[Standards of natural loss and production expenditure of drugs in pharmaceutical storage. 2].
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Drug Packaging↗
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Practice guidelines for community-based parenteral anti-infective therapy.
Practice guidelines for community-based parenteral anti-infective therapy (CoPAT) have recently been formulated in several countries. These guidelines emphasize the importance of teamwork and the interdisciplinary nature of CoPAT, and they use similar criteria for patient selection and evaluation, anti-infective agent selection and administration, and clinical monitoring. There are now guidelines or standards addressing the roles and responsibilities of the physician, nurse, and pharmacist in the delivery of CoPAT, and home care standards that address issues such as drug storage and preparation, treatment planning, and monitoring of ongoing care.
Anti-Bacterial Agents↗
Baclofen poisoning in children.
Six cases of acute baclofen (LIORESAL) overdose in children are reported. Rapid onset of central nervous system depression with respiratory depression was present to a greater or lesser degree in all patients. Agitation, convulsions and ataxia were also seen. The entire cohort responded to supportive management. An accurate assessment of the quantity of drug ingested was not possible. The need for education on safe drug storage and disposal is emphasized.
Ataxia↗
Providing clinical pharmacy services in an AIDS--oncology ambulatory-care clinic.
The activities of a pharmacist in an ambulatory-care AIDS-oncology clinic are described. In December 1984, the chief of the AIDS Activities Division of San Francisco General Hospital's Department of Medicine hired a clinical pharmacist to develop the pharmacokinetics sections of investigational drug protocols, provide drug therapy consultations, and supervise the reorganization of the drug storage and inventory system. Since joining the clinic staff, the pharmacist has become active in a variety of clinical, research, and educational activities. The pharmacist conducts weekly medication refill clinics and developed drug information sheets for clinic patients and health-care professionals. The pharmacist also supervises timely collection of blood samples for serum drug concentration determinations and helps to prepare the investigational drugs for dispensing. The pharmacist developed policies and procedures for the safe handling of antineoplastic agents and standardized the accountability procedures for investigational drugs. The pharmacist also serves as a liaison between the clinic and the hospital's department of pharmacy and as a preceptor of pharmacy students and residents. A clinical pharmacist can make an important contribution to the research and patient-care activities in an AIDS-oncology clinic.
Acquired Immunodeficiency Syndrome↗
[Drug supply to nursing homes for the aged].
BACKGROUND: The Federal Government of Germany intends to revise the relevant legislation for pharmacies to improve supply of medicines for inhabitants of nursing homes. According to this initiative pharmacies would sign agreements with nursing homes determining the supply order, service and quality of supply. Today, such a contract is prohibited on the basis of current legislation. The local inspectorates for pharmacies in North Rhine-Westphalia checked on the current supply and initiated an investigation. METHOD: The local inspectorates for pharmacies performed structured interviews with senior managements of 35 nursing homes in four cities of North Rhine-Westphalia focussing on service and quality of supply of drugs by pharmacies. RESULTS: 80 % of nursing homes were content with the regular service provided by retail pharmacies today. Additional information and consultation by pharmacists for managements, inhabitants and nurses about drug use is only provided in special cases, e. g. after detailed requests. CONCLUSIONS: To improve drug safety in nursing homes, it makes sense and it is necessary to revise the legislation for pharmacies and to make contracts possible in which the extent of service provided is laid down. Information, consultation and inspection of drug storage should be an essential part of future contracts.
Aged↗
Evidence for lysosomotropism of memantine in cultured human cells: cellular kinetics and effects of memantine on phospholipid content and composition, membrane fluidity and beta-adrenergic transmission.
