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1.
J Pharm Biomed Anal ; 177: 112872, 2020 Jan 05.
Artículo en Inglés | MEDLINE | ID: mdl-31525574

RESUMEN

It is often reported that falsified medicines have harmful effects on patients both Japan and abroad. In this study, we purchased vardenafil tablets on the internet and investigated their quality and authenticity using visual observations, authenticity investigations, non-destructive tests (handheld NIR and Raman spectroscopy), and quality analyses (active ingredient content and tablet dissolution rate). We used genuine 20-mg Levitra tablets that were sold in Japan and tablets from Bayer AG (Germany) as controls. In April 2015, we obtained 28 samples from 15 websites on the internet. Our authenticity investigations revealed that 11 (40%) were genuine products and 17 (60%) were falsified products. Handheld NIR and Raman results revealed that the falsified products had different spectra to the genuine products. Principal component analysis of the NIR and Raman spectra showed variation among the falsified products. The 11 genuine products were of good quality, and the 17 falsified products were of poor quality. The falsified products contained sildenafil (the active ingredient of Viagra) or tadalafil (the active ingredient of Cialis) instead of vardenafil. Our results show that falsified Vardenafil tablets are sold on the internet and that it is important to prevent illegal internet sales and increase consumer awareness of the presence of falsified medicines.


Asunto(s)
Medicamentos Falsificados/análisis , Disponibilidad de Medicamentos Vía Internet/normas , Control de Calidad , Agentes Urológicos/análisis , Diclorhidrato de Vardenafil/análisis , Medicamentos Falsificados/química , Medicamentos Falsificados/economía , Humanos , Japón , Disponibilidad de Medicamentos Vía Internet/economía , Análisis de Componente Principal , Citrato de Sildenafil/análisis , Espectrometría Raman , Comprimidos , Tadalafilo/análisis , Agentes Urológicos/química , Agentes Urológicos/economía , Agentes Urológicos/normas , Diclorhidrato de Vardenafil/química
3.
J Med Internet Res ; 20(4): e10029, 2018 04 27.
Artículo en Inglés | MEDLINE | ID: mdl-29613851

RESUMEN

BACKGROUND: On December 6 and 7, 2017, the US Department of Health and Human Services (HHS) hosted its first Code-a-Thon event aimed at leveraging technology and data-driven solutions to help combat the opioid epidemic. The authors­an interdisciplinary team from academia, the private sector, and the US Centers for Disease Control and Prevention­participated in the Code-a-Thon as part of the prevention track. OBJECTIVE: The aim of this study was to develop and deploy a methodology using machine learning to accurately detect the marketing and sale of opioids by illicit online sellers via Twitter as part of participation at the HHS Opioid Code-a-Thon event. METHODS: Tweets were collected from the Twitter public application programming interface stream filtered for common prescription opioid keywords in conjunction with participation in the Code-a-Thon from November 15, 2017 to December 5, 2017. An unsupervised machine learning­based approach was developed and used during the Code-a-Thon competition (24 hours) to obtain a summary of the content of the tweets to isolate those clusters associated with illegal online marketing and sale using a biterm topic model (BTM). After isolating relevant tweets, hyperlinks associated with these tweets were reviewed to assess the characteristics of illegal online sellers. RESULTS: We collected and analyzed 213,041 tweets over the course of the Code-a-Thon containing keywords codeine, percocet, vicodin, oxycontin, oxycodone, fentanyl, and hydrocodone. Using BTM, 0.32% (692/213,041) tweets were identified as being associated with illegal online marketing and sale of prescription opioids. After removing duplicates and dead links, we identified 34 unique "live" tweets, with 44% (15/34) directing consumers to illicit online pharmacies, 32% (11/34) linked to individual drug sellers, and 21% (7/34) used by marketing affiliates. In addition to offering the "no prescription" sale of opioids, many of these vendors also sold other controlled substances and illicit drugs. CONCLUSIONS: The results of this study are in line with prior studies that have identified social media platforms, including Twitter, as a potential conduit for supply and sale of illicit opioids. To translate these results into action, authors also developed a prototype wireframe for the purposes of detecting, classifying, and reporting illicit online pharmacy tweets selling controlled substances illegally to the US Food and Drug Administration and the US Drug Enforcement Agency. Further development of solutions based on these methods has the potential to proactively alert regulators and law enforcement agencies of illegal opioid sales, while also making the online environment safer for the public.


