Management of Chronic Pain in the Aftermath of the Opioid Backlash

http://jamanetwork.com/journals/jama/fullarticle/2627567

Chronic pain is a prevalent, disabling, and costly condition.¹ In the United States alone, an estimated 126 million adults reported some pain in the previous 3 months, with 25.3 million adults (11.2%) reporting daily (chronic) pain and 23.4 million (10.3%) a lot of pain.² Three musculoskeletal pain disorders—low back pain, neck pain, osteoarthritis—are among the leading 9 causes of disability and together with migraine headache and other musculoskeletal disorders account for 9.7 million years lived with disability compared with only 8.8 million years lived with disability produced by the 12 leading causes of medical disability combined.³ Low back pain is the leading cause of years lived with disability both in the United States and globally and accounts for one-third of all work loss. Chronic pain costs the United States an estimated $560 to $635 billion annually.¹ Regrettably, National Institutes of Health (NIH) funding for pain research declined sharply from 2003 to 2007 by an average of 9% per year, and the federal response to a 2011 Institute of Medicine report¹ on pain in the United States has been limited and disproportionally focused on reducing opioid use rather than increasing pain relief.

Analgesic options for patients with chronic pain have steadily declined. Acetaminophen has been found to have minimal efficacy for low back pain and only small benefit for osteoarthritis.⁴ Similarly, the analgesic effects of nonsteroidal anti-inflammatory drugs (NSAIDs) for low back pain are very small.⁵ Moreover, the US Food and Drug Administration has strengthened its warning about the cardiovascular risks associated with NSAIDs, noting that there may be some risk even with short-term use among healthy individuals, although the risk appears greater among those with cardiovascular disease, with cardiovascular risk factors, and with longer-term use. Several classes of drugs, such as gabapentinoids (gabapentin, pregabalin) and serotonin-norepinephrine reuptake inhibitors (duloxetine, milnacipram) are FDA-approved for neuropathic pain and fibromyalgia, but it is unclear if they are effective for the broader group of patients with low back pain, osteoarthritis, and other musculoskeletal pain disorders. Tricyclic antidepressants and muscle relaxants are often used as adjunctive pain treatments but have a relatively weak evidence base for chronic pain.

Opioid analgesics have generated an enormous amount of concern. Several decades ago, advocates for better pain management encouraged greater use of opioids for treatment of patients with non–cancer chronic pain. Consequently, the number of opioid prescriptions, deaths related to opioid overdose, and opioid misuse escalated.⁶ Nevertheless, the movement to virtually eliminate opioids as an option for chronic pain refractory to other treatments is an overreaction. First, an estimated 5 million to 8 million people in the United States use opioids for long-term management.⁶ While the advocacy for more liberal use of opioids in chronic pain began in the early 1990s, consensus guidelines in the past 5 years still included opioids as a later step in the analgesic ladder. Many patients currently receiving long-term opioids were started when opioids were still considered a viable treatment option and if satisfied with their pain control and using their medications appropriately should not be unilaterally compelled to wean off opioids. Second, recent NIH⁶ and Centers for Disease Control and Prevention⁷ guidelines recognize that judicious prescribing and monitoring of opioids is a viable option for selected patients. Third, placebo-controlled trials have shown a modest analgesic effect of opioids,⁸ whereas the paucity of evidence for long-term effectiveness is true of pain treatments in general. Fourth, many patients respond better to one analgesic than another, just as patients with other medical conditions have differential medication responses. Given the small analgesic effect on average of most pain drugs, the few classes of analgesic options, and the frequent need for combination therapy, eliminating any class of analgesics from the current menu is undesirable.

