- Invented, tested, and approved;
- Manufactured and distributed;
- Prescribed by your physician, nurse practitioner, physician’s assistant, dentist or other healthcare professional;
- Dispensed by your pharmacist.
While the federal government researches and develops some drugs through such agencies as the National Institutes of Health, most new drugs are developed by private pharmaceutical companies. There are smaller companies, but most pharmas are huge international enterprises, like Novartis, Pfizer and Roche, the top three by global sales.
In the United States, it’s the Food and Drug Administration (FDA) that regulates drugs. It requires that all drugs be tested and proven not only safe, but also effective at treating whatever disease they’re intended for. Critics say the agency puts too much emphasis on efficacy, slowing the rate at which new drugs reach the market. The FDA and its defenders say that efficacy is an essential part of safety. You can learn a lot more about the FDA’s procedures on its website.
The FDA, as its name implies, is responsible for investigating safety issues with food and drugs, as well as cosmetics. If you have experienced a serious and previously unreported side effect or adverse outcome from a licensed drug, there is a report form that you can use to alert the FDA to the problem. The FDA is also responsible for vaccines and has a separate way to report vaccine-related issues.
Closer to home
So basically, the first two steps in the drug process are overseen by the FDA and other agencies. The next two are much more local and are policed more by state and local agencies than by the feds.
Doctors and pharmacists play different roles but are on the same team. Doctors diagnose your illness or disorder and select one or more drugs based on their research, training and experience. They are policed by state medical boards. There’s one in every state and each one will investigate serious complaints. You can find a list here.
Once the prescription is written, your pharmacist then dispenses the drug based on the doctor’s instructions and on current clinical guidelines. You can — and should — feel free to ask your pharmacist for help at any time. He or she can consult with your physician to be sure you are getting the drug that works best for you.
Most of the time the process works, but sometimes you can have a bad experience, such as drug side effects or allergic reactions, or even undergo a medication error. Independent pharmacists, those who own or manage their own free-standing pharmacies, are quick to blame large chains like CVS or Walgreens for what appears to be a rising number of errors in filling prescriptions.
Unfortunately, a lot of these retail giants are placing more emphasis on performance metrics (i.e. number of prescriptions filled in a time period, number of flu shots given, etc.) than on patient-centered and -specific care. Encouraging pharmacists to be faster, at the expense of accuracy and safety, has also given rise to patients not realizing that filling a prescription is more than just counting out pills and slapping a label on the bottle. Pharmacists verify a prescription to ensure you are getting what the doctor prescribed, that it’s an appropriate treatment regimen, and that it’s safe for you to take. When pharmacists rush, that’s usually when mistakes happen.
If you should experience a medication error, you should immediately contact the pharmacy and ask to speak with the pharmacist-in-charge. Provide as much information as you can so he or she can thoroughly investigate the matter. The pharmacist-in-charge will work with you (and sometimes your doctor) to reach a satisfactory resolution.
Sometimes you may believe an error has occurred when it hasn’t, like a change in generic manufacturer causing your pill to look different. Even if it turns out not to be a mistake, you should always feel free to double check with your pharmacy.
Lastly, most pharmacies have strict protocols for reporting medication errors. Some companies have an internal review board and some state boards of pharmacy require pharmacies to report medication errors on a periodic basis. So while you may not always think so, these errors are definitely taken very seriously.