Asunto(s)
Analgésicos Opioides/provisión & distribución , Sustancias Controladas/provisión & distribución , Aprendizaje Automático/normas , Disponibilidad de Medicamentos Vía Internet/normas , Mal Uso de Medicamentos de Venta con Receta/prevención & control , Humanos , Internet , Mercadotecnía , Medios de Comunicación Sociales
4.
Trop Med Int Health ; 23(3): 263-269, 2018 03.
Artículo en Inglés | MEDLINE | ID: mdl-29314458

RESUMEN

OBJECTIVE: To evaluate the quality of omeprazole personally imported into Japan via the Internet and to compare the quality of these samples with previously collected samples from two other Asian countries. METHODS: The samples were evaluated by observation, authenticity investigation and pharmacopoeial quality analysis. Quality comparison of some selected samples was carried out by dissolution profiling, Raman spectroscopy and principle component analysis (PCA). RESULTS: Observation of the Internet sites and samples revealed some discrepancies including the delivery of a wrong sample and the selling of omeprazole without a prescription, although it is a prescription medicine. Among the 28 samples analysed, all passed the identification test, 26 (93%) passed the quantity and content uniformity tests and all passed the dissolution test. Dissolution profiling confirmed that all the personally imported omeprazole samples remained intact in the acid medium. On the other hand, six samples from two of the same manufacturers, previously collected during surveys in Cambodia and Myanmar, frequently showed premature omeprazole release in acid. Raman spectroscopy and PCA showed significant variation between omeprazole formulations in personally imported samples and the samples from Cambodia and Myanmar. CONCLUSIONS: Our results indicate that the pharmaceutical quality of omeprazole purchased through the Internet was sufficient, as determined by pharmacopeial tests. However, omeprazole formulations distributed in different market segments by the same manufacturers were of diverse quality. Measures are needed to ensure consistent quality of products and to prevent entry of substandard products into the legitimate supply chain.


Asunto(s)
Antiulcerosos/análisis , Química Farmacéutica/métodos , Composición de Medicamentos/normas , Omeprazol/análisis , Disponibilidad de Medicamentos Vía Internet/normas , Evaluación de Medicamentos/métodos , Humanos , Japón , Control de Calidad
5.
Eur J Clin Pharmacol ; 74(3): 349-356, 2018 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-29198063

RESUMEN

PURPOSE: Gamma-hydroxybutyrate (GHB) withdrawal is a life-threatening condition that does not always respond to standard treatment with benzodiazepines. Baclofen has potential utility as a pharmacological adjunct and anecdotal reports suggest that it is being used by drug users to self-manage GHB withdrawal symptoms. Here, we investigate current patterns of use and the online availably of baclofen. METHODS: Data triangulation techniques were applied to published scientific literature and publicly accessible Internet resources (grey literature) to assess the use of baclofen in GHB withdrawal. An Internet snapshot survey was performed to identify the availability of baclofen for online purchase and the compliance of retailers with the UK regulations. Data were collected according to pre-defined criteria. RESULTS: A total of 37 cases of baclofen use in GHB withdrawal were identified in the scientific literature, as well as 51 relevant discussion threads across eight Internet forums in the grey literature. Baclofen was available to purchase from 38 online pharmacies, of which only one conformed to the UK regulations. CONCLUSIONS: There is limited published evidence on the use of baclofen in GHB withdrawal, but both scientific and grey literature suggests clinical utility. Online pharmacies are readily offering prescription-only-medication without prescription and due to inadequate regulation, pose a danger to the public.


Asunto(s)
Baclofeno/uso terapéutico , Agonistas de Receptores GABA-B/uso terapéutico , Internet , Pautas de la Práctica en Medicina , Psicotrópicos/toxicidad , Oxibato de Sodio/toxicidad , Síndrome de Abstinencia a Sustancias/tratamiento farmacológico , Animales , Baclofeno/economía , Baclofeno/normas , Baclofeno/provisión & distribución , Investigación Biomédica/métodos , Tráfico de Drogas/economía , Agonistas de Receptores GABA-B/economía , Agonistas de Receptores GABA-B/normas , Agonistas de Receptores GABA-B/provisión & distribución , Humanos , Internet/economía , Internet/ética , Disponibilidad de Medicamentos Vía Internet/economía , Disponibilidad de Medicamentos Vía Internet/ética , Disponibilidad de Medicamentos Vía Internet/normas , Medicamentos bajo Prescripción/economía , Medicamentos bajo Prescripción/normas , Medicamentos bajo Prescripción/provisión & distribución , Medicamentos bajo Prescripción/uso terapéutico , Medios de Comunicación Sociales/economía , Medios de Comunicación Sociales/ética , Reino Unido
6.
Psychiatry Res ; 260: 248-254, 2018 02.
Artículo en Inglés | MEDLINE | ID: mdl-29220682

