmacy and the practitioners. The removal of human interfacing with patients and/or customers accounts many of the ethical problems that have arisen. This interfacing with the patient has deterred and often provided an intervention for many unethical behaviors. With the internet, human contact is lost. The ability to talk with a patient is quite revealing. As humans are the embodiment of ethical principles, the health care professional is able to discern and ask appropriate questions that will lead to better health outcomes that benefit not only the patient, but the health care profession, including medicine, nursing and pharmacy as well. The transparency in the dialogue often reveals information that assist in making the appropriate decisions often resulting in alerting others of concerns that can have negative consequences.

A major ethical concern with the internet is fraud and honesty. This is merely an understatement of the problem. Fraud is an inclusive term that relates to validity of the prescriptions that presented, the persons presenting the prescriptions, the authenticity of the drugs, delivered and received, the legal authorization of the pharmacies that are dispensing the drugs, etc. From the perspective of the patient and the pharmacist, the patient-pharmacist relationship is compromised. Honesty and truthfulness are compromised because of the lack of communication and the necessary patient counseling that is required by all third party payers. Can this occur over the internet? If the patient has questions about the drug and/or disease being treated, the availability of such an interaction is severely compromised in such an activity that may not be offered by the internet pharmacy.  Another issue that throws up red flags is the regulation of internet pharmacies. Is there an international regulatory board that would oversee the practice, especially between countries that border the United States, i.e. Canada and Mexico? How would the DEA have oversight with controlled substances that are being filled via the internet with the problems of fraudulent prescriptions and forgeries? Currently in many states, the physician cannot phone in “schedule two” prescriptions, i.e., narcotics on the phone, except for a 48-hour dosage, with the written prescription sent to the pharmacy within 48 hours. If the physician does not comply with the written prescription, the pharmacist must contact the DEA immediately.

The internet is very impersonal. It is a relationship with a machine as opposed to another human being. Jeffrey L. Cohen has written an article entitled, “Physician Interaction with Internet Pharmacies is Risky”. A patient in Texas contacted a physician in Florida and with a simple “Consent Medical Care” questionnaire and a prescription was filled by a Florida pharmacy. The physician had no personal relationship with the patient; neither examined, nor interviewed him. From my perspective as a pharmacist, this is horrendous and violates the codes of medical practice. Because Florida law requires that a proper doctor/patient relationship exists before a Florida physician can prescribe legend drugs via the Internet. The physician was fined and punished for being in violation of this law. If it happened this time, it can happen again. Because of this, a new Florida statute became effective in 2005.

To help enforce the moral code of physicians and their relationships with patients as endorsed by the AMA, a new Florida statute became effective. “(1) any Internet pharmacy that dispenses of drugs to Floridians must obtain a permit, (2) dispensing drugs to Floridians without a permit after July 204 is a felony, and (3) pharmacies and pharmacists must ensure that a proper physician/patient relationship exists before filling a prescription Additionally, Florida physicians should be aware of appropriate Drug Enforcement Administration guidance on the topic. For instance, Federal law requires the existence of a bona fide doctor/patient relationship.” “No to Internet Pharmacies”, an article published by the Canadian Medical Association. Journal states that the safety and integrity of the prescription drug supply should be ensured in their respective jurisdictions and “illegal importation severs the key to pharmacist-patient relationships”.

In any community and over time, a pharmacist begins to know and recognize the signature of many of the physicians from the medical institutions serving such an area. This is part of the relationship that helps to ensure that a patient who has presented himself to the pharmacy has a relationship with such physician. If there are any questions that may arise concerning the prescription or any other issue related to the patient’s treatment as determined by the pharmacist, the physician can be directly contacted or someone in his office within a matter of minutes. Sometimes, it can take days before the contact is actually made.

