The Risk Management Mandate - Pharmaceutical Executive

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The Risk Management Mandate
FDA says every new drug needs a plan for dealing with risk.


Pharmaceutical Executive


Interventions Implementing an RMP involves the dissemination of information to participants. Multiple interventions or multiple distribution methods are often required, if for no other reason than for the redundancy needed to ensure exposure to the key messages. For patient information, there are several communication vehicles, each with a slightly different purpose. (See "Communication Tools.") The vehicle(s) selected should be based on the purpose of the communication. If patient commitment to a long-term behavior is an issue, a patient agreement or contract may be advised. If situational cues are needed, packaging reminders or telephone calls may the right intervention. Tools should match the need for particular impact.

A broad process model may help companies select the right communication tools. One process model specifies that for communications to influence behavior, participants must:

  • be exposed to the information
  • pay attention to the communication
  • understand what is advocated
  • accept the persuasive intent
  • remember the message
  • incorporate the message in their decision-making process
  • display the advocated behavior over the time period as needed.

Designing a set of communications that will fulfill all of these steps is complex and requires some tradeoffs. For example, exposing patients to the message may be accomplished by delivering the information in the medication package. But patients may not pay attention to a long document written in small type on thin paper. Thus, a smaller document that provides key messages may be more likely to be noticed. That, in turn, may be augmented by a longer brochure provided by the physician or pharmacist that explains the rationale for advocated behaviors. Adding a reminder program, such as warning symbols on the package, could also help stimulate the advocated behaviors and provide a more complete communications program.

Information Transfer Drafting risk management communications requires attention to both the content and the style and format of the communication.

Content. The intended message needs to be clearly specified. Developing a list of communication objectives (COs) can help identify key messages for any document. COs may also be used to assess the effect of the communication and the RMP in general. To develop this list, it is important to rely on the FMEA system, the behavioral model, and the base beliefs of the target audience. Some risk communication experts advocate a mental-models approach to specifying content. In this case, the base beliefs of health experts are compared with those of recipients of the communication.

Areas in which the belief systems vary are highlighted to assure that the risk communication concentrates on areas where information is most needed. To the fullest extent possible, COs should be lean and focused. Too many COs can reduce the likelihood of communicating any single CO. For complex messages, specifying primary and secondary COs will help to organize the information to be communicated.

Style. The design of the communication also needs to match the objective's intent. Primary messages need to be emphasized by "signals" such as placement, graphics, and language. There are a number of document design principles that companies can use to help to make the communications clear and comprehensible. For example, short sentences, vivid and understandable terminology, and avoiding extraneous information can help to reduce the cognitive load of any communication and aid in achieving high levels of comprehension.

The first group of communication tools involves the one-way transfer of information. With well-designed documents and repeated interventions, the probability increases that key messages will be communicated. However, an education program that tests individual respondents' understanding of the messages can go a long way toward improving communication. Another group of tools involves the development of educational or certification systems. Using an interactive voice response (IVR) system, pharmaceutical companies can enroll patients in a system that surveys knowledge, based on the communication objectives. After tests are scored, a feedback message can be delivered to physicians and patients. The feedback message reinforces areas in which key messages were understood and provides tailored feedback and emphasized education in the areas in which the key messages were not understood.

This focus on the patient's knowledge—as opposed to the content and format of the message—improves the likelihood that patients and physicians will comprehend the company's core messages. By testing for beliefs, motivations, decision making ability, and behavioral intent, feedback forms can provide a variety of messages that are intended to influence behavior beyond mere knowledge transfer. Applying the test before prescribing the therapy establishes minimum test scores and assures the company that only competent patients are certified to receive prescriptions for the product.

The third class of intervention tools are used to control the distribution of the medication. Limiting distribution to patients who have provided evidence of compliance with advocated behaviors such as blood testing requires coordinated efforts and enhanced communication among prescribers, dispensers, patients, and sometimes others, such as those conducting laboratory tests.

A distribution control system may require training and commitment by healthcare providers to assure that the communication channels perform as designed. It may also require the development of a new distribution system—such as the use of a sticker on the prescription pad or the issuance of a debit card that must be engaged by the physician before the pharmacist can distribute the medicine. Evaluation programs are typically necessary to assure that these complex programs perform as designed.


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