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.

Survey of Customers Requesting Medical Information: Preferences and Information Needs of Patients and Health Care Professionals to Support Treatment Decisions.

BACKGROUND: Pharmaceutical manufacturer medical information (MI) departments play an important role in providing medical information to health care professionals (HCPs) and patients. A survey was conducted to gather insights on the utility of MI services and to understand the information needs/preferences to support therapy decisions. METHODS: Patients (n=40) and HCPs (n=192) who requested medical information in a 3-month time frame from 4 companies were surveyed (15 questions for patients; 28 questions for HCPs). RESULTS: Patients contacted MI departments for information on concerns about side effects, efficacy information, access/insurance coverage, how to take the medicine, switching medicine, how the medicine works, comparison to another medicine, medical condition information, and participating in trials. Patients reported that the medical information received changed the perception toward the treatment in the following ways: learned something new about the treatment, provided more confidence to talk to an HCP, and were potentially more likely to start treatment. Health care professionals requested medical information related to dosing, safety, patient selection, and differentiating between therapeutic options. The HCPs used the medical information to take an action (eg, managing treatment for patients or deciding to prescribe a medicine), to support informing-type of activities (eg, help guide discussions with patients, plan to use information for future treatment decisions/ discussion, help with insurance coverage determination, or help to enroll patients into ongoing clinical trials), and to meet an education need (eg, self-education or sharing information with practice/colleagues). CONCLUSIONS: These results describe patients' and HCPs' information needs/preferences that provide MI departments potential areas for enhancing services.

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.

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.

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.

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.