PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “DRUG ADULTERATION”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 127 records · Page 7Linked to original sources
PubMed2003

Analysis of adulterants in a traditional herbal medicinal product using liquid chromatography-mass spectrometry-mass spectrometry.

Adulterations with synthetic drugs are common problems with herbal medicine and this can potentially cause serious adverse effects. It is therefore important to determine the presence of synthetic drugs in herbal medicine to ensure patients' safety. The objective of this study was to develop sensitive and specific methods to analyse phenylbutazone, caffeine and oxyphenbutazone present in a traditional Indonesian herbal product. Liquid chromatography-mass spectrometry-mass spectrometry (LC-MS-MS) methods in the selected reaction-monitoring (SRM) mode were developed. It was found that the sample contained 0.53% w/w (n=3, RSD=7.56%) phenylbutazone and 0.04% w/w (n=3, RSD=8.39%) caffeine. This corresponded to 43.17 mg phenylbutazone and 3.23 mg caffeine in each sachet of powder. The methods were validated for linearity, precision, accuracy, LOD and LOQ. LOD and LOQ were found to be 3.69 and 12.29 ng/ml, respectively for phenylbutazone. For caffeine, the LOD and LOQ were 0.84 and 2.80 ng/ml, respectively. Oxyphenbutazone in the sample was found to be present at a level below the quantification level of 10.2 ng/ml. With better methods developed for analysis of adulterants in herbal medicine, the quality and safety of these medicines can be better controlled and regulated to ensure patients' safety.

Caffeine↗
PubMed2002

How natural are 'natural herbal remedies'? A Saudi perspective.

OBJECTIVE: There is a rapidly growing trend in the consumption of herbal remedies in industrialised and developing countries. Users of herbal remedies are at risk of toxicity and adverse interactions of herbal preparations due to their frequent contamination with metals and adulteration with synthetic drugs. The purpose of this study was to assess the quality of herbal remedies present on the market in Saudi Arabia in recent years. METHODOLOGY: 247 herbal remedies and related preparations were examined from 2000-2001 at the Toxicology Laboratory, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia. Herbal powder samples were the most common sample type examined (n = 80), followed by complete, packed preparations (n = 59), single undescribed capsules or pills (n = 46), loose plant leaves or seeds (n = 28), creams (n = 18) and liquid or jelly samples (n = 16). All samples were subjected to toxicological screening for organic substances using gas chromatographic-mass spectrometric analysis, screening for heavy metals (arsenic, mercury, and lead) using inductive coupled plasma-mass spectrometry and microbiological examination. RESULTS: The preparations analysed were used to treat the following indications: leukaemia and other forms of cancer (n = 22); obesity (n = 18); diabetes mellitus (n = 14); rheumatic disorders (n = 14); skin pigmentation problems (n = 11); or to enhance male sexual activity (n = 9). In 123 cases, the indication of use was not known. 39 samples contained high concentrations of heavy metals. This was particularly striking in remedies used to treat leukaemia (arsenic content of 522-161,600 ppm) and in creams for whitening skin (mercury content of 5,700-126,000 ppm). Eight preparations contained synthetic drugs (e.g. benzodiazepines and tricyclic antidepressants in sedative preparations, cyproheptadine in a remedy to gain bodyweight, ibuprofen and dipyrone in herbal capsules used to treat rheumatism). 18 samples were contaminated with micro-organisms. 14 samples contained toxic substances of natural origin. Of the 247 examined preparations, 77 (i.e. over 30%) were disqualified due to high heavy metals content, bacterial contamination or presence of toxic organic substances. CONCLUSION: The study shows an urgent need to control the production, importing and selling of herbal preparations.

Diabetes Mellitus, Type 2↗
PubMed2002

Serious adverse effects of unconventional therapies for children and adolescents: a systematic review of recent evidence.

