Retinopathy of prematurity: current risk management issues.
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Biomedical subjects
Publications and source records attributed to P A Greve.
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The increased complexity of pharmacotherapeutics and the expanded role of pharmacists in the drug-use process may bring about an increased liability exposure for failure to conform to a professional standard of care. Therefore, a survey of 51 state pharmacy practice acts was conducted: (1) to establish a nationwide statutory definition of pharmacy practice, and (2) to outline possible use of the statutes in civil and administrative law. Twenty percent of state statutes contain no definition of pharmacy practice. Of the remaining 41 states, dispensing (97.5 percent), compounding (92.5 percent), interpretation and evaluation of prescriptions (68.2 percent), and consultation (73 percent) are legally defined. Pharmacokinetic consultation, drug administration, pharmacist prescribing, and pharmaceutical research are defined in one, seven, four, and one state(s), respectively. Pharmacists may face legal responsibilities from both the courts and state boards of medical and pharmacy practice. Aggressively updating the statutes and regulations to reflect contemporary pharmacy practice may provide a mechanism for a defense in court litigation and regulatory action.
Hexachlorobenzene (HCB) has been found in clearly detectable concentrations in surface waters, sediments, fish, products of animal origin, animal feed, human tissues, human milk and certain pesticide formulations. To a minor extent, crops cultivated on HCB-contaminated soils can also contain HCB. The average daily intake of HCB in 1976-1978, estimated from a total-diet study, was 1 microgram/person (maximum value: 12 micrograms/person). Since the early 1970s many measures have been taken to minimize both environmental and human exposure to HCB. As a result, substantial decreases in HCB levels in all compartments have been achieved.
Examples of contamination of animal feed and food-stuffs of animal origin by pesticides and industrial contaminants such as hexachlorobenzene (HCB), polychlorinated biphenyls (PCBs), hexachlorocyclohexane isomers (HCHs) and tetrachloroethylene (TCE) are reported in the present paper. The need for an effective co-operation between investigators and policy makers is stressed in these examples, so that the best practical solution to the problems observed could be provided.
Ingestion of 12 g of endrin by a 49-year-old man caused convulsions persisting for 4 days, hypersalivation, hyperthermia, renal insufficiency, thrombocytopenia and recurrent hypotension. Death followed after 11 days, due to pulmonary complications (infection and haemorrhage) and hypoxaemia causing bradycardia and cardiac arrest. Endrin and dieldrin concentrations in blood 4 hours, 6 and 11 days after ingestion were respectively 450, 86 and 71 micrograms/l for endrin and 60, 19 and 19 micrograms/l for dieldrin. Dieldrin was also present, possibly because the endrin preparation contained traces of dieldrin. Endrin concentrations 11 days after ingestion were 0.071 mg/l in blood, in adipose tissue 89.5 mg/kg, in the heart 0.87 mg/kg, in the brain 0.89 mg/kg, in the kidneys 0.55 mg/kg and in the liver 1.32 mg/kg.
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The daily intake of bromide ion by humans was estimated from two total-diet studies conducted in the summer of 1976 and in the winter of 1978 and involving in each case investigation of 100 samples. The average daily intake found was 7.8 mg/person in the first study and 7.6 mg/person in the second study (with ranges of 2.9-15.0 and 1.8-17.2 mg/person/day, respectively). National surveys, covering several thousands of samples, showed that certain leafy vegetables and some herbs could occasionally contain high residues of bromide ion (greater than 200 mg/kg). An important source of these high residues is the treatment of soils with methyl bromide against nematodes. Action has been taken to minimize contamination of the human diet with bromide ion by this route.
The gas-liquid chromatographic method for the determination of bromide ion, as originally described for grain by Heuser and Scudamore, was adapted for use on lettuce, and later on products of other vegetable or of animal origin. After optimization of the ashing and derivatization conditions, 2 interlaboratory studies were carried out in The Netherlands. In the first, a preparatory study, 6 laboratories investigated freeze-dried lettuce; in the second definitive study, 8 laboratories investigated both freeze-dried and fresh lettuce. Four lots of lettuce with bromide contents ranging from about 5 to about 200 mg/kg were investigated. Average bromide contents (mg/kg) and between-laboratory coefficients of variation were 5.6 (11.0%), 13.3 (18.4%), 29.9 (8.3%), and 209 (12.8%). The results obtained are normal for the type of work and the conditions of the study. The method will be recommended for regulatory use in The Netherlands and in international organizations.
The Dutch aquatic environment was monitored from September 1969 to December 1975 for organochlorine pesticides and their metabolites, cholinesterase inhibitors, and aromatic amines. The 1,492 samples analyzed included surface water, rainwater, groundwater, and drinking water. The highest concentrations of hexachlorobenzene (HCB) and alpha- and beta-benzene hexachloride (BHC) were found in the Rhine River and its tributaries. Concentrations of the compounds in the Dutch part of the Rhine River decreased downstream. Other organochlorine pesticides and their metabolites, heptachlor, heptachlor epoxide, aldrin, dieldrin, endrin alpha- and beta-endosulfan, and sigmaDDT were detected occasionally, but only in low concentrations. Cholinesterase inhibitors and aromatic amines were always present in the Rhine River and its tributaries.
The purpose of the present study was to determine if food deprivation could modify the biological activity of hexachlorobenzene (HCB) in the rat. Male and female Wistar rats were divided into 6 groups containing 6 animals. Groups 1, 3 and 5 were fed standard control diet ad libitum for 2 weeks. For the next 4 weeks their respective diets contained 0, 20 and 100 ppm HCB. Groups 2, 4 and 6 were also fed a standard control diet for 2 weeks but at an intake of approximately 50% of those groups fed ad libitum. For the following 4 weeks food deprivation was continued but the control diets were replaced with diets containing 0, 40 or 200 ppm HCB. The parameters measured were food, body weight changes, changes in tissue weights, microsomal enzyme activity and histopathology of liver, kidneys, adrenals and pancreas. Tissue residue profiles were established for plasma, liver, brain and adrenals. Food deprivation augmented the induction of microsomal enzyme activity by HCB in both males and females at both dose levels. Liver hypertrophy was observed in both males and females fed 200 ppm HCB and subjected to food libitum. Food deprivation resulted in a higher plasma, liver, brain and adrenal accumulation of HCB in both males and females.
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