Posts Tagged drug

Special Report: Physician Leadership is Boosting War on Opioids

Special Report: Physician Leadership is Boosting War on Opioids

MONTGOMERY – According to a new report by the American Medical Association, physicians have taken the lead in the nation’s battle on opioids by lowering the number of opioid prescriptions they write, making better use of state prescription drug monitoring programs, becoming better trained and certified in the use of opioid use disorders, and in access to naloxone.

“Everyone can agree there is no quick fix to the country’s opioid epidemic. In Alabama, our physicians took a leadership role many years ago by taking a hard look at where we were and where we needed to be,” said Mark Jackson, executive director of the Medical Association of the State of Alabama. “As an association, we created the first educational program to train our physicians, and we passed legislation to reduce prescription drug abuse and diversion. Our Smart & Safe Alabama Program continues to be the only prescription drug awareness program in Alabama created and maintained by physicians. Even though Alabama has come a long way in the fight against opioids, we have a long way yet to go.”

According to the progress report, although physician leadership is helping to reverse the opioid epidemic, more than 115 people in the United States die from an opioid-related overdose every day. Physicians and medical specialty groups are continuing in a concerted effort to expand access to quality care for pain and substance use disorders in an attempt to quell the epidemic.

The report also found:

  • Opioid prescribing decreased for the fifth year in a row. Physicians have decreased opioid prescriptions nationwide for the fifth year in a row. Between 2013 and 2017, the number of opioid prescriptions decreased by more than 55 million — a 22.2 percent decrease nationally. During that time, Alabama beat the national average by decreasing opioid prescriptions by 23.3 percent.
  • Physicians are enhancing their education. In 2017, nearly 550,000 physicians and other health care professionals took continuing medical education classes and other education and training in pain management, substance use disorders and related areas. Many of these resources are offered by the AMA, state, and specialty societies, and more than 350 of these resources can be found on the AMA opioid microsite, end-opioid-epidemic.org. The Medical Association was one of the first states to offer an opioid prescribing education course in the country in 2009. The main course is offered three times each year and has reached more than 5,000 prescribers to date.
  • Access to naloxone is on the rise. Naloxone prescriptions more than doubled in 2017, from about 3,500 to 8,000 naloxone prescriptions dispensed weekly. So far in 2018, that upward trend has continued; as of April, 11,600 naloxone prescriptions are dispensed weekly – the highest rate on record. In 2016, the Medical Association helped pass legislation in Alabama authorizing the State Health Officer to sign a standing order to allow Alabama’s pharmacists to dispense naloxone to people in a position to assist others at risk of an overdose as well as to an individual at risk of experiencing an opiate-related overdose.

Posted in: Opioid

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President Trump Signs Right-to-Try Act

President Trump Signs Right-to-Try Act

On Wednesday, May 30, 2018, Pres. Donald Trump signed the Right-to-Try Act, which allows terminally ill patients the ability to try drugs in preliminary testing but not-yet-approved by the Food and Drug Administration. The aim is to make it easier for those patients suffering from fatal illness who have exhausted all other resources to access drugs unapproved by the FDA, which may provide them some relief from their illnesses.

The Right-to-Try Act is also intended to create a more open and competitive market for drugs still seeking FDA approval, therefore, lowering the cost of the drugs since insurance companies do not cover them. Supporters of the legislation say it gives hope to those who are out of options, while opponents argue the legislation gives a false hope to many who are already in a vulnerable and fragile state.

While the intent is to allow patients to try drugs not otherwise available to them, many point out the FDA already allows patients access to these drugs through an expanded access program. This program allows terminally ill patients access to drugs not FDA approved, ensures the drug is administered correctly and certifies those receiving the medication are adequately informed. Additionally, the approval rate of patients completing the application requesting these drugs since 2006 is 99 percent.

Supporters of the Right-to-Try Act argue these numbers do not reflect the hundreds of patients neglected by the application process through incomplete applications and other factors. Now, the Right-to-Try Act takes the FDA out of the equation and leaves the power with patients and their physicians to work with drug companies directly to access unapproved drugs.

Despite its potential for success, the Right-to-Try Act comes with a significant downside. Since the only requirement for the drugs are that they have passed Phase I testing with the FDA stating they are safe on humans, there is no real understanding of possible side effects these drugs may have on patients. The uncertainty and margin of error around medications not approved by the FDA leave physicians concerned for the health and safety of the patients who choose to use them.

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Trump Administration Releases Drug Pricing Blueprint

Trump Administration Releases Drug Pricing Blueprint

On May 11, The Trump Administration released “American Patients First,” the President’s blueprint to lower drug prices and reduce out-of-pocket costs, along with a request for information. The Blueprint was framed as advancing four specific goals:

  • Reducing list prices;
  • Improving government’s ability to negotiate better prices;
  • Encouraging competition through rapid entry to market of generics and biosimilars; and
  • Lowering patient out-of-pocket expenses.

The Blueprint proposes a broad number of changes to prescription drug programs in several federal health care programs – such as Medicare, Medicaid and other safety net programs – as well as Food and Drug Administration policies that should impact commercial and federal health care program access to affordable prescription drugs.

While some of these proposals can be undertaken through immediate regulatory or subregulatory actions, others are still on the drawing boards at the U.S. Department of Health and Human Services and some will require congressional action to implement. The Blueprint proposes a select number of programmatic and design changes, yet the Administration is seeking feedback for a large number of lingering questions.

