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EDITOR’S NOTE: On Oct. 12, I listened to the ACP-sponsored webinar presentation by Dr. Nick Morrison. In the presentation, I wasn’t hearing anything new until someone asked this question: "Can you request control from the compounding pharmacy regarding materials used and who produced the drug itself?"

Dr. Morrison replied: "Good Luck!! I’ve tried that and I’ve questioned the people very, very carefully and when I go to them they typically can’t answer the questions or they certainly don’t answer them to my satisfaction. They don’t want to really answer the questions and that’s where you run into problems.

"Another problem is compounding pharmacies will flat-out lie to you and tell you they have FDA-approved drugs when they do not," he continued. "So trying to get information from the pharmacies, even for example, I tried to find out if they were using pharma grade or commercial grade and while they would assure me that they were using pharma grade, would not produce a document telling me that. They would only tell me they were using FDA-approved stuff but they wouldn’t prove it."

So that’s my take from the webinar: All compounding pharmacists are liars.

Turns out, a compounding pharmacist was also participating in the webinar.

Pharmacist Takes Issue with ACP Webinar on Compounded Drugs

By Mike Haulsee, PharmaD

I recently attended a webinar presented by Dr. Nick Morrison in association with the American College of Phlebology titled "Compounded Sclerosants." As a pharmacist of 30 years, 19 of which I have owned and operated a compounding pharmacy, I was looking forward to this presentation from a well-respected phlebologist. However, very soon into the webinar, I realized that it was going to be a one-sided presentation rather than a well-balanced overview of sclerosants and compounding pharmacies.

In my opinion, in order to effectively critique or criticize a subject in a public forum, one must be well-versed in all aspects of the argument at hand. Dr. Morrison admitted he knew nothing about USP 797, the rules and regulations by which sterile compounding pharmacies work and are inspected. USP 797 is very stringent in reference to the environment sterile preparations are made, the training of the staff, testing of the final product and recordkeeping of the same. Adhering to USP 797, a pharmacy, when dispensing a finished sterile product, must have potency, sterility and endotoxin testing completed and documented. As well, the pharmacy will have on hand a certificate of analysis available for each ingredient used in the sterile compound.

Some of the "facts" presented were incorrect. The question was asked whether the FDA has jurisdiction over compounding pharmacies and was answered, "Pharmacies are not inspected by the FDA." The FDA can, and does, inspect any pharmacy compounding sterile medications. These inspections are routine and unannounced. Dr. Morrison also spoke about interstate shipping, stating "If they (compounding pharmacies) start operating so that they are, for example, shipping to other states, that starts to become more of a problem." Interstate shipping is legal, not a problem or concern, provided the pharmacy is properly licensed in the state to which they are shipping.

The "studies" presented to back up Dr. Morrison's opinions were from as long as 15 years ago and the methods used for these studies were never scrutinized. One study clearly stated that samples were obtained through Internet marketing pharmacies. This is hardly representative of pharmacies that are USP 797 compliant, performing all potency, sterility and endotoxin testing prior to dispensing any medication. One study was sponsored by a manufacturer of a commercially available product, which seems heavily one-sided.

Dr. Morrison also stated that compounding pharmacists would withhold information, make false claims that their products were FDA approved when they are not, and made the blanket statement that "all the pharmacists lie."

It is true that compounded products are never "FDA approved." Dr. Morrison may have misinterpreted the statement that compounding pharmacies are required by state pharmacy law to receive ingredients from an FDA approved wholesaler. This doesn't make a product FDA approved; it simply means the product was made with ingredients manufactured in an FDA-approved facility. The above documentation is always available for a prescriber to request and review. The only information that is not shared is proprietary formulations.

I don't think that Dr. Morrison intended to call an entire medical profession "liars," as that would be irresponsible and unprofessional. There are certainly people in many professions, including doctors, who are unethical and even incompetent. However, to paint the entire profession with the same brush is wrong, and does an extreme disservice to the accuser as well as the accused.

