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PubMed1992

Storage of vaccines in the community: weak link in the cold chain?

OBJECTIVE: To assess quality of storage of vaccines in the community. DESIGN: Questionnaire survey of general practices and child health clinics, and monitoring of storage temperatures of selected refrigerators. SETTING: Central Manchester and Bradford health districts. SUBJECTS: 45 general practices and five child health clinics, of which 40 (80%) responded. Eight practices were selected for refrigeration monitoring. MAIN OUTCOME MEASURES: Adherence to Department of Health guidelines for vaccine storage, temperature range to which vaccines were exposed over two weeks. RESULTS: Of the 40 respondents, only 16 were aware of the appropriate storage conditions for the vaccines; eight had minimum and maximum thermometers but only one of these was monitored daily. In six of the eight practices selected for monitoring of refrigeration temperatures the vaccines were exposed to either subzero temperatures (three fridges) or temperatures up to 16 degrees C (three). Two of these were specialised drug storage refrigerators with an incorporated thermostat and external temperature gauges. CONCLUSION: Vaccines were exposed to temperatures that may reduce their potency. Safe storage of vaccines in the clinics cannot be ensured without adhering to the recommended guidelines. Provision of adequate equipment and training for staff in maintaining the "cold chain" and the use and care of equipment are important components of a successful immunisation programme.

Child↗
PubMed1987

Structural determinants of cationic amphiphilic amines which induce clear cytoplasmic vacuoles in cultured cells.

Disobutamide (D), an antiarrhythmic cationic amphiphilic amine (CAA), was withdrawn from clinical testing when clear cytoplasmic vacuoles (CCV) were found in the rat and dog during toxicity studies. To delineate the structural determinants of amines that induce CCV, we exposed cultured rat urinary bladder carcinoma and rabbit aorta muscle cells to numerous cationic drugs and chemicals and examined cells by phase light microscopy. The cationic moiety of these CAA was responsible for the induction of CCV. The very potent inducers were compounds that had two strongly basic amine (cationic) centers. The bis tertiary amines were particularly potent inducers. Aliphatic diamines of minimal lipophilicity-induced CCV, thus showing that an "amphiphilic" structural feature, though present in many CAA drugs, is not necessary for CCV induction. The distance between the two cationic centers was irrelevant to the induction of CCV. These results support the concept that CCV are a manifestation of intracellular (e.g., intralysosomal) drug storage. These structural delineations will be useful in future drug design and for further understanding of drug-cell interactions. Based on these findings, we were able to synthesize an antiarrhythmic CAA which did not induce CCV.

Amines↗
PubMed1978

Studies of erythrocyte membrane loss produced by amphipathic drugs and in vitro storage.

Four amphipathic drugs, primaquine, propranolol, chlorpromazine and tetracaine, were used to cause endocytosis in glucose-depleted red cells, and the relative reduction of membrane surfaces was measured by the toluidine blue (TB) method. The TB measurements correlated well with the observed electron microscopic alterations. In vitro blood storage studies indicated loss of cell membrane during storage correlated with decreasing uptake of TB by the red cells. Regeneration of cellular ATP with adenosine did not always restore TB uptake by the cells. Loss of red blood cell membrane either by exocytosis or endocytosis may occur during normal in vivo or in vitro ageing, and may be increased in pathological states or by the action of drugs.

Adenosine Triphosphate↗
PubMed2004

Knowledge and perceptions of drug quality among drug sellers and consumers in Lao PDR.

In most developing countries, including the Lao People's Democratic Republic (PDR), high prevalence of low quality drugs has been reported. The aim of this study was to explore knowledge and perceptions regarding drug quality among drug sellers and consumers, in Savannakhet province, Lao PDR. Quantitative and qualitative methods were used. Fifty-nine drug sellers and 278 exit customers were interviewed. Eight focus group discussions with drug sellers and community members were conducted. There was inadequate scientific drug knowledge among drug sellers. Only a few customers were aware of the existence of low quality drugs. Only one drug seller knew what constitutes a good quality drug according to the given criteria, and only two drug sellers knew the correct temperature for drug storage. Forty-four per cent had correct knowledge on drug labelling and 73% could read the expiry date. Fifty-eight per cent stated that they bought some drugs from unauthorized sources. Both drug sellers and consumers also elaborated on a local definition of drug quality. They determined drug quality by its perceived efficacy in the sense that a drug is good if it takes the disease away. They also trusted the responsible authorities not to provide them with low quality drugs. A majority of the consumers (73%) did not worry about the quality of the drugs, their greatest problem being financial constraints. People living in urban districts had significantly more knowledge on aspects of drug quality than those living in rural and remote areas. The limitations in scientific knowledge among drug sellers and the low awareness among consumers may contribute to the continued existence of low quality drugs. Government interventions through training of drug sellers and drug information for lay people are suggested.

