Experts | University of the Sciences

We Must Prevent "Reform" from Taking the "Care" out of Health Care!

By Dr. Daniel A. Hussar is the Remington Professor of Pharmacy at University of the Sciences' Philadelphia College of Pharmacy. He serves as the author and editor of The Pharmacist Activist newsletter (http://www.pharmacistactivist.com) from which this editorial was taken.

 

This April issue of The Pharmacist Activist is reaching you several days late. One of the reasons for the delay was the challenge I encountered in selecting the topic for this editorial. No, I haven't run out of topics. In fact, there were four topics that I considered very important and timely and my difficulty was in choosing just one of them. I made a choice and typed several introductory paragraphs before leaving for a meeting at which I had been asked to speak.

The meeting was at a retirement community at which educational programs are held on a wide range of topics. My topic was "Drug interactions and adverse effects." Approximately 40 people were present, of which I was the youngest (although my students would have difficulty believing this and I should have had a picture taken). By the end of the meeting and the numerous additional questions discussed on an individual basis, I concluded that what I experienced was sufficiently important, and always timely, to change the topic for this editorial.

There is such a great need for the drug therapy knowledge, judgment, and consultation that pharmacists are in a position to provide. All of us in pharmacy recognize this and nowhere is that need more evident than in a gathering of "seniors" (or, as I prefer, the chronologically gifted). The comments I prepared for the meeting did not have to be long because, once the questions started, they continued until the moderator brought the meeting to a conclusion.

Many of those attending quickly identified with adverse events such as dry mouth with medications used for overactive bladder, but were less aware that blurred vision and other visual changes might be drug-related. They quickly agreed with my observation that the development of or change in symptoms should be considered to be drug-related (as distinct from what is too often assumed to be a consequence of the aging process) until that possibility is ruled out.

There were numerous questions about Fosamax, Coumadin, aspirin, and Lipitor, and various medications they had seen advertised on television. Some asked questions regarding Aricept and other possible treatments for Alzheimer's disease, primarily motivated by wanting to be certain that every possibility had been considered for their spouse with this disease. Others volunteered information about adverse events they had experienced.

One of the individuals spoke with me following the meeting on behalf of a resident who was in the nursing facility of the retirement community. She had a list of her symptoms and conditions, the ten medications being taken, and the adverse events associated with the use of each of the medications. Three of the medications were for high blood pressure and the patient was convinced that one or more of these medications was responsible for the tingling, pain, and occasional numbness she was experiencing in her hands and arms, and for which Neurontin had been prescribed but with little or no benefit. One of her favorite activities was knitting but she was no longer able to do that because of the discomfort in her hands and her reduced dexterity. Her advocate asked how she could obtain a pharmaceutical consultation as the physician was pleased that her blood pressure was stabilized and did not consider her other symptoms to be serious enough to change her therapy. I suggested several possible options with respect to a pharmaceutical consultation but she was not optimistic that those currently providing her health care would be receptive.

We could multiply that experience by millions! There are that many individuals who have no or very limited health-care services. Even among those who have access to comprehensive health-care services, many are receiving much less than optimal care and experience drug-related problems.

Health care reform

The federal legislation (i.e., Obamacare) that is promoted as "reform" for a broken health-care system has been claimed to be a program that will provide coverage for millions of currently uninsured individuals and greater scope and quality of coverage for all participants at a lower cost. There is no question that the previous/current health-care system was in great need of reform and has been burdened with extensive inefficiency, waste, and fraud. However, the legislation being implemented (unless the Supreme Court intervenes), after being developed through a secretive and flawed process, has the potential to further weaken the scope and quality of the current system. I have concerns about many of the provisions of the legislation and the flaws, exceptions, and loopholes that continue to be identified. The economics of the system are certainly important as our society must be in a position to financially support whatever health-care system is provided. However, I would contend that the obsession with the economics has masked what will be an unacceptable erosion of the quality of health care.

We have already observed the consequences for health-care services from the increased role and influence of government, insurance companies, and pharmacy benefit managers. Insurance companies are buying hospitals, hospitals are buying physician practices, physicians are expected to see more patients thereby having less time for individual patients, many pharmacists are practicing in stressful workplace environments with a corporate emphasis on how many and how fast prescriptions are dispensed, and patients are being forced or provided with financial incentives to obtain their prescriptions from mail-order pharmacies in distant locations without any personal interaction with a pharmacist. Is it any wonder that drug-related problems such as prescribing, dispensing, and administration errors, adverse events, drug interactions, and patient noncompliance occur so often, resulting in harm to and deaths of patients at a cost of billions of dollars? Patients, as well as health professionals, who attempt to obtain clarity and answers from the chaos of the maze of mandates and policies often receive an inadequate response (sometimes after being "on hold" for a long period of time) and a high level of frustration. Patients far too often have reason to ask, "Does anyone really care?"

We have already observed a trend that has increased the corporatization of health care and reduced the time that health professionals spend with patients. I am convinced that the too frequent absence of care, compassion, and time for communication with patients is the single most important reason for which drug-related problems and their severe consequences and costs occur. My greatest concern regarding the more recent legislative initiatives is that the care provided for patients on an individual basis will be further reduced. We must prevent "reform" from taking the "care" out of health care! (Please also see my editorial, "Both Patients and Health Care Have a Great Need for a Personal Touch!" in the March 2011 issue of The Pharmacist Activist.

Pharmacists have answers

Pharmacists have the expertise and are strategically positioned to greatly improve the appropriateness and effectiveness of drug therapy and to markedly reduce the occurrence of drug-related problems. However, the extent to which we are presently attaining these outcomes is very limited. The depth of the pharmacist's expertise and the potential benefits of our consultation and recommendations are invisible to most. We have not been effective in demonstrating and communicating beyond our profession the value of our services.

In 2004 the national pharmacy practitioner organizations developed the following vision statement:

"Pharmacists will be the health-care professionals responsible for providing patient care that ensures optimal medication therapy outcomes."

This is a bold and progressive vision and a goal was established for this vision to be implemented by 2015. (Please also see my editorial, "Pharmacy's Vision for 2015 OR a Large Surplus of Pharmacists?" in the June 2011 issue of The Pharmacist Activist.

Notwithstanding the very commendable accomplishments of a relatively small number of pharmacists in implementing medication therapy management and other professional practice initiatives, our profession will not attain the vision by 2015, and some are skeptical as to whether pharmacy will attain the vision at any time. However, the need for "pharmaceutical consultation" as requested by the woman at my meeting is so important for our patients and society, as well as for our profession, that we must not hold back in committing the time, effort, and resources needed to make this vision a reality at the earliest possible time.

We must start by caring more for our patients.

We must reject the "sign here" mentality and actually provide the information and counseling we say are of great value.

We must volunteer our time and services beyond the extent for which we are being paid.

We must document the results/benefits of our consultation and interventions.

We must hold ourselves and our professional organizations more accountable.

Many Prescription Medications Should be Available Without a Prescription from a Pharmacist

By Dr. Daniel A. Hussar is the Remington Professor of Pharmacy at University of the Sciences' Philadelphia College of Pharmacy. He serves as the author and editor of The Pharmacist Activist newsletter (http://www.pharmacistactivist.com) from which this editorial was taken.

