OBJECTIVES: The Pharmacy and Therapeutics Committee (P&TC) is a policy recommending and enforcing body which oversees the adoption of effective formulary system within the health care organization, the aim of the study is to explore the characteristics of P& TC in tertiary and secondary hospitals in Riyadh city, Saudi Arabia. METHODS: A cross-sectional survey targeted hospital pharmacy mangers in Riyadh city in 2014. The survey gathered information about P&TC organizational, communicational and functional characteristics. RESULTS: Of 30 hospital pharmacies, 23 (76.6%) pharmacy managers responded, 21(70%) hospitals met the inclusion criteria, 15 (71.4%) are governmental and 6 (28.6%) are private hospitals. Of 21 hospitals, 20 (95.2%) have P&T Committee. 15 (71.4%) committees have all required written policies and procedures that govern the committee business. The average total number of the P&T committee members is 13.5 (SD= 5), and dominated by physicians, pharmacists, and nurses (6.9 (SD= 3.4), 2.7(SD= 1.2), and 1.4(SD= 0.8)) respectively. 89.5% of these committees are chaired by physicians and 100% of them are coordinated by the pharmacists. Only 9 (45%) of the committees distribute the meeting agenda to their members 6 days or more before the meeting date. The average number of meetings is 12 (SD= 6) meeting per year, drug availability, formulary change updates, drug safety related issues were frequently discussed in each meeting of 11(55%) hospital P&T committees. Formulary non adherence is less frequently, and prescribing guidelines is the least frequent.
Background: Renal impairment (RI) is associated with substantial clinical and economic burden in patients with multiple myeloma (MM), but real-world data reporting on healthcare resource utilization (HRU) and outcomes in these patients are lacking. We assessed treatment patterns, overall survival (OS), HRU and associated costs across lines of therapy (LoT) in patients with MM who had baseline RI. Methods: We identified patients (aged ≥18 years) with continuous Part A, B and D coverage who initiated pharmacologic therapy for MM between January 1, 2012 and December 31, 2016. Baseline demographics, disease characteristics, and treatment patterns from first-line to fourth-line (1L-4L) were reported for all eligible patients (main cohort). Within this cohort, a subgroup of patients diagnosed with RI at baseline (RI subgroup) were identified using appropriate International Classification of Diseases (ICD)-9 and ICD-10 codes. Treatment regimens were identified during the first 60 days following start of each LoT; stem cell transplantation (SCT) in 1L was considered part of the 1L regimen. The end of each LoT was indicated by treatment augmentation, treatment switching (after >60 days), discontinuation of all agents (for >90 days), or death. Overall survival (Kaplan-Meier analysis) was defined as time from start of each LoT until death or censoring (end of data/Medicare coverage). All-cause HRU categories were identified during each LoT and reported as incidence rate per patient per month (PPPM); associated all-cause healthcare costs during LoT were reported in 2017 US$. Results are presented using standard descriptive statistics. Results: A main cohort of 10,026 patients was identified; of these, a RI subgroup of 714 patients with baseline RI was identified (7.1% of main cohort). At 1L initiation, the RI subgroup was generally younger (71.9 vs. 74.6 years), had a lower proportion of females (47.8% vs. 53.1%) and had a higher proportion of Medicare coverage for end-stage renal disease (62.9% vs. 6.3%) than the main cohort. Patients with RI had a higher mean Charlson Comorbidity Index score (excluding MM; 4.8 vs. 3.3) and a higher proportion of patients with comorbidities (anemia: 72.5% vs. 57.9%; diabetes with chronic complications: 38.7% vs. 27.1%; cardiovascular diseases: 97.2% vs. 82.5%) than the main cohort. In the RI subgroup, among patients who received SCT in 1L (n=76), bortezomib-dexamethasone (Vd) was the most frequent 1L regimen (39.5%), followed by bortezomib-lenalidomide-dexamethasone (VRd; 17.1%) and bortezomib-cyclophosphamide-dexamethasone (VCd; 15.8%). In patients who had no SCT in 1L, Vd was the most frequent 1L regimen (59.5%), followed by VCd (12.7%) and lenalidomide-dexamethasone (Rd; 12.1%). Among patients in the RI subgroup who progressed to 2L therapy, 61.7% received lenalidomide-based regimens in 1L. Newer MM therapies such as carfilzomib, pomalidomide, ixazomib, daratumumab, and elotuzumab were used more frequently in later LoTs (2L: 25.6%; 3L: 50.0%; 4L: 68.8%). Median OS from start of 1L was shorter in the RI subgroup than in the main cohort (29.9 vs. 46.5 months; Table), and this difference was consistent across each subsequent LoT. Incidence of HRU during 1L (Table) was generally higher in the RI subgroup than the main cohort, particularly for inpatient days (1.3 vs. 0.7 PPPM) and home health services (0.9 vs. 0.5 