Unconventional therapies have become popular in paediatric and adolescent populations. It is therefore important to define their risks. The aim of this systematic review was to summarise the recent evidence. Computerised literature searches were carried out in five databases to identify all recent reports of adverse events associated with unconventional therapies in children. The reports were summarised in narrative and tabular form. The results show that numerous case reports and several case series have been published since 1990. Investigations of a more systematic nature are, however, rare. Most of the adverse events were associated with herbal medications. Inadequately regulated herbal medicines may contain toxic plant material, be contaminated with heavy metals, or be adulterated with synthetic drugs. The adverse events included bradycardia, brain damage, cardiogenic shock, diabetic coma, encephalopathy, heart rupture, intravascular haemolysis, liver failure, respiratory failure, toxic hepatitis and death. A high degree of uncertainty regarding a causal relationship between therapy and adverse event was frequently noted. The size of the problem and its importance relative to the well-documented risks of conventional treatments are presently unknown. Several unconventional therapies may constitute a risk to the health of children and adolescents. At present, it is impossible to provide reliable incidence figures. It seems important to be vigilant and investigate this area more systematically.

Adolescent↗
PubMed2005

Chinese medicinal materials and their interface with Western medical concepts.

Chinese medicine (CM), one of the oldest continuously surviving traditions, has been practised to maintain good health and treat diseases in the Chinese communities and recently by other ethnic groups worldwide. Chinese medicinal materials (Chinese materia medica, CMM) and proprietary CM products (PCM), acupuncture and related physical therapies, as well as special life styles are often used together in the practice, co-existing with orthodox medicine (OM) in China and some regions in the Far East. Increasing uses of CMM have created both skepticism and support of CM practice that have been the major debate since the successful randomised clinical trial of the 10-CM herbs prescription in relieving atopic eczema was published in 1992. Available in the West, some CMM are supplied with wrong species or wrong named herbs that possess liver and kidney toxicity and some PCM adulterated with OM drugs. These do not give CMM the right reputation and recognition. These problems have been due to lack of recognition and regulation of the profession, qualified practitioners, quality-controlled CMM products and evidence-based clinical studies. Though practised widely, CM was not recognised officially in some regions such the EU and North America as part of the healthcare system run by western OM practice. Such circumstance has delayed the development of CM in these regions including Hong Kong comparing with that in Australia, Japan (As Kampo medicine), the UK, some European countries, and the USA. It can be considered as obstacles for proper development of CM in general. This paper addresses these key issues and attempts to propose ways for future research and development for CMM. The impact will certainly be modernisation in every aspect of CMM to cope with the fast growing demand in quality medicines in the 21st century. Several major areas are listed for discussion.

China↗
PubMed2003

Some aspects of toxic contaminants in herbal medicines.

A World Health Organisation survey indicated that about 70-80% of the world populations rely on non-conventional medicine mainly of herbal sources in their primary healthcare. In recent years, we have witnessed the increasing growth in popularity of over-the-counter (OTC) health foods, nutraceuticals, and medicinal products from plants or other natural sources in developed countries. This indirectly indicates that the public is not satisfied with their orthodox medical (OM) treatment. Such increase in popularity has also brought concerns and fears over the professionalism of practitioners, and quality, efficacy and safety of their treatment methods and products from herbal and natural sources available in the market. Over the past decade several news-catching episodes in developed communities indicated adverse effects, sometimes life threatening, allegedly arisen consequential to taking of OTC herbal products or traditional medicines from various ethnic groups. These OTC products may be contaminated with excessive or banned pesticides, microbial contaminants, heavy metals, chemical toxins, and for adulterated with orthodox drugs. Excessive or banned pesticides, heavy metals and microbial contaminants may be related to the source of these herbal materials, if they are grown under contaminated environment or during collection of these plant materials. Chemical toxins may come from unfavourable or wrong storage conditions or chemical treatment due to storage. The presence of orthodox drugs can be related to unprofessional practice of manufacturers. Some of these environment related factors can be controlled by implementing standard operating procedures (SOP) leading to Good Agricultural Practice (GAP), Good Laboratory Practice (GLP), Good Supply Practice (GSP) and Good Manufacturing Practice (GMP) for producing these medicinal products from herbal or natural sources. The public's belief that herbal and natural products are safer than synthetic medicines can only be ascertained by imposing regulatory standards on these products that should be manufactured using these Good Practices. Using Chinese medicines, as examples, this paper illustrate how advances in chemical and biomedical analysis would help to detect intentional and unintentional toxic contaminants in herbal substances. The paper also summarises how modernization and progress are being carried out to get the best out of Chinese medicines for public healthcare.

Consumer Product Safety↗
PubMed2004

Morphological, chemical and functional analysis of catuaba preparations.

