Quality care in epilepsy: Women’s counseling and its association with folic acid prescription or recommendation

       This study focused on women of child-bearing age who are being treated for epilepsy with antiepileptic drugs (AEDs). Taking folic acid during the pre-conceptual period has been found to decrease the risk for congenital malformations in babies born to women with epilepsy who take AEDs. The purpose of this study was to determine if annual counseling about contraception and pregnancy in a treatment setting for women with epilepsy is associated with increased recommendations or prescriptions for folic acid.

        This was a retrospective cohort study that collected the data by abstracting medical records from the subjects. 77 women of childbearing age were included in this study who had two or more visits for epilepsy at a neurology clinic. The assessment included a review of documentation from the first three visits for epilepsy within a 24-month follow-up window. The women in this study were placed into 2 groups based on the type of counseling they received about pregnancy and contraception in relation to their epilepsy treatment: one group received something called DFCW (N=28) while the other group did not receive DFCW (N=49). DFCW was defined as the health care provider perfectly adhering to annual counseling about the impact of epilepsy treatment on contraception or pregnancy during their sessions with the patients. A recommendation from the provider that the patient take over-the-counter (OTC) folic acid or a prescription for folic acid was independently abstracted from the chart at each visit.

       The group of subjects who received DFCW and the group who did not receive DFCW had no significant differences in respect to age, disease duration, baseline history of drug-resistant epilepsy (DRE), presence of concurrent psychiatric disease, epileptologist involvement, number of AEDs prescribed, types of seizures experienced, and etiology. The results were that 71.4% of subjects (20 women) in the DFCW group and 85.7% of subjects (42 women) in the non-DFCW group were NOT recommended or prescribed folic acid by their health care provider. These results show that providers are missing a big area of counseling for their female patients with epilepsy who are of child-bearing age. Even though many of the providers counsel their female epilepsy patients about how epilepsy treatment may affect contraception and pregnancy, they often times do not mention or actively recommend their patients to take folic acid if they are thinking about trying to conceive.

     I think the results of this study are interesting and very eye-opening. It is concerning to me that many health care providers are not mentioning the benefits of taking folic acid to their female epilepsy patients of child-bearing age because previous studies have proved that folic acid can prevent congenital malformations in babies born to women with epilepsy who took AEDs during their pregnancies. I am wondering if this finding about folic acid is relatively new in the treatment of women with epilepsy and that many providers, especially those who have been practicing for many years, are simply not aware of this finding. Whatever the reason is, I hope this study has been reviewed in the world of epilepsy treatment and that more providers start recommending the use of folic acid in their female epilepsy patients of child-bearing age in order to prevent more congenital malfunctions from the use of AEDs during pregnancy from occurring.

My question posed to colleagues: How can pharmacists play a role in making female epilepsy patients of child-bearing age taking antiepileptic drugs aware of the fact that taking folic acid could decrease the risk for their children having congenital malfunctions?

Moura, LMVR, Mendez, DY, De Jesus, J, et al. Quality care in epilepsy: Women’s counseling and its association with folic acid prescription or recommendation. Epilepsy Behav. 2015;44:151-154.  

Efforts in Epilepsy Prevention in the Last 40 Years

This was a study conducted to see if new-onset epilepsy prevention strategies have been identified and successfully implemented.  This was done in Finland from 1973 to 2013 and analyzed first-time inpatients with an epilepsy diagnosis.  “Epilepsy” in this study was defined as two or more “unprovoked” seizures.

Previously, antiepileptic drugs have been proven to subdue epilepsy, but have failed to prevent new-onset epilepsy in individuals at risk for developing it.  They studied three different age groups longitudinally to see if there was an increase, decrease, or lack of change in the rates at which first-time patients were admitted with new-onset epilepsy.

In the last 40 years, the rate at which those 65 and younger were admitted to the hospital and newly diagnosed with epilepsy was constant.  However, the rate at which those 65 and older were diagnosed increase 5-fold over the last four decades.