Initial review appears to show an increased access to lower-cost alternative generics. But closer review is needed on proposed changes to the Medicare Part D Prescription Drug Benefit Program and the Part B drug reimbursement methods to alleviate concerns the changes may limit patient access to medically necessary alternative brand or specialty treatments and result in additional administrative burdens on physicians and patients. The proposal may also eliminate the requirement that Part D plans include a minimum of two drugs proven to be effective in each therapeutic category or pharmacologic class, if available.

The Medical Association will be closely monitoring the Administration’s “American Patients First” Blueprint and will keep our members updated on any new developments as they become available.

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What If No One Was On Call [at the Legislature]?

What If No One Was On Call [at the Legislature]?

2018 Recap of the Regular Session of the Alabama Legislature

In times of illness, injury and emergency, patients depend on their physicians. But what if no one was on call? Public health would be in jeopardy.  However, the same holds true for the Legislature. During the 2018 session alone, if the Medical Association had not been on call advocating for you and your patients, unnecessary and costly standards of care would have been written into law, lawsuit opportunities against physicians would have increased and poorly thought out “solutions” to the drug abuse epidemic ─ that could’ve made the problem worse ─ would have become law. Keep reading to find out more.

Moving Medicine Forward

The 2018 Legislative Session is over, but continued success in the legislative arena takes constant vigilance. Click here to download our 2018 Agenda.

If no one was on call…increased state funding for upgrading the Prescription Drug Monitoring Program (PDMP) would not have occurred. Working with the Governor’s Opioid Task Force, the Medical Association proposed increased funding for the PDMP, to allow it to be an effective tool for physicians. As a result, the Task Force made the request its number one recommendation to the Governor and the 2019 budget for the Alabama Department of Public Health (the PDMP administrator) has a $1 million increase for making a long-overdue upgrade to the user-friendliness of the drug database.

If no one was on call…legislation helping veterans at-risk for drug abuse get the care they need and also leverage technology to combat the drug abuse epidemic would not have occurred. Through enactment of SB 200, the prescription information of VA patients will be shared between the VA and non-VA physicians and pharmacists who are outside the VA system, the same kind of information sharing of prescription data that exists for almost all other patients. Passage of SB 200 also establishes a mechanism for vetting requests for release of completely de-identified PDMP information that can be used to spot drug abuse trends and help state officials better allocate resources in combatting this epidemic. The proposals that resulted in the drafting of SB 200 originated with a recommendation from the Governor’s Opioid Task Force, one the Medical Association supported.

If no one was on call…the concerns of physicians regarding the current state of affairs surrounding the Maintenance of Certification program would not have been heard. A formal recommendation from the Medical Association’s MOC Study Committee resulted in the enactment of SJR 62 by Senators Tim Melson, M.D., Larry Stutts, M.D., and the entire Alabama Senate. The resolution was signed by Gov. Kay Ivey. SJR 62 vocalizes Alabama physicians’ frustrations with MOC and urges the American Board of Medical Specialties to honor its commitment to help reduce the burden and cost of MOC. Pursuit of a legislative resolution was just one of several recommendations from the Association’s MOC Study Committee this year.

If no one was on call…the Board of Medical Scholarship Awards could have seen its funding reduced but instead, the program retained its funding level of $1.4 million for 2019. The BMSA grants medical school loans to medical students and accepts as payment for the loan that student’s locating to a rural area to practice medicine. The BMSA is a critical tool for recruiting medical students to commit to practice in rural areas. As well, the economic footprint of every physician is at least $1 million, which improves both community health and local economies.

If no one was on call…Medicaid cuts could have been severe, possibly reducing access for patients within an already fragile system in which less than 20 percent of Alabama physicians participate. The 2019 budget has sufficient funds available for Medicaid without scheduled cuts to physicians. However, increasing Medicaid reimbursements to Medicare levels could further increase access to care for Medicaid patients and remains a Medical Association priority.

Beating Back the Lawsuit Industry

While Alabama’s medical liability laws have fostered fairness in the courtroom and improved the legal climate, each year personal injury attorneys seek to undo parts of the very law that helps keep “jackpot justice” and frivolous suits in check.

If no one was on call…bill language that could have pulled physicians into new lawsuits targeting opioid drug makers and opioid wholesale drug distributors could have been included in the final version of the legislation, whose subject matter was originally limited to placing new criminal penalties on unlawful possession, distribution and trafficking of Fentanyl. After the liability language was added on the House floor, a committee of the House and Senate removed the new cause of action language that could have affected physicians. Additionally, an unsuccessful attempt was made to amend this same bill to give law enforcement the authority to determine what is the unlawful “prescribing” or “dispensing” of prescription drugs. The final bill that passed contained neither of these elements that would have been problematic for physicians.

If no one was on call…physicians and medical practices could have been forced to provide warranty and replacement coverage for “assistive medical devices.” As originally drafted in the bill, the term “assistive medical devices” was broadly defined to include any device that improves a person’s quality of life including those implanted, sold or furnished by physicians and medical practices like joint or cochlear implants, pacemakers, hearing aids, etc. However, the Medical Association successfully sought an amendment to remove physicians, their staff and medical practices from having any new warranty or assistive device replacement responsibility under the act, and the final version doesn’t expand liability on doctors.

If no one was on call…legislation granting nurse practitioners and nurse midwives new signature authority outside of a collaborative practice and for some items prohibited under federal law – thereby significantly expanding liability for collaborating physicians – could have become law. The Medical Association successfully sought to ensure that all new signature authority granted to CRNPs and CNMs was subject to an active collaborative agreement and all additional forms or authorizations granted were consistent with federal law, protecting collaborating physicians from new liability exposure. The final bill was favorably amended with this language.

If no one was on call…physicians could have been held legally responsible for others’ mistakes including individuals following or failing to follow DNR orders on minors. The language of the final bill does not expand liability for physicians.

Protecting Public Health and Access to Quality Care

Every session, various pieces of legislation aimed at improving the health of Alabamians are proposed. At the same time however, many bills are also introduced that endanger public health and safety, like those where the Legislature attempts to set standards for medical care, which force physicians and their staffs to adhere to non-medically established criteria, wasting health care dollars, wasting patients’ and physicians’ time and exposing physicians to new liability concerns.

If no one was on callcollaborative practice in Alabama between nurse practitioners, nurse midwives and physicians could have been abolished. The legislation did not pass. Read the joint statement on the bill from the Medical Association and allied medical specialties here. The bill may return next session.

If no one was on call…legislation to give law enforcement the authority to determine what is the unlawful “prescribing” or “dispensing” of controlled substances (and making violations a Class B Felony) could have become law. The Medical Association sought changes to the bill to require prosecutors to have to prove beyond a reasonable doubt that a physician knowingly or intentionally prescribed controlled substances for other than a legitimate medical purpose and outside the usual course of his or her professional practice, and also to ensure sufficient qualifications for expert witnesses. The sponsor however – arguing that expert witness testimony for prosecuting a physician should not be required – asked the bill not be passed and instead “indefinitely postponed it,” killing the bill for the 2018 session. The bill will return next session.

If no one was on callmarriage and family therapists could have been allowed unprecedented authority to diagnose and treat mental illnesses without restriction. The legislation would also have deleted numerous prohibitions in current law including prescribing drugs, using electroconvulsive therapy, admitting to a hospital and treating inpatients without medical supervision, among other things. The Medical Association offered a substitute bill that (1) ensures all diagnoses and treatment plans made by MFTs are within the MFT treatment context; (2) ensures MFTs cannot practice outside the boundaries of MFT services; (3) prohibits MFTs from practicing medicine; and, (4) ensures all the current prohibitions in state law regarding prescribing of drugs, electroconvulsive therapy and inpatient treatment remain intact. The final bill that is now law contains all of these elements.

If no one was on call…legislation creating a new state board with unprecedented authority over medical imaging could have passed. The legislation would have required x-ray operators, magnetic resonance technologists, nuclear medicine technologists, radiation therapists, radiographers and radiologist assistants to acquire a new license from a new state board, a board granted total control over the scope of practice for each licensee. Quality and access to care concerns abounded with this legislation that many saw as unnecessary. The legislation did not pass, but is likely to return next session.

If no one was on call…proposals to move the PDMP away from the Alabama Department of Public Health and instead under the authority of some other state agency or even to a private non-profit organization could have been successful. In working with the Governor’s Opioid Task Force, the Medical Association stressed the Health Department was the proper home for the PDMP and the Task Force did not recommend that the PDMP be moved elsewhere.

If no one was on call…legislation to place new requirements on and increase civil liability exposure on referring physicians under the Women’s Right to Know Act could have become law. The legislation aimed to provide a woman seeking an abortion with notice that she can change her mind at any time and be entitled to a full refund for not going through with the abortion. The Medical Association sought to fix a longstanding problem that places information-provision requirements on referring physicians under the Women’s Right to Know law. While the Association’s language was adopted, the bill failed to pass. The bill is expected to return next session.

If no one was on call…state law could have been changed to require mandatory PDMP checks on every prescription. Attempts to change this are expected in 2019.

If no one was on call…law enforcement could have been granted unfettered access to the prescriptions records of all Alabamians. Attempts to change this are expected in 2019.

Other Bills of Interest

Rural physician tax credits…legislation to increase rural physician tax credits and thereby increase access to care for rural Alabamians did not pass but will be reintroduced next session.

Infectious Disease Elimination…legislation to establish infectious disease elimination pilot programs to mitigate the spread of certain diseases failed to garner enough support to pass this session.

Data breach notification…relating to consumer protection, is known as the “data breach bill.” In the event of a data breach by a HIPAA-covered entity, as long as the entity follows HIPAA guidelines for data breaches and notifies the attorney general if the breach affects more than 1,000 people, the HIPAA-covered entity is exempt from any penalties. Now, only North Dakota lacks a “data breach” notification statute. The bill was signed by the Governor.

School-based vaccine program…a Senate Joint Resolution urging the State Department of Education and the Alabama Department of Public Health to encourage all schools to participate in a school-based vaccine program passed in 2018. The Medical Association, Alabama Academy of Pediatrics and Alabama Academy of Family Physicians issued a joint statement in opposition to the resolution.

While we remain committed to increasing vaccine rates in Alabama for the very reasons outlined in the “Whereases” of the resolution, we are very concerned about the potential disruption that a widespread school-based program could bring to local practices and the likelihood of detrimental effects of adolescents not visiting the doctor-their medical home–during the critical teen years,” the joint statement from the medical societies reads.

