Illegal "no prescription" internet access to narrow therapeutic index drugs.

BACKGROUND: Narrow therapeutic index (NTI) drugs, because of proximity of therapeutic amounts to toxic amounts, require close professional oversight, particularly when switching formulations. However, safe use may be compromised by unsupervised switching through access to online "no prescription" Web sites. OBJECTIVE: We assessed no prescription online availability of NTI drugs, using an academically published list (core NTI drugs). METHODS: Using the Google search term "buy DRUG no prescription," we reviewed the first 5 search result pages for marketing of no prescription NTI drugs. We further assessed if National Association of Boards of Pharmacy (NABP) Not Recommended vendors were marketing NTI drugs. Searches were conducted from November 3, 2012 to January 3, 2013. RESULTS: For core NTI drugs, we found 13 of 14 NTI drugs (92%) marketed as available without prescription, all from NABP Not Recommended vendors. On the basis of these initial findings, we expanded our core list to 12 additional NTI drugs; 11 of 12 of these drugs (92%) were available from no prescription Web sites. Overall, 24 of 26 NTI drugs (92%) were illegally marketed as available online without the need for a prescription. CONCLUSION: Suspect online NTI drug access from no prescription vendors represents a significant patient safety risk because of potential patient drug switching and risk of counterfeit versions. Further, state health care exchanges with coverage limitations may drive patients to seek formulations online. Food and Drug Administration harmonization with tighter international NTI drug standards should be considered, and aggressive action against suspect online marketers should be a regulatory and public health priority.

Evaluating the evidence: direct-to-consumer screening tests advertised online.

OBJECTIVES: Unsupervised online direct-to-consumer (DTC) access to medical services has rapidly expanded to medical screening tests, which have not been critically evaluated for their evidence basis. The objective of this study is to identify the scope of online-advertised DTC screening tests, outline the evidence for use of available DTC testing and suggest regulatory reform to address the relevant issues. METHODS: An observational study of website advertisements, testing services and counselling/follow-up services for DTC testing was conducted. Data were collected from websites between 4 April and 1 June 2011. Each website was assessed for tests offered, advertised indications and availability of counselling/follow-up services. Advertised testing indications were compared with US Preventive Services Task Force recommendations and/or specialty guidelines and categorized as Supported, Against, Insufficient Evidence or No Guidance. RESULTS: Of 20 companies identified as offering DTC screening tests, 95% (19/20) do not clearly offer pretest counselling, post-test counselling and/or test follow-up. One hundred and twenty-seven different tests were identified. Only 19/127 (15%) could be Supported for screening in a target group selected for testing; 38/127 (30%) were given recommendations to avoid use in specific target group(s) selected for testing ('Against recommendations'); 29/127 (23%) had Insufficient Evidence of value, and for 64/127 (50%) No Guidance could be given. Only 4/127 (3%) tests were Supported for general screening use. CONCLUSIONS: Virtually all identified medical tests advertised and offered DTC are not recommended for use in screening by evidence-based guidelines. Limited oversight may lead to inaccurate self-diagnosis, treatment and wasted health resources.

Quality care opportunities: refining physician performance measurement in ambulatory care.

Accurately measuring the quality of care that ambulatory care physicians provide is an important endeavor. Current measurement instruments, while offering useful information about care systems, remain suboptimal for the measurement of individual physician performance. We offer the quality care opportunities model of ambulatory care physician performance measurement, which may address issues with current instruments while also offering useful information about efficiency and productivity for individual physicians and delivery systems from a patient-centered perspective.

Suspect online sellers and contraceptive access.

BACKGROUND: Issues surrounding contraception access have been a national focus. During this debate, adolescent and adult women may seek these products online. Due to safety concerns, including potential counterfeit forms, we wished to assess whether online "no prescription" contraceptives were available. STUDY DESIGN: We assessed online availability of reversible, prescription contraceptive methods resulting in <10 undesired pregnancies/year, i.e., Depo-Provera shot; oral contraceptives; NuvaRing; Ortho Evra patch; Paragard and Mirena IUDs; and Implanon/Nexplanon implants. Using Google search "buy ITEM no prescription," we reviewed the first five result pages for "no prescription" vendors. Searches were conducted 1/3/2012-2/20/2012. RESULTS: All contraceptives were available as "no prescription" products. Furthermore, IUDs were advertised as "over-the-counter" and YouTube videos provided "how to" videos, including a cartoon version. We also found that illicit online pharmacy marketing is shifting from direct search engine access to social media (Facebook, Twitter, Slidehare, flickr). CONCLUSION: Online contraceptive sales represent patient safety risks and a parallel system of high-risk product access absent professional guidance. Providers should educate patients, while policy makers employ legal strategies to address these systemic risks.

Online, direct-to-consumer access to insulin: patient safety considerations and reform.

The online, direct-to-consumer (DTC) medical marketplace is proliferating more rapidly than regulation is evolving to ensure proper patient safety and public health controls. Along with this growing body of unrestrained medical testing and pharmaceuticals offered DTC online, most types of insulin and insulin administration products may now be purchased without prescriptions or physician guidance. Given the relatively significant risks of insulin use, the abuse potential, the high prevalence of diabetes mellitus, and the rising population of uninsured and underinsured, it is imperative to reform the online DTC medical marketplace to ensure that patient safety and public health are protected.

Risks of online advertisement of direct-to-consumer thermography for breast cancer screening.

Direct-to-consumer online advertising for thermography as a sole agent with which to diagnose breast cancer is misleading and exploits women who are seeking preventive health care for breast cancer. Regulatory action should be taken against companies who continue to mislead the public to ensure patient safety and evidence-based public health information.