Excessive use of phrases like opioid epidemic should be avoided (a literature search revealed more than 100 articles with the words opioid and epidemic in the title). An epidemic generally suggests a disease that is widespread and usually highly contagious rather than limited to a minority of those exposed. Analysis of a large national pharmacy database found that among more than 10 million incident opioid recipients, the probability of transitioning to long-term opioids was only 1.3% by 1.5 years after the first prescription, 2.1% by 3 years, 3.7% by 6 years, and 5.3% by 9 years.⁹ Thus, only a small fraction of patients prescribed opioids progress to long-term use. Admittedly, the absolute number of patients taking long-term opioids is substantial given the large number who receive an opioid prescription. The reality, however, is that most patients receiving an initial opioid prescription do not proceed to chronic use and among the subset that do use long-term opioids, the majority neither misuse nor experience an overdose. An unintended consequence of excessive concerns raised about opioids could be an increasing reluctance among clinicians to prescribe even small amounts of opioids for a limited time for acute pain, including for patients discharged from the emergency department, those who are recuperating from surgical procedures, or persons with severe dental pain. No clinician wants to be accused of contributing to the opioid “epidemic.” Meanwhile, some patients may be embarrassed about asking for effective pain relief.

There is an emerging advocacy movement for greater use of marijuana for chronic pain that parallels changing statutes regarding medical use and, in some states, legalization for any use. However, the small number of trials evaluating marijuana for chronic pain have typically used synthetic cannabinoids rather than more complex marijuana products, showed modest benefits, had limited follow-up of 2 to 15 weeks, and focused on neuropathic pain more often than musculoskeletal pain. Thus, clinicians must be careful of replacing the opioid epidemic with a marijuana epidemic.

Nonpharmacological pain therapies provide a promising alternative. Cognitive behavioral therapy (CBT) has the strongest evidence. Pain self-management programs and regular exercise are also beneficial.¹ Emerging, although less conclusive, evidence exists for yoga, mindfulness or meditation-based therapies, acupuncture, chiropractic, and massage. However, these therapies are neither a panacea nor a universal replacement for analgesics. First, there is a paucity of head-to-head trials of analgesic vs nonpharmacological therapies. Second, placebo controls can only be fully masked in drug trials, making it more difficult to distinguish the specific vs nonspecific effects of nonpharmacological therapies. Third, evidence of long-term effectiveness is weak for nonpharmacological and analgesic treatments alike. Fourth, CBT, exercise, and other behavioral treatments require sustained practice and lifestyle changes, reducing their effectiveness in many individuals unable to sustain such activities over many years. Fifth, there is an inadequate workforce trained in pain-focused CBT, and reimbursement strategies often favor non–evidence-based procedural or surgical pain treatments. Similar to depression, which can be treated with medications or psychotherapy, the management of chronic pain should integrate patient preferences, response to previous treatments, adverse effects, costs, and treatment availability.

Whereas skeptics tend to focus on the rather modest separation from placebo of all treatments for chronic pain, placebo effects should not be entirely dismissed. Pain responses to placebo range from 30% to 50% and have a biological underpinning: Effective placebo manipulations trigger the release of endogenous opioid peptides that act on the same receptors as synthetic opioid drugs such as morphine. Because current medical practice does not ethically condone the administration of pure placebos, leveraging the specific placebo effects of evidence-based pain treatments is compassionate rather than disingenuous care.

Imperfect treatments do not justify therapeutic nihilism. A broad menu of partially effective treatment options maximizes the chances of achieving at least partial amelioration of chronic pain.

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Are CDC Opioid Guidelines Causing More Suicides?

www.painnewsnetwork.org/stories/2016/5/27/are-cdcs-opioid-guidelines-causing-more-suicides

Donald Alan Beyer of Bovill, Idaho was one of them.

After years of suffering from chronic back pain, the disabled logger went into his backyard on May 8 – his 47th birthday — and shot himself in the head.

“He was in so much pain he could barely get out of bed to go to the bathroom. I guess he felt suicide was his only chance for relief,” says Beyer’s son, Garrett.

“I have witnessed my Dad in more pain than any one person should deal with every day of his adult life due to degenerative disc disease that was made so much worse by an accident on the job that broke his back. This and the eventual hole in the healthcare system focused on ignoring people with chronic pain led to his suicide this month.”

