Advice and best practices for writing SOPs, training for product launch, outsourcing technical documentation, and more.

FDA Regulates Product Labeling to Validate Consumer Safety

Labeling refers to the act of attaching or adding a sticker, decal, or a tag to an object. This term can also be defined as the state of showing information about a product on its container, packaging or on the product itself.

Laws Behind the Healthcare Labels:

TechnicalWritingServicesFederal involvement with product labeling for healthcare items goes back to the mid-19th century when the U.S. government established the U.S. customs laboratories to administer the Import Drugs Act of 1848. Over the years, the various government agencies that oversaw food, drugs, and medical devices have evolved into what we know today as the Food and Drug Administration (FDA). The FDA is the regulatory agency that serves as the consumer protection watchdog for the U.S, healthcare industry. It has the authority to regulate medical devices before and after they reach the marketplace. It also regulates over-the-counter and prescription drugs, including generic drugs. Did you know that dandruff shampoos, sunscreens, antiperspirants, and fluoride toothpaste are all considered to be drugs that are regulated by the FDA?

The FDA’s definition of labeling for technical writing services covers what is packed with or on medical equipment. Labeling includes such documentation as User Manuals (including Technical Bulletin updates), Instructions for Use, packaging, labels, wall charts, etc. In short, it’s pretty much everything the consumer sees.

For a history of the FDA, read the article The Story of the Laws Behind the Labels on the FDA website. To learn about the FDA’s responsibilities, check out What does FDA regulate? To stay better informed about FDA regulated drugs and medical devices, check out FDA Consumer Updates and MedlinePlus.

Be an informed consumer:

Regardless of all the safeguards in place with FDA regulations, errors do happen…in hospitals, in pharmacies, or even at home. To reduce your chance of being involved in a preventable error, it’s important to become an informed consumer about your own healthcare. Use the Internet to learn all you can about your condition and any medications you are prescribed. Be cautions, however, about relying solely on information obtained from the Internet. Always discuss what you’ve learned with your doctor or pharmacist to make sure it’s accurate. If you don’t like what you hear, don’t be afraid to get a second opinion.

Create your own healthcare record:

Most people with multiple health problems see multiple doctors, and take multiple pills per day to control their problems. Remembering each pill’s name and dosage and who prescribed what can be a challenge, especially if confronted with an emergency situation. Should you or a family member find yourself in this situation, creating a personal healthcare record that you can keep with you will provide a quick background summary of what any healthcare provider needs to know to treat you.

Document every medicine you currently take, including prescriptions, over-the-counter medicines, dietary supplements, and herbal products.

  • List each medication name, dosage, time of day taken, doctor who prescribed it, purpose, and pharmacy.
  • Identify any allergies you might have.
  • List all your healthcare providers and a contact number for each.
  • Provide a comments section that includes the dates of any prescription changes and the reason for the change.

Keep a copy of your healthcare record with you at all times and have a second copy available to a family member or friend. This record will simplify your care in an emergency situation. Any time that your medications change or that you have a significant medical event, make sure you update your personal healthcare record and date it.

18 Tips for Getting the Most from Your Healthcare Providers

Use these tips to take charge and get the most from your healthcare providers for doctor visits, at the pharmacy, and at the hospital:

  1. Make sure that someone, such as your primary care doctor, coordinates your care. This is especially important if you have multiple health problems, see multiple doctors, or are in the hospital.
  2. Before each doctor visit, write a list of questions or concerns you want to discuss. This serves as a reminder of questions to ask and as review to make sure you have discussed everything before you leave.
  3. Ask your doctors how your personal records will be stored and protected. Know what type of backup is provided and who will have access to the information.
  4. Make sure all of your doctors know about every medicine you are taking. Provide a copy of your personal healthcare record of medications to each doctor.
  5. Bring all of your medicines and supplements with you to your doctor visits. This will provide an opportunity for discussion to find out if there are any problems you’re having, confirm any allergies and adverse reactions you might have had to medicines, and help your doctor keep your records current. It also gives you an opportunity to ask your doctor questions regarding your medicines.
  6. Make sure you understand the purpose of all your medications. If the doctor writes a new prescription, understand the brand and generic names, what the dosage is, what side effects might occur, and what to do if that happens. If your doctor gives you samples, make sure you double-check with your pharmacist that these samples do not interact with your other medications.
  7. Let every pharmacy you use know about every medicine you are taking. Your pharmacist can be your partner to help protect you against harmful drug interactions, duplicate medications, and other potential problems.
  8. Before leaving the pharmacy, make sure your pharmacist gives you printed information about the medication and make sure that you understand the answers to these questions:
    - Why am I taking this medication and what does it look like?
    - How long do I need to take this medication?
    - Does this medication interact with any of my other medications or any foods?
    - Does this medication replace anything else I was taking?
    - What are the brand and generic names of the medication?
    - What is the dosage I should take and how often should I take it?
    - When is the best time for me to take the medication?
    - What should I do if I miss a dose?
    - What side effects should I expect, and what should I do if they happen?
    - How should I store the medication?
  9. Ask your pharmacist for help when selecting over-the-counter medications. Make sure they won’t interact with your other medications, cause an allergic reaction, or not be accurate for your symptoms.
  10. If you have a choice, choose a hospital where many patients have had the procedure or surgery you need. Patients tend to have better results when they are treated in hospitals that have a great deal of experience with their condition.

  11. Bring a copy of your personal healthcare record with you when you go to the hospital. Your doctors and nurses will need to know what you are currently taking.
  12. Look at all medicines before you take them. If it doesn't look like what you usually take, ask why. It might be a generic drug, from a different manufacturer, or it might be the wrong drug. Ask the same questions you would ask if you were at the pharmacy.
  13. Make sure all healthcare workers involved with your personal care wash their hands before touching you. Handwashing helps prevent the spread of infections in hospitals.
  14. Make sure that all your doctors at the hospital have your important health information. Do not assume that everyone has all the information they need.
  15. Ask about the tests or treatments ordered. Find out why a test or treatment is needed and how it can help you. Ask how and when you will get the results.
  16. If you are having surgery, make sure that you, your doctor, and your surgeon all agree on exactly what will be done prior to the surgery. Wrong-site surgery mistakes are rare, but they can happen and they are 100% preventable.
  17. When you're ready to go home, have the doctor, nurse or pharmacist go over each medication with you and a family member. Update your personal healthcare record if any prescriptions change or if new medications are added.
  18. Ask when to schedule follow-up appointments and find out when you can get back to your regular activities. Getting clear instructions may help prevent an unexpected return trip to the hospital.

Effective communication with your healthcare provider is vital to getting healthy and staying healthy. In addition to the positive benefits to overall health, finding a provider you can communicate with aids in improving the quality of your healthcare decisions by enabling you to make the most informed decisions necessary for proper treatment.

Have you had an experience with FDA regulations that you’d like to share? Tell us about it in the comments below.

Interested in learning strategies for developing compliant documentation?

Register for our Free Webinar:

How to Produce Documentation that
Meets FDA Compliance and Launches On Time


Topics: outsourcing, technical writing services