In summary, I was disappointed to see a presentation with no intent to inform physicians with accurate, truthful information about the options available to them. I would encourage physicians to speak directly with their pharmacy to get answers to any questions regarding compounding, testing or any other concerns. VTN

Michael Haulsee, PharmD, is CEO and co-founder of PAYSA Health Services. It has always been his vision to create a sustainable ecosystem for healthcare where the geographical borders would cease to exist for quality healthcare access. From his early days as a clinical pharmacist to international consultant, Dr. Haulsee has developed a keen understanding of the complicated dynamics that can impact effective business. His unique method to empower a client encourages solution development that leads to success. Dr. Haulsee's experience is gained through his involvement within many facets of the pharmaceutical industry; manufacturing to wholesale to retail. Dr. Haulsee has owned pharmacy businesses worldwide, developed pharmaceutical manufacturing companies, assisted in the successful formation of international specialty pharmacies, and has become keenly knowledgeable of foreign cultural and regulatory differences.



By Jeff Miller, MD

As the presidential election draws closer, MedPage Today contacted doctors for both candidates. Actual knowledge of the candidates' physical fitness has come so far from letters released by their personal physicians, and observation. The letters were written before Hillary Clinton fainted in front of TV cameras and had to be forced into a van to take her first home and then to the hospital following her appearance at the Sept. 11 observance in New York City.

First the Clinton campaign said she became overheated. Then doctors said she was exhausted and had pneumonia and needed antibiotics and rest.


The first letter from a physician came in July 2015 from Lisa Bardack, MD, an internist in Mount Kisco, N.Y. and Hillary Clinton's personal physician.

Dr. Bardack's letter, which is eight paragraphs long, contains both specific and general information about Clinton — for example, it says that Clinton's most recent physical, in March 2015, found that her blood pressure was 100/65 and that her total cholesterol was 195, with an HDL of 64 and triglycerides of 69. It also notes that she is taking vitamin B12, antihistamines, and Armour Thyroid for hypothyroidism.

More generally, the letter says that Clinton "does not smoke and drinks alcohol occasionally. ... She eats a diet rich in lean protein, vegetables, and fruits. She exercises regularly, including yoga, swimming, walking and weight training."

The letter also makes note of two episodes of deep vein thrombosis in 1998 and 2009, and an incident in December 2012, in which Clinton "suffered a stomach virus after traveling, became dehydrated, fainted and sustained a concussion." Clinton had follow-up evaluations that found a transverse sinus venous thrombosis, and she was given anticoagulation therapy as well as glasses with a Fresnel prism to treat double vision resulting from the concussion.

"She had follow-up testing in 2013, which revealed complete resolution of the effects of the concussion as well as total dissolution of the thrombosis," the letter continued. "As a precaution, however, it was decided to continue her on daily anticoagulation" in the form of warfarin (Coumadin). Bardack concluded by saying that Clinton "is in excellent physical condition and fit to serve as president of the United States."

Information following the second debate indicated that Clinton is being attended by doctors other than those officially named as her physicians. These physicians are not submitting report to the media.


Donald Trump's physician, Harold Bornstein, MD, of New York City, released a letter in December 2015 that was much shorter and reflected fewer health problems. "Mr. Trump had a recent complete physical examination that showed only positive results," Bornstein wrote in a four-paragraph letter. "Actually, his blood pressure, 110/65, and laboratory results were astonishingly excellent."

Bornstein wrote that Trump had lost 15 pounds in the past year and that he takes 81 mg of aspirin daily along with a low dose of a statin. "His PSA test score is 0.15 .... His physical strength and stamina are extraordinary." Trump's cardiovascular status is "excellent," and he has no history of alcohol or tobacco use, Bornstein added.

After noting that Trump has no cancer and has never had any orthopedic surgery, Bornstein concluded, "If elected, Mr. Trump, I can state unequivocally, will be the healthiest individual ever elected to the presidency." Of course, he presented no facts to support that conclusion.

