Administrative complaint

The EPA may issue a civil administrative complaint to any person or company who violates the TSCA.30 This complaint may impose a civil penalty, including recovery of any economic benefit of noncompliance, and may also require correction of the violation. The penalties for violations of TSCA may be up to 27,500 per violation (per day). 

See, e.g., press release EPA Finds PCB-Containing Equipment for Sale Without Proper Identification on eBay (Oct. 2,2009), which announces the monetary settlement value and not the penalties that could have been sought in an administrative complaint, available at http //yosemite.epa.gOv/opa/admpress.nsf/ab2d81eb088f4a7e852573590036339/b29b37a0 ec602b9e852576430065c303 OpenDocument. 

One of the first things to do when a company receives an administrative complaint is to carefully review it to determine if it is legally adequate. The questions to ask include ... 

Ledbetter launched charges of discrimination before the Equal Employment Opportunity Commission (EEOC) in March 1998. Her formal administrative complaint specified that, in violation of Title Vll, Goodyear paid her a... 

The fines levied for improper disposal are not mandated by federal regulations. Rather, the local EPA administrator, usually in consultation with local authorities, determines the cleanup procedures and costs. Civil penalties for administrative complaints issued for violations of the PCB regulations are determined according to a matrix provided in the PCB penalty pohcy. This poUcy, published in the Federal Register, considers the amount of PCBs involved and the potential for harm posed by the violation. 

Administration of penicillamine has been associated with many adverse reactions, some of which are potentially serious and even fatal. The nurse carefully evaluates any complaint or comment made by the patient and reports it to the primary health care provider. Increased skin friability may occur, which may result in easy breakdown of the skin at pressure sites, such as the hips, elbows, and shoulders. If the patient is unable to ambulate the nurse changes the patient s position and inspects pressure sites for skin breakdown every 2 hours. 

Ocular complications following local or systemic administration of steroids include glaucoma, cataracts, adverse influence on specific ocular infections, pseudotumor cerebri, ptosis, mydriasis, subjective visual complaints, visual field defects, systemic absorption of the topical medication, conjunctival and palpebral petechiae, epithelial punctate keratitis, and, possibly, corneal and scleromalacia. ... 

Where the Panel rules that there is no breach of the Code, the complainant and the respondent company are so advised in writing and are given the reasons for the decision. Where the complaint is from a pharmaceutical company, the complainant must pay within twenty working days an administrative charge based on the number of matters alleged and ruled not to be in breach of the Code. 

Immunodeficiency 100-200 mg/kg/mo IV at 0.01-0.04 mL/kg/min to 400 mg/kg/dose max UP 400 mg/kg/dose IV daily x 5 d BMP 500 mg/kg/wk X in renal insuff Caution [C, ] Separate administration of live vaccines by 3 mo Contra IgA deficiency w/ Abs to IgA, severe thrombocytopenia or coagulation disorders Disp Inj SE Associated mostly w/ inf rate GI upset Interactions X Effects OF live virus vaccines EMS May cause anaphylactic Rxn OD Unlikely Immune Globulin, Subcutaneous (Vivaglobin) [Immune Serum] Uses Primary immunodeficiency Action IgG supl Dose 100—200 mg/kg BW subq wkly abd, thighs, upp arms, or lat al hip Caution [C, ] Contra Hx anaphylaxis to immune globulin some IGA deficiency Disp Inj SE Inj site Rxns, HA, GI complaint, fevCT, N, D, rash, sore throat EMS May be self administered at home may cause anaphylactic Rxn OD Unlikely to cause life-threatening Sxs... 

The adverse effects of methotrexate include gastrointestinal complaints, bone marrow suppression, alopecia and nephrotoxicity. The toxic effects of methotrexate may be terminated by administering the fully reduced folate coenzyme leucovorin (folinic acid). Leucovorin rescue permits the administration of high doses of methotrexate, for example in situations where partially resistance has occurred or to obtain cytotoxic concentrations of methotrexate in the CNS. 

Less common adverse effects include blurred vision, hallucinations, and paradoxical reactions consisting of excitement, stimulation, and hyperactivity. Also, a variety of gastrointestinal complaints occur, and blood dyscrasias have been reported, but these are rare. Benzodiazepine administration during pregnancy, delivery, or lactation has the potential to have adverse effects on the fetus or newborn. 

Most patients tend to respond in a positive way to any therapeutic intervention by interested, caring, and enthusiastic medical personnel. The manifestation of this phenomenon in the subject is the placebo response (Latin, "I shall please") and may involve objective physiologic and biochemical changes as well as changes in subjective complaints associated with the disease. The placebo response is usually quantitated by administration of an inert material, with exactly the same physical appearance, odor, consistency, etc, as the active dosage form. The magnitude of the response varies considerably from patient to patient and may also be influenced by the duration of the study. Placebo adverse effects and "toxicity" also occur but usually involve subjective effects stomach upset, insomnia, sedation, and so on. 

The DPDP ligand was synthesized in order to lower the toxicity of the man-ganese(II) ion and to provide selective tissue uptake [40]. The LD50 of an i.v. dose of Mn-DPDP is between 1.9-5.4 mmol kg1 in mice [18, 41]. No mortalities occurred in dogs injected i.v. with 1.8 mmol kg-1 [41]. With the recommended clinical dose of 0.005 mmol kg1, the safety factor for Mn-DPDP is at least 360 [41]. In the European phase III clinical trials adverse events were reported for 46 of 624 patients (7%) [42]. In comparison, 123 of 546 patients (23%) in the U.S. clinical trials reported at least one adverse event [43]. In both trials the most common complaints were headache, vomiting and nausea. In addition, 377 of 546 patients (69%) in the U.S. trials and 26 of 624 patients (4%) in the European trials reported discomfort at the site of injection. The difference between the two trials is likely due to the method of administration and formulation of the Mn-DPDP solution. In the European trials, a 0.010 mM solution of the agent was slowly infused while in the U. S. trials Mn-DPDP was administered as a bolus injection of a 0.050 mM solution. Experiments have demonstrated a lower incidence of adverse events with infusion of the agent [44]. 

Tacrolimus can be administered orally or intravenously. After oral administration, peak concentrations are reached after 1-4 hours. The half-life of the intravenous form is approximately 9-12 hours. Like cyclosporine, tacrolimus is metabolized primarily by P450 enzymes in the liver, and there is a potential for drug interactions. The dosage is determined by trough blood level at steady state. Its toxic effects are similar to those of cyclosporine and include nephrotoxicity, neurotoxicity, hyperglycemia, hypertension, hyperkalemia, and gastrointestinal complaints. 

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