While Gov. Ivey did not sign the resolution, it was ratified under state law without her signature.

Workers comp…legislation to penalize an individual from obtaining workers comp benefits by fraudulent means was introduced this session. The Medical Association successfully sought an amendment to require notice to the physician of termination of a worker’s benefits and to ensure continued payment of claims submitted by a physician until that notice is received. The bill failed to see any action this session.

Genital mutilation…legislation criminalizing the genital mutilation of a minor female was introduced this session. The Medical Association successfully sought an amendment to exclude emergency situations and procedures. The bill died in the Senate during the last days of the session. It is expected to return next year.

If the Medical Association was not on call at the Legislature, countless bills expanding doctors’ liability, placing standards of care into state law, lowering the quality of care provided and diminishing the practice of medicine could have passed. At the same time, positive strides in public health – like new funding for a much-needed PDMP upgrade, better data-sharing with VA facilities and the resolution on MOC – would not have occurred. The Medical Association is Alabama physicians’ greatest resource in advocating for the practice of medicine and the patients they serve.

Questions? For more information contact Niko Corley at ncorley@alamedical.org

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Successful Take Back Alabama Week Ends with Opioid Summit

Successful Take Back Alabama Week Ends with Opioid Summit

REVISED APRIL 27, 2018 ─ The Medical Association’s Take Back Alabama Week kicked off this week with a press conference at Walgreens in Birmingham on Monday, April 23. Representatives from AmerisourceBergen, Blue Cross and Blue Shield of Alabama, Pfizer, Prime Therapeutics and Walgreens joined Attorney General Steve Marshall and Birmingham physician Gregory Ayers to announce the installation of 13 new safe medication disposal kiosks in select Walgreens locations in Alabama.

“Once they are in the consumers’ hands, many of these medications are not all used,” Dr. Ayers said during the press conference. “A patient may use only a few pills out of a prescription, and then many of these medications are left over that just sit unused in a medicine cabinet…unsecured in most cases. These medications need to be disposed of safely so they don’t get into the hands of those who don’t need them. These kiosks offer a very safe avenue for disposal.”

The kiosks allow individuals to safely and conveniently dispose of unwanted, unused or expired medications, including controlled substances and over-the-counter medications at no cost. They are available during regular pharmacy hours.

The week ended with Take Back Alabama’s parent program, Smart & Safe Alabama, exhibiting at the Annual Opioid Crisis in Alabama: From Silos to Solutions to further spread the word about the new medication disposal kiosks as well as raising awareness for prescription drug safety.

Check out some of the news coverage, compliments of WIAT:

 


APRIL 20, 2018 ─ According to the Alabama Department of Public Health, 749 Alabama residents died in 2016 due to drug overdose, which includes prescription drug overdose. This number is up from 726 in 2015…and this is why the Medical Association of the State of Alabama created Take Back Alabama Week. In an unprecedented partnership, the Medical Association reached out to Walgreens, Blue Cross Blue Shield of Alabama and Pfizer to form a strategic alliance for education about and safe disposal of prescription medications.

Take Back Alabama Week is April 23-28, and kicks off Monday, April 23, with a media event at Walgreens located at 4700 Highway 280 in Birmingham. The event is the perfect opportunity to spread the word about the availability of safe medication disposal kiosks in 13 Walgreens locations across Alabama. Attorney General Steve Marshall and Birmingham physician Gregory Ayers will join representatives from Blue Cross and Blue Shield of Alabama and Pfizer to kick off the campaign.

“While Alabama has beaten the national average from 2013 to 2017 in the percentage of reduction in opioid prescriptions, we still lead the nation in the total number of opioid prescriptions on a per capita basis,” said Medical Association Executive Director Mark Jackson. “That’s why joining forces with Blue Cross Blue Shield of Alabama, Walgreens and Pfizer is so important. We are waging an information campaign to educate Alabamians not only of the dangers of the misuse of opioids and other prescription medications but also that there are alternatives to opioids. It begins with an open and honest conversation with your physician to find the best treatment plan for each patient.”

DISPOSAL LOCATIONS

Visit the following Walgreens locations to safely dispose of your unused medications:

7155 US Highway 431
Albertville, AL 35950

1815 9th Avenue N.
Bessemer, AL 35020

101 Green Springs Highway
Birmingham, AL 35209

4700 Highway 280
Birmingham, AL 35242

9325 Parkway E.
Birmingham, AL 35215

2940 W. Main Street
Dothan, AL 36305

900 Rucker Boulevard
Enterprise, AL 36330

2 Greeno Road S.
Fairhope, AL 36532

1801 Montgomery Highway S.
Hoover, AL 35244

7813 Highway 72 W
Madison, AL 35758

3948 Airport Boulevard
Mobile, AL 36608

6680 Atlanta Highway
Montgomery, AL 36117

2515 Crawford Road
Phenix City, AL 36867

Walgreens at these locations have drop boxes in which residents may safely deposit unused prescriptions and over-the-counter medications…no questions asked. These boxes are locked, and there is no danger of your medications getting into the hands of someone who could accidentally overdose or misuse them.

For more information, log on to www.SmartAndSafeAL.org/takeback.

Posted in: Smart and Safe

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Alabama SB39: Another Shot in the Opioid Battle

Alabama SB39: Another Shot in the Opioid Battle

On March 28, 2018, Alabama Senate Bill 39 was sent to Governor Ivey’s desk for signature. SB39 introduces stiffer penalties related to fentanyl possession and distribution. It amounts to a local effort forming part of a nationwide, multi-pronged response to the opioid epidemic that has plagued the country in recent years. While this bill is not yet law as of the date of this article, it came to the Governor’s desk with broad support from both the House and Senate, and an awareness of its contents (and its place in the larger opioid crisis) is valuable.

Fentanyl is a particularly strong opioid that has of recent been the target of much abuse. The National Institute on Drug Abuse notes that in 2016, fentanyl contributed to more than 20,000 overdose deaths; medical examiners reported that fentanyl or fentanyl mixtures were involved in the deaths of the musicians Prince and Tom Petty. SB39 includes several related features stiffening enforcement of abuses of fentanyl and related drugs: the bill would:

  1. add fentanyl and related analogues (e.g., butyrfentanyl and acetyl fentanyl) to Schedule I of the controlled substances list;
  2. make a person (unless otherwise authorized by law) who possesses, distributes, or traffics such drugs guilty of a felony, and conviction for distribution subject to enhanced penalties;
  3. include under the meaning of “trafficking” possession of fifty or more individual packages of the substance

A related proposal that was introduced but ultimately rejected by the legislature was a change to allow prosecution of physicians for over-prescribing opioids.

Of particular note are the low thresholds set for amounts of fentanyl and fentanyl analogues — an acknowledgment of both the potency of the drug and the severity of the current crisis. The bill would amend §13A-12-231 of the Alabama Code to make possession of one gram or more of fentanyl or a fentanyl analogue a felony of “trafficking in illegal drugs,” and includes substantial fines. As noted above, conviction can also occur if one is in possession of 50 or more individual packages of fentanyl or a fentanyl analogue, notwithstanding the fact the combined weight of the fentanyl or fentanyl analogues in the packages may be less than one gram.

At this point of the opioid epidemic, some physicians may well be experiencing opioid fatigue. News articles, legislative and regulatory initiatives, personal testimonies, seminar topics, and other avenues have been bringing this issue to the health care industry’s attention for years now. It is a complex problem, with a multiplicity of root causes and a variety of faces. The several penalties included in this recent bill are a reminder that staying abreast of all the many changes, initiatives and tools aimed at addressing opioid abuse is well worth the time and attention.

Whatever the eventual fate of SB39, this will not be the last shot fired in the response to opioid abuse. This bill is a reminder that the responses to this crisis are varied, and that although the opioid epidemic is a national problem, it also plays out on the state and local level. As “opioid” refers to a diverse range of drugs, the “opioid epidemic” refers to a complex quagmire. Being well aware of the problem, in general, is no substitute for familiarity with the many paths being carved through it. In addition to introducing potential changes to the criminal law code such as SB39, Alabama has also taken such steps as forming the Alabama Opioid Overdose and Addiction Council, formed in August 2017 by Governor Ivey, which has made such recommendations as improving and modernizing Alabama’s prescription drug monitoring program; the Alabama Department of Public Health is leveraging funding from the CDC’s Data-Driven Prevention Initiative (DDPI) on Opioid and Heroin Abuse to identify stakeholders of and solutions to the problem; Alabama Attorney General Steve Marshall filed a lawsuit in February 2018 against one of the largest drug manufacturers in the nation.

This is a constantly changing landscape, and the opportunity for missteps abound. Some of these missteps have consequences that reach beyond issues of reimbursement and licensure. The fate of SB39 is worth watching — its wide support in both chambers of the Alabama Legislature make it a prime candidate for signing into law by the governor. However, beyond offering a description of this one bill, this present article should serve as a reminder that opioid-related news deserves close attention because of, not despite, the frequency of the topic. New laws and initiatives are coming out regularly, and if you’ve seen one you have not seen them all.

Article written by Chris Thompson, an attorney with Burr & Forman LLP practicing in the firm’s healthcare group. Burr & Forman, LLP, is a partner with the Medical Association. Read other articles from Burr & Forman LLP.

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Just What the Doctor Ordered: An Alabama Perspective on the Opioid Epidemic

Just What the Doctor Ordered: An Alabama Perspective on the Opioid Epidemic

Sometimes, Alabama is No. 1. In 2012, Alabama was the highest per capita painkiller prescribing state, with an average of 143 prescriptions written per 100 people — almost three times the rate of the lowest prescribing state.1 Alabama has been home to other No. 1s, too. In 2012, Dr. Shelinder Aggarwal, a former Huntsville-area pain doctor, was the top Medicare prescriber of prescription painkillers in the United States, until he was sentenced to 15 years in prison, had to pay back some $9.5 million in fraudulently billed claims, and surrendered his medical license in the wake of an examination by the Board of Medical Examiners.2

Many aspects of Aggarwal’s practice, which was described in the charging documents against him as a “pill mill,” are almost beyond belief. Aggarwal was seeing 80 to 145 patients in his office each day in 2012. Alabama pharmacies filled about 110,013 prescriptions (12,313,984 pills) in calendar year 2012 for controlled substances prescribed by Aggarwal. That equates to 423 prescriptions and 144 patients per day, assuming Aggarwal worked a five-day work week and wrote about three prescriptions per patient.3