One of the major ethical concerns in health care is access. If one doesn’t have access, is there a corollary ethical concern that health care is a privilege and not a right? With more than 40 million people without health care insurance in this country, we are ultimately concerned with this issue and must answer this question at some level. With so many senior citizens using much of their social security income to buy their prescription drugs, the answer is that for many of these persons, it seems to be a privilege rather than a right. As baby boomers, the largest segment of the American population, move towards retirement and social security within the next 5-10 years and the current inflation of prescription drugs, the question, the question of being able to afford prescription drugs seems quite appropriate. Even now with rising health care costs and third party coverage of prescription drugs, many patients and customers are complaining of the ever increasing co-payments and deductibles that must be met. Drug therapy is the major therapeutic intervention in the health care system and if a disease or illness has been properly diagnosed by a physician and the patient cannot afford the prescription drug, the health problem remains with the potential impact of higher morbidity and perhaps death.

Jillian Claire Cohen addresses the problem of access in her article, “Pushing the Border: The Moral Dilemma of International Internet Pharmacy”. When one hears that the major Pharmaceutical Industries are selling prescription drugs cheaper to foreign countries, it is an overwhelming idea that causes anger and disappointment. One of the major reactions that has moral implications is going across the borders via the Internet to purchase these drugs at a cheaper cost. Cohen states that the United States has the world’s most lucrative pharmaceutical market and that 35 percent of Medicare beneficiaries lack drug benefits. And that about 25 percent of their income is used for drug expenditures is projected for the time period from 2000-2013. Canada’s pharmaceutical system has secure and excellent quality assurance and it makes economic sense for seniors to purchase medicines from Internet pharmacies in Canada since prices there are significantly lower. The drugs prices on the Ontario Drug Benefit Program, (a formulary), are significantly lower because of price regulation and a weaker Canadian dollar; however these prices are on par with other jurisdictions such as France, Italy and Sweden.

The right to purchase medicines for Canada through the internet makes moral sense and seniors with limited incomes should have the right to do such. Cohen states that Galaxosmithkline was the first pharmaceutical company to take action against the sale of Canadian pharmaceutical products in the United States. As a pharmacist and knowing how pharmaceuticals are priced and the extreme profit margin, I am outraged that these extremely wealthy companies would dare take action of these purchases knowing that many people are suffering because they cannot afford their medicines. Many of these prescriptions drugs are life saving and needed for chronic diseases and illnesses. This is immoral.  Further, many of the large American pharmaceutical companies have begun to limit the supply of pharmaceuticals to Internet pharmacies and to Canadian pharmacies that sell to Americans over the Internet. Is this being done for profit or care and concern for the patient?  Another major question is, if pharmaceutical firms are willing to lower prices in developing countries, should not they do the same at home?

The Pharmaceutical Market Bill was passed in Congress in 2003 and permits Americans to purchase medicines in Canada and other countries. The international research-based pharmaceutical industry argues that Internet pharmacies are concerned with profit and not the patient. This argument also could be the same for the wealthy pharmaceutical companies in this country. Is this another one of those where the teapot is calling the kettle black? The FDA enforces the safety and efficacy of all drugs within this country. The matter of re-importation of drugs previously sold to Canada could certainly present a problem. Are these the original drugs or is there fraudulent activity with internet or suppliers of drugs. The real issue is that pharmaceutical companies in this country should provide a solution that would indicate that they are more interested in the care of patients than profits. The message is that pharmaceutical firms need to price drugs at affordable levels.

In an article entitled, “Savings from Canadian Internet Pharmacies are Limited/In Response, Rothberg states that the savings from Canadian Internet pharmacies do not address the needs of two thirds of Americans who feel that drug prices are unreasonably high. Re-importation accounts for 1% of the US market. He states that the Congress missed an opportunity when they extended prescription drug coverage to Medicare patients. After negotiating prices on behalf of 40 million Medicare beneficiaries, Canada, in turn, lowered medication prices through the Patented Medicines Price Review Board. As stated in the previous article, many of the large drug firms have begun limiting sales to Canada. Merck will no longer sell to Canadian pharmacies that export to the United States. Canada has responded in turn by proposing legislation that would prohibit United States citizens from purchasing prescription drugs without seeing a Canadian physician. Once again the question arises is this about true patient concern and care or profit? One of the conclusions that Rothberg states is that the purchasing of drugs by the Veterans Administration has been successful, but a program that would benefit low-income Americans without drug prescription services is still desperately needed.

