While it is unpredictable how badly we will be affected by the upcoming flu season, it is estimated that the seasonal flu leads to approximately 200,000 hospitalizations and somewhere between 3,000 and 49,000 deaths each year, according to the Centers for Disease Control and Prevention (CDC). Flu season may begin as early as October and typically peaks in January or late February. Flu season can last as late as May, but usually eases up in March or April.

With all the reports in the news lately about parents not wanting to vaccinate their children, it begs the question, do adults themselves not get vaccinated either? Vaccination is one of the most important ways to avoid disease. With flu season knocking on the door, I thought a flu vaccine refresher course was in order. Here’s what you need to know!

Flu Vaccine Fast Facts

• 2011-2012 flu vaccine will protect against three flu viruses anticipated to be most common during the season
• According to the CDC, vaccination against the flu is recommended for all people six months of age and older in the United States
• There are four types of flu vaccines available: the traditional injection which is injected into the muscle; a high-dose injection for people 65 years of age and older; a new injection which is injected with a smaller needle into the skin; and a nasal spray
• Annual flu vaccinations should begin in September and continue throughout flu season
• Currently, manufacturers are projecting roughly 170 million doses of the flu vaccine will be available and almost 80 million doses of thimerosal-free or preservative-free vaccines
• Doctors and nurses aren’t the only ones who can immunize; Pharmacists can immunize now too!

The Bottom Line: How to Protect Yourself and Your Family from the Flu

• Use everyday preventive measures including staying away from sick people, hand washing and covering your mouth when you cough or sneeze
• If you get the flu, talk to your doctor about antiviral drugs, such as Tamiflu or Relenza, to reduce the risk of complications
• The single best way to protect yourself and your family against the flu is to get vaccinated each year!

According to a report, from the Centers for Disease Control and Prevention (CDC), on the burden of mental illness, bipolar disorder is the most expensive behavioral health care diagnosis, costing more than double what a diagnosis of depression costs an individual.  The economic burden of schizophrenia is typically greatest during the first year after the initial episode.

In our current economic environment, patients and providers are constantly searching for the most effective treatment options, while at the same time acutely aware of cost and spending. Prescribers are forced to choose between which treatment options best meets the needs of a patient and which options a patient can afford, if they can afford treatment at all. Here’s what you need to know about generic drugs, a quick summary of the FDA news release about generic olanzapine and, of course, The Bottom Line.

What Do You Need to Know About Generic Drugs?

• Generic drugs approved by the FDA are therapeutically equivalent to the brand-name versions
• Generic drugs have the same high quality, strength, purity and stability as the brand-name drugs
• The manufacturing, packaging and testing sites for generic drugs must pass the same quality standards as the brand-name drugs

What Did the FDA Say?

• The approval of generic olanzapine offers greater access to a widely used treatment option
• The availability of affordable treatment options benefits patients with long-term conditions that must be carefully managed
• Olanzapine must be dispensed with a Medication Guide outlining the risks and adverse reactions patients should be aware of when taking olanzapine
• Olanzapine has a black boxed warning that the drug can increase the risk of death in elderly people who have psychosis resulting from confusion and memory loss

The Bottom Line

• Generic olanzapine was approved to treat schizophrenia and bipolar disorder
• Olanzapine is not approved for treating psychosis in elderly people who have dementia

• Serious reactions may include high blood sugar, increased cholesterol and triglycerides, and weight gain
• Generic olanzapine tablets will be manufactured by Dr. Reddy’s Laboratories Ltd. and Teva Pharmaceuticals USA
• Generic olanzapine orally disintegrating tablets will be manufactured by Apotex Inc., Dr. Reddy’s Laboratories Ltd., and Par Pharmaceuticals Inc.

According to the Centers for Disease Control and Prevention (CDC), 8.3% of the U.S. population has diabetes and 16.3% of the U.S. adult population has high cholesterol. You’re probably asking yourself how many people account for 8.3 and 16.3 percent? I know I did. Well, it is estimated that approximately 26 million people in this country have diabetes. You do the math! With so many people affected by diabetes and high cholesterol in this country, it only makes sense that a drug company would finally come up with a pill that can treat both. The only thing I’m still wondering is what took them so long? Here are some fast facts about the new drug and, as always, the bottom line. Is Juvisync right for you? Read on and then chat with your doctor!

