Your Role in Medicine Safety
When it comes to taking medicine, you play an important role in ensuring your safety—and the safety of those you care for. By partnering with health professionals involved in your care, you can help them determine which medicines are most appropriate for you or your dependents. Partnering also helps your health care professionals teach you how to take these medicines safely.
In this section, you'll learn how to reduce your risks of medication safety problems at key points in your care:
- At your doctor's visit
- When you fill your prescription
- When you take your medicine
- After you take your medicine
Who plays a role in medicine safety?
- Pharmaceutical companies that develop, test, and produce medicines
- Regulatory agencies that approve the use of medicines—like the U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA)
- Health care professionals who prescribe medicines
- Pharmacists who dispense and provide counsel regarding your medicine
- Patients and caregivers who take medicines or give medicines to those they care for
What is involved in approving a medicine?
All medicines have benefits as well as risks. Before any new medicine is approved by regulatory agencies such as the EMA or the FDA, it undergoes extensive testing—usually in several thousand people. The goal of this testing is to determine how safe and effective the medicine is—and to show that its benefits outweigh the known risks. A medicine is approved for use by appropriate patients only when its benefits have been adequately shown to outweigh the risks for its intended use in those patients.
> Next: Partnering With Your Health Care Professional
Medicine Safety Education Home
Medicine safety is a shared responsibility. Throughout the life of a medicine, many individuals and organizations work to ensure that the medicine is safe—from the pharmaceutical companies that develop and produce medicines, to the regulatory agencies that approve their use, and the doctors and other health care providers who prescribe them.
Before it is approved for use, a medicine must go through extensive testing. A medicine is approved for use in appropriate patients only when its benefits outweigh the known risks for its intended use in that population.
But you also play an important role in ensuring medicine safety.
By partnering with your doctors, you can help them determine which medicines are most appropriate for you or those you care for.
In this section, you’ll learn more about how to maximize medicine safety.
Click Next to continue.
Partnering With Your Health Care Professional
Your doctor, pharmacist, nurse or other professionals involved in your care can learn about the known benefits and risks of a certain medicine. But to make sure it's right for you or someone you care for, they may need to ask you for information that only you can provide.
You can help make your treatment plan safer by:
- Telling your doctor about your complete health and medication history
- Asking questions and getting the facts about your medicine
- Seeking counsel from your pharmacist
> Next: Sharing Your Medical History
< Previous: Your Role in Medicine Safety
Medicine Safety Education Home
Health care professionals are continually learning about the known benefits and risks of medicines.
But to make sure a medicine is right for you or someone you care for, your doctor may need to ask you for information that only you can provide.
That’s why open and honest communication is essential. When you visit your doctor or other health care professional, you can help make your treatment plan safer by giving complete and accurate facts about yourself and your health, and by getting information about your treatment program, especially any new medicines you’ll be taking.
This means that at your health care visit, it’s important to tell your doctor about your health and medication history, ask questions, and get the facts about your medicine.
In this section, we’ll be focusing on the role your medical history can play, and how you can help give your doctor as complete an account of your medical history as possible.
Click Next to continue.
Sharing Your Medical
History
Your medical history is the foundation upon which your doctor builds the best treatment plan for you. A detailed history helps your doctor get to know you, identify possible causes of any health conditions, and determine which—if any—treatments you may need.
Your doctor may ask you about:
- Any symptoms you may be experiencing
- Any medical conditions you've been diagnosed with—such as heart disease or arthritis
- Any illnesses you have experienced—like flu or hepatitis
- Any surgical operations you have had—such as a tonsillectomy or caesarean section
- All medicines and treatments you are currently using
- Anything that could affect your ability to take medicine safely or regularly
What medicines should you tell your doctor about?
- Products you take every day or just once in a while
- Nonprescription (or over-the-counter [OTC]) medicines—such as pain relief products (including those applied to the skin), cold or allergy remedies, antacids, or laxatives
- Prescription medicines, including samples
- Vitamins, supplements, and herbal or natural remedies
- If you are a female, oral contraceptives, contraceptive patches, or long-acting contraceptive injections
You should also tell your doctor about the use of:
- Alcohol
- Cigarettes
- Substances such as marijuana or cocaine
Disclosing everything you take is extremely important because some medications can mix dangerously with others, even in small doses.