The Federal Register of Tuesday, February 28 (pages 12059 - 12062) included a notice from the Food and Drug Administration that it would hold a public hearing on March 22 and 23 to receive comments on the subject, "Using Innovative Technologies and Other Conditions of Safe Use To Expand Which Drug Products Can Be Considered Nonprescription." I was one of the participants in the hearing and presented the testimony provided below:

Food and Drug Administration Public Hearing

March 22, 2012

Comments provided by Daniel A. Hussar, B.S. (Pharmacy), Ph.D.
Remington Professor of Pharmacy,
Philadelphia College of Pharmacy
University of the Sciences in Philadelphia

I commend the Food and Drug Administration (FDA) for convening this hearing to receive comments and opinions on a topic that I believe represents a very important opportunity to improve health care for millions of individuals. The perspectives and recommendations I am providing are based on my responsibilities as a pharmacist and faculty member at the Philadelphia College of Pharmacy that include teaching our required Nonprescription Therapeutics course, having taught every area of drug therapy, and having written and spoken about every new drug marketed in the United States in the last 40 years.

As stated in the Federal Register announcement of this public hearing, "Undertreatment of many common diseases or conditions in the United States is a well recognized public health problem." Millions of Americans do not see a physician or other prescriber unless they are experiencing symptoms they can no longer tolerate. Millions of Americans use unregulated herbal and other natural products, as well as dietary supplements, for which there is no evidence of effectiveness and safety. It is my strong conviction that there are actions that can be taken that will greatly increase access to, effectiveness, and safety of a significantly larger number of medications. These actions will result in better health care that is provided in an efficient manner, and will also reduce the burden on emergency rooms and many physician providers.

The responsibilities of pharmacists currently include the assessment of the type and severity of symptoms described by patients, decisions whether to refer a patient to a physician/emergency department or to recommend the use of nonprescription medications, and, in the latter situation, to provide the counseling and monitoring needed to assure the appropriate management of the
condition. Pharmacists have the knowledge and accessibility to assume a greatly expanded role in the appropriate use of medications. The topics being addressed at this hearing are particularly important and timely with respect to their relationship to the recent Report to the Surgeon General, Improving Patient and Health System Outcomes through Advanced Pharmacy Practice.

My comments will primarily focus on the identification of medications that currently require a prescription, but which I would recommend for availability without a prescription in a pharmacy with the consultation of a pharmacist. The following medications are examples of those that I recommend for nonprescription availability from a pharmacist.

1. Epinephrine auto-injector for severe allergic reactions.
2. Albuterol for oral inhalation for acute asthma attacks.
3. Naloxone for narcotic overdosage.

Epinephrine, albuterol, and naloxone are used for the treatment of very serious and even life-threatening experiences. These events require emergency treatment and often occur in an area and/or at a time in which the local pharmacy is more accessible than a physician or a hospital.

4. Triptans (e.g., sumatriptan) for migraine headache.

Migraine attacks can be severe and disabling for some patients. The sooner the use of effective treatment can be initiated, the greater the likelihood of relieving symptoms on a timely basis and preventing worsening of the migraine attack.

5. Oseltamivir for influenza.

Oseltamivir is one of a very small number of medications that is effective for the treatment of influenza. However, for this drug to be optimally effective, it is very important that treatment be initiated as soon as possible following the onset of symptoms (within two days). Patients who experience influenza symptoms should be provided the fastest access possible to medication that might be of significant benefit.

6. Statins (e.g., atorvastatin, pravastatin, simvastatin) for hyperlipidemia.

Many individuals, rather than seeing a physician and receiving prescribed medications for high cholesterol concentrations, are purchasing dietary/nutritional supplements such as red yeast rice in which a statin is the primary active ingredient. These products have not been evaluated in clinical studies, there are little or no safety data, and there is often no assurance of standardization of active ingredients. In these situations, it is highly preferable to have nonprescription pharmacy availability of statins that have been extensively studied, have a known safety profile, and will be monitored by a pharmacist.

7. Diuretics (e.g., hydrochlorothiazide) for edema and high blood pressure.
8. Tamsulosin for benign prostatic hyperplasia.
9. Agents for overactive bladder (e.g., tolterodine).
10. Celecoxib for pain and inflammation.
11. Cyclobenzaprine for musculoskeletal symptoms.
12. Ramelteon for insomnia characterized by difficulty in falling asleep.
13. Corticosteroids (e.g., fluticasone propionate) for intranasal administration for allergic rhinitis.
14. Montelukast for allergic rhinitis.
15. Agents for smoking cessation (nicotine nasal spray, nicotine inhalation system, varenicline).

More than 440,000 Americans die each year as a result of smoking-related illnesses. Although some smokers have been successful in quitting with the use of nonprescription nicotine replacement therapy (gum, lozenge, patch) or other strategies, others have not had a successful experience with these products.

There are many smokers who want to quit but who will not set up an appointment with a physician to discuss other options. For these individuals, the nonprescription availability from a pharmacist of nicotine nasal spray, nicotine inhalation system, and varenicline will provide a pharmacist-monitored opportunity for a successful effort to stop smoking. It is an unacceptable irony that only proof of age is required to purchase a dangerous product like cigarettes whereas a prescription is required to obtain certain of the products that will help individuals stop smoking.

Attention should also be given to revision of the labeling of the nicotine replacement therapy formulations that are currently available without a prescription. For example, the labeling for these products contains the statement, "Do not use if you continue to smoke..." Although the goal is for the individual to not smoke at all, some are not able to resist the craving to smoke but do so on a less frequent basis. Because they have not followed the specific instructions, they may conclude that the treatment has not been successful and discontinue it. However, a substantial reduction in the number of cigarettes smoked should also be considered a positive result and a source of encouragement to stop smoking completely. The labeling for the nonprescription nicotine replacement therapies also includes a statement that individuals should not use a second nicotine-containing product concurrently. However, this statement may actually preclude the use of what, for some individuals, may actually be the best strategy to stop smoking, that is to use the patch to provide a sustained low concentration of nicotine and the lozenge or gum to provide a prompt, but brief, action when cravings to smoke are experienced.

In addition to these examples, there are also other prescription medications that can be considered for nonprescription availability from a pharmacist. With certain of the agents identified, there will be a need for specific parameters and guidelines to assure appropriate use and these will vary depending on the medication. However, this should not be reason to delay consideration of medicationsfor which a change in status can be made quickly.

The increase in the number of nonprescription medications that are available from a pharmacist will not only result in increased patient access to helpful medications, but will also make them available on a more cost-effective basis.

I also anticipate that there will be increased communication, collaboration, and referrals between pharmacists and prescribers as they fulfill their individual responsibilities for the patients being served. Neither the FDA nor the public should tolerate "turf battles" among the health professions as these issues are addressed. There is much more to be done in improving the scope and quality of health care and preventing drug-related problems than all of the health professions are doing now.

We can and must do much better. The opportunities that the FDA is considering are ones in which all participants can "win," and I urge your bold and prompt action.

Expert: Kids unlikely harmed by pharmacy mix-up

Dr. Dan Hussar was readily available to speak with the AP about the drug mix up in New Jersey.

