Tag Archives: prescriptions

Written opioid prescriptions drop 10 percent in Wisconsin

A system to track prescription painkillers in Wisconsin to prevent abuse shows a nearly 10 percent drop in the number of opioid prescriptions written and filled compared to this time last year.

Wisconsin’s Controlled Substance Board recently published its first quarterly report on the prescription drug monitoring database, which was established in 2013, Wisconsin Public Radio reported.

The report does not say what percentage of doctors, dentists or pharmacists check the database, but officials said its use has steadily increased. Doctors will be required to check it next year.

The Wisconsin Medical Society’s chief medical officer, Donn Dexter, said the organization is working to educate physicians on the database and get them ready for the mandates.

A year after the database started in 2014 only 30 percent of pharmacists used the database and 8 percent of doctors. Dexter said with the new database implemented in January that number is sure to go up.

“The reason it wasn’t used is I think our doctors are already very busy,” Dexter said.

He said it is challenging to implement because it’s difficult to use.

The purpose of the database is to crackdown on patients getting various prescriptions from doctors and filling the same prescription with multiple pharmacists.

“One thing that the Medical Society is working hard on is that the pendulum doesn’t swing too far; so that patients that need pain control still get pain control,” said Dexter.

Law enforcement also uses the database most commonly for stolen prescriptions.

Policy Prescriptions: Clinton and Trump and health care

Hillary Clinton has been involved in the nation’s health care debate for more than 20 years and, as her campaign likes to say, she has the scars to prove it.

The Democratic presidential candidate failed in her 1990s effort to steer her husband’s universal coverage program through Congress, as the complex plan collapsed for lack of political support. Since then, she has tacked sometimes to the right on health care, and sometimes to the left.

Clinton is campaigning as the candidate of continuity and would leave all major health care programs in place. She has a long list of tweaks and adjustments that reflect her familiarity with policy and would expand the government’s role in health care.

Donald Trump calls President Barack Obama’s health care law “a disaster,” and vows to repeal it. He’d provide a new tax deduction for health insurance premiums, but also limit federal support for Medicaid, which covers low-income people. An independent analysis recently estimated his seven-point plan would cause 20 million people to lose coverage.

Trump’s ideas on health care have shifted over time, and his latest plan hews to basic GOP talking points. He’s expressed a belief that an economically advanced country like the United States can’t have people “dying in the street” for lack of medical care.

Here is a summary of their proposals:

MEDICARE

The government’s premier health insurance program covers about 57 million people, including 48 million seniors and 9 million disabled people under age 65. It enjoys strong support from voters across the political spectrum, although its long-term financial outlook is uncertain.

CLINTON: She would authorize Medicare to negotiate drug prices with pharmaceutical companies, and she supports allowing patients to import lower-cost prescriptions from abroad. Medicare beneficiaries represent a big share of the market for medications.

Clinton would also allow people ages 55-64 to buy into Medicare, although her campaign has not released much detail on how that would work.

TRUMP: He promises not to cut Medicare, and has suggested that other Republicans like House Speaker Paul Ryan made a political mistake by calling for major changes. But it remains unclear how Trump’s proposed repeal of “Obamacare” would affect its improvements to Medicare benefits, including closing the prescription drug coverage gap known as the “doughnut hole.”

Earlier, Trump spoke approvingly of giving Medicare legal authority to negotiate prescription drug prices, but that idea currently is not mentioned in his health care plan. Instead, he also supports allowing drug importation.

MEDICAID

The federal-state program for low-income individuals covers more than 70 million people, from pregnant women and children to elderly nursing home residents. Under Obama’s health care law, states can expand the program to include more low-income adults. Medicaid has sometimes carried a social stigma, but polls show the program has a solid base of public support.

CLINTON: She’d work to expand Medicaid in the 19 states that have yet to take advantage of the health law. She’s proposing three years of full federal funding for those states, the same deal given to states that embraced the law right away.

TRUMP: In 2015 Trump told an interviewer: “I’m not going to cut Social Security like every other Republican. And I’m not going to cut Medicare or Medicaid. Every other Republican’s going to cut.”

But his campaign plan would convert Medicaid into a block grant, ending the open-ended federal entitlement and capping funding from Washington. Over time, such an approach is likely to result in a big cut.

PRIVATE INSURANCE

About 177 million people under age 65 have private health insurance, with nearly 9 in 10 getting their coverage through an employer. Rising out-of-pocket costs such as insurance deductibles and copayments are a sore point with consumers.

CLINTON: She has proposed a new tax credit of up to $5,000 per family, or $2,500 for an individual, for households that face “excessive” out-of-pocket costs. The credit would be refundable, meaning that people who don’t owe income tax could still get money back. An independent analysis of her plan defined “excessive” costs as exceeding 5 percent of household income.

Clinton would also require insurers to cover three sick visits to the doctor each year without patients needing first to meet their plan’s deductible, the annual amount patients pay before their insurance kicks in.

TRUMP: He has no similar proposals on out-of-pocket expenses but has called for requiring hospitals, clinics and doctors to disclose prices so patients can shop around to reduce costs. And he would expand the use of tax-sheltered health savings accounts, used to pay for medical expenses not covered by insurance.