What can affect your ability to take medications?
- Known allergies or sensitivities
- Being pregnant, trying to conceive, or breast-feeding
- Having memory problems
- Having trouble swallowing, seeing clearly, or using your hands
> Next: Getting All the Facts
< Previous: Partnering With Your Health Care Professional
If you’re not sure what kind of information your doctor may ask you for, the first place to start may be your medical history. Your medical history is a history of all the medical conditions, illnesses, and surgeries you have had. Even things that happened long ago can be very important, so be as detailed as you can.
Your doctor or other health care professionals may also ask you about all medications and other treatments you currently use, including things like dietary supplements and medicines you can get without a prescription. And, you should mention anything that could affect your ability to take a medication safely or regularly.
Now that you’ve learned what to tell your doctor, let’s see what you should be asking, too. Click Next to continue.
Getting All the Facts
It's not unusual to feel nervous or overwhelmed when discussing important health issues with your health care professional. But remember—understanding your medical condition and treatment plan is essential to good health.
Be an active patient or caregiver
- Prepare ahead of time—bring a list of questions with you to the appointment
- Record the most important facts about your medicines
- Visit Clear Health Communication's AskMe3 Web site to learn more about how to talk to your doctor. Visit www.AskMe3.org
- You may wish to bring along a friend or relative for additional support if you wish (discuss with your healthcare provider if joining consultation)
- Write down notes during your conversation with the doctor, nurse or pharmacist
- Tell your health care professional if you have any communication issues—like hearing loss or English as a second language
- Ask for clarification of anything you don't understand—and persist until you get answers that are clear to you
Considering a medicine
Before you and your doctor decide on a medicine, there are many important points you'll need to discuss. Roll over the graphic below to learn more.
To view this interactive feature, you must have Flash 9 installed on your computer.
If you do not have Flash 9, you can download it from the Adobe web site.
To view this interactive feature, you must have Flash 9 installed on your computer.
If you do not have Flash 9, you can download it from the Adobe web site.
> Next: Making Medicine Decisions
< Previous: Sharing Your Medical History
It’s not unusual to feel tense, overwhelmed, or concerned about taking too much of your doctor’s time. But being an informed patient or caregiver is essential to good health. It’s best to prepare ahead of time by writing down a list of questions you want to ask your doctor. Bring along pen and paper to jot down notes during your conversation. You may also want to bring a friend or relative along for support.
Ask for clarification of anything you don’t understand. And be sure to make your doctor aware of any communication problems you may have such as hearing loss or English as a second language—and ask questions until you get clear answers.
If you and your doctor decide you need to take medicine for a certain condition, it is important to discuss it carefully before deciding on which one is best for you.
Roll over the graphic to the left to learn about the important points you and your doctor should discuss when deciding on a medicine.
Now, let’s take a more in-depth look at the factors that may affect your, and your doctor’s, treatment decisions.
Making Medicine Decisions:
Risks, benefits, and choices
When you and your doctor decide on a certain medicine, you are making a choice—one that weighs the benefits the medicine can offer to your health against the risks of side effects. Together, you will decide how much risk you are willing to accept in light of the potential benefits.
What level of risk is "acceptable" to doctors and patients? The answer differs for every individual—and being aware of the factors that shape perspectives on risk can help you and the health care professionals involved in your care work more effectively as a team in making treatment decisions.
Factors that may affect risk perception include:
- Past experience (good or bad) with medicines, for yourself or a friend or family member
- Educational level
- Age
- Cultural background
- Personality (for example, optimistic versus pessimistic; eager to try new things versus prone to avoiding risk)
- Learning style (for example, persuaded by scientific data versus more affected by personal stories and anecdotes)
> Next: Videos
< Previous: Getting All the Facts
Every product and activity, including any kind of medicine or medical procedure, involves benefits and risks. People decide how much risk they are willing to accept in light of the potential benefits they anticipate.