Why is Juvisync Important?

• Some 20 million people in the United States have type 2 diabetes and many have high cholesterol as well
• When left untreated, or poorly treated, these two conditions can increase the risk of heart disease, stroke, kidney disease and blindness, as well as other chronic medical conditions

Juvisync Fast Facts

• First combination drug for type 2 diabetes and high cholesterol formulated in one tablet
• Fixed-dose combination medication containing two previously approved medications, sitagliptin and simvastatin
• Juvisync should only be prescribed when a patient requires treatment with both drugs
• Recommended starting dose is usually 100 mg/40 mg once daily in the evening
• Swallow Juvisync tablets whole. Do not break, crush, cut, dissolve or chew Juvisync tablets

The Bottom Line

• Juvisync is indicated for patients for whom treatment with both sitagliptin and simvastatin is appropriate
• The most common side effects include upper respiratory infection, stuffy or runny nose and sore throat, headache, muscle and stomach pain, constipation and nausea
• Juvisync is available in 100 mg/10 mg, 100 mg/20 mg and 100 mg/40 mg tablets
• Juvisync is marketed by Merck & Co., Inc.

So the question remains, to split or not to split? Many medications are safe to split in half, those of which are typically scored. You know, the ones with the line down the middle? While other medications, especially certain cholesterol and blood pressure medications, some of the more costly, are actually dangerous to split in half.

Physicians or insurance companies sometimes recommend their patients split tablets for easy dosage adjustments or as a cost saving measure. This increasingly prevalent and, often times, unsafe practice of pill-splitting has led the U.S. Food and Drug Administration (FDA) to take notice.

Why Pill-Splitting May Be Risky

• Accidental doubling of dosage if the patient forgets to split a higher dosage tablet
• Certain tablets are difficult to split perfectly, causing uneven distribution of medication
• Crumbling and breakage may occur if tablets are small, or unusually shaped, causing inaccurate dosing
• Not all tablets are safe to split! Capsules, coated and controlled-release tablets are not safe to split and should ALWAYS be swallowed whole

FDA Tips and Best Practices for Safe Tablet Splitting

• To check if your pills are FDA-approved to be split, check the “How Supplied” section of the package insert, or ask your pharmacist
• Don’t split your entire supply of tablets at once, split the tablet just before taking your dose; split tablets can be affected by heat, humidity and moisture
• Talk to your doctor or pharmacist about the best method to split your medication; usually a tablet splitter
• If you take a generic medication, check with your pharmacist if you receive a tablet made by a different manufacturer to be sure it is still safe to split (tablets made by different manufacturers can have different color or shape)

The Bottom Line

• Talk to your doctor or pharmacist before splitting tablets
• Not all tablets are safe to split
• For approved drugs, always use a tablet splitter to ensure accurate dosing!

In late summer 2011, McNeil, the manufacturer of Extra Strength Tylenol, announced plans for new dosing instructions beginning in Fall 2011. The change in dosing instructions will lower the maximum daily dose recommended for Tylenol products sold in the United States. The dosing changes affect single-ingredient Extra Strength Tylenol products. The proposed change includes lowering the maximum daily dose from 4000 mg per day to 3000 mg per day, or from eight tablets per day to six tablets per day. The dosing interval will also change from two tablets every four to six hours to two tablets every six hours.

Acetaminophen, the active ingredient in Tylenol, can be found in more than 600 over-the-counter and prescription medications including Tylenol, Sudafed, NyQuil, Percocet and Vicodin, just to name a few. If taking multiple products, patients often don’t realize they contain acetaminophen and accidentally take more than the recommended dose.

Why is McNeil changing the dosing instructions?

McNeil announced these changes to ensure the appropriate usage of acetaminophen products and in an effort to decrease the risk of accidental overdose, which still remains a serious public health problem.

