Saturday, April 19, 2014
Inquirer Daily News

Michael Cohen

POSTED: Thursday, April 10, 2014, 11:30 AM
Filed Under: Michael Cohen

I wanted to remind women about an issue with the prescription product Angeliq, a hormone-based medicine used to relieve the symptoms of menopause. Unfortunately, we’re aware of errors where it’s been dispensed or prescribed improperly as an oral contraceptive.

Our sister organization, ISMP Canada has received two reports where a physician provided a woman with samples of Angeliq to take as birth control. Both women took Angeliq for several months until the samples were finished. The mistakes were discovered when the women took prescriptions for further supplies of Angeliq to their pharmacies and referred to them as “birth control pills.”

Angeliq has a number of similarities to birth control pills that might have played a role in the mix-up. The labeling and packaging is similar in design to birth control pills. It’s available as a 28-day blister pack like many birth control pills. “Angeliq” also sounds like a woman’s name—many birth control pills also have female-sounding names (e.g., PORTIA, YASMIN).

POSTED: Thursday, April 3, 2014, 5:00 AM
Filed Under: Michael Cohen

Homeopathic remedies can be found on the shelf in just about every pharmacy, including the large chains like CVS, Walgreen and Rite Aid. Those who advocate their use believe that symptoms of illness are a normal response in the body to regain health. If a particular substance is causing these symptoms, homeopathic practitioners believe that giving a person a very small amount of that same substance will help boost the body’s normal healing process and cure the illness.

According to the National Center for Homeopathy, more than 500 million people worldwide use homeopathic remedies.  However, in my opinion these products offer nothing more than a placebo effect (sugar pills) at best and at worst they waste people’s money. Some of the claims made about them could impede effective therapy. I’m not even sure that patients realize they are using a homeopathic medicine because they may not be prominently marked as such.

The highly diluted active ingredients in homeopathic remedies are usually made from plant material, although some are made from specific minerals, salts, and insects. Very few are made from animal products or disease material itself. Most homeopathic remedies start with these active ingredients but have very little left after the dilution process. They are available in various forms, including capsules and tablets, creams and ointments, gels, granules, liquids, and sprays.

POSTED: Friday, March 21, 2014, 9:52 AM
Filed Under: Michael Cohen

Three out of four people make mistakes when measuring doses of liquid medicines, particularly when using dosing cups that come with OTC medicines. More than one-third of the mistakes are large overdoses, which can be particularly serious in children.

The errors are most often due to: 

1) confusing teaspoons with tablespoons, especially since the markings “tsp” and “tbsp” look similar;

POSTED: Thursday, March 13, 2014, 5:30 AM
Filed Under: Michael Cohen

Over-the-counter (OTC) liquid medicines can be found in practically every household. They are commonly used for children or adults who have difficulty swallowing pills. In some cases, the medicine itself is absorbed better and faster in a liquid form, so even people who do not have difficulty swallowing pills might use liquid medicines.

Surprisingly, so far there isn’t a standard way for drug manufacturers to state the dosage measure for OTC liquid medicines. Both the directions for use and the markings on a dosing syringe, cup, spoon, or dropper may include one or more of these volume measurements:

  • Household measurements, such as teaspoons (tsp) or tablespoons (tbsp)
  • Metric measurements, such as milliliters (mL) or cubic centimeters (cc)
  • Apothecary measurements, such as drams (dr or ʒ) or ounces (oz or ℥)
  • Other measurements, such as drops (gtts) or dropperfuls

If these volume measurements are confused with each other, too much or too little of the medicine can be given. Many errors happen where the dosing directions recommend a teaspoonful but the dosing cup that comes with the product is marked not only in teaspoons but also tablespoons, milliliters, drams and ounces and the patient uses an incorrect measure.

POSTED: Wednesday, March 5, 2014, 9:24 AM
Filed Under: Michael Cohen

Medication safety in the home is an important public health issue. Almost half of all Americans have taken at least one prescription medication in the last month and more than three-quarters have taken an over-the-counter (OTC) drug. Most of these medications are taken in the consumer’s home or other residential or community setting. In these settings, the risk of medication errors is ever present as consumers with variable health literacy and unlicensed healthcare personnel undertake the complex processes associated with safe medication management. 

Our sister organization, the Institute for Safe Medication Practices (ISMP) Canada, recently collaborated with several provincial Offices of the Chief Coroner and Chief Medical Examiner in Canada to conduct an analysis of medication events associated with deaths in the community setting. The analysis uncovered clear themes and contributing factors that led to the fatal events. The findings are noteworthy since there is good reason to believe that the same issues are causing fatal medication errors in US homes. 

The overarching theme of the analysis was that of knowledge deficits leading to various patient safety risks. One of the key areas involved knowledge deficits related to people’s misperceptions or myths about medications, indicating their failure to appreciate general risks associated with prescription and OTC drug therapy. Most of the deaths involved an intentional therapeutic overdose, sharing of prescribed medications, and unsafe storage of medications.