But what level of risk is "acceptable"? The answer differs for every individual, based on factors from age and cultural background to past experiences with medicines and learning style.
Health care professionals are also influenced by these factors in making their treatment recommendations. When you and your doctor are both aware of the personal factors that shape your perspectives on risk, you will be able to work more effectively as a team in deciding on treatments that are right for you.
Click Next to listen to stories based on real-life factors involved in medication decisions.
Making Medicine Decisions:
Videos
The decision to take a medicine is a personal one that is made jointly by a patient and doctor. Together, you and your doctor take knowledge about how a medicine affects the patient population overall, and then apply it to your individual health situation—also taking into account personal feelings, experiences, beliefs, and values.
Listen to these stories about medicine decisions based on some of the factors that affect patients' real-life choices. You may recognize some of the same reasons and concerns that you feel when making decisions about medicine.
Remember, there is no single right answer for every person or situation—be sure to discuss your personal decisions about medication with your doctor.
Diagnosis: High Blood Pressure
To view this interactive feature, you must have Flash 9 installed on your computer.
If you do not have Flash 9, you can download it from the Adobe web site.
Colin, 55
Diagnosis: High blood pressure
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Colin, 55
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2390750581001
Ben, 54
Diagnosis: Osteoarthritis
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Dan, 65
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Elena, 62
Diagnosis: ADHD
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Jenna, 7 (and her mom, Peggy)
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Tyler, 8 (and his mom, Kathy)
> Next: Filling Your Prescription
< Previous: Making Medicine Decisions
The decision to use a particular medicine should come from a doctor/patient discussion that carefully weighs the potential benefits and risks for that individual.
Press play to listen to stories about medicine decisions based on some of the factors that affect patients’ real-life choices.
Then, click Next to learn how you can work with your pharmacist to help keep yourself—and your family—safe when taking medicines.
Good Questions for Your Good Health
Do you know...The name of your medicine? What it is used for? How to take it? The side effects?
If you answered no to any of these questions, you are not alone. Many patients leave their doctor's office or pharmacy without the information they need to take their medicine properly and safely.
Pfizer Inc., in partnership with the National Patient Safety Foundation (NPSF), has created a resource, Ask Me 3 For Medicine Safety, that will help you get the information you need to take your medicine properly and safely. Click here to download a PDF that lists questions to ask your doctor, nurse, or pharmacist at your next visit.
Ask Me 3 For Medicine Safety builds upon the success of the Ask Me 3 program that was created to help you have a better conversation with your health care provider. Click here to download a PDF that will help you learn more about Ask Me 3.
The National Patient Safety Foundation is an independent non-profit organization. Its mission is to improve the safety of patients. NPSF joined forces with the Partnership for Clear Health Communication (PCHC). Together, their main focus is helping patients and health care providers communicate even better, for better health.
Filling Your Prescription
Your pharmacist is a valuable partner in your care. To help keep you and your family safe, always take these steps when filling a prescription for yourself or someone you care for:
- Make sure you have the right medicine and dosage—and that you understand how to take the medicine—before leaving the pharmacy
- Download tips to reduce your risk of medication errors
- Find out the active ingredient of any nonprescription medicine—and avoid taking more than one kind of medicine containing that ingredient
- Ask your pharmacist to explain anything that is unclear
- Make the most of your pharmacist's expertise
Reading the label
The label on your prescription contains important information to help you take your medicine safely. Roll over the bottle below to learn more about medicine labels.
To view this interactive feature, you must have Flash 9 installed on your computer.
If you do not have Flash 9, you can download it from the Adobe web site.
> Next: Taking Your Medicine
< Previous: Videos
When you fill a prescription for medicine, for yourself or someone you take care of, make sure you take advantage of a valuable partner in your care—your pharmacist—and make sure to read the label on your prescription.
