Stacey M. Fung

Superwarfarin and Glass Ingestion with Prolonged Coagulopathy Requiring High‐Dose Vitamin K1 Therapy

A 23‐year‐old man was brought to the emergency department after eating four boxes of brodifacoum‐containing rodenticide over a 4‐day interval and pieces from approximately two bottles of glass over the previous 2 weeks. He was asymptomatic but his prothrombin time was markedly elevated with an international normalized ratio (INR) of 37.8. A plain abdominal film showed diffuse radiopaque foreign bodies, presumably glass, in the large and distal small intestines. Treatment for ingested glass consisted of stool softeners and bulk‐forming laxatives. The patient developed mild gingival bleeding and received fresh frozen plasma (FFP) infusions and vitamin K1 orally. At a vitamin K1 dosage of 300 mg/day, the INR corrected to less than 2.0 and the patient was discharged taking that dosage. He returned 26 days later with hematuria and flank pain, and his INR was 189. He was administered FFP and packed red blood cells, and his vitamin K1 dosage was increased to 800 mg/day; his INR returned to baseline. Compliance with taking the vitamin K1, which required ingestion of 60–160 tablets/day, was a serious problem, requiring numerous follow‐up calls and visits to the patient at home and work. At 5‐month follow he was doing well. Compliance with large daily doses of vitamin K1 for treatment of “superwarfarin” ingestion may be poor because of the duration of treatment and large number of pills required. A more concentrated formulation may be advantageous for management of patients with brodifacoum poisoning.

Comparative Toxicity of Tapentadol and Tramadol Utilizing Data Reported to the National Poison Data System

Background: Tapentadol (TAP) and tramadol (TRA) provide pain relief through similar monoaminergic and opioid agonist properties. Objective: To compare clinical effects and medical outcomes between TAP and TRA exposures reported to the National Poison Data System of the American Association of Poison Control Centers. Methods: A retrospective cohort study was conducted analyzing national data for single medication TAP or TRA cases reported from June 2009 through December 2011. Case outcomes, dichotomized as severe versus mild; clinical effects; and use of naloxone were compared. Results: There were 217 TAP and 8566 TRA cases. Significantly more severe outcomes were associated with TAP exposures for an all-age comparison (relative risk [RR] = 1.24; 95% CI = 1.04-1.48), and for the <6-year-old age group (RR = 5.76; 95% CI = 2.20-15.11). Patients with TAP exposures had significantly greater risk of respiratory depression (RR = 5.56; 95% CI = 3.50-8.81), coma (RR = 4.16; 95% CI = 2.33-7.42), drowsiness/lethargy (RR = 1.38; 95% CI = 1.15-1.66), slurred speech (RR = 3.51; 95% CI = 1.98-6.23), hallucination/delusion (RR = 7.25; 95% CI = 3.61-14.57), confusion (RR = 2.54; 95% CI = 1.56-4.13) and use of naloxone (RR = 3.80; 95% CI = 2.96-4.88). TRA exposures had significantly greater risk of seizures (RR = 7.94; 95% CI = 2.99-20.91) and vomiting (RR = 1.96; 95% CI = 1.07-3.60). Conclusion: TAP was associated with significantly more toxic clinical effects and severe outcomes consistent with an opioid agonist. TRA was associated with significantly higher rates of seizures and vomiting.

Granulocyte Macrophage—Colony Stimulating Factor and Oral Mucositis:

OBJECTIVE: To evaluate the effect of granulocyte macrophage—colony stimulating factor (GM-CSF) in patients with oral mucositis. DATA SOURCES: Literature was accessed through MEDLINE (1966–June 2000) and bibliographic searches. DATA SYNTHESIS: Published literature assessing the use of GM-CSF to treat or prevent oral mucositis was analyzed. CONCLUSIONS: Reports of GM-CSF improving mucositis have been published; however, because of limitations in these reports, insufficient evidence confirms the benefits of GM-CSF. These preliminary studies provide a rationale to conduct well-designed, double-blind, randomized trials to evaluate the safety and efficacy of GM-CSF in the treatment and/or prevention of oral mucositis induced by chemotherapy and/or radiotherapy.

