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PubMed1998

From ideology to logistics: the organizational aspects of syringe exchange in a period of institutional consolidation.

The initial period in the establishment of syringe exchange projects is often characterized by overt conflict: between community AIDS activists, on the one hand, and public officials and political leaders who remain ideologically opposed to the introduction of measures perceived as condoning illicit drug use. In this context, professionals concerned with legitimating the new institutions of syringe exchange may sometimes neglect aspects of their everyday logistics and social organization, obscuring the important choices which have to be made to carry these initiatives forward. In particular, the contrast between formally-constituted institutions-the "storefront" or "community-based" syringe exchange programs (SEPs)-and the model of low-threshold syringe availability through pharmacies, vending machines, and user networks, is here presented not as an either/or choice but rather as a pair of complementary strategies which respond to diverse needs and target different populations. The advantages and disadvantages of each particular approach make it likely that maximum effectiveness will be achieved through a combination of every possible form of needle distribution, each tailored to specific and cultural circumstances. The case is here examined in the light of the experience of the SEPs in New York City, from their clandestine origins in 1990 through their first years of official functioning in 1992-1996.

Attitude of Health Personnel↗

PubMed1999

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

The production, distribution and sale of counterfeit or substandard pharmaceutical products on the world market are of increasing concern to drug authorities and the international agencies that recommend standards for ensuring the quality, efficacy and safety of drugs. This report of an international group of experts convened by the World Health Organization presents recommendations concerning the quality assurance of pharmaceuticals and specifications for drug substances and dosage forms. It looks at activities related to the further development of The international pharmacopoeia and also covers good manufacturing practices, inspection and monitoring, and drug regulatory legislation. The aim of the report, of particular relevance to drug regulatory authorities, is to provide guidance to promote harmonization at an international level and encourage countries to establish and strengthen their own regulatory systems through national legislation and training programmes. A number of annexes attached to the report further develop areas where countries might themselves take action, and include detailed examples of provisional legislation and guidelines on specific aspects of good manufacturing practice, the inspection of drug distribution channels, and the development of training programmes for the inspection and examination of counterfeit pharmaceuticals.

Drug Compounding↗

PubMed2000

The complex processes of antimicrobial resistance and the information needed to manage them.

Wide use of a succession of different manufactured antimicrobial agents during the past 60 years has prompted the eventual emergence and progressive spread through the world's interconnecting bacterial populations of a growing variety of genes expressing resistance to those agents. The complex processes that spread and link resistance genes into different distributions at different times and places are driven by antimicrobial selection and by contagion. Management of resistance by reducing selection and contagion in a coordinated way requires better information. Most of the information about the spread of resistance exists in laboratory files of isolates at medical centers, and the information about patient antimicrobial use is found in pharmacy files at the same centers. Putting these in a combined database at each center would give a valuable tool to each center's antimicrobial resistance management team. Merging such databases from multiple centers would provide a public health resource for benchmarking, overview surveillance, and general resistometrics.

Anti-Bacterial Agents↗

PubMedDate not supplied

[Consumption of home enteral nutrition products in the Autonomous Community of Madrid].

The purpose of the present paper is to identify the changes in the consumption of home enteral nutrition products paid for by the National Health System in the light of the amendments to the regulations governing this service within the scope of the Madrid Regional Community. To this end, the official Social Security forms prescribing these products have been studied for the months of October, 1998, May, 1999, and May, 2000. These have been classified by brand names the number of units and cost have been tabulated. With the data obtained from this analysis, progress has been studied in terms of the following points: type of product, number of units, cost of each and share of consumption by manufacturers. The conclusion that can be drawn from the results obtained is that, since the start of the trend for increased consumption of this kind of product in November, 1998, this trend has continued upwards both in terms of the number of units and their cost. Greater diversification can be seen in the products used, with a reduction in the prescription of those items which were financed almost exclusively by the system prior to the change in the regulations, and this has to some extent constrained the displacement of consumption towards the different distribution brands and considerably increasing the consumption of those products considered more specific and therefore with a higher mean cost. Furthermore, as these products are covered by the Spanish Defence of Competition Act, in other words, the market price is not restricted, there are significant differences in the prices invoiced for the same product depending on the pharmacy outlet dispensing it.

