Costs associated with United States pharmacopeia compliant infusion clinics

Purpose As costs continue to rise in oncology, a strategy that has been implemented to limit these costs is use of alternative sites of care. However, there are differences in regulatory standards between common sites of care such as freestanding infusion clinics and hospital outpatient departments. The costs associated with United States Pharmacopeia compliance were evaluated in order to better understand the cost of universally compliant hospital outpatient departments. Methods Annual operational costs associated with United States Pharmacopeia compliance were estimated for a 30-chair infusion clinic with United States Pharmacopeia <797> and <800> pharmacy cleanrooms for non-hazardous and hazardous drugs, respectively. Annual United States Pharmacopeia compliance costs included: competency assessments, personal protective equipment, closed system transfer devices, labels, cleaning supplies, and environmental monitoring. One-time costs included initial cleanroom construction and renovations. Published information and benchmarks provided baseline assumptions for patient volume, staffing, and unit costs. If no published data was available, prices were estimated based on a similarly sized clinic. Results Recurring annual costs for a 30-chair fully compliant infusion clinic were calculated to be $785,207. One-time costs associated with initial construction and renovations were estimated to be $1,365,207–$1,535,207 and $965,207–$1,005,207, respectively. Conclusions Costs associated with increased operational oversight and regulatory standards are a major contributing factor to the facility fee of hospital outpatient departments. Ultimately, all sites of care share in the goal to provide optimal patient care while considering all aspects of patient care, including cost. Therefore, a move towards consistent regulatory standards across all settings would aid in preventing discrepancies in care.

Quality assessment of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya

Introduction Quality of medicines in both developed and developing countries is sometimes compromised due to infiltration of counterfeit, substandard or degraded medicines into the markets. It is a public health concern as poor quality medicines endanger public health where patients are exposed to chemical toxins and/or sub-therapeutic doses. This could lead to reduced treatment efficacy and promote development of drug resistance. Co-trimoxazole, a fixed dose combination of sulfamethoxazole and trimethoprim, is a broad spectrum for bacterial diseases and is also used as a prophylaxis for opportunistic infections in HIV infected individuals. This study evaluated quality of selected co-trimoxazole suspension brands marketed in Nairobi County, Kenya. Methods A total of 106 samples were collected, categorized into 15 brands and evaluated for active pharmaceutical ingredient content (API) and pH following United States Pharmacopeia. Assay for API was conducted using High Performance Liquid Chromatography. Results were compared with pharmacopeia references. Visual examination of labels and confirmation of retention status of the brands with Pharmacy and Poisons Board retention register was carried out. Results The samples were primarily of local origin (86.7%). On October 23, 2019, retention status of six of the fifteen brands documented were no longer listed in the Pharmacy and Poisons Board retention register. Of the 106 samples tested 70.6% and 86.8% were compliant with United States Pharmacopeia (USP) specifications for pH and API respectively while 84.0% adhered to packaging and labelling requirements. Conclusion This study has demonstrated that majority of co-trimoxazole suspensions tested were compliant with USP requirements. Additionally, it has provided evidence of poor quality co-trimoxazole medicines that could compromise treatment of infectious diseases in children. This emphasizes the need for regular quality assurance tests to ensure only quality medicines are in the market.

Quality Attributes Comparison of Selected Brands of Rosuvastatin Calcium Tablets Marketed in the US and Bangladesh

Aims: This study investigated whether locally marketed rosuvastatin calcium tablets in Bangladesh have comparable physical and chemical attributes, including in vitro bioequivalence profiles, to the proprietary brand. Methodology: Nine generic products (G1-G9) containing 10 mg of rosuvastatin calcium were compared to the proprietary brand Crestor® (R1) and an FDA approved generic rosuvastatin calcium tablet (R2). Weight variation, diameter, thickness, friability, drug content, disintegration time and dissolution profiles were tested according to United States Pharmacopeia (USP) guidelines. In vitro bioequivalence requirements were assessed by calculating difference (f1) and similarity (f2) factors. Results: The generic products complied with the pharmacopeial requirements for weight variation, disintegration time and friability. All the tablets had drug ranging between 92%-105% and released more than 80% of rosuvastatin within first 15-30 minutes. However, for brands G5, G7 and G8 the f1 values were 15.7%, 15.82% and 25.21% respectively and their f2 values were 41.8, 41.6 and 32.6 respectively whereas for G9 the f2 value was 43.4. These brands have thus failed to meet in vitro bioequivalence requirements. Conclusion: We conclude that few substandard generics of rosuvastatin calcium has somehow found its way to the market and further studies are required to ascertain their noncompliance.