That hole in the healthcare system turned into an abyss when Beyer’s doctor retired last year. Beyer searched frantically for a new doctor, according to his son, but was unable to find anyone willing to take a new patient with chronic pain.

After months without pain medication, Beyer reached his breaking point.

DONALD BEYER

Pain News Network has been contacted by dozens of pain patients in recent months who say their physicians are weaning them off opioids or abruptly cutting them off completely.

Others say they are being dismissed by their longtime doctors – often with the excuse of a failed urine drug test. Still others say they are contemplating suicide, rather than face a life of intractable pain.

A 67-year old Florida woman who has suffered from migraines since the age of five wrote to us, saying she was having trouble finding a doctor.

Poulson has a question for CDC director Tom Frieden, who said the guidelines couldn’t wait because “so many people are dying” from overdoses.

“Then I ask you, are you willing to deal with a new epidemic of increased suicide rates, as many are dying of a result of unintended suffering?” said Poulson.

We’ll never know just how many patients kill themselves because their pain was untreated or under-treated. Experts believe many suicides go unreported or are misclassified as accidental, often covered up by grieving family members or accommodating medical examiners.

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Pharmacy accuses insurance claims processor Prime Therapeutics of squeezing it out of business

http://cookcountyrecord.com/stories/511114389-pharmacy-accuses-insurance-claims-processor-prime-therapeutics-of-squeezing-it-out-of-business

A family-owned pharmacy says in an antitrust lawsuit filed May 9 in federal court in Chicago it’s being squeezed out of business by an insurance claims processor, allegedly to benefit Walgreens.

Sharif Pharmacy, of Chicago, said it opened in 1995 with a goal of serving an elderly, low-income community mainly dependent on Medicaid and Medicare. It reported several acquisition advances by Walgreens in recent years, which it rejected because, it says, “six families” rely on the pharmacy for income and many Sharif customers would be otherwise be left unable to walk to the nearest Walgreens should Sharif close.

On Dec. 4, 2014, Sharif signed a contract with Prime Therapeutics, LLC, which processes claims and conducts audits for Blue Cross Blue Shield, as well as Medicaid and Medicare. Prime, based in Eagan, Minn., is owned by 13 Blue Cross Blue Shield companies, none incorporated in Illinois, and services 26 million customer accounts.

A 2016 eight-month audit Prime conducted revealed a discrepancy, which Sharif said was the first such finding in 22 years of business. That led to a Dec. 2, 2016, letter in which Prime told Sharif it owed $25,914.79. The pharmacy appealed, but Prime rejected the appeal in 11 days.

Sharif said the rapid turnaround denied it an opportunity to conduct its own audit or verify the information its suppliers provided to Prime. Sharif paid the fine — reasoning the audit and legal fees would cost more than the fine — stating in writing it was not admitting liability. On Feb. 7, Prime sent notice it was terminating Sharif’s contract as of May 15, “which is in effect shutting down the pharmacy,” per the complaint, as 75 percent of its customers use Medicare, Medicaid or BCBS.

According to the complaint, the timing of the audit is suspect as it relates to an Aug. 29, 2016, partnership announced between Walgreens and Prime to increase market share as a means of competing with CVS – as well as other pharmacies, like Sharif. The complaint further cites portions of Prime’s website identifying it as a mail order pharmacy, meaning it directly competes with Sharif in that regard, as well.

On March 6, Prime sent another letter retracting the Dec. 2 notice, and Sharif said that should force postponement of the scheduled May 15 contract termination. As such, it wants the court to issue a temporary restraining order and preliminary injunction to prevent Prime from terminating Sharif’s participation in the provider network.

Sharif said throughout the audit and appeal Prime “failed to respond or cooperate” with Sharif lawyer William Coughlin, despite “multiple telephone calls, letter and emails.” Coughlin ultimately “withdrew his representation of the Pharmacy as a result of Prime’s lack of response and cooperation,” per the complaint.