PRESCRIPTION DRUGS

More than half of U.S. adults take prescription drugs, and according to a recent Kaiser Family Foundation poll most of those patients report no major problems affording their own medications.

But consumers have been alarmed by the introduction of breakthrough drugs costing tens of thousands of dollars a year, along with a spate of seemingly random price hikes for older medications. More than 3 out of 4 say the cost of prescription drugs is unreasonable. A majority favors government action to curb costs.

CLINTON: She has several proposals, including a new government board with the power to penalize drug companies for “unjustified, outlier price increases,” a monthly limit of $250 on patients’ copayments for prescription drugs, lowering the period of protection from generic competition for biologic drugs from 12 years to 7 years, and requiring drug companies to provide rebates for medications used by low-income Medicare recipients.

Those ideas are on top of Medicare negotiations and allowing patients to import lower-cost prescription drugs from abroad.

TRUMP: In addition to backing drug importation, he also has called on Congress to remove barriers to competition from lower-price, equally effective medications.

‘OBAMACARE’

The 2010 Affordable Care Act expanded coverage for the uninsured and made carrying health insurance a legal obligation for most people. It offers subsidized private insurance for people who don’t have access to a job-based plan, along with a state option to expand Medicaid.

About 11 million people are covered through the law’s private insurance markets, while the Medicaid expansion has added at least 9 million to that program. It’s unclear if all those people were previously uninsured, but experts say the law deserves most of the credit for 21 million gaining coverage since its passage. Americans, however, remain deeply divided over “Obamacare.”

CLINTON: She wants to strengthen Obama’s signature law. Clinton would resolve a “family glitch” that denies health insurance subsidies to some dependents, sweeten subsidies for people buying coverage on the health law’s markets, and offer a new government-sponsored insurance plan to compete with private companies.

Her proposals would expand coverage to about 9 million more uninsured people, according to a recent study by the Commonwealth Fund and the RAND Corporation.

But Clinton would repeal the law’s tax on high-cost insurance, known as the “Cadillac Tax.” Many economists are critical, saying repeal of the tax would eliminate a brake on costs.

TRUMP: He would completely repeal the 2010 law and start over again. Trump has proposed a tax deduction for health insurance premiums, and also allowing insurers to sell policies across state lines, a longstanding GOP idea.

Critics say a deduction, usually claimed after the end of the tax year, wouldn’t do much to help lower-income people squeezed to pay premiums.

And the idea of selling across state lines has been opposed in the past by state insurance commissioners and attorneys general, who warned that it would undercut consumer protections. The insurance industry is divided, with smaller companies fearing it would favor major insurers.

Questions, concerns arise over FDA’s ‘Botox Police’

On April 5, 2012, a criminal investigator from the Food and Drug Administration named Robert West charged into an oncology clinic in Greenville, Tennessee.

West was chasing a lead that Dr. Anindya Sen and his wife, the clinic’s office manager Patricia Posey Sen, purchased an unapproved Turkish version of the cancer drug Avastin.

But “Cowboy Bob,” as some defense attorneys call him, did not realize his interview was caught on the clinic’s surveillance cameras. West told Posey Sen she was guilty of buying counterfeit drugs and looked like a “deer in the headlights,” court records say.

Without a warrant or permission, he and an FBI agent rifled through cabinets, seizing drugs that appeared to have foreign, non-FDA approved packaging. At one point, West snatched a drug out of a nurse’s hands as she treated a chemotherapy patient.

A U.S. judge later said West’s tone was “ominous and threatening” and that his statement about the drugs being counterfeit “apparently was not the truth.” West’s search was declared illegal, and the evidence was deemed inadmissible at the Sens’ criminal trial in December 2013.

Earlier that year, managers at the FDA’s Maryland-based Office of Criminal Investigations, or OCI, had promoted West to senior operations manager, where he oversaw hundreds of similar investigations. Last year, he was promoted to special agent in charge in Miami. In February, he taught a class to new agents on how to pursue similar probes.

West declined interview requests.

West’s approach in Tennessee and FDA managers’ eagerness to reward him open a window into a collision unfolding inside the historically staid U.S. drug agency, pitting investigators who object to what they see as cowboy tactics against a small cadre of managers who control the opening of investigations.

FDA leaders, including West, Special Agent in Charge of the headquarters office Thomas South and OCI Director George Karavetsos, are pursuing an agenda that has opened a divide over the office’s handling of criminal investigations, interviews and records show.

Prosecutors are declining to pursue many FDA cases, citing a lack of prosecutorial merit, criminal intent or strong evidence, Reuters found in a review of more than 170 letters detailing why the Department of Justice declined cases. The letters, obtained under the Freedom of Information Act, appear to bolster critics’ claims of agency overreaching.

From fiscal 2008 to 2015, more than half of OCI cases – 53 percent – were closed without action. By contrast, at the Environmental Protection Agency in the same period, 71 percent of opened cases spurred criminal charges. At the Internal Revenue Service’s criminal unit, 68 percent of initiated investigations resulted in charges. The FDA criminal investigation office had more cases closed without action than it had arrests, Reuters found.

Some FDA agents complain they have turned into the “Botox Police” – chasing down every doctor who purchased authentic versions of the popular anti-wrinkle drug that were labeled for use in other countries, an exercise producing few prosecutions.