Enteral Nutrition↗

PubMed2003

[E-commerce of pharmaceuticals].

The emergence of the Internet as a new communications and information technology caused major social and cultural changes. The dramatic increase in accessibility and availability of information empowered the consumer by closing the information gap between the consumer and different suppliers. The objective of this article is to review many new internet-supported applications related to the pharmaceutical market. E-commerce is divided into two major components: Business to Consumer (B to C), and Business to Business (B to B). The main applications in B to C are dissemination of medical and drug information, and the sale of drugs through the Internet. Medical information on the Internet is vast and very helpful for patients, however, its reliability is not guaranteed. Online pharmacies increase the accessibility and availability of drugs. Nevertheless, several obstacles such as security of the data provided (both financial and clinical) prevent the widespread use of online pharmacies. Another risk is the health authorities' inability to regulate Internet sites effectively. Therefore, unregulated sale of prescription drugs, fake or substandard, often occurs on the Internet. B to B relates to physicians, clinics, hospitals, HMO's and pharmaceutical companies. There is a vast number of applications ranging from clinical research, marketing and sales promotion, to drug distribution and logistics. In conclusion, the Internet is dynamic and has contributed to the development of numerous new applications in the field of pharmaceuticals. Regulatory authorities should be active in developing new policies that will deal with those new Internet-based applications.

Drug Industry↗

PubMed1980

Quality-control plan for intravenous admixture programs. I: Visual inspection of solutions and environmental testing.

Two components of a model quality-control plan for intravenous admixture services--a 100% visual inspection and an environmental testing program--were developed and evaluated in two hospitals. Visual inspections are recorded by technicians on two forms that detail the types of solution, container, and device defects that should be checked. One form covers stock solutions and supplies, and the other covers prepared solutions. The environmental testing program uses two forms to record performance and results of routine microbial monitoring. The detailed quality-control forms are presented. Procedures for handling defective items and contamination problems are discussed. Evaluation of the visual and environmental plans showed they provided a systematic, workable, and modest-cost method of assuring and documenting conditions in an i.v. admixture service. To assure competent preparation, use and distribution of high-quality i.v. solutions, both components of the quality-control system must be performed on a routine basis.

Drug Combinations↗

PubMed2005

ASHP survey of ambulatory care pharmacy practice in health systems--2004.

PURPOSE: The characteristics of and trends in pharmacy practice in ambulatory care settings across the United States were studied. METHODS: A 2004 national survey of the ambulatory care responsibilities of pharmacists across a spectrum of organizational types (community hospitals, county facilities, Indian Health Services facilities, Veterans Affairs (VA) facilities, teaching institutions, integrated health networks, military facilities, and health maintenance organizations) was conducted and related to organizational features that could promote pharmacist participation. RESULTS: From 1672 deliverable Web-based surveys, 233 organizations reported at least some pharmacist involvement in ambulatory activities, while 475 reported none. Over half of the 228 organizations with some pharmacist involvement reported pharmacists tracking adverse drug reactions (67%), providing written (53%) or oral (52%) information with new prescriptions, and conducting medication management programs (51%). Some 85% reported having at least one clinic with pharmacist involvement. Clinics for anticoagulation services (36%) and oncology services (28%) were most prevalent, followed by primary care or family practice clinics (23%) and diabetes clinics (21%). New survey items found a high prevalence of pharmacist involvement in emergency preparedness programs (90%), medication management services in complex medication situations (63%), and using evidence-based practice guidelines (60%). Of nine enabling factors (factors potentially promoting pharmacist involvement) investigated, participation on multidisciplinary teams and having collaborative practice agreements were significantly associated with pharmacist participation in at least one ambulatory care activity. Having at last one ambulatory care staff pharmacist with advanced training, having at least one residency program, and having collaborative practice agreements were significantly associated with pharmacist participation in at least one clinic or program. Pharmacist participation in ambulatory care activities was not equally distributed across different types of organizations, and VA facilities were notable for the amount and extent of participation. CONCLUSION: Pharmacists' roles and responsibilities in ambulatory care appear to continue to evolve, with VA facilities leading the way.