“Prime never disclosed the specific deficiencies found in the audit prior to denying the appeal,” the complaint stated, further arguing the Dec. 2 letter and subsequent retraction intentionally withheld information to get Sharif to pay the fine and accept liability, thereby justifying termination. Those omissions, it argued, “constitute false and fraudulent conduct on behalf of Prime.”

Sharif also contended Prime committed conversion when it improperly took $51,824.91 from submitted claims without consent based on a “unilateral determination” of contract breach tied to the audit.

Additional complaints include a violation of the Sherman Antitrust Act and interstate commerce rules and tortious interference with business relations. Sharif said Prime is encouraging customers to switch their pharmacy, though many have not because they are unable to reach a different outlet.

In addition to the injunction and restraining order, Sharif seeks a jury trial and compensatory, punitive, actual and statutory damages.

Representing Sharif in the matter is attorney M. James Salem, of Palos Heights.

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DEA might have inadvertently told teens where to hide drugs

http://nypost.com/2017/05/11/the-dea-might-have-accidentally-told-teens-where-to-hide-drugs/

Teens are using a host of seemingly benign household items — teddy bears, alarm clocks, calculators and even highlighters — to stash drugs, the Drug Enforcement Agency warns parents on a new website.

The site, Get Smart About Drugs, also links common teenage characteristics such as forgetting homework, lack of energy or motivation, enjoying their privacy, and asking for money as indicators of possible drug use.

The anti-drug agency tells parents to search their child’s room or car for drugs if they exhibit any of these behaviors and even provides a detailed breakdown of places to search:

Alarm clocks: Next time you’re in your kid’s room, try opening the battery compartment, there may be bags of drugs in there.

Highlighter: This common school supply is not just a fancy pen used to emphasize important text in a book, your child may be hiding small amounts of drugs inside the caps.

Shoes: Your kid is probably hiding baggies of drugs in the toes of the shoes to keep them out of sight.

Candy: Edible drugs such as ecstasy and certain types of edible marijuana can be easily camouflaged inside a candy wrapper.

Posters: What do Fifth Harmony, Justin Bieber, Taylor Swift and Harry Potter have in common? If your kid has a poster of any of these beloved pop culture staples, they may very well be flattening small drug-filled baggies and taping the bags behind them.

Teddy bears: Be very suspicious if your teen is holding onto this childhood toy. The inside seams of the “adored” stuffed animal is one of the best hiding spots for small amounts of drugs.

Car interior: If you were wondering why your teen begged and pleaded with you for a car, it isn’t because they wanted an easier way to get around town. Cars have a plethora of hiding spaces: glove compartments, seats, a steering wheel, and a trunk, among other things.

Game console: Wiis, Nintendo Switches, Playstations — all these devices have hidden crevices to stash drugs.

While teen drug abuse is a serious issue, the US National Institute on Drug Abuse notes fewer teens are using illegal drugs and marijuana than ever before, adding that they are also less likely to fall victim to prescription drug use — which, ironically, plagues many adults in the US.

Not surprisingly, the paranoia-inducing site for parents has drawn derision online, with more than a few people noting that it probably does more to give teens ideas on where to hide drugs than preventing abuse.

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Lawmakers Ask DEA for Information Regarding Opioid Diversions

http://www.hstoday.us/briefings/daily-news-analysis/single-article/lawmakers-ask-dea-for-information-regarding-opioid-diversions/fb3475fa2556aef3e02c123f61ae91e2.html

Concerned about whether the Drug Enforcement Administration (DEA) is doing enough to investigate and prosecute the illicit diversion of opioids, Senate Committee on Homeland Security and Governmental Affairs Chairman Ron Johnson (R-WI) and ranking member Claire McCaskill (D-MO), this week sent a letter to DEA Acting Administrator Charles P. Rosenberg requesting information regarding anti-diversion investigations conducted by the agency since 2011 in the wake of the opioid crisis.

DEA is instrumental in preventing and investigating diversion of controlled pharmaceuticals from both government and private facilities.