Large pharmaceutical companies sometimes refer cases to the FDA or help the agency investigate targets, and some doctors ensnared in the dragnet say the investigations ultimately help drug makers charge top dollar in the United States.

In one example, Botox maker Allergan referred a case to the FDA against an unlicensed Virginia distributor accused of illegally selling Botox, court records show – helping the agency land convictions. Another time, a former OCI agent-turned security official for a drug maker conducted his own undercover work before sharing his findings with the FDA.

The FDA said its focus differs from other agencies, with a mandate to protect public health, and that it follows leads from all sources –agents, the public and industry. “The public health risks of unapproved drugs from foreign sources outweigh any potential cost savings,” the FDA said in a statement.

In an interview, Karavetsos said statistics are not a good benchmark to measure OCI’s success. Protecting public health will “always trump the criminal investigation,” said Karavetsos, who became OCI director in January 2015.

He points to successful prosecutions, including one against the former Peanut Corporation of America president who sold Salmonella-tainted peanuts, and another involving a fatal meningitis outbreak in Massachusetts.

Through an FDA spokesman, South declined comment.

UNKNOWN OFFICE, BIG POWER

The 280-unit Office of Criminal Investigations, with an annual budget of $77.3 million, is a little-known corner of the FDA created in the 1990s in response to a generic drug scandal.

The FDA agents carry guns and only investigate criminal violations, though the unit is housed inside the agency’s civil regulatory arm, the Office of Regulatory Affairs. Historically, many agents were hired from the Secret Service.

FDA leaders say they are trying to better align OCI’s priorities with agency centers that set policy over areas including food, drugs and tobacco. They are setting investigative goals and revamping training and hiring – changes, they say, that may be causing growing pains.

“Before the realignment, the decision-making about what types of cases OCI would take was less centralized than it is now,” said Howard Sklamberg, deputy commissioner for the FDA’s Office of Global Regulatory Operations and Policy.

Current and former FDA agents say managers push cases that lack legal merit at the expense of others with more potential that were not pursued, including probes involving steroids, the street-level sale of counterfeit painkillers and the importation of drugs like Kratom, a plant used as an alternative to opioids.

Agents say they are instructed to focus primarily on cases involving the “legitimate supply chain.” In the United States, the majority of drugs move through one of three major wholesale distributors – McKesson, Cardinal Health and AmerisourceBergen Corp.. OCI headquarters wields complete control over which cases to pursue.

Most agents who spoke for this article did so anonymously. Reuters obtained letters written by several agents describing tensions and low morale.

“The vast majority of referrals I received from within OCI, especially from Headquarters, involved conduct that did not even rise to the level of a knowing crime,” former FDA special agent Ken Petroff wrote in a March letter to FDA Commissioner Robert Califf. “Some of the referrals involved no crime at all yet I was ordered to spend (waste) time on these cases.”

Petroff sent the letter, he said, to share concerns about waste and management within FDA. Four months later, Associate Commissioner for Regulatory Affairs Melinda Plaisier replied, “I appreciate the information you have provided.”

DEAD-END INVESTIGATIONS

One example of the fissure emerging within the FDA: a push by headquarters to investigate the use of imported unapproved drugs by doctors, such as Botox, an injectable cosmetic made by Allergan to reduce wrinkles.

The Botox cases are part of a larger effort to crack down on what are known as foreign unapproved medical products – so-called “FUMP” cases. A drug is deemed foreign unapproved if it is manufactured without FDA oversight or lacks labels approved by the agency. The designation doesn’t necessarily mean the drug is counterfeit or harmful.

Concerns about the agency’s handling of Botox cases emerged as early as 2013. In one field office, a psychologist sent to defuse internal tensions heard complaints of “micromanagement” of cases and of Botox inquiries wasting “valuable agent time” and antagonizing relations with U.S. attorneys, documents show.

The Botox initiative has produced few tangible results, but has rankled agents who say they are little more than “Botox Police” or the “ATF”— Allergan Task Force. Some complain the crackdown protects pharmaceutical companies’ drug prices more than consumers.

“In the European Union, price controls govern the amount they can charge,” attorney Kevin Marino said in a 2014 trial defending a client acquitted of illegally shipping Botox. “Here in the United States, apparently the last bastion of capitalism in the world, they can charge whatever they please.”

Investigations into doctors who purchase foreign unapproved cosmetic products are unlikely to prompt prosecutors to press charges, records and interviews show. There is little demonstrable harm to public health or the national purse since taxpayer-funded insurance programs do not accept claims for Botox unless it has been prescribed for an approved medical purpose.

And, the majority of the Botox seized by the OCI was later found to be legitimate products made by Allergan but labeled for use in other countries, according to some 140 FDA lab reports examined by Reuters.

Allergan calls the manufacture and sale of counterfeit Botox a “significant threat.” Unauthorized suppliers may not store it at the proper temperature, decreasing its effectiveness and triggering “adverse effects,” Allergan said.

The company “frequently” receives reports about unauthorized sellers and refers them to law enforcement when necessary, a spokesman said.

Letters drafted by agents and sent to U.S. Attorney’s Offices detail why the bulk of the FDA’s Botox prosecutorial referrals were declined.