Adolescent↗
PubMed1981

Amiodarone keratopathy: drug-induced lipid storage disease.

Therapeutic administration of amiodarone, an antiarrhythmic drug, to eight patients resulted in the formation of vortex-like figures within the anterior cornea. Clinical examination disclosed no visual loss or other ocular abnormality attributable to the drug. In one patient, light and transmission electron microscopy of corneal epithelium, bulbar conjunctiva, and cataractous lens revealed complex lipid deposits within lysosome-like intracytoplasmic inclusions in corneal, conjunctival, and lens epithelium, conjunctival fibrocytes, and conjunctival vascular endothelium. Amiodarone keratopathy is compared clinically and morphologically with the corneal alterations seen in Fabry's disease and in chloroquine use as an example of a drug-induced lipid storage disorder.

Aged↗
PubMed1985

The effects of drug counseling and other educational strategies on drug utilization of the elderly.

The medication behavior of 183 elderly apartment residents was assessed for problems in medication regimen compliance, regimen comprehension, drug interactions, and drug storage. Following an initial assessment, the residents were given instructions in drug utilization and access to drug counseling was provided intermittently for almost 2 years. Approximately 1 year after the educational intervention a final assessment of a sample of 39 residents, who initially were found to have the greatest numbers of problems, revealed a significant 11% decrease in the number of prescriptions taken and a significant 39% decrease in the number of medication behavior problems. The initial average was 3.7 prescriptions currently used and 2.7 problems per person that subsequently decreased to 3.3 prescriptions and 1.6 problems for the same residents at the end of the study. Results suggest that pharmacist consultation provides an effective health prevention strategy in elderly resident settings. Educational strategies used in this study appear to be well adapted for use with elderly home-based populations.

Aged↗
PubMed2006

Pharmacokinetics and mammary elimination of imidocarb in sheep and goats.

The pharmacokinetics and mammary excretion of imidocarb dipropionate, a therapeutic/prophylactic agent against a variety of tick-borne hemoparasitic diseases in domestic animals, have been investigated in sheep and goats. A commercial formulation of imidocarb di-propionate was injected i.m. at a single dose of 3 mg/kg of body weight in 7 mature lactating ewes and 8 lactating does in good health. Blood samples were collected for 48 h after administration and milk samples were collected every 12 h for 10 d. A weak cation-exchange solid-phase procedure was used to remove imidocarb from plasma. A hexane/isoamyl alcohol liquid-liquid procedure was adopted to extract the drug from the milk of sheep. The same method was used for goat milk after exposing the matrices to enzymatic digestion. The extracted samples were analyzed by HPLC. The i.m. disposition kinetics of imidocarb in the 2 species showed significant differences in the rate of elimination (0.0075 +/- 0.002 and 0.025 +/- 0.004 L/h in sheep and goats, respectively), being faster in ewes than in does. Nevertheless, a smaller area under the concentration-time curve (12.21 +/- 0.76 and 9.49 +/- 0.54 microg/mL per h in sheep and goats, respectively), a larger volume of distribution (4.18 +/- 0.44 and 7.68 +/- 0.57 L/kg in sheep and goats, respectively), and a longer mean residence time (9.07 +/- 0.77 and 14.75 +/- 2.20 h in sheep and goats, respectively) were found in goats, suggesting a more rapid and effective drug storage in tissues during the first 48 h after the injection. The concentrations of imidocarb in milk of both species were higher than in plasma. However, a fast passage through the blood-milk barrier and a high storage of imidocarb were observed in the milk of ewes, whereas the drug concentrations were not as high nor was the extent of drug penetration from blood to milk as great in the milk of goats (AUC(milk 0-48)/AUC(plasma 0-48) = 2.5 +/- 0.45 and 1.26 +/- 0.27 in sheep and goat, respectively). Despite the differences in pharmacokinetic behavior, and considering the sensitivity of pathogens to imidocarb, the same dosage regimen can be used for clinical efficacy against Babesia spp. infection in both species. In contrast, the differences in depletion of imidocarb residue in milk and the large variability in mammary drug elimination found in goats suggests that great care should be taken in defining the withdrawal time in small ruminant dairy species.