MedPage Today noted that these health disclosures should be seen in the same light as candidates' income tax disclosures, Whitehouse continued. "I'd do it on a voluntary basis" — that is, candidates shouldn't be required to disclose their health records, "but if you don't ... you're subject to scrutiny as to why not."


The other experts contacted by MedPage Today all agreed that some degree of medical disclosure for candidates was necessary — the question is, how much information to disclose?

"Candidates for very high office, like president, do have an obligation to disclose if they have a serious health problem, like if they have cancer or have had a stroke." said Doug Brugge, PhD, professor of public health and community medicine at Tufts University in Boston. "If they just have risk factors — like high cholesterol — most of us have risk factors, so that is not such a big deal."

"As a matter of public policy, public interest and what may remain of a 'right to know' for the electorate, the medical fitness of a prospective U.S. president is important," Jay Wolfson, DrPH, JD, professor of public health, medicine, and pharmacy at the University of South Florida, in Tampa, wrote in an email to MedPage Today. "Prospective and actual public officials lose some of the private prerogatives they may have enjoyed (or presumed) prior to their entrance on the stage of public service. And being a candidate is being on that stage."

Clinton's concussion and its aftermath have been the subject of much speculation, including from physicians. Drew Pinsky, MD, discussed Clinton's medical record on his TV show in January, saying that as a result of the concussion, "She had to wear these prism glasses. .... That is brain damage, and it's affecting her balance."

Some mental health specialists have weighed in on Trump as well. Trump has "textbook narcissistic personality disorder," Ben Michaelis, PhD, a clinical psychologist in New York City, told The Atlantic last November. Howard Gardner, PhD, a professor of cognition and education at Harvard, agreed, calling Trump "remarkably narcissistic."

The American Psychiatric Association reminded its members in August of the association's "Goldwater Rule" — named for the late Republican presidential candidate Barry Goldwater. The association’s rule prohibits psychiatrists from offering opinions for someone they haven't personally evaluated.

Experts were generally in agreement that clinicians of any kind should not be diagnosing either candidate from afar. "I do think it is questionable for physicians to make comments about anyone as it pertains to their health without actually personally evaluating them," Mohana Karlekar, MD, medical director for palliative care at Vanderbilt University, in Nashville, Tenn, told MedPage Today. "Physicians must be mindful that any statement they make that includes a medical assessment will be interpreted by the general public as a valid assessment." VTN

Jeffrey H. Miller, MD, is the founder and CEO of Miller Vein with five offices located in Southeast Michigan. Dr. Miller is a board certified interventional radiologist and certified by the American Board of Venous and Lymphatic Medicine. He has received numerous awards and honors in his field, including being named one of Hour Detroit Magazine’s "Top Docs."



In this year’s presidential campaign, healthcare has taken a back seat. But one issue appears to be breaking through: the rising cost of prescription drugs.

The blockbuster drugs to treat hepatitis C as well as dramatic price increases on older drugs, most recently the EpiPen allergy treatment, have combined to put the issue back on the front burner.

Democrat Hillary Clinton just issued a lengthy proposal to address what her campaign calls "unjustified price hikes for long-available drugs." That’s in addition to a broader proposal to address high drug prices the campaign put out last fall.

Republican Donald Trump, meanwhile, has said little about healthcare since announcing his candidacy in 2015, but he has several times called for a change in law to allow Medicare to negotiate drug prices for the population it serves.

Here are five reasons why this issue is back — and why it is so difficult to solve.

One is the introduction of brand-name blockbuster drugs, such as Sovaldi and Harvoni. They effectively cure hepatitis C — but at a total cost of more than $80,000. Federal statisticians singled out the hepatitis C medications as a key reason prescription drug spending increased by 12.2 percent in 2014, up from 2.4 percent the year before.