The Nevada U.S. Attorney’s Office rejected a case against a doctor who twice purchased foreign-made Botox for his wife. Other prosecutors declined cases because the Botox was authentic, small amounts were purchased, and no insurance claims were submitted.

Still, agents are instructed by managers in the office’s headquarters in Rockville, Maryland, to interview every doctor suspected of purchasing foreign unapproved drugs and upload their findings into a non-public FUMP database used to mine for criminal targets. “There are no assurances that unapproved products from foreign sources are safe or effective,” the FDA said.

Another investigation that faltered: a nationwide undercover sting championed by Karavetsos in 2015 involving the purchase of a variety of dietary supplements marketed for weight loss, sexual performance and strength building sold at retail chains including GNC, The Vitamin Shoppe, and Vitamin World.

Though agents bought about $16,000 in supplements, the investigation produced no prosecutions because the supplements all came back with a clean bill of health from the FDA’s lab, documents obtained by Reuters show.

“Wasting investigative resources on cases that go nowhere raises concerns about the responsible use of tax dollars,” said Senate Judiciary Chairman Charles Grassley, R-Iowa.

Karavetsos described the probe as a proactive investigation.

MISDEMEANORS AND QUESTIONS

Unlike Europe, the U.S. does not impose price controls on pharmaceuticals. This makes costly drugs like Botox popular in America’s “gray market,” where distributors divert drugs with foreign labels into the United States and sell them to doctors at a discount.

“There is a reason why a doctor in the United States is incentivized to buy foreign-sourced Botox,” said Andrew Ittleman, a defense attorney with Fuerst Ittleman David & Joseph PL. “All of this relates to… the lack of price controls and Allergan trying to control its market.”

The FDA launched a mission to interview doctors who buy foreign-sourced clinical drugs, hoping to halt fraud in the supply chain. But the effort brought limited success.

The FDA’s push was sparked when a fake version of Roche’s cancer drug Avastin infiltrated the supply chain. Distributors offered to sell the drugs at cheaper prices to oncologists who operate sole practices and had no power to negotiate discounts.

A Roche spokeswoman said the company learned of the issues from a Swiss wholesaler in December 2011; the FDA contacted the company in January 2012 after learning counterfeit vials were shipped to the U.S.

From 2011 to 2015, FDA investigations into foreign unapproved oncology drugs led to criminal charges against suppliers and distributors as well as more than two dozen doctors, nurses, office managers and clinics who bought the drugs and billed them to federal insurance programs.

Yet most doctors, nurses and office managers were charged with less serious misdemeanor violations of the Federal Food, Drug and Cosmetic Act, which makes it a crime to introduce or receive a counterfeit, adulterated or misbranded drug into interstate commerce.

The FDA is the lead federal agency enforcing violations of the law, with FUMP cases among its investigative priorities.

After devoting more than 218,000 man hours on FUMP investigations from 2012-2015, many cases were declined for prosecution or closed. Of 878 investigations opened from 2009 through Aug. 1, 2016, 110 convictions resulted and 437 cases were closed without action, records show.

In an irony, many doctors criminally prosecuted had purchased real versions of the drugs that were misbranded, while some who actually bought fake Avastin were not charged.

The Roche spokeswoman did not directly respond to a question about the disparate prosecutorial treatment, but said the company supports the government’s efforts.

In two California cases, doctors who purchased counterfeit Avastin reached civil settlements. In Arizona, doctors whose patients suffered adverse reactions to counterfeit Avastin were not charged due to “the lack of interest” by prosecutors, records show.

Karavetsos defended the efforts, saying each U.S. attorney’s office has unique priorities and OCI is focusing on high-volume purchasers and repeat offenders.

“We don’t have the luxury to play Russian roulette with the consumers in the United States,” he said.

Charging doctors with misdemeanor violations has sparked debate.

Doctors are typically not trained to identify misbranded packaging, yet can be convicted of a misdemeanor if they unintentionally buy a misbranded drug. An FDA expert once testified he didn’t learn how to identify foreign unapproved labels until he joined the agency. West, in a 2013 email to field managers, admitted having a hard time detecting misbranded medical devices.

A drug can fall afoul of branding rules over small details. Those failing to display “RX only” or containing foreign writing on the outer package or insert could skirt rules.

Often, prosecutors cited a lack of criminal intent in turning down FDA cases.

“You don’t have to be a philosopher king to understand there is an elemental unfairness in holding someone criminally liable for conduct of which they had no knowledge or intent,” said Richard Callahan, U.S. Attorney for the Eastern District of Missouri.

Callahan said he strives to bring felony charges, but on rare occasion files misdemeanors in hopes of using the charges to build larger cases.

To be sure, some doctors ignore red flags.

One in Tennessee got a two-year prison term after he ignored nurses’ concerns that some of the drugs he bought had foreign languages on the labels; he had the drugs shipped to a storage building to avoid detection. Karavetsos said the FDA has nearly a dozen active cases into doctors who continued buying drugs after warnings.

But many doctors say they did not knowingly break the law.

A CASE IN TEXAS

One is Dr. Eduardo Miranda, an oncologist treating primarily impoverished patients in Laredo, Texas.

The drugs Miranda bought were made by the real manufacturers, but labeled for use in other countries. No patients were harmed.

Miranda said he ordered from a company called Quality Special Products because he was facing a shortage of an anti-nausea drug. QSP also offered a discount.