PPPM); this pattern was consistent between cohorts across each subsequent LoT. Total costs in the 1L RI subgroup vs. main cohort (Table) were $14,782 vs. $12,451; the cost differential was maintained across each subsequent LoT. The key driver of this difference was the additional medical service costs ($12,047 vs. $7,459 in 1L) incurred by patients with RI. Conclusion: Patients with MM who had baseline RI were shown to experience higher clinical and economic burden in real-world clinical practice than the overall MM population. This burden was maintained across LoTs. Efficacious regimens that help improve renal function with minimal toxicity would enable patients with MM and RI to persist with treatment and may help address unmet need in this subgroup of patients. Table Disclosures Hari: BMS: Consultancy; GSK: Consultancy; Janssen: Consultancy; Amgen: Consultancy; Takeda: Consultancy; Incyte Corporation: Consultancy. Araujo:Sanofi Genzyme: Current Employment. Latremouille-Viau:Sanofi Genzyme: Consultancy, Other: Dominique Latremouille-Viau is an employee of Analysis Group, Inc. which received consultancy fees from Sanofi Genzyme.; Novartis Pharmaceutical Corporation: Consultancy, Other: Dominique Latremouille-Viau is an employee of Analysis Group, Inc. which received consultancy fees from Novartis.. Lin:Sanofi Genzyme: Current Employment. Davidson:Sanofi Genzyme: Other: Mikhail Davidson is an employee of Analysis Group, Inc which received consultancy fees from Sanofi Genzyme.. Guerin:Sanofi Genzyme: Consultancy, Other: Annie Guerin is an employee of Analysis Group, Inc. which received consultancy fees from Sanofi Genzyme.; Abbvie: Consultancy, Other; Novartis Pharmaceuticals Corporation: Consultancy, Other: Annie Guerin is an employee of Analysis Group, Inc. which received consultancy fees from Novartis.. Sasane:Sanofi Genzyme: Current Employment.
A13Objectives: Since 1992, the Food and Drugs Administration (FDA) accelerated approval pathway has enabled market entry of drugs for serious conditions based on a surrogate endpoint that is likely to predict clinical benefit with confirmatory trials to be completed post-approval. However, five drugs have since been withdrawn or severely restricted following accelerated approval due to lack of efficacy (bevacizumab, [indication: breast cancer;
BackgroundThe United States-Peru Free Trade Agreement required changes in the Peruvian pharmaceutical legislation that resulted in the National Drug Policy (NDP) of 2009. This study evaluated the registration of brand and generic anti-infectives before and after the agreement and implementation of the NDP and assessed the availability of anti-infectives in community pharmacies located in Arequipa-Peru.MethodsAnti-infectives registration database, provided by DIGEMID (Peruvian Drug Regulatory Authority), was evaluated from January 2005 to August 2014. Registration status included: new registrations, re-registrations, awaiting registration; or expired, denied, suspended, canceled and disregarded registrations. In addition, ten retail pharmacies located in different socio-economic areas in Arequipa were sampled in August 2014. Descriptive statistics and chi-square test were used for the analysis.ResultsA total of 6112 anti-infectives registrations were categorized (5007 = antibacterials, 340 = antimycotics, 143 = antimycobacterials, and 622 = antiviral drugs). New registrations for brand and generic anti-infectives decreased from 2005 to 2013 (311 to 60 and 164 to 20 respectively). Re-registrations were from 121 (brand) and 115 (generics) in 2005 to 6 (brand) and 5 (generics) in 2013. Anti-infectives awaiting registration increased from 0 in 2005 to 351 (brand) and 137 (generics) in 2013.The retail pharmacy survey included 1105 anti-infectives. These pharmacies carried 647 (58.6%) products awaiting registration, 74 (6.7%) expired (mostly combination of sulfonamides and trimethoprim followed by penicillin with extended spectrum, and fluoroquinolones), 4 (0.4%) suspended, and 2 (0.2%) denied registrations. Pharmacies in the low socio-economic area of the city had the highest proportion of generics (59.0% vs. 16.1%) from foreign origin (mainly India), and brand anti-infectives from Peruvian manufacturers (68.8% vs. 48.1%). High socio-economic areas had highest proportion of branded anti-infectives (83.9% vs. 41.0%).ConclusionsThe new NDP reduced the number of brand and generic registrations; generics had the largest decline in registrations. Anti-infectives found in pharmacies located in low-income areas were more likely to be generics, and less likely to be currently registered by DIGEMID. The potential reduction in generic registrations resulting from the implementation of the NDP as a consequence of the bilateral trade agreement could result in lower availability of low cost medicines, but may increase the safety, efficacy and quality of marketed medicines.
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