It may sound obvious, but many people ignore the instructions or warnings that come with their medications. Or they may be confused about the directions or the sticky labels on their pill bottles, and never bother to get answers.
Rollover the image of the pill bottle to the left to learn about the important information included on your prescription label.
And remember—anytime you’re uncertain about information concerning your medicine, ask your pharmacist or doctor.
Click Next to continue learning how you can take medicine safely.
Taking Your Medicine
Your role in medicine safety continues after you take your medication home from the pharmacy. Each time you take your medicine—or give medicine to someone you care for—you are playing a key role in ensuring your safety and the safety of those in your care.
Take your medicine (or, as a caregiver, give it to the patient) exactly as directed:
- Read the directions and special instructions on your medicine, every time you take it
- Follow the directions on the label along with any other instructions from your health care team
- Do not change the usual daily dosage without talking to your doctor first
- Store the medicine according to any instructions provided, and be sure to keep it out of the reach of children and pets
> Next: Reporting Side Effects
< Previous: Filling Your Prescription
Your role in medicine safety continues after you take your medication home from the pharmacy.
Each time you take your medicine, or give medicine to someone you care for, read all of the directions and special instructions. Follow the directions on the label along with any other instructions from your health care team.
It's also important not to change the dosage without talking to your doctor first. Some medications don’t make you feel better right away and some need to be taken even after you feel better. With some medications, if you and your doctor decide that you should stop taking them, you may need to stop gradually.
There's one more important step in ensuring medication safety—recognizing and reporting any problems that might be related to the medicines you take. Click Next to learn more.
Reporting Any Side Effects
One of the most important things you can do to keep yourself and those you care for safe is to promptly recognize and report any problems that might be related to the medication. Here's how:
- Be alert to how you feel after starting the medication
- Report any side effects to your doctor or another health care professional right away. For side effects that seem severe, such as difficulty breathing, extreme dizziness, or a very bad rash, contact emergency services
- For parents and caregivers: Download these helpful guides to learn more about medication safety for children and seniors
- Medication safety for children: A guide for parents and caregivers
- Medication safety for the elderly: A guide for patients and caregivers
> Next: Understanding Safety Updates
< Previous: Taking Your Medicine
One of the most important things you can do to keep yourself and those you care for safe is to promptly recognize and report any unwanted effects that might be related to the medication.
Be alert to how you feel after starting the medication, and tell your doctor or other health care professional right away if you think you may be having any unwanted effects from it. You may need a different dose or a different kind of medication.
If you are caring for a child or elderly person, you will also need to be aware of special challenges and concerns relating to the safety of medication for both old and very young patients.
Download our guides to learn more about medication safety for children and seniors.
Understanding Safety Updates
A medicine is approved for use in patients only when extensive testing shows that its benefits outweigh the risks for its intended use. But, sometimes safety issues may arise even after a medicine is approved, as it is used by greater numbers of people with more varied backgrounds than those involved in clinical studies.
Pharmaceutical companies and regulatory agencies, such as the U.S. Food and Drug Administration (FDA), act promptly to address all credible information about emerging medicine safety issues. These organizations work together to:
- Analyze the available evidence
- Communicate findings to health care professionals and the general public
- Continue to monitor additional information
- Take appropriate action as required
Taking action in response to emerging safety information
When learning about the action taken by regulators and pharmaceutical companies in response to emerging safety information, it can be hard to know what it means for individual patients. That's because different information requires different actions. For example:
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Changes may be made to the professional Prescribing Information.
Learn more -
Letters may be sent out to health care professionals.
Learn more -
A special strategy to manage the risks, known as a Risk Evaluation and Mitigation Strategy (REMS), or an update to an existing REMS, may be required.
Learn more -
Information may be issued by regulatory agencies.
Learn more - A batch of product may be recalled.
- New clinical studies may be planned.
> Next: Prescribing Information Changes
< Previous: Reporting Side Effects
Changes to a Medicine's Professional Prescribing Information
Sometimes, when new safety information arises about an approved medicine, changes must be made to the professional Prescribing Information—designed to help health care providers use the medicine safely and effectively.
