By Michael R. Cohen
In my entire career at the Institute for Safe Medication Practices, the meningitis outbreak was the worst safety disaster that I have ever seen, making 2012 a watershed year in drug safety stories. So without further adieu, the following are this year's top 10 worst cases in drug safety:
Meningitis outbreak. In October, a deadly, multistate fungal meningitis outbreak began to unfold, exposing a lack of federal or state safety oversight of pharmacies that compound sterile drug products. Some pharmacy compounders have evolved into unregulated pharmaceutical manufacturers that distribute unapproved drugs in large quantities across state lines, often in response to drug shortages (see #2 below). The toll so far? Over 600 hospitalized and 39 deaths across 19 states, making this the worst drug-related public health disaster since a 1937 drug safety disaster that led to the Federal Food Drug and Cosmetic Act. FDA Commissioner Margaret Hamburg believes a new system is needed under which nontraditional pharmacies would have to register with the FDA and undergo regular inspections, similar to pharmaceutical manufacturers.
Drug shortages. Authorities are still grappling with an ongoing shortage of commonly used medications, including critically important drugs for cancer, emergency medications like sodium bicarbonate, nutritionals like calcium injection, pain medications including morphine, and even certain mainstay antibiotics and anesthetics for surgery patients. Importation of critical drugs from countries outside the US and new legislation signed by President Obama in July is helping FDA to address some of the causative factors. But the crisis still sometimes rivals what might be seen in developing nations! Even children with otherwise treatable cancer have sometimes been left without optimal treatment. One anesthesiologist, who usually uses IV drugs to put people under, told us he's returned to inhalation anesthesia. Let's hope we don't need to bring back ether.
Prescription pain-killer related deaths. The Center for Disease Control and Prevention (CDC) says that drug abuse related deaths have more than tripled since 1990, with most of these deaths caused by prescription drugs. Overdoses claim more lives than heroin and cocaine combined! Much of the problem has been with drugs like OxyContin and Vicodin, but other drugs like Xanax, Adderall, tranquilizers and anxiety medications are also a big part of the problem. Health officials have been focusing on how the drugs are obtained illegally. But much of the problem has been kids stealing from their parents' medicine cabinet. We've proposed new packaging requirements to more easily identify missing doses but retail pharmacists haven't come on board so far. Doctors who overprescribe these drugs aren't helping the situation either. In July, FDA announced approval of a "risk evaluation and mitigation strategy" (REMS) to address the problem with doctors. But it's only voluntary, so don't expect much improvement to follow.
New "blood thinners"and bleeding issues. Two new drugs are available to help prevent strokes related to atrial fibrillation, a heart condition, where the upper chambers of the heart fail to contract entirely. This sometimes causes blood clots to form and travel to the brain, where a potentially damaging or life-threatening stroke may occur. The new drugs, Pradaxa and Xarelto, work differently and for some, may be more effective in preventing strokes than the drug that's been used in the past, Coumadin (warfarin). However, there's a problem. With Coumadin, doctors and pharmacists had a lab test to assure blood wasn't too "thin," which increases the risk of bleeding. Also, if bleeding did occur, it could be treated effectively with a medicine that reversed the effect of Coumadin. Unfortunately, there's no good way to monitor the anticoagulation effect of in patients taking Pradaxa or Xarelto and there's also no specific way to reverse a bleed, a big concern for cardiologists treating patients with this condition. The issue is particularly a concern for patients who are elderly or have kidney disease.
Clear Care keeps on burning eyes. Based on the number of cases submitted to the ISMP National Medication Error Reporting Program, this popular over-the-counter product for cleaning contact lenses has hurt more patients than any others in memory. If you Google "Clear Care" you'll find many cases described on the Internet. If you know someone who uses the product, you may know someone who's suffered. People who wear contact lenses have told us they either assumed Clear Care was just another multipurpose solution for rinsing and soaking lenses or have mistaken Clear Care for a soaking solution and poured it into their flat contact lens holder for an overnight soak. Clear Care is not just another soaking solution. It's for cleaning and disinfecting lens and it contains 3 percent hydrogen peroxide, which should never get into the eyes. The result? Extreme excruciating pain and possible damage to the eye's delicate tissues. For over two years, we've alerted FDA and the manufacturer to this problem, yet little has been done to address it. Consumers beware!
