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Official websites use. Share sensitive information only on official, secure websites. This article is published under license to BioMed Central Ltd. Samples were analyzed by visual inspection, registration status, and biochemical analysis. Samples failing to meet all Pharmacopeia quality tests were considered substandard. In the rural provinces, 69 out of samples were substandard, giving an estimated prevalence of substandard drugs of There were 85 unregistered samples, giving a prevalence estimate of unregistered drugs of In the urban Ulaanbaatar districts, out of samples were substandard, giving an estimated prevalence of substandard drugs of There were unregistered samples, giving a prevalence estimate of unregistered drugs of In the rural provinces, 35 out of 85 The prevalence of substandard and unregistered drugs is higher in rural provinces. There is a significant association between substandard and unregistered drugs in the provinces but not in the urban districts. The underlying causes for substandard drugs need to be further investigated in order to help formulate strategies to improve pharmacovigilance and the drug supply quality in Mongolia. Poor quality drugs have been increasingly recognized as a global public health threat because they have the potential to result in inadequate treatment, cause adverse effects from toxic ingredients, and promote drug resistance. The nomenclature of the categories of poor quality medications can be confusing. Fernandez, et al. The true extent of the problem is difficult to ascertain. Reasons for this include the difficulty and expense in performing a methodologically sound study, reluctance of governments to disclose information and the fact that many of the effects on patients are difficult to detect and hidden in other public health statistics Cockburn et al. In his article, Newton states there is an urgent need for data of sufficient sample size, with random sampling design to reliably estimate the prevalence of poor quality medicines Newton, et al. The World Health Organization WHO conducted a survey on the quality of selected anti-malarial medication in 6 subSaharan African countries, which found that Another WHO survey was conducted on the quality of anti-tuberculosis medications in Russia, and found In the current system, the Division of Pharmaceutical and Medical Devices, Mongolian Ministry of Health MoH is responsible for the policy, planning and regulatory affairs in providing pharmaceutical care in Mongolia. The special licenses for manufacturing, importing, purchasing pharmaceuticals and medical devices are granted by the Special Permission Committee of the MoH. Drugs are distributed through drug wholesalers and retail drug outlets community pharmacies and revolving drug funds RDF. Wholesalers can import and procure drugs with an approval and special permission from the Mongolian Minister of Health. In , there were registered drug wholesaling companies and 42 local drug manufacturing companies, some of which act as both wholesalers and retailers. Poor quality drugs have been a concern in Mongolia, supported by the findings from a study on unregistered, falsified and substandard drugs Mongolia Ministry of Health A study by Tsetsegmaa found that 11 of the 16 medications reported in the surveillance were substandard Tsetsegmaa In a report, lack of knowledge about the effectiveness of drug quality monitoring in Mongolia was reported as a gap that should be a priority for further investigation Abdelkrim This research study was undertaken to address these concerns, and provide data of good methodological quality to accurately determine the prevalence of substandard drugs in the rural and urban areas of Mongolia after the decentralization and privatization of the Mongolian pharmaceutical system. This information will be of value to Mongolian policy makers, public health officials and pharmaceutical practitioners to reliably determine the extent of the problem, and then can serve as a valid comparison for future studies to evaluate interventions to improve the drug supply quality. It will also help guide further research to better understand the health impact of poor quality medications in Mongolia. Because the conditions in rural provinces vary greatly from the urban area of Ulaanbaatar, samples were collected, analyzed, and reported independently. Samples for this study were collected from 4 districts in Ulaanbaatar Chingeltei, Khan-Uul, Bayanzurkh, and Songinokhair and 4 rural provinces Bayan-Uglii, Dornogobi, Selenge, and Umnugobi representing the main geographic regions of the country. Samples were obtained from the different types of drug outlets in the provinces: Revolving Drug Fund RDF- a government outlet , retail pharmacy outlets, and wholesalers. In Ulaanbaatar districts, samples were only obtained from retail pharmacy outlets and wholesalers, as RDF outlets are only present in the provinces. Samples from unofficial drug outlets and the informal market were not included in this study. Medications included in the study were selected based on high therapeutic importance and utilization based on discussions with local experts from Schools of Pharmacy, Public Health, and Mongolian National University of Medical Sciences. They are all on the Essential Drug List and available with or without a prescription. All samples were tablets or capsules and include antimicrobials ampicillin, amoxicillin, co-trimoxazole, metronidazole, doxycycline, nystatin , analgesics paracetamol and ibuprofen , and bromhexin, a commonly used medication for respiratory illness Table 1. This calculation was samples for each drug for all drug types combined distributed among the provinces or districts. The sampling strategy included weighting the sample size by population and the number of the types of drug outlets in the province or district. Drug outlets to be sampled were selected randomly. A sample was defined as dosage units tablet or capsule of a given drug of the same lot number purchased in blister packs of 10 dosage units. These were trained field workers, who presented themselves as local customers, and followed the study protocol for obtaining drug samples based on recommended sampling techniques Newton et al. If they were unable to purchase the necessary quantity for a complete sample from one batch or lot, this was noted and attempts were made to purchase it from another