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Official websites use. Share sensitive information only on official, secure websites. Corresponding Author: Emmanuele A. The counterfeit phenomenon is a largely under-reported issue, with potentially large burden for healthcare. The market for counterfeit drugs used in sexual medicine, most notably type 5 phosphodiesterase inhibitors PDE5i , is rapidly growing. To report the health risks associated with the use of counterfeit medications, the reasons driving their use, and the strategies enacted to contain this phenomenon. A systematic scoping review of the literature regarding counterfeit PDE5i was carried between January and June , then updated in August We primarily aimed to clarify the main drivers for counterfeit PDE5i use, the health risks associated, and the currently available strategies to fight counterfeiters. One hundred thirty-one records were considered for the present scoping review. Production of fake PDE5i is highly lucrative and the lacking awareness of the potential health risks makes it a largely exploitable market by counterfeiters. Adulteration with other drugs, microbial contamination and unreliable dosages make counterfeit medications a cause of worry also outside of the sexual medicine scope. Several laboratory techniques have been devised to identify and quantify the presence of other compounds in counterfeit medications. Strategies aimed at improving awareness, providing antitampering packaging and producing non-falsifiable products, such as the orodispersible formulations, are also described. Improving our understanding of the PDE5i counterfeit phenomenon can be helpful to promote awareness of this issue and to improve patient care. Despite the systematic approach, few clinical studies were retrieved, and data concerning the prevalence of counterfeit PDE5i use is not available on a global scale. The counterfeit phenomenon is a steadily growing issue, with PDE5i being the most counterfeited medication with potentially large harmful effects on unaware consumers. Facing Counterfeit Medications in Sexual Medicine. Sex Med ; The efficacy of type 5 phosphodiesterase inhibitors PDE5i has been verified by countless studies, and indeed these drugs have been included as the first-line treatment for the management of erectile dysfunction ED. However, the widespread knowledge of these drugs in media and social networks 2 has made them widely adopted lifestyle drugs, 3 thus drawing the attention of counterfeiters. National regulatory agencies have seldom joined efforts on an international scale, and the consequences for counterfeiters are generally less severe than one would expect. Such drugs often include other pharmaceutical products than those intended, possibly increasing the health risks of consumers. In this scenario, experts in sexual medicine and andrologists should not underestimate the phenomenon of counterfeit medications. Counterfeit drugs used to improve sexual function represent a growing issue for public health, and while several strategies have been developed to fight counterfeiters, the market is constantly increasing. In the present systematic scoping review, we aimed to provide a thorough overview of the extent of this problem, answering the following questions: why do patients choose to actively look for counterfeit products, rather than following the traditional complaint-diagnosis-therapy track? What are the risks associated with counterfeit medications, and particularly with counterfeit PDE5i? Which are the possible strategies to prevent these risky behaviors? We systematically reviewed all publications found on PubMed and Google Scholar using the following search string: pde5 or phosphodiesterase or sildenafil or tadalafil or vardenafil or avanafil and fake or counterfeit or falsified. The initial systematic search was performed between January and June , and a subsequent update was performed in August As shown in Figure 1 , following removal of duplicate results, unique record were thus found, among which 12 were not assessed due to language constraints, 18 had no full-text available including 5 conference abstracts and 5 were not research papers one conference program, one application note, and three investigation reports. One hundred sixty-seven full texts were thus evaluated, and 36 papers were considered off-topic for the present study. Flowchart of the papers included in the present systematic scoping review. Drug counterfeiting has been a known phenomenon for many centuries, with reports of fake antimalarial drugs being sold since the 17th century. The most recent WHO Global Surveillance and Monitoring System GSMS report on substandard and falsified medical products 4 highlights several factors limiting the reporting of inadequate products, such as low detection levels, cultural reasons to refrain from reporting, and the already mentioned blurry definition of counterfeit products in several countries. As an example, no reports were addressed between and to the WHO GSMS by many countries, including Canada, Portugal, and Australia: however, this is not an indication of no counterfeit medications being illegally sold, but rather that no reports were escalated to the WHO, possibly being investigated and managed internally. Furthermore, as counterfeit products are generally produced abroad and sold through the internet, reports are closer to a depiction of the international situation than to the snapshot of the reporting country. Lifestyle drugs are the most counterfeited products found by police investigations in developed countries, such as in Europe and North America, with PDE5i having the largest share of the market and other appearance and performance enhancing drugs, such as anabolic androgen steroids, being close second. The use of counterfeit medical products carries a significant risk for the user's health, due to