In 2009, an FDA agent confronted Miranda and accused him of ordering from QSP to make more money. Later, with TV cameras rolling, agents wearing bulletproof vests and carrying guns raided his office while patients awaited care.

Miranda stopped purchasing from QSP and created a new compliance program. In 2013, the U.S. Attorney for the Southern District of Texas prosecuted Miranda. He pleaded guilty to a misdemeanor of introducing a misbranded drug into interstate commerce.

“I think I was used by them to make a statement,” Miranda said. “They didn’t care that I was the only clinic providing care for indigent patients.”

Miranda is trying to appeal a 13-year ban from participating in federal health programs. In a nod to the role Miranda plays in his community, the Health and Human Services Inspector General carved out an exemption allowing him to continue billing the government as long as he remains in Laredo. Separately, the Texas medical board declined to fine him.

Miranda pays $17,000 in monthly restitution to Medicare, Medicaid and Blue Cross Blue Shield. Drug maker Sanofi petitioned for restitution on top of that, saying it lost $300,000-plus in profit because Miranda did not pay the U.S. market rate. The judge rejected that argument.

Sanofi takes “threats to patient safety” seriously and seeks restitution “as an additional deterrent,” a spokeswoman said.

Miranda’s attorney, Russell Soloway, said the case sends another message: “The laws and regulations are set up to safeguard the … big drug supply companies.”

Some legal experts believe the law should differentiate between clear criminal conduct, such as selling watered-down products, versus buying the same drugs cheaper.

“You would hope they would focus on people endangering the public health,” said Kevin Outterson, a professor of health law at Boston University.

SHIFTING FOCUS

After the discovery of bogus Avastin, OCI initially focused on tracking down doctors who purchased foreign unapproved cancer medications.

In 2013, the focus shifted. That year, Rockville managers dispatched investigators to interview 1,100 doctors suspected of buying foreign unapproved drugs from Medical Device King, a licensed wholesale distributor in Great Neck, New York, internal records show.

Former OCI agent Jim Dahl, then a security official for drug maker Eisai, conducted undercover purchases of the anti-nausea drug Aloxi from Medical Device King and shared his findings with the FDA, later testifying for the government.

Dahl, now a board member for the non-profit Partnership for Safe Medicines, said Eisai was motivated by patient safety. “If we find a crime, we refer it to the government,” he said.

As agents made their rounds, they encountered many doctors who had only purchased Botox or medical devices. Some got less than $1,000 worth of drugs.

Special Agent in Charge South instructed agents to conduct surprise visits to doctors’ offices, refer each for prosecution and seek asset forfeitures, an April 2013 email shows. Agents often entered offices without warrants.

Thomas Kubic, president of the non-profit Pharmaceutical Security Institute, sees value in agents visiting doctors. “You don’t know if it is genuine or counterfeit,” he said.

Only a handful of doctors have faced prosecution for buying foreign, unapproved Botox.

One, Anoushirvan Sarraf, was convicted at trial in 2014 on felony charges in connection with illegally importing and purchasing Botox from Gallant Pharma, an unlicensed Virginia supplier the FDA began investigating in 2009 after complaints from Allergan. Jonathan Simms, Sarraf’s attorney, said his client denied being part of a conspiracy.

In the same case, court testimony shows, the FDA asked Allergan to help it find a doctor who would go undercover, though the effort failed. Other drug makers hired their own private investigators to make undercover purchases and shared the results with the FDA. Drug companies “very frequently” send complaints to OCI, an FDA agent testified.

West unveiled plans to launch the FUMP database in an April 2013 email to field managers, saying it would help gather intelligence. “These cases are not ‘stupid’ as an agent recently stated,” wrote West, who is retiring this month.

In June 2013, an FDA employee lodged a complaint with the HHS Inspector General, saying the Botox cases drained resources. The complaint detailed the hours spent chasing doctors who bought small quantities, and said managers chided agents raising questions.

Nothing came of the complaint, the former employee said.

THE CASE IN TENNESSEE

In Tennessee, the Sens won a victory in convincing a judge to suppress evidence from West’s search. Dr. Sen and his wife faced multiple misdemeanor counts for buying foreign unapproved drugs. Office manager Posey Sen faced felony charges, including allegations she lied to West.

The jury acquitted Posey Sen of all felony charges. It convicted the Sens of misdemeanors involving introducing misbranded drugs into interstate commerce.

The convictions did not stand for long.

The Sens appealed, but before their case was heard, the Justice Department announced in December 2014 it would vacate the convictions. The DOJ declined to provide Reuters documents detailing its rationale.

Still, the DOJ has pursued civil charges against Dr. Sen, records show, and the government withheld about $1 million in reimbursements tied to the drugs. The Sens had to fight to convince HHS to let them participate in federal insurance programs.

Dr. Sen is again treating patients.

Posey Sen described the case as a “horrible ordeal.” At one point during her arraignment, she said, West swabbed her mouth for a DNA sample. “He personally did the DNA testing on me,” she said.

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America’s other drug problem: Copious prescriptions for hospitalized elderly

Dominick Bailey sat at his computer, scrutinizing the medication lists of patients in the geriatric unit.