NJ CVS Gives Breast Cancer Pills To Kids: "Fortunately, it's very unlikely that this specific drug would cause any serious or adverse effects when used for only a short periods of time," said Daniel Hussar, a professor with the Philadelphia College of Pharmacy at the University of the Sciences.

Chain Pharmacy CEOs Must Stop the Sale of Cigarettes!

By Dr. Daniel A. Hussar who is the Remington Professor of Pharmacy at University of the Sciences' Philadelphia College of Pharmacy. He serves as the author and editor of The Pharmacist Activist newsletter (http://www.pharmacistactivist.com) from which this editorial was taken.

The potential consequences of smoking cigarettes are well known but the tobacco-related carnage continues unabated within our society. On November 10, the Centers for Disease Control and Prevention issued a press release that includes the following observations and statistics:

March, 2010 issue of The Pharmacist Activist. Continuing communications have identified a number of what I consider to be advantageous reasons for the particular chain to discontinue the sale of tobacco products. However, to date, my efforts have not been successful. None of these companies have changed their policies, and none of the CEOs has been willing to meet with me. In fact, there has been turnover in the executive ranks of each of these four companies since I began communicating with them, with the result that there have now been eight CEOs who have either not responded to me at all or have declined to meet with me in a written response. The highest executive officer currently serving at each of these companies is identified below:

"Tobacco use remains the leading preventable cause of death and disease, including cancer, chronic obstructive pulmonary disease and other lung disease, in the United States. Smoking and exposure to secondhand tobacco smoke kill an estimated 443,000 Americans each year. For every 1 smoking-related death, another 20 people live with a smoking-related disease….Approximately 26 percent of heart attacks and 12-19 percent of strokes are attributable to smoking."

It has seemed almost impossible to capture or describe the impact of these consequences in a manner that motivates sustained action that will substantially reduce disease and deaths attributed to smoking. Every year statistics similar to those above are communicated, but ignored or quickly forgotten by most. Some years ago I was a participant in a meeting on tobacco-related problems in which a physician speaker made the following statement:

"The tobacco industry should be treated as a criminal enterprise that thrives on addiction and murder."

Some find it convenient to ignore this observation because it is legal to produce and sell tobacco products. However, many years later I remember this statement verbatim because of its boldness in identifying the addiction and other destructive health consequences that result from using tobacco products. Although some may take exception to an allegation of "murder," there can be no debate that death is a consequence. The statement serves as a reminder for me to persist in efforts to discourage the use of tobacco products and to discontinue their sale in pharmacies.

Cigarettes in pharmacies

Except in San Francisco, Boston, and several other cities that have taken actions to prohibit such sales, it is legal to sell cigarettes in pharmacies. However, this does not mean that selling cigarettes in pharmacies is the right thing to do and I strongly contend that such sales are contradictory to the role of pharmacists as health professionals and providers of medications and information that promote and improve the health of patients and communities. Indeed, it is hypocritical to promote such a message at the same time that products that can cause harm and death can be purchased just steps from the prescription counter.

Most independent pharmacies do not sell cigarettes whereas most chain pharmacies do. Accordingly my efforts to have the sales of cigarettes discontinued have primarily been directed to chain pharmacies. In speaking with numerous chain pharmacists and other employees, I found that the vast majority agreed with my concerns but felt they have no authority or influence with respect to this decision. They identified the CEO of their company as the only individual with the authority to make a decision to discontinue the sales of cigarettes. It was at this point that I decided that my efforts should be directed to meeting personally with the CEOs of four of the largest chains that sell tobacco products - CVS, Rite Aid, Walgreens, and Walmart. Just these four companies operate more than 20,000 pharmacies and, therefore, account for a large percentage of the tobacco sales in the United States, as well as a corresponding percentage of the victims of resultant disease and death.

Communications with chain CEOs

My first communication with the CEOs of these four chains encouraged them to be a leader among chain pharmacies in discontinuing the sale of tobacco products, and also requested the opportunity to meet with them. My experiences in communicating with these four chains are described in more detail in the

CVS - Mr. Larry Merlo

Rite Aid - Mr. John Standley

Walgreens - Mr. Gregory Wasson

Walmart - Mr. Mike Duke

My lack of success in what I have been attempting to accomplish could be attributed to naivety in anticipating affirmative responses to what I considered to be appropriate requests, or written off as an exercise in futility. However, I can't ignore the realization that hundreds of thousands of our family members and neighbors are dying every year from the consequences of smoking cigarettes. It is no consolation to hear that they made the choice to smoke or if they couldn't buy their cigarettes in pharmacies that they would buy them somewhere else. Indeed, most smokers have tried on multiple occasions to stop but the addiction to nicotine that has been described as "second to no other" is so powerful that they have not been successful in quitting.

Smoking kills! Certain pharmacies have enabled and even promoted the purchase of these products that are known to cause addiction, disease, and death. Most importantly, this is a potentially deadly disservice to their customers. It also is a betrayal of the role of the profession of pharmacy as an advocate for wellness and restoration and improvement of health. As noted above, there is only one individual at CVS, Rite Aid, Walgreens, and Walmart who has the authority to make a decision that his company will no longer sell cigarettes. I urge these individuals to make this decision and to be leaders among chain pharmacies in providing an example that I am confident other pharmacies that sell tobacco products will follow. If, however, they continue to permit their companies to sell these products, they, at the very least, are contributors to the sequence of events that, for many, will be the cause of death. They will become known as MERCHANTS OF DEATH.

Deception and Hypocrisy from Mail-order Pharmacies

By Dr. Daniel A. Hussar who is the Remington Professor of Pharmacy at University of the Sciences' Philadelphia College of Pharmacy. He serves as the author and editor of The Pharmacist Activist newsletter (http://www.pharmacistactivist.com) from which this editorial was taken.

Having devoted two recent editorials to the topic of mail-order pharmacies (please see the May and July issues of The Pharmacist Activist), I would much prefer to now address other subjects. However, recent comments by the CEOs of Medco and Express Scripts are too deceptive to be ignored.

CEO Insults Medco Pharmacists
At a meeting earlier this month, the CEO of Medco is reported to have stated that Medco's "robots" are "twenty-three times more accurate" than human pharmacists with respect to errors in dispensing prescriptions. Why is the "leader" of a pharmacy company even suggesting that robots and pharmacists can be compared, particularly when the comparison he states is so demeaning to pharmacists? His statement is most insulting to his own Medco pharmacists because these are the only pharmacists whose accuracy Medco is in a position to determine. Medco pharmacists must be furious! Only several months ago it was announced that Medco had agreed to be acquired by Express Scripts. If the acquisition is approved, there is every reason to believe that the CEO of Medco will become even wealthier than he is now as his "reward" for facilitating the acquisition. At the same time, however, many Medco pharmacists and other employees face the uncertainties of whether their positions will be eliminated or whether they may have to relocate to retain their positions. Then, to add insult to injury, Medco's CEO lauds the accuracy of its robots. However, someone had to program the robots. Could it have been Medco pharmacists that their CEO somehow overlooked?