Animals↗
PubMed2004

Preventing medication errors.

(1) 319 adverse effects due to errors occurring during the drug use process, as well as errors spotted before any incident, were collated in French hospitals in 2000-2001 and characterised for their type, cause, contributing factors, and consequences. (2) All stages of the drug use process were implicated in errors: prescription, transcription, preparation, dispensing, administration, and drug monitoring. (3) Dosing errors (often overdose) were the most common. (4) The main causes were poor practices and inadequate knowledge, followed by problems of communication, packaging and confusion over drug names. (5) Contributing factors included failure to follow rules and procedures, inadequate communication or training, interruptions and distractions, and drug storage on the wards. (6) The prevention of adverse effects linked to drug errors requires a commitment to record all problems, analyse them in depth, and enforce safe working practices for all health professionals.

Drug-Related Side Effects and Adverse Reactions↗
PubMed1989

Covalent and noncovalent protein binding of drugs: implications for hepatic clearance, storage, and cell-specific drug delivery.

This review deals with the mechanisms by which the liver disposes of drugs that are covalently or noncovalently associated with proteins. Many drugs bind to plasma proteins such as albumin (mainly anionic compounds) and alpha 1-acid glycoprotein (cationic compounds). Nevertheless, the liver is able to clear such drugs efficiently from the circulation because of intrahepatic dissociation of the drug-protein complex. This clearance may involve spontaneous dissociation because of progressive removal of the unbound drug during liver passage, a process that can be rate limiting in hepatic uptake. Alternatively, the porous endothelial lining of the hepatic sinusoids may allow extensive surface interactions of the drug-protein complexes with hepatocytes, leading to facilitation of drug dissociation. Binding to plasma proteins and intracellular proteins in the cytoplasm or cell organelles is an important factor determining the hepatic storage and elimination rate of drugs. Drugs noncovalently associated with glycosylated proteins, which can be endocytosed by various liver cells, are not coendocytosed with such proteins. However, covalently bound drugs can be internalized by receptor-mediated endocytosis, which permits specific targeting to hepatocytes, endothelial cells, Kupffer cells, and lipocytes by coupling to different glycoproteins that are recognized on the basis of their terminal sugar. The endocytosed drug-carrier complex is routed into endosomes and lysosomes, where the active drug is liberated by cleavage of acid-sensitive linkages or proteolytic degradation of peptide linkers. This concept has been applied to antineoplastic, antiparasitic, and antiviral drugs.

Animals↗
PubMed1996

Drug-induced lysosomal storage of sulphated glycosaminoglycans.

1. Certain compounds (e.g., the immunomodulator tilorone and congeners) are able to induce lysosomal storage of sulphated glycosaminoglycans (GAG), thus, producing cytological and biochemical alterations reminiscent of the inherited mucopolysaccharidoses. The drug-induced GAG storage has been studied in cultured fibroblasts of several species and in rats, and it is likely to occur also in humans. 2. The cytological hallmarks of GAG storage are enlarged lysosomes congested with material that is intensely stained by cationic dyes. With respect to fixation techniques, one has to keep in mind that the GAGs are highly water-soluble and are leached during conventional fixation and tissue processing. Biochemically, the elevation of GAG contents in tissues and cultured fibroblasts is due to storage of dermatan sulphate, predominantly. 3. The molecular structure of the potent inducers of GAG storage is characterized by a planar tricyclic aromatic ring system that is symmetrically substituted with two side chains of 4-5 sigma bond length, each carrying a protonizable nitrogen atom. The lysosomal storage of GAG is accompanied by lysosomal accumulation of the inducing drug, with the molar ratio of drug to GAG-disaccharide unit amounting to > 1:1. The reversibility of GAG storage is rather slow. 4. The pathogenic mechanisms underlying the drug side effects are discussed and the following hypothesis is put forward: The compounds in question are lysosomotropic weak bases. They get trapped in the acidic lysosomes and accumulate highly there. Physicochemical data suggest that the drugs form complexes with the sulphated GAGs, particularly with dermatan sulphate: The positively charged nitrogen atoms of the drug side chains interact with the negative charges of sulphate and carboxy groups of the GAGs, thereby crosslinking at least two GAG helices. Moreover, the interlinking drug molecules form parallel stacks resulting from interaction of the aromatic pi-electrons of the planar ring systems. This further stabilizes the complexes. The GAGs within the complexes are thought to be resistant to the degrading lysosomal enzymes. 5. Drug-induced GAG storage has not been directly demonstrated in man. Yet, clinical reports on keratopathy and basophilic cytoplasmic inclusions in blood lymphocytes of tilorone-treated patients suggest that this drug side effect may also occur in man.