several factors which are not always immediately obvious to the consumers themselves. First and foremost, the largest health threats come from the use of wrong dosages of the intended drug — either too low to be effective, or at excessively high and possibly toxic levels, with large variations in drug contents. Counterfeit products are often produced in poor quality laboratories, resulting in the presence of residual solvents and contaminants in the finished product. Salts and compounds used during the preparation of the drugs can alter the pharmacodynamic properties of the main API, 91 and in some cases can act as APIs on their own, as reported for 2-Mercaptobenzothiazole-contaminated sildenafil tablets. Another potential risk comes from the use of different APIs in the preparation of the counterfeited product, either voluntarily, in order to increase efficacy, 59 or involuntarily, following inadequate quality control. While in theory the effects of the combined drugs might lead to increased efficacy, the risk of developing side effects is similarly increased; additionally, the association of these drugs is not recommended by any of the regulatory agencies or guidelines. A clear picture of the potential risks associated with the use of contaminated drugs comes from an outbreak of hypoglycemia occurring in in Singapore: nondiabetic men were admitted to public hospitals for hypoglycemia due to adulteration of both counterfeit tadalafil tablets and herbal remedies with glibenclamide, with lethal outcome for four of the involved consumers. This phenomenon is not limited to drugs or remedies being taken to improve male sexual health: contamination of slimming products, skin creams, and analgesics 38 has also been reported, with orlistat, sibutramine, corticosteroids, and other appearance and performance enhancing drugs being added without being declared. Herbal supplements containing flibanserin and tadalafil have also been identified. Given that most, if not all, classes of medication are able to exert a tangible effect on sexual health — antidepressants, antihypertensives and opioids being known examples of this phenomenon — the issue of drug adulteration is extremely relevant for sexual medicine specialists. Microbial growth resulting from production of the counterfeited drug in nonsterile laboratories has also been reported. Another issue, largely unrecognized by most subjects buying counterfeit products online, lies in the unsupervised use of the intended API. Concerning treatments for sexual dysfunctions, while PDE5i have a generally good safety profile, clinicians prescribing these drugs should be well aware of the potential contraindications in selected patients, such as those undergoing nitrate therapies: individuals buying these drugs online might not be aware of the potential risks associated with other concomitant treatments. Another fundamental professional help is skipped when buying online counterfeit PED5is, that is, that one from the pharmacist. First and foremost, as previously reported, the high success of the genuine drugs made them quite recognized even to the general population and widely adopted worldwide. Additionally, although several well conducted in vitro and in vivo studies demonstrated a role of herbal remedies in the management of male sexual health, , , , , , the potential effects of these remedies are largely disputed. It is, therefore, necessary to educate potential consumers in order to prevent them from falling prey to counterfeiters. It is not uncommon for patients to ask for compounded medications, that is, drugs prepared in a pharmacy laboratory by trained professionals; such products are clearly different from counterfeit medication, being the application of pharmaceutical expertise to provide tailored treatment. Historically, drug manufacture and preparation were among the chief tasks for a pharmacist in the past. As of today, the need for higher quality standards and for mass production has moved this process from pharmacies to industries; however, compounded medications are still prepared for tailored treatment of patients with particular needs. The use of counterfeit medication has several costs for society and public health, from the damage to intellectual property to the already reported harmful effects to the consumer. Harmful effects on consumers, on the other hand, might be more evident to the general population. First and foremost, money spent on a nonworking treatment is effectively lost, result in a direct economic damage to the user; the same would apply for unsuccessful transactions in which despite the payment, no product is received by the buyer. On top of that, the public health costs of undesired effect of contaminants — whether microbial, chemical, or APIs — should also be considered: as occurred with the glibenclamide contamination, use of counterfeited medication might also have potentially fatal consequences. Based on current evidence, it can be assumed that the counterfeit market is flourishing because of an ever-increasing demand, largely supported by the lacking awareness of the health risks and sub-standard efficacy of these products. Education thus becomes the most reliable way to prevent the spread of the counterfeit phenomenon, and physicians should always suggest their patients not to buy medications online. Henceforth, the Council of Europe is currently supporting an international convention dealing with the criminal law field on counterfeiting of medical products and similar crimes involving threats to public health. The Fakeshare is a European project coordinated by the Italian Medicines Agency AIFA , launched in and aiming to produce public awareness on the pandemic use of counterfeit medicines in the continent. Machine Learning, which has been used with some successes to combat digital opioid access, has also been considered among the possible