Tubing determination in an hematology oncology clinic

United States Pharmacopeia (USP) Chapter <800> for hazardous drug (HD) handling in healthcare settings requires HD be primed intravenously with a non-HD solution prior to dispensing. This review details our clinic’s algorithm for determining tubing needs for medications used in an hematology oncology clinic. Factors to consider are volume, irritant and vesicant properties, and compatibility with hydration solution.

Efficacy of Three Commercial Disinfectants in Reducing Microbial Surfaces’ Contaminations of Pharmaceuticals Hospital Facilities

To evaluate and validate the efficacy of disinfectants used in our cleaning procedure, in order to reduce pharmaceutical hospital surfaces’ contaminations, we tested the action of three commercial disinfectants on small representative samples of the surfaces present in our hospital cleanrooms. These samples (or coupons) were contaminated with selected microorganisms for the validation of the disinfectants. The coupons were sampled before and after disinfection and the microbial load was assessed to calculate the Log10 reduction index. Subsequently, we developed and validated a disinfection procedure on real surfaces inside the cleanrooms intentionally contaminated with microorganisms, using approximately 107–108 total colony forming units per coupon. Our results showed a bactericidal, fungicidal, and sporicidal efficacy coherent to the acceptance criteria suggested by United States Pharmacopeia 35 <1072>. The correct implementation of our cleaning and disinfection procedure, respecting stipulated concentrations and contact times, led to a reduction of at least 6 Log10 for all microorganisms used. The proposed disinfection procedure reduced the pharmaceutical hospital surfaces’ contaminations, limited the propagation of microorganisms in points adjacent to the disinfected area, and ensured high disinfection and safety levels for operators, patients, and treated surfaces.

Dispersive liquid–liquid microextraction of Cd, Hg and Pb from medicines prior to ICP OES determination according to the United States Pharmacopeia

A simple, sensitive and matrix effect free analytical method for simultaneous determination of Cd, Hg and Pb in drug samples (i.e., commercial dosage tablets) by inductively coupled plasma optical emission...

New Approaches to Sample Preparation and Integrated Spectroscopic Methods for The Identification of Polioxyethylene Triolate Sorbitane for Pharmaceutical Examination of Drugs

Due to the fast pace of development of spectroscopic research methods in the pharmaceutical expertise of drugs presented in the United States Pharmacopeia (USP) and European Pharmacopoeia (Ph. Eur.), in this paper, we examined complex methods for the identification and preparation for analysis of polyethylene sorbitan trioleate. Two new systems were identified for purification of 98% polyoxyethylene sorbitan trioleate from organic impurities in column chromatography: acetonitrile 100% and acetonitrile/acetone 7.5/2.5. It was also revealed that a chamber with metallic iodine was the most suitable for selecting an eluent and controlling the cleaning by the TLC method. Proton NMR did not detect organic impurities. Identification of polyoxyethylene sorbitan trioleate was carried out on H1, C13, COSY, and IR spectra. These research methods are characterized by simplicity in sample preparation, the availability of reagents, the effectiveness of identification and quantification analyzes, and the efficiency in labor and material costs

Comparative In Vitro Evaluation Of Different Brands Of Metformin Hydrochloride Film Coated Tablets Marketed In Addis Ababa, Ethiopia

Metformin hydrochloride is a biguanide class of drug widely used to treat Type 2 diabetes mellitus. Its oral bioavailability is about 50 to 60 % with a half-life of about 3 h. This study focused on evaluation and comparison of the physicochemical properties of different brands of metformin hydrochloride (500mg) film coated tablets available in drug retail outlets in Addis Ababa, Ethiopia. Some different in vitro tests including hardness, weight variation, disintegration time, dissolution study, and assay were conducted as per United States Pharmacopeia. To compare dissolution profiles of the generic products against the innovator product (product A), a model independent method, similarity factor (f2), was also used. Weight variation result showed that all brand fall within the 5% limit from the average which is acceptable. Disintegration time of less than 15 minutes was observed for all brands. The in vitro drug release study results for the products ranged between 82 and 93% release within 30 minutes which is above 80% limit as per the United States Pharmacopeia requirement. The similarity f2 values for generic products ranged from 53 to 75%. Furthermore, assay value of the studied brands varied from 95.60 to 104.37% which was within standard limit (95-105%). It can be concluded that all brands of metformin hydrochloride tablets met pharmacopoeial specification for the tested parameters of physicochemical properties like weight variation, hardness of tablets, disintegration time, drug release study and assay.