Issues in Pharmacotherapy Practice

Canadian Online Pharmacies Serving U.S. Citizens: Patient Care or Profits?

Mark J. Makowsky BSP1, G. Michael Legal B.Sc.(Pharm)1, Susan S. Buchkowsky B.Sc., B.Sc.(Pharm)1, Sheri L. Koshman B.Sc.(Pharm)1, Peter J. Jewesson, Ph.D., FCSHP1,2
 
1
Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, BC, Canada
2
Pharmaceutical Sciences Clinical Service Unit, Vancouver Hospital & Health Sciences Center, Vancouver, BC, Canada 

E-mail: pjj@interchange.ubc.ca


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Abstract

Background: American consumers have turned to Canadian online pharmacies (COPs) as a less expensive source of medications than those purchased in their own country.  
Objectives:  In this article we examine some of the positive and negative aspects of Canadian pharmacists providing this service to American customers.
Results: Several arguments for and against COPs dispensing medications to U.S. Citizens are presented.  Issues of international price disparities and controls, pharmaceutical industry motives and profits, pharmacist ethics, best practices and patient rights and needs are just some of the factors that need to be considered when judging the relative benefits and risks of COPs.  
Conclusion: Considering the substantial cost savings to American consumers, the profits being made in Canada and the substantial revenue loss that the pharmaceutical industry suffers as this practice expands, it is no surprise that COPs are receiving so much media attention.  When forming your own opinion about COPs, consider what would likely happen if the current medication price conditions were reversed.

J Inform Pharmacother 2004;15:300-318.

Introduction

In an attempt to improve access to affordable medications, American consumers have turned to Canadian online pharmacies (COPs) as a less expensive source of medications than those purchased in their own country.  In the United States (U.S.), virtual pharmacies (otherwise known as internet pharmacies, cyberpharmacies or e-pharmacies) first surfaced in 1999. (1)  Since then, many online pharmacies have sprung up in the U.S. and this form of community pharmacy business has also become popular in Canada.  In 2002, there were at least 70 COPs (over one-half are based in Manitoba) and these were reportedly shipping in excess of $500 million U.S. of pharmaceuticals to American consumers during that calendar year. (2)

While the presence of COPs is relatively new, the concept of cross-border shopping for medications is not.  American citizens have been purchasing drugs in Canada for many years.  Prices are cheaper and in some cases, drugs are easier to access than those in the U.S..  The advent of the Internet has simply served to broaden the reach of this practice. 

Let’s examine some of the positive and negative aspects of Canadian pharmacists providing this service to American customers.

Some Arguments In Support for COPs Dispensing Medications to U.S. Citizens  

1.     COPs are simply filling a market niche and provide support for uninsured American consumers.

The U.S. market for international drug supplies is driven by high U.S. drug costs (including the prices of patented drugs (3)) and the high incidence of Americans without health insurance. Some specific examples of disparate drug prices include celecoxib which sells at $78.50 U.S. for one hundred 100mg capsules from a COP versus $144.98 U.S - $178.63 U.S. at two American online pharmacies (4,5), and tamoxifen which Walgreens sells at $380.97 U.S. for 180 tablets while this product retails for $102.90 U.S. at a Manitoba-based web pharmacy. (6)  Many other examples (both brand and generic) can be found on the COPs websites themselves. (7-9)  The price of many drugs in the U.S. is also rising at an average rate that is several fold greater than that of inflation. (10)  This is in marked contrast to the lower drug prices and annual patented drug price increases in Canada. (3)

These price pressures are especially difficult for the 65 million Americans (nearly 20% of the U.S. population) who do not have outpatient prescription insurance. (11)  To make matters worse, these uninsured persons are reportedly charged higher prices for drugs than HMOs, insurance companies and federal agencies. (12)  Together, these factors have created a group of consumers for whom prescriptions are a luxury that they cannot afford.  This reality is evident in the observation that uninsured persons fill 30% less of prescriptions received than those with insurance. (13)

2.     COPs allow American consumers to pay for the cost of pharmaceutical innovation instead of advertising  and lobbying.