randomly selected outlet of the same type. Collected samples were placed in a box, then transported to and stored in lockers at the School of Pharmacy, Mongolian National University of Medical Sciences. The transport box and lockers met the temperature and humidity requires of the WHO Guidelines for the Sampling of Pharmaceutical Products, and were accessible only by the main study investigator. Sample analysis for each sample consisted of visual inspection of the packaging and labeling, and determination of registration status, expiration date, country of manufacture, biochemical analysis, and company of manufacture. An online database developed by the Ministry of Health in Mongolia Licemed and archive documents from the registration of drugs were used to complete the visual inspection. The database includes information such as size, color, labeling and numbers of the packages and labeling. World Health Organization A sample was considered suspicious if the package and labeling was not consistent with registered information for that drug and manufacturer. Samples with suspicious packaging and labeling were sent to the manufacturers for confirmation. If the manufacturer confirmed that it was their product, the sample was considered acceptable. The registration status of all samples was determined by visual inspection of the packaging, and then confirmed using the drug registration archives at the Mongolian Ministry of Health. Registration was not considered a requirement for determining whether or not a sample was substandard. These laboratories are accredited by the Standardization and Technical Regulatory Office of the Centre for Standardization and Measurement in Mongolia, which is responsible for the technical standards in local production and quality control. The Pharmacopoeias were chosen according the country of origin of the sample or specification requirements of the manufacturer Table 1. These requirements vary by drug, and include 8—11 of the following tests: appearance, assay, disintegration, dissolution, hardness, identification, irradiance absorption, water, friability, weight average and weight variation Table 2. The qualitative analysis included: 1. Quantitative analysis included assay of active compounds by spectrophotometric, titrometric and chromatographic methods. A sample was considered to be substandard if it failed to pass all required tests for the drug required by the article requirements in the Pharmacopeia used, that is, if the sample failed one or more of the required tests it was considered substandard. The number of samples collected for this study was from the rural provinces and from the urban districts of Ulaanbaatar. The distribution of the samples based on location by drug outlet type is presented in Table 3 , and location by drug in Table 4. Out of samples from the rural provinces, only 3 were found to be past expiration date. There were 4 others that expired within the data collection period of May to August , so may have recently expired. Out of samples from the Ulaanbaatar districts, none were found to be past expiration date. On initial inspection, 22 drug samples from the rural provinces and urban districts combined were found to have variation in the packaging and labeling of the drugs when compared with the products registered in Mongolia. Upon review by the manufacturer, all 22 were found to be acceptable or meeting standards due to packaging updates. Failure to pass the assay test e. Failure to pass this test indicates that the sample did not meet the threshold requirements regarding amount of drug present and does not give any information about the degree or direction of deviation from the required standard Table 5. In the provincial group, 51 out of The other common reasons were weight variation and weight average. There were a few samples failing tests for dissolution, disintegration and friction Table 6. In the Ulaanbaatar district samples, 55 out of 6. The other common reasons were disintegration and dissolution. There were a few samples that failed the following tests weight variation, weight average, and friction Table 7. Out of samples collected from all 4 rural provinces, 69 were classified as substandard. This gives a substandard drug prevalence rate of Out of samples collected from all 4 urban districts of Ulaanbaatar, were classified as substandard. This gives a prevalence rate of Out of samples collected from the 4 provinces, 85 were unregistered. This gives a prevalence estimate of unregistered drugs in the provinces of Out of the 85 unregistered samples, 35 were substandard Out of samples, collected from the 4 districts of Ulaanbaatar, were unregistered. This gives a prevalence estimate of unregistered drugs in the Ulaanbaatar districts of Out of unregistered samples, 18 were substandard Our results provide prevalence estimates for substandard drugs in Mongolia of While our study design does not allow us to directly compare these results from these 2 regions, it is interesting to note a modestly higher prevalence of substandard drugs in the rural sample. We also noted a significant association between substandard and unregistered drugs in the provinces, but not in the urban districts. Our prevalence estimates of substandard drugs of The most common reason for a sample to be substandard was failure to pass assay test, which is consistent with the findings of other studies Almuzaini et al. Failure to pass the assay test, along with failure to pass the disintegration and dissolution tests, the other most common reasons in our study, indicates that the bioavailability of the active ingredients was compromised. This can lead to ineffective treatment, and in the case of antibiotics, promote drug resistance. Of note, almost none of the samples were found to be post-expiration date, suggesting other factors are contributing to the degradation in drug quality. Further investigation into drug transport and storage conditions may help better understand this, especially given the extreme weather conditions found in Mongolia. Another interesting finding of our study was the This raises the importance of further investigation of the drug supply chain and evaluation of drug regulatory policies. Such initiatives could be undertaken at the national level and through collaborations with neighboring countries. We believe this may be an especially important step to improve the quality of the drug supply in the provinces where there