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Each issue will include an editorial on a topic that is important for the profession of pharmacy, as well as a review of a new drug that includes a comparison of the new drug with previously marketed drugs that are most similar in activity, and a New Drug Comparison Rating (NDCR) for the new drug. Read on for this month's issue.
May 2010 Issue
Guide to Selecting a Pharmacist*
New Drug Review
Click Here to download PDF format
Herb Denenberg - The Ultimate Activist and a Great Friend of Pharmacy
Herb Denenberg died on March 18, 2010. His credentials and accomplishments would fill a book, and a short list includes PhD and JD degrees, service as the Insurance Commissioner and Public Utility Commissioner in Pennsylvania, a professorship at the Wharton School of the University of Pennsylvania, service as a consumer and investigative reporter for several television stations, columnist for newspapers, authorship of insurance laws and a widely acclaimed series of shopper's guides regarding insurance and health care, and membership in the Institute of Medicine of the National Academy of Sciences. He was the recipient of hundreds of awards in recognition of his accomplishments.
The following tributes are examples that capture the passion and expertise that characterized Herb's work:
From NBC Philadelphia:
"He spent his life fighting for the little guy."
"He made the news because he made a difference. Many consumers have better, safer choices because of Herb."
"You could not intimidate Herb and he never thought twice about going head to head with product makers, big business or the government to right a wrong."
From Pennsylvania Governor Ed Rendell:
"He wasn't afraid of taking on anybody, any politician, any company, any multinational. He didn't care. If he thought things had to be changed, he went after it with a vengeance."
From Ralph Nader (at the time Herb was Pennsylvania Insurance Commissioner):
"He's clearly the most consumer-oriented insurance commissioner in American history."
However, it was not the awards and tributes that motivated Herb to be such a driven activist on behalf of consumers ("the little guys"). He had a genuine concern for the health and welfare of his fellow man, and was not willing to tolerate the deception, indifference, and incompetence that characterized many of the issues and individuals he addressed. He identified what motivated him in this manner: "My greatest satisfaction is keeping some kid from drinking poison or making some government agency do what it is supposed to do."
The pharmacy connection
When Herb Denenberg was the Pennsylvania Insurance Commissioner in the early 1970s, he had great concerns about the health care system and how he felt it was failing consumers. He made some very critical comments regarding pharmaceutical and insurance companies, hospitals, and health professionals, including pharmacists. Many of his criticisms were valid but we felt that his comments about pharmacists were off target and did not reflect an understanding of the importance of the expertise and professional services of pharmacists. We requested a meeting to which he quickly agreed. Approximately 20 pharmacists from throughout Pennsylvania came to Harrisburg and met with him. What was initially anticipated to be a brief meeting extended for more than two hours. He was attentive to our response to his criticisms, he asked questions, he listened, and he was surprised by our description of the role and services of pharmacists of which he was previously unaware. I was very impressed by his receptiveness to our comments and by his desire to learn more.
The outcome of this meeting was far more positive than we could have ever anticipated. Herb became an enthusiastic advocate for pharmacists and the importance of patients speaking with their pharmacists, although he reserved the right to be critical when we deserved it. In the mid-1970s, he wrote one of his renowned "Guides" on the topic of, "How to Choose Your Pharmacy," that was published in Parade magazine, a supplement to Sunday newspapers across the country. His promotion and enthusiasm for our profession and our role was more effective and persuasive than what most of us within the profession could have written.
Herb and I became good friends. Although his interests were broad-based, health care and drug therapy were among his favorite topics. He would usually speak with me when he was developing a newspaper column regarding medications, and I was often a guest on his television and radio interviews/programs. I have been the beneficiary of his wisdom and perspectives. He demonstrated the importance of having the courage of your convictions and being bold in communicating them. He was the ultimate activist and I highly value what I learned from his example.
In 1999, we asked Herb to update his "Guide to Selecting a Pharmacist," and it was published as a supplement to the American Pharmacists Association's publication, Pharmacy Today. I have reprinted two of the six sections of the "Guide" on the accompanying page. His observations continue to be so important and timeless that not a single word needs to be changed. I encourage you to use this in your interactions with your patients and in your communities (it is not necessary to obtain permission). It would be one more way to honor this great friend of pharmacy.
Herb Denenberg is survived by Naomi, his wife and highly capable contributor to his commentaries and to his success. Naomi has experienced some health challenges in recent years and Herb was devoted to her care.
Daniel A. Hussar
Guide to Selecting a Pharmacist*
by Herb Denenberg**
Tips for choosing your pharmacist
Look for a broad range of expertise and services. You need to be sure the pharmacist is knowledgeable about the proper use of over-the-counter medications and all the prescriptions you use.
Select a pharmacy and stick with it. Using more than one pharmacy can put you in jeopardy if you are taking several kinds of medications.
Get recommendations from doctors, nurses, and other health care workers as well as from friends and relatives. Pharmacists build their practices around satisfied patients and excellent relationships with other health care providers.
Talk with the pharmacist and observe the pharmacist at work. Look for evidence of professionalism and expertise. Check the atmosphere, too: Is the pharmacist always rushed and overworked? Does the pharmacy have a location set aside for consultations with the pharmacist?
Ask the pharmacist questions. Is the pharmacist readily accessible and approachable? If you need more than a few minutes of the pharmacist's time, is the pharmacist willing to telephone you or set aside a time for an appointment to spend more time with you?
