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At least 127 records · Page 7Linked to original sources
PubMed1993

Gelatine production, the six steps to maximum safety.

Gelatine production is described in detail, from the slaughterhouse where the raw material for gelatine manufacturing is collected, through the processing treatment, to the final product which is ready for pharmaceutical or edible purposes. The influence of the veterinary inspection of the animal, the batch size of the production, the degreasing and acidulation process for bones and the different possibilities of the alkaline treatment of hide splits and ossein followed by the sterilization steps during the final gelatine manufacturing are discussed with regard to the potential destruction of a theoretical BSE infection. The question is raised to what extent further activities of the gelatine industry seem to be necessary.

Animals↗
PubMed1997

Injection drug users' practices and attitudes toward intervention and potential for reducing the transmission of HIV.

Miami is one of the major centers of illegal drug activity and has a significant proportion of AIDS cases among injection drug users (IDUs). Since Needle Exchange Programs (NEP) are illegal and therefore do not exist in the state of Florida, other strategies must play a large role in reducing the transmission of HIV among IDUs. In order to effectively communicate with IDUs about needle safety, it is necessary to understand the practices and culture of IDUs, including where and how the needle/syringes are obtained and used. Data from recent studies conducted in Miami and other local sites indicate that IDUs inject frequently, averaging more than 1,000 per year, per person. While the vast majority of IDUs feel it is very important to clean needles and to use a needle only one time, these sentiments are not always practiced. Furthermore, data indicate that the context where shooting takes place must be considered in the planning of HIV risk reduction interventions. These findings suggest the importance of understanding patterns of drug use, attitudes toward intervention, and the cultural context where risky behaviors occur. Although Needle Exchange Programs are illegal in Florida, intervention programs must still stress the importance of using only new needles, but since new needles cannot always be obtained, IDUs should be taught and motivated not to use contaminated drug paraphernalia.

Acquired Immunodeficiency Syndrome↗
PubMed1988

MPTP in mice: treatment, distribution and possible source of contamination.

Mice were treated daily with [3H]MPTP (30 mg/kg, 1 uCi, s.c.) for 1, 3, and 10 days to determine the fate and localization of tritiated compounds. An untreated mouse was housed either in the same cage ("cage-mate control") or in an adjacent cage separated by mesh-wire ("near-neighbor control"). The radioactivity measured in blood, brain, liver, and remaining body of [3H]MPTP-treated mice was dependent on the total dose of the drug the animals received and did not vary with the type of tissue analyzed. Significant amounts of radioactivity were found in the tissues of the "cage-mate control" mice, but not of the "near-neighbor control" mice. The route of transmission appears to be through the urine, as the urine of [3H]MPTP-treated mice was highly radioactive after the drug injection. Only traces of radioactivity were found in their feces and there was no increase in the background radiation in the environment of the cages, indicating that the tritiated compounds were not exhaled. Proper disposal of urinary products of MPTP-treated animals is therefore necessary to reduce the risk of possible drug contamination in humans.

1-Methyl-4-phenyl-1,2,3,6-tetrahydropyridine↗
PubMed1984

Clinical, biochemical, serological, histological and ultrastructural features of liver disease in drug abusers.

Heroin abusers are frequently found to have abnormal liver function tests and hepatic histology. Hepatitis viruses A, B, and NANB, other drugs or drug contaminants and excessive alcohol consumption are factors thought to contribute. One hundred and sixteen heroin abusers attending a London treatment centre were studied. Sixty two (53%) had a raised aspartate transaminase. This was not explained by current infection with hepatitis A and B, cytomegalo or Epstein-Barr viruses, excessive alcohol consumption (greater than 80 g/day) or concomitant drug taking. Abnormal liver function tests were as frequent in those with markers of current or past HBV infection as those without and there was evidence that both HBV infection and the cause of the abnormal liver function tests were acquired in the first few years of intravenous drug abuse. Liver biopsies from eight patients showed chronic hepatitis with a mild lobular and portal inflammatory infiltrate, fatty change and prominent sinusoidal cells. Electron microscopy showed cytoplasmic trilaminar tubular structures and dense fused membranes in dilated endoplasmic reticulum. These clinical, biochemical, serological, and histological features would suggest a major role for NANB virus infection in the aetiology of hepatitis in heroin abusers.

Adult↗
PubMed1993

BSE--a risk for man through pharmaceutical products? Position and politics of the German pharmaceutical industry.