RESUMEN

The use of online pharmacies to purchase prescription drugs is increasing. The patient experience when searching to buy commonly prescribed psychiatric drugs was investigated. Using the search term "buy [drug name] online" in Google, 38 frequently prescribed drugs, including 13 with a high potential for abuse, were searched by brand and generic names. The first page of results were analyzed, including with pharmacy certification checkers and ICANN WHOIS. Search results for all drugs yielded 167 pharmacies, of which 147 (88%) did not require a prescription. Considering all searches, the average number of pharmacies requiring a prescription was 2.7 for a brand name drug and 2.4 for a generic name. A phrase like "buy without a prescription" usually appeared on the search results page. All results for drugs with a high potential for abuse were for illegal pharmacies. Information from certification agencies was often conflicting. Most pharmacies were registered internationally. Patients searching online to purchase prescription psychiatric drugs are presented predominantly with illegal pharmacies, and find conflicting certification data. Patient education should address typical search results. Societal pressures may increase the use of online pharmacies including prescription drug costs, stigma, loss of trust in expert opinion, and the changing patient role.


Asunto(s)
Internet/estadística & datos numéricos , Disponibilidad de Medicamentos Vía Internet/estadística & datos numéricos , Medicamentos bajo Prescripción , Psicotrópicos , Humanos , Internet/legislación & jurisprudencia , Internet/normas , Disponibilidad de Medicamentos Vía Internet/legislación & jurisprudencia , Disponibilidad de Medicamentos Vía Internet/normas , Medicamentos bajo Prescripción/provisión & distribución , Psicotrópicos/provisión & distribución
7.
BMC Med Inform Decis Mak ; 17(1): 31, 2017 03 27.
Artículo en Inglés | MEDLINE | ID: mdl-28347304

RESUMEN

BACKGROUND: The rising prevalence of chronic diseases is pressing health systems to introduce reforms. Primary healthcare and multidisciplinary models have been suggested as approaches to deal with this challenge, with new roles for nurses and pharmacists being advocated. More recently, implementing healthcare based on information systems and technologies (e.g. eHealth) has been proposed as a way to improve health services. However, implementing online pharmaceutical services, including their adoption by pharmacists and patients, is still an open research question. In this paper we present ePharmacare, a new online pharmaceutical service implemented using Design Science Research. METHODS: The Design Science Research Methodology (DSRM) was chosen to implement this online service for chronic diseases management. In the paper, DSRM's different activities are explained, from the definition of the problem to the evaluation of the artifact. During the design and development activities, surveys, observations, focus groups, and eye-tracking glasses were used to validate pharmacists' and patients' requirements. During the demonstration and evaluation activities the new service was used with real-world pharmacists and patients. RESULTS: The results show the contribution of DSRM in the implementation of online services for pharmacies. We found that pharmacists spend only 50% of their time interacting with patients, uncovering a clear opportunity to implement online pharmaceutical care services. On the other hand, patients that regularly visit the same pharmacy recognize the value in patient follow-up demanding to use channels such as the Internet for their pharmacy interactions. Limitations were identified regarding the high workload of pharmacists, but particularly their lack of know-how and experience in dealing with information systems (IST) for the provision of pharmaceutical services. CONCLUSIONS: This paper summarizes a research project in which an online pharmaceutical service was proposed, designed, developed, demonstrated and evaluated using DSRM. The main barriers for pharmacists' adoption of online pharmaceutical services provision were the lack of time, time management and information systems usage skills, as well as a precise role definition within pharmacies. These problems can be addressed with proper training and services reorganization, two proposals to be investigated in future works.


Asunto(s)
Actitud del Personal de Salud , Investigación sobre Servicios de Salud/métodos , Satisfacción del Paciente , Disponibilidad de Medicamentos Vía Internet/normas , Proyectos de Investigación/normas , Adulto , Humanos , Farmacéuticos
8.
J Antimicrob Chemother ; 72(5): 1521-1528, 2017 05 01.
Artículo en Inglés | MEDLINE | ID: mdl-28333179

