Center for Public Integrity
4/3/2007

http://www.pharmaceuticalonline.com/content/news/article.asp?DocID=%7B14928F57-8EDB-4B16-B9F0-BAD31D7B61D8%7D&Bucket=Current+Headlines&VNETCOOKIE=NO

Summary:

From January 2005 to June 2006 pharmaceutical companies spent $155 million lobbying the federal government. One of the most heavily lobbied against was the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, that “barred the federal government from negotiating on the Medicare drug prices.� Other agendas include protection of drug patents and prevention importation from Canada. It was also reported $650 million has been spend since 1998. During the same time period, the drug companies had substantial sales in the quarter trillion dollars. The ratio of pharmaceutical lobbyist to congress members to 2 to 1.

Implication to pharmacy:

In such a market driven country and economy, lobbying to protect their assets and profits is expected. However, spending $650 million in the last 8 years on lobbying, is a new level. This could have been a cost saving transfer to consumers, instead of trying to prevent amendments and bills from decreasing their business. If the companies were fair to begin with, then no one would want legislative bills against the companies to decrease their profits. Previously articles have representatives from pharmaceutical companies concerned about safety and counterfeiting of importing drugs. Of course their primary concern is their loss of any potential profit. If these are the same manufacturers that are selling these drugs oversees, there should be no difference in safety and efficacy, unless its made differently for each country which is highly doubtful. Importation would not be an issue if prescription drug prices were more reasonable to the American public. With all the money they’re spending on lobbying, they could just lower the prices to the consumer and the issue would not be so prevalent in the public.

Moreover, pharmacists are involved in pharmaceutical company’s processes. In a way, this a negative impact on the pharmacists who do work for industry as greedy individuals, but these are also individuals who are establishing drugs available to the public to help with medical conditions. The drug development process is long and extensive, so of course the company would like their investment returned substantially and before their patent is expired. We need to ask though, how much is enough in return? With a business driven mentality, pharmacists are not in charge. Business is in charge, and money is the main driver. This is where we are, profit driven health care system with consumers paying. In essence, we are consumers also and we are all apart of an uncontrollable process in a free market world for people’s health.

By Sherri Davis-Garner
April 2, 2007

http://www.clarionledger.com/apps/pbcs.dll/article?AID=/20070402/OPINION/704020311/1166

Summary:

This article emphasizes Mississippi residents’ support for the Pharmaceutical Market Access Act by encouraging Sen. Lott to support the bill. Last year, he supported the Stabenow-Lott legislation which, would have allowed Americans to get lower-cost generic prescription drugs to market. AARP is a large influences trying to get the senator to endorse the bill. � According to a recent AARP poll, 89 percent of Mississippi residents want Medicare to leverage the buying power of 43 million Medicare members to negotiate lower prices for prescription drugs.�

Implication on pharmacy:

Ms. Sherri Davis-Garner is an advocate for the Pharmaceutical Market Access Act and wrote this to encourage Mississippi voters to contact Senator Lott to support the legislative act also. We can see from this article the public, mostly older Americans, see the solution to their healthcare costs is to decrease prescription drug costs, mainly by increasing the bargaining power of Medicare. I don’t think they know of any other solutions besides the immediate costs they face. Not saying Americans are not informed but maybe not presented with all the facts before they start deciding. It seems that costs is the main drive for the bill, however, little safety concern is seen in the public, as of now. By the public thinking that prescription costs are the big factor in high healthcare, pharmacists receive their concerns, and sometimes frustration, about the costs. This is especially true in retail pharmacy, when there is a relationship with the patient. Dealing with insurance and trying to get the patient their medication at affordable costs is difficult for a pharmacist who has no control over the system. However, if we are knowledgeable about the best drug therapy available for the patients’ disease state, then that in the long run would be cost saving to them, so they would not be taking medicine that is ineffective or not as effective as another type.

http://www.statesman.com/news/content/news/stories/nation/03/18/18drugimports.html

Summary:

This article emphasizes the support of Pharmaceutical Market Access Act by Democrats. Many major democratic players brought this legislative bill last year but was rejected. Particulary, Senator Byron Dorgan is most optimistic about the bill. “Dorgan's bill would allow drugs manufactured in the United States and sold to Canada and other Western industrialized nations to be reimported into the United States as long as the Food and Drug Administration approved the "chain of custody."� Dorgan said the Congressional Budget Office has projected that the bill would save consumers about $50 billion over the next 10 years and that the federal government would save about $6.1 billion. A potential veto by President Bush was mentioned, if the bill is not demonstrated to include safety measure of the imported drugs. Another supporter, Sen. Jim DeMint, stated the FDA’s role in the safety inspection of imported drugs is just an expansion of their responsibilities because the FDA already inspects imported food and such. A former congressman and current pharmaceutical company employee, Billy Tauzin, brought up European importation and trade has seen increase in counterfeit drugs and this should be a concern before any bill is approved.

Implication to pharmacy:

This article brings all points of arguments to the drug importation issue. Although prescription drug costs are a large concern, safety and general public health is an issue that should be addressed before American start taking harmful drugs that were meant to be beneficial. As future pharmacists, this does not have a clear impact on our profession. However, whatever outcomes from this long debate, will definitely affect how pharmacists are viewed, as drug information specialists and patient care personnel. Pharmacists will be the primary defense in counterfeit drug identification and drug safety in importation of the drugs. Moreover, the best drug therapy regimens may be a better healthcare expenditure to keep overall costs down. Pharmacists in are in the front lines to help determine the best regimens to be most effective.

March 26, 2007
http://www.drugnewswire.com/14241/

From March 7; PRNewswire-USNewswire

Summary:
The AARP, non-profit organization for elderly (age 50 and up), testified in Congress endorsing the Pharmacuetical Market Access Act citing high rates of prescription drug costs to Americans. “AARP endorsed the bipartisan Pharmaceutical Market Access and Drug Safety Act of 2007" (S. 242, H.R. 380), which would legalize the importation of FDA-approved medications from certain countries beginning with Canada, impose strict safety standards to prevent drug counterfeiting, and include important provisions to prevent potential trade obstructions.� It was cited that 38 million elderly regard prescription drug prices as the most important barrier to obtaining the necessary drugs. “The importation of prescription drugs is not the sole solution to soaring drug prices in the U.S. However, AARP believes that a system providing for the safe and legal importation of prescription drugs can serve to put downward pressure on drug prices and will permit consumers to realize some savings on the cost of their prescription drugs.� Several parts

Implication to pharmacy:

The endorsement by the AARP raises further support by the group of Americans in which utilize much of the prescription drug age categories. This in turn supports elderly voters who are most concerned with their well being. As pharmacists, you want the best for your patients’ health. As I have previously stated, this act may be a short term resolution to an exponentially growing problem we face in health care. Pharmacists in turn should be more aware of counterfeits and other related problems, such as the correct drug regimen. A foreign pharmaceutical company may not evaluate the drug therapy at the same standard that we would here. Also even with customer support lines to call in for questions, the waiting times and the inconvenience of calling may deter patients from getting to their question. Moreover, I presume many elderly are more comfortable with human contact rather than a voice over the phone or a letter stating drug interactions. Yes, the legislative act could potentially lower prescription drug prices, but as pharmacists, we learn drug therapy assessments that a foreign pharmacy may not do. Can we really trade safety and efficacy for monetary value? Until the questions of safety and equivalence has been determined equivalent in the foreign pharmacies, the legislative act could prove detrimental to those who need prescription medications to maintain their health.

By Lisa Richwine
ABCNews Internet Ventures
3/8/07

http://www.abcnews.go.com/Politics/wireStory?id=2932684

Summary:

Democratic and Republican senators are pushing forward to legalize prescription drug importation. One of the measures included is to provide “money and safeguards for the Food and Drug Administration to assure the imports were not dangerous.� The senators hope the bill will increase competition for prescription drugs and eventually lower prescription drug prices. “The legislation would allow consumers, pharmacies and wholesalers to purchase FDA-approved medicines sold in Canada and other industrialized countries. Congress would provide money so the FDA could make sure the medicines and manufacturing sites met agency standards.� The FDA has warned against this measure, stating “the agency cannot vouch for drugs purchased from foreign sources,� mainly safety and efficacy, as well as equivalence, cannot be determined or assured.