The lawmakers said that, “In 2015, when the committee examined allegations of opioid abuse at a VA facility in Tomah, Wisconsin, we learned that the DEA had been investigating allegations of diversion relating to the facility since at least 2009. Two years after news broke of the tragedies—and eight years since the DEA began its investigation—we are unaware of any administrative or criminal charges stemming from the tragedies at the Tomah VA facility.”

The two lawmakers said, “According to news reports … DEA has also been slow to target private pharmaceutical distributors … for example, when DEA agents ‘began to target wholesale companies that distributed hundreds of millions of highly addictive pills to the corrupt pharmacies and pill mills that illegally sold the drugs for street use,’ DEA officials at headquarters ‘began delaying and blocking enforcement actions.’ The DEA has also reportedly provided ‘conflicting guidance’ to a pharmaceutical company about its responsibilities to report suspicious orders from retailers. The conflicting guidance reportedly contributed to the government’s inability to obtain criminal convictions following its investigation.”

“DEA officials [also] may have presented conflicting guidance to a pharmaceutical manufacturer concerning its obligation to know its ‘customers’ customers,” they stated, asking Rosenberg to “describe any obligations manufacturers hold to monitor and report suspicious activity by pharmacies and doctors, the sources for these obligations under law or DEA regulations, and any related guidance the DEA has provided to manufacturers.”

“As the chief federal law enforcement agency responsible for enforcing the nation’s drug laws, the DEA has a duty to investigate violations of controlled substance laws. Accordingly, we write to request information about the DEA’s practices with respect to enforcement actions in anti-diversion investigations,” the lawmakers wrote Rosenberg.

“To assist the committee in better understanding how the DEA has pursued anti-diversion investigations during the opioid epidemic, we respectfully request the following information and material:

For each year since Fiscal Year 2011, please provide the following data relating to the DEA’s anti-diversion activities:

• The number of civil case filings against distributors, manufacturers, pharmacies and doctors;

• The number of immediate licensure suspension orders or orders to show cause against distributors, manufacturers, pharmacies and doctors;

• The number of voluntary license surrenders by doctors, including the number of such surrenders related to DEA enforcement actions; and

• The number of administrative enforcement actions brought against opioid distributors and manufacturers.

For each entry, the lawmakers are seeking the identity of the entity, the date of the DEA’s action, the nature of the allegations and the disposition of the matter.

For each year since FY 2011, they’ve requested identification of all fines DEA has levied against distributors and manufacturers, including the amount, date and recipient of each fine.

For each year since FY 2011, they’ve asked DEA to provide a list of the number of reports to DEA from manufacturers and distributors concerning suspicious orders of pharmaceuticals, broken down by the individual manufacturer or distributor.

For each year since FY 2011, lawmakers also want all the following data relating to the DEA’s anti-diversion activities:

• The number of anti-diversion investigations relating to a Department of Veterans Affairs facility or doctor;

• The number of license suspensions or civil proceedings against a VA facility or doctor; and

• The number of criminal proceedings brought against a VA provider.

For each entry, they’ve also asked DEA to identify the relevant facility, date of the proceeding, the nature of the allegations and the disposition of the matter.

The lawmakers stated that “beginning in 2013, DEA attorneys ‘started requiring a higher standard of proof’ before civil cases could move forward. According to former officials, DEA leadership changed the burden of proof that investigators needed to meet before proceeding with administrative cases from a ‘preponderance of evidence’ to ‘beyond a reasonable doubt.’ Is this assertion accurate?  If so, please explain the reasoning behind this change and provide supporting material.”

And, “If accurate,” the lawmakers stated, they asked DEA to “explain whether [it] received approval or guidance from the Department of Justice, including the Office of the Deputy Attorney General, before requiring a higher standard of proof before proceeding with administrative cases.”

Continuing, the lawmakers stated, “As mentioned above, DEA officials may have presented conflicting guidance to a pharmaceutical manufacturer concerning its obligation to know its customers’ customers.’ Please describe any obligations manufacturers hold to monitor and report suspicious activity by pharmacies and doctors, the sources for these obligations under law or DEA regulations and any related guidance the DEA has provided to manufacturers.”