RESUMEN

Background: Improved antibiotic stewardship (AS) and reduced prescribing in primary care, with a parallel increase in personal internet use, could lead citizens to obtain antibiotics from alternative sources online. Objectives: A cross-sectional analysis was performed to: (i) determine the quality and legality of online pharmacies selling antibiotics to the UK public; (ii) describe processes for obtaining antibiotics online from within the UK; and (iii) identify resulting AS and patient safety issues. Methods: Searches were conducted for 'buy antibiotics online' using Google and Yahoo. For each search engine, data from the first 10 web sites with unique URL addresses were reviewed. Analysis was conducted on evidence of appropriate pharmacy registration, prescription requirement, whether antibiotic choice was 'prescriber-driven' or 'consumer-driven', and whether specific information was required (allergies, comorbidities, pregnancy) or given (adverse effects) prior to purchase. Results: Twenty unique URL addresses were analysed in detail. Online pharmacies evidencing their location in the UK ( n = 5; 25%) required a prescription before antibiotic purchase, and were appropriately registered. Online pharmacies unclear about the location they were operating from ( n = 10; 50%) had variable prescription requirements, and no evidence of appropriate registration. Nine (45%) online pharmacies did not require a prescription prior to purchase. For 16 (80%) online pharmacies, decisions were initially consumer-driven for antibiotic choice, dose and quantity. Conclusions: Wide variation exists among online pharmacies in relation to antibiotic practices, highlighting considerable patient safety and AS issues. Improved education, legislation, regulation and new best practice stewardship guidelines are urgently needed for online antibiotic suppliers.


Asunto(s)
Antibacterianos , Internet , Disponibilidad de Medicamentos Vía Internet/estadística & datos numéricos , Programas de Optimización del Uso de los Antimicrobianos/legislación & jurisprudencia , Programas de Optimización del Uso de los Antimicrobianos/normas , Estudios Transversales , Humanos , Disponibilidad de Medicamentos Vía Internet/legislación & jurisprudencia , Disponibilidad de Medicamentos Vía Internet/normas , Medicamentos bajo Prescripción , Reino Unido
9.
Int J Clin Pharm ; 39(1): 78-87, 2017 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-27888454

RESUMEN

Background Growth hormones are widely available on the Internet for those who want to enhance their physical performance and improve body satisfaction. Illegitimate websites market somatropin injections without medical prescription and encourage misuse. Customers potentially put their health at risk when purchasing parenteral medications online. Objective The objective of our study was to evaluate the online market of no-prescription somatropin products and to analyse and document Internet pharmacy characteristics, distribution and pharmaceutical quality. Setting Websites indexed in Google promoting somatropin for sale direct to patients. Method Websites promoting the sale of growth hormone products were identified and analysed from June to August 2014. Internet vendor sites were evaluated to identify possible patient and medication safety concerns. Website characteristics, delivery time, storage conditions, packaging and attached product information were assessed. Investigation of the somatropin content was achieved using capillary electrophoresis with UV detection and electrospray ionization mass spectrometry. Main outcome measure Accessibility and quality of somatropin injections. Results Seventeen individual Internet vendor websites distributed somatropin products directly to patients, majority (94%) did not require a valid medical prescription before dispensing the products. Majority (70%) of Internet pharmacies displayed no medical information and none (0%) of the vendors displayed any regulatory body logo. All online samples had significantly (p < 0.001) lower somatropin concentration than labelled. Conclusion Our results clearly illustrate that prescription only biologic drugs are widely available online and can be easily accessed by anyone. Unprofessional distribution and handling is likely to cause degradation and possible patient safety concerns.


Asunto(s)
Medicamentos Falsificados , Hormona de Crecimiento Humana/normas , Internet/normas , Disponibilidad de Medicamentos Vía Internet/normas , Medicamentos bajo Prescripción/normas , Humanos , Internet/legislación & jurisprudencia , Disponibilidad de Medicamentos Vía Internet/legislación & jurisprudencia
10.
Optom Vis Sci ; 93(10): 1196-202, 2016 10.
Artículo en Inglés | MEDLINE | ID: mdl-27536974

RESUMEN

PURPOSE: To compare spectacles bought online with spectacles from optometry practices. METHODS: Thirty-three participants consisting of single vision spectacle wearers with either a low (N = 12, mean age 34 ± 14 years) or high prescription (N = 11, mean age 28 ± 9 years) and 10 presbyopic participants (mean age 59 ± 4 years) wearing progressive addition lenses (PALs) purchased 154 pairs of spectacles online and 154 from UK optometry practices. The spectacles were compared via participant-reported preference, acceptability, and safety; the assessment of lens, frame, and fit quality; and the accuracy of the lens prescriptions to international standard ISO 21987:2009. RESULTS: Participants preferred the practice spectacles (median ranking 4th, IQR 1-6) more than online (6th, IQR 4-8; Mann-Whitney U = 7345, p < 0.001) and practice PALs (median ranking 2nd, IQR 1-4) were particularly preferred (online 6.5th, IQR 4-9, Mann-Whitney U = 455, p < 0.001). Of those deemed unacceptable and unsafe, significantly more were bought online (unacceptable: online 43/154 vs. practice 15/154, Fisher's exact p = 0.0001; unsafe: online 14/154 vs. practice 5/154, Fisher's exact p = 0.03). CONCLUSIONS: Participants preferred spectacles from optometry practice rather than those bought online, despite lens quality and prescription accuracy being similar. A greater number of online spectacles were deemed unsafe or unacceptable because of poor spectacle frame fit, poor cosmetic appearance, and inaccurate optical centration. This seems particularly pertinent to PAL lenses, which are known to increase falls risk. Recommendations are made to improve both forms of spectacle provision.


Asunto(s)
Comportamiento del Consumidor/estadística & datos numéricos , Anteojos/normas , Optometría/normas , Prioridad del Paciente/estadística & datos numéricos , Disponibilidad de Medicamentos Vía Internet/normas , Prescripciones/normas , Adulto , Publicidad Directa al Consumidor , Femenino , Humanos , Masculino , Persona de Mediana Edad , Sistemas en Línea , Ajuste de Prótesis , Agudeza Visual , Adulto Joven
12.
J Affect Disord ; 193: 59-65, 2016 Mar 15.
Artículo en Inglés | MEDLINE | ID: mdl-26766033

RESUMEN

BACKGROUND: There is increasing use of online pharmacies to purchase prescription drugs. While some online pharmacies are legitimate and safe, there are many unsafe and illegal so-called "rogue" online pharmacies. This study investigated the availability of psychotropic drugs online to consumers in the US, using 5 commonly prescribed drugs for bipolar disorder. METHODS: Using the search term "buy [drug name]" in the Google, Yahoo and Bing search engines, the characteristics of the online pharmacies found on the first two pages of search results were investigated. The availability of the requested dosage and formulations of two brand (Seroquel XR, Abilify) and three generic drugs (lamotrigine, lithium carbonate and bupropion SR) were determined. RESULTS: Of 30 online pharmacies found, 17 (57%) were rated as rogue by LegitScript. Of the 30 pharmacies, 15 (50%) require a prescription, 21 (70%) claim to be from Canada, with 20 of these having a Canadian International Pharmacy association (CIPA) seal on the website. Only 13 of the 20 sites with a CIPA seal were active CIPA members. There were about the same number of trust verification seals on the rogue and legitimate pharmacy sites. Some rogue pharmacies are professional in appearance, and may be difficult for consumers to recognize as rogue. All five brand and generic drugs were offered for sale online, with or without a prescription. However, many substitutions were presented such as different strengths and formulations including products not approved by the FDA. LIMITATIONS: No evaluation of product quality, packaging or purchasing. CONCLUSIONS: Psychotropic medications are available online with or without a prescription. The majority of online pharmacy websites were rogue. Physicians should ask about the use of online pharmacies. For those who choose to use online pharmacies, two measures to detect rogue pharmacies are recommended: (1) only purchase drugs from pharmacies that require a prescription, and (2) check all pharmacy verification seals directly on the website of the certifying organization, every time, before purchase.


Asunto(s)
Trastorno Bipolar/tratamiento farmacológico , Disponibilidad de Medicamentos Vía Internet/estadística & datos numéricos , Medicamentos bajo Prescripción/provisión & distribución , Psicotrópicos/provisión & distribución , Canadá , Prescripciones de Medicamentos/estadística & datos numéricos , Humanos , Disponibilidad de Medicamentos Vía Internet/legislación & jurisprudencia , Disponibilidad de Medicamentos Vía Internet/normas , Medicamentos bajo Prescripción/uso terapéutico , Psicotrópicos/uso terapéutico , Estados Unidos
14.
Int J Clin Pharm ; 37(1): 148-58, 2015 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-25564180

RESUMEN

BACKGROUND: Evidence suggests that consumers potentially put themselves at risk when purchasing medicines on-line. Whilst logos provided by regulators may provide some level of reassurance there may be other indicators which could be used by consumers to identify those websites which may be safely used. OBJECTIVES: Identify characteristics of on-line pharmacies which are related to whether websites are regulated or non-regulated and those characteristics which could be used by patients to increase the likelihood of accessing regulated sites. SETTING: Online pharmacies which supply diazepam, fluoxetine and simvastatin. METHODS: Using piloted search terms via Google and Yahoo search engines, identified websites were screened for regulatory status, adherence to regulatory standards, administrative requirements, clinical assessment requirements and additional details deemed to be of relevance to a user. Characteristics of regulated and non-regulated (defined as those with an absence of a correctly linked regulatory logo) websites were compared to identify differences which could be used to improve patient safety. MAIN OUTCOME MEASURE: Regulatory status, adherence to regulatory standards, quality of information provision, barriers to medicines access. RESULTS: 113 websites sold diazepam, fluoxetine and simvastatin; were identified within the first 100 results. Less than quarter were found to be regulated online pharmacies. 80 websites were willing to sell the medication without a prescription. The unregulated internet pharmacy websites (defined as those with an absence of a correctly linked regulatory logo) were found to adhere more closely to the clinical criteria, were less significantly likely to disclose a contact name and address, telephone number of the pharmacy or demand a prescription prior to sale (P < 0.05, Fisher's Exact). CONCLUSIONS: The three prescription-only medicines which are liable to abuse, have potentially serious interactions and require counselling to ensure patient safety are readily available via the internet. When purchasing medicines via this route UK consumers should be made aware of the importance of regulatory logos and additionally should ensure that the seller can be meaningfully contacted by the contact details provided. The provision of clinical information should not be used alone as an indication of the seller's provenance.


