HHS: Don’t Withdraw Opioids Suddenly

HHS: Don’t Withdraw Opioids Suddenly

Department issues guideline on tapering and discontinuation

Clinicians seeking to wean patients off opioid painkillers should do so slowly and only with shared decision-making involving the patient, according to a new guideline released Thursday by the Department of Health and Human Services (HHS).

The lone exception is when patients face a life-threatening crisis if opioids are continued, the document stated.

HHS also lists situations in which clinicians should consider tapering dosages or discontinuing opioids altogether, starting with “Pain improves” and ending with “The patient has been treated with opioids for a prolonged period (e.g., years), and current benefit-harm balance is unclear.”

In between are common-sense scenarios including patient request, overdose, evidence of misuse, and use of other medications that shouldn’t be combined with opioids.

Sudden Tapering is Risky

But the guideline’s main thrust is to discourage clinicians from simply stopping prescriptions abruptly.

“Risks of rapid tapering or sudden discontinuation of opioids in physically dependent patients include acute withdrawal symptoms, exacerbation of pain, serious psychological distress, and thoughts of suicide,” the document emphasizes in a colored box. It also notes, perhaps unnecessarily, that “patients may seek other sources of opioids, potentially including illicit opioids, as a way to treat their pain or withdrawal symptoms” if suddenly deprived without their agreement.

Among the steps clinicians should take before changing doses were making a commitment “to working with your patient to improve function and decrease pain.” This could include alternative medications as well as nonpharmacological treatments, the document indicates, adding, “Integrating behavioral and nonopioid pain therapies before and during a taper can help manage pain and strengthen the therapeutic relationship.”

“Obtain Patient Buy-In”

The guideline also advocates a thorough discussion with patients that includes soliciting their perceptions of the risks and benefits of continuing on opioids.

Notably, it also states that “tapering does not need to occur immediately. Take time to obtain patient buy-in.”

Included in the guideline is a multi-step flow chart to walk clinicians through the decision-making process, from the initial assessment of benefits and risks of patients’ current regimens to a recommended quarterly re-evaluation of patients’ progress. And, also in a colored box, is the definition of opioid use disorder as given in the DSM-5 diagnostic manual.

“Care must be a patient-centered experience. We need to treat people with compassion, and emphasize personalized care tailored to the specific circumstances and unique needs of each patient,” said Adm. Brett P. Giroir, MD, assistant HHS secretary for health, in a statement announcing the guideline. “This Guide provides more resources for clinicians to best help patients achieve the dual goals of effective pain management and reduction in the risk for addiction.”

Originally published in MedPage Today

Will “Produce Prescriptions” Show Healthy Returns?

Will “Produce Prescriptions” Show Healthy Returns?

Federal, private funders bet food-as-pharmacy programs will deliver healthcare cost savings

When low-income patients with high blood pressure fill their “produce prescriptions” at certain New York City pharmacies, they walk away with $30 in vouchers to spend on fresh fruits and vegetables at the city’s farmer’s markets.

The city’s “Pharmacy to Farm Prescriptions Program” has reached more than 1,000 hypertensive SNAP recipients since it launched in 2017, and has grown from 3 to 16 participating pharmacies. It is set to report outcomes data next year.

The program is supported in part by a grant from the U.S. Department of Agriculture (USDA), which is poised to make an even bigger impact on the food-as-pharmacy programs that have been growing in popularity. The 2018 Farm Bill established a national Produce Prescription Program that sets aside millions in grants each year.

With diet-related illnesses like heart disease and obesity costing hundreds of billions of dollars each year in the U.S., other funders are also expecting a healthy return-on-investment (ROI) in these programs, which means more initiatives like New York City’s may find the means to thrive.

Not Just for SNAP Recipients

USDA has been supporting projects to increase healthy food consumption among SNAP recipients since 2014, under the Gus Schumacher Nutrition Incentive Program (GusNIP, formerly the Food Insecurity Nutrition Initiative). The bill now guarantees GusNIP can administer $25 million in produce prescription grants—not just for SNAP-based programs—for the fiscal year beginning in 2018, jumping to $45 million for the 2019 fiscal year and rising to its cap of $56 million in 2023. The first grants will be awarded in October.

The Local Food Hub in Charlottesville, Virginia, currently receives funding from local businesses and philanthropies, but has applied for a federal grant. Its Fresh Farmacy program provides low-income patients who have chronic disease with produce from local farmers. Participants pick up their “shares” every other week during the growing season.

“We have seen first-hand the impact of incorporating healthy food to manage weight, maintain healthy blood glucose levels, and reduce the risk of diabetes complications,” said Patricia Polgar-Bailey, a nurse practitioner at the Charlottesville Free Clinic, which participates in Fresh Farmacy.

Non-Profit and Private Sectors Pitch In

Federal dollars aren’t the only way to keep food-as-pharmacy programs afloat. Wholesome Wave, a non-profit that was co-founded by Gus Schumacher, has been supporting produce prescription projects since 2010.

Wholesome Wave gets money from philanthropies and corporate partners – including Target, Chobani, and Humana, to name a few – to foster such programs.

“There are non-profits and private-sector supporters trying to prove the model in the interest of getting insurers and the healthcare industry to really step up,” said Julie Peters, director of programs at Wholesome Wave.

An example of the organization’s support: it’s putting money into a produce prescriptions pilot for diabetes at Community Health and Wellness Partners (CHWP) in Logan County, Ohio, which is also supported by state and federal dollars.

Healthy Food = Healthier Lives

Once a month, participants attend nutrition classes taught by staff dietitians, and subsequently receive vouchers for up to $120, depending on family size, to purchase produce at local grocery stores or farmer’s markets.

Among those who have completed three months of classes, HbA1c has already declined 0.6 percentage points on average, said Jason Martinez, a clinical pharmacist at CHWP who has analyzed preliminary data from the program.

Will these improvements translate to reduced healthcare costs? That has been the case at Geisinger Health System’s Fresh Food Farmacy initiative. The program focuses on patients with type 2 diabetes who experience food insecurity. In addition to 15 hours of disease and nutrition counseling, participants get enough healthy food for 5 days of the family’s weekly meals.

Over 18 months, participants’ HbA1c levels fell 2.1 points on average, compared with declines of 0.5-1.2 points for those taking two or three medications only. Along with improvements in weight, cholesterol, and hypertension, that has translated to an 80% drop in healthcare spending for 37 of about 200 participants who were insured by Geisinger, according to early data.

“We know the cost of the program, all-in, for the food and the clinical care is around $2,500, so it’s reasonable to assume that there’s an ROI that we would experience with that,” said Allison Hess, vice president of health and wellness at Geisinger. She’s hopeful that ROI will convince insurance companies “to potentially fund this as part of a benefit package.”

Similarly—albeit hypothetically—a recent simulation study of Medicare and Medicaid recipients predicted that providing a 30% subsidy on fruits and vegetables would prevent nearly 2 million cardiovascular events and save almost $40 billion in annual healthcare costs.

This story was originally posted on MedPage Today.

Expert: Forget Detox for Substance Use Disorder

LAS VEGAS — There’s a lot more to substance abuse disorder than physical dependence, which means that acute detox treatment by itself isn’t an effective therapy, a researcher said here.

The real key, said Debra Gordon RN, DNP, of the University of Washington in Seattle, in a talk here at the annual PAINWeek conference, is establishing a relationship with patients so that behavioral changes can be implemented.

Withholding opioids from patients with substance use disorder will not cure their addiction, she said. Moreover, providing them with opioids will not necessarily worsen their addiction and may help them accept behavioral therapies.

“There is no evidence that detoxing someone in an acute situation or hospital setting is going to impact that disease,” Gordon said in a presentation. “In fact, the evidence seems to be they will be more at risk for using at their discharge and having an overdose, some of that being in the prison system, but you see that in hospitals too.”

Patients with substance use disorder continue to use drugs despite recurrent problems in their social, workplace, or familial spheres that occur because of their use. Many take multiple substances and have underlying mental health disorders, both of which need to be screened for, Gordon said.

These patients have a higher pain threshold and the prevalence of chronic pain is also much higher in patients with drug abuse disorder. As such, using the Numeric Rating Scale (NRS-11) to define their pain will be insufficient, and providers should determine whether the source of pain is acute, chronic, or related to the patient’s addiction.

Clinicians should also anticipate that patients with substance abuse disorder may have had negative experiences with the healthcare system previously, Gordon said, and asking open-ended questions without judgment may mitigate feelings of shame or fear that prompt them to withhold information.

Seemingly obvious physical comforts, like turning off the lights or keeping a room quiet, also go a long way as well, Gordon said. Cognitive behavioral therapy can also help patients change their perception of pain and help with sleep, mood, and anxiety issues co-occurring with substance use disorder.

Still, some patients may not be willing to change, and others may try to use within the hospital. When encountering patients who deny having a problem, or who recognize the disorder but are unwilling to change, providers should focus on helping them transition out of the hospital when the time comes and providing naloxone emergency overdose kits to patients who may return to illicit drug use.

“Failure to engage in treatment is not a failure,” Gordon said. “It’s part of the process and it’s part of the disease.”

But despite the treatment options available for patients with substance abuse, some providers may be unaware they exist, or may be unsure of what they are authorized to provide, Gordon said.

“There are barriers in the healthcare system in terms of the way we’ve traditionally been trained and traditionally work in silos, and to care for this population we have to really have a team approach,” Gordon told MedPage Today. “It’s one thing to say stuff on paper and another to try and find out how it works in the real world.”

This story was originally posted on MedPage Today.

The Rules of Verbal Jiu-Jitsu With Patients: how to deflect and defuse manipulative conversations

The Rules of Verbal Jiu-Jitsu With Patients: how to deflect and defuse manipulative conversations

You are seeing a newly booked patient in your jail medical clinic. He states that the last time he was in jail, he was given a second mattress because he had surgery on his back many years ago. You note that the patient has not seen a doctor on the outside for many years, that the patient walks and moves normally, and that he has a normal neurological examination. You tell the patient that medical does not give out passes for extra mattresses. The patient angrily erupts in a blaze of obscenities and threatens a lawsuit.

Manipulation happens when a patient wants something that they should not have (like an extra mattress and pillow) and will not accept “NO” for an answer. There are several strategies patients may employ in an attempt to force practitioners to change a “No” to a “Yes.” This patient started with the “other doctors gave me what I want” strategy and when that didn’t work, he employed the “threatening” strategy. (I covered this in more detail in a post last month.)

Verbal Jiu-Jitsu is what I call the technique of deflecting and defusing such manipulative confrontations. The first and most important rule of Verbal Jiu-Jitsu is to remember that this is not a war or a contest! There should be no “battle of wills” between you and your patient. There is no winner or loser. Instead, you and your patient are having a conversation. The whole goal of Verbal Jiu-Jitsu is to avoid any kind of verbal battle.

I know that it is tempting to think of an unpleasant verbal exchange as a debate-style contest, with a winner and a loser at the end. But even if you “win” a verbal battle, you’ve actually really lost because you have not accomplished your goal of getting your patient to understand and accept your treatment plan! Your patient is still not happy and will simply renew the verbal battle at another time in another way — and maybe more effectively next time.

The second rule of Verbal Jiu-Jitsu is to have compassionate understanding of your patient. That person in front of you is not an opponent to be defeated. He is your patient. Like everybody else, inmates are just trying to get by as well as they can in a very tough environment — they’re in jail! It’s just that many inmates (and people on the outside, for that matter) have poor interpersonal skills and resort to pathological social habits. This is what they know and what works for them. If a patient has successfully gotten his way throughout his life by bullying and threatening others, that is how he is going to interact with you, too.

You don’t have control over this — but you do have control over your reaction. When patients confront you with threats, they will expect you to respond the way that most other people would — which is either to fight back or to give in. You should do neither.

Take, for example, the case of this patient in your clinic who has angrily threatened to sue you plus has lobbed in a few F-bombs for good measure. There he is, red faced, fists clenched, and LOUD. Nurses, deputies, and other inmates are watching. How are you going to handle this? How will you accomplish your goal of defusing the situation and facilitating reasonable communication with your patient?

The single worst thing you could do would be to respond to anger with anger: “You can’t talk to me like that! Get the hell out! Who do you think you are?” First of all, the patient is accustomed to this type of response and will be far more comfortable and effective with a loud confrontation than you.

Second, the patient (and everyone watching) have now learned that a verbal confrontation is an effective way of getting under your skin — very useful information! Also, since you (hopefully) are not practiced and adept at angry shouting, your heart will be jack-hammering and you’ll develop a monster headache — at least that’s what would happen with me. You will have ruined your own mood for the rest of the day. How effective are you then going to be with the rest of your clinic schedule?

Finally, the fight is not over! The patient can (and will) renew the attack at another time.

Another wrong response is to compromise: “There is no reason to be angry! Calm down and we can work something out.” This is a mistake! If you compromise, you have established the precedent that becoming angry is an effective strategy with you. Other inmates will learn this and you will inevitably have to endure many more confrontations like this.

Instead, defuse and deflect. One way would be to say: “I see that you are angry, so we are done for now. Security will take you back to your dorm. We’ll talk again later after you’ve calmed down.” It’s important to say this without raising your voice and, if possible, to betray no emotion on your face or body language. The lack of any reaction goes a long way to defusing such situations. No compromise, no bargaining, no reaction.

The next day — or even in an hour or two — you can call the patient back to medical and confidently expect a more productive conversation. It is important at this second interaction not to upbraid or belittle the patient. You should act as if the last incident is forgotten.

It takes training, practice, and time to master verbal defense skills. The best way to learn is through role-playing scenarios. The response to angry outbursts happens to be one of the easiest Verbal Jiu-Jitsu skills to learn. The principles are: betray no reaction or emotion, end the session (if the patient will not calm down immediately), but make sure that such patients know that they are welcome back as soon as they calm down. Bring them back later and act as if the incident is forgotten.

This story was originally posted on MedPage Today.

NPs and PAs Match Docs for Circumcision Outcomes

NPs and PAs Match Docs for Circumcision Outcomes

Low complication rates for procedures performed by advanced practice providers

Advanced practice providers (APPs) performed office-based neonatal circumcisions with results comparable to those of physicians, according to two studies reported here.

A circumcision clinic led by nurse practitioners (NPs) had a 5-year complication rate of 4.1% as compared with 3.4% for circumcisions performed by physicians. Neither the overall rate nor any of the rates for specific types of complications differed significantly between NPs and MDs, reported Jonathan A. Gerber, MD, of Texas Children’s Hospital (TCH) in Houston, at the American Urological Association annual meeting.

The second study showed a 3-year complication rate of about 5% for circumcisions performed by a specially trained physician assistant (PA). That compared with complication rates of 4%-5% in published reviews of physician-performed circumcisions. The PA-performed circumcisions also generated substantial revenue for the urology practice, said Kaity Colon-Sanchez, PA-C, of Nemours Children’s Hospital in Orlando.

“We felt that utilization of advanced practice providers in our newborn services clinic has allowed pediatric urologists to focus their attention on the most complicated cases in the practice, while the more simple newborn circumcisions are being performed safely and effectively by advanced practice providers,” said Gerber. “Additionally, the results suggest that the longstanding age and weight cutoffs for newborn circumcisions need to be reconsidered, because our study shows similar outcomes in older and heavier children.”

About 70%-80% of newborn male infants undergo circumcision, making it the most common urologic procedure. An ongoing shortage of pediatric urologists has created a significant imbalance between the need for circumcision and the resources to provide the service. To address the problem, TCH established an APP-led newborn circumcision clinic, said Gerber.

