Why must prasugrel (Effient) be stored in the original bottle?

Prasugrel (Effient) is a new platelet inhibitor manufactured by Eli Lilly. During the review process by the FDA it was discovered that the base form of the medication was not as well absorbed by patients on proton-pump inhibitors or H2 antagonists (both increase the gastric PH). So the company developed a salt form of the medication prasugrel HCL which is better absorbed at high PH.

In addition, the company discovered during the quality control process of their manufacturing that a reaction occurs (strongly correlated with temperature and high humidity) that drug degrades from the salt form to the base form. Analysis was completed it was found that the Cmax is delayed, when the base form is administered in patients with high PH, which theoretically could have clinical significance as it delays the time of maximal platelet inhibition. No clinical significance of the conversion from salt to base was described in analysis submitted to the FDA in terms of outcomes from the clinical trials. Even in situations of high conversion to the base, and high PH, the pharmacodynamic effects of prasugrel were superior to clopidogrel.

This type of manufacturing quality control examination has not occurred with all medications and the extent of conversion from salt to base forms for other medications is unknown. The company has packed the medication to minimize the potential impact of the conversion of salt to base by recommending storage in the original bottle and the addition of a desiccant to control humidity.

It is currently available as 5mg tablets (bottles of 7 and 30) and 10mg tablets (bottles of 30 and unit-dose blisters 90). This leads to challenges for hospitals that dispense medications in unit-dose tablets as the 5mg tablets are not available in a unit-dose formulation. This has implications for patient safety as the manufacturer currently recommends against repackaging their product. Pharmacists are awaiting the release of a 5mg unit dose product or clarification from the company about repackaging.

How do I take suboxone?

Suboxone enters the bloodstream under the tongue.

To help get the best adsorption into the blood you should take the following steps:

1. Drink some water to moisten your mouth... it will help the tablets dissolve more easily

2. Place the tablet under your tongue, if your dose is two tablets place one tablet on the left side and one on the right side (a mirror may help with the placement), and lean your head slightly forward.

3. Do not dissolve more than 2 tablets at a time, if your prescribed dose is more than 2 tablets, dissolve 2 tablets first and put the next tablets in after the first tablets have completely dissolved.

4. It will take about 5 to 10 minutes for the tablets to dissolve.

5. DO NOT chew or swallow the tablets, DO NOT talk while the tablets dissolve, as you will not get the correct dose and it will not work as well.

What are the side effects of suboxone?

Suboxone is used for the treatment of addiction to opioids (drugs like morphine, heroin, oxycodone). The side effects caused by the medication are difficult to discern from side effects commonly seen with the use of opioids and symptoms of withdrawal.

The most commonly reported side effects with the use of this medication in clinical trials were: headache, withdrawal syndrome, pain, nausea, constipation, insomnia, hypotension (low blood pressure), and dizziness.

Important safety information about TREN-Xtreme, MASS Xtreme, ESTRO Xtreme, AH-89-Xtreme, HMG Xtreme, MMA-3 Xtreme, VNS-9 Xtreme, and TT-44-Xtreme

Important safety information has been released by the FDA that the following products: TREN-Xtreme, MASS Xtreme, ESTRO Xtreme, AH-89-Xtreme, HMG Xtreme, MMA-3 Xtreme, VNS-9 Xtreme, and TT-40-Xtreme contain steroids.

Serious adverse events are associated with the use of these products and other similar products include: liver injury, stroke, kidney failure and pulmonary embolism (blockage of an artery in the lung). It is recommended that you immediately stop using all body building products that claim to contain steroids or steroid-like substances. Consult a health care professional if you are experiencing symptoms possibly associated with these products, particularly nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, jaundice (yellowing of the skin or whites of the eyes) or brown/discolored urine.

This type of misbranding (including ingredients in a product that are not listed on the label) is common among dietary supplements. One hypothesis for some professional athletes (e.g. major league baseball players) testing positive for steroids is the use of dietary supplements such as these that contain steroids not listed on the label.

Saftey Alert Leukotriene Inhibitors: Montelukast (Singulair), Zafirlukast (Accolate), Zileuton (Zyflo and Zyflo CR)

The FDA has provided healthcare professionals with updated information about the ongoing safety review for the leukotriene inhibitors, montelukast, zafirlukast and zileuton. Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information. The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor.

• Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications.
• Patients should talk with their healthcare providers if these events occur.
• Healthcare professionals should consider discontinuing these medications if patients develop neuropsychiatric symptoms.

