Today, it is routine to approach your local pharmacy counter and complete your transaction in five minutes or less, if you even bother to get out of your car. You get to the counter, ask for your prescription, and barely hear the pharmacist ask you: “Do you have any questions about the medication?” before you nod or answer “no.” Without thinking, you find yourself signing your name on the pharmacy notepad, acknowledging that you are aware of ALL the warnings and side effects associated with the prescription you are about to take and that you have no other questions for the pharmacist.
But, honestly, did you really understand the instructions for your prescription? Did you understand the side effects you may be exposed to once you consume the drug? Have you read the real warning label for your drug – and had a conversation with your pharmacist or physician about the drug being prescribed? Sadly, most would have to answer “no” to these important questions. However, the truth is that patients need to be more proactive in protecting themselves, because, sadly, they may be the only one with the desire and motivation to ensure that safety.
The first step in ensuring your safety is to know where to look for information. Here are some starting points:
Prescription drug warning label – a sticker on the vial that contains information about your medication and usually, critical warnings, such as the ability for the drug to cause drowsiness. This label or sticker contains, at best, a couple highlights and is nowhere near the full information about the safety risks of a particular product.
Prescription information sheet/receipt – an information sheet that is printed by your pharmacy and attached to your prescription package as a part of the receipt. This is often authored by a third party vendor and, often, these warnings are outdated and fail to include very significant risks from the actual drug warning label.
Patient Package Insert or Medication Guide – usually included inside your prescription packaging. This is written by the drug manufacturer and provides a summary of the characteristics of the drug, how it is to be taken, and includes a number of warnings, precautions and disclosures regarding side effects. These Patient Package Inserts are relatively new, and are only required to be given to patients for certain drugs, such as hormone products (oral contraceptives, hormone replacement therapy, etc.). In an effort to improve drug safety, there has been a movement at the Food & Drug Administration to require the preparation and dissemination of Patient Package Inserts for a number of new drugs.
Professional Monograph of Package Insert – actual full warning label that is produced for a medication and subject to review by the FDA. These warnings are available upon request at the pharmacy and are often folded multiple times into a very compact document with tiny print that is included in the drug packaging. These package inserts are not written in an easy-to-understand format and can contain as many as 30 to 40 pages. Some package inserts may also include a Patient Medication Guide that is written in laymen’s terms. These package inserts are available online through the FDA and can also be obtained from the manufacturer’s web sites. This document is the warning label that drug manufacturers rely upon in defending themselves in lawsuits relating to defective drugs and failure to properly warn of the side effects associated with their products
According to The Institute of Medicine, about 90 million Americans have trouble understanding health information, including the instructions on prescription drug labels. Staffers from Consumer Reports performed a sample study to see how well retail pharmacies inform patients of the instructions, risks, and side effects associated with their prescription, with disheartening results.
When Consumer Reports staffers filled prescriptions for Warfarin – a blood thinner with known, dangerous side effects – at Costco, CVS, Target, Walgreens and Wal-Mart pharmacies, they found that the information included with the drugs was confusing, hidden or incomplete. In comparing warnings, they found that Target did the best job of communicating safety risk with four clearly-conveyed warnings to patients. Walgreens also conveyed four warnings, although not as well as Target. CVS only conveyed three warnings to patients, and Costco’s patient information only included two essential warnings. Wal-Mart, one of the biggest retailers of prescription drugs, failed to convey any warnings to consumers in this study, although later visits by Consumer Reports researchers noted that Wal-Mart’s patient information for the drug included three warnings. As exhibited by this study, patients are not receiving critical information about their drugs from the FDA, manufacturers, or retailers, all of whom share responsibility for products they sell.
The ideas behind labeling are that, (1) patients are entitled to information about known and potential side effects to make an informed decision about taking the medication; (2) when patients make an informed decision about a drug, they are likely to follow directions for product use; and (3) educated decisions ultimately will result in increased effectiveness of the medication. Universal requirements for disclosures to patients, including the requirement of formal Patient Medication Guides, would greatly enhance the consumer’s ability to understand their medications, take them as directed, be able to properly weigh risks vs. benefits, and identify potential drug safety issues that may have been missed by their healthcare providers, pharmacists, and others responsible for their health and welfare. The study by Consumer Reports also found that that the warnings and information would be difficult for the average person to understand. For example, medication information and warning labels were difficult to understand, filled with medical jargon, typed in “fine” print, and too-closely spaced together.
When pharmacies fail to properly label prescription drugs with key safety warnings or include the medication guides required by the FDA, patients are left unaware of the dangers associated with their prescription drug use. When consulting with your physician, ask questions, lots of questions, about each of the medications that you are prescribed:
- Whether the warning label has changed over time;
- How it should be taken;
- What possible drug interactions should be watched or avoided;
- Whether there is information in the medical literature that raises questions about the safety or effectiveness of the drug;
- Whether there are safer alternatives; and
- How does your prescriber keep abreast of the latest information on drug safety issues.
The next time you are picking up a prescription at your local pharmacy, take a moment to speak with the pharmacist about your medications, as they may be your best source for reliable information about drug safety issues.