POSTED: Monday, February 17, 2014, 9:23 AM
Filed Under: Michael Cohen

Two recently published studies of one of the newer blood thinners, Pradaxa, point the way to reducing the risk of its major drawback—high rates of bleeding of 16% a year.  

Pradaxa was approved in October 2010 as an alternative to the standby blood thinner Coumadin (warfarin). Both are effective in reducing the risk of disabling strokes in people with a condition known as atrial fibrillation, a heart disorder affecting about 2.5 million mostly older patients in the U.S.

Pradaxa’s marketing advantage was that it was easier to use than Coumadin, which requires careful monitoring of its blood clotting effects and often a dose adjustment.  The FDA approved Pradaxa with only a single standard therapeutic dose of 150 mg, taken twice a day. The laboratory test for Coumadin, called INR, was not useful or accurate with Pradaxa for determining whether blood clotting was inhibited too much—leading to bleeding—or not enough, which might increase stroke risk. However, unlike Coumadin, no antidote exists for Pradaxa to halt bleeding quickly should it occur.

POSTED: Tuesday, February 11, 2014, 12:05 PM
Filed Under: Michael Cohen

Rotavirus is a virus that causes a type of gastroenteritis (inflammation of the lining of the stomach and intestines) that can lead to severe watery diarrhea, vomiting, fever, and abdominal pain. According to the CDC, rotavirus gastroenteritis can also lead to dehydration (loss of body fluids) in babies and young children. This is a serious complication that may require hospitalization for administration of IV fluids. The virus is a major cause of death in children around the world.

Fortunately there are two oral live rotavirus vaccines available in the US that can protect children against rotavirus gastroenteritis. But since the use of live oral poliovirus vaccine was discontinued in the United States in 2000, other than rotavirus vaccines, no other oral vaccines are routinely given to children in the U.S. Therefore, providers now have less experience administering oral vaccines and, on occasion, by mistake they’ve accidentally injected oral rotavirus vaccine, making it completely ineffective.

Recently the Centers for Disease Control and Prevention (CDC) examined reports of accidental injection submitted to the Vaccine Adverse Event Reporting System (VAERS), operated jointly by CDC and FDA. There were 39 reports of injection overall. A Merck product, RotaTeq, is available as a liquid in a squeeze applicator. This was involved in only 6 out of 39 errors reported by CDC. Most cases (33 out of 39) happened with the Glaxo SmithKline (GSK) product, Rotarix, which requires mixing a dried out form of the vaccine into a liquid before giving it.

POSTED: Monday, January 27, 2014, 9:31 AM
Filed Under: Michael Cohen

The country is experiencing a serious shortage of certain IV fluids, mainly involving sodium chloride injection 0.9% (IV saline) in 1,000 mL bags. Some hospitals have also been short of Lactated Ringer’s solution.  Smaller size bags are available right now but we’re hearing that those supplies are dwindling.

This latest drug shortage seems to have started back in November but has gotten progressively worse in the past couple of weeks and now hospitals are scrambling. The market in the US is served by Baxter (45%), Hospira (45%) and B. Braun (10%). Apparently the acute situation is related to increased demand (patients with influenza who are hospitalized) combined with a planned shutdown at Baxter for maintenance in December.  All of the manufacturers have communicated about supplies with their customers. The shortage is such that they’re allocating solutions to customers already under contract. It’s unclear how long this shortage situation will last but everything we’re hearing is that it’s going to be several weeks at least, and for some solutions it will be into March.  I’ve spoken to all three companies and they tell me they are working hard to get supplies back up to normal.

There are other IV solutions available such as 5% dextrose in water, 5% dextrose with smaller concentrations of sodium chloride than 0.9%, and many others, but they may not always be appropriate for a particular patient.  How long supplies of the various solutions will last is not known but we could very well see shortages with these too. Although it should be a last resort, it’s possible for hospital pharmacists to compound sodium chloride IV solutions using small volumes from very high concentration sodium chloride injection vials to bring solutions of lesser concentration up to 0.9%. But doing so can increase the potential for compounding errors so this should be a last resort. Compounding requires strict quality control checks to prevent accidentally adding too much or too little sodium chloride, either of which can be harmful.  Also, if compounding became routine it could lead to shortages of the high concentration sodium chloride vials, which happened last year due to production issues at one of the generic injectable companies. 

About this blog

Check Up covers major health events in our region and offers everything from personal health advice to an expert look at health reform. Read about some of our bloggers here.

For Portions of this blog may also be found in the Inquirer's Sunday Health Section

Michael Cohen id the president of the Institute for Safe Medication Practices in Horsham.

Daniel Hoffman is the president of Pharmaceutical Business Research Associates (PBRA) in Glenmoore, Pennsylvania, a healthcare research and consulting company specializing in key account positioning and messaging.

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