Asunto(s)
Internet/normas , Seguridad del Paciente/normas , Disponibilidad de Medicamentos Vía Internet/normas , Medicamentos bajo Prescripción/normas , Humanos , Internet/economía , Seguridad del Paciente/economía , Disponibilidad de Medicamentos Vía Internet/economía , Proyectos Piloto , Medicamentos bajo Prescripción/economía , Reino Unido/epidemiología
15.
J Clin Pharm Ther ; 40(1): 68-75, 2015 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-25381836

RESUMEN

WHAT IS KNOWN AND OBJECTIVE: Generic manufacturers help decrease the cost of antiretroviral (ARV) and antimicrobial medications which are used to treat opportunistic infections (OIs) in developing countries. Concerns have been expressed about potential quality issues with such medications as a result of the identification of numerous counterfeit medications in developing countries. However, few studies have assessed the quality of these medications using the United States Pharmacopeia (USP) compendial standards. The goal of this study was to assess the quality of ARV and OI medications obtained from various sources, including South Africa, United States, China, Ethiopia, Thailand, Laos, Mexico, Nigeria and five Internet pharmacies. METHODS: Zidovudine, lamivudine, efavirenz, nevirapine, isoniazid and sulfamethoxazole/trimethoprim tablets/capsules were obtained from eight countries and five Internet pharmacies. The tablets/capsules were separated into distinct samples, based on the drug's active ingredient, manufacturer and drug control number. Each distinct sample was analysed for drug content, dissolution, content uniformity and breaking force using USP 32-National Formulary 27 (USP 32-NF 27) compendial methods and compared to the USP standards. RESULTS AND DISCUSSION: A total of 2027 tablets/capsules were obtained with 88 distinct samples identified. All samples met the USP 32-NF 27 standards for drug content with a range of 92.7-108.6%. Six of the 88 samples failed the dissolution test by 1.5-8.3% below the standard range. Ninety-eight per cent of all 88 samples met the USP criteria for content uniformity based on weight variation. One sample of isoniazid was found to have a low breaking force of 2.8 kiloponds. The results of this study show that there were no problems with the samples of ARV and OI medications tested for drug quality from the specified locations. As there are many studies and reports that discuss the poor quality of generic medications with only a few assessing drug quality, the implications of this study's results are to: (i) help better understand patient outcomes; (ii) help patients gain access to beneficial medications for HIV and OIs; and (iii) ensure an overall increase in access to medications where needed. WHAT IS NEW AND CONCLUSION: This study is one of the largest to date concerning medication type and sample size for the assessment of ARV and OI medications using drug content as a measure of quality. The samples were obtained from more diverse geographical locations compared to previous studies and, for the first time, included Internet pharmacies. In addition to drug content, this study evaluated a more complete quality profile including dissolution, content uniformity and breaking force. This study showed that drug quality should be assessed consistently in order to better identify counterfeit medications compared to current assessments and that there should be uniform guidelines for how to assess quality.


Asunto(s)
Antiinfecciosos/normas , Antirretrovirales/normas , Medicamentos Genéricos/normas , Internet , Disponibilidad de Medicamentos Vía Internet/normas , Farmacias/normas , Calidad de la Atención de Salud/normas , China , Países en Desarrollo , Etiopía , Humanos , Laos , México , Nigeria , Infecciones Oportunistas/tratamiento farmacológico , Sudáfrica , Tailandia , Estados Unidos
16.
Pharmacoepidemiol Drug Saf ; 23(4): 411-8, 2014 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-24493556