The Bottom Line

• Change in dosing instructions not mandated by the FDA
• New dosing instructions will appear on Extra Strength Tylenol packaging in the United States beginning Fall 2011
• According to McNeil, dosing instructions will change for Regular Strength Tylenol and other McNeil products beginning in 2012
• McNeil is working with other manufacturers of acetaminophen products in an effort to ensure consistency in dosing instructions
• New dosing instructions will change to two tablets every six hours; maximum daily dose six tablets per day
• Talk to your doctor or pharmacist about the medications you take, to avoid taking more acetaminophen than is recommended
• Excess amounts of acetaminophen can cause liver damage
• When taken as directed, acetaminophen is safe!

Recently, the U.S. Food and Drug Administration (FDA) approved Brilinta, a new blood-thinning drug to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS).  Brilinta joins the ranks of other available blood-thinning agents, such as the blockbuster drug, Plavix, and the less widely prescribed, Effient.

What is ACS?

According to the FDA, ACS is a group of symptoms for a condition, such as angina or heart attack, which could result from a decrease in blood flow to the heart.

How Does Brilinta Work?

Brilinta prevents the formation of a new blood clot helping to maintain blood flow in the body and reducing the risk of another cardiovascular event.

How Does Brilinta Compare?

According to clinical studies, Brilinta was more effective than Plavix in preventing heart attacks and death. However, the advantage of Brilinta over Plavix was demonstrated with aspirin doses of 75 to 100 mg once daily. The downside of Brilinta is that it is less effective if patients take more than 100 mg of aspirin daily and it wears off faster than both Plavix and Effient.

The Bottom Line

• Brilinta prevents the formation of blood clots that can block circulation to the heart and cause cardiovascular events
• Maintenance dose is 90 mg twice daily
• Administered with a low dose of aspirin
• Brilinta can be taken with or without food
• The most common side effects are bleeding and difficulty breathing
• Brilinta is available in 90 mg tablets
• Brilinta is manufactured by AstraZeneca

Recently, the FDA announced that the use of Actos, for more than one year, may be associated with an increased risk of bladder cancer. The prescribing information and patient Medication Guide, for all pioglitazone-containing products, will now be updated to include the risk of bladder cancer as an addition to the Warnings and Precautions section. Here are some pioglitazone fast facts, a quick rundown of what the FDA had to say and, of course, the bottom line of what you may want to chat with your doctor about!

Pioglitazone Fast Facts

• Used to improve blood sugar levels in adults with type 2 diabetes, along with diet and exercise
• Formulated as a single-ingredient product marketed under the brand-name Actos
• Available as a combination product with metformin (Actoplus Met, Actoplus Met XR) and glimepiride (Duetact)

FDA News

• Warning based on a review of data, from an ongoing study, which found Actos increased the risk of bladder cancer
• Increased risk of bladder cancer was among patients taking the drug over a long period of time at the highest dose
• Don’t take Actos if you are being treated for bladder cancer

The Bottom Line

• Continue taking Actos, or other pioglitazone-containing medications, unless instructed otherwise by your doctor
• Tell your doctor right away if you develop any symptoms of bladder cancer including blood or red color in the urine, an urgent need to urinate or pain while urinating, or pain in your back or lower abdomen
• Talk to your doctor about the risks versus benefits of treatment with Actos, or another pioglitazone-containing medication, to determine if it is still right for you!

For those of you who have been instructed by your doctors to take a “baby aspirin” to prevent heart attack and stroke, you are likely already familiar with the name Bayer. Now, the well-known drug maker has reminded younger consumers of the basics of aspirin therapy, pain relief! Bayer recently introduced a quick-release formulation of one of the oldest pain relievers out there. The original Bayer aspirin was first introduced in 1899. According to the manufacturer, the all-new Bayer Advanced Aspirin is clinically proven to relieve pain twice as fast.