Finally, they wrote, “When investigating a VA facility or provider, please explain the process by which the DEA obtains investigative information from the VA. Has the DEA ever experienced difficulties obtaining information from the VA necessary to complete an investigation? Please explain.”

The lawmakers gave DEA “by no later than May 22, 2017” to respond, after which they said “the committee may seek a staff-level briefing at the appropriate time.”

As more and more are dying from illegally imported drugs from Mexico and China… lawmakers are concerned about diversion from legit distribution channels ?

This reminds me of a old joke…

This one person was walking down the sidewalk and saw this other person under a street light…walking around looking at the ground… as if they were looking for something .. maybe something that had been lost… the first person asked the person walking around under the street light if they had lost something… sure enough the person stated that they had lost a ring and was not able to find it… the first person asked exactly where they thought that they had dropped the ring.. and the person pointed down the street – which was completely dark… the sun had already set and there was no moon and there were no street lights down the street where the person indicated that they had lost the ring… the first person asked the “ring seeker” if they thought that they had lost the ring down the street .. why they were looking for the ring down on this part of the street… the ring seeker stated, rather matter of factually ,  that it was dark down the street and this is where the street light is… ???

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Mystery solved: Addiction medicine maker is secret funder of Kennedy-Gingrich group

www.statnews.com/2017/03/03/kennedy-gingrich-group-funder/

A

company that sells a new opioid-addiction medication is a secret funder of an advocacy group fronted by Newt Gingrich and Patrick Kennedy that is pushing for more government funding and insurance coverage of such treatments.

Gingrich, the former Republican House speaker and a Trump confidant, and Kennedy, a former congressman and son of former US Senator Edward Kennedy, are paid advisors to Advocates for Opioid Recovery. They have generated a flurry of media attention in those roles, including joint interviews with outlets ranging from Fox News to the New Yorker.

Gingrich told STAT this week he didn’t know who was funding Advocates for Opioid Recovery, and the nonprofit group’s officials refused to disclose its financial backers.

The answer, according to a filing with the Securities and Exchange Commission, is Braeburn Pharmaceuticals Inc. The private company, based in Princeton, N.J., won approval last year to market an implant that continuously dispenses the opioid addiction medicine buprenorphine.

In a prospectus filed with the SEC in late January as part of a now-postponed effort to take the company public, Braeburn disclosed it entered into an agreement to make a $900,000 charitable donation to Advocates for Opioid Recovery. The filing indicates the company had paid $675,000 to the nonprofit group as of Sept. 30. It did not specify when the remaining funds would be paid.

The filing indicates Braeburn entered into the agreement to fund the nonprofit group through the private equity fund that owns the drugmaker.

That fund, called Apple Tree Partners, is also an investor in CleanSlate Addiction Treatment Centers. Kennedy has been a member of the board of directors of CleanSlate since 2015. The treatment center is also a sponsor of the Kennedy Forum, a mental health advocacy outfit headed by Patrick Kennedy.

Anne Woodbury, a former Gingrich aide who serves as executive director of Advocates for Opioid Recovery, did not immediately respond to a request for comment. A request for comment from Braeburn was also not immediately returned.

Kennedy declined to be interviewed this week, as did Van Jones, the CNN commentator and former Obama aide who is another paid adviser. Earlier this week, Woodbury and a spokesman for the nonprofit refused to say who was funding it, adding that the donors wanted to remain anonymous.

While there is widespread support in the treatment community for use of the medicines being promoted by the three men, there is growing concern about misuse of the drugs. And some addiction experts have expressed skepticism that the Braeburn implant will be an effective treatment option. There are alternative opioid-addiction treatments that do not rely on medication, including abstinence-based and behavioral therapy programs.

Last month, Braeburn shelved a planned initial public offering, citing poor market conditions. The company’s implant drug, branded as Probuphine, relies on four tiny rods implanted under the skin of the upper arm to dispense the addiction-treatment drug buprenorphine for six months at a time.

