A same-day standard for responding to drug information requests by a pharmaceutical company.
A system is described that provides the necessary support for a pharmaceutical company drug information department to provide timely responses to drug information requests by healthcare professionals. This system uses a same-day standard for providing responses to most drug information requests. This system is based in part on the development of a pervasive departmental culture developed by establishing written performance standards and in part on the development of facilitating materials and procedures. The physical components of the system utilize several easy-to-implement features that can be adapted to a variety of drug company settings where rapid communication of information is valued as an important drug information department goal.
Key Words Drug inquiries; Organizational culture; Drug information department; Response standard
As part of his job responsibilities at a prior pharmaceutical firm, the senior author (C. F. Curran) responded to a telephone inquiry from a physician during the physician's first weekend as a new resident. An inadvertent extravasation of a vesicant antineoplastic drug had occurred in a patient at three attempted injection sites, and the physician requested information regarding immediate and follow-up local treatment at these sites. The senior author sent many relevant published reports and other information by telephone and fax to the requesting physician. The patient, severely debilitated by primary disease prior to the triple extravasation, required limb amputation and died soon thereafter. The urgency of the exchange of information during this event convinced the senior author that many drug inquiries to pharmaceutical corporations are used in making critical therapeutic decisions, often on a real-time basis.
Further experiences led him to conclude that the majority of inquiries were made in attempts to rapidly resolve individual patient management dilemmas or other patient management problems. Other inquiries had considerable urgency because the materials supplied were to be used in making formulary decisions under Light deadlines. Hence, much information supplied at the request of healthcare professionals has great time value. Consequently, requested drug information that is supplied too late to be incorporated into any therapeutic decision process is, in effect, useless since it is poorly-timed, and can reflect negatively on both the information provider and the drug company.
The following is a description of a system implemented in a pharmaceutical company that provides a same-day standard for responding to drug information requests.
DESCRIPTION OF SETTING AND INFORMATION SYSTEM
Forest Pharmaceuticals, Inc., a subsidiary of Forest Laboratories, Inc., manufactures and markets a diverse line of medications in a variety of therapeutic categories. Professional Affairs, the drug information department of this firm, was formed in 1998. Prior to this time, a pharmacist and two staff members shared responsibility for handling drug inquiries, adverse reaction reports, and product complaints. The volume of inquiries at that time ranged from more than 300 to almost 550 inquiries per month. The department was formed in anticipation of the market launch of a major drug product.
Current staffing of Professional Affairs consists of eight pharmacists, an administrative assistant, a file assistant, and a director. The monthly volume of drug information requests fluctuates widely (1900 to more than 3300 requests per month in recent months). Physicians and other healthcare professionals are the primary requestors. The sales force receives and forwards many of these requests. Professional Affairs also accepts and responds to consumer inquiries, which comprise a minority of the requests received.
Almost two-thirds of the current inquiries concern two primary therapeutic drug classes in the company's product line (selective serotonin reuptake inhibitor antidepressants and thyroid supplementation drugs, respectively). Information requested is exceptionally diverse, with more than 800 topics requested during the past six months concerning a single Forest drug. Topics include many labeled and unlabeled potential clinical applications, the drug interaction potential when used together with a large number of other drugs, drug composition and clinical dosage inquiries, and a variety of requests concerning specific adverse reactions. Approximately 3200 published clinical studies and case reports are retained on file to facilitate responses.
FORMALIZATION OF PERFORMANCE STANDARDS
In 1998, during the formation of the department responsible for handling all external requests for drug information, performance standards and expectations were developed. These included same-day responses whenever feasible (with recognized and explicitly stated exceptions, as described below). This standard exceeds the 24-hour standard which is emerging in the drug industry (1).
Performance standards are explicitly stated in the department Policies and Procedures Manual in the "Response Standard" and "Guidelines of Service Excellence" sections, as follows (Figure 1 and 2, respectively). The manual was developed within three months of forming the department. Each newly hired staff member, following a brief period of orientation, is required to read this manual and sign the signatures page to verify that he/she has read and understands the contents of the manual.
FORMS AND ORGANIZATION OF MATERIALS
The information system utilizes the following physical and administrative components, which facilitate the attainment of stated performance standards.
Convenient documentation of inquiries is entered on a form (Figure 3) possessing the following attributes:
* Major drugs, inquiry categories, and common inquiry topics are preprinted in convenient check list format, and
* Ample space is provided for documenting ad hoc requests that allow documentation of materials sent to the inquirer.
This form is provided to the drug information associates, all of whom are pharmacists, in conveniently bound pads. The form is revised as new drugs are marketed or new topics of request become more common. Six format revisions have been made over four years.
Preassembled response materials for common requests are prepared prior to product launch and are updated as new reports are published. The first packet is prepared early in the development of a given drug to facilitate answering inquiries requesting a basic characterization of the drug; it may contain both published reports and summaries, as well as press releases or other sources of information. When relevant new information is received, it is either added to or replaces dated materials. Additional packets are developed to address particular topics or issues as the need arises.
Each packet contains a cover sheet that identifies the drug and topic, followed by a list of the published articles or other materials contained in the packet. These packets are retained by the administrative assistant in individual plastic sleeves until a copy of a packet is needed to fulfill a request.
Standardized letters are written in sufficiently easy-to-read language to facilitate the following uses:
* Efficient conveyance of clinically useful information through concise content focus,
* As verbal response scripts whenever verbal responses over the telephone are sufficient to meet inquirer needs,
* As text for electronic mail responses, and
* In training pharmacy externs and new professional staff.
The general emphasis in these letters is that they be concise, coherent, and clear. Key standardized letters for each drug are circulated in a formalized review process to the medical, marketing, and regulatory affairs divisions and, when appropriate, drug safety and legal counsel.
THE REVIEW PROCESS
A systematized review process was developed for evaluating newly published studies so that when appropriate, their contents and findings are rapidly disseminated to the professional staff, incorporated into the preassembled materials described above, and discussed in the respective summary letter.
Each major drug, other than the generic drugs in the company's product line, whether marketed or investigational, has a drug information associate who is the department monitor for that drug. This monitor typically announces the availability of major new published studies to the Professional Affairs staff by e-mail and assesses the article for possible use in appropriate information packets, either as an addition or as a replacement for a less-useful article in the packet.