Roll over the graphic below to learn more about some of the sections of the professional Prescribing Information most commonly changed in response to new safety information.
To view this interactive feature, you must have Flash 9 installed on your computer.
If you do not have Flash 9, you can download it from the Adobe web site.
Click here to see monthly summaries of safety labeling changes approved by the FDA
> Next: Letters to Health Care Professionals
< Previous: Understanding Safety Updates
Letters to Health Care Professionals
In certain cases, manufacturers of a medical product may need to inform doctors, pharmacists, and other health care providers about new safety concerns that have arisen about one of their marketed medical products.
To do this, they send what are known as "Dear Health Care Professional" letters. These letters may include information about:
- Warnings and/or Precautions added to the label
- New data regarding significant adverse events
- Other important information about the product
> Next: Strategies to Manage Risk
< Previous: Prescribing Information Changes
Strategies to Manage Risk
When new safety information emerges about a medicine, the U.S. Food and Drug Administration (FDA) may require a company to develop a Risk Evaluation and Mitigation Strategy (REMS)—or update an existing REMS—to manage these potential serious risks. The goal of a REMS is to ensure that the medicine is used appropriately so that its benefits outweigh its risks.
View the FDA's list of products with an approved REMS
Components of a REMS may include:
- A timetable for measuring how well the REMS is working—Required for all REMS
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A Medication Guide—A key component for many medicines, created to inform patients of the risks of a specific medicine and how to take that medicine safely. Generally, a paper handout of the Medication Guide must be given to the patient each time that medicine is dispensed to a patient or caregiver
View the FDA's list of products that have Medication Guides - Additional communication, or special training, for health care professionals who prescribe or dispense the medicine
- Special monitoring of patients who take the medicine
> Next: Regulatory Agency Communications
< Previous: Letters to Health Care Professionals
Regulatory Agency Communications
In addition to medicine safety information communicated by pharmaceutical companies, regulatory agencies also issue communications to keep patients and health care professionals up to date on the latest developments.
For example, the U.S. Food and Drug Administration's (FDA) Web site contains a page titled Postmarket Drug Safety Information for Patients and Providers, which serves as a portal to many different types of publically available documents concerning medicine safety issues.
Go to the FDA's Postmarket Drug Safety Information for Patients and Providers
Available documents may include:
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Drug Safety Communications
Learn more -
Safety Alerts for Human Medical Products
Learn more -
Quarterly reports of potential medicine safety issues
Learn more
> Next: Drug Safety Communications
< Previous: Strategies to Manage Risk
Drug Safety Communications
Drug Safety Communications are short FDA bulletins that are issued and updated as needed to provide public with a single source for the current "headline news" concerning the safety of a medical product.
Each Drug Safety Communication contains:
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A Safety Announcement, including:
—The source of new safety information (reports of side effects in patients, clinical study results, etc.)
—The identified or potential problem
—The actions that have been taken or are being considered, which may include:
— Convening Advisory Committees to seek expert opinion
— Requiring new clinical studies
— Recalling a product
— Adding warnings to the product label
— Creating or updating a Medication Guide - Additional Information for Patients
- Additional Information for Healthcare Professionals
- Data Summary
- References
- Links to any related information
Find out whether a medicine you're taking—or consider taking—appears on the FDA's Drug Safety Communications page.