That is separate from the price hikes coming from companies set up specifically to buy up older, generic drugs and reap as much profit as they can. The poster child for these efforts, which have gained attention during the past year, is Martin Shkreli. His firm Turing Pharmaceuticals purchased Daraprim, a drug used to treat toxoplasmosis, a disease caused by a parasite that can be life-threatening for people with compromised immune systems, and hiked the price from $13.50 to $750 per pill. In the case of EpiPen, the treatment for life-endangering allergic reactions, the drug itself is actually inexpensive and long off-patent. But the company has almost literally created a monopoly by patenting the simple-to-use delivery mechanism.

It seems every time drug prices spike up, policymakers pay attention.

Congress first addressed the issue of rising drug prices in 1984, when it passed a bipartisan bill that made it easier for generic copies of brand-name drugs to be approved. But lawmakers also gave brand-name drug makers more time without generic competition by allowing them to keep their products on their patents longer to make up for often years-long approval process at the Food and Drug Administration.

In 1990, concern about rising medication costs to the Medicaid program, the joint federal-state insurance coverage for low-income residents, led to a law requiring drug makers to provide significant discounts.

During the late 1990s and early 2000s, Congress repeatedly debated the idea of lowering drug prices by allowing consumers to purchase drugs that were brought in from other industrialized countries that impose price controls. A few such "re-importation" proposals were passed into law. But the laws required certification by federal health officials and both Democratic and Republican administration officials blocked the efforts, which they said threatened the safety of the U.S. drug supply.

Advocates for seniors, who use more prescription drugs on average than younger people, raised concerns about that time also that drug prices were hurting their ability to purchase their medicine. So in 2003, Congress passed a law creating a Medicare prescription drug benefit.

A dramatic increase in use of generic drugs for the next several years helped keep the cost of the new Medicare benefit in check, and kept drug prices mostly off the political front burner.

But now, not only are prices rising again, but many people also have insurance that requires them to pay more out-of-pocket for drugs. Those patients complain, in turn, to lawmakers, who feel the need to address the issue.

Both Clinton and Trump have endorsed a change in the law to allow Medicare to negotiate drug prices, a practice that is currently banned.

But analysts agree that negotiations alone could not reduce overall costs by very much, unless Medicare was also allowed to grant preference to some drugs that offer good discounts, which is what most insurance plans do. In Medicare, however, that would be extremely controversial. And Medicare, like other insurers, would have trouble negotiating lower prices for drugs that have no competition. Thus, the Congressional Budget Office has said, repeatedly, "broad negotiating authority by itself would likely have a negligible effect on federal spending."

Another popular proposal, included in Clinton’s drug plan and already in effect in several states, seeks to cap the amount individual consumers have to spend out-of-pocket on prescription medications.

While that would clearly help protect the individuals affected, it would do nothing to actually lower drug costs. In fact, by passing most of the cost back to insurers, the proposal would likely increase insurance premiums for everyone.

In California, meanwhile, voters this fall will face a proposal to ban state health programs from paying any more for drugs than the price at which they are sold to the Veterans Health Administration, which gets large discounts, but also covers only a limited list of drugs. The proposal is strongly opposed by the drug industry, but even some likely supporters have raised questions about whether it would work.

The public is clearly ready for some action on the issue. Poll after poll finds large majorities of those surveyed think drug prices are too high and the government should do something to lower them. The public is also decidedly negative in its opinion on the drug industry overall. It’s no surprise politicians are feeling pressure to act.

On the other hand, the pharmaceutical industry remains one of the most powerful forces in Washington, not to mention many state capitals. Drug industry lobbying has blocked efforts to allow people to buy cheaper drugs from overseas, ensured that the Medicare prescription drug benefit did not allow the federal government to set or negotiate prices, and kept efforts to rein in drug prices out of the Affordable Care Act.