Since BSE is not a zoonosis and the occurrence is with some exceptions extremely low or absent, the risk to man through pharmaceuticals is remote. However, the agent of BSE is very resistant and the disease in cattle is always lethal, as are analogous diseases of man. Therefore, the German pharmaceutical industry, through a working group, actively contributes to reasonable measurements leading to a further reduction of any theoretical risk. This theoretical risk has to be evaluated by a balanced consideration of various risk and safety factors. Process validation should be reserved for occasional single cases, since it is still time-consuming and contradicts animal protection. Industry prefers further research into the characteristics and behaviour of the BSE agent. The "Note for Guidance..." recently established by the EC commission seems a reasonable approach for a harmonized attitude of both industry and authorities. The German pharmaceutical industry would appreciate a balanced consideration of both pharmaceutical and food industries, which would also re-establish the confidence of the public.

Animals↗
PubMed2000

Neurological complications of drug abuse: pathophysiological mechanisms.

Drug abuse is associated with a variety of neurological complications. The use of certain recreational drugs shows a marked temporal association with the onset of both haemorrhagic and ischaemic strokes, the majority of which develop within minutes to 1 h after the administration of the index drug. Delayed onset of stroke has also been observed. Acute, severe elevation of blood pressure, cardiac dysrhythmias, cerebral vasospasm, vasculitis, embolization due to infective endocarditis or dilated cardiomyopathy, embolization due to foreign material injected with the diluents under non-sterile conditions and 'street drug' contaminants with cardiovascular effects have been suggested as possible underlying mechanisms. Rupture of aneurysms and arteriovenous malformations have been detected in up to half of the patients with haemorrhagic stroke due to cocaine abuse. The less common findings reported have included a mycotic cerebrovascular aneurysm in a patient with infective endocarditis and haemorrhagic stroke. In addition to stroke, cocaine seems to provoke vascular headache. Seizures precipitated by recreational drug abuse are usually caused by acute intoxication in contrast to the withdrawal seizures encountered in subjects with alcohol abuse. Movement disorders and cerebral atrophy correlating with the duration of abuse have been described. Snorting of organic solvents may cause encephalopathy. Cases of spongiform leukoencephalopathy in heroin addicts have also been reported. Peripheral neuropathy is occasionally precipitated by drug poisoning after intravenous administration. Impurities of the drug, risky administration techniques, and the use of mixtures of various drugs, frequently with simultaneous alcohol drinking, should be taken into account when assessing the background of the adverse event as well as the overall lifestyle of the addicted subjects.

Brain↗
PubMedDate not supplied

Risks incurred by children of drug-addicted women: some medical and legal aspects.

A review of recent literature shows a dramatic increase in the number of drug-addicted pregnant women, which increases the number of infants susceptible to the adverse effects of such addiction. The majority of new-born infants born to mothers addicted to opiates show a narcotic withdrawal syndrome. The risk of prematurity and other health disorders occurring in a new-born infant is substantially increased by the mother's abuse of narcotics during pregnancy. The microbial infection of children by a contaminated drug abused in the family, and accidental poisoning of children by drugs, have also been reported. The treatment of drug-addicted pregnant women has raised certain medical and legal questions, such as the breach of confidentiality of medical information and the criminal failure to report offences, as well as the failure to render assistance. The promotion of information and education about drug abuse during pregnancy, and the effects of such abuse on the pregnant women, her foetus and the future of a new-born infant is an urgent necessity.

Amphetamines↗
PubMed2003

In vivo effect of PC-SPES on prostate growth and hepatic CYP3A expression in rats.

PC-SPES, a proprietary mixture composed of eight different herbs, is used worldwide as an alternative treatment by prostate cancer patients. It has been suggested that the clinical and in vitro antitumor activity exhibited by PC-SPES may be due to estrogenic activity, which in turn may be mediated by the presence of undeclared prescription drug contaminants. Here, we evaluated the in vivo effects of two different commercial lots of PC-SPES in male and female rats. Our high-pressure liquid chromatography analysis coupled with gas chromatography/mass spectrometry analysis by an independent laboratory suggested that PC-SPES lot 5430125 was contaminated with diethylstilbestrol (DES), whereas lot 5431249 was not. Treatment of male rats with PC-SPES lot 5430125 or DES alone reduced the weight of androgen target organs and decreased circulating levels of sex steroids and luteinizing hormone, whereas lot 5431249 was without effect. In addition, lot 5430125 and DES, but not lot 5431249 increased uterine weight in female rats. These results suggest that the inhibitory effects on androgen targets are mediated through suppression of the hypothalamic-pituitary axis and this suppression is probably due to DES contamination. We assessed the effects of both lots of PC-SPES and DES on hepatic cytochrome P450 expression and activity. Both lots of PC-SPES and DES reduced CYP3A activity and protein levels. Because the response of CYP3A to PC-SPES was not dependent on whether it contained DES, a phytochemical component of PC-SPES is most likely responsible for this effect. Inhibition of CYP3A has important implications for potential herbal-drug interactions.