Fourteen commercial samples of the popular Brazilian aphrodisiac Catuaba specified as bark drugs of Anemopaegma, Erythroxylum and Trichilia species were examined for identity and purity. Only a minority of the examined Catuaba samples contained the crude drugs claimed on the labels. More than half of the products were adulterated with different crude drugs. The majority of the samples contained a bark originating from Trichilia catigua. The TLC fingerprints confirmed the heterogeneity, in 50% of the samples tropane alkaloids of various concentrations were detected. TLC and HPLC methods for separation and identification of the tropane alkaloids were developed and their analytical data (RF values, retention times, ESI-MS) given. The structure elucidation of the two main alkaloids, catuabine D and its hydroxymethyl derivative, is presented. The 1H- and 13C-NMR assignments of these alkaloids are discussed with regard to literature data. Neither aqueous nor methanolic extracts of the Trichilia catigua reference material nor alkaloid-enriched fractions of commercial samples showed any effect on the rabbit corpus cavernosum in an in vitro test.

Animals↗
PubMed2007

Quantification of the amphetamine content in seized street samples by Raman spectroscopy.

A Raman spectroscopy method for determining the drug content of street samples of amphetamine was developed by dissolving samples in an acidic solution containing an internal standard (sodium dihydrogen phosphate). The Raman spectra of the samples were measured with a CDD-Raman spectrometer. Two Raman quantification methods were used: (1) relative peak heights of characteristic signals of the amphetamine and the internal standard; and (2) multivariate calibration by partial least squares (PLS) based on second derivative of the spectra. For the determination of the peak height ratio, the spectra were baseline corrected and the peak height ratio (h(amphetamine at 994 cm(-1) )/h(internal standard at 880 cm(-1) )) was calculated. For the PLS analysis, the wave number interval of 1300-630 cm(-1) (348 data points) was chosen. No manual baseline correction was performed, but the spectra were differentiated twice to obtain their second derivatives, which were further analyzed. The Raman results were well in line with validated reference LC results when the Raman samples were analyzed within 2 h after dissolution. The present results clearly show that Raman spectroscopy is a good tool for rapid (acquisition time 1 min) and accurate quantitative analysis of street samples that contain illicit drugs and unknown adulterants and impurities.

Journal Article↗
PubMed2000

Toxicity of complementary therapies: an eastern perspective.

Chinese traditional medicine is used extensively in Chinese populations, and other Asian countries employ similar therapies. Herbal treatments have a major role in these systems, and although most have a well-established safety record, occasional adverse effects are seen. Problems arise when toxic herbs are used in excessive doses, with improper preparation, or when they are substituted erroneously. There may also be adulteration with Western drugs or heavy metals, and interactions between herbs and Western drugs may also occur. It is always prudent to obtain a complete history of the use of herbal medications during any clinical assessment, particularly in Asian patients.

Complementary Therapies↗
PubMed1997

Safety issues in herbal medicine: implications for the health professions.

The use of herbal medicines in Australia is widespread. A number of factors make assessment of adverse effects associated with these products more complex than for pharmaceuticals. Problems have resulted from contamination with heavy metals and adulteration with prescription drugs in overseas herbal products. A classification is proposed for adverse effects associated with herbal medicines, and medical practitioners are encouraged to include use of these preparations in a patient's drug history and in reports of suspected adverse drug reactions. It may be necessary to develop a separate database to promote adverse drug reaction reporting for herbal medicine and the wider field of complementary and alternative medicine.

Adverse Drug Reaction Reporting Systems↗
PubMed1991

[Heroin-induced acute rhabdomyolysis].

A 24 year ald-man, was admitted in intensive care with coma and shock, 4 hours after intravenous injection of heroin. Awakening was obtained by naloxone. Diagnosis of acute rhabdomyolysis associated with heroin addiction was asserted by association of anury, hyperkalemia, and CPK increase. Recovery was obtained with, however, neurologic after-effects. Pathophysiology of acute rhabdomyolysis associated with heroin addict is obscure. Hypotheses for the cause of the muscle damage include the effects of toxicity (either directly or immunologically mediated) of the drug or an adulterant. However prolonged coma and immobilization in one position with either direct compression of the muscles or occlusions of the regional vascular supply can play a major role.

Acute Disease↗
PubMed1984

Major medical problems and detoxification treatment of parenteral drug-abusing alcoholics.