Implication to pharmacy:

This article is just a reminder in the progression of the Pharmaceutical Market access act. It shows the struggles between legislators trying to please the millions of Americans by allowing cheaper, international drugs to be imported and lowering drug costs versus the FDA being concerned about the drugs’ safety and efficacy for the public. This has an implication on the availability of pharmaceutical care given to warn patients that do not possibly possess all the knowledge they need to know about the drugs they’re ingesting. It would also affect the progress of pharmacy profession moving from pharmaceutical care. Although we have learned in class, internet pharmacies have provided a convenience to patients, however, personal experience also draws patients into their local pharmacies. I feel this a short-term resolution to a health-care system that needs to be revised. They’re focusing on pharmaceutical costs as a way to reduce healthcare expenditure, however, a large systematic review and interdisciplinary care would allow for more efficient healthcare services and lower overall costs. This a change that pharmacists are able to help to optimize the most efficient drug therapy, along with other health professionals to increase overall public health and awareness.

By Charles Cirtwill
The Public Policy; The American Spectator
2/28/2007
http://www.spectator.org/dsp_article.asp?art_id=11075

Summary:

Charles Cirtwill tries to break down the importation legislature, along side with healthcare costs. He states that each country creates its own free market in regards to pharmaceutical drugs and our efforts to lower American consumer costs by importing from Canada will increase the Canadian prices. Also, he mentions prevention drugs as a means to cheaper healthcare, the reason why so many Americans, and consumers worldwide, pay for “small cures.� As stated, on average “..an additional 100 prescriptions would mean 16.3 fewer days in the hospital. And every additional dollar spent on prescription drugs reduces total health care costs by $2.65 in fewer hospital visits.� The articles also states that in developing formularies and restrictions on prescription drug coverage, there has been a decline in overall health and thus an increase in treatment costs. “…even a small increase in co-payments on necessary prescriptions can force individuals to cut back on treatment regimens for long-term conditions like asthma, diabetes, or chronic heart failure.� He proposes a interdisciplinary health care system that works together to reduce the costs of healthcare, rather than solely concentrating on prescription drugs aspect. In doing so Americans may have better access to healthcare and increase in overall health, without the high costs that we currently have.

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Implication on Pharmacy:

He points out a sector of pharmacy, managed care pharmacy, that is able to lower costs to consumers with high cost, chronic illnesses, such as diabetes and asthma. He states this is a first step in increasing the effectiveness of our health care. Pharmacists then are in the front lines to help alleviate overall healthcare costs by managing effective drug therapies to prevent the high costs treatments that would result from hospitalizations. There is such a large focus to reduce only one sector of healthcare, prescription drugs. To me, this is because consumers are seeing these costs first hand, while other costs of healthcare are not being presented to them properly. Those not in the healthcare profession may not be informed of all the options there are present to start initiating change. The importation of drugs, or Pharmaceutical Market Access Act, is a quick fix to our healthcare crisis. There are risks, as previously stated in other blogs, to importing drugs from other countries whose regulations differ from ours or even worse with counterfeit drugs, which would have a tremendous impact with ineffective therapies. This is a topic we have encountered in class, so I was very intrigued when I stumbled across this article because its directly applicable to our profession and the future of pharmacy. Just by decreasing one sector of healthcare doesn't change the problem that we face; it will only become a larger problem later on. There isn't one place to look for to increase American's health, but its a process and a system to really prevent before chronic illnesses/ onsets to happen.

