February 2002

From: Mylan Pharmaceuticals

New products are the lifeblood of every pharmaceutical company.  That's why each year we are proud to highlight our new products (and our existing products!) in the Mylan Pharmaceuticals Product Identification Guide, which is enclosed.

As a result of new approvals and acquisitions, we have increased the number of products in our line by nearly 20% over the past two years.  Our most recent introductions have included:

 Buspirone Hydrochloride Tablets

 Butorphanol Tartrate Nasal Spray 

 Enalapril Maleate and Hydrochlorothiazide Tablets

 Etoposide Capsules

 Famotidine Tablets

 Lovastatin Tablets

 Sotalol Hydrochloride Tablets

 Spironolactone Tablets

This grotwth, coupled with the ongoing commitment of pharmacists who dispense our products every day, has helped Mylan remain the #1 most dispensed line of pharmaceutical products in America--branded or generic.*

Please review this year's Product Identification Guide and make note of the Mylan Products that you would like to add to your line.  Then call your healthcare distributor to order. . . .and be sure to ask for The Mylan Brand by name.  If your supplier does not stock the Mylan Product(s) that you need, please call us at 800-RX-MYLAN and we will direct you to a supplier that does.  For future reference, you may wish to insert this Identification Guide in the 2002 PDR® or RedBook.®

As always, we remain committed to providing you and your patients with the products and services that are most needed.  After all, we know that you have a choice. . . .and we hope that choice will continue to be Mylan.

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Important notice concerning increased availability of ALPHAGAN® P

From ALLERGAN  02-05-02

ALLERGAN is pleased to let you know that ALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.15% is being well received in physician offices everywhere.  ALPHAGAN® P continues to be readily available to your patients and is in good supply for all retail drug stores through normal ordering channels.  Allergan is committed to ensuring that the rising demand of ALPHAGAN® P continues to be met and that product is easily obtainable by patients for whom it is prescribed.

As a reminder, the ordering information for ALPHAGAN® P ophthalmic solution is as follows:

• 5 ml NDC 0023-9177-05

• 10 ml NDC 0023-9177-10

• 15 ml NDC 0023-9177-15

Thank you for your support of Allergan products, especially ALPHAGAN® P.

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January 2002                                                                      

From: GlaxoSmithKline

GlaxoSmithKline (GSK) is very excited to provide the Orange Card for seniors and the disabled enrolled in Medicare who have annual incomes below $26,000 single/ $35,000 couples and are currently without public or private insurance coverage for prescription medicines.

We would like to clarify some details about the Orange Card and clear up any confusion regarding this program that may have been created by a recent article in Pink Sheet.

GSK wants Orange Card prescriptions filled through a broad retail network.  It is our hope that all pharmacies will accept the Orange Card and continue to provide the current level of personal customer service and counseling to these patients.

GlaxoSmithKline is committed to being a leader in many areas from research to delivery of medicines to the world.  The Orange Card is the latest example of our commitment to work collaboratively with physicians and pharmacies to meet the needs of patients.

We hope that you will join us in this effort.  We look forward to making this program a success for your elderly and disabled patients in need.

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From AMIRA MEDICAL   January 2002

Important information From AMIRA MEDICAL AtLast® Blood Glucose System

To Pharmacists:

Recently, Amira Medical, manufacturer of the AtLast Blood Glucose System, was purchased by Roche Diagnostics, maker of Accu-check diabetes management products. Amira has valued you as a customer. Roch Diagnostics is equally committed to supporting you and your patients. The AtLast product was discontinued as of December 2001. Below is information to asssist you in managing and informing your patients. Over the next several months, this information will be communicated to all patients currently using the AtLast System.

1. AtLast System Kits were discontinued December 14, 2001. AtLast Test Strips and Lancets will be available through April 30, 2002.

2. All Atlast users will have access to a replacement meter from the Accu-Chek line of products, including the newest member, Accu-chek Active Meter, which can be used to test on less sensitive parts of the body, such as the forearm.

3. To familiarize themselves with the Accu-chek family of products, your patients also can be encouraged to visit the website at www.accu-chek.com.

4. Until their conversion to the Accu-chek brand, Atlast users may continue to contact AtLast Customer Care at 1-877-264-7263 with any questions regarding use or operation of their AtLast meters.

Please feel free to contact your Roche sales representative or Accu-chek Customer Care at 1-800-440-3638 for additional information. Thank you again for your support of Amira Medical and the AtLast System.