strategies to face the increasing use of social networks, like Facebook, Instagram, and Twitter, 2 , to spread and sell illegal and counterfeit drugs. However, this solution has not been adopted yet to detect, classify, and report illicit online marketing and sales of drugs for sexual medicine. Additionally, the enactment of telemedicine during COVID has proven that remote consultations are an attractive approach for sexual health, as for many other branches of clinical medicine. Telemedicine might also be beneficial in the fight against counterfeit medications: the availability of quick, anonymous and possibly cheap remote consultations issued by certified specialists might encourage patients to refrain from self-diagnosis and self-treatment. However, no definite evidence exists at this time of the efficacy of this strategy. While social interventions are fundamental to contrast counterfeit drugs, technical solutions may also be crucial and could be helpful to overcome the potential gaps Figure 3. While, as a rule of thumb, it would be wise to refrain from buying drugs online at all, it is not uncommon for people to get PDE5i from peers such as friends and colleagues, with little information, if any, on the source of the drug. Several studies performed in the last years have collected the telltale signs of a counterfeit medication: drugs shipped or sold without accompanying leaflets or outer packaging, missing a clear expiration date or information on manufacturing country 19 , 65 are most likely not genuine products. Since pills and tablets are the most likely products to be counterfeited and their form allows for easy storage once again, increasing the risks of microbial contamination , the product's shape, color and aspect can be selected or modified by the manufacturer to increase similarity to the genuine product. Therefore, several strategies have also been envisioned by pharmaceutical companies to identify a counterfeit product by the external packaging only, including the use of serial numbers, barcodes, holography, radiofrequency identification device, or unreplaceable sealings on the package itself. From a technical point of view, different analyses on samples are available to researchers having access to a modern laboratory : several techniques have been successfully used in the last decades to perform assessment of any tablet's contents Table 1. While some chromatography techniques require destruction of the tablet itself, possibly becoming a problem from a legal point of view, 14 , 68 nondestructive techniques, such as near-infrared spectroscopy, 14 Raman spectroscopy 12 or nuclear magnetic resonance relaxometry, 48 , could be helpful in these regards by leaving the tablet intact. Available techniques also differ for sensitivity, costs, required training and personnel, limiting the possible applications in different settings: therefore, relying upon technical investigations alone in order to identify all counterfeit medications being shipped worldwide is not a feasible strategy. Last, but not least, among the possible pharmaceutical forms of the PDE5i, the orodispersible one seems particularly interesting for its pharmacokinetic characteristics. Moreover, SODF does not require the intake of a liquid, hence reducing the anxiety of the patient and the stigma of assuming a well recognizable drug to address ED, while the large surface area leads to rapid disintegration in the mouth. Therefore, on top of the already demonstrated safety and efficacy, , , , the reliability and reduced risk of counterfeiting are additional added benefits of the SODF formulation. In this review, we systematically reviewed currently available literature concerning the use of counterfeit PDE5i, highlighting several topics relevant for sexual medicine experts as well as for the general population. To our best knowledge, this is the first time that this topic has been addressed systematically, highlighting all known risks for individual and public health as well as pointing out available strategies aimed to contain the counterfeit phenomenon, and reasons for their partial success. The present paper, however, has some limitations, mostly inherent to the available literature being investigated — such as the lack of any clear rate of counterfeit medication use and the presence of a limited amount of clinical studies. While generally under-reported, counterfeit medications are a tangible issue requiring intervention, due to the potential risks for healthcare. This becomes of paramount importance in the context of sexual medicine, being pro-erectile drugs the most counterfeited products in several countries. As reported in different guidelines, , , , , , PDE5i are safe and effective if appropriately used; however, several risks and complications might arise following use of counterfeit medications. While technologies to detect counterfeit are increasingly available, political aspects and the costs and required expertise limit their application. Within the various pharmaceutical formulations, the ODF is the less likely to be prone to be counterfeited and warrants a unique originality of its content, dosage, and safety. Physicians treating sexual dysfunctions and pharmacists should inform their patients and clients about the issues of counterfeit medical products, as well as suggest refraining from buying drugs online and taking tablets of dubious origin from peers. Andrea Sansone, Emmanuele A. Jannini: Funding Acquisition; Emmanuele A. Jannini: Resources; Emmanuele A. Jannini: Supervision. The other authors have no conflict of interests to declare. As a library, NLM provides access to scientific literature. Sex Med. Find articles by Andrea Sansone. Find articles by Emmanuele A Jannini. Published by Elsevier Inc. Open in a new tab. 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. Desorption electrospray ionization DESI mass spectrometry.