As a result, three Harvard Medical School researchers wrote in a comprehensive look at the drug price issue in the Journal of the American Medical Association, "Prescription drugs are priced in the United State primarily on the basis of what the market will bear." Attempting to set prices or otherwise constrain industry profits, they added, "would have major marketplace ramifications and is not at present politically feasible, in part because of the power to the pharmaceutical lobby in Washington, D.C." VTN



W. L. Gore & Associates Inc. announced results from a prospective, multicenter Investigational Device Exemption (IDE) Clinical Study of the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in Japan (synonymous with the CBAS Heparin Surface).

The device demonstrated excellent outcomes in treating long, complex lesions in the superficial femoral artery (SFA), achieving 88 percent primary patency at 12 months. The findings were presented during a Gore event hosted in conjunction with the Vascular Interventional Advances 2016 (VIVA) Conference in Las Vegas in late September.

The prospective single-arm study enrolled 103 patients for analysis across 15 trial sites. The trial enrolled a challenging patient population with greater than 10cm long lesions, including 84.5 percent TASC II C/D lesions, and 65.7 percent of lesions having chronic total occlusions (CTO). The GORE VIABAHN Endoprosthesis showed favorable outcomes consistent with previous clinical studies. Primary patency at 12 months in all lesions (average of 21.8cm) was 88 percent, while lesions less than or equal to 20cm recorded 93 percent primary patency. The study also demonstrated 100 percent limb salvage with zero cases of acute limb ischemia (ALI), bypass or amputation.

"Eighty-eight percent is an extremely high primary patency for these long complex lesions with an average length of 22cm, especially given the scrutiny of the study design: a prospective, multicenter IDE clinical study that was core lab adjudicated and reviewed by the Japanese regulatory authority. The GORE VIABAHN Endoprosthesis, for the first time in endovascular history, may replace bypass surgery for femoro-popliteal disease," said Takao Ohki, MD, principal investigator of the Gore Japan IDE Clinical Study.

The Gore Japan IDE Clinical Study is now the fourth prospective, multicenter trial to study performance of the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in complex de novo and restenotic SFA disease. When all figures and data from the research are combined, the 359 limbs studied in these four trials have an average lesion length of 21cm with 71 percent CTO. The combined 12-month primary patency seen in the Gore VIPER Clinical Study, VIASTAR Trial, the GORE VIABAHN Device 25cm Trial, and the Gore Japan IDE Clinical Study is 78 percent. VTN




Union activity is on the rise in hospitals across the nation as frustrated doctors and nurses say hospitals value profits over patients and encourage a culture of overwork to make up for inadequate staffing.

For example, nurses at Einstein Medical Center in Philadelphia voted to form a union in April, to protest unsafe conditions and inadequate staffing, according to The Nation. Meanwhile, in January, nurses at Hahnemann University Hospital in Philadelphia, owned by the for-profit Tenet chain, voted by a wide margin to join the Pennsylvania Association of Staff Nurses & Allied Professionals (PASNAP), The Nation reports. St. Christopher’s Hospital for Children in Philadelphia joined shortly after.

Even doctors are fed up, according to the article. After years of tension within the workplace, three doctors in Minnesota joined a professional unit of Steelworkers Local 9460, which finalized its first contract at Lake Superior Community Health Center in Duluth.

Lack of adequate staffing is frequently cited as the reason for such organizing efforts, according to the article. A March PASNAP survey of recently organized nurses found that 70 percent say they’ve never worked in an organization that had sufficient staffing. Yet, research shows that in addition to improving workplace conditions, increased staffing levels leads to better patient outcomes, while inadequate staffing is a major driver of mortality.

Established healthcare unions also report recent successes. In August, the 1199 SEIU United Healthcare Workers East, which represents 5,000 workers at Boston’s Steward Health Care System, signed a contract with the system to maintain health benefits while agreeing on a 5.5 percent raise over three years for its technicians and non-clinical staff, according to The Boston Globe.

In West Virginia, the 4th Circuit Court of Appeals has ordered Bluefield Regional Medical Center and Greenbrier Valley Medical Center to recognize nurses’ right to organize and join them at the collective bargaining table, according to the Register-Herald.

Nurses and doctors who serve on the frontline of care are ideally poised to lead on labor issues, PASNAP President Patty Eakin told The Nation. "One of the biggest things we’re going to get out of [a union]," she said, "is a legal voice, and a way to raise our voices up together and say, ‘This has to change.’" VTN



Physicians, executives and physician assistants lead the healthcare profession in compensation, but job satisfaction varies widely throughout the industry, according to a new report from Health eCareers.

Researchers surveyed 20,000 healthcare professionals and found that 87 percent of respondents made more or the same compared to the year before. However, nearly 30 percent of those surveyed plan to change employers in the next year. Among the highlights of the report:

  • Physicians and surgeons were the highest-paid, making $255,648 on average, which represents a 2.5 percent increase.
  • Executives were in second place. Their average salaries fell 12.9 percent from 2015 to $134,632.
  • PAs made an average of $105,856 and saw a bigger pay bump than doctors, at 4.3 percent.
  • Nurse practitioners saw an even higher bump of 5.3 percent, for an average salary of $100,549.
  • But nurses actually report a 3.1 percent decrease in pay, for an average salary of $61,875.

"It struck us that NP and PAs received a higher pay bump than physicians," Bryan Bassett, managing director at Health eCareers, said in a statement. "This could, at least in part, be attributed to the physician shortage, which is causing healthcare providers to hire NPs and PAs in larger numbers, and having to pay them more to be competitive."

But location does matter. For example, the report finds that physicians in California are paid nearly $40,000 more a year than their Florida counterparts, and nurses in New York are paid $7,000 more than those who work in Colorado.

Satisfaction with salaries and jobs varied widely, according to the report; only 44 percent of nurses are satisfied with their salaries, with the dissatisfaction driven primarily by the perception that their pay is below what their experience warrants.

Thirteen percent of nurses are actively looking for new jobs, while 17 percent are satisfied in their current positions and plan to stay there.

Satisfaction is higher among physicians and surgeons, but higher still for PAs, 60 percent of whom are happy with their pay and 27 percent of which are "very happy" with their current positions. More than half of surgeons and doctors reported satisfaction with their pay. VTN




Teladoc is getting support from the Federal Trade Commission and the Department of Justice in its lengthy battle with the Texas Medical Board (TMB). The TMB requires a face-to-face appointment requirement before a physician can prescribe medications via telemedicine.

Teladoc says that such a requirement limits and hinders use of telemedicine services within the state.

Last December, TMB was denied a motion to dismiss Teladoc’s 2011 antitrust lawsuit; the board then appealed that decision in January.

In an amici curiae brief, filed in the Fifth Circuit Court, the FTC and DOJ call that appeal an attempt to “evade the substance of federal antitrust law," and add that, basically, the court doesn't have jurisdiction over the appeal.

The brief goes on to say that if the court does feel it has a right to jurisdiction over the appeal, "it should hold that the state action doctrine does not shield the TMB’s rules from federal antitrust scrutiny because the TMB did not carry its burden to show active supervision."

"There is no evidence that any disinterested state official reviewed the TMB rules at issue to determine whether they promote state regulatory policy rather than TMB doctors’ private interests in excluding telehealth — and its lower prices — from the Texas market," the brief says.

In conclusion, DOJ and FTC say that the appeal should be dismissed "for lack of appellate jurisdiction." The FTC has shown support for telemedicine before, backing a telemedicine provision presented in March as part of legislation working its way through the Alaska Senate. VTN


As telemedicine use increases in the healthcare industry, there’s something that remains unclear: The service’s tax implications. The Internal Revenue Service has not yet made a decision on how it will tax telemedicine.

That, according to Sandra Feinsmith, a tax managing director, and Laura Kalick, a national nonprofit tax consulting director with BDO USA, could lead to providers being exposed to possible audit and accounting risks. Feinsmith and Kalick, in a post at Becker’s Health IT and CIO Review, say that currently, tax-exempt healthcare entities using telemedicine follow IRS rules under unrelated business income (UBI).

However, these rules don’t always fit with the practice of telehealth — mostly because of the definition of patient. A patient is someone who gets treated physically in the hospital or in-person by a physician: neither apply for telemedicine.

Providers must be sure to show that a patient receiving care remotely is a patient of the hospital or that the service is "related to the hospital’s healthcare mission," according to the authors. To show this, hospitals must have detailed medical records, show how the service serves community needs, documents patient-physician interaction or have written treatment consent.

They add that another issue is a lack of state-level tax guidance.

"From most states' perspective, if any of the telemedicine activity generates UBI and crosses state lines, the income may require apportionment among the states based on activity in the respective states and the hospital may have to file a tax return in that state," they write.

Feinsmith and Kalick called current criteria for UBI dated, and say that the IRS and states should "reexamine the definitions of a patient, as well as the definition of providing healthcare services."

Telemedicine has other battles to fight, as well, including issues with reimbursement and fragmentation of state policies. VTN



American Well has joined the growing field of telepsychiatry, rounding out the telemedicine company’s offerings in remote behavioral health services.

American Well’s Online Care Group now includes psychiatrists, who can see adult patients and prescribe medications through the company’s Amwell video app. Physicians still can’t write prescriptions for controlled substances, but American Well is working on certification of its technology to facilitate that, said Zereana Jess-Hoff, vice president of behavioral health.

As part of the expansion, Boston-based American Well recently hired Jess-Hoff. She had been CEO of the Maryland market for Beacon Health Solutions, a payer-focused outsourcing firm.

The telepsychiatry service launched this week in Arizona, Colorado, Florida, Nebraska, North Dakota and South Carolina. American Well said it would add more states monthly until telepsychiatry was nationwide by early next year.

American Well will mostly call on psychiatrists for medication management rather than talk therapy, since the Online Care Group already has about 400 behavioral health professionals to handle those roles, Jess-Hoff said. VTN



While telemedicine can help prevent medical errors, potential dangers of its use may not be known or fully understood, according to a perspective article at PSNet, the Patient Safety Network.

The authors, Partners HealthCare Connected Health’s Stephen Agboola, MD, and Joseph Kvedar, MD, write that while there are many benefits to telemedicine use, there must be more research conducted to determine where patient safety issues lie.

They point to research showing that telemedicine can improve continuity of care and patient self-management and at the same time reduce costs. Other research backs telemedicine as a way to prevent treatment-related errors between clinic visits and detect preventable treatment-related adverse events that might otherwise go unnoticed by care providers.

While telemedicine is expected to adhere to the same standards as in-person care, some are calling for stricter standards, and those boundaries are one of the primary points research should address, they say.

While mobile health apps are proliferating, many are developed without medical input and marketed directly to consumers without formal testing for safety or effectiveness, a situation the Food and Drug Administration and the Federal Trade Commission are scrambling to address.

"Rather than stop the forward progress, we argue for a more thoughtful, continuous safety improvement process that could start from the moment of project conception," write Drs. Agboola and Kvedar.

Partners HealthCare is no stranger to advancements in mobile health, conducting studies on the technology's role in stress management and the use of mobile mood trackers.

To better ensure the safety of the tools, the authors other suggestions include requiring safety testing, but not solely in academic medical settings; increasing regulatory and industry organizations' involvement in creating consensus-driven guidelines; and making risks clear at patient enrollment in telemedicine programs, among other practices. VTN



Featured Contributor

Jeffrey H. Miller, MD

Jeffrey H. Miller, MD, is the founder and CEO of Miller Vein, with five locations in Southeast Michigan. Dr. Miller has received numerous awards and honors in his field, including being named one of Hour Detroit Magazine’s “Top Docs.” His multi-site company has received numerous accolades including Coolest Place to Work by Crain’s Business Detroit, Novi Chamber of Commerce’s Customer Service Excellence Award and several Corp! Michigan’s Economic Bright Spots Awards.

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