The Arizona Republic, The Tuscan Republic

2/02/2007
http://www.tucsoncitizen.com/daily/local/41463.php

Summary:

Arizona govoner, Janet Napolitano, visited Mexican President Felipe Calderon to delegate increase trades between the Mexican and Arizona border. Several countries have expressed interest in a growing Mexican economy, including Spain, Brazil, and Chile. Arizona exports $4 billion to Mexico annually, with 80% going to Sonora state in Mexico. Govonor hopes to take on border security, drug trafficking, and to encourage the Mexican government to fund transportation routes to/from the United States and Canada, “Canamex Corridor Project, an effort to link Mexico, Canada and the United States via superhighways running through Arizona.�

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“Diet Drug Acomplia Now on Sale in Some Mexican Border Pharmacies�

Summary:

An unapproved FDA diet drug, Acomplia (Rimonabant), has been rumored to be sold at pharmacies across the Mexican border in Los Algodones, Tijuana, and Nuevo Laredo. However, there seems to have not been any confirmed reports of anyone obtaining Acomplia from a Mexican pharmacy or even some pharmacies carrying it. Reports had Acomplia going for $100 for 28 pills in the Mexican pharmacies, which is cheaper than buying it from European mail-order pharmacies. This site gives several tips/warnings to consumers about buying drugs in Mexico, like declaration of the drugs to customs, prescription drugs, counterfeit drugs, and importation of unapproved drugs by FDA is prohibited.

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Implication to Pharmacy:

I combined the two articles because Mexico is also a market for American consumers to get cheaper drugs. With the Arizona govonor visiting Mexico, along with President Bush, we can see that trade with Mexico will increase. With prescription drug costs so high in the U.S., Mexican businesses are bound to have pharmacies readily available to American consumers. Drug importation is easier done with neighboring countries, such as Mexico and Canada. However, Mexican policies and drug inspection rates are not similar to ours, as Canada has tougher regulations (as I mentioned in a previous blog). I saw an ABC program where there are hundreds of street pharmacies across the Mexican border now and people trying to make sales of prescription drugs like they would try to sell a t-shirt or hat to tourists. Americans are flocking across the Mexican border to get cheaper drugs, as well as treatments, some not approved by the FDA.

It’s also known that illegal drug trafficking also occurs at these borders. With illegal trafficking, there is greed and greed brings along dishonest people trying to make quick cash. Americans can become susceptible to scams, fraudulent programs, and counterfeit drug with these foreign traders who know high drug prices in the U.S.

Our high healthcare costs has driven Americans to rely on outside healthcare systems, which is an indicator that our system is beginning to fail because of its free market access. I know and hear of many Americans getting their drugs, diagnosis, and even treatments from other countries because the cost is so high in the U.S. Being apart of the healthcare profession, we should work together to decrease the need to travel out of the country to get treatment, as well as assuring patients the proper care and preventative medicine needed. Business is what is driving our healthcare system, not healthcare. I believe to efficiently run and manage our healthcare system drastic changes need to occur, although many are not aware or willing to accept a total different healthcare system. But how truly safe is it to save $100 by going to the Mexican border? Is the drug a counterfeit? Have they mixed in other active ingredients? Prescription drug trade may also mask and increase other illegal drug trafficking into the United States.

"Prescription Drug Imports up 34% in January 2007"

By: Timothy Perterson, CANAMERICA Global February 8, 2007

Summary:

Jeremy Chaney, preseident of CANAMERICA Global, reports increase sales of drugs to the U.S. CANAMERICA is a Canadian pharmacy that has been permitted to import drugs internationally. "CanAmerica Drugs.com (www.canamericadrugs.com) has a perfect BBB rating, and is heading into it’s sixth year of providing safe, effective, and affordable medications to the American public." It is one of only 20 pharmaciess in Canada that has ISP license to provide international pharmaceutical services (ISP) by mail. The company endorses the Pharmaceutical Market Access and Drug Safety Act and welcomes inspection by the FDA . HOwever, Chamey warns that ordering through the company may not save much on prescription drugs. He also mentions that the wholesalers' supply to a Canadian company may not be sufficient to supply the U.S. consumer market for a long length of time.

