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PubMed1999

Ten guiding principles for teaching children and adolescents about medicines. US Pharmacopeia.

In 1996, an open conference sponsored by the US Pharmacopeia (USP) and attended by more than 100 health care professionals established the need and rationale for teaching children and adolescents about medicines. After the conference, a public, iterative, consensus-development process including participation by 35 health-professional organizations was undertaken. This process resulted in a USP position statement, "Ten Guiding Principles for Teaching Children and Adolescents About Medicines," which supports the right of children and adolescents to receive developmentally appropriate information and direct communications about medicines that are consistent with their health status, capabilities, and culture. The position statement is intended to stimulate activities that will help children become active participants in the process of appropriate use of medicines and prepare them for the day they begin to use medicines independently.

Adolescent↗
PubMed2000

Artefact formation in the determination of residual solvents according to a method of the European Pharmacopeia.

Method 2 of the procedure for the identification and assay of residual solvents, of the European Pharmacopeia 3rd edition 1999 addendum, leads to artefactual formation of N-chlorodimethylamine when the hydrochlorides of basic compounds are examined. This is due to degradation of the dissolution solvent N,N-dimethylformamide under the prescribed conditions. N-Chlorodimethylamine has been detected during analysis of several hydrochloride salts of nitrogen bases including drug substances. Artefact formation did not occur consistently with all the compounds examined, but with diltiazem hydrochloride it was observed in the majority of experiments. The discovery that the alkylating reagent N,N-dimethylaminoethyl chloride (DMC) used in the synthesis of diltiazem gives apparently high yields of N-chlorodimethylamine was cause for concern. However, it has been confirmed that production batches of diltiazem hydrochloride contain <1 ppm of this synthetic intermediate. The formation of N-chlorodimethylamine in the presence of the drug substance is probably due to a reaction between dimethylformamide and HCl, that would be released as a result of hydrolysis by residual water of the O-acetyl function of diltiazem. In view of these findings, the compendial general method should be reviewed. It may be necessary to adopt a different approach to the drafting of methods for volatile impurities, since most of the operating conditions are in practice specific to the substance being examined.

Calcium Channel Blockers↗
PubMed2002

Determination of propylthiouracil using 1,3-dibromo-5,5-dimethylhydantoin (DBH): analytical methods of pharmacopeias with DBH in respect to environmental and economical concern: part 9.

USP 2000 [The United States Pharmacopeia, Rockville USA, 24th ed., 2000, pp. 1436] and PH. EUR. 1997 [European Pharmacopoeia, third ed., Council of Europe, Strasbourg, 1997, p. 1401] determine propylthiouracil using neutralization titration, whereby 0.1 M silver nitrate and twice boiling is necessary. With the application of 1,3-dibromo-5,5-dimethylhydantoin (DBH), the assay of propylthiouracil can be performed easily, faster and friendlier to environment. A mean deviation of 0.03% and a relative standard deviation of 0.3% are obtained. 5-Bromo-6-propyluracil is formed, when propylthiouracil is determined with DBH.

Antithyroid Agents↗
PubMed2002

Determination of iodine values according to Hanus using 1,3-dibromo-5,5-dimethylhydantoin (DBH): analytical methods of pharmacopeias with DBH: part 7.

USP/NF 2000 [The United States Pharmacopeia, Rockville USA, 24th ed., 2000, p. 1868, The National Formulary, 19th ed. 2000] and PH. EUR. 1997 [European Pharmacopoeia, third ed., Council of Europe, Strasbourg, 1997, pp. 63-64] determine the iodine values according to Hanus with iodine monobromide in glacial acetic acid. This reagent can be replaced by a solution of 1,3-dibromo-5,5-dimethylhydantoin (DBH) and potassium iodide or iodine in the same solvent. Both reagents yield equivalent results by means of method comparison according to Passing and Bablok [J. Clin. Chem. Clin. Biochem. 21 (1983) 709; 22, (1984) 431] in relation to the official method of PH. EUR.

Hydantoins↗
PubMed2000

A new United States Pharmacopeia (USP) Chapter 1046: cell and gene therapy products.

The United States Pharmacopeia (USP) has published the first draft of a new information chapter on cell and gene therapy products in January, 2000. The chapter discusses the manufacturing and testing cell and gene therapy products. It is intended for people working in the field as well as for pharmacists and clinicians who would like more information on this subject. This article outlines the background of USP and explains how it became involved with cell and gene therapy and what an information chapter is. It details the subjects covered by the chapter and the philosophy behind the chapter. This draft will be revised based on comments received from the public and then published as a revision subject to further comments before it becomes an official chapter in a supplement to USP 24-NF 19.

Advisory Committees↗
PubMed2006

Shear-induced variability in the United States Pharmacopeia Apparatus 2: modifications to the existing system.