Memantine, an amantadine derivative, is therapeutically used for the treatment of various neurological and psychiatric disorders such as Parkinson's disease, spasticity, and dementia. Pharmacokinetics of memantine and its effects on phospholipid content and composition, on membrane properties and functions such as fluidity and beta-adrenergic transmission were studied in cultured human fibroblasts and macrophages. The kinetic behaviour of memantine was characteristic for a lysosomotropic drug. Fibroblasts exposed to 14C-memantine in the microM range accumulated the drug up to 200 fold above initial medium concentrations. Lysosomal drug storage was proven by indirect evidence and by analyses of subcellular fractions. Repetitive exposure to memantine resulted in a cumulative uptake. While memantine uptake after single exposure was fully reversible, the rate and extent of release of chronically accumulated drug was reduced but could be enhanced by the addition of unlabelled memantine or ammonium chloride to the medium. Chronic, but not single, exposure to memantine above 10 microM resulted in a concentration dependent phospholipid accumulation and in a shift in the phospholipid composition. There was an overproportionate increase in phosphatidylinositol at the expense of phosphatidylserine and sphingomyelin. Chronic exposure of cultured cells to memantine increased fluidity in the superficial layers of the plasma membrane and reduced the isoproterenol-stimulated cAMP-response without affecting beta-adrenoceptor density. All these findings were compatible with the kinetic behaviour and the effectiveness expected of a weak lysosomotropic drug.
Anisotropy↗
Rifampin in drug-incorporated diet: effect of duration and temperature of storage. Relevance to drug-susceptibility testing in mice inoculated with M. leprae.
This paper is in two parts. Plasma concentrations of rifampin were assayed at 11 time points in 24 hr in mice fed one of three dosages of rifampin, either by gavage or by dietary incorporation. The drug-mixed diets had been stored for a maximum of 3 weeks at 4 degrees C or at room temperature (30 degrees C-35 degrees C). The peak concentration of rifampin produced by gavage was approximately 11/2 times higher than the maximum plasma concentration of the corresponding dosage in fresh diet. Plasma concentrations decreased with the increasing duration of storage of the drug-mixed diet, irrespective of whether the diet was stored at 4 degrees C or at room temperature. This decrease was less when the diet was stored at 4 degrees C than at room temperature. Drug levels were also assayed in another set of mice selected from ongoing drug-susceptibility experiments; these mice were fed a rifampin-incorporated diet stored at room temperature. The plasma concentrations in these mice, assayed at the time of foot pad harvest, were generally higher than in the 24-hr experiment. The harvest results from these mice were compared with the harvest results from a third set of mice, also from ongoing drug-susceptibility experiments, but fed a rifampin-mixed diet stored at 4 degrees C. Multiplication of Mycobacterium leprae in mouse foot pads was prevented by rifampin mixed in the diet at a dosage of greater than or equal to 0.003%, whether stored at room temperature or at 4 degrees C.(ABSTRACT TRUNCATED AT 250 WORDS)
Administration, Oral↗
[Drug interactions during storage of mixtures of the antacid group. II. Effect of temperature on the formation of hydrotalcite in neutralizing suspensions].
Eight antacid mixtures were stored for 110 days at 25 degrees C, 35 degrees C and 45 degrees C in the form of suspensions in water. Changes in pH were followed, and the structural changes in suspension components were studied by X-ray analysis. It has been stated that formation of hydrotalcite, the product od interaction of the mixture components depends mainly on the kind and ratio of the suspension reactants, and only to a little degree on the storage temperature.
Aluminum Hydroxide↗
Adriamycin-activated macrophages as tumor growth inhibitors.
Flow cytometry has been used to study the influence of Adriamycin- and Corynebacterium parvum-elicited cytostatic macrophages on the cell cycle of HeLa cells. Macrophages harvested from the peritoneal cavity of mice given i.p. injections of Adriamycin retain cytostatic activity for 3 to 4 days in vivo. Many of these macrophages fluoresced with the red emission spectra characteristic of Adriamycin. The decline in the presence of macrophages exhibiting red fluorescent cytoplasmic particles paralleled the loss in cytostatic activity. Drug-induced cytostatic macrophages exhibited at least as high a level of growth inhibition as did C. parvum-activated cells. In contrast to the apparent G1 block of HeLa cells which resulted from interaction wih C. parvum-activated macrophages. Adriamycin-stimulated macrophages inhibited growth in the G2-M phase characteristic of the free drug. Multiple freeze-thaw cycles removed all activity from C. parvum macrophages but had no influence on the Adriamycin-elicited effector cell activity. The data suggest that in vivo drug storage by macrophages may represent an important step in tumor cell destruction by Adriamycin.
