While Americans never have enjoyed access to so many pharmaceutical products with such life-sustaining and lifesaving properties, these drugs also have proven to be expensive — prohibitively so for many — and, as I've written in this blog before, subject to shortages. As a result, patients are taking unorthodox, even risky, steps to fill their prescriptions. And from counterfeit medicines bought online to contaminated injections from established compounding pharmacies, federal regulators and the public now find themselves dealing with some of the dire consequences.
Prominent in the news, of course, has been the devastating outbreak of fungal meningitis, linked to contaminated steroid injections prepared at The New England Compounding Center. Across 18 states , the tainted product has caused dozens of deaths, while more than 400 have fallen ill.
What went wrong in this situation? More importantly, how can we prevent a future crisis?
Compounding Woes
First, let's run through a primer on pharmaceutical compounds. These are products created at special pharmacies, from a doctor's prescription, to fit the needs of an individual patient. Such needs typically include changing a medication from a solid pill to a liquid, preparing a medication without an inactive ingredient that a patient is allergic to, or slightly altering the dosage of a medication to one not manufactured by pharmaceutical companies.
Compounding pharmacies also have filled gaps left by recent shortages of manufactured drugs, creating their own equivalents of these medications. Compounded equivalents also are sometimes used to provide medication at a lower cost. Compounded products account for an estimated 1 percent to 3 percent of the $320 billion spent on prescriptions in this country last year.
In theory, compounded medicines can be riskier than manufactured drugs, because they are not subjected to Food and Drug Administration (FDA) approval and instead rely on a physician's judgment and a pharmacist's quality of practice. In reality, though, problems with compounds almost exclusively involve those that are injected, not taken orally, notes my colleague Rita Shane, director of our pharmacy services.
Issues arising with injections usually involve those made with powders that are not manufactured as sterile ingredients, but are subsequently sterilized onsite. This requires an environment and practice that is more pristine than an operating room, explains Shane, noting, "Pharmacists cannot wear nail polish, makeup or any jewelry, for example."
The lethal steroids made at the New England Compounding Center involved nonsterile powder. In addition to unsanitary conditions, this facility operated more like a small pharmaceutical manufacturer, making large quantities of product, rather than individual orders, and shipping its products nationwide rather than locally, federal investigators have found.
This terrible incident has put the fuzzy and fragmented regulations that govern compounding pharmacies in the spotlight and spurred proposed legislation to strengthen the FDA's authority.
It's a step in the right direction. Compounding pharmacies now operate under a hodgepodge of state regulations. And while California's are among the most comprehensive, more frequent inspections and heightened oversight of these facilities should be mandated. Contrast the way commercial compounding operations work with hospital pharmacies that are regulated under the strictest conditions mandated by the Joint Commission.
Online Woes
Another significant safety concern that regulators have expressed concerns over is patients seeking to fill their prescriptions via a proliferation of shady, online pharmacies. Purchasing prescriptions over the Internet can be convenient and cost effective. Only about 3 percent of the thousands of sites peddling pharmaceuticals, however, comply with United States pharmacy laws, according to the National Association of Boards of Pharmacy (NABP). Some of the rest — known as rogue pharmacies — dispense fraudulent products that have expired, been tampered with, or simply are fake. Many also illegally sell controlled drugs and drugs that have been banned in this country. (To its credit, the Los Angeles Times has highlighted the challenges and dangers that prescription medications can pose, even when administered by trained medical specialists in specialized settings and conditions. Medical experts in the Times stories make a point that criminal abuse of prescription drugs is a burgeoning, difficult to control woe.)
The appeal of online is understandable. Many Americans cannot afford the medications they need and rogue pharmacies offer rock-bottom prices, often without requiring a prescription. According to a recent survey, one in five Americans do not fill prescriptions and one in six either cut pills in half or skip doses, due to economic hardship.
Senior citizens continue to be the biggest consumers of prescription drugs and may be unaware how risky it is to shop online. To avoid frauds, the NABP recommends sticking with sites accredited through the VIPPS (Verified Internet Pharmacy Practice Sites) or those registered with LegitScript.com. Avoid those that are listed on the association's list of Not Recommended Sites. Since new rogue operators pop up like weeds after the rain, be aware of the red flags yourself. These include pharmacies that: dispense medication based only on an online questionnaire not a prescription; don't provide a contact phone number; do not have a pharmacist available for questions; and send spam solicitations.
Even that online pharmacy from Canada may not be safe. In fact, chances are it isn't even in Canada. There's a high likelihood it's actually based in Asia, South America or Eastern Europe. Importing drugs from any country, even a Canadian pharmacy that you visit in person, is not recommended, since the FDA cannot ensure its safety. Importing medication is also illegal, with minor exceptions.
Talk to Your MD, Pharmacist
So what can patients do to afford pricey drugs? Start by talking with your doctor and pharmacist. Unfortunately, few do. Establishing a relationship with a trusted pharmacist, as well as physician, is essential.
Most patients, 68 percent, are uncomfortable about initiating the conversation about their difficulties in paying for medications, according to the findings of a recent survey by Consumer Reports. What's more, practically none asked the price of the medication prescribed while still at the doctor's office.
Make sure that you do. If the prescribed drug is too expensive, ask about a "therapeutic equivalent" that costs less or that your insurance provider covers at a better rate. A therapeutic equivalent is a drug that offers the same effect in the treatment of a disease or condition, but isn't necessarily chemically equivalent.
Generic versions of medications generally are less costly, too — sometimes by as much as 95 percent. Generics contain the same active ingredient (the ingredient that produces the therapeutic effect of the medicine) and have met the same standards for quality, strength and purity as the original, brand name. They may contain different inactive ingredients than those used to formulate the pill, liquid or topical preparation, and, therefore, may look different.
With a few exceptions, patients experience no difference in switching to a generic version.
Speak up and ask your doctors about generic substitutes. Don't assume your health care provider will talk to you about your medication options. Consumer Reports found that patients reported that 40 percent of doctors sometimes or never recommend generic medications instead of brand-name drugs. You can check yourself if a generic version of your prescription is available at Drugs@FDA, an online catalog of FDA-approved drug products. For newly and tentatively approved generics, check the FDA'S First Generics page. Generic drugs offer consumers an estimated savings of $8 billion to $10 billion annually.
Check out discount programs, too. Many chain drugstores and supermarkets offer a number of generic medications for as little as $10 for a three-month supply. The California Board of Pharmacy website offers a list of programs available here.
Pharmaceutical companies also offer patient assistance programs. You can access this information on a number of websites, such as Needy Meds and Partnership for Prescription Assistance.
For common ailments, such as allergies or gastro esophageal reflux disease, you may find that a cheaper, over-the-counter medicine is just as effective. Ask your physician and pharmacist for suggestions.
I also recommend using the same pharmacy for all of your prescriptions so that the pharmacists know you and have a complete list of your medications on file. Patients should keep their own up-to-date lists, including over-the-counter medications, as well and make a copy of the list for a family member, advises Shane.
She also suggests that "at least once a year, sit down with your pharmacist and assess all the medications you are taking. Too many people are overprescribed. They're taking drugs to offset the side effects from other drugs or taking something for an issue they no longer have. Review the list and ask, 'Do I really need all of these prescriptions?'"
That's excellent counsel. Still, as I noted at the outset, prescription drugs provide millions with life-changing therapy for disease and chronic conditions. We need to ensure that these game-changing medications are available, affordable, effective — and safe. Patients play a critical role in achieving these goals through communication with health care providers and policy-makers, as well as with your everyday common sense: That cut-rate drug that sounds too good to be true? It probably isn't.