Exactly how Aggarwal was able to prescribe controlled substances in such volumes is no less shocking. According to charging documents, initial visits entailed little more than a superficial physical exam and a urine drug test and lasted only five minutes. Follow-up visits could last as little as two minutes. Aggarwal allegedly did not retrieve a patient’s medical history, nor did he treat his patients with anything other than controlled substances. He was known to ask patients what medications they wanted, and he even wrote prescriptions for controlled substances to patients who admitted to using illegal drugs, or whose drug screen showed illegal drugs in their system.4

Aggarwal’s example, perhaps, is on the extreme end of the spectrum, but it highlights the gravity of the “opioid epidemic” Alabama and the United States are facing right now. Every physician has a role to play combating these opioid problems, and there are tools out there to help.

Prescription Drug Monitoring Program

The Alabama Prescription Drug Monitoring Program, or PDMP, is designed to “promote the public health and welfare by detecting diversion, abuse and misuse of prescription medications classified as controlled substances under the Alabama Uniform Controlled Substances Act.”5 Under the authorizing act and implementing regulations for the PDMP, any dispenser of Class II, III, IV or V controlled substances must report the dispensing of these drugs to the PDMP.6 Therefore, in most cases, you should be able to see any controlled substance (e.g. opioids) that have been dispensed to a patient if you check the PDMP. Although the PDMP authorizing act does not require prescribers to check the PDMP, they are allowed to access PDMP
information for a current or prospective patient,7 and their applicable licensure board may impose requirements to check the PDMP by regulation. Prescribers and dispensers should consult the PDMP and may suggest other health providers also consult the PDMP if there is information that may be important to the other health provider. Note: Neither the PDMP report nor any information from the PDMP report should be disclosed — that’s why you should suggest the other health provider consult the PDMP if you have a concern, rather than revealing information directly from the report.8

BME Risk and Mitigation Strategies Rule

The PDMP statute does not require prescribers to consult the PDMP, but certain licensure boards do. For instance, the BME recently finalized a new rule on risk and mitigation strategies (RMS) for prescribing physicians.9 The new rule requires prescribers to check the PDMP at frequencies that vary based on the morphine milligram equivalency (MME) of medications they are prescribing: (1) upon each prescription for controlled substances greater than 90 MME; (2) at least twice each year for controlled substances between 30 and 90 MME; and (3) consistent with “good clinical practice” for controlled substances less than 30 MME. Additionally, physicians are required to document the use of RMS in the patient’s medical record. Physicians should take care to adequately document appropriate RMS without running afoul of the PDMP prohibition on disclosing the PDMP report or the information contained therein. This can be a difficult task to fulfill when you can’t keep a copy of the PDMP report in the patient’s medical record.10 A simple notation in the patient’s medical record that you have checked the PDMP and that there are no contraindicated prescriptions likely would suffice.

The new RMS rule sets forth other RMS, including pill counts, urine drug screenings, patient education, and others, some of which are described below from the CDC. Physicians should note that failure to fulfill their obligations under this rule could lead to adverse licensure actions.11

CDC Guidelines for Prescribing Opioids for Chronic Pain

The Centers for Disease Control and Prevention, after a rigorous period of research, consultation and public comment, has also issued opioid prescribing guidelines for primary care physicians treating patients with chronic pain.12 Below is a brief description of the guidelines:

  • Consider nonpharmacologic therapy; only prescribe opioids if risks outweigh benefits;
  • Establish treatment goals;
  • Discuss known risks and benefits of opioid therapy with patients, as well as clinician responsibilities for managing therapy;
  • Consider prescribing immediate-release, rather than extended-release opioids;
  • Prescribe the lowest-effective dosage;
  • For short-term (acute) pain, prescribe the lowest-effective dose and only in the quantity needed for the expected duration of pain severe enough to require opioids;
  • Evaluate risk factors for opioid-related harms and implement a risk mitigation plan;
  • Review the PDMP for harmful quantities or combinations of controlled substances;
  • Conduct urine drug testing before starting opioid therapy;
  • Avoid prescribing opioids and benzodiazepines concurrently, if possible;
  • Offer evidence-based treatment for patients with opioid-use disorder.

A full report listing methods, clinical evidence, and a full discussion of the above recommendations are available from the CDC (see link in footnote 12 below for reference).

These are just a few tools to help you help your patients and mitigate the opioid epidemic. Let’s not win anymore No. 1s of the kind described above for the State of Alabama.

References

1 Prescribing Data, Centers for Disease Control and Prevention (Dec. 20, 2016), https://www.cdc.gov/drugoverdose/data/prescribing.html; Leonard J. Paulozzi, MD et al., Vital Signs: Variation Among States in Prescribing Opioid Pain Relievers and Benzodiazepines—United States, 2012, CDC: Morbidity and Mortality Weekly Report (July 4, 2014), available at https://www.cdc.gov/mmwr/preview/mmwrhtml/mm6326a2.htm?s_cid=mm6326a2_w.

2 Huntsville Pill Mill Doctor Sentenced to 15 Years in Prison for Illegal Prescribing and Health Care Fraud, Department of Justice: U.S. Attorney’s Office, Northern District of Alabama (February 7, 2017), available at https://www.justice.gov/usao-ndal/pr/huntsville-pill-mill-doctor-sentenced-15-years-prison-illegal-prescribing-and-health.