A doctor had prescribed blood pressure medication for a 99-year-old woman at a dose that could cause her to faint or fall. An 84-year-old woman hospitalized for knee surgery was taking several drugs that were not meant for older patients because of their severe potential side effects.

And then there was 74-year-old Lola Cal. She had a long history of health problems, including high blood pressure and respiratory disease. She was in the hospital with pneumonia and had difficulty breathing. Her medical records showed she was on 36 medications.

“This is actually a little bit alarming,” Bailey said.

He was concerned about the sheer number of drugs, but even more worried that several of them — including ones to treat insomnia and pain — could suppress Cal’s breathing.

An increasing number of elderly patients nationwide are on multiple medications to treat chronic diseases, raising their chances of dangerous drug interactions and serious side effects. Often the drugs are prescribed by different specialists who don’t communicate with each other. If those patients are hospitalized, doctors making the rounds add to the list — and some of the drugs they prescribe may be unnecessary or unsuitable.

“This is America’s other drug problem — polypharmacy,” said Dr. Maristela Garcia, director of the inpatient geriatric unit at UCLA Medical Center in Santa Monica. “And the problem is huge.”

The medical center, where Bailey also works, is intended specifically for treating older people. One of its goals is to ensure that elderly patients are not harmed by drugs meant to heal them.

That work falls largely to Bailey, a clinical pharmacist specializing in geriatric care.

Some drugs can cause confusion, falling, excessive bleeding, low blood pressure and respiratory complications in older patients, according to research and experts.

Older adults account for about 35 percent of all hospital stays but more than half of the visits that are marred by drug-related complications, according to a 2014 action plan by the U.S. Department of Health and Human Services. Such complications add about three days to the average stay, the agency said.

Data on financial losses linked to medication problems among elderly hospital patients is limited. But the Institute of Medicine determined in 2006 that at least 400,000 preventable “adverse drug events” occur each year in American hospitals. Such events, which can result from the wrong prescription or the wrong dosage, push health care costs up annually by about $3.5 billion (in 2006 dollars).

And even if a drug doesn’t cause an adverse reaction, that doesn’t mean the patient necessarily needs it. A study of Veterans Affairs hospitals showed that 44 percent of frail elderly patients were given at least one unnecessary drug at discharge.

“There are a lot of souvenirs from being in the hospital: medicines they may not need,” said David Reuben, chief of the geriatrics division at UCLA School of Medicine.

Some drugs prescribed in the hospital are intended to treat the acute illnesses for which the patients were admitted; others are to prevent problems such as nausea or blood clots. Still others are meant to control side effects of the original medications.

University of California, San Francisco researcher and physician Ken Covinsky, said many doctors who prescribe drugs in hospitals don’t consider how long those medications might be needed. “There’s a tendency in medicine every time we start a medicine to never stop it,” Covinsky said.

When doctors in the hospital change or add to the list of medications, patients often return home uncertain about what to take. If patients have dementia or are unclear about their medications, and they don’t have a family member or a caregiver to help, the consequences can be disastrous.

One 2013 study found that nearly a fifth of patients discharged had prescription-related medical complications during their first 45 days at home. About 35 percent of those complications were preventable, and 5 percent were life-threatening.

UCLA hired Bailey about three years ago, after he completed a residency at University of California, Davis. The idea was to bring a pharmacist into the hospital’s geriatric unit to improve care and reduce readmissions among older patients.

Speaking from his hospital bed at UCLA’s Santa Monica hospital, 79-year-old Will Carter said that before he was admitted with intense leg pain, he had been taking about a dozen different drugs for diabetes, high blood pressure and arthritis.

Doctors in the hospital lowered the doses of his blood pressure and diabetes medications and added a drug to help him urinate. Bailey carefully explained the changes to him. Still, Carter said he was worried he might take the drugs incorrectly at home and end up back in the hospital.

“I’m very confused about it, to tell you the truth,” he said after talking to Bailey. “It’s complicated. And if the pills are not right, you are in trouble.”

Having a pharmacist like Bailey on the team caring for older patients can reduce drug complications and hospitalizations, according to a 2013 analysis of several studies published in the Journal of the American Geriatrics Society.

Over a six-month stretch after Bailey started working in UCLA’s Santa Monica geriatric unit, readmissions related to drug problems declined from 22 to three. At the time, patients on the unit were taking an average of about 14 different medications each.

Bailey is energetic and constantly on the go. He started one morning recently with a short lecture to medical residents in which he reminded them that many drugs act differently in older patients than in younger ones.

“As you know, our elderly are already at risk for an accumulation of drugs in their body,” he told the group. “If you put a drug that has a really long half-life, it is going to last even longer in our elderly.”

The geriatric unit has limited beds, so older patients are spread throughout the hospital. Bailey’s services are in demand. He gets paged throughout the day by doctors with questions about which medications are best for older patients or how different drugs interact. And he quickly moves from room to room, reviewing drug lists with patients.

Bailey said he tries to answer several questions in order to determine what’s best for a patient. Is the drug needed? Is the dose right? Is it going to cause a problem?

One of his go-to references is known as the Beers list — a compilation of medications that are potentially harmful for older patients. The list, named for the doctor who created it and produced by the American Geriatrics Society, includes dozens of medications, including some antidepressants and antipsychotics.