RESUMEN

PURPOSE: The increase in online purchasing of medications raises safety concerns regarding teratogenic drugs. The use of the teratogenic drug 'isotretinoin' for women of childbearing age requires strict adherence to the Pregnancy Prevention Programme (PPP), a risk minimisation measure imposed on prescribers and users. We sought to determine how readily consumers can purchase isotretinoin online and the associated safety procedures and information. METHODS: A descriptive cross-sectional survey was conducted of 50 e-pharmacies identified from commonly used search engines. E-pharmacy characteristics and isotretinoin PPP specific criteria were evaluated. Purchases of isotretinoin from seven e-pharmacies not bearing authentication logos and not requiring a prescription were assessed for PPP policy adherence, purchasing procedures and compound quality. RESULTS: Forty-three (86%) of the e-pharmacies did not have an authentication seal/logo. Isotretinoin could be purchased from 42 sites without a valid prescription. Information on isotretinoin causing birth defects was lacking in 25 of the 50 sites, on not taking isotretinoin in pregnancy in 24 sites and not taking isotretinoin if planning or at risk of a pregnancy in 33 sites. Of the eight attempted purchases, seven arrived, all without any patient information leaflet. All were verified as isotretinoin. CONCLUSION: The Internet provides a loophole for purchasing of medications known to cause congenital abnormalities, which needs to be addressed by medicines regulatory agencies worldwide. The current PPP for isotretinoin may be failing to protect mothers and babies from preventable harm-clinicians need to be aware of this, and the public needs to be educated about the potential risks.


Asunto(s)
Anomalías Inducidas por Medicamentos/prevención & control , Fármacos Dermatológicos/administración & dosificación , Isotretinoína/administración & dosificación , Disponibilidad de Medicamentos Vía Internet/estadística & datos numéricos , Comercio/normas , Comercio/estadística & datos numéricos , Estudios Transversales , Fármacos Dermatológicos/efectos adversos , Prescripciones de Medicamentos , Femenino , Adhesión a Directriz , Encuestas de Atención de la Salud , Humanos , Internet , Isotretinoína/efectos adversos , Educación del Paciente como Asunto/métodos , Educación del Paciente como Asunto/estadística & datos numéricos , Disponibilidad de Medicamentos Vía Internet/normas , Guías de Práctica Clínica como Asunto , Pautas de la Práctica en Medicina/normas , Embarazo , Teratógenos/toxicidad
17.
J Med Internet Res ; 15(9): e199, 2013 Sep 10.
Artículo en Inglés | MEDLINE | ID: mdl-24021777

RESUMEN

BACKGROUND: A growing number of online pharmacies have been established worldwide. Among them are numerous illegal websites selling medicine without valid medical prescriptions or distributing substandard or counterfeit drugs. Only a limited number of studies have been published on Internet pharmacies with regard to patient safety, professionalism, long-term follow-up, and pharmaceutical legitimacy verification. OBJECTIVE: In this study, we selected, evaluated, and followed 136 Internet pharmacy websites aiming to identify indicators of professional online pharmacy service and online medication safety. METHODS: An Internet search was performed by simulating the needs of potential customers of online pharmacies. A total of 136 Internet pharmacy websites were assessed and followed for four years. According to the LegitScript database, relevant characteristics such as longevity, time of continuous operation, geographical location, displayed contact information, prescription requirement, medical information exchange, and pharmaceutical legitimacy verification were recorded and evaluated. RESULTS: The number of active Internet pharmacy websites decreased; 23 of 136 (16.9%) online pharmacies ceased operating within 12 months and only 67 monitored websites (49.3%) were accessible at the end of the four-year observation period. However, not all operated continuously, as about one-fifth (31/136) of all observed online pharmacy websites were inaccessible provisionally. Thus, only 56 (41.2%) Internet-based pharmacies were continuously operational. Thirty-one of the 136 online pharmacies (22.8%) had not provided any contact details, while only 59 (43.4%) displayed all necessary contact information on the website. We found that the declared physical location claims did not correspond to the area of domain registration (according to IP address) for most websites. Although the majority (120/136, 88.2%) of the examined Internet pharmacies distributed various prescription-only medicines, only 9 (6.6%) requested prior medical prescriptions before purchase. Medical information exchange was generally ineffective as 52 sites (38.2%) did not require any medical information from patients. The product information about the medicines was generally (126/136, 92.6%) not displayed adequately, and the contents of the patient information leaflet were incomplete in most cases (104/136, 76.5%). Numerous online operators (60/136, 44.1%) were defined as rogue Internet pharmacies, but no legitimate Internet-based pharmacies were among them. One site (0.7%) was yet unverified, 23 (16.9%) were unapproved, while the remaining (52/136, 38.2%) websites were not available in the LegitScript database. Contrary to our prior assumptions, prescription or medical information requirement, or the indication of contact information on the website, does not seem to correlate with "rogue pharmacy" status using the LegitScript online pharmacy verification standards. Instead, long-term continuous operation strongly correlated (P<.001) with explicit illegal activity. CONCLUSIONS: Most Internet pharmacies in our study sample were illegal sites within the definition of "rogue" Internet pharmacy. These websites violate professional, legal, and ethical standards and endanger patient safety. This work shows evidence that online pharmacies that act illegally appear to have greater longevity than others, presumably because there is no compelling reason for frequent change in order to survive. We also found that one in five websites revived (closed down and reopened again within four years) and no-prescription sites with limited medicine and patient information are flourishing.