Adjuvants, Immunologic↗
PubMed2001

Drug therapy in the elderly: what doctors believe and patients actually do.

AIMS: To examine the medication adherence among old persons living in their own homes, to assess their knowledge of their medication, and to indicate target areas for intervention. METHODS: A cross-sectional study of data collected from randomly selected samples of 348 persons, aged 75 years recruited from a population-based register in the municipality of Aarhus, Denmark. Information on all drugs was collected from the subjects during a home visit, and their drug storage was examined. Information was collected from the general practitioners (GP). The measures of adherence were scores of agreements between the GPs' lists and the subjects' actual drug consumption. RESULTS: We found disagreement between the drug information collected from the study population and from the GPs: concerning drugs in 22% of the study-population, concerning doses in 71%, and concerning regimens prescribed by the GP in 66%. Twenty-four percent stated that they did not always follow prescriptions. Most of the deviations from prescriptions were toward lower doses and less frequent drug intake. The drugs most often involved in deviations were hypnotics, analgesics, bronchodilators and diuretics. Sixty percent of the participants knew the purpose of medication, and 21% knew the consequences of omission of the drugs. Less than 6% of the subjects knew about the toxic risks, side-effects, or potential drug interactions. The participants' knowledge of the drugs was positively associated with their adherence. We found a correlation between an increased number of prescribed frequency of drug intake per day and deviation from the regimen (r = 0.25, P = 0.01). There was a positive association between nonadherence and the use of three or more drugs (odds ratio (OR) 2.5; 95% confidence interval (CI) 1.5,4.1), prescriptions from more than one doctor (OR 2.5; 95% CI 1.3,4.8), and probability of dementia (OR 9.0; 95% CI 1.1,72.5). Moreover compliance aids facilitated adherence (OR 4.4; 95% CI 1.6,12.3). Persons living alone were more prone to medication errors (OR 2.0; 95% CI 1.1,3.5). CONCLUSIONS: A differentiated evaluation of adherence by considering the drug, the dose, and the regimen separately produced quantifiable data concerning the subjects' medication habits. Non-adherence ranged from 20 to 70% depending on the measuring method. The participants' knowledge of the treatment was poor. Our results suggest that better information on medication and the use of compliance aids may prevent nonadherence. Special attention should be paid to persons receiving three or more drugs, living alone, receiving drugs from other doctors, and to persons with predementia symptoms, as they are at higher risk of nonadherence.

Aged↗
PubMed1998

Solubilization and interaction of sulindac with beta-cyclodextrin in the solid state and in aqueous solution.

A sulindac-beta-cyclodextrin complex was obtained by the coprecipitation method. Kneaded solids and physical mixtures were also prepared. The complex was shown by x-ray powder diffraction to be noncrystalline whereas pure drug and any of the other sulindac-beta-CD system were crystalline. the endothermic peak of sulindac due to the fusion of drug disappeared in DSC thermograms for the coprecipitate product, which confirmed the interaction between sulindac and beta-CD in the solid state. After a 1-year storage drug crystals could not be observed by x-ray diffractometry, which indicated that the complex formed was stable. The complex showed the fastest dissolution rate which might be attributed to the high-energy noncrystalline state and the inclusion complex formation in solution. UV spectra were modified and the apparent solubility of the drug increased with the addition of beta-CD, which confirmed the interaction between sulindac and the ligand in solution. The apparent stability constant, K1:1, for the complex at pH 2 and 25, 30, and 37 degrees C was 340, 220, and 160 M-1, respectively, which confirmed the influence of temperature on the complex stability. The value of K1:1 at pH 6 and 25 degrees C was 139 M-1, which indicated that the complex is formed easier with the non-ionized sulindac. The enthalpy change, delta H degree, showed that the binding process is exothermic.

Chemical Phenomena↗