Pharmaceutical Medical Information Contact Centers: Results of Three Benchmarking Surveys

Pharmaceutical medical information contact centers are often a key interface among a company, the medical community, and the general public. Results from three benchmarking surveys are reviewed. The surveys were designed to provide contact center leaders with unbiased and relevant information for use in assessing operations and setting strategic direction. The surveys were similar in focus and conducted at three time points (2004, 2005, and 2008). The surveys focused on the organizational structure and operations, sourcing options, technology, and globalization. These findings provide not only a snapshot of current contact centers, but also a view over time of the progression of changes to organizational and operational processes of medical information contact centers. The trends and challenges faced by pharmaceutical medical information contact centers included (a) increasing efficiency and productivity of the process to handle increased call volumes to meet customer expectations; (b) creating or maintaining a validated environment for business processes and systems to improve service, efficiency, and compliance; (c) utilizing outsourcing options, including offshore or international contact centers, to help maintain costs and obtain flexibility; and last (d) continuing to add and show value to the overall organization. This information is presented as a resource as contact centers develop and refine strategies for managing in todays challenging environment.

Treatment of Bulimia Nervosa with Ondansetron

OBJECTIVE: To evaluate ondansetron as a treatment for bulimia nervosa. DATA SOURCE: Literature was accessed through MEDLINE (1966–November 2000). Key terms included ondansetron, bulimia nervosa, binge eating, and eating disorders. DATA SYNTHESIS: Treatment of bulimia nervosa includes cognitive behavioral therapy and antidepressants. Fluoxetine is approved by the Food and Drug Administration for binge eating and vomiting behaviors in moderate to severe bulimia nervosa. An evaluation of ondansetron for bulimia nervosa was conducted. CONCLUSIONS: Ondansetron for bulimia nervosa was reported to be effective in three small trials by one group of investigators, and may be an option after failure of traditional therapies. Further studies will define the role of serotonin (5-HT3) receptor antagonists in the management of bulimia nervosa.

Nontraditional Roles for Certified Pharmacy Technicians in a Pharmaceutical Company

OBJECTIVE To describe nontraditional roles for Certified Pharmacy Technicians (CPhTs) within pharmaceutical industry. SETTING Drug information department within a large biotechnology/pharmaceutical organization. PRACTICE DESCRIPTION The Medical Communications department within Genentech uses a skills-mix staffing model in which employees with varying educational and training backgrounds work as a team on meeting the informational needs of consumers and health professionals who contact the company. One position within the department is that of Medical Communications Associate, responsible primarily for managing product inquiries. PRACTICE INNOVATION Medical Communications Associates have degrees in life sciences or an equivalent combination of education and experience, including a minimum of 2 years of related experience in the health care industry. Currently, four of the seven Medical Communications Associates in the department are CPhTs. INTERVENTIONS Not applicable. MAIN OUTCOME MEASURE Ability to recruit CPhTs for Medical Communications Associate positions, and job satisfaction of those hired into these positions. RESULTS Critical basic skills needed for the Medical Communications Associate position include strong computer literacy, ability to multitask, and ability to work in an environment with frequent interruptions. Strong oral and written communications skills, customer service skills, ability to deal with stressful situations, product-specific knowledge, ability to work on a daily basis with Medical Communications Pharmacists, and knowledge of medical terminology are also important. The skills set of CPhTs matches these requirements, as evidenced by the experiences of the four staff members who have worked in the department for a total of 17 person-years. CONCLUSION This nontraditional role for CPhTs can be rewarding and beneficial to all, affording an unique opportunity within the pharmaceutical industry. The skill set and experience of CPhTs can be used in the nontraditional pharmacy practice setting of drug information.