Update - Why is there a shortage of desiccated thyroid (e.g. Armour thyroid, Thyroid (dessicated), Nature-Throid, Westhroid, Thyrolar))

The tincture of time has not helped to resolve the shortage. In fact, since my last post, the shortage has worsened leaving patients with few options to manage diseases of low thyroid.

Reason for the Shortage

• Several thyroid (desiccated) products have been discontinued. The manufacturers would not provide a reason for the discontinuations; however these products are not FDA-approved. Forest states that the shortage of Armour Thyroid is due to a shortage of raw material. Major and RLC will not provide a reason for the shortage.

Estimated Resupply Dates

Major has all strengths on back order and the company cannot estimate a release date.

Forest has available Armour Thyroid 240 mg and 300 mg tablets. All other strengths are on back order and the company cannot estimate a release date.

RLC has all presentations of Nature-Throid on back order and the company estimates a release date of early-December, 2009.

RLC also has all presentations of Westhroid on back order and the company estimates a release date of early-December, 2009.

Products in short supply

Thyroid (desiccated) 120 mg tablets, Major - discontinued
Thyroid (desiccated) 30 mg tablets, Major
Thyroid (desiccated) 30 mg tablets, Major
Thyroid (desiccated) 60 mg tablets, Major
Thyroid (desiccated) 60 mg tablets, Major
Thyroid (desiccated) 120 mg tablets, Major
Thyroid (desiccated) 180 mg tablets, Major

Armour Thyroid 15 mg tablets, Forest
Armour Thyroid 30 mg tablets, Forest
Armour Thyroid 30 mg tablets, unit dose, Forest
Armour Thyroid 30 mg tablets, Forest
Armour Thyroid 60 mg tablets, Forest
Armour Thyroid 60 mg tablets, unit dose, Forest
Armour Thyroid 60 mg tablets, Forest
Armour Thyroid 90 mg tablets, Forest
Armour Thyroid 120 mg tablets, Forest
Armour Thyroid 120 mg tablets, unit dose,Forest
Armour Thyroid 120 mg tablets, Forest
Armour Thyroid 180 mg tablets, Forest
Armour Thyroid 180 mg tablets, Forest

Nature-Throid NT-1/4 16.25 mg (1/4 grain) tablets, RLC
Nature-Throid NT-1/2 32.4 mg (1/2 grain) tablets, RLC
Nature-Throid NT-1 64.8 mg (1 grain) tablets, RLC
Nature-Throid NT-2 129.6 mg (2 grain) tablets, RLC
Nature-Throid NT-3 194.4 mg (3 grain) tablets, RLC

Westhroid 32.5 mg (1/2 grain) tablets, RLC
Westhroid 32.5 mg (1/2 grain) tablets, RLC
Westhroid 65 mg (1 grain) tablets, RLC
Westhroid 65 mg (1 grain) tablets, RLC
Westhroid 130 mg (2 grain) tablets, RLC
Westhroid 130 mg (2 grain) tablets, RLC

Thyrolar tablets, Forest Laboratories - all strengths
12.5/3.1, 25/6.25, 50/12.5, 100/25, 150/37.5

Discontinued Products

Thyroid (desiccated) capsules (Bio-Tech Pharm) - discontinued
Thyroid (desiccated) tablets (Qualitest) - discontinued
Thyroid (desiccated) tablets (Time-Cap) - discontinued

Orlistat (Alli, Xenical) linked to liver damage

The Food and Drug Administration has announced it is reviewing adverse reports of liver injury in patients taking the weight loss drug orlistat, also known as Xenical or Alli.

Over a 9 year period starting in 1999, the FDA received 32 reports of serious liver injury in patients taking orlistat. Of those reports, 27 reported hospitalization and six resulted in liver failure. The most commonly reported side effects included yellowing of the skin or whites of the eyes (jaundice), weakness, and stomach pain.

The FDA is performing an analysis of data from clinical trials and the manufacturer these data. To date no definite association between liver injury and orlistat has been established. The FDA will release its findings on orlistat as soon as the review is completed and is not recommending to stop taking the medication at this time.

If you have used or continue to use orlistat you should consult a health care professional if you experience symptoms possibly associated with development of liver injury: weakness or fatigue, fever, jaundice, or brown urine. Other symptoms may include abdominal pain, nausea, vomiting, light-colored stools, itching, or loss of appetite.

Why is there a shortage of desiccated thyroid (e.g. Armour thyroid, Thyroid (dessicated), Nature-Throid)

There is a lot of speculation about the reasons for the shortages of desiccated thyroid preparations. Typically drug shortages exist due to the discontinuation of a product by a manufacturer, raw ingredient shortage, manufacturing problems, or regulatory action by the FDA. In the case of the current desiccated thyroid shortage, it may be a combination of factors. The only manufacturer to provide information about the shortage is Forest who stated their shortage is due to a manufacturing change.