Introduced in January 2010, Drug Safety Communications replaced a range of different types of documents used previously, including:
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Healthcare Professional Sheets
Click here to see Healthcare Professional Sheets issued from 2005 to 2009 -
Public Health Advisories (Drugs)
Click here to see Public Health Advisories issued up until 2009 - Early Communications and Early Communications about Ongoing Safety Reviews
> Next: Safety Alerts for Human Medical Products
< Previous: Regulatory Agency Communications
Safety Alerts for Human Medical Products
The U.S. Food and Drug Administration (FDA) may issue a safety alert to inform health care professionals when new safety information is available for medicines that they prescribe or administer. These alerts may include:
- A Drug Safety Communication
- Safety-related labeling changes
- Product recalls
These brief communications are organized as follows
- Audience: The healthcare specialty for which the information is intended (e.g., Family Medicine, Oncology)
- Issue: A brief summary
- Background: A brief summary
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Recommendations on handling the safety issue, such as:
— Avoiding the use of the medicine with certain kinds of patients
— Switching patients from the medicine in question to an alternative therapy
— Monitoring patients for certain conditions or adverse effects when using the medicine
— Providing patients with additional information or precautionary warnings
Find out whether a medicine you're taking—or considering taking—has any active Safety Alerts. View the FDA Drug Index
View the FDA's Safety Alerts pages
> Next: Quarterly Reports
< Previous: Drug Safety Communications
Quarterly Reports
The U.S. Food and Drug Administration (FDA) stores all reports received about adverse events experienced by patients taking medicines in a single database. This database is regularly examined by the FDA staff. When a potential signal of a serious risk is identified, it is logged as a medicine safety issue. A new listing is then issued each quarter, showing newly identified Potential Signals of Serious Risks and New Safety Information Identified from the Adverse Events Reporting System.
View the FDA Quarterly Reports of Potential Safety Issues
The appearance of a medicine in this quarterly listing does not mean that the FDA has concluded that the medicine is the cause of the safety risk. It simply means that the FDA has identified a potential safety issue. It also does not mean that the FDA is suggesting that health care providers should not prescribe the medicine or that patients taking the medicine should stop taking it. Patients who have questions about their use of the identified medicine should contact their health care provider. The FDA will complete its evaluation of each potential safety issue and may take further action as appropriate.
> Next: Helpful Resources
< Previous: Safety Alerts for Human Medical Products
A Resource Kit for Safer Medicines
Click on the links below to download resources on reducing or managing your medication risks. Keep these easy-to-print information sheets for your reference or share them with your doctor, pharmacist, or other health care professionals.
My health and medications: A fact sheet for my health care team
This tool was developed to improve the safety of patients by asking them to be partners in their care. Keep it updated and bring it to your doctor, clinic, hospital, or pharmacy. If you are a caregiver for a child or an elderly person, fill it out for them and make a copy available to other responsible or trusted people, such as day care providers, who might need it in case of emergency.
Avoiding medication errors
Learn simple ways to help reduce your risk of getting the wrong drug or dose. Plus, find out how to dispose of old medicines safely.
Your pharmacist: A partner in drug safety
The knowledge and experience of your pharmacist can help reduce your risk from nonprescription or prescription medicines. Here's how to get the most from them.
Medication safety for children: A guide for parents and caregivers
Children often have special safety issues regarding medicine. This guide presents some important ones and how to handle them.
Medication safety for the elderly: A guide for patients and caregivers
Older adults also often have special safety issues regarding medicine. Learn how to help manage safety for yourself or seniors you care for.
Understanding side effects
Gaining a better understanding of side effects can help you weigh the benefits and risks of your treatment options. Learn more about side effects so you and your doctor can choose the medicines that are right for you.
> Next: Helpful Links
< Previous: Quarterly Reports
Helpful Links
The Web sites below can help you learn more about medicine safety. These Web sites are neither owned nor controlled by Pfizer. Pfizer is not responsible for the content or services of these sites.
What you need to know to use medicine safely (FDA)
Safety information for patients and health care providers (FDA)
Safety information for specific drugs (FDA)
Patient health literacy (AMA)
Consumers Advancing Patient Safety (CAPS)
SafeMedication.com (ASHP)
Tips for seniors (ASCPF)
Preventing medical errors (AHRQ)
More on safety (PhRMA)
How to dispose of unwanted or expired medicines safely
How to get the most from your pharmacist (APhA)
> Next: Understanding Risk
< Previous: Helpful Resources
Studies of High Risk Patients: A combined analysis of 6 studies in people who have suffered a previous vascular event.
The Physicians' Health Study: A study of over 10,000 male physicians
The Women's Health Study: A study of nearly 20,000 female health care providers in the U.S.