3 United States v. Shelinder Aggarwal, Information Against Shelinder Aggarwal, Sept. 22, 2016.

4 Id.

5 Alabama Department of Public Health: Prescription Drug Monitoring Program Home (June 23, 2017), http://www.alabamapublichealth.gov/pdmp/index.html.

6 Ala. Code § 20-2-213 (1975); Ala. Admin. Code r. 420-7-2-.12 (Nov. 24, 2014).

7 Ala. Code § 20-2-214(2) (1975); Ala. Admin. Code r. 420-7-2-.13 (Nov. 24, 2014).

8 See Ala. Code §§ 20-2-215 to 20-2-216 (1975) (making records and information in the PDMP privileged and confidential and creating a Class A Misdemeanor for individuals who intentionally make an unauthorized disclosure of information from the PDMP); see also FAQ, Alabama Department of Public Health: Prescription Drug Monitoring Program (May 31, 2017), http://www.alabamapublichealth.gov/pdmp/faq.html.

9 See Ala. Admin. Code r. 540-X-4-.09 (March 9, 2017).

10 See FAQ, Alabama Department of Public Health: Prescription Drug Monitoring Program (May 31, 2017), http://www.alabamapublichealth.gov/pdmp/faq.html.

11 Ala. Admin. Code r. 540-X-4-.09(8) (March 9, 2017).

12 Deborah Dowell, MD et al., CDC Guideline for Prescribing Opioids for Chronic Pain—United States, 2016, CDC: Morbidity and Mortality Weekly Report (March 18, 2016), available at https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm#suggestedcitation.

 

Article contributed by Christopher L. Richard with Gilpin Givhan, P.C. Gilpin Givhan, P.C., is a Bronze Partner with the Medical Association.

Posted in: Legal Watch

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FDA Classifies Kratom as Opioid

FDA Classifies Kratom as Opioid

The U.S. Food and Drug Administration has officially classified the plant kratom, originally seen as an opioid alternative, as an opioid itself, stating that compounds in kratom act like prescription-strength opioids.

Found in Malaysia, the leaves of the kratom plant are traditionally crushed and made into a tea to treat pain as well as heroin or morphine dependence and possibly reduce withdrawal cravings. According to the American Kratom Association, there are 3 million to 5 million kratom users in the U.S. The supplement can be found in head shops and gas stations sold as powders, pills, capsules and energy drinks.

FDA scientists analyzed the chemical structures of the 25 most common compounds in kratom and concluded that all of the compounds share structural characteristics with controlled opioid compounds, such as morphine derivatives. They also found that compounds in kratom bind strongly to mu-opioid receptors, comparable to opioid drugs.

The scientific data and event reports have “clearly revealed” compounds in kratom make it “not just a plant — it’s an opioid,” said FDA Commissioner Scott Gottlieb, M.D., “and it’s an opioid that’s associated with novel risks because of the variability in how it’s being formulated, sold, and used recreationally and by those who are seeking to self-medicate for pain or who use kratom to treat opioid withdrawal symptoms.”

The FDA announced the voluntary destruction and recall of all kratom-based products manufactured nationwide under the brand names Botany Bay, Enhance Your Life and Divinity by Divinity Products Distribution. The FDA encourages all companies currently involved in the sale of products containing kratom intended for human consumption to take their products off the market and submit any necessary evidence to the FDA.

“The extensive scientific data we’ve evaluated about kratom provides conclusive evidence that compounds contained in kratom are opioids and are expected to have similar addictive effects as well as risks of abuse, overdose and, in some cases, death,” said Dr. Gottlieb. “To protect the public health, we’ll continue to affirm the risks associated with kratom, warn consumers against its use and take aggressive enforcement action against kratom-containing products.”

The FDA recommends consumers not use any kratom products and dispose of any products currently in their possession. “At this time, there’s no evidence to indicate that kratom is safe or effective for any medical use,” said Dr. Gottlieb.

The FDA has received 44 reports of deaths associated with the use of kratom. Additionally, the FDA and the U.S. Centers for Disease Control and Prevention are carefully monitoring an active nationwide outbreak across 20 states of a rare type of salmonella associated with kratom products.

Posted in: Opioid

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Medical Association’s 2018 State and Federal Agendas

Medical Association’s 2018 State and Federal Agendas

The Medical Association Board of Censors has met and approved the Association’s 2018 State and Federal Agendas. These agendas were developed with guidance from the House of Delegates and input from individual physicians. As the Alabama Legislature and U.S. Congress begin their work for 2018, additional items affecting physicians, medical practices and patients may be added to this list.