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ABBOTT Abbott is aware of the news reports circulating today regarding Synthroid.  Abbott wants to reassure patients, physicians and pharmacists that Synthroid is a safe and effective treatment for hyperthyroidism.  Abbott will be submitting a New Drug Application (NDA) in accordance with FDA guidelines in order to ensure that the eight million patients effectively treated with Synthroid have continued to access to their medication.  Abbott has notified the FDA of its intents to submit its NDA and is working cooperatively with the agency to meet the filling time frames. Like some other drugs that were marketed before 1962, Synthroid and all other levothyroxine sodium products did not receive formal approval from FDA,  In 1997, FDA issued a Federal Register notice calling for all manufactures of levothyroxine sodium products to either submit an NDA, or to file a citizen petition to show that their products are not new drugs, and therefore do not require a NDA.  In compliance with this notice, Knoll, the manufacturer of Synthroid at the time, filed a citizen petition in 1997 requesting that FDA acknowledge that Synthroid could be given a legal designation, "generals recognized as safe and effective." (GRASE/E) Abbott obtained Synthroid on March 2, 2001, through its acquisition of BASF Pharma/Knoll.  On April 27, 2001 FDA informed Abbott that it would not grant GRAS/E status for Synthroid under Knoll's citizen petition.  Abbott Laboratories promptly responded that it would submit an NDA for Synthroid. Synthroid is the leading levothyroxine sodium product that has been trusted by physicians and patients for 42 years.  The safety and efficacy of Synthroid has been extensively studied and validated.  The results of these studies have been published in prominent peer-review journals such as New England Journal of Medicine.  The place of Synthroid in clinical practice is well established as a trusted therapy by physicians, and by the more than eight million patients with hypothyroidism depend on it every day. "Synthroid is a tried and trusted product with decades of use and physicians and patients should continue to have confidence in Synthroid," Said Leonard Wartofsky, M.D., chairman, Department of Medicine, Washington Hospital Center, Washington, D.C.  "It would be dangerous for patients if Synthroid were removed from the market." Physicians and patients should understand that FDA has not made a determination that any levothyroxine sodium product, on the market with or without NDAs, are interchangeable with another.  Therefore, these products have not been determined to be therapeutically equivalent by FDA.  The FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations, does not list any levothyroxine sodium products as therapeutically interchangeable.  Switching from Synthroid to another levothyroxine sodium product would require individual alteration by a physician. As part of the delicate endocrine system, the thyroid gland impacts essentially every cell, tissue, and organ in the body. Guidelines  several endocrinology organizations, such as the American Association of Clinical Endocrinologist (AACE), state that, once established, thyroid patients should be maintained on the same brand of medication throughout the treatment.  If changes in the medication brand are made, costly re-testing must occur to ensure proper dose adjustment treatment. Thyroid hormones, either alone or together with other medications, should not be used for the treatment of obesity, and should not be taken by patients with untreated thyroticosis (excess of thyroid hormone), uncorrected adrenal insufficiency, or apparent hypersensitivity to thyroid hormones or any inactive product constituents.  Adverse events to Synthroid other that those related to thyrotoxicosis as a result of overdose are rare:  however, if a patient experiences any unusual symptoms, he or she should consult with their health care provider. Abbott Laboratories is a global, diversified health care company devoted to the discovery, development, manufacture, and marketing of pharmaceuticals, nutritional, and medical products, including devices and diagnostics.  The company employs approximately 70,000 people and markets it products in more than 130 countries. Abbott's news release and other information are available on the company's web site at  http://www.abbott.com. Responses to Synthroid News Reports for Pharmacists Q:      Will Synthroid remain available? A:       Abbot will be submitting a New Drug Application (NDA) in accordance with the FDA guidelines as part of its commitment to providing continued access to Synthroid to the eight million patients who rely on it everyday.  Abbott has notified the FDA of its intent to submit its NDA and is working cooperatively with the agency to meet the filing timeframes. Q:       Can I continue to fill Synthroid prescriptions? A:        Synthroid continues to be available for patients.  Abbott Laboratories reminds you of Synthroid's long history of clinical use in millions of patients.   Abbott wants patients, physicians and pharmacists to know that the clinical use of Synthroid has been extensively studied.  The results of these studies have been published in prominent peer-reviewed journals such as the New England Journal of Medicine.  More than eight million patients with hypothyroidism depend on Synthroid everyday. Q:       What should pharmacists tell patients? A:       Synthroid continues to be available for patients.  Patients should discuss this matter with their physician if they have other concerns.             Physicians and patients should understand that FDA has not determined that any levothyroxine sodium product, on the market with or without and NDA, in interchangeable with another.  Therefore, these products have not been determined to be therapeutically equivalent by FDA.  The FDA publication, Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), does not list any levothyroxine sodium products as therapeutically interchangeable.             As part of the delicately-balanced endocrine system, the thyroid gland impacts the entire body.  Guidelines of several endocrinology organizations, such as the American Association of Clinical Endocrinologists (AACE), state that, once stabilized, thyroid patients should be maintained on the same brand of medication throughout treatment.  Switching brands requires re-testing in order to ensure proper dose adjustment. Q:      Why doesn't Synthroid have FDA approval? A:        Like some other drugs that were marketed before 1962, Synthroid and all other levothyroxine sodium products did not receive formal approval from FDA.  In 1997, FDA issued a Federal Register notice calling for all manufactures of levothyroxine sodium products to either submit and NDA, or to file a citizen petition to show that their products are not new drugs, and therefore do not require and NDA.  In compliance with this notice, Knoll, the manufacturer of Synthroid at the time, filed a citizen petition in 1997 requesting that FDA acknowledge that Synthroid could be given in a legal designation, "generally recognized as safe and effective." (GRAS/E).   Abbott obtained Synthroid on March 2, 2001, through its acquisition of BASF Pharma/Knoll.  On April 27, 2001 FDA informed Abbot that it would not grant GRAS/E status for Synthroid under Knoll's citizen petition.  Abbot Laboratories promptly responded that it would submit an NDA for Synthroid. Clinical Use and Safety Information Synthroid is used to treat hypothyroidism.  Thyroid hormones, either alone or together with other medicines, should not be used for the treatment of obesity, and should not be taken by patients with untreated thyrotoxlcosis (excess of thyroid hormone), uncorrected adrenal insufficiency, or apparent hypersensitivity to thyroid hormones or any inactive product constituents.  Adverse events to Synthroid other that those related to thyrotoxlcosis as a result of overdosage are rare; however, if a patient experiences any unusual symptoms, he or she should consult with their health care provider. Please see Synthroid Full Prescribing Information go to Abbott.com