Patients with combined addictive disease are frequently encountered in New York City. Three detoxification schedules have been developed which, alone or in combination, may be used for almost all substance abusers who require pharmacologic detoxification. Numerous factors contribute to pathogenesis of infections in parenteral drug-abusing alcoholics, including aspiration, impaired pulmonary function, immunologic abnormalities, and changes in endogenous microbial flora. The acquired immunodeficiency syndrome (AIDS) has recently emerged as a serious medical complication of parenteral substance abuse. Liver disease in parenteral drug-abusing alcoholics is also multifactorial. The direct hepatotoxic effects of alcohol, the adulterants of illicit, injectable drugs, and infections with the hepatitis B virus, non-A, non-B viruses, and the delta agent may all be contributing factors.

Acquired Immunodeficiency Syndrome↗
PubMedDate not supplied

Explanations and unresolved issues pertaining to the development of the Nuclear Pharmacy Compounding Guidelines.

OBJECTIVES: To provide background information related to the development of the Nuclear Pharmacy Compounding Guidelines, to discuss regulatory complexities related to radiopharmaceutical compounding practice, and to summarize the gaps in the current compounding regulations for radiopharmaceuticals. DATA SOURCES: The Guidelines closely follow the provisions of section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the monographs and chapters related to pharmacy compounding in the United States Pharmacopeia (USP), and the recommended guidelines published by the American Society of Health-System Pharmacists. SUMMARY: The Food and Drug Administration Modernization Act (FDAMA) of 1997 established parameters under which the compounding of drug products is appropriate and lawful, but these criteria expressly do not apply to radiopharmaceuticals. The Nuclear Pharmacy Compounding Practice Committee, a group of nuclear pharmacists convened by the American Pharmaceutical Association, developed the Nuclear Pharmacy Compounding Guidelines to establish a set of principles and guidelines for good radiopharmaceutical compounding practice. The intent of the new document is to provide guidance on radiopharmaceutical compounding practices that have evolved over the last 2 decades and to place them in an appropriate regulatory framework in accordance with previous enforcement policies and guidelines issued by the U.S. Food and Drug Administration (FDA) regarding the exemption of certain pharmacy practices from enforcement of adulteration, misbranding, and new drug requirements. CONCLUSION: The Nuclear Pharmacy Compounding Guidelines, recently released by APhA, is the first official document that provides realistic and practical compounding guidance for nuclear pharmacists. Even though the United States Court of Appeals for the Ninth Circuit recently ruled section 503A of the FD&C Act to be invalid in its entirety, and the Supreme Court upheld that ruling, the compliance policy guides issued by FDA in March 1992 and revised in May 2002 maintain guiding principles on pharmacy compounding similar to those stated in section 503A of the FD&C Act. The Nuclear Pharmacy Compounding Practice Committee is optimistic that the practical information contained in the Guidelines will assist state boards of pharmacy, FDA, and the United States Pharmacopeial Convention in setting appropriate standards for nuclear pharmacy compounding practice that will ensure the continued availability of high-quality compounded radiopharmaceuticals at reasonable cost.

Drug Compounding↗
PubMed1999

Adulteration of urine by "Urine Luck".

BACKGROUND: In vitro adulterants are used to invalidate assays for urine drugs of abuse. The present study examined the effect of pyridinium chlorochromate (PCC) found in the product "Urine Luck". METHODS: PCC was prepared and added to positive urine controls at concentrations of 0, 10, 50, and 100 g/L. The controls were assayed for methamphetamine, benzoylecgonine (BE), codeine and morphine, tetrahydrocannabinol (THC), and phencyclidine (PCP) with the Emit II (Syva) and Abuscreen Online (Roche) immunoassays, and by gas chromatography/mass spectrometry (GC/MS). Two tests were also developed to detect PCC in urine: a spot test to detect chromate ions using 10 g/L 1,5-diphenylcarbazide as the indicator, and a GC/MS assay for pyridine. We tested 150 samples submitted for routine urinalysis, compliance, and workplace drug testing for PCC, using these assays. RESULTS: Response rates decreased at 100 g/L PCC for all Emit II drug assays and for the Abuscreen morphine and THC assays. In contrast, the Abuscreen amphetamine assay produced apparently higher results, and no effect was seen on the results for BE or PCP. The PCC did not affect the GC/MS recovery of methamphetamine, BE, PCP, or their deuterated internal standards, but decreased GC/MS recovery of the opiates at both intermediate (50 g/L) and high (100 g/L) PCC concentrations and apparent concentrations of THC and THC-d3 at all PCC concentrations. Two of 50 samples submitted for workplace drug testing under chain-of-custody conditions were positive for PCC, whereas none of the remaining 100 specimens submitted for routine urinalysis or compliance drug testing were positive. CONCLUSIONS: PCC is an effective adulterant for urine drug testing of THC and opiates. Identification of PCC use can be accomplished with use of a spot test for the oxidant.

