By Chelsea M. Zavilla, B.S.P.S., School of Pharmacy, University of Pittsburgh, and Sue Skledar, R.Ph., M.P.H., FASHP, clinical specialist, UPMC Health System Formulary Management and Drug Use Policy Associate Professor, School of Pharmacy, University of Pittsburgh
If you are one of the millions worldwide who experience seasonal allergies, the fall season can bring about real discomfort. Allergies occur when your body’s immune system reacts to an allergen, such as pollen, weeds, grass, dust, or pet dander. More
By Adam Trimble, Pharm.D., PGY-1 Pharmacy Resident at St. Rita’s Medical Center, Lima, OH
Whenever you pick up a prescription medication, you may notice little stickers on the bottle that say “Take on an empty stomach” or “Take with food.” You may also find similar instructions on the nonprescription (over-the-counter) Drug Facts label as well. More
By Christopher Campbell, Pharm.D., PGY1 Resident, George Regents Medical Center, Augusta; and Christina E. DeRemer, Pharm.D., BCPS, Primary Care Clinical Pharmacist & Medicine Team Supervisor, Georgia Regents Health System
Does your family have a stockpile of prescription medications that you keep “just in case?” Have you ever used a prescription medication that was not meant for you? How often have you given someone else your medications?
Prescription medication is intended to be used under the direct care of a doctor who is responsible for...More
By Terri Albarano, M.S., Pharm.D., Clinical Marketing Manager, Specialty Pharmaceuticals/Nutrition, Baxter Healthcare, Round Lake, IL; and Sean McGonigle, Pharm.D., PGY2 Infectious Diseases Pharmacy Resident, Allegheny General Hospital, Pittsburgh, PA
Recent reports of measles outbreaks in California and a number of other states are a real cause for concern for parents, caregivers, individuals who have an impaired ability to fight disease, and healthcare providers. Any individual who is unvaccinated is at risk for contracting this highly contagious disease. Here is what you need to know about the measles virus and what you can do to prevent yourself or anyone in your family from catching it...More
By Rivka Siden, M.S., Pharm.D., Clinical Pharmacy Specialist, and Kim Redic, Pharm.D., BCPS, Manager, University of Michigan Health-System Research Pharmacy, Ann Arbor, MI
Medications used in clinical studies include both medications that have not yet been approved by the U.S. Food and Drug Administration (FDA) as well as FDA-approved medications that are being tested for safety and effectiveness to treat new or different health conditions.
If you are participating in a clinical study and are taking a study medication, here is some important information on how to safely take, handle, and store it. More
New FDA Rules Will Help Pregnant and Breastfeeding Women Understand Their Medication Options
If you are pregnant or breastfeeding, you may wonder which prescription medicines are safe to take. Recently, the U.S. Food and Drug Administration (FDA) created new rules for drug manufacturers on what they should tell doctors and pharmacists about the risks of certain medications to pregnant or nursing mothers.
The FDA decided to no longer use letter-based categories (formerly called A, B, C, D, and X) to show risk. FDA officials believed the categories were confusing and unclear about the risks of a drug to pregnant and breastfeeding females and in females and males who wish to have children.
Now, information on prescription drug labeling will be organized into three categories: pregnancy (including labor and delivery), lactation (including nursing mothers), and females and males of reproductive age.
The medication information for women who are pregnant will describe any known risks of birth defects or miscarriage. Your doctor will consider this information before prescribing this medication for you.
Your doctor or pharmacist may also see a reference to a “Pregnancy Exposure Registry,” which is a study that collects health information from women who take medications while pregnant. A list of existing registries can be found on the FDA’s Office of Women’s Health website. This collection of information tracks any problems with medications prescribed to pregnant or breastfeeding mothers and helps to improve a medication’s safety information.
The medication information for mothers who are breastfeeding describes the amount of a drug in breast milk and any possible effects on the breastfed infant. Some medicines cannot be used during breastfeeding.
The medication information for females and males of reproductive age applies to women of child-bearing age and their partners. This section includes information such as whether you should take a pregnancy test or not get pregnant before, during, or after taking the medication. It also will provide any known information about whether the medicine might affect your ability to get pregnant.
All new prescription drugs submitted by the manufacturer for FDA approval after June 30, 2015, must include information in this new format. Labeling for prescriptions drugs approved by the FDA on or after June 30, 2001, will be updated gradually. These changes do not apply to non-prescription medicines.
This new way of providing medication risk information will help you and your doctor or pharmacist decide what is best for you and your child.
By Sandy Moreau, Pharm.D., BCPS, Clinical Pharmacist, Jersey City Medical Center, and Assistant Professor, Ernest Mario School of Pharmacy, Rutgers University