The shortage has required patients to switch to levothyroxine (T4), Cytomel (T3), or alternative desiccated thyroid preparations (if they can find them). Coordination of these switches should occur under the supervision of a physician to ensure appropriate monitoring. There is a small subset of patients unable able to use levothyroxine as they lack the ability to covert T4 to T3. A combination synthetic T4/T3 combination product is marketed but is also currently on backorder (Thyrolar, Forrest).

At the beginning of August the following preparations were experiencing shortages:

Thyroid (desiccated) 30 mg tablets (Major)
Thyroid (desiccated) 30 mg tablets, (Major)
Thyroid (desiccated) 60 mg tablets, (Major)
Thyroid (desiccated) 180 mg tablets, (Major)

Armour Thyroid 15 mg tablets, (Forest)
Armour Thyroid 30 mg tablets, (Forest)
Armour Thyroid 30 mg tablets, (Forest)
Armour Thyroid 30 mg tablets, (Forest)
Armour Thyroid 60 mg tablets, (Forest)
Armour Thyroid 60 mg tablets, (Forest)
Armour Thyroid 60 mg tablets, (Forest)
Armour Thyroid 90 mg tablets, (Forest)
Armour Thyroid 180 mg tablets, (Forest)
Armour Thyroid 180 mg tablets, (Forest)

Nature-Throid NT-3 194.4 mg (3 grain) tablets, (RLC)

The following products have been discontinued:

Thyroid (desiccated) 120 mg tablets, (Major)

Thyroid (desiccated) capsules (Bio-Tech Pharm)
Thyroid (desiccated) tablets (Qualitest)
Thyroid (desiccated) tablets (Time-Cap)

Is the pharmacist shortage over?

Over the last decade or so, the U.S. has experienced a pharmacist shortage. This has resulted in a high job vacancy rate, higher salaries, and increased workload. It appears that the pharmacist shortage may be coming to an end. This is due in part to the opening of dozens of new pharmacy schools increasing the graduation rate and the increased use of automation. In addition, healthcare reform will have an impact. With finite healthcare resources, pharmacists will need to continue to become more operationally efficient. Also, as quality becomes a more important metric, the provision of high-quality pharmacy services will be required of pharmacists.

The next decade is likely to see changes to the profession and a shift to more clinical activities and less dispensing related functions. Although the demand/need for medication experts is likely to continue to expand, it appears that their will be the supply to meet this demand.

New Creon dose - why was there a change?

The Food and Drug Administration (FDA) regulates the efficacy and safety of medications. Drugs marketed prior to 1938 were "grandfathered" in and did not require submission for FDA approval. One example of these types of drug include pancreatic enzymes (Creon, Ultrase, Pancrease, Pancrecarb) commonly used for patients with diseases of the pancreas, cystic fibrosis, and pancreatic enzyme deficiency.

In May of 2009 the FDA approved a new Creon formulation, the first and only FDA approved pancreatic enzyme. The new Creon formulation was available from the manufacturer in July of 2009.

Although the ingredients on the label differ on the old and new formulations, the amount of pancreatic enzymes in each corresponding capsule are the same and no change in dosing is necessary when converting from old to new formulation. The old formulation had "extra enzymes in the capsule that were not included in the label. The new formulation has been labeled with the actual amount of enzymes.

Creon 5 = Creon 6,000

Creon 10 = Creon 12,000

Creon 20 = Creon 24,000

The new formulation does require a new prescription for filling at your pharmacy.

Are prescriptions from Canada or internet pharmacies safe?

As the price of prescription drugs continue to rise, consumers are always looking for ways to save money on their medications. One such method that has become increasingly popular is to obtain medications from Internet pharmacies or prescriptions from Canada.

The problem with obtaining prescriptions in this fashion is that the medications you receive could contain the wrong medication, contain no active ingredients, or be contaminated with lead/other toxic agents.

Although many of the Internet pharmacy sites look authentic and reputable, there is no regulation at a state or federal level of these entities. So the prescription you think is coming from Canada may be coming from China, Russia, etc. The prescription does not need to be filled by a pharmacist and their is no recourse for the consumer if the wrong/counterfeit medication is dispensed.