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Pfizer Presents New Information on Head Lice Resistance.

We know that parents rely on your consultation about their health and the health of their children, and you're probably fielding more than a normal number of calls from parents who are confused and concerned about how they should treat an outbreak of head lice in their family.

Media coverage of head lice resistance has been melodramatic and at times, incomplete and inaccurate. The recent anecdotal reports of a resistant"super louse" and its resistance to conventional, proven therapies has produced an abundance of home treatments which cover the spectrum from dangerous to absurd-ie, kerosene, petroleum jelly, even mayonnaise.

Pfizer wants to try to differentiate fact from faction. The following is a summary of the current facts regarding resistance associated with three products available in the United States for the treatment of head lice:

Low-level resistance to lindane appeared upon its introduction over 50 years ago.

Resistance to permethrin ( a synthetic pyrethroid) has been suggested as a cause of treatment failures in the U.S. and elsewhere. Permethrin leaves an active residue, which diminishes over time, advancing the theory that a suboptimal level of pediculicide may cause some lice to survive and give rise to resistant strains.

Pyrethrin/piperonyl butoxide, the active ingredients in RID Shampoo, (pyrethrin is also known as pyrethrum extract) does not leave an active residue. Piperonyl butoxide has been show to suppress the development of resistance in sheep lice. The properties of pyrethrin/piperonyl butoxide preparations may hamper the ability of human head lice to develop resistance, a view supported by the lack of any documented evidence for this type of pediculicide resistance.

A recent trial conducted by the Harvard School of Public Health and published in Archive of Pediatrics and Adolescent Medicine studied the survival of head lice exposed to permethrin. The study concluded that head lice in the U.S. show some degree of resistance to permethrin. Pyrethrin/piperonyl butoxide was not studied.

Clinical Data: Both pyrethrin/piperonyl butoxide and permethrin formulas have met Food and Drug Administration standards for safety and effectiveness, have been used in the U.S. for nearly 20 years and are the preferred treatments today.

How can you be sure your recommendations are still the most effective ones? We, at Pfizer, believe that your recommendation of Maximum Strength RID Shampoo is well placed. It is proven safe and effective by rigorous clinical testing.

Pfizer's RID Shampoo, when used as directed, and in concert with careful lice egg removal, is a dependable, efficacious and safe therapy for the vast majority of patients who encounter a head lice infestation. However, lice treatment must be used properly. Reapplication of the shampoo and egg removal are required to ensure complete effectiveness. See label for important infomation on safety and effectiveness. Proper treatment is the best defense against head lice infestation.

Our multilanguage patient instruction material is unsurpassed in thoroughness, claity, and simplicity.

It is available to you at no cost. Please call 1-800-RID-LICE to obtain what you need. Our web site www.licerid.com also guides parents through the treatment process step by step.

Maximum Strength RID Shampoo will get rid of your patients' head lice problems. We guarantee it ...with a money-back guarantee.