One previous study documented results of a service wherein NPs performed minor urologic procedures, but the procedures all occurred in an operating room. The TCH service is provided in an outpatient setting.

Pediatric urologists trained APPs to perform Gomco clamp circumcisions. The training consisted of observing 10 newborn circumcisions, assisting in 10 procedures, and then performing 10 circumcisions under direct supervision of a pediatric urologist. Thereafter, a pediatric urologist was on call for all APP-performed circumcisions. APPs were limited to performing circumcisions for infants <30 days old and weighing <10 lbs.

Investigators retrospectively reviewed records for circumcisions performed over a 5-year period, which allowed for comparison of outcomes before and after implementation of the APP-led clinic.

Gerber reported data for 314 APP-performed circumcisions and 237 performed by pediatric urologists. The analysis focused primarily on complications. The study population had a mean age of 23.8 days and mean weight of 8.6 pounds. Physicians performed circumcisions on older (28.4 vs 20.3 days, P<0.0001) and heavier (8.9 vs 8.4 lb, P<0.0063) infants and used more lidocaine per procedure (0.96 vs 0.8 mL).

Overall, 21 complications occurred, with no significant differences between the APP and physician procedures:

  • Total: 13 (4.1%) vs 8 (3.4%)
  • Revision circumcision: 1 each
  • 30-day return to emergency department (ED): 2 vs 0
  • Other penile surgery: 2 vs 4
  • Intraprocedure bleeding: 11 vs 4

The data showed no difference in outcomes for patients <30 vs ≥30 days or weight <10 vs ≥10 lbs, the traditional age and weight cutoffs for uncomplicated circumcision.

Colon-Sanchez reported her 3-year experience performing clinic-based circumcision in a pediatric urology service. She evaluated 371 infants for neonatal circumcision. They had a mean age of 7.8 weeks (range of 1 to 13 weeks) and weighed an average of 5.2 kg (11.4 lbs) and had a weight range of 3.2-7.5 kg. Subsequently, 95 infants did not undergo circumcision, 91 because of an abnormal genital exam. Colon-Sanchez performed 272 circumcisions with the Plastibell device and four with the Gomco device.

The clinic charged $366 for families that paid for the procedures themselves, and billed $722 when procedures were covered by insurance. Colon-Sanchez noted that the 95 patients excluded from the analysis did not represent lost revenue, as the office visit was considered billable and many of the patients required additional surgery.

Records revealed a complication rate of 6.43%, consisting of retained Plastibell device in 1.80% of cases, swelling in 1.40%, adhesions in 1.10%, cosmesis issues in 0.73%, and ED visits for bleeding in 1.40%.

The results compared favorably with those from studies of circumcisions performed by physicians, said Colon-Sanchez. A study of more than 1,000 circumcisions performed by pediatricians and ob/gyns showed an acute complication rate of 3.9%, all involving bleeding. A study of 9,000 surgeries at a pediatric urology service showed that 4.7% of the procedures involved late complications of circumcisions. Additionally, 7.4% of visits to the pediatric urology outpatient clinic during a 1-year period involved concerns related to newborn circumcisions.

“Well-trained physician urology physician assistants can perform neonatal circumcisions,” said Colon-Sanchez. “The data support low complication rates with well-trained PA providers. Urologist back-up is readily available. Office-based neonatal circumcisions provides an additional revenue stream.”

In response to a question, she described a training program similar to the one the APPs in Gerber’s study completed. She said she felt comfortable with her abilities after about 30 procedures.

Gerber and Colon-Sanchez disclosed no relevant relationships with industry.

This story was originally posted on MedPage Today.



You have Successfully Subscribed!

Listen to the Chapter Podcasts for Jonas and Kovner's Health Care Delivery in the United States


Gain a better understanding of the current state of the US health care system and how it might impact your work and life.

You have Successfully Subscribed!