Audits by the state of Minnesota and Wisconsin of a Canadian internet pharmacy pointed out significant safety problems, such as:

• several pharmacies used unsupervised technicians to enter medication orders and to try to clarify prescriptions
• one pharmacy had its pharmacists review 100 new prescriptions or 300 refill prescriptions per hour (a typical safe number is around 10-20 prescriptions per hour);
• one pharmacy failed to label its products, instead it shipped the labels unattached in the same shipping container, even to patients who received multiple medications
• drugs requiring refrigeration were being shipped un-refrigerated;
• dispensing medications that had been recalled or removed from the market by the FDA;
• dispensing expired medications

The bottom line is that the potential cost savings of using these pharmacies does not outweigh the significant risks to consumers.

Recommendations for drug disposal

There has been a lot of publicity over the last decade about ground water contamination and drinking water contamination with prescription drugs. The short-term and long-term effects of this contamination on the environment and humans in unknown. One step that can help to minimize the potential for ground water contamination is proper drug disposal.

1. Do not flush prescription drugs down the toilet or dump down a sink drain unless the label or accompanying patient information specifically instructs you to do so.

2. To dispose of prescription drugs not labeled to be flushed, you may be able to take advantage of community drug take-back programs or other programs, such as household hazardous waste collection events, that collect drugs at a central location for proper disposal. Call your city or county government’s household trash and recycling service and ask if a drug

take-back program is available in your community.

3. If a drug take-back or collection program is not available:

• Take your prescription drugs out of their original containers.
• Mix drugs with an undesirable substance, such as cat litter or used coffee grounds.
• Put this mixture into a disposable container with a lid, such as an empty margarine tub, or into a sealable bag.
• Conceal or remove any personal information, including Rx number, on the empty containers by covering it with black permanent marker or by scratching it off.
• Place the sealed container with the mixture, and the empty drug containers, in the trash.

Federal Guidelines

FDA recommendations

Why should I keep a medication list?

I commonly hear from patients that they do not need to keep a medication list because that information is in their "medical record". Unfortunately, this is not the case as most patients see multiple providers that do not share common medical records. For example, you cardiologist may have a different chart than your internist. In addition, patients take a variety of non-prescription (over-the-counter) products, herbals, and dietary supplements. Even when providers have a medication, this list is often what is prescribed vs. what the patient is actually taking.

One of the best things you can do as a patient is to keep an updated list of your medications in your wallet/purse.

The list should include the name, dose, how you take it, why you take it, and who told you to take it. Your list should be updated every time there is a change in your medications.

There are a number of websites that have templates you can use.

Safe Care Wisconsin

Safe Medication

Institute for Safe Medication Practices

UW Health

When I interview patients admitted to the hospital where I work, I find that on average there are 2-10 errors found between what the doctor orders and what the patient is actually taking at home when admission orders are written. The main source of this error is that patient's do not have an accurate list of medications with them and the doctor must rely on what information they have which is often out of date and incomplete.

These errors can include but are not limited to:

• ordering a drug that has stopped
• not ordering a drug that is being taken
• ordering the wrong dose
• ordering a drug that has already been taken today
• ordering a medication that has caused allergic reactions in the past

Any of these errors can complicate your admission and in some cases lead to death. Taking the time to create and update your list of medications is one of the best things you can do for your health.

Who should get the H1N1 influenza (a.k.a. swine flu) vaccine?

The H1N1 influenza (swine flu) pandemic has led to the pursuit of a vaccine by Novartis AG, GlaxoSmithKline PLC, and Baxter International. Clinical trials testing the safety and efficacy of the vaccine are expected to begin soon. The US Department of Health and Human Services has set aside $1 billion dollars for the development and manufacture of a vaccine.

On July 29th, the Centers for Disease Control (CDC) Advisory Committe on Immunization Practices provided recommendations on who should receive the vaccine. The committee recommended the vaccination efforts focus on five key populations. Vaccination efforts are designed to help reduce the impact and spread of novel H1N1. The key populations include those who are at higher risk of disease or complications, those who are likely to come in contact with novel H1N1, and those who could infect young infants. When vaccine is first available, the committee recommended that programs and providers try to vaccinate:

• pregnant women,
• people who live with or care for children younger than 6 months of age,
• health care and emergency services personnel,
• persons between the ages of 6 months through 24 years of age, and
• people from ages 25 through 64 years who are at higher risk for novel H1N1 because of chronic health disorders or compromised immune systems.

The groups listed above total approximately 159 million people in the United States.

Safe Use of Medications

The American Society of Health-System Pharmacists have created a website, safemedication.com, to help promote the safe use of medications. This resource has a template to list your medications along with tips and tools for safe medication use.

The tools include:

• Using medications safely
• Preparing for emergencies
• Gluten in medications
• Using alternative medications safely
• Using antibiotics wisely
• Recognizing counterfeits
• Preventing accidental poisoning
• Traveling safely with medications
• Preventing diseases with vaccines