The primary goal of the pharmaceutical industry is to make a profit. (14)  Industry representatives claim that their business is one that involves high risk.  While it is true that the cost of bringing a drug to market is significant (15), pharmaceutical companies are among the most profitable businesses on the Fortune 500 list and these profits have been consistently high for at least a decade. (16) 

Unfortunately, the high prices for pharmaceuticals do not simply reflect the research and development costs of bringing a drug to market, they also encompass the high costs of marketing and lobbying.
In 2000, the pharmaceutical industry spent $2.5 billion U.S. for advertising in the U.S. alone. (17)  To put this into context, more money is spent on the advertising of Vioxx® than advertising of Pepsi or Budweiser beer. (18)  In fact, eight
of the top nine pharmaceutical companies reportedly spent at least two-fold more on marketing, advertising, and administration than they devoted to research and development in 2001. (19)  According to Public Citizen research, the pharmaceutical industry  also spent $91.4 million U.S. on federal lobbying in 2002, a 12% increase over the previous year. (20)  These expenses are simply rolled into the prices charged for drug products.  It’s clear that U.S. citizens are paying heavily for advertising and lobbying, and not necessarily for innovation.

3.     COPs serve to alert American consumers about drug price conditions outside of their own country and the lack of price controls within.

The high cost of drugs in the U.S. is largely due to a lack of price controls.  This has been described as “America’s other drug problem”. (21)  In fact, the U.S. is the only industrialized nation that does not employ price control mechanisms.  For more than a decade, U.S. congress has failed to provide increased drug coverage by expanding their medicare plan, a plan that would moderate the price of prescription drugs. (21,22)

In Canada, the Patented Medicines Price Review Board (PMPRB) is responsible for regulating the prices that patentees charge for patented drugs sold in Canada. The manufacturers’ prices of patented drugs, as measured by the Patented Medicine Price Index (PMPI) fell by 1.2% in 2002 and mirrors the price declines and near-negligible increases in the PMPI commencing in 1993. Since the mid-1990’s and up until 2001, Canadian prices for patented drugs have remained 5-12% below the median of foreign prices. (3)  

Despite these price controls, the pharmaceutical industry in Canada continues to prosper. Total sales by manufacturers of pharmaceuticals for human use in Canada were estimated to be $13.1 billion CAN in 2002. (3)  This represents an increase of 13.9% over 2001 sales. The share of patented drugs within total drug sales rose from 45% in 1996 to 67.4% in 2002. Total sales of patented drugs, as reported by patentees, reached $8.8 billion CAN in 2002, an increase of 17.3% over the previous year. In fact, in 2002 the median prices of patented medicines in the Canadian market have crept up to a value that is about 1% higher than the median of foreign prices in the seven countries. (3) 

4.     COPs have been welcomed by American consumers and have received U.S. governmental support.

The presence of COPs has increased American consumer awareness as to how much lower prescription prices are outside the U.S. and a revolt is in the making.  Seniors groups and other organizations are now working with reputable COPs to bridge the gap between U.S. and Canadian drug costs. (23)  There is also evidence that municipal, state, and federal governmental support for COPs is mounting.  For example, at the municipal level, the local government of Springfield Massachusetts has a plan in place to buy drugs from Canadian Internet pharmacies for its employees. (24)  At the state level, the Governor of Illinois is considering a plan to have state employees obtain medications from Canada (25)  At the federal level, after a long and heated American Congress debate in July 2003, the house voted in favour of allowing American citizens to buy prescription medicines abroad. (26)  This was a defeat for the pharmaceutical industry and appears to be heralding even further changes  to Medicare and prescription price controls in the U.S..

5.   COPs promote more efficient American spending on health care at time when public consumption of       prescription drugs has reached an all time high.

American prescription drug consumption is higher than ever, putting the U.S. health care system under significant economic pressure.  COPs sales to the U.S. results in direct savings to American consumers and should also indirectly help to reduce system pressures.   However, these sales will also negatively impact on North American profits for the pharmaceutical industry.

The American drug market accounts for the largest portion of sales and revenue for the global pharmaceutical industry. According to IMS Health, in 2002 the U.S. accounted for 53.4% of the world’s pharmaceutical sales (3) and significant financial losses could be incurred if American drug prices were regulated.  The industry is  attempting to curtail sales of their products through COPs (27-30) and is misinforming government officials about the safety of drugs provided by legitimate Canadian outlets. (14, 31)  It is apparent, however, that their efforts so far have been insufficient to quell the building momentum.  Undoubtedly industry will step up its campaign against COPs over the next several months.

