[FOOD CONTAMINATION WITH DRUGS AND CHEMICALS].
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Herbal medicines have become a popular form of therapy. They are often perceived as being natural and therefore harmless. This article reviews the recent literature on the adverse effects of herbal remedies. Examples of allergic reactions, toxic reactions, adverse effects related to an herb's desired pharmacological actions, possible mutagenic effects, drug interactions, drug contamination, and mistaken plant identities are provided. Because of underreporting, our present knowledge may well be just the "tip of the iceberg." Little is known about the relative safety of herbal remedies compared to synthetic drug treatments, although for some herbal remedies, the risks may be less than for conventional drugs.
This paper summarizes parenteral drug contamination case studies presented at industry conferences and a Food and Drug Administration advisory committee meeting in the period of 2000-2004. CGMP deficiencies associated with each contamination event are discussed. The key role of a well-functioning quality system in contamination prevention is emphasized.
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In this paper a survey is given concerning the production of illegal MDMA preparations. It was found that the reductive amination and the Leuckart syntheses were used for this purposes.
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The particulate contamination of five frequently prescribed drugs was studied. Samples were obtained in a laminar flow workbench according to millipore technique. The dry sample filters were examined with a binocular microscope at 50x and 100x. Particles were sized as to fibers, greater than 100 microns, 51 to 100 microns, 25 to 50 microns, and 10 to 24 microns. The results show the variability of contamination. Particulate counts appear to correlate with the manufacturing process. Bulk powders are highly contaminated, followed by lyophilize powders, then stable solutions. Until the clinical importance is resolved and manufacturing processes improved, in-line filters may be of value in selected patients.
The toxicity of antineoplastic drugs has been well known since they were introduced in the 1940s. Because most antineoplastic drugs are nonselective in their mechanism of action, they affect noncancerous as well as cancerous cells, resulting in well-documented side effects. During the 1970s, evidence came to light indicating health care workers may be at risk of harmful effects from antineoplastic drugs as a result of occupational exposure. Since that time, reports from several countries have documented drug contamination of the workplace, identified drugs in the urine of health care workers, and measured genotoxic responses in workers. Evidence also exists of teratogenic and adverse reproductive outcomes and increased cancers in health care workers. During the past 30 years, professional organizations and government agencies have developed guidelines to protect health care workers from adverse effects from occupational exposure to antineoplastic drugs. Although many safety provisions were advanced to reduce worker exposure in the 1980s, recent studies have shown that workers continue to be exposed to these drugs despite safety policy improvements. In 2004, the National Institute for Occupational Safety and Health (NIOSH) published an alert reviewing the most recent information available and promoting a program of safe handling during their use.
OBJECTIVE: (1) To compare the rate of contamination of syringes prepared under laminar flow conditions in pharmacy with those prepared by nurses in the emergency department; (2) to determine whether the time elapsed since preparation or number of doses given affected the contamination rate; (3) to determine whether any adverse effects resulted from bacterially contaminated drugs. METHODS: Prospective, blinded trial exploring the effect of method of preparation, time since preparation, and number of doses given on contamination rates and infective adverse events associated with bacterially contaminated specimens. RESULTS: The rate of bacterial contamination was 12% (95% confidence interval 6% to 18%). There was no difference in contamination rate in respect of method of preparation, number of doses given, or time since preparation. No infective complications were identified. CONCLUSIONS: Abandonment of titrated intravenous opioids is not justified by the results. However, there is concern about the use of this technique of pain control for immunocompromised patients and those with prosthetic heart valves.
Workplaces, e.g. hospital pharmacies and hospital departments, where antineoplastic drugs are handled might be contaminated with these drugs, and pharmacy personnel and health care workers may be exposed. In this study potential sources for exposure of antineoplastic drugs were investigated. Unbroken drug vials and tablet blister packages, both containing cyclophosphamide (CP) and their outer packaging were wipe sampled. Analysis was performed by liquid chromatography combined with tandem mass spectrometry (LC-MS/MS). The result showed that almost every part of the primary packaging was contaminated with CP and ifosfamide (IF). However, the amounts of CP and IF were low, and most likely not harmful for the personnel handling these packaging in association with drug preparation. The contamination must originate from the pharmaceutical manufacturer. Different surfaces in the preparation unit of a Swedish hospital pharmacy were also investigated at two different occasions by wipe sampling. In the preparation unit CP and IF were found as contaminants on the majority of the investigated surfaces. After the first measurement the hospital pharmacy improved its routines. Lower amounts of CP and IF were detected at the second measurement. A low degree of contamination with CP and IF was also detected on the floor outside the preparation unit and this indicated a small distribution of antineoplastic drugs to the surroundings.