When he’s not talking to other doctors at the hospital, Bailey is often on the line with other pharmacists, physicians and relatives to make sure his patients’ medication lists are accurate and up to date. He also monitors patients’ new drugs, counsels patients about their prescriptions before they are discharged and calls them afterward to make sure they are taking the medications properly.

“Medications only work if you take them,” Bailey said dryly. “If they sit on the shelf, they don’t work.”

That was one of his main worries about Cal, the 74-year old with chronic obstructive pulmonary disease. Standing at her bedside, Bailey pored over the list of 36 drugs. Cal told him she only took the medications that she thought seemed important.

Bailey explained to Cal that he and the doctors were going to make some changes. They would eliminate unnecessary and duplicate drugs, including some that could inhibit her breathing. Then she should take as prescribed all of the medications that remained on the list.

Bailey said he’s constantly weighing the risks versus the benefits of medications for elderly patients like Cal.

“It is figuring out what they need,” he said, “versus what they can survive without.”

This story was reported while its author, Anna Gorman, participated in a fellowship supported by New America Media, the Gerontological Society of America and The Commonwealth Fund.

KHN’s coverage of aging and long-term care issues is supported by a grant from The SCAN Foundation, and its coverage of late life and geriatric care is supported by The John A. Hartford Foundation. Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation.

Democrats push health care reform, GOP pushes repeal

Americans filled 4.3 billion prescriptions last year, and they’re still ailing from the skyrocketing cost of drugs.

Democratic presidential candidates Bernie Sanders and Hillary Rodham Clinton gave voice to patient problems and consumer complaints this fall, with both issuing plans to rein in outrageous prices for prescription medicine.

“The pharmaceutical industry has become a health hazard for the American people,” said Sanders, an independent senator from Vermont. “We now pay, by far, the highest prices in the world for prescription drugs and one in five Americans … cannot afford to fill the prescriptions their doctors write.”

In 2014, an estimated 34 million people could not fill their prescriptions because of costs. Surveys now show that about 70 percent of Americans believe drug costs are unreasonable and that drug companies put profits before people.

Those polls were conducted before Turing Pharmaceuticals CEO Martin Shkreli made headlines in September for raising by more than 5,000 percent the price of Daraprim, a medication used to treat toxoplasmosis in AIDS patients. 

Within hours of Turing purchasing the right to retail Daraprim, the price for a pill that’s been sold for $13.50  went to $750.

“For Turing to charge insurance companies and self-pay individuals with a cost (so much) greater for the same drug is unconscionable,” said Scott Caruthers, chief pharmacy officer of the AIDS Healthcare Foundation, the largest global AIDS group.

AHF president Michael Weinstein said Turing’s greed “is likely to go down in history as the straw that broke the camel’s back on drug pricing.”

Shkreli announced in late September that he would lower the cost “in response to the anger.”

Sanders, an advocate of universal health care, in mid-September released a prescription drug plan that said the federal government should use its bargaining power to negotiate with companies for better prices; allow imports from licensed Canadian pharmacies; prohibit deals that keep generics off the market; and require drug companies to report information affecting pricing.

Clinton, as first lady, led an effort blocked by congressional Republicans that would have provided comprehensive, universal health care. She responded to Turing’s price-gouging almost immediately, pledging on Twitter a plan to reform the prescription drug market that would “both protect consumers and promote innovation — while putting an end to profiteering.”

Clinton has since issued a series of proposals to address rising drug costs, including a monthly $250 cap on out-of-pocket drugs to help patients with chronic or serious health conditions.

The candidate also proposed requiring that health insurance plans provide for three sick visits per year without counting toward a patient’s annual deductible and offering a refundable tax credit of up to $5,000 for families for excessive out-of-pocket care costs.

“When Americans get sick, high costs shouldn’t prevent them from getting better,” Clinton said in a statement. “With deductibles rising so much faster than incomes, we must act to reduce the out-of-pocket costs families face.”

A survey recently released by the Henry J. Kaiser Family Foundation found that employer-sponsored health insurance premiums rose about 4 percent in 2015, considered a moderate increase. But since 2010, both the share of workers with deductibles and the size of the deductibles have increased sharply — about seven times over the rise in worker wages.

A recent Kaiser analysis found comparable countries outperforming the United States on life expectancy at birth, cost-related barriers to health care access and the burden of disease, which takes into account years of lost life due to premature death and years of life lost to poor health.

The Obama administration expects to see improvements as more people have greater access to care under the five-year-old Affordable Care Act, which mandated insurance coverage, expanded eligibility for Medicaid, prohibited insurers from denying coverage for pre-existing conditions, provided for preventative care and lifted lifetime health benefit caps.

New data from the U.S. Census Bureau shows that the national uninsured rate dropped to a historic low of 9.2 percent in early 2015, with 15.8 million people gaining coverage since the health care marketplaces opened in 2013.

Still, the GOP focus in the health care debate is almost solely on repealing the Affordable Care Act. Congressional Republicans have voted more than 50 times to repeal all or parts of the law and, on Sept. 29, they voted again to advance legislation that would dismantle the ACA.

The House Ways and Means Committee chaired by Wisconsin Congressman Paul Ryan voted along party lines to repeal the mandate requiring Americans to get health insurance and also the mandate requiring larger companies to provide health benefits to employees.