Animals↗
Drug-induced intralysosomal storage of sulfated glycosaminoglycans (GAGs): a methodical pitfall occurring with acridine derivatives.
The present communication deals with an adverse drug action which is exerted by a series of dicationic amphiphilic compounds such as the immunomodulatory drug tilorone and congeners. The drugs induce lysosomal storage of sulfated glycosaminoglycans (GAGs) in intact organisms and in cultured cells by impairing the lysosomal GAG degradation. This impairment was proposed to be due to the formation of non-degradable GAG-drug complexes. GAGs are highly water-soluble and not preservable by aldehyde fixatives. Therefore, usually the lysosomes appear optically empty in histological preparations, unless the fixative is supplemented with a GAG-precipitating agent. When acridine derivatives were used for the induction of GAG-storage, the lysosomal storage material displayed unexpected and unsystematic variability with regard to its preservability and ultrastructure. In the present study, evidence is presented that the acridine derivatives (a) remain bound to the stored GAGs for some time after glutaraldehyde fixation; and (b) they precipitate GAGs in vitro. Thus, apart from their unwanted action in the living cell, i.e., disturbing lysosomal GAG-degradation, the drugs function as precipitants and "fixatives" for the intralysosomal GAGs. The uncontrolled persistence of the drugs after tissue fixation leads to variable degree of GAG-preservation and thus to unpredictable variability of the ultrastructure of the storage lysosomes. If this pitfall is not realized, the resulting inconsistencies may rise confusion among toxicologic pathologists who deal with drug-induced lysosomal storage disorders.
Acridines↗
The Australian Incident Monitoring Study. The "wrong drug" problem in anaesthesia: an analysis of 2000 incident reports.
Amongst the first 2000 incidents reported to the Australian Incident Monitoring Study, there were 144 incidents in which the "wrong drug" was nearly or actually administered to a patient. Thirty-three percent of the incidents involved ampoules and just over 40% syringes; in over half of the latter the syringes were of the same size, and also, in over half, they were correctly labelled. In 81% of the 144 incidents the "wrong drug" was actually given. This was more common with syringes (93%) than ampoules (58%). Thus the most common error was actually giving the wrong drug from a correctly labelled syringe. The most common drug involved was a muscle relaxant in both ampoule and syringe incidents. In 74% of all reports, there was the potential for serious harm to the patient; however no deaths were reported. Factors which contributed significantly to the incidents were similar appearance, inattention and haste. "Failure of communication" was a significant factor in syringe incidents when two or more staff were involved. The only significant factor which minimised the outcome was rechecking of the syringe or drug ampoule before giving the drug. Strategies suggested to address the "wrong drug" problem include education of staff about the nature of the problem and the mechanisms involved; colour coding of selected drug classes for both ampoules and syringes; the use of standardised drug storage, layout and selection protocols; having a drawing up and labelling convention; and the use of checking protocols.
Anesthesia↗
Investigation of systems to prevent diversion of opiate drugs in general practice in the UK.
BACKGROUND: Statutory regulations govern the procedures that must be followed by general practitioners (GPs) in the UK to minimise the risk of diversion of prescribed opiate drugs for illicit use. However, evidence presented at the trial of Harold Shipman, a GP convicted of murdering patients with diamorphine, suggests that the regulations and monitoring of GPs' prescribing are failing. AIM: To assess the policies followed by general practices in Leicestershire and Rutland with regard to the controlled drugs regulations. METHODS: A semi-structured interview was administered to a purposeful sample of lead GPs to explore how their practices applied the regulations. The controlled drugs registers and drug storage facilities in these practices were inspected. A questionnaire was sent to all the remaining practices to seek information about their application of the regulations, any concerns they had about the regulations, and any suggestions for improving them. RESULTS: Of the 142 general practices in Leicestershire, the lead GP in 14 took part in the interviews. Respondents expressed dissatisfaction with current policies including the design of controlled drug registers, and generally supported the reintroduction of an inspection scheme. Ninety (70.9%) of the 127 practices to whom the questionnaire was sent responded and, of these, 31 (34.4%) no longer held a supply of controlled drugs. Those that did hold controlled drugs indicated concern about the regulations, confusion about some aspects including the return and disposal of unused drugs, and a desire for advice and support in the implementation of the regulations. Forty two of the 59 respondents who held a supply of controlled drugs (71.2%) would welcome regular inspection. CONCLUSION: GPs are confused about the controlled drugs regulations and have little support in implementing them. The suspension of inspection schemes has reduced the amount of advice and support available to them and, in consequence, the regulations are interpreted differently in different practices. These findings are cause for concern about the risk of diversion of controlled drugs, and illustrate how patient safety systems can decay when they are not maintained.