Asunto(s)
Disponibilidad de Medicamentos Vía Internet/legislación & jurisprudencia , Farmacias/legislación & jurisprudencia , Medicamentos Falsificados/efectos adversos , Estudios de Seguimiento , Humanos , Internet , Legislación Farmacéutica , Disponibilidad de Medicamentos Vía Internet/normas , Farmacias/normas , Medicamentos bajo Prescripción/efectos adversos , Medicamentos bajo Prescripción/normas , Seguridad
18.
Health Aff (Millwood) ; 32(1): 27-35, 2013 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-23297268

RESUMEN

In response to the Institute of Medicine's To Err Is Human report on the prevalence of medical errors, the Leapfrog Group, an organization that promotes hospital safety and quality, established a voluntary hospital survey assessing compliance with several safety standards. Using data from the period 2002-07, we conducted the first longitudinal assessment of how hospitals in specific cities and states initially selected by Leapfrog progressed on public reporting and adoption of standards requiring the use of computerized drug order entry and hospital intensivists. Overall, little progress was observed. Reporting rates were unchanged over the study period. Adoption of computerized drug order entry increased from 2.94 percent to 8.13 percent, and intensivist staffing increased from 14.74 percent to 21.40 percent. These findings should not be viewed as an indictment of Leapfrog but may reflect various challenges. For example, hospitals faced no serious threats to their market share if purchasers shifted business away from those that either didn't report data or didn't meet the standards. In the absence of mandatory reporting, policy makers might need to act to address these challenges to ensure improvements in quality.


Asunto(s)
Prescripción Electrónica/normas , Hospitales/normas , Errores Médicos/prevención & control , Sistemas de Medicación en Hospital/organización & administración , Sistemas de Medicación en Hospital/normas , Administración de la Seguridad/organización & administración , Administración de la Seguridad/normas , Recolección de Datos , Implementación de Plan de Salud/organización & administración , Implementación de Plan de Salud/normas , Investigación sobre Servicios de Salud , Humanos , Sistemas de Entrada de Órdenes Médicas/organización & administración , Sistemas de Entrada de Órdenes Médicas/normas , Disponibilidad de Medicamentos Vía Internet/organización & administración , Disponibilidad de Medicamentos Vía Internet/normas , Mejoramiento de la Calidad/organización & administración , Mejoramiento de la Calidad/normas , Estados Unidos
19.
Drug Alcohol Depend ; 130(1-3): 238-40, 2013 Jun 01.
Artículo en Inglés | MEDLINE | ID: mdl-23201172

RESUMEN

BACKGROUND: Use of illicit buprenorphine is increasingly recognized, but it is unknown if the Internet currently represents an accessible source. METHODS: A series of Internet searches were conducted. Twenty searches were performed on two different search engines. The first 100 results of each search were classified into categories based on content. All Internet pharmacies were searched for buprenorphine preparations and if available, sites were examined to determine if a prescription was required for purchase, for the cost of buprenorphine, the geographical origin of the pharmacy, and evidence of validation by an online pharmacy verification service. RESULTS: Of the 2000 links examined, 1422 were unique. Six percent of links were to illicit commercial sites, 2% were to legitimate commercial sites, and 2% were to illicit portal sites, which contained links to many illicit commercial sites. Twenty pharmacies offering buprenorphine for purchase without a prescription were identified. The monthly cost of a typical starting dose of 2 mg buprenorphine daily ranged between $232 and $1163 USD. No pharmacies were listed by online pharmacy verification services. CONCLUSION: Twenty online pharmacies advertising buprenorphine formulations for sale without a prescription were identified. Prices varied widely between illicit pharmacies but were uniformly more expensive than legitimate pharmacies. Illicitly obtained buprenorphine formulations appear to be relatively inaccessible and at high cost on the Internet.


Asunto(s)
Analgésicos Opioides/economía , Buprenorfina/economía , Prescripciones de Medicamentos/economía , Internet/economía , Disponibilidad de Medicamentos Vía Internet/economía , Disponibilidad de Medicamentos Vía Internet/legislación & jurisprudencia , Analgésicos Opioides/normas , Buprenorfina/normas , Prescripciones de Medicamentos/normas , Control de Medicamentos y Narcóticos/legislación & jurisprudencia , Control de Medicamentos y Narcóticos/métodos , Humanos , Internet/normas , Disponibilidad de Medicamentos Vía Internet/normas
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