Adverse incidents types reported

The objective of risk management and a safety culture should be a proactive treatment of clinical risk and therefore minimisation of adverse incidents arising from HIT. Nevertheless this should not detract from the notion that one can learn a great deal from analysing incidents or near misses. A patient safety incident is an event or circumstance which could have resulted, or did result, in unnecessary harm to a patient [22]. The ongoing study of incident reports can help identify common types of problems [23] and incident reporting has been cited as one of the major steps in improving the safety of HIT [24]. 

In addition to the CIR process the cosmetic industry has instituted a second, important, self-regulatory procedure the voluntary reporting of adverse reactions, which is intended to provide data on the type and incidence of adverse reactions noted by consumers or by their medical advisors. This reporting procedure creates early awareness of problems handled outside hospital emergency facilities or centers for acute poisoning. 

Drug interactions In a randomized, double-blind study, Zenapax or placebo was added to an immunosuppressive regimen of cyclosporine, mycophenolate mofetil, and steroids to assess tolerability, pharmacokinetics, and drug interactions. The addition of Zenapax did not result in an increased incidence of adverse events or a change in the types of adverse events reported. The following medications have been administered in clinical trials with Zenapax with no incremental increase in adverse reactions cyclosporine, mycophenolate mofetil, ganciclovir, acyclovir, azathioprine, and corticosteroids. 

In controlled studies, azelastine nasal spray produced a high incidence of itching and burning of the nasal mucosa together with taste disturbance and sometimes unpleasant smell. Sedation does not seem to be frequent in most studies, the frequency of fatigue and drowsiness was not significantly different from placebo. In an open trial in which 119 patients with various types of pruritic dermatoses were treated with oral azelastine, 27 patients reported mild adverse effects such as drowsiness (15 cases, 12.5%) and a bitter after-taste (six cases, 5%). In four patients the treatment was withdrawn because of adverse effects (SEDA-15, 2). 

Skin rashes are relatively common with flnoroqninolones. A retrospective cohort stndy in patients in general practice in the Netherlands focused on the nse of antibacterial agents and the occnrrence of adverse cntaneons events covered 469 505 consnltations with 87 475 patients, of whom 13 679 received prescriptions for antibiotics (57). After adjnstment for age, sex, and co-medications, the incidence density ratio (incidence density per 1000 exposed days) for varions gronps of antibacterial agents was as follows tetracyclines 1.0, macrohdes 1.1, flnoroqninolones 2.8, penicillins 2.9, and co-trimoxazole 4.4 (57). No details of the types of skin reactions were given, and it is therefore possible that phototoxic events were inclnded. Compared with other stndies, the reported rate of antibiotic-associated adverse cntaneons events in this ontpatient popnlation was rather low. 

Olprinone is an inhibitor of phosphodiesterase type III, and has a positive inotropic effect. It is given intravenously and is mostly eliminated by the kidneys. Its pharmacological effects have been reviewed (1). Its major adverse effects are cardiac dysrhythmias and thrombocytopenia, the latter with a reported incidence of 0.43%. 

In order to determine the prevalence of adverse reactions to radiopharmaceuticals, a 5-year prospective study (1989-94) was performed in 18 institutions in the USA (2). The reported incidence rate was 0.0023%. No adverse reaction required hospitalization or had significant sequelae. The adverse reactions and types of radiopharmaceuticals are shown in Table 1. 

Neurotoxicity is a dose-hmiting adverse effect of suramin and there are two distinct types of neuropathy a mild, length-dependent, axonal poljmeuropathy, and a more serious subacute demyehnating, GuUlain-Barre-like polyneuropathy. The reported incidence of neuropathy is 25-90% with a mean of about 50%. Various neuropathies were noted in four of 38 patients infused with suramin for various malignancies (14). 

Moutsopoulos et al. [165, 166] reported that anti-Ro (SSA) positive Greek rheumatoid arthritis patients experienced a significantly high frequency of side effects from D-penicillamine. Despite their dissimilar chemical structures, the thiol compounds, sodium aurothiomalate and D-penicillamine, have remarkably similar clinical effects, and this similarity extends to the incidence and type of adverse effects [138,167]. Several investigators have noted the association between prior gold nephropathy and D-penicillamine. Billingsley and Stevens reported the significant correlation of D-peni-cillamine-induced proteinuria to a previous history of... 

Although differences in the incidence of renal adverse events between bisphosphonates have been reported from clinical trials, the reasons for these observations remain unknown but may be specific to a particular drug, dosing regimen, or prunary tumour type. Although more common in patients with pre-existing renal impairment, nephrotoxicity is not exclusive to this patient population. Clearly, further comparative chnical trials would be needed to directly compare the renal safety profiles of different i.v. bisphosphonates. 

A number of adverse reactions to mannitol have been reported, primarily following the therapeutic use of 20% w/v aqueous intravenous infusions.The quantity of mannitol used as an excipient is considerably less than that used therapeutically and is consequently associated with a lower incidence of adverse reactions. However, allergic, hypersensitive-type reactions may occur when mannitol is used as an excipient. 

The incidence of adverse reactions to radiophannaceuli-eals is estimated to be le.ss than 0.(M)6%. Most reactions are allergic and occur within minutes after intravenous injection. In the ease of radiolabeled murine antibodies, an anaphylactic reaction may occur, although serious reuelions of this type have not been reported. 

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