OBJECTIVE: To describe five outbreaks of hepatitis A virus (HAV) infection associated with illicit drug use during a statewide outbreak of HAV infection in Queensland. DESIGN: Risk factor prevalence survey. PATIENTS AND SETTING: All 875 cases of HAV infection notified to Public Health Units in Queensland in the 12 months to 30 November 1997. MAIN OUTCOME MEASURE: Type and prevalence of illicit drug use. RESULTS: Risk factor assessment was completed for 804 cases (91.9%). We identified five outbreaks of HAV infection linked to illicit drug use. These outbreaks accounted for 24.6% (215/875) of all notified cases and 39% (190/482) of notified cases in the 15-34 years age group. The main type of illicit drug use in four of the five outbreaks was injecting drug use (74%; 118/160), while in the other outbreak it was sharing of smoking implements for marijuana (38%; 21/55). CONCLUSION: Illicit drug use may be an under-recognised risk factor for HAV infection, particularly in young people. Faecal-oral transmission through poor personal hygiene, including sharing of implements for smoking marijuana, is the most probable route of transmission in these drug-linked outbreaks. The role of contaminated drug and needle-sharing remains to be clarified.
Pulsed-field gel electrophoresis and polymerase chain reaction genome fingerprinting based on repetitive chromosomal sequences (rep-PCR) were used for typing 14 strains of Ochrobactrum anthropi. Six strains isolated during an outbreak of bacteraemia in patients who had received a contaminated rabbit anti-thymocyte globulin gave identical patterns by both techniques. Different patterns were found in sporadic and reference strains, except for one clinical isolate received from another hospital that showed the same pattern as the epidemic clone. This patient had also received rabbit anti-thymocyte globulin from the same source at the time of the outbreak. This study illustrates the advantages of genetic typing methods in terms of high typeability and discriminating power, even for rare pathogens. Furthermore, it highlights the need for interhospital communication for effective identification of common sources of outbreaks related to intrinsic drug contamination.
In this paper a case of good tolerance to benzathine benzylpenicillin, but benzylpenicillin potassium allergy in subject with history of multidrug hypersensitivity was described. The same therapeutic agent is contained in both commercial drugs and dosage formulation can cause the unpredictable adverse drug reactions (ADRs). This thesis was confirmed by positive intradermal test with the same, but negative with other commercial product of benzylpenicillin potassium. Later chromatographic analysis shows drug contaminations. Thus an exclusion of allergy to drug impurities (and additives) is necessary for correct diagnosis benzylpenicillin allergy (and any active constituent). Furthermore, allergy to drug impurities (and additives) closely resemble cross-reactions or multiple chemical sensitivity syndrome (MCSS).
PURPOSE: The results of three studies that describe the external contamination of chemotherapy drug vials are presented. New techniques for the improved decontamination of vials containing cisplatin are also described. SUMMARY: Study 1 evaluated the external contamination of drug vials with cyclophosphamide and ifosfamide in a pharmacy setting. Widespread contamination of the outside of drug vials was found with each drug. Study 2 evaluated the surface contamination of drug vials with cyclophosphamide and fluorouracil in three pharmacies. Sporadic contamination with fluorouracil was detected, while cyclophosphamide was found on most vials. In study 3, investigators compared the decontamination abilities of a standard decontamination procedure at the manufacturer level with an improved decontamination procedure and the use of sleeves to further decrease contamination. Though the methods of each study reported herein differed, the outcomes were similar. All chemotherapy drug vials studied demonstrated levels of contamination with the drug well above the limit of detection. Improved decontamination procedures, combined with the use of protective sleeves, reduced the level of platinum contamination by 90%, suggesting that standard decontamination procedures should be reconsidered. CONCLUSION: The results of these studies are consistent with several others that have reported contamination of the outside surface of drug vials for a number of chemotherapy drugs. Contamination can be reduced by using decontamination equipment and protective sleeves during the manufacturing process.