The hydrodynamics within the United States Pharmacopeia Apparatus 2 have been shown to be highly non-uniform with a potential to yield substantial variability in dissolution rate measurements. Through the use of readily available engineering tools, several geometric modifications to the device were evaluated in this study. Specifically, we examined the influence of impeller clearance, agitator type (radial and axial), and vessel geometry (PEAK vessel) on the fluid flow properties and their relation to measured dissolution rates. Increasing the impeller clearance was observed to exacerbate the heterogeneity in shear and would likely result in greater variability in dissolution measurements. Altering the impeller type was shown to yield changes in the hydrodynamic behavior; however, the overall properties and problems with the test remain the same. Use of the PEAK vessel was observed to reduce shear heterogeneity in the regions where tablets are most likely to visit during testing; however, higher shear rates may result in the inability to discriminate between true differences in dissolution rates.

Chemistry, Pharmaceutical↗
PubMed2002

In vitro evaluation of dissolution behavior for a colon-specific drug delivery system (CODES) in multi-pH media using United States Pharmacopeia apparatus II and III.

United States Pharmacopeia dissolution apparatus II (paddle) and III (reciprocating cylinder) coupled with automatic sampling devices and software were used to develop a testing procedure for acquiring release profiles of colon-specific drug delivery system (CODES) drug formulations in multi-pH media using acetaminophen (APAP) as a model drug. System suitability was examined. Several important instrument parameters and formulation variables were evaluated. Release profiles in artificial gastric fluid (pH 1.2), intestinal fluid (pH 6.8), and pH 5.0 buffer were determined. As expected, the percent release of APAP from coated core tablets was highly pH dependent. A release profile exhibiting a negligible release in pH 1.2 and 6.8 buffers followed by a rapid release in pH 5.0 buffer was established. The drug release in pH 5.0 buffer increased significantly with the increase in the dip or paddle speed but was inversely related to the screen mesh observed at lower dip speeds. It was interesting to note that there was a close similarity (f2 = 80.6) between the release profiles at dip speed 5 dpm and paddle speed 100 rpm. In addition, the release rate was reduced significantly with the increase in acid-soluble Eudragit E coating levels, but lactulose loading showed only a negligible effect. In conclusion, the established reciprocating cylinder method at lower agitation rates can give release profiles equivalent to those for the paddle procedure for CODES drug pH-gradient release testing. Apparatus III was demonstrated to be more convenient and efficient than apparatus II by providing various programmable options in sampling times, agitation rates, and medium changes, which suggested that the apparatus III approach has better potential for in vitro evaluation of colon-specific drug delivery systems.

Acetaminophen↗
PubMed2003

Simulating the hydrodynamic conditions in the United States Pharmacopeia paddle dissolution apparatus.

The objective of this work was to examine the feasibility of developing a high-performance computing software system to simulate the United States Pharmacopeia (USP) dissolution apparatus 2 (paddle apparatus) and thus aid in characterizing the fluid hydrodynamics in the method. The USP apparatus was modeled using the hydrodynamic package Fluent. The Gambit program was used to create a "wireframe" of the apparatus and generate the 3-dimensional grids for the computational fluid dynamics solver. The Fluent solver was run on an IBM RS/6000 SP distributed memory parallel processor system, using 8 processors. Configurations with and without a tablet present were developed and examined. Simulations for a liquid-filled vessel at a paddle speed of 50 rpm were generated. Large variations in fluid velocity magnitudes with position in the vessel were evident. Fluid velocity predictions were in good agreement with those previously published, using laser Doppler velocity measurements. A low-velocity domain was evident directly below the center of the rotating paddle. The model was extended to simulate the impact of the presence of a cylindrical tablet in the base of the dissolution vessel. The presence of the tablet complicated the local fluid flow, and large fluid shear rates were evident at the base of the compact. Fluid shear rates varied depending on the tablet surface and the location on the surface and were consistent with the reported asymmetrical dissolution of model tablets. The approach has the potential to explain the variable dissolution results reported and to aid in the design/prediction of optimal dissolution conditions for in vitro--in vivo correlations.

Chemistry, Pharmaceutical↗
PubMed2006

Impact of United States Pharmacopeia chapter 797: results of a national survey.

PURPOSE: The initial response of the pharmacy profession to United States Pharmacopeia (USP) chapter 797 and the current state of hospital pharmacy practice as it relates to implementing this chapter were studied. METHODS: A stratified random sample of 600 hospital pharmacy directors across the nation were surveyed by mail. RESULTS: A total of 251 surveys (41.8%) were returned. Larger hospitals (> or =200 staffed beds) were more likely than smaller hospitals (<200 staffed beds) to have read USP chapter 797 (80.0% versus 45.8%, respectively) and have a copy of the chapter (94.6% versus 78.0%, respectively). Overall, respondents felt that chapter 797 would negatively affect workload and pharmacy's ability to provide sterile preparations in a timely manner. Conversely, respondents replied that the new standard would have a positive effect on the quality of care provided by the hospital. Overall, 45.3% of respondents reported plans to build a clean-room, and 21.7% reported plans to obtain new equipment to comply with chapter 797. Furthermore, 42.3% of respondents had decreased the quantity of high-risk compounding. Respondents also reported that their pharmacy's budget had increased in order to comply with chapter 797. The most common requirements with which respondents were not willing to comply were validating the accuracy of automated compounding devices, sterilizing products and equipment before entering the cleanroom, rotating the type of disinfectants, and prohibiting use of cosmetics by staff. CONCLUSION: USP chapter 797 standards have influenced the compounding practices of hospital pharmacies nationwide, including a decrease in the compounding of high-risk preparations, an increase in budgetary allocations, and implementation of better quality assurance practices. Larger hospitals tended to implement more changes than did smaller hospitals, and there remains room for improvement overall.