As there are many ethical and legal concerns and controversies in Internet Pharmacy; many having to do with rogue pharmacies and cyber doctors. In the article, “Controversies and Legal Issues of Prescribing and Dispensing Medications Using the Internet”, Constance Fung addresses these issues. The development of online pharmacies has prompted regulatory and monitoring actions at the federal, state and professional organization levels. There are obvious benefits of Internet pharmacies and major controversies that are legal and ethical. Consumer Reports priced 5 common brand-named drugs at various outlet including drugstore chains, independent pharmacies, supermarkets, mass merchants and online/mail order pharmacies and found savings up to 29% with on/line mail order pharmacies. Other advantages may include accessibility to patients with limited mobility, placing orders 24 hours/day, anonymity that encourages patients to ask questions about some medications that they would be too embarrassed to ask in a busy pharmacy and sending questions any time of the day about adverse effects of medications.

The regulatory framework of Internet pharmacies includes the FDA, DEA and State Boards of Pharmacies. The FDA enforces the Federal Food, Drug and Cosmetic Act, which mandates a prescription for drugs that cannot be used safely without the supervision by a licensed professional. It also regulates the Internet Drug Sale Action

Plan adopted in July 1999. The DEA enforces regulations about the dispensing and sale of controlled substances, including transactions that take place on the Internet. The US Customs Service and the US Postal service also enforce statutes and regulations related to the importation and domestic mailing of drugs. At the state level, boards of pharmacies enforce requirements that physicians and pharmacists obtain licenses in the states in which they practice. The volume of prescriptions that are filled daily is a tremendous problem which may provide serious problems for all the agencies to contain the problem of volume. The controversies are many. A cross-sectional study of Internet pharmacies, researchers found that 19.6% (9/46) of pharmacies identified in the study did not require a prescription or physician consultation before dispensing medications. Other investigators found that 13% (25/190) of online pharmacies dispensed medications without prescriptions. From a legal perspective, dispensing prescription drugs without a valid physician order is a violation of the FDCA. Patient safety issues, e.g., drug-drug interactions, drug-disease interactions and adverse effects are extremely possible when prescription drugs are obtained this way. The importation of unapproved, misbranded or adulterated drugs is unlawful. Many of these drugs do not meet FDA standards and requirements. Some sites may dispense expired, sub-potent, contaminated or counterfeit products. Limited resources of the FDA, DEA, and Boards of Pharmacies limit effective oversight. Because of the health risks associated with these products, the FDA is revising the Agency’s personal importation policy. In Addition, the FDA has had difficulty enforcing the FDCA for online pharmacies administered offshore because the companies are not physically in the United States and therefore are not susceptible to meaningful agency action.

When considering the major health care ethical principles of autonomy, nonmaleficence, beneficence, justice, access, etc, one is able to clearly see that these principles have been or likely to be violated at some time if the major problem of access is not dealt with in an efficient manner. The inaccessibility of health care and prescription drugs in this country, and especially by the most vulnerable, is of major ethical concern. Millions of persons are just not able to pay the staggering costs and ever occurring inflation of prescription drugs. Internet pharmacies would not be the problem if the major drug companies in this country were more empathetic and worked with the government, businesses and the health care industry to come up with a feasible plan to address the problem.

Bibliography

Canadian Medical Association. Journal. Ottawa: Jun 24, 2003. Vol. 168, Iss.13; pg 1701

Cohen, Jeffrey. Physician Interaction with Internet Pharmacies is Risky, Chest. Chicago: April 2005. vol. 127, Iss. 4; pg 1462

Cohen, Jillian Claire. Pushing the Borders: The Moral Dilemma of International     Pharmacy. The Hastings Center Report. Hastings-on-Hudson: Mar/Apr 2004.Vol.

            34, Iss.2; pg15

Fung, Constance, Controversies and Legal Issues of Prescribing and Dispensing    Medications Using the Internet, Mayo Clinic Proceedings, Rochester: Feb 2004.                                Vol. 79, Iss.2; pg 188

Rothberg, Michael, Savings from Canadian Internet Pharmacies is Limited, Annals of       Internal Medicine. Philadelphia: Feb. 7, 2006. Vol. 144,  Iss. 3; pg 224