You are on page 1of 1

Assessment of pharmaceutical industry-based medical information websites

d James B. Lewin, PharmD,1,2 Mauricio Muñoz, PharmD,1 S. Suresh Madhavan, MBA, PhD2
d

West Virginia University

1ISTA

Pharmaceuticals, Inc., Irvine, CA; 2Department of Pharmaceutical Systems and Policy, West Virginia University, Morgantown, WV

Background
 As the general population adopts the use of new technologic platforms for accessing information, Medical Information (MI) professionals must determine if there is a need to modify the accessibility and dissemination of MI.  Despite the growing interest in medical information websites (MIWs) among pharmaceutical companies, there is a lack of published data evaluating these electronic tools; in order to provide insight to companies that are considering the implementation or enhancement of a MIW, research evaluating current industry practices is needed.  In December 2011, the FDA issued a draft guidance for industry that addressed unsolicited requests for information that may be encountered through electronic media: requests for off-label information would be considered solicited if (1) prepared standard letters can be accessed via pull-down menus naming various disease states; (2) standard letters can be accessed using search terms that are not within the scope of information contained in the letters; or (3) if a company provides the uniform resource locator (URL) of the website, and that specific URL implies the availability of off-label information.1  Many questions regarding the dissemination of MI through electronic platforms still remain unanswered.

Demographics and Utilization
Figure 1: Response rate and overall MIW utilization
Survey distributed to 47 companies
Participants could choose to opt-out via a link contained in the original email and had the option to exit the survey at any time

Selected Survey Results
Website Features
Figure 3: HCP Verification (n=7)
14% (n=1)
Disclaimer

Discussion
 The utilization rate of MIWs among the companies represented in this survey was 30.3% (Figure 1).  The companies with a MIW had a higher mean annual sales volume than those without a MIW, but this is difficult to interpret due to the small number of companies with a website compared to those without one; other demographic characteristics were similar among all companies.  Companies that are not considering the future use of a MIW shared similar reasons including regulatory concerns, financial constraints, lack of Information Technology (IT) support, and low volume of inquiries. Additionally, one respondent reported that the company had a MIW in the past but deactivated it due to low activity and high maintenance costs.  Although the companies in this survey do not offer publications on their MIWs (Figure 6), one did report that the website contains links to PubMed abstracts for the references used in any response documents — provision of reprints along with response documents may be an area of increased focus for MI departments following the open comment period for the recent FDA draft guidance.  The three most common resources found on current MIWs are also perceived as the most important resources to offer to HCPs (Figure 6 and Table 2).  Two potential areas to consider for future evaluation of MIWs include (1) relationships between company size or sales volume and the presence of a website, and (2) the frequency of content updates and auditing procedures. Limitations  Survey questions have not been validated.  Rating scales and Likert items yield subjective results and may not represent the opinions of other MI professionals.  Some participants [30.3% (10/33)] did not complete the entire survey.

Essential Resources
 In order to gauge consensus opinion, all company respondents were asked to rate various resources in terms of their importance in being offered to HCPs searching for the specified information. We chose a rating scale that would better gauge differences in the degree of importance because we assumed that very few MI professionals would rate these materials as “not important.”  Rating scale: 1 = Not important 2 = Neither important nor unimportant 3 = Important 4 = Very important 5 = Extremely important Table 2: Perceived importance of resources among all companies surveyeda,b
Informational Resource
Prescribing Information
n=3

Response rate: 70.2% (33 /47)

43% (n=3)

Registration Professional license number No verification
a

30.3% (10/33) have a MIW

69.7% (23/33) do not have a MIW

29% (n=2) 14% (n=1)
aAlthough

Percent of Companies

 Respondents classified their company as pharmaceutical (56.5%), biopharmaceutical (26.1%), or both (17.4%).  The majority of companies indicated that the MI department supports less than six promoted products (52.2%) or between six and twenty products (39.1%).  The mean annual sales volume ($, in billions) of the companies surveyed was 8.9 [Standard Error of the Mean (SEM)]=2.2); the mean annual sales for companies with a MIW was 13.8 (SEM=4.0) and that for companies without a MIW was 6.8 (SEM=2.6) — See Table 1.
Table 1: Company Size Comparisons Based on 2011 Global Pharmaceutical Salesa
ANNUAL SALES VOLUME All Companies ($, in billions) (N=33)
Results for each data set are presented as the percent of companies followed by the number (n) Have MIW (n=10) Do Not Have MIW (n=23)

one company does not have a verification system in place, users could only access on-label information on the company’s MIW.
Figure 4: What can the HCP submit to the company via the MIWa (n=5)

Figure 5: How are HCPs made aware of the MIWa,b (n=5)
Following a MI request Proactively n=4

MI Requests

n=5

R e f e r e nc e s

n
23 23 23 22 22

Median (IQR)
5.0 (4.0 - 5.0) 4.0 (3.0 - 5.0) 3.0 (3.0 - 4.0) 3.0 (2.0 - 3.0) 2.5 (2.0 - 3.0)

100% 80% 60% 40% 20% 0%

Mean ± SD
4.6 ± 0.7 3.7 ± 1.2 3.3 ± 1.0 2.9 ± 1.0 2.5 ± 1.1

On-label Standard Letters Off-label Standard Letters Ongoing Trial Information Material Safety Data Sheet
n=0

Purpose
1. Benchmark current industry practices in disseminating information to external stakeholders via the use of MIWs. 2. Identify resources that are essential to offer to health care professionals (HCPs) who are seeking information on an industry-based MIW. 3. Estimate the impact of a MIW on a MI department in relation to resource allocation and service quality.