Animals↗
PubMed2005

Methylenedioxymethamphetamine (ecstasy)-related hyperthermia.

MDMA (or 3, 4 methylenedioxymethamphetamine) was first manufactured in the 1920s and found to have structural similarities to both mescaline and amphetamines. Used briefly by some therapists in the 1970s and early 1980s as an adjunct to psychotherapy, it is now primarily abused by teenagers and young adults as an illicit recreational drug known as "ecstasy." As its popularity has increased, so have the number of fatalities and adverse events related to its use. We report six patients suffering fatal or life-threatening hyperthermia after MDMA use. These cases illustrate that hyperthermia associated with MDMA use cannot be solely attributed to rave parties (high ambient temperatures, excessive dancing, dehydration, and overcrowded conditions), drug contaminants, or co-ingestants. A better understanding of the etiology of hyperthermia after MDMA use is needed so that appropriate harm-reduction measures can be developed and instituted.

Adolescent↗
PubMed2005

Epidemiological investigation of a Serratia liquefaciens outbreak in a neurosurgery department.

Between February 2001 and March 2003, 17 patients from the neurosurgery department of the University Hospital of Rangueil (Toulouse, Southern France) developed Serratia liquefaciens infections. Due to the atypical antibiotype displayed by the clinical isolates (i.e. gentamicin resistance), an outbreak was suspected. Molecular analysis carried out by pulsed-field gel electrophoresis demonstrated a genetic link for all patients. Furthermore, the patient who introduced the epidemic Serratia strain was also identified and shown to be related to the two epidemic peaks observed during the outbreak period. Investigation failed to reveal a reservoir among the antiseptics and soaps, or among the mechanical ventilators used. However, when the colonization of patients was investigated, positive carriage was observed and could be considered as a potential risk for the spread of the epidemic strain. Due to the delay between antibiotherapy and S. liquefaciens colonization, a selection effect had to be considered. Finally, implementation of hygiene measures was accompanied by control of the outbreak.

Anti-Infective Agents, Local↗
PubMed2002

Cisplatin contamination observed on the outside of drug vials.

Exposure to cytotoxic drugs is of great concern today. Special regulations for handling these drugs during preparation and administration have been implemented in most countries. Concern has also been raised as to whether exposure to these drugs can occur due to contaminated drug vials. In this investigation, wipe samples were taken from drug vials used for platinum-containing drugs, e.g. cisplatin and related drugs. The vials were randomly picked from unbroken packages from different manufacturers. The results showed that drug vials may already be contaminated on the outside when delivered from the manufacturer.

Cisplatin↗
PubMedDate not supplied

Determination of conditions for the production scale sterilization of prefilled syringes.

External and internal differences in pressure of prefilled syringes can cause plunger movement during sterilization, which might cause drug product contamination. Consequently the pressure inside the autoclave during sterilization should be controlled carefully to prevent contamination of the drug product by microorganism and particulates. A previously determined theoretical relationship of temperature to pressure in sealed bottles was modified for prefilled syringes to take plunger movement into account. This modification yielded a correction factor that includes a coefficient of linear thermal expansion for the syringe, thermal expansion of the plunger, and friction between the plunger and the syringe wall. To confirm the accuracy of this modified relationship, 100 mL polypropylene prefilled syringes with butyl rubber plungers, some of which carried pressure and temperature sensors, were used to test various sterilization conditions at the experimental scale. The results showed that the major problem in establishing the pressure conditions for production scale sterilization is temperature distribution throughout the load. However, an over pressure sterilization cycle at 121 degrees C and 0.34 MPa showed the best results. Microbial challenge and light-obscuration particle count tests were performed on the syringes from the worst-case location predicted from modified relationship; the results show that these conditions preserved the sterility of the drug product and protected it from particulate contamination.

Disposable Equipment↗
PubMedDate not supplied

Development of a standard, freeze-dried serum containing the drugs assayed most often in French hospitals.