Drug and Narcotic Control↗
Documentation of chemotherapy infusion preparation costs in academic- and community-based oncology practices.
Significant changes in Medicare reimbursement for outpatient oncology services were proposed as part of the Medicare Modernization Act of 2003. The purpose of this study was to identify the "true cost" associated with drug-related handling for the preparation and delivery of chemotherapy doses to estimate the impact of changing reimbursement schema by Medicare. Two academic medical outpatient infusion centers and 2 community cancer centers provided data used to estimate all costs (excluding drug cost) associated with the preparation of chemotherapy doses. The data included both fixed costs (drug storage, space, equipment, and information resources) and variable costs (insurance management, inventory, waste management, pharmacy staff payroll, supplies, and shipping). The average cost for the preparation of chemotherapy doses across all sites was dollar 34.27 (range, dollar 32.08-dollar 41.23). A time-and-motion study was also performed to determine what tasks were conducted by pharmacy staff and how much time was spent in the preparation of the top 15 chemotherapeutic drugs and regimens used in the 4 sites. Data from the 4 centers was projected to show that if 3,990,495 million chemotherapy infusions were administered to a national Medicare population in 2003, when multiplied by the average cost of preparation for infusions determined by the current study (dollar 34.27), the estimated total annual cost to Medicare for chemotherapy preparation by pharmacists is dollar 136,754,263.65. The pharmacists spent most of their days (90% or more) performing tasks directly related to the preparation of these agents. These data provide scientific support for the consideration of appropriate reimbursement for chemotherapy services provided by pharmacists to Medicare beneficiaries.
Academic Medical Centers↗
Pharmacokinetics of secobarbital in rabbit.
The pharmacokinetic study of secobarbital in the rabbit utilizing gas chromatography (GC) indicated a correlation between blood levels and brain tissue levels; and that the distribution of the drug appears to be more complex than a first order process is suggested by the compartmental simulation midel. The liver and kidney which eliminate the drug into bile and urine, respectively, tend to follow first order elimination kinetics more closely than those which act as depots for drug storage such as muscle and fat. The two dose levels of secobarbital indicate the same relationship with blood and tissues, therefore an increase or decrease in the dosage has no effect on the pharmacokinetics of secobarbital. The termination of action of secobarbital is due to the combination of rapid uptake by liver and its disposition there and a slower uptake by muscle. Computer simulation of secobarbital distribution has strongly suggested the elimination of this drug in bile and that the rebound rise in liver amy be due to enterohepatic circulation.
Adipose Tissue↗
Information contents of drug advertisements: an Indian experience.
OBJECTIVE: To critically analyze the drug information contained in Indian pharmaceutical advertisements. DESIGN: Analysis of pharmaceutical advertisements supplied by drug representatives (DRs) to prescribers from July 1, 1995, to June 30, 1996. SETTING: A university-affiliated urban teaching hospital in India. PARTICIPANTS: 585 pharmaceutical ad pamphlets. MAIN OUTCOME MEASURES: The ads supplied by DRs to physicians in different clinical departments of the hospital were collected. These were distributed to different systems/categories and a special reference to fixed-dose drug combinations was given. The drug information contained in these ads was evaluated by using a checklist, framed by incorporating the World Health Organization ethical guidelines for medicinal drug promotion and some relevant items from other studies. RESULTS: The most frequently occurring ads were for antimicrobial agents. The ads on fixed-dose drug combinations constituted 37.9% of the total. More than 85% of the ads mentioned the generic name, brand name, contents, and pharmaceutical dosage forms, as well as the name and address of the company. The information concerning adverse effects, precautions, contraindications, warnings, major interactions, ingredients known to cause problems, pharmacology, drug overdose, references, drug storage, and cost was present in less than 40% of these ads. CONCLUSIONS: There has been inadequate information in pharmaceutical ads supplied by DRs to the physicians in India. The current scenario could be improved by formulating some definite legislative guidelines for the minimum level of information to be included in pharmaceutical ads and adhering to that legislation.
