Just last month, I read that the U.S. Food and Drug Administration (FDA) approved a new medication for plaque psoriasis, called Cosentyx, which offered a completely new method of attacking the skin disease, offering patients with this painful chronic condition a safe and effective new treatment option. Three cheers for scientific advancement! Hip-hip- hoo…
Not so fast.
Reading further, I learned that the FDA also required a Medication Guide with this drug to inform patients that because Cosentyx affects the immune system, there is greater risk of infection.
A Medication Guide? What’s That?
I have taken meds for various infections, and I’ve sometimes read the package insert, but I didn’t know what a Medication Guide is –- and that would not please the FDA, which has issued more than 400 of them. Who knew?
When did Medication Guides first appear – and why?
Medication Guides first appeared in 1998, when the FDA issued regulations establishing requirements for the distribution of labeling for patients for certain medications used primarily on an outpatient basis without direct supervision by a healthcare professional.
As healthcare settings changed, in 2008 the FDA amended the basis for Medication Guides to include some drugs that are often provided in outpatient settings where the drug is dispensed to a healthcare professional, such as community pharmacies or hospital-based ambulatory care units.
Likewise, the FDA requires Medication Guides for some drugs administered in inpatient settings — a medical facility, for example, like a hospital, hospice care and skilled nursing facilities where patients receive care for longer than 24 hours. The FDA acknowledges that it’s impractical for healthcare professionals to have to give out Medication Guides each time a drug is dispensed in these settings — BUT a patient is entitled to ask for one. In addition, particularly when the drug is first dispensed, the health care professional should instruct their patient(s) on the appropriate use of a drug, address potential side effects and answer any questions.
How is a Medication Guide different from the Package Insert?
All medications include a package insert (PI – also known as prescription drug product insert or professional labeling) to provide detailed drug information compiled and distributed by the drug manufacturer, after FDA review and approval. The purpose of the package insert is to provide complete and unbiased prescribing and safety information to health care professionals, in other words, the prescriber.
So when should patients receive a Medication Guide? According to the FDA:
- Any patient or patient’s agent who requests a Medication Guide should receive one. Not every drug is required to have a Medication Guide, so ask a healthcare professional or pharmacist or go online: You can view all Medication Guides on the FDA website.
- Medication Guides should be provided to patients in outpatient settings, when the drug will be administered without direct supervision from a health care professional. These types of settings could include community pharmacies, hospital-based ambulatory care units or apply to patient samples.
- In outpatient settings when patients return often, like a dialysis center, health care professionals should provide a Medication Guide only the first time a drug is dispensed.
- If a Medication Guide has been materially changed it needs to be provided in all outpatient settings the first time a drug is dispensed following the change. (Pharmaceutical companies notify health care professionals whenever material changes take place in Medication Guides — for example, when a new indication or new safety information is added.)
- Some drugs are subject to a Risk, Evaluation and Mitigation Strategy (REMS) that includes specific requirements for reviewing or providing a Medication Guide. (In 2007 the FDA was given authority to require a REMS from manufacturers to ensure that the benefits of a drug or biological product — newly or previously approved — outweigh its risks.)
- In an inpatient facility, rather than provide a Medication Guide every time a drug is prescribed or dispensed, health care professionals should instruct their patients on the appropriate use of a drug, address potential side effects and answer any questions.
What do Medication Guides look like?
Medication Guides are paper handouts that come with many prescription medicines to describe, in detail, risks, appropriate use and proper treatment and storage of the medication. They are meant for patients or caregivers to help use the medication safely and understand risks — in plain language and with illustrations.
A Medication Guide includes the same information as the PI, but is written in a different format with risk information right up front and in language geared toward a patient or consumer, rather than a healthcare professional.
Why are some drugs required to have a Medication Guide?
According to the FDA, the Agency requires that Medication Guides be issued with certain prescribed drugs and biological products when officials determine that:
- certain information is necessary to prevent serious adverse effects;
- patient decision-making should be informed by information about a known serious side effect with a product;
- patient adherence to directions for the use of a product are essential to its effectiveness.
How does a Medication Guide help?
The guides are meant to help us better understand our medications and use them appropriately to avoid serious side-effects. They offer answers to such crucial questions as
- What is this drug and what does it do?
- What’s the most important information that I need to know about the medication?
- What are the risks involved in taking this?
- What are the possible side effects?
- Who shouldn’t take the drug?
- What ingredients are in this medication?
“Medication Guides generally focus on a specific risk or aspect of patient adherence, as opposed to providing broader information on how to appropriately use a medicine,” says Paul Seligman, M.D., M.P.H., former associate director for Safety Policy and Communication in FDA’s Center for Drug Evaluation and Research.
How does this apply in the real world?
Back to Cosentyx: this drug is administered as an injection under the skin, so a professional healthcare practitioner is involved, although he or she may decide to allow the patient to administer the medication at home. The FDA required a Medication Guide to alert patients that because Cosentyx affects the immune system, they may be at greater risk for infection while taking the drug. That’s why patients need to understand the side-effects and take part with their physician in weighing risk vs. benefit. In the case of Cosentyx, the FDA deemed it particularly important for people to tell their physician if they have
- a chronic infection or history of recurrent infection;
- active Crohn’s Disease;
- tuberculosis (TB) or have been in contact with someone with TB.
In addition, the Cosentyx Medication Guide provides information about storage, ingredients, how to administer the medication, precautions, risks and other side effects, including the most common ones, which include:
- serious allergic reactions;
- diarrhea;
- upper respiratory infections.
How do you know if there is a Medication Guide for a drug?
OK, most of us know that prescription meds — like Coumadin, Ritalin, Botox and Oxycontin — have side effects — especially when used at the wrong doses. But did you know that Motrin (ibuprofen), has a Medication Guide? So does Prevacid (lansoprazole), one of the top 5 prescription brands in the US to treat heartburn and GERD.
Hoo boy. It’s complicated
Yep — but you don’t need a medical degree. Most important is to ASK your doctor or your pharmacist about side-effects and use. Or go online. You can view all Medication Guides on the FDA website here: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm