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A Case Study Illustrating Professional Care Judgement Within an Ethical Framework, by Julia C.  Jean-Pierre, PT, MSH.

Physical Therapy in the long term care setting is a challenging profession. Because the occupation is called physical therapy, most people would assume that decisions about moving and positioning of individuals are the most crucial. However, sometimes even more important professional decisions can result from moral and ethical contemplation about whether to continue treatment or not with a particular patient.

Recently at my workplace, a favorite resident of our facility suffered a majorly debilitating cerebral vascular accident. Prior to this episode, the resident was conversive, ambulatory and independent in all activities of daily living. After the event, the resident was virtually non-responsive and dependent for all mobility skills and care. All three disciplines Occupational Therapy, Physical Therapy and Speech Therapy received orders from the resident's physician for evaluation and treatment as indicated. After a three day evaluation of the patient, it became obvious to me, having seen many individuals with similar medical backgrounds, age and cerebral vascular accidents that the prognosis for the patient was very poor. My decision was to set up a comprehensive range of motion and positioning program for the patient and to discharge him from physical therapy services in one week, when all nursing staff had been inserviced on the patient's program. Occupational and speech therapy decided to treat this resident on an on-going basis, seeing more potential in the patient's outcome and possibly not wanting to "give up" on this once vibrant resident of our facility. Part of my decision was that the physical therapy department would continue to communicate with occupational and speech therapy and personally screen this patient every two weeks to see if the condition improved to warrent re-initiation of physical therapy services. The decision to discontinue physical therapy treatment in this individual presented a conflict between my personal moral and professional codes, making it a difficult decision.

My personal moral code includes the principle of not depriving any individual of beneficial skilled physical therapy intervention. In this case this belief was intensified by the individual's high level of activity prior to the cerebral vascular accident. Another facet of the dilemma reflected the rights of the individual since my moral code also includes the belief that all people have the right to receive the best care possible. Even though nursing could perform the patient's range of motion and positioning program, a skilled physical therapist would most probably do a superior job. In another way, the principle of nonmaleficence was called upon. By not providing the daily skilled physical therapy service, was this ultimately goig to harm the patient by not allowing him to improve with a more vigorous program? The final moral principle that influenced me was justice. My feeling that all individuals, no matter what age or diagnosis should receive the same degree of healthcare made it difficult to decide whether the individual should continue to receive physical therapy services or not.

On the other hand, my professional code of ethics presented some opposing views. Although all of the moral principles apply to my professional code of ethics as well, the professional ethic of beneficence was applicable. Although the patient may benefit from continued physical therapy treatments, would the outcome from these treatments balance the cost? Even fifteen minutes of physical therapy treatment is very costly, and it isn't professionally ethical to keep a patient on a caseload for financial or personal reasons, even if you have the reasonable expectation that the patient will receive some benefit from these treatments. Additional professional direction is provided through the Medicare system in this instance. Medicare states clearly that the rehabilitation services should not be performed unless there is documentable progress in each case. This is an important part of the physical therapy code of ethics as well which implies we must not provide unneeded services just to increase financial gain. One final part of my professional code of ethics played a role in my decision, and this is discernment. It was very important that I was able to problem solve and reach my decision without being unduly influenced by personal attachment to this favorite resident or his rather assertive family which was resistant to the idea of discontinuing the resident's treatment.

There was a rather obvious conflict between moral code and principles and professional principles. In summary, morally I was drawn to the ideas of providing skilled service to this patient so that he might receive the best possible treatment, but professionally I knew that the cost versus benefit issue made continued treatment unreasonable.

Further conflict arose when occupational and speech therapy decided to continue daily treatment with this individual, both of these disciplines felt my decision was incorrect, even though the resident would continue to be considered for re-initiation of treatment, if any improvement in status was recognized. The conflict was resolved by realizing that part of my motivation for wanting to keep the patient active in occupational and speech therapy felt my decisionwas hasty and was not compassionate enough. There were several antagonistic discussions regarding the reasons and ramifications of my decision. Secondly, the patient did not receive the amount of range of motion exercises that I had deemed minimally necessary from nursing. This resulted in several frustrating attempts to increase carryover of my instructions, knowing had I kept the patient on my caseload the proper instructions would been followed. Thirdly, five weeks later, the patient died. This reaffirmed the fact that my decision was the appropriate one. Occupational therapy continued to see the patient until the end, showing what I perceive as misuse of silled therapeutic intervention.

In this instance, after being temporarily caught between apparently equal but conflicting principles, I was able to deliberate about the situation to come to a successful justification of my decision so that the patient received appropriate medical care for this particular situation. However all decisions of this sort are ethically very difficult since moral, emotional and professional factors come into play. Each new situation requires new deliberation.

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