Providing Product Information to Healthcare Professionals
Providing Product Information to Healthcare Professionals
In your thirst for knowledge, be sure not to drown in all the information.
–Anthony J. D’Angelo
One of the effects of living with electric information is that we live habitually in a state of information overload. There’s always more than you can cope with.
–Marshall McLuhan, Canadian communications theorist.
Guidelines for Bureaucrats
1. When in charge, ponder.
2. When in trouble, delegate.
3. When in doubt, mumble.
–James H. Boren
Virtually all pharmaceutical companies with marketed products have a person or group designated to provide information about their products to healthcare professionals and patients. This group may or may not have additional responsibilities (e.g., providing drug samples, responding to requests for compassionate plea drugs, or providing information on investigational drugs) to outside healthcare professionals. In some companies, the same group also provides information on products to company staff and may be involved in review of proposed advertising and literature support activities. This chapter does not discuss the many “drug information centers” based outside the pharmaceutical industry that are based in hospitals, schools of pharmacy, or other institutions (e.g., local, state, and national government centers for poison control, smoking cessation, or healthcare in general). Many of these centers and their associated websites provide information to not only healthcare professionals, but to patients and the public as well. This chapter focuses entirely on the role of providing information to healthcare professionals.
The product information group may act in a reactive manner to outside requests for information as well as in a proactive one to achieve its goals (Table 99.1).
An example of a proactive role is the preparation of responses to anticipated questions prior to launching a new drug. With good planning, most people believe that about 75% of questions can be anticipated. Inquiries come from a range of sources, from healthcare professionals to sales representatives or even from employees within the company. The various functions that this group often fulfills are listed in Table 99.2.
Table 99.1Standard goals of drug information groups
To provide healthcare professionals with information that is:
1.
Accurate, balanced, and correct as to opinions and data
2.
Factually detailed and succinct so that the information is useful
3.
Professionally reviewed and sound in any interpretation(s) made or expresseda
4.
Rapid in its turnaround
a Some regulatory authorities may prefer that interpretation of data not be done.
Proactive dissemination of product information (e.g., Dear doctor letters) to healthcare professionals is usually done by marketing groups. Other names for the product information group include professional communications, medical information, and medical and scientific information.
Specific details of individual company product information services have been presented in several symposia and journals (Anonymous 1990). Because company-specific computer hardware and software used to carry out this function vary widely and change continually, those aspects are not discussed here.
Table 99.2Types of functions that may be assigned to a product information group a
Prepare information for annual regulatory reports of investigational and marketed drugs.
4.
Update investigators’ brochures used in clinical trials.
5.
Prepare package labeling draft documents.
6.
Coordinate changes to the package label.
7.
Help train medical staff, marketing staff, and sales representatives.
8.
Coordinate adverse event reports with responsible groups.
9.
Coordinate information issues with other information services within the multinational company.
10.
Handle product complaints.
11.
Prepare updates to compendia.
12.
Answer questionnaires submitted by trade associations or other organizations.
13.
Coordinate with public relations groups within the company.
a Some of these functions are conducted entirely within the company (e.g., Numbers 2, 9, and 13), but most involve external interactions as well.
b This is the only function that is assumed to be always assigned to the information group described in this chapter.
ORGANIZATIONAL LOCATION OF THE INFORMATION GROUP
There are numerous areas within a pharmaceutical company that would provide an appropriate “home” for the group that interacts with external healthcare professionals to answer questions and provide information. These include:
The marketing professional services area
The postmarketing surveillance group
The technical information group that provides information to professionals within the organization
A Phase 4 medical services group
Corporate services
Numerous other areas (e.g., safety surveillance, regulatory affairs, legal)
Of these possibilities, the two generally favored by the author are Groups 3 and 4, although any of these choices could be optimal in a specific company.
Members of research and development departments often assume that, if a group within marketing responds to an information request from a healthcare professional, the reply may be biased, whereas a member of research and development would provide a scientifically based response. This view cannot be accepted, particularly because well-trained scientists could work within a marketing information group to provide such services (or, conversely, marketers could work with research and development to provide the information). To prevent a marketing orientation in replies to external questions, most companies do not place the product information group under direct marketing control.
TYPES OF QUESTIONS RECEIVED
Questions received by the information group come directly from physicians and other healthcare professionals via telephone, e-mail, letter, facsimile or are submitted to the group by the company’s sales representatives. The most common areas questioned are listed in Table 99.3. The company may distribute postage-paid cards at scientific exhibits, at conferences, or by mail to elicit questions, but the company must be prepared to address large numbers of such cards (if they are signed by physicians). Telephone calls received at the company are initially screened and then routed by company operators (Fig. 99.1) unless there is a toll-free telephone number that rings directly in the product information group, or at a company hired to provide such information. A toll-free number is usually placed in the front of the Physicians’ Desk Reference (PDR). If company operators are used to route telephone calls, then they should receive adequate training to ensure they fill this role correctly. This includes being able to refer or route medical emergencies to local emergency personnel.
Many questions received from healthcare professionals about a company’s products deal with off-label use of drugs. Virtually no source outside the company would have as much information on off-label use of a company’s drug as the product information group. Most healthcare professionals would think of contacting a sponsor first if the question was clearly identified as an off-label one. It is important that the company be aware of off-label uses and their outcomes. This may be accomplished by surveying the customer base and compiling published literature on off-label uses. The information group often seeks input from relevant groups within the company to help prepare their standard answers (Fig. 99.2) so that it can provide information to a wide spectrum of external groups (Fig. 99.3). Note that Fig. 99.3 also illustrates a company’s indirect relationship with patients, as companies seldom provide product information to patients directly. However, companies will provide information requested by consumer organizations. Most companies refer patients to their physicians and the company’s website for information about their drug because of the learned intermediary concept that is an important part of a legal defense. Some companies are willing to provide patients with readily available product information that is in the public domain. There has been a trend over the past decade to provide more information directly to patients, not just via direct-to-consumer advertising but also via company staff trained for this purpose.
Table 99.3Representative areas in which questions are asked by healthcare professionals a
1.
Unapproved indications
2.
Adverse events
3.
Clinical use
4.
Interactions
5.
Compatibility
6.
Dosages
7.
Stability
8.
Pharmacology
9.
Chemistry
10.
Market availability
a These are listed in the approximate order of the frequency of request from most to least.
Figure 99.1 Flow of questions from healthcare professionals into a pharmaceutical company and routing to various departments for a response.
Figure 99.2 Processing a question by a company’s external information department when additional help from the company’s staff is needed.
Questions Received by Sales Representatives
If the question received directly from a healthcare professional is unclear or inappropriate, it may be relevant for the company’s sales representatives to act as an intermediary. A sales representative also may act as the conduit for questions even though the response is sent directly to the healthcare professional that raised the question. (Often, the company will send a copy of the response to the sales representative involved and even to sales representatives in the local area who were not involved in the transmittal of the questions. On the other hand, this practice is avoided by some groups who believe that the sales representative may use the information as promotional material.) If the unclear or inappropriate question was received via a sales representative, then the company’s information group would probably contact the professional directly.
Some companies require that healthcare professionals seeking information on unapproved uses of a drug submit their questions in writing. This procedure is designed to help protect the company against accusations that it is promoting the use of the drug for unapproved uses. Moreover, in providing information on unapproved uses, the company often reminds the healthcare professional that the drug is not approved for the indication and may mention the basis on which the drug could be used in that indication. Care must be exercised to avoid promoting the drug for the unapproved indication. This could be achieved by stating that the company has no recommendations regarding its use for the purpose discussed.
Only gold members can continue reading. Log In or Register to continue