False Negative Reactions↗
PubMed1999

[Morphological studies on 18 species of gualoupi].

OBJECTIVE: To gain a clear idea of the drug Gualoupi and its adulterants. METHOD: Collecting data and spot investigating in 30 provinces, cities and autonomous regions in China. RESULT: Gualoupi used as drug in China consists of 15 species of Trichosanthes, 1 species of Momordica, 1 species of Citrullus and 1 species of Adenia(Passifloraceae). CONCLUSION: The main commodity is the rind of T. kirilowii or T. rosthornii, and the main adulterant is the rind of T. hupehensis.

Drug Contamination↗
PubMed1995

CEDIA for screening drugs of abuse in urine and the effect of adulterants.

The performance of the Microgenics CEDIA DAU assays for screening amphetamines, barbiturates, benzodiazepines, cocaine, opiates, phencylidine (PCP), and tetrahydrocannabinol (THC) was evaluated on the Boehringer Mannheim/Hitachi 717 in urine. Limits of detection ranged from 0.6 ng/mL for PCP, to 34.1 ng/mL for benzodiazepines. The average within run and total precision for these assays ranged from 1.3 to 7.3% for controls at cutoff concentrations, and control values at -25% and +25% of cutoffs. The rate separations by CEDIA between the negative and cutoff calibrators for all drugs were greater than corresponding EMIT II (Syva Co.) assays. The relative sensitivity and specificity of CEDIA as compared to EMIT II were 95.6 and 98.8%, respectively, on 13,535 urine samples. All positive samples, and those samples producing discordant results between the assays were confirmed by quantitative gas chromatography/mass spectrometry (GC/MS). Using SAMHSA cutoff limits (and including barbiturates and benzodiazepines at 300 ng/mL), the relative sensitivity and specificity of CEDIA vs. EMIT II were 96.7 and 98.8%, respectively. The overall sensitivity of CEDIA vs. GC/MS was 98.9% with 179 false positives, as compared to 96.2% with 189 false positives for EMIT II vs. GC/MS. The effect of adulterants added to urine to potentially invalidate screening results was also tested. CEDIA produced strong interferences for most drug assays in the presence of glutaraldehyde, detergent, and high concentrations of bleach and Drano. Minimal or selective interferences were seen with golden seal tea lemon juice, Visine, and low concentrations of bleach and Drano. Essentially no interference was observed with bicarbonate, sodium chloride, and vinegar.

Gas Chromatography-Mass Spectrometry↗
PubMedDate not supplied

The effect of glutaraldehyde adulteration of urine specimens on syva EMIT II drugs-of-abuse assays.

The effect of glutaraldehyde (the active component of "UrinAid") on Syva EMIT II drugs-of-abuse screening assays was studied. It was found that, dependent on the assay involved, concentrations of between 0.75 and 2.00% (v/v) of glutaraldehyde in urine could give rise to false-negative screening results. A simple method for identifying urine specimens that have been adulterated with glutaraldehyde, based on final absorbance rate readings (dA/min), is proposed.

Absorption↗
PubMed1990

Medical devices; patient examination and surgeons' gloves; adulteration--FDA. Final rule.

The Food and Drug Administration (FDA) is issuing a final rule to: (1) Define adulteration for patient examination and surgeons' gloves; and (2) establish the sample plans and test method the agency will use to determine if these gloves are adulterated as defined by the rule. With the prevalence of human immunodeficiency virus (HIV) infection and the risk of clinical transmission of other infections, the importance of the quality of an effective barrier to the transmission of infection in health care settings is crucial. The public health will benefit through improved quality control of these protective barriers.

Cross Infection↗