But perhaps the Medco CEO was attempting to compare the Medco robots with pharmacists in local pharmacies. To my knowledge, there is no study that directly compares mail-order pharmacies and local pharmacies with respect to accuracy rates in dispensing prescriptions. So where does the Medco CEO's allegation that his robots are twenty-three times more accurate come from? Did Medco conduct a study that they have not published or otherwise made available? Or is this yet another extrapolation of a study done years ago that was designed by Medco personnel using study parameters that they selected, and that was conducted by individuals having a vested interest in the results. There were no local pharmacies included in this study. However, that did not stop the Medco personnel from attempting to compare the results of their "study" with the results of a different study in local pharmacies conducted by objective researchers. Medco and other mail-order pharmacies have attempted to use their data to claim that their pharmacies make fewer errors. However, this is blatant deception! Even the Medco authors of the paper they published regarding their study acknowledge that "Ébecause mail-service pharmacies differ in their operation and degree of automation, these findings cannot be generalized to mail-service pharmacies as a class." I agree with this acknowledgement. However, if the study findings can't even be considered applicable to other mail-order pharmacies, there is absolutely no credibility to the claims of Medco and others that these findings can be considered applicable to local pharmacies.

Dissing Retail Pharmacy
In the same meeting in which the comment about the robots was made, the Medco CEO made the observations about retail pharmacy that "Éthere's a fiction that a pharmacist comes out and dialogues with you. ÉIn reality, a high school student hands you a script from the shelf." He prefaced these comments by noting "I'm not dissing retail [pharmacy]É" However, this contradictory disclaimer can in no way diminish his outrageous denigration of community pharmacy practice. I will acknowledge that there are some local pharmacies in which there is no communication between the pharmacist and patient, and little or no professional service provided. I am critical of these pharmacies - but at least prescriptions are provided on a timely basis and a pharmacist is quickly available to respond to questions. How can the Medco CEO make such demeaning remarks about the profession of pharmacy from which his company has derived huge profits? How can he be so critical of community pharmacy practice and completely ignore the limitations and failures of the mail-order pharmacy for which he has responsibility?

Different Venue-Different Message
The planned acquisition of Medco by Express Scripts has raised numerous concerns that are being addressed by the Federal Trade Commission (FTC) and Congressional committees. Those opposing the acquisition are concerned that the merger of two of the three largest pharmacy benefit managers (PBMs) will result in a dominant and anticompetitive influence in the marketplace that will force an even larger number of consumers to obtain their prescriptions from the mail-order pharmacies that these PBMs own. Many local pharmacies will not be able to survive financially and the provision of medications and professional services on a timely basis for patients will be diminished.

The testimony provided by the Medco CEO before the FTC has strikingly different content and tone when compared with his comments identified earlier. His comments include: "More than 85% of prescriptions filled for Medco customers are filled through our networks of more than 60,000 retail pharmacies. Medco is dependent on the continued existence of strong independent retail pharmacies." Can these comments be provided by the same individual who speaks so disparagingly about the accuracy of pharmacists compared with his robots? The message clearly depends on the audience and, for the FTC, the message is that there are tens of thousands of local pharmacies on whom Medco is dependent and a competitive marketplace will continue. Compared with the other comments of the Medco CEO and the actions of Medco in the marketplace, this message is hypocritical.

The Express Scripts Message
At a hearing of a House subcommittee that is examining the planned acquisition of Medco, the CEO of Express Scripts noted that the acquisition would result in "safer and more affordable" drugs. I have already refuted the allegation that mail-order pharmacies are safer than local pharmacies. One response to the claim that drugs will be more affordable if the acquisition is permitted is the following question: What has happened to the cost of prescription drugs during the period of time in which the number of prescriptions dispensed by mail-order pharmacies has greatly increased? The answer is that the cost of prescription drugs has also greatly increased. If these PBMs were not able to make drugs more affordable during the period in which their size, power, and influence have markedly increased, why would they be able to do this if they were permitted to merge? The answer is they can't and they won't. This issue is addressed in greater detail in the editorial in the July issue of The Pharmacist Activist - "Express Scripts and Medco - A Fallen Giant or a Bigger Monster?"

When the CEO of Express Scripts was asked at the House subcommittee hearing to identify the best way to reduce prescription drug costs, his response was by reducing waste, fraud, and abuse. This is a laudable goal but his response invites attention to the most important reasons for the waste of medications and the resultant costs. The most frequent explanation is the large quantities of medications received from mail-order pharmacies that are not used.

The Drug Enforcement Administration (DEA) has held three National Drug Take-Back Days - in September, 2010, April, 2011, and on October 29, 2011. On the first two of these days, more than 309 tons of medications were collected. If a study was done of randomly selected quantities of the collected medications (while preserving the confidentiality of the patients who turned in the medications), my expectation is that the medications supplied by mail-order pharmacies would represent a disproportionately high percentage.

Actions
The National Community Pharmacists Association and the National Association of Chain Drug Stores, as well as a number of consumer organizations, have mounted strong opposition to the acquisition of Medco by Express Scripts. Individual pharmacists, particularly those in local pharmacies, must join this effort. Owners of pharmacies should individually assess their participation in prescription benefit programs in which there are non-negotiable, take-it-or-leave-it terms of participation, inadequate compensation, abusive audits, and insulting criticism from those administering the programs.

Daniel A. Hussar

The Impacts of Our Profession

    Recognized as one of the most trusted of the health professions, pharmacists have always played a key role in the healthcare continuum. As young pharmacists in training, we are at the forefront of a profession that has taken on greater responsibility in providing patient care and management while helping to reduce healthcare costs.

    Did you know that pharmacists are not just responsible for dispensing medication but now provide important services such as:

• Immunization and flu shot administration 
• Diabetes counseling 
• Blood pressure medication management through medication therapy management and substance abuse counseling, just to name a few.

    With the ongoing debate in the United States regarding healthcare costs, pharmacists are on the front lines to:

• Increase access to healthcare and decrease costs by working with patients
• Guard for proper administration of medications that has the potential to cut down on ailments and ER visits
• Work on teams with other healthcare providers to ensure the best care for patients and provide important answers to many questions regarding medications and health conditions

    The fall months mark the start of Cold and Flu Season! That means more doctor visits and more so the increase in purchasing over the counter medications to combat the cold and flu.

• According to the American Pharmacists Association, 82% of consumers purchase over the counter products recommended by their pharmacist

• With so many medications on the market and their thousands of active ingredients, patients are encouraged to consult their pharmacist to maximize benefits.

• The role of the pharmacist is to provide and counsel patients with the right over the counter medications

    We can provide patients with information about drug-food interactions, drug-drug interactions, or drug-supplement interactions

     We help patients select products that address the patient’s individual needs and help them sort through the many products that are available

 

PHARMACISTS ARE MOST ACCESSIBLE WHEN IT COMES TO MEDICATION RELATED NEEDS!

 

 

-Alyssa Lesko, 2014 PharmD Candidate and APhA-ASP Chapter President-Elect 2011-2012

 

The TYLENOL Follies

By Dr. Daniel A. Hussar who is the Remington Professor of Pharmacy at University of the Sciences' Philadelphia College of Pharmacy. He serves as the author and editor of The Pharmacist Activist newsletter (http://www.pharmacistactivist.com) from which this editorial was taken.

Which of the following is the recommended maximum amount of acetaminophen that may be taken (in divided doses) by an adult during a 24-hour period?

a. 4,000 mg
b. 3,000 mg
c. 3,250 mg
d. 3,900 mg
e. It depends on the particular formulation
f. It depends on the company making the formulations
g. All of the above

And the answer is "g" - all of the above.
We will come back to this question later after considering some background information.

