TCPR: An issue that most psychiatrists encounter every day is assessing and helping patients manage side effects. You recently published a paper on this in The Journal of Clinical Psychiatry. What did you learn?
Dr. Zimmerman: I wrote this paper based on my concern about the way we ask global questions about side effects in our clinical practice. What I learned is that our patients are underreporting side effects and we are underdetecting them. [You can read the whole paper at Zimmerman M et al, J Clin Psychiatry 2010;71(4):484–490].
TCPR: So something is going wrong in the communication between us and our patients when it comes to side effects. Where is the disconnect?
Dr. Zimmerman: I think the norm among doctors is to globally inquire about the presence of side effects, for example, by asking: “Have you been experiencing any side effects?” And answers are based on spontaneous report rather than direct inquiry. And that is why you end up with ridiculously low side effect prevalence rates in a number of studies. Doctors are not asking specific enough questions.
TCPR: So how did you set up your study to address this?
Dr. Zimmerman: We devised a methodology in which the participating clinicians were not even aware what we were studying. Basically we approached psychiatrists and asked if they’d be willing to recruit their patients with major depression into a quality of care study. Those who agreed simply had to hand patients a sealed envelope recruiting them into the study. Patients answered a 31 item assessment of side effects—a modification of the Toronto side effects scale—after their appointments. Then we compared the results from this pool of about 300 patients to the side effects reported on their medical records.
TCPR: And what did you find?
Dr. Zimmerman: On the self-report scale, patients not only checked off side effect presence, but also rated them on two Likert Scales, one scale being a frequency scale: “how often did this occur?” and the other being a burden or severity scale: “how much trouble does it cause you?” When we compared frequencies, we found that a lot more information was reported on the self-report scale compared to what was recorded in the charts.
TCPR: How much is a lot?
Dr. Zimmerman: Across 300 patients there was a total of 2,301 side effects reported on the self-report scale, an average of almost 8 per person. According to the psychiatrists’ notes, there was a total of 167, or an average of 0.6 per patient.
TCPR: What were some of the major side effects that went unrecorded by the psychiatrists?
Dr. Zimmerman: It was across the board in all organ systems, except that the psychiatrists in our study were good at picking up on sexual side effects. There were no differences in detection or reporting rates between the self reports and the medical record on sexual side effects.
TCPR: Some side effects, though, are hard to distinguish from symptoms, right?
Dr. Zimmerman: Some of them may well represent symptoms versus side effects. So if someone says he has “fatigue” you wonder if that is a side effect of the antidepressant or if it is an unresolved symptom. So certainly some side effects such as nervousness and agitation may sound more like symptoms, but others such as constipation, diarrhea, and nausea sound more like side effects.
TCPR: So are GI side effects something we as psychiatrists should focus on asking about?
Dr. Zimmerman: GI side effects and CNS side effects, such as sweating, headache, dizziness, were all more frequently reported in the self reports. Weakness, fatigue, and dry mouth were missed, as well.
TCPR: Were the patients in your study on one medication or were they taking many?
Dr. Zimmerman: The majority of individuals were on more than one medication. The mean number of medications was 2.1 but 67% were taking two or more. One-quarter were taking three or more. Almost one-third were on benzos. Slightly more than half were on an SSRI.
TCPR: So what was the main conclusion of your study?
Dr. Zimmerman: The bottom-line message is that patients seem to be experiencing more side effects than we are detecting. There are different ways of interpreting this; for example, is this a reflection of doctors just not documenting? We didn’t get a sense that that was what was really going on. We think sometimes what happens is that patients don’t report side effects to their doctors simply because they have grown so used to them.
TCPR: This might be the case with something as ubiquitous as dry mouth, for example.
Dr. Zimmerman: Right. So some of it is underreporting, and some of it is inadequate assessment.
TCPR: How do you suggest we change our practices to address the issues you found in your study?
Dr. Zimmerman: My team and I combed the literature and came up with a side effect questionnaire for patients to complete before we see them. That can be used, free of charge, by registering on www.outcometracker.org. You can send your patients there to answer the questionnaire before coming in for a visit.
TCPR: You also talked about making direct inquiries. What are some specific examples?
Dr. Zimmerman: It depends on the medications that individuals are taking and what their most common side effects are. For example, patients on SSRIs or SNRIs may not directly talk about sweating, so you have to ask. These patients may bring up asthenia, or emotional flatness, which is perceived as more bothersome.
TCPR: And how would you distinguish “asthenia” from depression in your questioning?
Dr. Zimmerman: Let’s say a patient being treated for depression comes in and he notes a feeling of numbness that seems distinct from depression. I am more willing to think it is a side effect. I will ask if he is enjoying things like he normally does, and if he says no, I dig deeper. For example, “Are you feeling somewhat disconnected?” If he points out, “Yes, because I’m depressed,” I may remind him that when he first came in he said was not sleeping or eating, and was feeling fatigued. And it sounds like a lot of these things have gotten better. Once we determine it’s a side effect and not a symptom, we need to determine how bothersome it is to the patient and if it’s worth switching meds, lowering the dose, or adding something else in.
TCPR: Let’s return to sexual side effects. This is sometimes an awkward topic to bring up with patients. Any advice on how to make sure we’re asking and patients are telling us about these side effects?
Dr. Zimmerman: It should begin with the initial prescribing of the medication. I always specifically tell patients an antidepressant can affect various phases of sexuality—it can have an impact on interest in sex, physical arousal, orgasm. I tell men it can make erection more difficult or can delay ejaculation or make it so they can’t ejaculate. With women I use the words arousal and orgasm.
TCPR: There are some of us who are reluctant to go into that level of detail, not necessarily because of embarrassment, but perhaps we are worried it would dissuade the patient from choosing to take a medication we think they need to take.
Dr. Zimmerman: Well, we do need to consider how good of a job we do in matching patients to medications. So if a patient says to me, “I am not taking anything that could possible cause sexual dysfunction,” then I need to talk about medications that are less likely to cause that, like Wellbutrin and Remeron. However, it’s more common for patients to say they won’t take something because of the possible risk of weight gain.
TCPR: Recently there have been some quite controversial side effects of SSRIs, that such as GI bleeding, osteopenia, or osteoporosis. Would you recommend discussing those?
Dr. Zimmerman: I tend not to bring up very rare side effects unless it has been pretty well established that a specific medication has been linked to it.
TCPR: Finally, how do you talk about side effects when you are prescribing a newly FDA-approved medication?
Dr. Zimmerman: There are methodological factors that impact on the reporting of side effects. Probably the best example of that is the use of scales for assessing sexual dysfunction if you believe your product is less likely to cause it than another product. So I tell patients about the side effects reported in the studies, but let them know that these are new drugs without a lot of history to gather data from.
TCPR: Thank you, Dr. Zimmerman.