Prescription drug importation gets renewed attention

Buying coke online in Andorra

The growth of online purchasing of prescription medicines is significant and has been amplified by social isolation related to the COVID pandemic, with many patients unable to obtain medicines as they normally would. By contrast, there are licensed, certified, legitimate retail pharmacies that provide significant and vital services to patients. OBJECTIVE: To review the major public health threat from illegal entities that sell any type of prescription medicines to individuals without proper physician oversight. This article presents the differentiation between the types of legal and illegal Internet pharmacies, as well as the actions that are currently in play to affect the illegal online purchase of prescription medicines. Much must be done in a collaborative, global effort to address the public health threat of obtaining prescription drugs via the Internet. In many ways, all of us are living in the age of the Internet. Where purchases are made and will be made have changed and will continue to evolve in the US marketplace and worldwide. With disruptions in obtaining medications from pharmacies because of social isolation during the COVID pandemic, the appeal of obtaining prescription drugs via the Internet has increased dramatically. In these sites, there is no person-to-person physical interaction. The criticism of these sites focuses on the reliance of questionnaires or surveys for assessment of the patient. For example, many websites provide drugs for erectile dysfunction to consumers only after a questionnaire is filled out online by the consumer. Online drug shops, which sell prescription drugs after consumers indicate what drugs they wish to purchase online and submit payment. No physician is involved in those sites. Table 1 lists 4 websites from the United States that allow for the assessment of the legitimate validity and certification of online pharmacies. In providing unrestricted accessibility to medicine, the Web has democratised consumerist opportunities and allows more people than ever before to engage in illegal and deviant activities. Carmen A. Instead, these Canadian pharmacy websites sell US patients medicines manufactured in places where buyers would not even drink the water, e. Outside these closed and tightly regulated drug supply chains, the safeguards put in place to ensure the identity, efficacy, and safety of prescription medications no longer apply. Based on our experience, for the following reasons NABP believes this action would have grave consequences. First, he says, suggesting that there are safe sites is a gamble that could cost lives. Counterfeit drug purchases can readily cause significant harm and health problems for patients when healthcare professionals and patients do not know or cannot be ensured of the reliability of the source of prescription medications. A study of the nonmedical use of prescription drugs in Europe showed that across 5 countries ie, Denmark, Germany, Great Britain, Spain, and Sweden , Internet pharmacies, without physician oversight, were a source of obtaining stimulants 7. In , Jena and Goldman published an analysis of the rise of prescription drug abuse in the United States between and and its relationship with the online availability of abused drugs. The controlled substance drugs with high risk for abuse that were included in the search are shown in Table 2 ; each of these drugs harbors serious abuse potential. Monteith and Glenn concluded that when searching for online access to psychiatric medications, the Internet consumer is presented with rogue Internet pharmacies that do not require a prescription and present suspect accreditation documentation. All the bipolar drugs were available online as either a brand-name or a generic pharmaceutical, with or without a prescription. These researchers expressed concern that users of modafinil often report purchasing these drugs from the Internet. Counterfeiters are now entering the mainstream pharmaceutical and device markets with more sophistication, which makes these drugs and devices harder to detect. These drugs and devices may include adulterated oral or injectable diabetes medications, and blood glucose test strips and measuring devices. None of the online vendors were classified as legitimate or accredited by the NABP22 or LegitScript 23 online pharmacy verification databases. There is a widespread inappropriate use of the unregulated online purchasing of medications in the United States and worldwide. A Call to Action: Much-Needed Next Steps The means to ameliorate inappropriate Internet access to counterfeit and substandard medications will require significant actions from many entities. These efforts must come from international cooperative agreements between countries, individual country actions, health professional involvement, and individual consumers and patients. The Model Law on Medicine Crime contains provisions pertaining to criminal activities that include 32,33 : The prohibition of manufacturing, trafficking, or selling poor-quality medications Principles for punishing offenders appropriately Special segments for Internet-based criminal actions Inducements for encouraging the cooperation of whistleblowers with law enforcement Incentives for third-world governments to strengthen drug regulatory capacities. Nayyar and colleagues have echoed the call for the implementation of the Model Law on Medicines and Crime, but also have suggested the implementation of a Sustainable Development Goal, as well as an international convention to ensure drug quality and safety. The use of radio waves detects digital fingerprints on the packaging of suspected illegal drugs. The tester that has been developed facilitates the finding of a unique fingerprint for reliable medications that other substandard drugs can then be compared with and identified as counterfeit. This need is global in nature. New and emerging efforts to stem the negative outcomes from access to substandard and illegal medications are promising. A concerted effort is required to provide advice on which Internet pharmacies are legitimate and to educate consumers consistently on vigilance concerning the medications they take, and from whom they obtain these drugs. Skip to main content. Online First. Published online ahead of print, December Jack E. Fincham, PhD, RPh. Download PDF. Manuscript received July 10, Accepted in final form September 2, Disclosures are at end of text. Related Items. Michele Berrios , Bruce S. Waters, PhD. Claire Szewczyk. Web Exclusives published on October 20, in Clinical. Lori A.

Buying coke online in Andorra