Month: March 2021

REMS: Why We Can’t Be Hasty When It Comes to Drug Safety

REMS: Why We Can’t Be Hasty When It Comes to Drug Safety

To be, or not to be? When it comes to drug safety, it is up to the U.S. Food and Drug Administration (FDA) to decide if a medication may be, or not be. The Risk Evaluation and Mitigation Strategy (REMS) requirement was set up by the FDA for select prescription medications which pose a high potential for serious adverse effects. As its name suggests, the REMS program is concerned with drug safety and in ensuring the benefits of a certain drug outweigh the risks1. REMS does not only oversee adverse effects alone, but seeks to “prevent, monitor and manage” any medication the FDA expects could potentially violate safe medication practices1. Although the FDA is in charge of determining whether REMS must be enforced for a medication, it is the manufacturer who is in charge of the program and submission of assessment reports for quality improvement or assurance efforts2. Below is a helpful guide provided by the FDA which can be very useful if you ever find yourself counselling a patient on a REMS classified drug. 

Image Reference: A Framework for Benefit-Risk Counseling to Patients About Drugs with a REMS

Drug safety efforts and their importance in public health can be seen as early as 1937. The antibiotic sulfonamide would result in hundreds deaths due to the toxic excipient diethylene glycol, supposedly claimed as being inert (you can read more about the incident via the June 1981 issue of the FDA Consumer magazine titled “sulfonamide disaster”)3. Later in the 1960s thalidomide was used for antiemetic effects in pregnant women, but resulted in severe teratogenic adverse effects made clear when babies were born with missing or deformed extremities3

Image Reference: Wikipedia Creative Commons

The difference between these two events, however, is significant from the perspective of the United States. You see, after the sulfonamide tragedy the FDA mandated the 1938 Food, Drug, and Cosmetic Act (FDCA). At this point, pharmaceutical companies were required to conduct actual studies proving a drug is safe before becoming readily available to the general public (which was exactly why sulfonamide slipped through the cracks)3. So thalidomide was never actually approved in the United States due to data suggesting deformities on animal models despite lobbying and immense political pressure against the clinical director at the time3.. As such, the unfortunate teratogenic effects seen with thalidomide were mitigated on home soil. This brief dive into history barely scratches the surface on the importance of drug safety and pharmacovigilance but is helpful in understanding what can happen if we get a little too hasty when it comes to drug safety. As such, this brings us back to REMS. You can view a list of all current REMS medications on the FDA website alongside their associated goals, materials and a comprehensive timeline of program updates for each REMS medication. Additionally, if you want to go really deep into the U.S. regulations for REMS please visit this PDF slidedeck created by the FDA. 

Sincerely,

Jean Hanna

References:

  1. Center for Drug Evaluation and Research. “Risk Evaluation and Mitigation Strategies (REMS).” U.S. Food and Drug Administration, FDA, www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems.
  2. Center for Drug Evaluation and Research. “FAQs about REMS.” U.S. Food and Drug Administration, FDA, www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/frequently-asked-questions-faqs-about-rems.
  3. Alshammari, Thamir M. “Drug Safety: The Concept, Inception and Its Importance in Patients’ Health.” Saudi Pharmaceutical Journal, vol. 24, no. 4, 9 May 2014, pp. 405–412., doi:10.1016/j.jsps.2014.04.008.
  4. “A Framework for Benefit-Risk Counseling to Patients About Drugs with a REMS.” U.S. Food and Drug Administration.

Contraceptive Options for Contraindicated Patients

Contraceptive Options for Contraindicated Patients

In 2015-2017, it was estimated 64.9% of women in the United States between the ages of 15-49 were using some form of contraception1. The National Survey of Family Growth (NSFG) reported female sterilization (18.6%), oral contraceptive pills (12.6%), long acting reversible contraceptives (10.3%) and male condoms (8.7%) as the most popular and common options but the degree of usage for each varied largely by age1. Although some methods of contraception are far more efficacious than others, it is important to take into consideration other factors too. These include demographics, side effects, duration, reversibility and contraindications when offering contraceptive counseling, and assisting patients in deciding on the most appropriate form of birth control for their specific needs. Likewise, dual protection should always be considered to prevent risks from HIV and STIs as even highly effective methods of contraception such as Intrauterine Device (IUDs) or surgical sterilization do not protect against these infections2

As a whole, contraceptives can be grouped into hormonal and non-hormonal categories. See the interactive diagram which compares typical effectiveness per contraceptive method below alongside their degree of hormonal properties to get a feel for what options are available on the market and how they compare to one another.

Although there are many options to choose from, some patients may find themselves contraindicated for hormonal contraceptives, specifically estrogen. The CDC provides a helpful summary chart (U.S. Medical Eligibility Criteria for Contraceptive Use) which outlines a comprehensive medical eligibility criteria across four categories of severity for several potential conditions and sub conditions. I have put together a more condensed version of the legend below:

For women who find themselves in category 3, it would be wise to consider alternative birth control methods whereas women who find themselves in category 4 are completely contraindicated. Most commonly, this contraindication is due to hormonal therapy associated with estrogen releasing products. Patients contraindicated to hormone birth control methods can consider the following options which either circumvent hormones altogether or rely on progestin alone:

When considering the above birth control methods, it is important to tailor the best option to the patient. For example, if a patient is looking to space their children out evenly across 3 years, a Nexplanon implant might be a good option. Likewise, a patient who is no longer interested in having children may be better suited for more permanent options such as sterilization or a long term IUD. I hope our dive into contraceptives has been helpful and as always I wish you all the best of luck with your studies. 

Sincerely,

Jean Hanna

References:

  1. Products – Data Briefs – Number 327 – December 2018. (2018, December). Retrieved from https://www.cdc.gov/nchs/products/databriefs/db327.htm
  2. Contraception. (2020, August 13). Retrieved from https://www.cdc.gov/reproductivehealth/contraception/index.htm
  3. Contraception. (2020, August 13). Retrieved from https://www.cdc.gov/reproductivehealth/contraception/index.htm
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