How can pharmacists ensure the safety of the patient on these medications, especially in an outpatient setting? While pharmacists can more easily recommend changes and recommend routine lab monitoring to physicians in an inpatient setting via daily checks of the patient’s electronic health record, it is a bit more challenging in the outpatient/community setting. Drug-drug, drug-disease, and drug-lab interactions need to be taken into consideration when dispensing drugs with black box warnings, and that information is not always readily available like it is in the inpatient setting. While pharmacists should educate patients on these potential serious adverse events and have the patients contact their physician if they experience any unexpected changes in their body, pharmacists should also contact the provider and provide decision support on any drugs with black box warnings that he/she may have prescribed prior to dispensing the drug. The provider may have been unaware of the black box warning or may not have had time to look up information on each drug they prescribed, especially with patients with multiple comorbid conditions. Pharmacists should also recommend the providers set up appointments with their patients to come in for lab monitoring every few weeks or every few months depending on the type of drug and black box warning.
Some examples of commonly prescribed medications with black box warnings are: pioglitazone (Actos) and rosiglitazone (Avandia), for Type 2 Diabetes, have a warning for heart failure; most commonly prescribed antidepressants (selective serotonin reuptake inhibitors (SSRI), serotonin-norepinephrine reuptake inhibitors (SNRI), and tricyclic antidepressants (TCA)) have a warning for suicidal thoughts in young adults; fluoroquinolones (levofloxacin (Levaquin), ciprofloxacin (Cipro)) have a warning for tendon rupture, especially in elderly and athletes who may put a lot of stress on their tendons; and combination oral contraceptives, which contain estrogen and progestin (Yaz, Loestrin, Beyaz, Alesse), have a warning for an increased risk of serious cardiovascular events with smoking cigarettes. While there are many other effective diabetes medications that can be tried first, thus potentially avoiding the use of pioglitazone and rosiglitazone, that is not necessarily the case with antidepressants. For example, with a commonly prescribed antidepressant, fluoxetine (Prozac), an SSRI, providers should initially prescribe the lowest recommended dose (20mg PO daily), enough to cover them until their follow up appointment, which should be scheduled within 3-4 weeks. After 3-4 weeks, patients should see and feel improvements, and providers can titrate up accordingly. Patients should strongly be encouraged to see a therapist, as well as assess for family and friend support. Pharmacists should also make sure to let patients know that they may feel worse before feeling better and to keep taking their medication as prescribed. The same recommendations should be made for most of the other commonly prescribed antidepressants.
Bottom line, yes, they can be dangerous, but if the benefits outweigh the risks, close monitoring will keep away the fatality.
- FDA Black Box Warnings. DrugWatch. https://www.drugwatch.com/2012/01/18/fda-black-box-warnings. Published January 18, 2012. Accessed March 3, 2017.
- FDA Safety Alerts for Drugs and Medication-Related Medical Devices. FDA Safety Alerts. http://www.ismp.org/Tools/FDASafetyAlerts.asp. Accessed March 6, 2017.
- Lasser K, Seger D, Yu T, et al. Adherence to Black Box Warnings for Prescription Medications in Outpatients. Archives of Internal Medicine. http://jamanetwork.com/journals/jamainternalmedicine/fullarticle/409756. Published February 13, 2006. Accessed March 6, 2017.
- Matheny M, Sequist T, Seger A, et al. A Randomized Trial of Electronic Clinical Reminders to Improve Medication Laboratory Monitoring. Journal of the American Medical Informatics Association. https://academic.oup.com/jamia/article/15/4/424/731680/A-Randomized-Trial-of-Electronic-Clinical. Published July 1, 2008. Accessed March 6, 2017.
- Nischal A, Tripathi A, Nischal A, Trivedi JK. Suicide and Antidepressants: What Current Evidence Indicates. Mens Sana Monographs. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3353604/. Published 2012. Accessed March 6, 2017
- SSRI Risks – Zoloft, Paxil, Prozac & Other Antidepressants. DrugWatch. https://www.drugwatch.com/ssri. Published August 7, 2012. Accessed March 6, 2017
- Suchard J. Fluoxetine Overdose-Induced Seizure. Western Journal of Emergency Medicine. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2672257. Published August 2008. Accessed March 8, 2017.
- Image: http://www.cipro-poisoning.com/2013/09/fda-announces-new-black-box-warning.html
Posted by Christine Choe, PharmD Candidate 2018