Background
Acetaminophen is the most widely used medication in the United States. It is supplied as a single active ingredient in numerous products, and with one or more other active ingredients in hundreds of combination products. When used in the recommended dosage, it is one of the safest medications available. Because of its safety, as well as its effectiveness, I consider it to be the OTC analgesic of first choice for most situations associated with mild to moderate pain.

Very serious, and sometimes fatal, problems may result when acetaminophen is used in amounts that exceed the recommended maximum dosage. Acetaminophen overdosage is the most frequent cause of liver failure in the United States and approximately 100 people die each year from accidental overdoses (as distinct from intentional overdoses [i.e., suicide attempts]). Many of the accidental overdoses result from the concurrent use of two or more acetaminophen-containing products, and most of the deaths have involved the use of prescription combination products such as Percocet (acetaminophen and oxycodone) and Vicodin (acetaminophen and hydrocodone).

On June 29 and 30, 2009, 37 health professionals who serve on three FDA advisory committees were convened by the FDA for the purpose of recommending ways through which acetaminophen overdosages could be reduced. The most important of these recommendations are considered in my editorial in the

July 2009 issue of The Pharmacist Activist.

Recent actions
In early 2011 the FDA notified health professionals that it has asked manufacturers to limit the amount of acetaminophen in prescription drug products (primarily combinations of acetaminophen and opioids [e.g., Percocet, Vicodin]) to 325 mg per tablet, capsule, or other dosage unit, as a step to reduce the risk of severe liver injury. This action is planned to be implemented over a three year period, and does not apply to OTC products. In the FDA communication, health professionals are reminded to advise patients not to exceed the acetaminophen maximum total daily dose, identified as 4 grams/day.

In May it was announced that the companies that make single-ingredient liquid acetaminophen pediatric products would now provide them in only one standard concentration (160 mg/5 mL) to help prevent dosing errors. The more concentrated solutions of acetaminophen intended for administration as drops will no longer be supplied. I agree with this action although I sympathize with the parents having the challenge of administering a larger amount of liquid to a young child.

The recalls
Over the last two years, Johnson & Johnson/McNeil Consumer have had to initiate recalls of dozens of lots of Tylenol and other OTC and prescription products for a variety of reasons primarily related to manufacturing, production, and storage issues. For a company that has enjoyed such an exceptional reputation for decades, due in large part to the confidence of consumers and health professionals in the quality of its products, the continuing series of recalls has been nothing short of shocking. Explanations have been incomplete and unconvincing, but that is another story.

One consequence of the recalls has been that some Tylenol and other OTC products have not been available for many months. When consumers can't find the products they are looking for, with whom do they speak? Although some may contact the company, the vast majority present their questions to pharmacists who then commit the time to explain why the product they are looking for is not available and to recommend another product. I hesitate to even estimate the number of discussions (and the amount of valuable time committed) that pharmacists have had with consumers resulting from the recalls of just the Tylenol products and/or dosage issues relevant to these products. I was interested in the comments of an executive with McNeil Consumer that the company had received more than 73,000 phone calls in 2008 and 2009 about infants' and children's Tylenol products. Based on this number of calls received by the company during a two year period, I have to think that the discussions between consumers and pharmacists regarding Tylenol products number in the many millions.

In my opinion, Johnson & Johnson/McNeil Consumer should be greatly indebted to the nation's pharmacists for the amount and value of time they have devoted to providing responses to questions about recalls and dosage issues regarding Tylenol products (and its other recalled products). However, I am not aware of any acknowledgement or expression of appreciation from the company or its executives for the service and time committed by pharmacists in explaining/clarifying problems the company caused.

Even more confusion ahead
As Johnson & Johnson/McNeil Consumer begins to bring recalled products back to the market, it is making changes in the dosage recommendations for some Tylenol products. In late July, it announced "plans for new dosing instructions lowering the maximum daily dose for single-ingredient Extra Strength Tylenol products sold in the U.S. from 8 pills per day (4,000 mg) to 6 pills per day (3,000 mg). The dosage is designed to help encourage appropriate acetaminophen use and reduce the risk of accidental overdose." These new dosing instructions will appear on packages of this product this fall.

The announcement also notes that the company "will also be lowering the maximum daily dose for Regular Strength Tylenol and other adult acetaminophen-containing products beginning in 2012." It is my understanding that the maximum daily dose that will be recommended for Regular Strength Tylenol will be 3,250 mg (10 tablets each containing 325 mg), and that the maximum daily dose for Extended-release Tylenol will remain at 3,900 mg (6 caplets each containing 650 mg). As a consequence, there will be Tylenol products for adult use that have maximum daily doses of 3,000 mg, 3,250 mg, and 3,900 mg. How do these changes reconcile with the request from the FDA earlier this year that health professionals advise patients to not exceed the maximum daily dose of 4,000 mg?

The dosage changes being implemented give every appearance of being some sort of marketing strategy rather than a plan to enable optimum pain relief and safety. If anything, the title of this editorial, The Tylenol Follies, is too weak of a description for this plan. If it is really important that the maximum daily dose of Extra Strength Tylenol be reduced to 3,000 mg, why should the maximum dose of Extended-release Tylenol not also be reduced in a similar manner?

Johnson & Johnson/McNeil Consumer has acted unilaterally in changing the dosage of certain Tylenol formulations. The FDA has not required these changes to be made. There is no reason to think that the other companies that make acetaminophen-containing products will decide that it is wise for them to change to the same multiple maximum doses being implemented for Tylenol products. Although the Johnson & Johnson/McNeil Consumer announcement notes that it "...is working closely with other manufacturers of acetaminophen products to help ensure consistency in dosing instructions," what incentive is there for other companies to do that? Indeed, the company that markets the new formulation of acetaminophen that is administered intravenously has specifically confirmed that the approved dosage recommendations remain at 4,000 mg/day for adults. The FDA should require Johnson & Johnson/McNeil Consumer to rescind its plans to change the dosage of Tylenol products until dosage regimens that provide the best balance of efficacy and safety considerations can be identified and adopted by all companies that supply acetaminophen-containing products.

The Johnson & Johnson Credo
Johnson & Johnson has what I consider to be an exceptional Credo (that may be accessed on its website), but it has one very important omission in the first sentence (noted below):

"We believe our first responsibility is to the doctors, nurses, and patients, to mothers and fathers and all others who use our products and services."

The omission to which I refer is that pharmacists should be specifically identified as individuals to whom Johnson & Johnson has a responsibility. I have written to the current CEO and the previous CEO of Johnson & Johnson to specifically request this change. I received courteous responses from both individuals with the basic message (with my paraphrasing) that the company loves pharmacists but rarely changes its Credo.

Johnson & Johnson must no longer ignore the expertise, services, and time of pharmacists that have been of great value in the past success of its products and company. It should change the Credo now to include pharmacists. Our professional associations should take action to obtain this long-overdue recognition.

DRUG SHORTAGES - Pharmaceutical Companies Have Caused This Problem and it is Their Responsibility to Resolve it!

By Dr. Daniel A. Hussar who is the Remington Professor of Pharmacy at University of the Sciences' Philadelphia College of Pharmacy. He serves as the author and editor of The Pharmacist Activist newsletter (http://www.pharmacistactivist.com) from which this editorial was taken.