Ambulatory Care↗

PubMed1985

Formulary system controversies in the new environment of DRGs.

The currently rapid growth in the hospital industry is expected to continue. The massive increase in the aged population in the US, resulting in a shift from acute to chronic care, will also result in changes in reimbursement strategies. These changes, as well as structural changes in the health care system (HMOs, multihospital systems, PPOs, and so on), will have a profound impact on the way in which the P & T Committee functions. Contemporary management of drug distribution systems is essential in order to maintain financial viability within institutions. Implications for the role of P & T Committees in the future are discussed.

Diagnosis-Related Groups↗

PubMed1999

Prescription Drug Marketing Act of 1987; Prescription Drug Amendments of 1992; policies, requirements, and administrative procedures. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is issuing a final rule to set forth procedures and requirements implementing the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA) and the FDA Modernization Act of 1997 (the Modernization Act). The final rule sets forth requirements for the reimportation and wholesale distribution of prescription drugs; the sale, purchase, or trade of, or the offer to sell, purchase, or trade, prescription drugs that were purchased by hospitals or health care entities, or donated to charitable organizations; and the distribution of prescription drug samples. FDA is also amending certain sections of the regulations entitled "Guidelines for State Licensing of Wholesale Prescription Drug Distributors" to make them consistent with this final regulation.

Drug Industry↗

PubMed2003

[Computerized decision support in drug prescribing II: A national database to provide up-to-date and unbiased information].

Prescribers today encounter increasing demands for up-to-date knowledge of medical advances and drug therapies, and for a straightforward dialogue with patients. Cost-effective drug treatment calls for fast and intuitive access to information about drugs, treatment strategies and patient data. There are several computer-based drug-prescribing systems in Sweden. Information independent of the drug industry is wanting, as are uniform national standards for medical content and functionality. Decision-support systems must facilitate decisions about therapy, drug distribution and intake, as well as quality work, i.e. support the entire process which defines an effective drug therapy. A very important feature is access to a patient's drug list showing all current drugs. This joint initiative by county councils aims at drawing up a national Swedish specification of requirements for a suitable decision-support system and at creating a national entity responsible for distributing unbiased information from a unique database to a range of computerized medical records systems.

Catalogs, Drug as Topic↗

PubMed1997

Dispensaries in counties Armagh and Down in the pre-Famine years.

This paper traces the development of dispensaries in the counties of Armagh and Down in the decades prior to the Great Famine. It examines the number and distribution of dispensaries and discusses their management, finance and daily administration. The role of dispensary doctors, their conditions of employment and the diseases which they treated are also considered.

History, 19th Century↗

PubMed1994

Pharmacokinetic study of (S)-(-)-2-(N-propyl-N-(2-thienylethyl)amino)-5-hydroxytetralin infusion in cynomolgus monkeys.

A pharmacokinetic study of the dopamine D2 receptor agonist (S)-(-)-2-(N-propyl-N-(2-thienylethyl)amino)-5-hydroxytetralin+ ++-HCl (N-0923) infused in female cynomolgus monkeys over a 4-h period was carried out at International Research and Development Corporation. The purpose of this study was to estimate the elimination half-life and elucidate the dose-clearance relationship in cynomolgus monkeys with a randomized three-way crossover intravenous (iv) infusion study design. Six female cynomolgus monkeys were dosed by iv infusion for 4 h with 0.1, 0.5, and 1.0 mg/kg/h. Plasma samples were drawn during the infusion and up to 4 h post infusion. The plasma concentrations were determined by a sensitive and specific HPLC assay with electrochemical detection after solid-phase extraction at the Department of Toxicology and Bioanalysis at the University Center for Pharmacy in Groningen, The Netherlands. The plasma data were best described by a two-compartment open model. Mean elimination half-lives of 36.8, 39.6, and 52.4 min and mean clearance values of 229 +/- 35, 202 +/- 85, and 191 +/- 36 mL/min/kg were obtained for doses of 0.1, 0.5, and 1.0 mg/kg/h, respectively. The steady-state volumes of distribution were estimated as 3.89 +/- 0.816, 3.53 +/- 1.62, and 4.70 +/- 3.67 L/kg for the same doses, respectively. There were no significant differences between any of the estimated pharmacokinetic parameters for any of the infusion doses. Clearance was not dose dependent and steady-state plasma concentration appeared directly proportional to dose, suggesting linear pharmacokinetics in this dose range for monkeys.