Look for a pharmacist who is your health care advocate. A pharmacist must be willing to give you specific recommendations that help you address your needs. A pharmacist must be willing to refer you to other health care professionals and to work with your physician directly when needed.
Make sure the pharmacist asks about and keeps records of your medical history. To advise you properly or to share information with your physician, the pharmacist must know your medical history. Your history should include personal data (such as age, height, and weight), medical conditions, and all medications you take (including prescription and over-the-counter medications and any vitamins or other nutritional supplements). The pharmacist is bound to maintain the confidentiality of that information.
Determine how effectively the pharmacist communicates. The pharmacist must be able to provide verbal and written instructions, and they should be clear and specific. You should feel confident about the information you receive, and you should feel comfortable enough to return for more advice or telephone the pharmacist if you have questions.
Choose a pharmacist who looks for ways to help you keep to your medication regimen. The pharmacist should be ready to help you find solutions to issues that may affect your ability to follow advice and to take your medications as directed. This might include talking to your doctor about ways to simplify drug therapy or reduce the number of doses, checking for insurance coverage, or exploring less expensive alternatives.
Be an active, informed health care consumer. Your pharmacist should welcome your inquiries and assist you in learning more about your health care.
Your pharmacist and you: partners in health
Today more than ever, you—the patient—are the most important person on your health care team. Your pharmacist is trained and ready to help you take charge of your health.
So take advantage of the expertise of your pharmacist and the full range of medication counseling and wellness support that today's professional pharmacist has to offer. Talk to your pharmacist about the role that medications, self-care products, home health medical devices, and nutritional supplements can play in achieving better health. Go to your pharmacist when you're trying to decide whether a minor problem can be safely self-treated or requires a doctor's advice and care. Get recommendations from the pharmacist when you're trying to choose an over-the-counter medication or when you're having trouble taking your prescription medicines.
The pharmacist is your partner in health. So choose wisely—and look for the best. You owe it to yourself!
*These two sections are excerpted from a longer "Guide" that was published by the American Pharmacists Association as a supplement in Pharmacy Today.
**The late Herb Denenberg was an acclaimed consumer and investigative reporter whose numerous responsibilities included service as Pennsylvania Insurance Commissioner.
New Drug Review
(Ampyra - Acorda)
Agent for Multiple Sclerosis
New Drug Comparison Rating (NDCR) = 4
in a scale of 1 to 5, with 5 being the highest rating
As a treatment to improve walking in patients with multiple sclerosis (MS).
None (The other medications that have been approved for the treatment of patients with MS are indicated for the management of other symptoms and/or parameters of the disease.).
- Is the first drug to be demonstrated to be effective in increasing walking speed in patients with MS;
- Has a unique mechanism of action (potassium channel blockade);
- Is administered orally.
Most important risks/adverse events:
- Most patients in the clinical studies did not experience benefit;
- Risk of seizures;
- Available only in a restricted distribution program.
Risk of seizures (contraindicated in patients with a history of seizures; use should be discontinued in patients who experience a seizure during treatment; clearance is reduced in patients with renal impairment and seizure risk is increased (contraindicated in patients with moderate or severe renal impairment; estimated creatinine clearance should be known before initiating treatment; in patients with mild renal impairment, plasma concentrations may be higher than those associated with the recommended dosage, and treatment should be closely monitored); should not be used in patients being treated with another formulation of the drug (also known as 4-aminopyridine and fampridine); should not be used by a nursing mother.
Most common adverse events:
Urinary tract infections (12%), insomnia (9%), dizziness (7%), headache (7%), nausea (7%), asthenia (7%), back pain (5%), balance disorder (5%).
10 mg twice a day, approximately 12 hours apart; this dosage should not be exceeded and, if a dose is missed, double or extra doses should not be taken.
Extended-release tablets - 10 mg; available only through a limited network of specialty pharmacies and Kaiser Permanente.
The symptoms most often associated with MS include fatigue, vision problems, numbness in the limbs, loss of balance/coordination, and difficulty walking. The medications that have been approved to treat various symptoms/stages of MS include interferon beta-1a (Avonex, Rebif). interferon beta 1-b (Betaseron), glatiramer acetate (Copaxone), mitoxantrone (Novantrone). and natalizumab (Tysabri). Dalfampridine is also known as fampridine and by its chemical name, 4-aminopyridine. It is a potassium channel blocker that, in animal studies, has been shown to increase conduction of action potentials in demyelinated axons. It was evaluated in two clinical trials in which the primary measure of efficacy was walking speed as measured by the Timed 25-foot walk. A significantly greater number of patients treated with the drug showed faster walking speed compared with patients receiving placebo (35% vs. 8% and 43% vs. 9% in the two studies).
The most important concern with the use of dalfampridine is the risk of seizures, which is dose related, and the contraindications and warnings regarding this risk must be observed. Approximately 90% of a dose of the drug is excreted unchanged in the urine, thereby increasing the risk of seizures in patients with impaired renal function.
Unlike most new drugs, dalfampridine was available (as 4-aminopyridine) before it was officially approved by the FDA, and some physicians have prescribed it in formulations compounded by pharmacists. Precautions must be observed to prevent patients from taking more than one product containing this active ingredient.
Daniel A. Hussar