Drug Compounding↗
PubMedDate not supplied

Drug utilization review: mechanisms to improve its effectiveness and broaden its scope. The U.S. Pharmacopeia Drug Utilization Review Advisory Panel.

OBJECTIVE: To address important problems and needed changes in online and retrospective drug utilization review (DUR) programs. Emphasis is placed on reliability of DUR criteria and the shift of traditional retrospective DUR programs toward disease management and health care outcomes. DATA SOURCES: Published literature evaluating the role of online and retrospective DUR programs. STUDY SELECTION: Particular attention was given to studies assessing DUR criteria reliability and new interventions with retrospective DUR programs. DATA SYNTHESIS: A literature review was conducted along with an expert summary from the U.S. Pharmacopeia Drug Utilization Review Advisory Panel. Studies have revealed variations in DUR criteria that could be affecting clinical practice and patient care. Appropriate formal methodologies and use of consistent procedures in developing online prospective DUR programs and systems could help resolve these problems. Traditional retrospective DUR is also shifting to incorporate disease management and methodologies from health outcomes and pharmacoeconomics studies. CONCLUSIONS: Refinements are needed to improve the reliability and validity of online DUR criteria and to minimize false positive messages. Databases created as a result of DUR efforts have been used in new and innovative ways to incorporate health outcomes data and disease management interventions. Additional outcomes data, combined with quality assurance efforts, should increase the utility of DUR/disease management efforts in evaluating health systems while improving the effectiveness and efficiency of pharmacists' health care interventions.

Computer Systems↗
PubMed1996

Prevalence of adverse reactions in nuclear medicine. Pharmacopeia Committee of the Society of Nuclear Medicine.

UNLABELLED: This investigation sought to determine the prevalence of adverse reactions to radiopharmaceuticals and to nonradioactive drugs used in interventional nuclear medicine. We also tabulated all adverse reactions reported to manufacturers of radiopharmaceuticals commercially available in the United States. METHODS: A prospective 5-yr study was performed of 18 collaborating institutions using a questionnaire which enumerated monthly the number of procedures used and adverse reactions noted. An algorithm to determine the level of etiologic probability of an adverse reaction from an administered radiopharmaceutical was developed. We reviewed all available literature on adverse reactions in nuclear medicine. RESULTS: During this period, 783,525 radiopharmaceutical and 67,835 nonradioactive drug administrations were analyzed. Ten of the 18 adverse reactions to radiopharmaceuticals were rashes. No patient experiencing an adverse reaction to a radiopharmaceutical required hospitalization or had significant sequelae. Reproducibility of the adverse reactions algorithm was validated by independent evaluation of 30 adverse reaction reports from the U.S. Pharmacopeia-Society of Nuclear Medicine adverse reaction reporting system. All adverse reactions to 49 commercially available radiopharmaceuticals were tabulated and referenced. CONCLUSION: Radiopharmaceuticals have an excellent safety record. An algorithm to evaluate putative radiopharmaceutical reactions is highly reproducible.

Adverse Drug Reaction Reporting Systems↗
PubMed1995

[Improving on the Japanese pharmacopeia--on assays and determinations].

Dr. Mitsuo Watanabe has offered many suggestions and points to be considered on the Japanese Pharmacopeia. His points of the matter include the nomenclature of reagents. Issues on electrodes and volumetric standard solutions to be used in nonaqueous potentiometric titrations are also involved, as well as the justification of a method for quantitative determination and analytical method validation. His concerns have prompted studies and careful surveys of these vital points to consider investigating that the nomenclature of reagents should be directed to prencipally follow the rules of IUPAC. Consideration has also been given to an issue of nonaqueous potentiometric titration, where problems many frequently be found with liquid junction between the electrode and the solution under titration. To work out the issue, investigations have started of an alternative technique characterized in using a platinum (or silver) electrode and a glass electrode as an indicator electrode and a reference electrode, respectively, without any liquid junction. For any titration system in question that can be regarded as nonaqueous titration from viewpoints of analytical chemistry. It has been suggested the use of any volumetric standard solutions of aqueous system should generally be avoided. Other points received consideration include sampling procedures for testing, interpretation of results from quantitation, and analytical method validation.

Japan↗