Analysis of Variance↗

PubMed1981

Aminoglycoside monitoring program.

An aminoglycoside monitoring program (AMP) using pharmacokinetic variables is described. The AMP was established in one patient-care pharmacy that served 69 medical/surgical beds. The pharmacists received a two-hr instructional course designed to refamiliarize them with basic pharmacokinetic concepts and the practical application of these concepts. A form was developed to assist monitoring. From data recorded on the form, pharmacists calculate ideal body weight, creatinine clearance, predicted rate of elimination, half-life, volume of distribution, serum peak (Cmax) and serum trough (Cmin) concentrations, dosing interval, and maintenance dose. Aminoglycoside therapy is evaluated and assessed daily based on whether or not: (1) predicted Cmax or Cmin concentrations are above the recommended concentrations, (2) predicted Cmax or Cmin are below the recommended concentrations, or (3) actual serum concentrations are necessary before a dose assessment is made. The pharmacist notifies the physician and records any recommendations concerning aminoglycoside therapy. Within the first year of the program, 304 patients were placed on tobramycin or gentamicin therapy; for 21% of them, dosage recommendations were made to the physician. The AMP provides the hospital pharmacist with an opportunity to use aminoglycoside pharmacokinetic theory in everyday practice.

Aminoglycosides↗

PubMed2000

Survey of ASHP-accredited pharmacy residency programs.

The results of a survey of the requirements and features of pharmacy residency programs are reported. The survey was mailed on March 5, 1999, to the directors of 414 pharmacy practice and specialty residency programs with ASHP accreditation as of March 1, 1999. Included were questions on stipends, staffing requirements, and benefits. Information not typically included in the ASHP residency directories was also sought. Three hundred surveys were returned, for a 72% response rate. Of the responding programs, 174 (58%) were pharmacy practice programs and the rest specialty programs. The specialties with the largest number of respondents were primary care (30 of 126, or 24%) and drug information (23, or 18%). The practice setting varied widely, but a university-based practice site was most frequent (122 of 300 programs, or 41%). The overall median stipend range was $28,000-$28,999; stipends varied relatively little by geographic region but were highest in New York and New Jersey. Most residency programs had a staffing requirement, which averaged eight hours per week. A substantial part of residents' time was spent on drug distribution and patient care activities, such as medical rounds and patient counseling. The most common benefits reported were paid time off, health and medical coverage, and reimbursement for specific professional expenses. Ultimately, the creation of an Internet-accessible electronic database will maximize the availability and timeliness of such information and minimize the cost and labor involved in updating currently available resources. A survey of ASHP-accredited residency programs yielded data that provide a valuable supplement to the information in ASHP residency directories.

Accreditation↗

PubMed2006

Identification of potential drug-related problems in the elderly: the role of the community pharmacist.

OBJECTIVE: The high prevalence of multiple drug use combined with age-related changes in pharmacokinetics and pharmacodynamics makes older adults more vulnerable to drug-related problems (DRPs). This pharmacy-based study was performed to identify potential DRPs from prescription records of the elderly and the role of the pharmacist in this process. METHOD: The study was performed from June 2002 to February 2003 in 16 community pharmacies in the Netherlands. Medication assessment of elderly patients aged 65 and over using six or more drugs concomitantly took place on the date of inclusion. Ten types of potential DRPs, grouped into three categories, were determined. The three groups were patient-related, prescriber-related or drug-related potential DRPs. We looked at the occurrence, nature and determinants of differential potential DRPs. RESULTS: The mean number of prescriptions per patient was 8.7. In total 3.9 potential DRPs per elderly person were identified. The distribution of the potential DRPs over the three categories was: patient related 4.7%, prescriber related 55.7% and drug related 39.6%. Use of NSAIDs (OR 29.9; 95% CI 4.1-219) and digoxin (OR 15.7; 95% CI 4.9-50.5) were associated with the highest risk for potential DRPs. CONCLUSION: In this vulnerable group of elderly patients potential DRPs frequently occur. Community pharmacists can play an important role in the identification, assessment and prevention of potential DRPs in the elderly. It is useful to investigate which part of potential DRPs can be avoided by the intervention of the community pharmacist in collaboration with the prescriber and the patient.

