# Presentation: 647056

## Medication Guides: Top-Line Feedback from Patients Taking Antidepressants

- Presented by:
- Cassie Plummer, PharmD, MPH
- cassie.plummer@iguard.org
- www.iGuard.org

**Notes:**
I would like to thank the committee for allowing me to speak
I have no financial disclosure other than iGuard is a subsidiary of Quintiles
Today  Im going to speak about a survey we conducted with our membership

## About iGuard.org

- Medication Safety Checks for drug and disease interactions
- Personalized Drug Safety Alerts as new information arises
- Bi-monthly printable medication record
- Access to information through iGuard.org on-line Patient Drug  Reviews

- www.iGuard.org

**Notes:**
iGuard.org is a web-based Medication Monitoring Service for Patients. Patients complete an online medication profile

We are monitoring medications and emailing personalized safety alerts for over 1 million patients

Our membershipe gives us unique opportunity to explore preferences of patients who actively seek medication informtation through the internet.

## Study Rationale

- Consumer medication information leaflets have been studied extensively
- Medication Guides (MG) are one of the newest mechanisms for delivery of medication safety information – and appear to be increasing in prevalence post-REMS
- iGuard.org initiated a survey of patients taking antidepressants to obtain feedback on Medication Guides
- This presentation summarizes top-line findings; a more complete analysis will be submitted to the docket

- www.iGuard.org

**Notes:**
We conducted a survey on Medication Guides 

10 of 22 (almost 50%)  NMEs approved in the year since REMS began -  had a Medication Guide.

We initiated a survey of our membership who were taking antidepressants  to gather feedback about Medication Guides and the Medication Guide program

## Methods

- Web-based survey to patients taking an SSRI, SNRI or Wellbutrin
- 50 respondents 18 to 64 years of age
- 50 respondents 65 years and older
- Survey collected data on:
- Frequency that patients receive and read the antidepressant MG
- Difficulty of information in the antidepressant MG
- Preferences for MG delivery (method and frequency)
- How often patients discuss suicidality (primary focus of MG) with their physician and pharmacist
- Patients were offered an honorarium of $10 for their time
- iGuard.org received an IRB waiver from Independent Review Consulting, Inc (IRC) for this study

- www.iGuard.org

**Notes:**
We sample to have 50 respondents in each age group

We showed pts an exampled of the antidepressnat MG 

## Respondent Demographics

|  | (n = 100) |
| --- | --- |
| Female: | 69% |
| Mean age: | 59 years |
| Years of school: | 25% High school or lower
42% Some college
32% College graduate |
| Ethnicity: | 91% Non-hispanic/latino
2% Hispanic/latino
7% Do not know / do not wish to provide |
| Race: | 93% White
4% Non-white
3% Do not know / do not wish to provide |
| Work Status: | 32% Working
66% Not working
2% Do not wish to provide |
| Antidepressant Use 2 or more years: | 74%  |

- www.iGuard.org

**Notes:**
We did not see large difference in answers between age groups – due to limited presentation time we are presenting the combined data of the two age groups.

We did not conduct a statistical analysis – so we can only comments on data trends and not statistical significante

## Frequency of Receipt and Reading

- Two-thirds of study respondents receive a MG with each antidepressant prescription fill
- Of patients who have received a MG for their antidepressant, 97.5% have read the MG one or more times
- Less than 20% of patients find the MG difficult, very difficult or extremely difficult to understand

- www.iGuard.org

*If you have received a Medication Guide with your antidepressant prescription, how *_*often*_* do you *_*read*_* it?*

**Notes:**

When we asked patients about the ease or difficulty of the information contained in the MG

## Delivery Method & Frequency

- www.iGuard.org

*If you were to receive a new prescription with a medication guide, would you like to receive a copy from...*

*How often would you prefer to receive a Medication Guide for your antidepressant?*

**Notes:**
To look at preferred method of delivery, we asked a series of yes/no questions “if you were to receive a new prescription with a medication guide, would you like to receive a copy form....

Interestly, we can also look at the number of patients who would anwered yes to from doctr AND phamacy, 46 of the 100 or 46% said that would like to receive this information from both – In essence, nearly half patients want to receive medication safety information both at the point of prescribing and and the point of dispensing. 

Also interesting to note, in this group of patients who are internet users, only 53% would like to receive MG info by email

We then asked patients how often they would prefer to receive the Medication Guide – patients were only allow to select one answer.

## Discussion of MG Information with a HCP

- www.iGuard.org

*How often have you and your physician discussed the potential risk of suicidal thoughts or actions associated with your antidepressant?*

*How often have you and your pharmacist discussed the potential risk of suicidal thoughts or actions associated with your antidepressant?*

**Notes:**
Finally, we asked patients about how often they discussed the potential risk of suicidal thoughts or actions associated with their antidepressant with their doctor or their pharmacist

## Conclusion

- Patients are receiving and reading the Medication Guide for antidepressants
- Although patients were provided with a sample of the Medication Guide for antidepressants with the survey, it is unclear whether they recognize the MG or if they are able to differentiate between the Medication Guide and a Consumer Medication Information Leaflet
- Most patients wish to receive the MG from their pharmacy, but only with new prescriptions and when there are updates
- There is limited health care professional support of the Medication Guide program – most doctors and pharmacists are not discussing the risk of suicidality with patients taking antidepressants

- www.iGuard.org

**Notes:**
Limitation of online survey  - recall bias – are pateints able to remember which document they receive with their prescription? can the differentiate them when thinking back over their previous refills

Attention bias. – because they are aware of being involved in the study, they may tend to  give more favorable responses

Do patients know the difference btween MG and CMI? Do the even know the purpose of the MG?  45% of patients were not familiar with the Medication Guide program.

2) Method of delivery – Where should we dispense this information? At the point of prescribing? In the pharmacy? How should we deliver this informaiton? Paper? Electronic? With the advancing of technology, it was mentioned that electronic delivery of this informaiton should explored

In a group of internet users, most patients wish to receive the info in the phamracy, although 46% of pts would like to rec’v MG from both the doctor and pharmacy

3) Should we be considering greater question of improveing a  system of communication? Although the content and format of medication safety information is important, it is clear that we need to encourage risk communication directly between by health care professionals and the patient.