6.     COPs likely represent one of the safest sources of international drug supplies for American consumers.

While counterfeit drugs are a legitimate concern, the distribution of counterfeit drug products is an activity that existed long before the advent of the Internet and the potential for this unscrupulous practice is not limited to COPs alone. (32) American citizens are in fact receiving prescription drugs from numerous countries including Canada. (33)  This includes countries with a high prevalence of counterfeit drugs (e.g. Mexico, Argentina, China) where reports suggest that up to 50% of drug products may not meet stated claims. (32)

Drug products produced in Canada are regulated by the Food and Drugs Act. (34)  Canadian laws and standards regarding drug purity and quality are at least as stringent as those of the U.S. Food and Drug Administration.  Licensed pharmacists from legitimate COPs dispense these drugs to American consumers in accordance with Canadian regulations and with proper labeling in English.  Product quality should not be an issue when dealing with legitimate COPs who obtain their drug supplies from the same manufacturers and wholesaler sources as traditional brick and mortar pharmacies.  In fact, most drug products dispensed to Canadian consumers originate in the U.S. and are produced by American subsidiaries of the parent conglomerate pharmaceutical companies.  These products are simply purchased from the U.S. through pharmaceutical wholesalers and dispensed back to American customers (“reimportation”).  Ironically, the pharmaceutical industry is claiming potential safety concerns associated with drugs that they themselves are manufacturing.  What the industry is really objecting to is the sale of products at prices that are less than those in the U.S.. 

7.     COPs are able to apply the same standards of practice to American citizens as those that apply to Canadians.

COPS that dispense prescriptions to U.S. citizens must comply with standards of practice pertaining to patient care and drug delivery, as well as the code of ethics of Canadian licensing bodies and prescription regulations of American state board regulators. (35-38)  Unlicensed pharmacies have been fined. (39)  Examples of some COPs that are in operation and adhere to these regulations are Canada Discount Pharmacy (www.canadadiscountpharmacy.com), Canada Meds (www.canadameds.com), and Cross Border Pharmacy (www.crossborderpharmacy.com).  In contrast, there are unlicensed pharmacies in Mexico (e.g. www.pillvalue.com, www.safemeds.com) that do not have this type of regulation.

In response to public concern over the safety of pharmacy practices on the Internet, the National Association of Pharmacy Regulatory Authorities (NAPRA) and the U.S. National Association of Boards of Pharmacy (NABP) have developed a certification system denoted Verified Internet Pharmacy Practice Sites (VIPPS) to allow legitimate businesses to operate. (40)  Although this program does not set standards for cross-border Internet pharmacy, it represents an acknowledgment by American and Canadian regulatory authorities that Internet pharmacy can be a legitimate alternative to traditional brick and mortar pharmacies.

In addition, there are independent organizations such as the North American Pharmacy Accreditation Commission (NAPAC) and the Canadian International Pharmacy Association (CIPA) that have been formed  for the specific purpose of ensuring the quality of cross-border internet pharmacies. (41,42)  Accreditation by one of these organizations provides some degree of protection for the patient through the setting of minimum quality standards.  While NPAC or CIPA accreditation is not mandatory, the consumer can easily identify accredited sites by prominently displayed accreditation seals on the COPs homepage.  A review of 13 sites (accessible via www.canadadrugstores.com) revealed two sites accredited by CIPA only, one by NPAC only, six by both CIPA and NPAC, while four sites did not list a specific accreditation.