Aged↗

PubMed1994

Clinical use of ganciclovir during renal failure and continuous hemodialysis.

OBJECTIVE: Data is scarce concerning ganciclovir, used in CMV-related diseases in transplant patient with renal failure, especially when dialysis is necessary. DESIGN: Prospective trial. SETTING: Intensive care unit in a university hospital, and pharmacy laboratory. PATIENTS: pharmacokinetics were obtained in 3 patients undergoing continuous veno-venous hemodialysis (CVVHD) (PAN 69). INTERVENTIONS: HPLC measurements of plasmatic and ultrafiltrated ganciclovir were determined at 17 times intervals after a 5 mg/kg every 48 h dosage. RESULTS: Peak and trough concentrations were respectively 16.1 +/- 2.4 and 5.5 +/- 0.5 mg/l, sieving coefficient 0.75-0.95, and volume of distribution at steady state 0.64 +/- 0.09 l/kg, half life (beta phase) 18.6 +/- 1.8 h. No direct toxicity, or CMV-related death occurred. CONCLUSION: Plasma concentrations were higher than the ID 90. A dosage of 5 mg/kg/48 h of ganciclovir could be used during CVVHD, and ideally adjusted to monitoring of plasma drug levels.

Chromatography, High Pressure Liquid↗

PubMed1984

Preparing the P & T committee agenda for new drug requests.

Preparing an agenda is an important element in conducting an effective P & T Committee meeting. A key responsibility of P & T Committee members is reviewing the rationale for formulary requests. Therefore, it is generally an agenda item. This article describes a process for planning, preparing, and distributing agenda materials for a committee meeting. A specific format and sequence for reviewing new drugs for formulary admission and criteria for selecting new drugs are discussed.

Formularies, Hospital as Topic↗

PubMedDate not supplied

[FARMAC: a program designed for monitoring the prescription of antimicrobials in hospitals].

INTRODUCTION: The use of computer programs for monitoring the prescription of antimicrobial agents in hospitals is of paramount importance in the incorporation of electronic databases developed and analyzed by several hospital committees, including the following: infection control; pharmacy; morbidity and mortality; and quality assurance committees, as well as other key areas or departments such as pathology, pharmacy, microbiology, radiology, or hospital administration. OBJECTIVE: To describe the development and use of an "information system" employed for monitoring the prescription of antimicrobial agents in hospitalized patients. MATERIAL AND METHODS: A printed format was developed in order for physicians to ask for authorization for the use of restricted antimicrobial agents (i.e. third-generation cephalosporins and other newly introduced beta lactams, fluoroquinolones, antifungals, antivirals, etc). A computer program, "FARMAC", was designed using the Dbase IV program. FARMAC contemplates the presentation on a screen of a main menu allowing for the use of several options: admissions; antibiotic changes; consultations; discharges; hospital transfers; reports, and distribution. The reports are generated from the menu and appear on the screen or are printed in representative tables and figures. Generally speaking, the system processes information on the use of antimicrobial agents, files information, allows for consultation, of the information and generates reports quickly and efficiently. RESULTS: The presentations were defined on screen, taking into account the space needed in order to avoid an inadequate distribution of the messages, therefore obtaining an optimal image. A database was created defining the necessary fields for storing information with reference to patients and usage patterns of restricted antimicrobial agents. DISCUSSION: The development of an information and surveillance system on the prescription of antibiotics allows for consulting updated information, making the data analysis easier for decision making. Its use will allow for surveying tendencies and usage patterns of controlled and non-controlled antimicrobial agents.

Anti-Infective Agents↗