Advertising↗
Family physicians' preferences for computerized decision-support hardware and software.
BACKGROUND: While computers are now widely used by family physicians for billing and patient registration purposes, their use as decision-support tools is still quite limited. The purpose of this study was to determine the current use of computer hardware and software by family physicians, and the characteristics these physicians desire in computerized decision-support hardware and software. METHODS: A cross-sectional survey of a random sample of 250 Michigan family physicians was undertaken in mid-1995. These physicians were asked about their current use of a variety of computer hardware and software. They were also asked to rate the value of different kinds of decision-support information potentially available by computer. The survey instrument also gathered the family physicians' preferences for design factors (both hardware and software), such as the size of a computer, the time needed to access information, and the frequency of updates. RESULTS: Word processing on desktop computers and hospital information systems are the most widely used computer applications by family physicians. Physicians are most interested in computer-based information on drugs, storage and generation of patient education materials, and accessing treatment recommendations. Most feel that semiannual or annual updates of information are adequate, and would like a uniform interface. A high percentage of physicians (84.5% of all physicians and 94.1% of younger physicians) stated that they would consider carrying a handheld computer. CONCLUSIONS: There is significant interest in several types of clinical decision-support software. Based on the results of this study, such software should have following characteristics: (1) be available for handheld as well as networked and desktop computers, (2) include drug information (particularly warnings, interactions, and side effects), (3) include overviews of treatment recommendations, (4) include patient education materials, and (5) have a uniform user interface and be updated at least annually.
Adult↗
Methamphetamine and amphetamine concentrations in postmortem rabbit tissues.
The feasibility of detecting methamphetamine and its major metabolite, amphetamine, in postmortem tissues over a 2-year period was examined. It is important to determine if the abuse and toxic effects of drugs can be proved from evidence found in decayed, submerged, or stained tissue materials. The blood, urine, liver, skeletal muscle, skin and extremity bones from rabbits given methamphetamine intravenously were kept at room temperature, under 4 different conditions: sealed in a test tube, dried in the open air, submerged in tap water and stained on gauze. Methamphetamine was present in all the samples, with slight change in concentration in case of sealed and air dried tissues. Changes varied in bones kept in water. There were considerable decreases in methamphetamine in blood and urine stains. Despite long term storage, drug abuse and/or toxicity could be determined, in all tissues examined.
Amphetamine↗
Findings from the ISMP Medication Safety Self-Assessment for hospitals.
BACKGROUND: Hospital medication practices should be assessed, awareness of the characteristics of a safe medication system heightened, and baseline data to identify national priorities established. DESIGN: A cross-sectional survey of U.S. hospitals (N = 6,180) was conducted in May 2000. The survey instrument contained 194 self-assessment items organized into 20 core characteristics and 10 larger domains. Hospitals were asked to voluntarily submit their confidential assessment data to the Institute for Safe Medication Practices (ISMP) for aggregate analysis. METHOD: A weighting structure was applied to the individual items and used to calculate core characteristic scores, domain scores, and overall self-assessment scores. These scores were then compared to identify areas most in need of improvement. RESULTS: The 1,435 participating hospitals scored highest in domains related to drug storage and distribution; environmental factors; infusion pumps; and medication labeling, packaging, and nomenclature issues. These hospitals scored lowest in domains related to accessible patient information, communication of medication orders, patient education, and quality processes such as double-check systems and organizational culture. CONCLUSIONS: Enormous opportunities exist to improve medication safety, especially in domains related to culture, information management, and communication.
American Hospital Association↗