Download the Medical Association’s 2018 State and Federal Agendas (PDF)

 

2018 STATE AGENDA

 

The Medical Association supports:

  • Ensuring legislation “first do[es] no harm”
  • Extending the Medicaid payment bump for primary care to all specialties of medicine
  • Eliminating the health insurance-coverage gap for the working poor
  • Ensuring fair payment for patient care and reducing administrative burdens on physicians and medical practices
  • Strengthening existing tort reforms and ensuring liability system stability
  • Empowering patients and their doctors in making medical decisions
  • Continued physician compounding, dispensing of drugs
  • The same standards and reimbursements for telehealth and face-to-face visits
  • Training, education and licensing transparency of all individuals involved in patient care
  • Continued self-regulation of medicine over all areas of patient care
  • Increased state funding to upgrade the Prescription Drug Monitoring Program to a useful tool for physician monitoring patients at risk for drug interactions and overdose potential
  • Using data analytics to combat the drug abuse epidemic by strengthening research capabilities of pre-approved, de-identified prescription information
  • Maintaining the Alabama Department of Public Health as the repository for PDMP information to ensure continuity for prescribers and dispensers and security for patients
  • Standard opioid education in medical school so the physicians of tomorrow are prepared to face the realities and responsibilities of opioid prescribing

 

The Medical Association opposes:

  • The radical Patient Compensation System legislation
  • Legislation/initiatives increasing lawsuits against physicians
  • Non-physicians setting standards for medical care delivery
  • Tax increases disproportionately affecting physicians
  • Expanding access to the Prescription Drug Monitoring Program (PDMP) for law enforcement
  • Statutory requirements for mandatory PDMP checks
  • Further expansion of Maintenance of Certification (MOC) requirements
  • Changes to workers’ compensation laws negatively affecting treatment of injured workers and medical practices
  • Any scope of practice expansions that endanger patients or reduces quality of care
  • Biologic substitution legislation that allows lower standards in Alabama than those set by the FDA that doesn’t provide immediate notifications to patients and their physicians when a biologic is substituted, and that increases administrative burdens on physicians and medical practices

 

2018 FEDERAL AGENDA

 

The Medical Association supports:

  • Meaningful tort reforms that maintain existing state protections
  • Reducing administrative and regulatory burdens on physicians and medical practices
  • Repeal of the Affordable Care Act and replacement with a system that:
    • Includes meaningful tort reforms that maintain existing state protections
    • Preserves employer-based health insurance
    • Protects coverage for patients with pre-existing conditions
    • Protects coverage for dependents under age 26
    • With proper oversight, allows the sale of health insurance across state lines
    • Allows for deducting individual health insurance expenses on tax returns
    • Increases allowed contributions to health savings accounts
    • Ensures access for vulnerable populations
    • Ensures universal, catastrophic coverage
    • Does not increase uncompensated care
    • Does not require adherence with insurance requirements until insurance reimbursement begins
    • Reduces administrative and regulatory burdens
  • Overhauling federal fraud and abuse programs
  • Reforming the RAC program
  • Prescription drug abuse education, prevention and treatment initiatives
  • Allowing patient private contracting in Medicare
  • Expanding veterans’ access to non-VA physicians
  • Reducing escalating prescription drug costs
  • A patient-centered MACRA framework, including non-punitive and flexible implementation of new MIPS, PQRS and MU requirements
  • Congressional reauthorization of CHIP (Children’s Health Insurance Program) at the current enhanced funding level
  • Better interstate PDMP connectivity
  • Eliminating “pain” as the fifth vital sign
  • Repealing the “language interpreters” rule
  • Requiring all VA facilities, methadone clinics and suboxone clinics to input prescription data into state PDMPs where they are located

 

The Medical Association opposes:

  • Non-physicians setting standards for medical care delivery
  • Publication of Medicare physician payment data
  • National medical licensure that supersedes state licensure
  • Legislation/initiatives increasing lawsuits against physicians

Posted in: Advocacy

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Trump: Opioid Epidemic “Worst Drug Crisis” in U.S. History

Trump: Opioid Epidemic “Worst Drug Crisis” in U.S. History

President Trump called the opioid epidemic the “worst drug crisis” to strike the U.S. in its history while declaring a public health emergency – not a national emergency as promised earlier in the summer. According to the Centers for Disease Control and Prevention, more than 140 American die every day from an opioid overdose, which made President Trump’s announcement one of the most anticipated of the last few months yet not quite what health care advocates were expecting.

“Nobody has seen anything like this going on now. As Americans, we cannot allow this to continue,” Trump said at a White House ceremony. “It is time to liberate our communities from this scourge of drug addiction. … We can be the generation that ends the opioid epidemic. We can do it.”

There’s a legal distinction between a public health emergency, which the secretary of Health and Human Services can declare under the Public Health Services Act, and a presidential emergency under the Stafford Act or the National Emergencies Act. The President’s Opioid Commission recommended in July for a declaration of national emergency in order for the president to have more power to waive privacy laws and Medicaid regulations.

However, declaring a public health emergency, which can only last for 90 days and be renewed a number of times, demonstrates the complexity of an opioid crisis that continues to grow through an ever-evolving cycle of addiction, from prescription pain pills to illegal heroin to the lethality of fentanyl.

What the public health emergency won’t do is free up much federal funding. Acting Health and Human Services Secretary Eric Hargan will be given more room to loosen certain regulations that he otherwise would not be able to.

The declaration will expand access to telemedicine to better help those with an addiction in remote areas receive medications; allow for the shifting of resources within HIV/AIDS programs to help people eligible for those programs receive substance use disorder treatments; and more. It could spur a fight for funding in Congress, as Senate Democrats have introduced a bill to put $45 billion toward the epidemic. Many Republicans also back much more funding to combat the epidemic.

The opioid action is the first public health emergency with a nationwide scope since a year-long emergency to prepare for the H1N1 influenza virus in 2009 and 2010.

Posted in: Opioid

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