According to http://www.npr.org/sections/health-shots/2016/05/27/479755813/long-acting-opioid-treatment-could-be-available-in-a-month  The SIX MONTH therapy cost approx $5000.00 and the pt will now be dependent on a C-III medication… replacing their dependency on a C-II or C-I drug.

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Drug importation is dangerous

http://www.washingtonexaminer.com/drug-importation-is-dangerous/article/2622644

Like millions of Americans, I take allergy medicine. A few years ago, my doctor urged me to bid farewell to my local pharmacy and instead buy my medication from an online Canadian drug store, where it was cheaper. What terrible advice! The website was counterfeit and sent me “medicine” that was anything but — causing me to get severely sick for many months.

Millions of Americans could soon suffer the same fate. Congress is about to consider a bill that would make it legal for patients to import drugs from Canada. Lawmakers promise that the imports will be safe and effective. Unfortunately, that’s wishful thinking.

Let’s rewind. I started purchasing my allergy medicine online because it was cheaper. When the package arrived, nothing seemed amiss and the pills looked just like the ones from my local pharmacy. A few weeks after I started taking the new pills, I developed terrible migraines, stomachaches and gastrointestinal issues. I went to the doctor’s office, but no one could conclude what was wrong. After months of diagnostic work ups and a hospital visit, I still had no answers.

I began to suspect the pills themselves after hearing many online pharmacies provide counterfeit medication. I stopped taking them and as mysteriously as they had begun, my symptoms quickly disappeared. I went online to investigate whether anyone else had similar experiences. What I found was jarring.

The seemingly legitimate online pharmacy I used was operating illegally, and it wasn’t an exception. Over 96 percent of internet drug stores are illegal, according to a 2014 survey from the National Association of Boards of Pharmacy. Many don’t require a prescription. Some don’t even have a physical address.

Counterfeit drugs containing dangerous toxins — such as rat poison, lead and paint thinner — abound on these sites. The World Health Organization warned that over half the drugs sold by online pharmacies with either no physical address, or a fake physical address, are counterfeit.

These risks are precisely why the government has long banned drug imports. The Health and Human Services department admits it is unable to guarantee the safety of imports. The FDA has similarly warned that these foreign medicines pose great risks to patients.

Supporters of importation argue that the government could protect patients by only allowing imports from Canadian pharmacies. Yet many supposedly Canadian pharmacies traffic in counterfeits. The FDA periodically confiscates and examines illegal drug imports. Officials found that 69 percent of confiscated shipments contained unsafe drugs — and 80 percent of the shipments came from Canada.

Oftentimes, illegal online pharmacies claim to sell Canadian medicines, but actually obtain their drug supplies from unsafe developing countries. Even if the U.S. government tried to limit imports only to legitimate Canadian drug stores, many Americans would be fooled by extremely convincing imposter sites claiming to be Canadian.

If we open the door to widespread drug importation, I shudder to think how many patients will end up in the hospital — or worse. FDA officials and scientists are experts in their fields. They’ve repeatedly said legalizing imports would endanger patients.

I can only hope that Congress comes to its senses and listens to them. Better safe than sorry when it comes to our health.

Ali Schroer resides in Denver, Colorado.

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Woman’s skin ‘melts off’ after medication error

http://www.11alive.com/news/local/investigations/womans-skin-melts-off-after-medication-error/437871972

SNELLVILLE, Ga. — “I never lost anybody close to me, but that’s what it feels like.”

When 26-year-old Khaliah Shaw looks at pictures of herself from three years ago, she doesn’t recognize that person from before. Before her skin burned from the inside out. Before her sweat glands melted. Before the medically-induced coma. People can click this link here now if they need the best skin care routine. 

Before the mistake.

“I didn’t have to have people staring at me or wondering why I look different,” she said. “Three years ago, my life changed forever.”

In 2014, Shaw went to a doctor’s office because she felt depressed.  She received a prescription for lamotrigine. A pending lawsuit claims Shaw received the wrong dosage, and her pharmacy didn’t catch it.

For the first two weeks, “everything was ok.”