was a statistically significant association between unregistered and substandard drug samples. An adequate sample size is essential to obtaining valid results. However, there are some weaknesses in our study that could underestimate our prevalence estimates. These include the potential for drug outlet personnel to selectively provide drugs if they were suspicious about the reason for the purchase, and excluding drug samples from the unlicensed market, where the prevalence of substandard drugs has found to be significantly higher Almuzaini et al. Another potential issue is that the biochemical analysis was performed at 3 different drug testing laboratories in Mongolia. Although they all used the same Pharmacoepeia standards, the possibility of variability in testing between facilities exists. Because of budgetary constraints, only 4 substandard samples 2. These 4 samples were all verified as correctly classified, but it is not a large enough number and did not include any acceptable samples, therefore we cannot claim to validate our findings by outside reference laboratory testing. Another important limitation of our study is that it does not provide any details about the degree of variation from the threshold requirements of the Pharmacopeia quality standards. Our study also does not provide any information about the presence of harmful ingredients. Because of this, our ability to make any inferences about the potential clinical, safety, or economic impact of the substandard drugs in Mongolia is limited, but it does support the need for increased pharmacovigilance and review of drug regulatory policies. Further details of the biochemical analysis of the substandard samples, particularly the degree and direction of the deviation of the samples failing the assay, could provide additional valuable insight into the public health impact of poor drug quality. Our findings indicate that the presence of substandard drugs raise a genuine concern in both urban and rural areas of Mongolia. In addition, we found that unregistered drugs are common in both areas, with a significant association between substandard and unregistered drugs in the rural provinces. This highlights an important opportunity to improve the quality of the drug supply in Mongolia by reviewing and enforcing drug registration and inspection polices. Improving drug storage conditions and importation monitoring at borders are other interventions that can potentially improve drug supply quality, especially in rural provinces. Other areas for further investigation to better understand the quality of the drug supply in Mongolia would be to determine the degree of variation in the assay results for substandard drug samples, sampling the unlicensed market, and investigating the drug supply chain, especially in the provinces. Another important area for further study of the public health impact of substandard drugs is evaluating the patterns of antibiotic resistance and health outcomes for people living in areas with a high prevalence of substandard drugs. These organizations were not involved in the study design; in the collection, analysis, and interpretation of data; writing of the manuscript; and the decision to submit the manuscript for publication. DK: Contributed to conception and design of research, acquisition and analysis of data, drafting and revising manuscript, final approval of manuscript. GD: Contributed to conception and design of research, acquisition and analysis of data, revising manuscript, final approval of manuscript. EB: Contributed to acquisition and analysis of data, revising manuscript, final approval of manuscript. MC: Contributed to acquisition and analysis of data, revising manuscript, final approval of manuscript. TS: Contributed to conception and design of research, acquisition and analysis of data, revising manuscript, final approval of manuscript. TM: Contributed to conception and design of research, drafting and revising manuscript, final approval of manuscript. MM: Contributed to design of research, analysis of data, revising manuscript, final approval of manuscript. KM: Contributed to conception and design of research, acquisition and analysis of data, drafting and revising manuscript, final approval of manuscript. As a library, NLM provides access to scientific literature. Find articles by Daariimaa Khurelbat. Find articles by Gereltuya Dorj. Find articles by Enkhtuul Bayarsaikhan. Find articles by Munkhdelger Chimedsuren. Find articles by Tsetsegmaa Sanjjav. Find articles by Takeshi Morimoto. Find articles by Michael Morley. Find articles by Katharine Morley. Received Sep 25; Accepted Nov 17; Collection date Open in a new tab. Test Definition Appearance Clean, smooth surface and uniform color of tablet or capsule Friction and substantial Tablet crushing strength Weight average Average weight of 20 tablets Weight variation Difference between the weight of the content of each solid form and the average weight of solid forms Disintegration Disintegration or disbursement of solid preparations into fragments or particles in a liquid medium Dissolution Rate and degree of dissolution of active ingredients in liquid medium Content uniformity Contents of single ingredient solid preparations Water Loss on drying Determine water loss on drying Identification Verify identity by visual inspection Irradiance absorption Absorbance in the ultraviolet region Assay Determine content of active ingredients. Sample analysis for drugs by acceptability from rural provinces. Sample analysis for drugs by acceptability from urban districts. Prevalence of unregistered drug samples by location. Substandard samples by location and registration status. Competing interests The authors declare that they have no competing interests. Similar articles. Add to Collections. Create a new collection. Add to an existing collection. Choose a collection Unable to load your collection due to an error Please try again. Add Cancel. Mongolian National Pharmacopeia British Pharmacopeia Difference between the weight of the content of each solid form and the average weight of solid forms. Disintegration or disbursement of solid preparations into fragments or particles in a liquid medium.
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How can I buy cocaine online in Ulaanbaatar
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How can I buy cocaine online in Ulaanbaatar
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