There have been numerous concerns voiced about the high cost of prescription medications to which the pharmaceutical companies have responded that this level of revenue is necessary to support their extensive research programs that will result in the development of new life-saving drugs. The companies have had their way and, unless there are strong competitive restraints, have been able to set the prices for their medications at whatever level they choose or, as some would suggest, whatever the market will bear. A recent example is ipilimumab (Yervoy), an important new drug for the treatment of metastatic melanoma, for which the cost of a four-dose treatment regimen is approximately $120,000. And it is not just these intravenously-administered monoclonal antibodies for which the cost is high. For example, the cost of the important orally-administered antibiotic linezolid (Zyvox) is more than $100 for each tablet.

Although the high cost of medications is a continuing concern, it is mentioned here primarily for context in considering what I would suggest is a related issue - drug shortages - including situations in which certain life-saving medications are not available on a timely basis at any cost.

Shortages of drugs used to be isolated experiences. However, in 2011 alone, more than 200 drugs have been in short supply and some of these situations have reached crisis proportions. There have been serious shortages of medications used in surgery (e.g., propofol), critical care situations (e.g., furosemide, norepinephrine, labetalol), and the treatment of certain cancers (e.g., cytarabine). Patients with a diagnosis of cancer have a huge challenge in coping with the implications of their illness. They should not have to experience the additional uncertainties and anxiety as to whether the medications they need will be available, or the fear prompted by a call from the oncologist to cancel an appointment because the dose of the medication to be administered is not available. The American Society of Health-System Pharmacists is providing important leadership in increasing the awareness and urging action with respect to the shortages and the extremely important risks presented, and the Food and Drug Administration is doing much more to identify situations in which drug shortages exist or can be anticipated. However, progress has been slow and the need for action is urgent.

Consequences of Drug Shortages

Some of the medications for which there are shortages are life-saving drugs and patients may be endangered when they are not available on a timely basis. This is clearly the consequence that requires the highest priority attention.

Price-gouging has been another consequence of the shortages, with the prices requested for some drugs being 50 times their usual costs. An article titled, "Drug Shortages Lead to price gouging," (Liz Szabo in USA Today, August 18, 2011, p. 3D) begins:

"Scalping tickets to a rock concert can get you arrested. But reselling lifesaving medications at a hefty markup is a thriving business."

The antihypertensive drug labetalol is often used in emergency situations and is one of the examples cited. The usual cost is approximately $25 a dose but some hospitals have been asked to pay as much as $1,200.

Shortage situations result in the development of a "gray market" in which drugs may not be available from the manufacturer or usual wholesaler(s), but can be obtained from "nontraditional" suppliers about whom little may be known. Such situations raise questions as to whether the stability and quality of the products have been maintained, and even whether counterfeit supplies of medication have been distributed in these secondary distribution channels. The profession of pharmacy should establish a "registry" of organizations and individuals who are involved as secondary suppliers of medications and/or in the sale of medications at prices that differ significantly from the usual price. This registry could have a Better Business Bureau-like role. Experiences of pharmacists who have purchased medications from these suppliers could be entered in the registry that could be accessed by other pharmacists considering such purchases.

There have been allegations that some of the current shortages may have been anticipated and that "speculators" were able to buy large quantities of these drugs that they were later able to sell at a much higher price. It does not require a leap of imagination to recognize that, for certain drugs, unscrupulous individuals could create a shortage by buying most of the supply at a relatively low price and reselling it at a much higher price when its availability has been artificially limited.

There are even allegations that some pharmaceutical companies may be using concerns about drug shortages as a scare tactic in the marketing strategies for certain of their drugs. This could be done by suggesting to pharmacies that they buy a larger-than-usual amount of a drug so that they would be assured of having an adequate supply in the event of a shortage. A variation of this strategy is to note that there is only a limited supply of an important drug (e.g., an anticancer drug) and, that to guarantee the continued availability of this medication for their patients, physicians should register them in a special program with the company.

Pharmaceutical Companies Must be Accountable

Most of the medications that are currently in short supply are not drugs for which sophisticated technology is required for their production or for which demand has unexpectedly and sharply increased. Various explanations for the shortages have been proposed including increased regulatory requirements and monitoring, less reliable sources of raw materials, and consolidation within the pharmaceutical industry. Some are advocating greater regulatory authority for the FDA and/or legislative action that would help prevent drug shortages. However, there has been too little attention given to the need for the pharmaceutical industry to be more accountable.

Many of the drugs for which shortages are of the greatest concern (i.e., life-saving or life-extending medications) are older drugs for which patents have expired resulting in their availability in less expensive generic formulations. These drugs are no longer highly profitable for the companies that developed and initially marketed them, and there is not an incentive for these companies to be certain that there are adequate supplies of these drugs available. Indeed, in a number of situations, a company that initially developed and marketed a drug that generated billions of dollars in profits during the period in which it had patent protection, discontinues marketing the drug or sells it to another company when generic equivalent products become available.

The pharmaceutical industry takes pride and credit, and rightfully so, for the development of life-saving drugs and many other medications that cure or effectively control numerous medical problems and/or greatly improve the quality of life. These companies justify the high prices for the medications they bring to the market by claiming that this revenue is needed to support the research programs that will result in the development of more life-saving drugs. However, if this pricing strategy of the companies is to be credible, and if the companies are to be recognized for the development of drugs that are of great value for patients, the companies must also accept the responsibility for assuring the availability of these drugs on a timely basis, even after patents have expired and they are available generically.

The pharmaceutical industry, collectively and as individual companies, must resolve the drug shortage problems that currently exist and should develop a system/strategy through which needed medications are available on an uninterrupted basis and shortages are avoided. One approach could be to have the FDA's initial approval of a drug include a commitment from the company to make supplies available on a timely basis unless, at some future time, there is agreement between the company and the FDA that there is no longer a valid need for the drug, or that arrangements deemed acceptable to the FDA are made through which the responsibility for supplying the drug is transferred to another company. In this latter situation, if a company is purchased by another company, the responsibility for maintaining the supplies of the medications would also be assumed by the purchasing company.

Express Scripts and Medco: A Fallen Giant OR a Bigger Monster?

By Dr. Daniel A. Hussar who is the Remington Professor of Pharmacy at University of the Sciences' Philadelphia College of Pharmacy. He serves as the author and editor of The Pharmacist Activist newsletter (http://www.pharmacistactivist.com) from which this editorial was taken.

It was only two months ago that my editorial was on the topic of mail-order pharmacy programs (May 2011 issue of The Pharmacist Activist - "Mail-Order Pharmacy Programs - Limitations, Inequities, and Deception"). However, the implications and concerns regarding the recent announcement that Express Scripts plans to buy Medco for $29.1 billion warrant further consideration of this topic.

Some background

The administration of prescription benefit programs has been dominated by three pharmacy benefit managers (PBMs) - Medco being the largest and followed in size by CVS Caremark and Express Scripts. Although it usually would not be expected that a smaller company would be in a position to acquire the largest company, Medco has recently lost three huge contracts including one with the insurer United Health Group (which now plans to manage its own prescription program) that accounts for approximately 17% of Medco's business. One suggested explanation underlying the planned acquisition is that Medco, rather than risking a further weakening of its position and unable to rule out the possibility of CVS Caremark selling its PBM to Express Scripts, identified to Express Scripts that it was receptive to being purchased. The proposed name for the combined company is Express Scripts Holdings Company and the current chairman and chief executive of Express Scripts will retain both his titles.

The potential for the new company to control the PBM marketplace in an anticompetitive manner has raised antitrust concerns and expectations of some that the acquisition will not be approved by the Federal Trade Commission (FTC). Others anticipate that the FTC will provide approval based on the reasoning that CVS Caremark, United Health, and smaller PBMs can provide sufficient competition in the marketplace.

Cost savings?

The executives of Express Scripts and Medco are promoting approval of the acquisition based, in large part, on their contention that the combined company will have sufficient influence to reduce the cost of prescription medications. Needless to say, a claim that a company can reduce the cost of any component of health care immediately attracts interest from government agencies, employers, unions, and others. However, before such a claim can be considered credible, important questions must be evaluated.

For a number of years the PBMs have operated in an essentially unregulated manner through which they have attained substantial influence, revenues, and growth. The first question that must be asked is: What has happened to the cost of prescription medications during this period of time in which the PBMs have had such a strong influence? The answer is that the cost of prescription drugs has markedly increased. Although some will quickly blame these increases on the pharmaceutical companies, why were the PBMs not able to reduce, or at least control, the costs of prescription medications in the recent past when they suggest they will be able to do so in the future if they are permitted to become bigger?

How will a combined Express Scripts and Medco be able to reduce the cost of prescription medications? The answer is that they will use their greater size and influence to obtain greater rebates from pharmaceutical companies and negotiate lower fees with chain pharmacies. And the independent pharmacies for which the PBMs dictate "take it or leave it" terms will be at an even greater disadvantage than they are now. The challenges that exist even now for independent pharmacies as a consequence of the PBMs' anticompetitive programs and policies should be reason just by itself for the FTC to reject the plan of Express Scripts to acquire Medco.

As unlikely as a reduction in overall costs of prescription medications would seem to be, some anticipated and unprecedented changes in the marketplace suggest that such a change could occur during the next several years. This is because there will be a large number of widely-prescribed and expensive medications (e.g., Lipitor, Plavix, Zyprexa, Lexapro, Seroquel) for which patent protection will expire and much less expensive generic formulations will become available. However, these opportunities for reduced costs of important medications will result regardless of whether Express Scripts and Medco exist as two companies or one company. Indeed, it will be very interesting to observe whether the PBMs pass on the savings to clients when they experience sharply reduced costs for these generic products.

If a reduction in the cost of prescription medications is attained as Express Scripts and Medco propose, who will be the beneficiaries of the savings? Most certainly these PBMs will retain as much of the savings as they can, and perhaps pass some of it on to their clients. If patients/consumers/the public experience any reduction in the cost of their prescription medications, it will be a very small fraction of the amount saved.

As I was writing this editorial, I received a communication from John Buck, the Editor-in-Chief of NEWS-Line Publishing, the organization that publishes The Pharmacist Activist. He is preparing a commentary regarding the proposed acquisition for another NEWS-Line publication, and shared the following observation:

"In searching for news and opinions about the merger, I found more articles on how to profit from it or on Wall Street's reaction to it, than its effect on the consumer, healthcare, or community pharmacies. That is just sad."

His comments are absolutely on target! The quality and scope of the services provided patients by pharmacists, as well as the timely availability and affordability of medications for patients, should receive the highest priority. However, these issues are rarely mentioned in the media coverage. Lest I also be considered guilty of an excessive focus on the economic issues, please also read my May 2011 editorial.

Some responses

As noted earlier, one of the ways in which the combined Express Scripts and Medco would expect to reduce the costs of medications is to reduce the compensation to participating community pharmacies. Therefore, not surprisingly, the National Community Pharmacists Association (NCPA) and the National Association of Chain Drug Stores (NACDS) were among the first to respond to the announcement of the planned acquisition with a statement that reads, in part:

"Today's announcement that Express Scripts will buy Medco creates a middle man that is too big to play fair, and will have immense power to unfairly dominate the market. This combination will monopolize control of the supply line for brand and generic prescription drugs, threaten access to pharmacy patient care, and is a bad deal for America for healthcare plans, for pharmacies, and - most notably - for patients."

I fully concur with this statement. The characterization of "too big to play fair" also invites the observation that these two companies, as well as CVS Caremark, have been viewed by many as being unfair and worse even as separate entities. This is reflected, in part, by their payment of hundreds of millions of dollars to settle claims of fraud and deceptive practices so that these companies can avoid acknowledging any wrongdoing and escape further prosecution. The anticipated consequence of permitting these companies to become bigger and wield more influence would be a further abuse of their power.

It is appropriate that NACDS has taken a strong position against the proposed acquisition. Even though individual chains can negotiate program terms and compensation with the PBMs, most are in a weak bargaining position when dealing with a huge PBM. It is noteworthy that the immediate past chairman of the Board of Directors of NACDS is the president and CEO of CVS Caremark, the strongest competitor of Express Scripts and Medco. The vice chairman of the NACDS Board is the president and CEO of Walgreens. Walgreens recently announced that it would not accept the terms of a new contract (with estimated revenue of more than $5 billion) offered by Express Scripts to participate in its prescription programs. In the face of the implications of the proposed acquisition of Medco, it will be very interesting to observe whether Walgreens stands its ground against Express Scripts or whether it reaches an agreement as it did last year when it threatened to discontinue participation in programs administered by CVS Caremark.

There has been very little comment regarding the proposed acquisition from the pharmaceutical companies that the combined and more powerful PBM will expect to provide greater rebates for their medications. It is ironic that the same pharmaceutical companies that initially caused the chaos regarding the pricing of pharmaceuticals may now be victims of the giant PBMs to whose growth the companies' pricing policies significantly contributed.

No opportunity to respond

There is another important group who either do not have a forum in which they can respond or there is not enough interest on the part of their company, the media or others in whether they have a response. This group includes the Medco pharmacists and other employees. When a deal valued at $29 billion is planned and implemented, company stock holders are expected to benefit and the highest level executives are provided substantial additional compensation and/or other benefits. Little or no attention is given to the welfare of the employees whose dedication and efforts have significantly contributed to the growth of a company to the point that it motivates another company to acquire it.

As strongly as I feel that the type and scope of pharmacy practice that I advocate can not be provided through a mail-order pharmacy program, I have a genuine concern for the Medco pharmacists and other employees whose lives will be affected by a decision that they probably did not know was even being considered. They have been sold out by their executives. Uncertainties regarding closing of facilities and loss of jobs or need for relocation are challenging at any time but particularly during the current economic climate that includes a tightened employment market for pharmacists.

Actions

Although the proposed acquisition of Medco by Express Scripts would have the largest impact on pharmacy practice and patient care in the community setting, it has important implications for the entire profession of pharmacy. Accordingly, the associations of pharmacy practitioners should object to the acquisition in a unified and strong voice to the FTC and our legislators. However, this should be viewed as a short-term intervention to prevent a bad situation from becoming worse.