Bayer Advanced Aspirin Extra Strength Fast Facts:

• Dissolves and enters the blood stream faster than other aspirin products
• Provides quicker pain relief than other Bayer Aspirin tablets
• Bayer Advanced Aspirin is the official pain reliever of Major League Baseball (MLB)
• Should be taken with a full glass of water
• Dose is one or two tablets every four to six hours; do not exceed eight tablets in a 24 hour period

The Bottom Line:

• Quick-release aspirin formulation
• Clinically proven to relieve pain twice as fast as compared to previous Bayer Aspirin tablets
• Available in 500 mg coated tablets
• For adults and children 12 years of age and older
• Easily located on pharmacy shelves by its bright purple packaging

−Kay Redfield Jamison, Ph.D., An Unquiet Mind, 1995

Bipolar disorder or manic-depression is a brain disorder that causes extreme changes in mood, from intense feelings of euphoria and/or irritability (mania) to deep depression. Bipolar disorder causes severe shifts in energy, activity levels, and the ability to carry out day-to-day tasks.

Many famous musicians, writers, and leaders of society have had bipolar disorder. About 5.7 million American adults suffer from this disorder. The condition often develops in a person’s late teens or early adult years and continues throughout life. At least half of all cases start before age 25. People with the disorder are at increased risk for alcohol and other substance abuse, and are 15 times more likely than the general population to commit suicide. They are also 15 times more likely to be in the lowest category of income earners. Bipolar disorder exacts a huge financial burden on the American economy.

Bipolar disorder is a chronic, disabling illness with no cure. But adequate treatment can help manage symptoms for a healthy, productive life. Long-term treatment that combines medication and psychosocial interventions (e.g., psychotherapy) is optimal for managing this disease.

Medication is the cornerstone of treatment for bipolar disorder as it helps to minimize the highs and lows of the disease. Mood stabilizing medications with demonstrated efficacy include lithium, and anticonvulsants such as Depakote, carbamazepine, and lamotrigine. Atypical antipsychotics are all FDA-approved for the acute treatment of mania (e.g., quetiapine, olanzapine, risperidone). Generally speaking, mood stabilizing medications are more effective at treating or preventing mania associated with bipolar disorder; while, other medications (e.g., fluoxetine, quetiapine, aripiprazole) have demonstrated efficacy for the treatment of bipolar depression.

Managing symptoms and preventing complications of bipolar disorder begins with a thorough knowledge of the illness. Henceforth, education is also a key component of treatment.  Living with bipolar disorder can be challenging, and having a solid support system of family and friends makes all the difference in outlook and motivation.

Hepatitis C is a viral infection that affects the liver. Hepatitis C is transmitted through the blood.  The most common way people in the US become infected with the Hepatitis C virus is through sharing of needles or other equipment to inject drugs.  Needle stick injuries in health care settings can also cause the spread of the virus. A new baby born to a mother who is Hepatitis C positive can also become infected.  Less common ways that a person may contract Hepatitis C is by sharing personal items that have come in contact with an infected person’s blood, such as toothbrushes and razors, or having sexual contact with an infected individual.

Hepatitis C can be an acute or chronic infection. About 75% to 85% of people infected with Hepatitis C virus will develop a chronic infection. Chronic Hepatitis C can lead to liver damage, including cirrhosis or liver cancer. According to the CDC, 3.2 million people in the United States have chronic Hepatitis C infection.  Chronic Hepatitis C can lead to serious health complications and even death.

In May 2011, two new medications were approved for the treatment of chronic Hepatitis C – Incivek (telaprevir) and Victrelis (boceprevir). Both medications are protease inhibitors. Protease inhibitors work by binding to the virus and preventing it from multiplying.  These medications must be used in combination with peginterferon alfa and ribavirin. Peginterferon alfa and ribivirin have been the standard of care for people with Hepatitis C infection. Unfortunately, less than 50 percent of people who use this therapy regimen for 48 weeks respond. When one of the 2 new medications is added to peginterferon alfa and ribavirin, much better response rates are seen. According to the FDA, the response rates for therapy that included Incivek were 20% to 45% higher than standard care alone. Also instead of the 48 week regimen used previously, some patients may only have to be treated for 24 weeks to achieve a response.

However, Incivek and Victrelis are not for everyone. These medications can cause birth defects, anemia (low red blood cell count), as well as other adverse effects. Incivek and Victrelis can also interact with a number of medications. If you have Hepatitis C, and want to know if either of these medications would be appropriate for you, talk to your health care provider.