8.     COPs permit adequate patient-pharmacist interaction to ensure safe therapy.

The patient-pharmacist relationship is a critical part of the pharmaceutical care process.  This is recognized by Canadian pharmacy licensing bodies and organizations setting quality standards for Internet pharmacies. (43,44)  Without face-to-face communication, COPs must find other ways to ensure this relationship is maintained. COPs typically provide a toll-free telephone number and invite patients to call or e-mail questions to a pharmacist.  Others actually incorporate a telephone consultation into the process. (45) 

One Alberta-based COPs reports success with such consultations even claiming that many American customers feel they received better information through the telephone consultation than they did in face-to-face interactions with their local pharmacist in the U.S.. (46)  In addition, most COPs claim to focus their services toward meeting patients’ chronic medication needs.  While this does not negate the potential for drug misadventure, it could be expected to reduce the likelihood of complications associated with the initiation of new drug therapy.  This should, in turn, limit the complexity of their professional interactions, since patients are likely to already be stabilized and familiar with the medication(s) in question. Finally, the convenience and anonymity of the Internet may allow patients the opportunity to ask questions in a less intimidating environment, at a time suitable to them.  In this way the Internet may actually facilitate better communication. (1)  Thus, while there is the potential for the patient-pharmacist interaction to suffer as a result of the absence of direct contact, good communication between the patient and pharmacist is still possible and in some ways, it may actually be enhanced.

9.     COPs are not the perfect solution, but they represent a reasonable interim solution for some American consumers.

COPs are not the ideal solution for American consumers who require medications.  Ideally, patients would be expected to form a patient-professional relationship with a local community pharmacist.  However, COPs do not preclude such a relationship from forming and being maintained.  In the context of purchasing costly chronic medications, however, they currently represent a reasonable lower cost alternative to American pharmacies.

If a drug is medically necessary but not affordable, the prescription won’t be filled.  COPs make drugs more affordable for the U.S. citizens who  might otherwise go without.  Consequently, one could argue that COPs have an ethical obligation to continue to support these customers.

Some Arguments In Opposition to COPS Dispensing Prescriptions to U.S. Citizens

1.     COPs dispensing prescriptions to American consumers is at best controversial, probably unethical and possibly illegal. 

Canada and the U.S. have well-established authorities whose mandate is to regulate pharmacy practice within their jurisdiction.  It is unclear under which jurisdiction U.S. patients who are receiving Canadian pharmacy services should fall.  Canadian provincial pharmacy regulatory authorities recognize that the exportation of prescription drugs from Canada raises legal, ethical, and public policy issues for Canadians, in the context of health care, pharmacy services and availability of prescription drugs.  Several of these authorities have published guidelines that state it is unethical to provide services against the law of other countries. (47)

Provincial pharmacy regulatory authorities in Canada and U.S. state pharmacy regulatory authorities agree that the international movement of prescription drugs between Canada and the United States undermines the regulatory systems established in each country to protect consumers. (48)  These organizations identify that failure to regulate (as evidenced by the continued cross-border sale of drugs) provides opportunities for illegitimate groups and medication “facilitators” to establish themselves. (33)  This regulation would require significant manpower to achieve and the negative fallout from patient groups would be politically charged. (49)  No one wants to arrest seniors attempting to purchase life-supporting medications from COPs. (50)

Most provinces have guidelines stating that pharmacists should follow the laws in the provinces and countries to which they provide a service. (51)  Present U.S. law does not permit U.S. citizens to import prescription drug products that are otherwise commercially available in the U.S. and COPs violate the intent of this law. (52)    Alberta pharmacists have been informed that they should not participate in any scheme or service to provide such activity.  Pharmacies and/or pharmacists that accommodate such services may be considered to be practicing unethically, and may be charged with professional and/or proprietary misconduct. (36)  In Manitoba, pharmacists have been advised that they must not contravene rules or regulations in effect in the jurisdiction where the patient resides. (35)

2.     COPs are unlikely to substantially improve prescription fill rates and these outlets are simply being used as a political tool to gain votes.

Ethically, pharmacists are obliged to undertake reasonable steps to ensure patient compliance with their medication and this would include ensuring its affordability.  While some would argue that cost is a major contributor to poor medication adherence (53,54), others question whether inability to pay is truly a major factor contributing to non-compliance in the senior population.  U.S. studies have shown that affordability can be linked to prescription non-compliance in 1.5-14% of U.S. seniors. (55)  Data from the Medicare Current Beneficiary Survey for 1996 through 1999 suggest that while economic barriers were the most commonly stated reason for not filling a prescription, more than 97% of all seniors obtained the medications prescribed for them by their physicians. Thus, it would appear that the problem of poor prescription filling by seniors may not be as widespread as is often believed. (56)

For years, politicians have been rallying votes by organizing bus trips to Canada in search of affordable drugs. (57) Recently, Illinois Governor Rod Blagojevich has advocated using Canadian pharmacies to manage his drug budget for the state health insurance plan including employees, dependants and retirees. (58)  This is a population that is already insured, without issues of accessibility.  These are both attempts to band-aid the situation in the U.S. rather than to find a long-term sustainable plan for all  Americans.