Pain patch dangers. All too often we learn about problems associated with the use of pain patches, especially those containing fentanyl. These include ongoing prescribing errors and situations where kids mistake them as Band-Aids. Some patients fail to remove the old patch when placing a new one. That's a problem because used patches may still contain unused drug that keeps getting absorbed. That can lead to an overdose. In April, we shared the story of a 2-year-old boy who was found unconscious 2 days after visiting a relative in a nursing home. He later died, and a patch containing fentanyl was found in his throat. That led to discovery of a much wider problem – people often don't dispose of patches properly, which puts children at great risk. These tragic events highlight the need for increased public awareness about the safe use and disposal of this unique form of medicine.By now, my medical colleagues are well aware of these issues and they have computer systems to stop dangerous fentanyl patch prescriptions and remind staff about the need to educate patients. Still, that clearly isn't happening!
Pertussis outbreak and vaccine issues. Whooping cough (pertussis) vaccine refusal and failure to revaccinate adults has taken on new urgency because there's been a resurgence of whooping cough nationally. There are also new concerns about the vaccine's effectiveness over time. In2012, increased pertussis cases or outbreaks have been reported in a majority of states and 49 states and Washington, D.C. have reported increases in disease compared with the same time period in 2011. Provisional counts indicate more than 39,000 cases of pertussis were reported to CDC through December 8, 2012. Another problem is that many young children are getting the wrong form of a vaccine. They sometimes get the adult form Tdap instead of DTaP to protect against whooping cough (pertussis) diphtheria and tetanus, leaving them inadequately protected. And at the same time, some adults getting booster shots are getting the form used for children (DTaP), sometimes experiencing a local reaction. We've begun a new program to track vaccine errors to help immunization professionals learn more about their causes so they can advocate for changes in practices and product design that will help to prevent them.
Measuring liquid medications safely. Over-the-counter (OTC) liquid medications can be found in practically every medicine cabinet. But surprisingly, there's not a standard way to measure them. All too often caregivers use household measuring devices like teaspoons or tablespoons, and doctors may even prescribe them this way. But this way of measuring can provide inaccurate dosing since teaspoons and tablespoons aren't calibrated for medicines. Worse, some other measuring devices like syringes, dosing cups, and droppers use a metric scale (milliliter) plus other scales on the embossed on the very same device. That, along with continued use of "teaspoons" has led to ongoing confusion between various dosing scales, where for example someone accidentally prescribes or administers one teaspoonful (5 mL) instead of 1 mL – a 5-fold overdose. The problem is so frequent that our board of trustees has been advocating sole use of the metric system for measuring liquids. The CDC has also been supporting standardization through a new initiative called "PROTECT" as has the OTC drug industry through the Consumer Healthcare Packaging Association (CHPA). There's now a widespread belief that this public-private partnership will lead to needed changes and bring fewer medication errors.
Drugs most frequently involved in adverse drug reactions. In our May, 2012 regularly published Quarter Watch feature on our Institute's website, we estimated that 2 to 4 million persons suffered serious, disabling, or fatal injury associated with prescription drug therapy. This was based on our analysis of a full year of reports to the U.S. Food and Drug Administration. The most frequently identified suspect drugs in direct reports to the FDA were the anticoagulants dabigatran (Pradaxa) and warfarin (Coumadin), showing that inhibiting clotting ranks among the highest risk of all drug treatments. The 10 drugs with the largest numbers of reports sent directly to the FDA by healthcare practitioners and consumers in 2011 in order of frequency were Pradaxa, Coumadin, Levaquin, Carboplatin, Zestril, Cisplatin, Zocor, Cymbalta, Cipro and Bactrim. These are the medications that health professionals and consumers told the FDA were causing serious and fatal side effects that year. It's interesting to note that just two of these drugs were first introduced in the last decade (Pradaxa and Cymbalta), and only one in the previous year (Pradaxa), suggesting that major drug safety issues are not confined to recently approved drugs. We'll be doing a similar analysis for 2012 early next year.