Preceptor

Ann Maloney
Director, Drug Regulatory Affairs - Approved Products

Description

The Technical Product Information (TPI) group is responsible for the primary intake of all product complaints, adverse experience reports and requests for technical product information from medical professionals and patients. Providing accurate, concise technical product information is a critical function of our Technical Product Information Group. Roxane Laboratories is planning to launch four new products within the next year. These products include two opioid analgesic products (two strengths of each product) for the control of moderate to severe pain, an epidural injectable also to be used in pain management and a methylxanthine for the treatment of apnea of prematurity.

The opioid analgesic products contain the same active drug substance (two immediate release and two sustained release product strengths). The active ingredient is a semisynthetic narcotic with multiple actions qualitatively similar to those of morphine; the most prominent of these involve the central nervous system and organs composed of smooth muscle. The drug is a pure agonist opioid whose principle therapeutic action is analgesia. Like all pure opioid agonists, there is no ceiling effect to analgesia, such as seen with partial agonists or non-opioid analgesics.

The epidural injection is a line extension of Roxane's Duraclon product. Duraclon (clonidine hydrochloride injection) is a centrally-acting analgesic solution for use in continuous epidural infusion devices. Clonidine Hydrochloride is an imidazoline derivative and exists as a mesomeric compound. Epidurally administered clonidine produces dose-dependent analgesia not antagonized by opiate antagonists. The analgesia is limited to the body regions innervated by the spinal segments where analgesic concentrations of clonidine are present. Clonidine is thought to produce analgesia at presynaptic and postjunctional alpha-2-adrenocepters in the spinal cord by preventing pain signal transmission to the brain.

Apnea of prematurity is defined as cessation of breathing for periods from 10 ­ 30 seconds, with or without bradycardia or cyanosis (Lagercrantz, 1995; Aranda, 1997). It is considered to be the most important disorder related to the control of breathing in the preterm infant (Aranda, 1979). Although the pathogenesis of apnea of prematurity is not clearly understood, it is commonly believed that it is the result of an immature central nervous system (Kriter, 1989). The primary pharmacologic agents which have been used to treat apnea of prematurity since the early 1970's are caffeine and theophylline. The methylxanthines have been shown to normalize respiratory patterns, decrease frequency of apneic attacks, and reduce the need for mechanical ventilation in neonates (Davis, 1987). It has also been proposed that they are effective by altering the sensitivity of the medullary respiratory center to carbon dioxide (Davis, 1987). Roxane's product will be the first approved product available for the treatment of apnea of prematurity.

In preparation for these new product launches the Resident, working with the Technical Product Information group, will assemble product information files for the above products. These product information files should contain data on formulation, compatibility, stability and answers to anticipated commonly asked questions. The product information files will be an essential element for the successful launch of these products. Anticipated questions on the new products shall be determined by reviewing the current complaint and question database for similar products (if available) and interviewing health care professionals. After the questions are determined draft letters and/or reports will be written to address the questions. These reports and letters will be reviewed internally and serve as templates for responses when the questions are received by TPI after the products are launched.

Objectives

1. Interview a cross-section of health care professionals in and around Columbus, interpret results, and generate a listing of potential technical questions which may be received when the above products are launched.

2. Review existing complaint and question databases for similar dosage forms identifying the most commonly asked questions.

3. Analyze, evaluate and interpret literature organizing into draft letters, reports and/or files for future dissemination to health care professionals.

4. Demonstrate ability to perform literature searches and proficiency in the use of computerized information databases.

Requirements and Activities

1. To be present at the site for a minimum of 40 hours per week, or at off-site location as dictated by the nature of the work being completed and agreed upon by the preceptor and the resident.

2. Perform medline searches, obtain references and provide drug information for the compounds described.

3. Interact with internal and external consultants in the pharmaceutical industry to establish an understanding of what information may be needed by health care professionals and patients in the use of each new drug product.

4. A weekly review meeting will be held with the preceptor to review the status of the project.

Required Readings

None Listed