3.     COPs will result in drug shortages in Canada.

Canada pharmaceutical sales represents less than 3% of the total world drug sales market, while the U.S. represents over 53% of the global market. (3,56)  Considering the large number of American citizens (including about 7.6 million seniors) without health insurance, the potential American consumer demand for drug supplies from COPs could be overwhelming. (21)

Cross-border sales of prescription drugs are beginning to concern officials at Health Canada. (60)  While there may be no direct evidence that COPs are resulting in Canadian drug shortages, their continued presence or expansion could aggravate a pre-existing drug supply problem that exists in both countries.  Although difficult to predict, it is possible that total North American medication consumption could increase by a factor at least as great as the proportion of previously unfilled U.S. prescriptions that would now be honoured by COPs.  Canadian consumers  would be most vulnerable to this situation since most drugs originate in the U.S. and shortages in that country could reduce exports to all others.

In response to increasing COPs sales, manufacturers have begun to limit drug supplies to Canadian outlets that are, or appear to be, engaged in cross-border medication shipping. (27,28,56)  Should industry be unwilling to increase the exportation  of drugs to Canada to meet the growing demand related to COPs, drug shortages for Canadian consumers could become a reality.

4.     COPs exacerbate a pre-existing shortage of Canadian pharmacists needed to support Canadian patient needs.

There is a pharmacist shortage in Canada, the U.S. and elsewhere. (61,62)  A survey conducted in 2001 by the Canadian Association of Chain Drug Store identified a vacancy rate of 10% for pharmacist positions across the country and that this shortage has existed for at least the 2 years prior to the survey. (63)  COPs are now attracting new Canadian graduates with salaries that cannot be matched in the balance of the community and hospital sectors.  It is estimated that 15-20% of pharmacists in Manitoba alone are involved with the Internet pharmacy industry. (64)  Continued growth of these COPs can be expected to further drain pharmacists away from the pool of those who are available to meet the needs of Canadian consumers.  This can only lead to a decline in the quality of pharmaceutical care provided to our citizens. 

5.     COPs put patient safety at risk by shipping drugs under uncontrolled conditions to American consumers.

There are potential safety risks associated with the cross-border transport of drugs. COPs that ship medications to the U.S. may be compromising good drug distribution practices through improper drug labeling, storage, handling and non-use of safety caps. (51)  In a recent U.S. Pharmacopeia-sponsored study, over 90% of mail packages were exposed to temperatures outside the recommended range.  Over 25% of these supplies were exposed to temperatures in excess of 40°C. (65)  Although, the investigators did not report the number of packages shipped cross-border, the study nevertheless demonstrates that the integrity of packages shipped to the U.S. may be compromised.  Concerns regarding humidity and radiation have also been expressed. For example, the FDA has recently reported the interception of insulin supplies that were shipped across the border unrefrigerated. (59)  As a consequence of these concerns, the Food and Drug Administration, whose mandate is to ensure the safety of Americans, has declared that it cannot guarantee the quality of drugs that are not made and sold in the U.S., and it believes the importation of drugs from Canada represents a potentially dangerous situation. (52)

6.     COPs fail to develop adequate patient-health care professional relationships leading to unsafe provision of pharmaceutical care. 

 The Canadian Pharmacist Association has recently published a position statement on international prescription services and distance provisions of pharmaceuticals. (51)  This organization emphasizes the need to place the health and safety of patients above all other concerns and declares that a relationship between the patient and pharmacist is essential for the safe and effective use of medications.  The Association explicitly advocates face-to-face communication between patients and pharmacists to build a relationship crucial to optimal management of drug therapy.  These standards are mandated provincially and territorially.  Finally, the Association endorses that all pharmacies in Canada (including COPs) meet these established standards of practice.  Needless to say, face-to-face communication is not possible with COPs.