They concluded that no advances had been made in the prevention of epilepsy.  However, I’d like to pose a question…is there really a way to definitively tell if someone will develop epilepsy in the future?  Often our healthcare is reactive not proactive–meaning we only treat things when there’s a problem.  If there aren’t any health complications, we don’t usually go seeking potential ones.  This can relate back to the study.  Yes, we have not been able to make strides with epilepsy prevention, but is that attainable at this time?

Sillanpaa M, Gissler M, Schmidt D. Efforts in Epilepsy Prevention in the Last 40 Years. JAMA Neurol. doi:10.1001/jamaneurol.2015.4515 (15 February 2016).

Lorazepam vs. Diazepam for Pediatric Status Epilepticus

In pediatric patients indicated for status epilepticus, benzodiazepines are considered first line therapy. Lorazepam is not FDA approved for this indication, but studies show it may be more effective and safe.

A double-blind, randomized clinical trial was conducted from March 1, 2008 to March 14, 2012 using 273 patients aged 3 months to younger than 18 years. Patients included in the trial had generalized tonic-clonic status epilepticus, which is defined as, 3 or more convulsions within the preceding hours and currently experiencing a convulsion, 2 of more convulsions in succession with no recovery of consciousness and currently experiencing a convulsion, or a current single convulsion with a duration of least 5 minutes.

140 were given 0.2 mg/kg diazepam IV and 133 were given 0.1 mg/kg lorazepam IV. In the diazepam group, 72.1% of patients had cessation of the status epilepticus and in the lorazepam group, 72.9% of patients had cessation of the status of epilepticus. Sedation was seen in 50% of patients taking diazepam and 66.9% of patients taking lorazepam.

It was determined that between the 2 medications, there were no significant differences in primary efficacy and safety outcomes. This does not support the theory that lorazepam is the superior treatment. This is interesting because the study showed that the medications have fairly equal efficacy, but lorazepam has an increase risk of producing sedation. Pharmacists should be aware of this when recommending medications for pediatric patients.

JAMA. 2014;311(16):1652-1660.

Generic-to-generic lamotrigine switches in people with epilepsy: the randomised controlled EQUIGEN trial

Switching between generic medications can often be a difficult decision or transition for the patient, as there are many concerns about less effective medications or new side effects. This study looked at the effect of switching between two generic lamotrigine immediate-release drugs in patients who have epilepsy.

This was a double-blind, randomized, crossover study that recruited adult patients already taking generic immediate-release lamotrigine twice daily at either 100mg, 200 mg, 300 mg, or 400 mg. Patients in the study were then randomly assigned a treatment sequence (1 or 2). The study was then divided into two 14-day portions. For the first 14 days of the study they would continue to receive the doses they were on before the study. After 14 days, the patients were changed to the other generic product. This study aimed to measure the bioequivalence of the different generic drugs, so at the end maximum plasma concentration and AUC for the generic forms were analyzed.

The study found that the maximum plasma concentrations and AUC were within equivalence limits, and that the exposures were equivalent between the different generic forms. No significant side effects were reported by the patients, and there were no changes in clinical lab values or vital signs during the study.

I found this study fascinating because I thought it dealt with how the perception of a drug can really effect it’s use. Even though the FDA has approved interchanging generic anti-epilepsy medications, there is still this perception among both physicians and patients that you’re putting the patient at risk for potentially increased toxicity or decreased efficacy. I think that this showed how research studies can not only bring novel uses or innovations to the medical field, but also sometimes serve to reassure practitioners about safe practices.

 

 

Link: http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(16)00014-4/abstract

 

Citation:

Privitera, M., Welty, T., Gidal, B., Diaz, F., Krebill, R., & Szaflarski, J. et al. (2016). Generic-to-generic lamotrigine switches in people with epilepsy: the randomised controlled EQUIGEN trial. The Lancet Neurology. http://dx.doi.org/10.1016/s1474-4422(16)00014-4