A quality control program for the therapeutic drug monitoring methodology used to determine serum levels of the fourteen drugs assayed most frequently by French hospital laboratories is described. The program has been adopted by the Societé Française de Biologie Clinique (SFBC), which provides participating laboratories with a statistical analysis of the performance data. The control samples developed for the program are prepared by spiking calf serum with, in one case, phenobarbital, phenytoin, carbamazepine, sodium valproate, amikacin, lithium carbonate, digitoxin and hydroquinidine, and, in the other case, caffeine, quinidine, digoxin, isoniazid and gentamycin. After freeze-drying the spiked serum, the drugs were shown to be stable for at least a year when stored at -20 degrees, +4 degrees and +22 degrees; at the end of this time, the samples were pathogen free. For checking therapeutic drug monitoring methods, the freeze-dried serum is diluted with distilled water (10 ml); these solutions are chemically stable, and remain pathogen-free, when stored in stoppered glass tubes at -20 degrees or +4 degrees for 4 weeks.

Drug Contamination↗
PubMed2006

Chiral separation of rac-Ornidazole and detection of the impurity of (R)-Ornidazole in (S)-Ornidazole injection and raw material.

(S)-Ornidazole is a subject of research as an antifertility agent in male animals at present. However, there seems to be no relative report on chiral separation for rac-Ornidazole, which has been used as an effective medicine for more than 30 years. In this article, the chiral separation of rac-Ornidazole on a Chiralcel OB-H column based on normal-phase high-performance liquid chromatography (NP-HPLC) is investigated and the methodology for detection of impurity of (R)-Ornidazole in (S)-Ornidazole injection and raw material is established. The novel mobile phase is utilized by mixing n-hexane, methanol and isopropyl alcohol (95:4:1, v/v/v) instead of the typical mobile phase of n-hexane and isopropyl alcohol, although the methanol, which offers a good resolution factor for the enantiomeric separation in this system, is not recommended on the Chiralcel OB-H column according to the instruction supplied by Daicel Chemical Ind., LTD (Japan).

2-Propanol↗
PubMed1978

A clinical safety trial of stroma-free hemoglobin.

A stroma-free hemoglobin (SFH) solution was prepared which was sterile, pyrogen free, and contained only 1.2% of the stromal lipid present in unpurified hemolysate, 250 ml of which was administered slowly intravenously to 8 healthy men. Two control subjects received 250 ml of serum albumin. The SFH infusions were generally well tolerated by 7 of the 8 men. One subject developed abdominal pain and costovertebral angle tenderness after infusion, which disappeared within 48 hr. Bradycardia and a mild increase in blood pressure was present during ths SFH infusions and for 4 to 5 hr thereafter. A decrease in urine output and endogenous creatinine clearance appeared during the SFH infusions and for 2 to 4 hr after infusion. A mild prolongation of the activated partial thromboplastin time developed immediately after infusion. Gross hemoglobinuria appeared as expected during the SFH infusions and completely disappeared by 6 to 10 hr after infusion. All the cardiovascular, renal, and clotting changes were present for only a few hours after the SFH infusion, during the hemoglobinemia (free Hb in plasma). At 24 hr and 7 days after infusion all measurements were normal, and 6 mo follow-up showed no abnormalities or hepatitis.

Adolescent↗
PubMed1997

Adulteration by synthetic therapeutic substances of traditional Chinese medicines in Taiwan.

The adulteration by synthetic therapeutic substances of traditional Chinese medicines has been reported on various occasions and has been a public health concern in Taiwan over the past several years. A large-scale effort was initiated in 1992 to screen traditional Chinese medicines that were suspected of adulteration with synthetic therapeutic substances. The term "adulteration" refers to traditional Chinese medicines that are tested and found to contain chemical substances not prescribed or labeled as part of the intended use. A total of 2,609 samples were collected by eight major general hospitals in Taiwan. Samples were collected through physicians' referrals during patients visits. The samples were analyzed by hospital pharmacists following the established standard procedures in comparison to references by thin-layer chromatography. An average of 23.7% (n = 618) of the samples collected from the eight hospitals were adulterated. Four samples with either a rheumatoid or an antiinflammatory indication contained six different kinds of adulterants. More than half (52.8%) of the adulterated traditional Chinese medicines contained two or more adulterants. The sources of adulterated samples and their claimed indications, as well as the most frequently detected synthetic therapeutic substances, are presented in this report. The controversies regarding the combination of synthetic therapeutic substances and traditional Chinese medicines without adequate labeling should be resolved through regulatory actions for better safety of drug use.

Acetaminophen↗