 The College of Pharmacists of British Columbia has recently developed a comprehensive framework of professional practice that defines the role and functions of a pharmacist. (66)  This organization states  that the primary role of the pharmacist is to provide pharmaceutical care which involves assessment of the client’s health status and needs, developing a care plan, supporting and monitoring client progress with the plan and then documenting findings, follow-ups, recommendations, information provided and client outcomes.  Again, these professional practice standards cannot be met with COPs. Some on-line pharmacies request only that the client fill out a questionnaire that is reviewed by a doctor after which time the pharmacist fills the prescription. (49)  Completing a written questionnaire is deemed all that is required to establish a patient-physician relationship.  Such a superficial exchange puts the patient at risk for drug misadventure.

To illustrate this concern, there have been several widely published problems with online pharmacies based in the U.S..  The FDA recently cited a case of a 52-year old man with episodes of chest pain and a family history of heart disease who died of a heart attack after taking sildenafil (Viagra®) that was purchased from an online source that only required completion of a questionnaire to get the prescription filled. (67)  While there was no definitive way to prove that sildenafil caused or contributed to patient’s death, the FDA concluded that a face-to-face interaction with the doctor and/or pharmacist along with a physical exam may have better ensured the appropriateness of the drug.  In another published case report involving a U.S. 20-year old female who required ICU admission after an unintentional overdose of phentermine, it was revealed that the patient with a history of anorexia nervosa had ingested 15 tablets over the course of 8 hours to curb her appetite. (68)  The prescription had been filled over the Internet with no direct patient-physician contact and the pharmacy from which the prescription was obtained was from another state.  While this was a U.S. Internet pharmacy-related incident and did not involve cross-border prescriptions, it nevertheless reflects the potential dangers associated with a lack of adequate patient assessment before the prescribing of a medication.   In another published report, a person of normal weight was able to obtain a weight loss drug. (69)  Another woman who said she had asthma received a prescription for celecoxib, and a reporter was able to order sildenafil for her 6-month old son using his actual height, weight and birth date.  Yet another individual was able to obtain sildenafil using vital data from his cat. (69)  And finally, two additional studies have been published that assessed the quality of service provided by Internet consulting physicians. (70)  The investigators posed as patients with known contraindications to sildenafil (i.e. females with coronary artery disease for one and a male with a history of heart attack currently taking nitrates).  Three of 10 physicians prescribed and the Internet pharmacies provided the drug to the women, while 1 of 5 pharmacies dispensed the medication to the male patient despite these contraindications. These are just some of the published examples of potential dangers associated with online pharmacies.  Extending this practice across an international border can only be expected to heighten the potential for misadventure.

In Summary

Cross-border shopping and transportation of goods has been popular as far back as the days of U.S. alcohol prohibition and earlier.  Americans have also purchased medications from Canada on a smaller scale for many years; the extent of this phenomenon has been just “under the radar” until the advent of the internet pharmacy.  Considering the substantial cost savings to American consumers, the profits that are being made by Canadian pharmacies (and Canada in general), and the even greater revenue loss that the pharmaceutical industry suffers as this practice expands, it is no wonder that COPs are now the focus of much public attention.

Issues of international price disparities and controls, pharmaceutical industry motives and profits, pharmacist ethics, best practices and patient rights and needs are just some of the factors that need to be carefully considered when judging the relative benefits and risks of COPs.  While COPs may be an interim solution for Americans, we must also contemplate the net cost of this practice to Canadians. 

When forming your own opinion about COPs, consider what would happen if the current conditions were reversed.   Do you think that U.S. pharmacists would be willing to provide pharmaceuticals to Canadian citizens if drug prices were lower to the south?  Do you think that drug supplies dispensed from U.S. pharmacies would be safe enough for Canadians to consume?  Do you think U.S. pharmacists are professionally and ethically capable enough to provide services to our citizens?  Or do you believe that pharmacists participating in COPs have simply lost sight of their pledge to help people achieve their desired health outcomes in the interest of profits? We would welcome your opinions on this complex issue.

Authors Competing Interests

None declared.

Acknowledgment

This paper was based upon a Pharmacy 554 debate conducted by members of the 2005 graduating class of the UBC Doctor of Pharmacy Program in October 2003.  All authors collaborated towards the creation of the drafts and final editing of this paper.

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