Ryan, in a statement, said, “This bill is a big step toward dismantling Obamacare. … By tearing down many of the worst parts of the law — like forcing people to buy insurance only to later tax them for it — we would stop Obamacare in its tracks and start working toward a more affordable, higher-quality, patient-centered system.”

Wisconsin Gov. Scott Walker also wants the Affordable Care Act repealed, although health care advocates in the state maintain provisions have mostly benefited Wisconsinites.

“The ACA has dramatically reduced the number of uninsured in Wisconsin and improved access to preventive health care,” said Jon Peacock, research director for the nonprofit Wisconsin Council on Children and Families.

The WCCF said by the end of June, more than 230,000 Wisconsinites had signed up for a marketplace plan under the ACA and about 90 percent were eligible for tax credits to offset costs.

GOP lawmaker addresses heroin addiction in Wisconsin in response to daughter’s struggle

A Republican lawmaker whose daughter has struggled with heroin addiction announced Tuesday he plans to introduce another round of legislation focusing on opiate prescriptions that can lead to heroin abuse.

Rep. John Nygren of Marinette spearheaded seven bills designed to curtail heroin abuse and help addicts recover last session. He told reporters during a news conference Tuesday he has four more bills ready to go. Assembly Speaker Robin Vos, R-Rochester, Dr. Tim Westlake, vice chairman of the state Medical Examining Board and a member of the state’s controlled substance board, and Wisconsin Attorney General Brad Schimel all stood with Nygren in a show of support.

Nygren said the new bills are designed to attack the root of the problem — addictions to opiate prescriptions that pave the path to heroin.

“As we said last session, there were no silver bullets contained in those seven pieces of legislation,” Nygren said. “We knew that we had more that needed to be done.”

The new legislation would require anyone who dispenses opiates to enter the prescriptions in a statewide tracking database within 24 hours rather than the seven days currently allowed under state law. Doctors would be required to check the database before prescribing opiates. Nygren said those moves could help identify addicts and doctors who are overprescribing.

Police who discover an opiate prescription at the scene of an overdose would have to enter the prescription in the database and notify the prescribing physician of the incident.

The package also would create registries for pain and methadone clinics. Nygren said little is known about how such clinics operate.

Nygren’s daughter Cassie has battled a heroin addiction for several years. She was sentenced to a year and a half in prison in 2009. She pleaded guilty this past March to felony narcotic possession and was sentenced to drug court.

Nygren has often cited her story in his push to advance anti-heroin legislation. His bills last session included measures that funded additional treatment facilities; established immediate punishments for parole and probation violators and immunity for anyone who reports an overdose; and allowed first-responders with training to administer Narcan, a drug that counteracts heroin overdoses. Gov. Scott Walker signed the proposals into law last spring after all seven bills passed the Assembly and Senate unanimously.

Myranda Tanck, a spokeswoman for Senate Majority Leader Scott Fitzgerald, R-Juneau, said Fitzgerald hasn’t discussed the new bills specifically with his caucus but supports efforts “to fight narcotic abuse in Wisconsin.”

Sen. Sheila Harsdorf, R-Hudson, appeared at the news conference to support Nygren, calling the bills “common sense reforms.” Sen. Alberta Darling, R-River Hills, who co-chairs the Legislature’s powerful budget committee with Nygren, issued a statement saying she stands with him, too.

A Walker spokeswoman didn’t immediately respond to an email seeking comment on Nygren’s bills.

Nygren said he still wants to address a shortage of treatment beds, detoxification centers that won’t accept active drug users and help recovering addicts stay sober and remain employed. He didn’t offer any details.

Prescription stimulant abuse on rise among young adults

Young adults often misuse and abuse prescription stimulants as a way to manage the daily demands of academics, work and social pressures. This is the finding of a survey from the Partnership for Drug-Free Kids.

Among young adults between the ages of 18 to 25, 1 in 6 — 17 percent — has abused a prescription stimulant. Overall, young adults are most likely to abuse the prescribed stimulants Adderall (60 percent), Ritalin (20 percent) and Vyvanse (14 percent), which are prescribed for Attention Deficit Hyperactivity Disorder.

The reasons that young adults give for abusing these Rx medications are focused on achieving functional goals such as

The study confirms that young adults generally misuse and abuse prescription stimulants for functional reasons:

• Half of all young adults surveyed report abusing Rx stimulants to study or improve academic performance

• About 41 percent say they misuse or abuse them to stay awake.

• About 24 percent misuse or abuse Rx stimulants to improve work performance at a job.

• Nearly two-thirds of college students who report abusing Rx stimulants claim doing so helped them obtain a higher grade, improve work performance or gain a competitive edge.

• About 28 percent who have been legally prescribed Rx stimulants share their medicine with friends.

• About 52 percent report being pressured into sharing or selling their Rx stimulants.

“These new data confirm that college students are misusing and abusing Rx stimulants in a misguided effort to manage their lives because they are burning the candle at both ends — feeling the need to perform better and achieve their academic and social goals,” said Steve Pasierb, president and CEO of the Partnership for Drug-Free Kids.

Overall, young adults view the abuse of Rx stimulants as less risky than the abuse of prescription pain relievers, smoking cigarettes or binge drinking.