And then it wasn’t.

Blisters broke out all over her body. “I was in excruciating pain. It felt like I was on fire,” she said.

She was diagnosed with Stevens Johnson Syndrome a rare serious skin disorder. It’s usually caused by reaction to a medication or an incorrect dosage.

PHOTOS | Show progress of Stevens Johnson Syndrome

“It essentially causes your body to burn from the inside out and you pretty much just melt,” said Shaw.

The syndrome has left Shaw’s previously flawless skin burned and scarred. She is slowing losing her vision. Her sweat glands are gone, and her finger nails will never grow back. 

“This did not have to happen. This was not just some sort of fluke in my opinion. This happened as a directly result of somebody’s error,” said Shaw.  

An 11Alive investigation discovered those errors are happening at an alarming rate.

According to the Food and Drug and Drug Administration, errors jumped from 16,689 in 2010 to more than 93,930 in 2016. That’s a 462 percent increase. 

The numbers come from FAERS, or the FDA Adverse Event Reporting System (FAERS), a database that contains information on adverse event and medication error reports submitted to the agency. FAERS is a voluntary reporting system, so the numbers are likely higher.

The FDA says the spike is due to improvements made to its reporting system over the past two years. Pharmacy industry experts believe the numbers also reflect more people filling more prescriptions than ever.

Some experts believe there is something Georgia could do to reduce errors.

Matt Perri is a pharmacy professor at the University of Georgia. “When pharmacists get busier or pressure gets placed on the pharmacist, it makes it harder for them to do their jobs accurately,” he said.

To reduce errors, some states have tried to limit the number of prescriptions a pharmacist can fill to about 150 per shift. Georgia has no limits. Perri isn’t sure what the magic number would be, but he believes there could be benefits in setting limits.

“If you’re filling three or four hundred prescriptions by yourself, that’s clearly way too much for one pharmacist,” said Perri. “The idea of setting limits is unappealing on the business perspective, but on a patient safety perspective, it would be a good thing if we had a general idea of where those limits were.”

Jeff Lurey, with the Georgia Pharmacy Association, disagrees. “Patients come into the pharmacy at different times when they need to get medication filled. To put a restriction, I’m not so sure that’s in the best interest of our patients,” he said. “I’m just not convinced that cuts down on [medication] errors.”

Lurey argues training will have a bigger impact. This year, the association published a six-part training series focused on how pharmacists can reduced medication errors.

Perri’s advice for patients: make sure you’re consulted by a pharmacist. Georgia law mandates a pharmacist offer consultation when you pick a new prescription. Not a pharmacy tech, but an actual pharmacist.

Life after the mistake goes on. 

Shaw spent five weeks in medically induced coma while her skin slowly peeled off. There is no cure for Stevens Johnson Syndrome, and she could relapse.

“They’re telling me this could happen again, and they’re telling me if it did happen again, that it would be worse,” said Shaw.

According to the lawsuit filed on her behalf, medical bills have already reached more than $3.45 million. Extensive and prolonged medical care are expected to continue to add to those bills. 

Shaw is represented by two attorneys, Trent Speckhals and Robert Roll, both specialize in medication error litigation. 

“We continue to see the same errors over and over. [They’re] typically the result of pharmacists being too rushed, too busy, filling too many prescriptions and the use of [pharmacy] techs that really don’t have the training and the ability that a pharmacist would,” Speckhals said. “That’s one of the sad things, shocking things about it. It continues to happen at an alarming rate.”

“I never heard of Steven Johnson Syndrome until I was in the hospital with my skin melting off of my body. That’s when I learned what it was,” Shaw said. It’s a lesson she says no one should have to learn. “It’s important to know what’s in your body.”

“Be an advocate for yourself. Educate before you medicate,” she said. “Know what the side effects are.”

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REP. JENKINS TO DEA: RE-EVALUATE OPIOID QUOTA SYSTEM

https://evanjenkins.house.gov/media-center/press-releases/rep-jenkins-dea-re-evaluate-opioid-quota-system

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