Survey of Health Care Practitioners’ Preferences for Medical Information Collective Insights for Impacting Patient Care

Background: Medical information (MI) departments play an integral role in providing fair and scientifically balanced MI to health care professionals, patients, and caregivers. Though there have been multiple surveys conducted to assess the value of MI, insights on what the informational needs are from the perspective of the health care professional to confidently making patient care decisions have not been addressed. A survey administered to health care professionals that collected insights and feedback on the utility of MI services across different pharmaceutical companies provided an understanding of the informational needs of different health care professionals for prescribing drug therapy with confidence. Methods: A total of 276 health care professionals who requested medical information in a 6-month time frame from 8 companies completed a 30-minute Internet-based survey (n = 260) or a 20-minute telephone survey (n = 16). Results: Most health care professionals preferred obtaining medical information from traditional routes such as discussions with sales representatives or via the telephone, while very few preferred alternate routes such as mobile applications, video chats, or text. The type of medical information requested among practitioners included topics related to dosing, safety, patient selection, and differentiating between therapeutic options. When making patient care decisions, health care professionals identified 3 levels of evidence—prospective studies, practice guidelines, and meta-analyses—to be most important. Medical information responses were used for education purposes and provided physicians the confidence to make treatment decisions. For nurse practitioners/physician assistants, nurses, and pharmacists, the information provided by MI departments enhanced the quality of patient management. Conclusions: These findings provide information regarding the utility of medical information services while providing insights on the informational needs of health care professionals today. MI departments provide an important service to health care professionals that impart confidence for making treatment decisions.

The Changing Roles of Medical Communications Professionals: Evolution of the Core Curriculum

This article provides an update to the published instructors notes for the Core Curriculum tutorial presented annually at the Drug Information Association medical communications workshop. The original publication has become the foundation for training individuals new to industry-based drug information practice. This update to the Core Curriculum publication describes the evolving role of medical communications professionals, highlighting changes from the original publication that impact the core role of a medical communications professional as well as describing new activities. Medical communications departments play a role throughout a products development and life cycle. They serve both external customers and internal business partners with various services. This article reviews these customers and partners and highlights various activities that medical communications can be involved in such as promotional review, scientific meeting support, training, product labeling support, publication planning, medical education, clinical trial recruitment, and postmarketing clinical communications (including Academy of Managed Care Pharmacy dossier development). Additional support of postmarketing programs includes involvement with safety risk management, field-based medical groups (medical liaison teams), and training.

Quality Assurance Practices for Pharmaceutical Industry-Based Drug Information Departments: A Review and Case Study

Quality assurance programs are developed to ensure the quality of products and services. Reasons for performing quality assurance and the types of quality assurance programs in industry-based drug information departments will be reviewed. Recent findings from a benchmarking survey will also be provided. Finally, the quality assurance program for the Medical Communications Department at Genentech, Inc. will be described. Factors to consider and thelessons learned will be high-lighted.

Assessing Medical Information Needs via an Internet-Based Survey

Genentechs Medical Communications Department provides verbal and written responses to unsolicited requests for medical information relating to company products. Two surveys were conducted with the following objectives: to assess health care professional informational needs during the postapproval period, to evaluate customer satisfaction during a time of increased departmental workload, to explore relevance and usefulness of information provided, and to identify differences in informational needs between customer segments. Genentechs Medical Communications, in collaboration with marketing, identified a professional research group to coordinate the customer surveys. The Internet-based surveys were developed and implemented by the professional research group. The surveys were conducted following product or indication approvals. Overall, the majority of respondents were satisfied with the service and information received, and reported the information was relevant to clinical practice. Additionally, a majority indicated the information would be discussed with colleagues and patients, and used to self-educate. The most frequent reasons for contacting the Medical Communications Department following a new product approval were for safety information, use with other products, administration questions, and patient monitoring questions. The most frequent reasons for contacting Medical Communications during a label extension included questions on use in combination with other products, safety information, dosing, and identifying appropriate candidates for the new use. Using an Internet-based survey was an effective tool. Genentech customers overall were satisfied with the information received from the Medical Communications Department. In addition, all customer segments reported that the information assisted in therapeutic decision making.