The prescription benefit programs that are currently available have serious flaws, are a disservice to patients with respect to their limitations in quality and scope, and are inequitable for pharmacists. The profession of pharmacy must design better prescription benefit plans that give the highest priority to the provision of optimal drug therapy for patients by pharmacists who meet with and participate in the direct care of patients.

I am convinced that better programs can be developed that will also be cost-effective. The flawed programs administered by PBM "middlemen" are extracting billions of dollars from the health care system without participation in direct patient care and contributing nothing to the overall quality of pharmacy services. These resources must be redirected to programs that will attain positive outcomes.

The profession of pharmacy can not expect that the government, insurance companies, or PBMs will develop prescription benefit programs that will fully utilize the expertise and scope of services of pharmacists for the benefit of patients. As a profession, we must accept the responsibility for the development of a model prescription benefit program and secure the resources to evaluate it on a pilot basis. I am optimistic that a model program can be so successful and cost-effective that the wisdom of using it for much larger programs will be quickly recognized and embraced.

Pharmacy's Vision for 2015 OR a Large Surplus of Pharmacists?

By Daniel A. Hussar who is the Remington Professor of Pharmacy at University of the Sciences' Philadelphia College of Pharmacy. He serves as the author and editor of The Pharmacist Activist newsletter (http://www.pharmacistactivist.com) from which this editorial was taken.

The Joint Commission of Pharmacy Practitioners (JCPP) provides a forum in which the chief executive officers and chief elected officers of the national pharmacy organizations meet to discuss issues that are of importance to the profession. In late 2004 the JCPP developed the following vision statement that was endorsed the following year by all of the major pharmacy practitioner organizations;

"Pharmacists will be the health care professionals responsible for providing patient care that ensures optimal medication therapy outcomes."

This vision statement is followed by a discussion titled, "Pharmacy Practice in 2015," that addresses "The Foundations of Pharmacy Practice", "How Pharmacists Will Practice", and "How Pharmacy Practice Will Benefit Society". The section on "How Pharmacists Will Practice" is provided below:

How Pharmacists will Practice. Pharmacists will have the authority and autonomy to manage medication therapy and will be accountable for patients' therapeutic outcomes. In doing so, they will communicate and collaborate with patients, care givers, health care professionals, and qualified support personnel. As experts regarding medication use, pharmacists will be responsible for:

• rational use of medications, including the measurement and assurance of medication therapy outcomes;
• promotion of wellness, health improvement, and disease prevention;
• design and oversight of safe, accurate, and timely medication distribution systems.

Working cooperatively with practitioners of other disciplines to care for patients, pharmacists will be:

• the most trusted and accessible source of medications, and related devices and supplies;
• the primary resource for unbiased information and advice regarding the safe, appropriate, and cost-effective use of medications;
• valued patient care providers whom health care systems and payers recognize as having responsibility for assuring the desired outcomes of medication use.

I fully concur with this vision statement and its accompanying responsibilities. It is progressive and bold, and will serve individual patients, society, and the profession of pharmacy well. Nothing would please me more than to see this vision implemented in as comprehensive a manner as possible. However, I have serious concerns regarding what I consider to be the very slow pace in the progress toward implementing this vision, or even actively discussing it and establishing plans.

I recognize that the year 2015 is a goal and not a rigid deadline for implementing the vision statement. However, we are now closer to 2015 than to 2004 when the statement was developed, and it is appropriate to assess the progress that has been made and what remains to be accomplished. The profession can identify programs such as the Asheville project, an increasing number of medication therapy management (MTM) programs, the Pharmacy Practice Model Initiative, and some innovative practice opportunities as evidence of positive steps in implementing the vision. As important as these activities are, they often exist in isolation rather than as a type or standard of practice that is provided for more than a limited population. The result is that the vast majority of patients/society has no understanding or experience with the role and responsibilities articulated for pharmacists in the vision statement. Indeed, there are many pharmacists who do not feel prepared or are not otherwise eager to assume the responsibilities of the vision.

It would be expected that organizations of pharmacists, colleges of pharmacy, and pharmaceutical manufacturers would be among those having the strongest interest and commitment to having pharmacists assure optimal medication therapy outcomes. Yet, it is my impression that only a small fraction of these organizations provide a health benefit program for their employees that includes MTM and related services from pharmacists. If the organizations whose own interests are best served by the inclusion of such a benefit for their employees do not insist on this coverage, how can it be expected that other organizations and government programs with less knowledge of the value of these services will be motivated to provide them as a benefit?

Whose responsibility?
It was appropriate that the vision statement for pharmacy practice was developed by representatives of a coalition of pharmacy practitioner organizations. However, the development of the statement can be considered to be the easy part of the process. To make this vision a reality is a much more formidable challenge.

The implementation of the vision will not occur without clear direction, strategies, and plans, as well as the resources to support them and the collaboration of the other professions and organizations whose support will be necessary. It will not be accomplished by the action of one or several pharmacy organizations, or even multiple organizations working independently. The same coalition of pharmacy organizations that developed the vision statement must assume the responsibility for the planning and implementation steps that will ensure the intended outcomes. But is this discussion and collaboration occurring?

The need
There is no question that there is an important need for the outcomes identified in the vision for pharmacy practice (i.e., optimal medication therapy outcomes). Pharmacists have the expertise and are strategically positioned to provide the information, counseling, monitoring, and services needed to ensure optimal drug therapy outcomes and their resultant overall contributions to the improvement of health care. There has been extensive publicity regarding drug-related problems (e.g., adverse events, drug interactions, noncompliance, medication errors) and their resultant harm to patients, as well as the billions of dollars in costs incurred to manage often-preventable problems. Patients, health professionals, and society should not continue to tolerate the current situation. But, if pharmacy will not assume the responsibility for ensuring optimal medication therapy outcomes, others (e.g., nurse practitioners, physician assistants) will have to!

The supply of pharmacists
Until recently there had been a shortage of pharmacists in many areas of the United States. However, during the last two years the job market for pharmacists has tightened and there is now a surplus of pharmacists in some areas. A paradoxical situation exists in which, at the same time that there has probably never been a greater need for the expertise and services of pharmacists, many pharmacists are having difficulty identifying a full-time position. This situation makes it all the more important that the profession of pharmacy be successful in implementing its vision for pharmacy practice.

If pharmacists are used to ensure optimal medication therapy outcomes to the extent such services are needed, many more pharmacists will be needed than are currently available. Indeed, there could be a shortage of pharmacists for the foreseeable future, even with the rapidly increasing number of pharmacy graduates. If, however, our profession is not successful in implementing its vision and/or health professionals other than pharmacists assume these responsibilities, the surplus of pharmacists being observed in some areas could increase precipitously with numerous ramifications. The potential for this situation must also be addressed with high priority by our profession (please also access the editorials in the August 2008 and July 2010 issues of The Pharmacist Activist).

Urgent action is needed
Through the JCPP the profession has identified an exceptional vision for the practice of pharmacy that is of great value for patients and society. The "match" between the need for better medication outcomes for patients and the expertise and services that can be provided by pharmacists is seemingly a perfect fit. However, the challenges to successfully implement the vision are huge and demand an unprecedented commitment and collaboration of our practitioner organizations. I want to believe that within our profession we have the will, resolve, and leadership to be successful in attaining our vision.