Implication with Pharmacy:

CANAMERICAdrugs.com was quoted to be "the world’s largest network of mail-order pharmacies." The article also stated an increase in younger consumers (not the elderly). This is an important move that shows patients are becoming more aware of their prescription drug costs. With a large company like CANAMERICAdrugs.com, safety of the drugs has been assured by the Canadian government, which probably would be a reason why more consumers are trusting to use their online pharmacy. However even Mr. Chamey, the president, stated with increase in drugs imported, the costs to patients may not be mch cheaper than if we were to directly buy here in the U.S. The Pharmaceutical Market Access Act sounds like a better alternative to patients who are paying high costs, but again, the patients need to be better consumers and compare rather than just assume drugs imported through mail-order will save them more money.

Inspection by the FDA of these online pharmacies will put more consumers at ease. The problem lies in even Mr. Chamey stating that there wouldn't be significant savings for patients with mail-order pharmacies with large, bulky order. Retail pharmacies may not be too affected, yet, because of the personal contact pharmacists gives. With the little savings, the convenience of mail-orders may lie in our busy society and having prescription drugs delivered to your door. Where would patient care/counseling reside when drugs are delivered straight to our doorsteps?

"Fake drugs and false pride: Congress and Presctiption Drug Importation"

Lewisville, Texas. February 1, 2007

Techbytes published by IPI Center for Technology Freedome of Institute for Policy Innovation

Summary:

This article brings up the subject of increasing drug importation (mail-order) from Canada, specifically. The author brings up the notion that many Americans beleive the Canadian safety, efficacy, and purity regulations on their drugs are almost equivalent to the US system. "..this amendment is narrowly focused on Canada because we are talking about a system that is very similar, almost exactly the same in terms of the safety and the rigorous oversight.� Sen. Debbie Stabenow (D-Mich.)." However, there have been new safety concerns from Canadians themselves about the safety of their drugs. In addition, there are concerns legitimacy of Canadian Internet pharmacies, whether it would be counterfeits or even poisoned pills. They raise the question of terroism to kill Americans by sending cyanide or anthrax to those that buy their medications from outside of our tightly regulated systems.

Implication with pharmacy

This is just a continum of the Pharmaceutical Market Access Act (in my previous blog). I find it interesting that Senator Debbie Stabenow was mentioned because I remember some of her topics during the election was for prescription drugs. Looking at a person who is on many medications per month, the legislation seems practically because we, as Americans, are paying the most for our prescription worldwide. However if we view this from a pharmacy professional point of view, the author does bring up important points to cover of safety and efficacy of these cheaper drugs. It is true that we view Canada as an equal, in terms of developed country, and their regulation for drug safety would be almost equivalent to ours. With mail- order and internet pharmacies, how do we know which pharmacy is going to provide the correct medication and which pharmacy are going to be sending out phony/ counterfeit drug? Or even worse, what if a terrorist group sets up a pharmacy aimed at doing harm to americans? Furthermore, how much would the average consumer know to discriminate between a legitimate site versus a fraudulent site? Even if we had a seal or logo to identify safe internet pharmacies, how secure is it that someone that's out to do harm won't make a logo similar to it? The main points before legislation continues with drug importation are with the safety of the drugs being sold and the potency these drug will have. Someone with a chronic condition may be able to save money on internet pharmacies, but how effective are these meds in controlling their condition?

There seems to be a stronger push toward getting drugs from our neighbors, Canada, which seems very feasible. I beleive it may work with Canadian companies/ pharmacies to lower the cost of prescription drugs, especially if we envoke some diplomacy. Wouldn't it be more effective to work the the drug companies that are increasing the prices toward American consumers and having lower costs to other consumers worldwide? Again, I believe regulation of the drug market would be a more effective answer. For now, the easiest answer is to move to Canada to get the cheaper drug, but what do we do when something goes wrong or a loop hole in the Canadian system accidentally allows terrorists to send innocent Americans deadly, counterfeit drugs?

Don't get me wrong. If this is the easiest way for someone to get their medication, with cost-friendly benefits, then its a good legislative act. I feel like the costs has had people overlook the risk of counterfeit, ineffective, or even toxic drugs. You can't fix someone's health if they don't know what is happening. If Congress continues on and put the Pharmaceutical Market Access Act into effect, they would also need to produce guidelines for the safety of the drugs being imported in.

"Vitter could revive drug bill"

by Gerard Shields, Advocate Washington bureau