Adverse Events

n=2

n=1

MIW Feedback
0%

n=3
20% 40% 60% 80% 100%

Investigational Product Info
Disease State Information Dossiers Peer-reviewed Publications Abstracts / Posters

22
23 23 23 23

2.0 (2.0 - 3.0)
2.0 (2.0 - 3.0) 2.0 (2.0 - 3.0) 2.0 (1.5 - 3.0) 2.0 (1.5 - 3.0)

2.6 ± 1.1
2.4 ± 1.0 2.4 ± 0.9 2.4 ± 1.1 2.2 ± 1.0

Medical Affairs Personnel
aSelected bAnother

Sales Personnel

Percent of Companies

≥ 20 10 to 20 1 to 10 <1
aInformation

15.2% (5) 15.2% (5) 36.4% (12) 33.3% (11)

40.0% (4) 10.0% (1) 30.0% (3) 20.0% (2)

4.3% (1) 17.4% (4) 39.1% (9) 39.1% (9)

aSelected

all that applied

all that applied option, “company website links,” was selected by 60% (n=3) of companies

Conclusion
 Most companies surveyed do not have a medical information website but many are considering the use of one in the future; of note, finalization of the regulatory draft guidance may affect industry trends.  On-label and off-label standard response letters are important resources and should be accessible to health care professionals seeking information on a company’s website as long as the website requires specific search terms be used to access the appropriate information.  The perceived impact of websites varied widely: further research using objective measures is warranted and may help medical information professionals determine whether this platform would be appropriate for their firm based on individual company factors.

Methods
 In December 2011, pharmaceutical and biopharmaceutical companies were contacted in order to request the email address of the MI department or that of a specific MI professional and to explain the purpose, design, confidentiality, and voluntary nature of the research.  A web-linked survey was sent to the companies that provided a valid email address. Only one participant from each company was allowed to complete the survey, and only one survey could be submitted by each participant.  SurveyMonkey software (SurveyMonkey.com LLC, Portland, OR) was used for data collection.  Descriptive statistics were performed for all questions and variables.  Acknowledgement of this research is on file with the West Virginia University Institutional Review Board. Definition of MIW Specified for Analysis  A MIW is a searchable website intended for the dissemination of medical information in response to unsolicited requests from external stakeholders. This is not referring to websites that only offer the prescribing information (PI); however, the PI may, of course, be one of the resources available on a MIW.

obtained from company press releases and financial reports for the year ending December 31, 2011; however, 2010 sales were used for those companies that did not release a financial report by February 19, 2012 (n=9). Sales volume includes revenues from generics and vaccines but does not include revenues from OTC or animal health products, royalties, or contract manufacturing. Income reported in currencies other than US dollars were converted using exchange rates based on the midpoint average interbank rate for the last day of the fiscal year.

Figure 6: Resources available to HCPs on current MIWsa,b (n=5)
On-label Standard Letters Off-label Standard Letters Prescribing Info Product Dossier Disease-state Info Ongoing Trial Info Investigational Product Info Abstracts/Posters Slide Decks/Presentations Material Safety Data Sheet n=1 n=1 n=1
0%
aSelected

Presentations / Slide Decks
Continuing Medical Education
aListed

22
22

2.0 (1.0 - 3.0)
2.0 (1.0 - 2.0)

2.1 ± 1.0
2.0 ± 1.1

n=4 n=3 n=5 n=1 n=1 n=2 n=2

in order of importance based on median score (non-rounded mean scores were used to differentiate resources that had the same median (IQR) bAbbreviations: IQR=interquartile range; SD=standard deviation

 Of the companies with a MIW, 14.3% (1/7) have implemented the website within the past year and 85.7% (6/7) have had the MIW in use for at least 3 years.  The results showed that all of the MIWs are intended to be used by HCPs only.  Companies without a MIW were directed to the question represented in Figure 2.

Website Impact
Figure 7: Results from Likert items (n=5)
Note: The first three items (beginning from the top of the y-axis) began with the phrase "Implementation of a MIW has..."
...allowed for more time and resources to be allocated to other important MI functions

Figure 2: Is your company considering the future utilization of a MIW? (n=21)
Percent of Companies

Likert Items

50% 40% 30% 20% 10% 0%
Yes, within 1 year Yes, within 2 years
n=3 n=2

n=9
n=7

...required a substantial amount of time and resources for maintenance purposes ...led to an improvement in the consistency of responses

Strongly disagree Somewhat disagree Neutral Somewhat agree Strongly Agree
20% 40% 60% 80% 100%

References
1. Department of Health and Human Services, Food and Drug Administration. Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices; Availability. Fed Regist. 2011;76(251):82303-82306. http://www.gpo.gov/fdsys/pkg/FR-2011-1230/html/2011-33550.htm. Accessed February 22, 2012. Acknowledgements: Vivien Nguyen, PharmD for assisting with the identification of potential participants. Disclosures: The authors of this presentation have no disclosures concerning possible financial or personal relationships with commercial entities that may have a direct or indirect interest in the subject matter of this presentation. Correspondence: James B. Lewin at: lewinjim1@gmail.com

25%

50%

75%

100%

Percent of Companies
Yes, but not sure when No

all that applied bZero companies indicated that their MIW offers “peer-reviewed publications” or “continuing medical education”

I would recommend the implementation of a MIW to a colleague 0%

Poster session presented at: Shining Light on the Value of Medical Communications. Drug Information Association 23rd Annual Medical Communications Workshop; 2012 March 5-7; Orlando, FL.