New York | Opioid Learning Institute

NY requiere que doctores receten naloxona a algunos pacientes que toman analgésicos opioides

Aunque los titulares son por las muertes por sobredosis de drogas ilícitas vendidas en la calle, el riesgo de sufrirlas también es real para los pacientes que toman opioides recetados por sus médicos.

Sin analgésicos opioides para aliviar el dolor de rodillas y otras articulaciones, Arnold Wilson no podría caminar media cuadra. El ex enfermero de la ciudad de Nueva York, de 63 años, tiene una artritis incapacitante y toma OxyContin dos veces al día, y oxicodona cuando necesita un alivio adicional.

En los últimos años, también ha tenido otro remedio a mano: naloxona, un medicamento para revertir una sobredosis, al que generalmente se menciona con el nombre de marca Narcan.

“Me da una sensación de alivio y seguridad”, dijo Wilson, quien tiene aerosol nasal Narcan en su auto y en su casa. Su médico en el Centro Médico Montefiore, en el Bronx, le recetó opioides en 2013, después que un episodio de meningitis exacerbara los problemas en las articulaciones que Wilson tenía como resultado de dos aneurismas cerebrales y varios accidentes cerebrovasculares. Su médico lo instó a comenzar a tener Narcan en 2017.

Generalmente otras personas administran la naloxona, que comienza a revertir una sobredosis en cuestión de minutos. Aunque nunca la ha necesitado, la hija de Wilson, de 18 años, sabe cómo usarla. “Le he dado instrucciones sobre cómo hacerlo, en caso de que esté letárgico”, dijo. Su novia y sus amigos también saben qué hacer.

Una ley recientemente promulgada en Nueva York tiene como objetivo garantizar que la naloxona esté disponible si la necesitan personas como Wilson que toman opioides recetados.

Según la ley, vigente desde el verano pasado, los médicos deben recetar naloxona junto con la primera receta de opioides cada año.

Los factores de riesgo que activarían el requisito incluyen tomar una dosis diaria alta de un opioide (al menos el equivalente a 90 miligramos de morfina, o MME); tomar ciertos medicamentos, como sedantes hipnóticos; o tener antecedentes de adicciones.

Al menos otros 10 estados tienen leyes similares, según una investigación de Network for Public Health Law.

“A veces, los pacientes, especialmente si han estado tomando opioides durante mucho tiempo, no entienden los riesgos”, dijo la doctora Laila Khalid, codirectora de la clínica de dolor crónico del Centro Médico Montefiore. La clínica proporciona naloxona gratis a los pacientes a través del programa de prevención de sobredosis de opioides del estado.

Por ejemplo, la persona puede haberse olvidado cuándo tomó la última dosis y, sin darse cuenta, tomar demasiado, o tomar algunos tragos adicionales en una fiesta, dijo Khalid. El alcohol y algunos medicamentos, como las benzodiazepinas, amplifican los efectos de los opioides.

“Las muertes por sobredosis de drogas continúan aumentando, como cada año durante más de dos décadas”, dijo Emily Einstein, jefa del área de Política Científica del Instituto Nacional sobre el Abuso de Drogas.

En 2021, apuntó Einstein, las muertes por sobredosis en Estados Unidos superaron las 100,000 estimadas por primera vez, según datos provisionales de los Centros para el Control y la Prevención de Enfermedades (CDC). Según estos datos, la gran mayoría de esas muertes, más de 80,000, involucraron a opioides, agregó. Si bien la mayoría de las muertes por sobredosis de opioides se atribuyeron al fentanilo ilegal, aproximadamente 17,000 muertes involucraron opioides recetados, incluida la metadona.

La naloxona, disponible como aerosol nasal o inyección, se considera segura y causa pocos efectos secundarios. No es adictiva. Los CDC recomiendan que las personas con riesgo de sobredosis la lleven consigo para que un familiar o transeúnte pueda administrarla si es necesario.

Los expertos en política de drogas señalan una estadística clave que leyes como la de Nueva York pretenden abordar: en casi el 40% de las muertes por sobredosis, otra persona está presente, según los CDC.

Si los transeúntes hubieran tenido la naloxona, “la mayoría de esas personas no habrían muerto”, dijo Corey Davis, director del Harm Reduction Legal Project en la Network for Public Health Law.

En todos los estados, incluido Nueva York, los farmacéuticos están autorizados a dispensar naloxona, a menudo bajo “órdenes permanentes” que permiten dispensarlo sin una receta, por lo general a personas que corren el riesgo de sufrir una sobredosis o están en condiciones de ayudar a alguien en riesgo.

Entonces, ¿por qué exigir que los médicos hagan recetas?

Obligar es más efectivo que recomendar, dicen expertos. Al requerir que los médicos receten el medicamento, más personas que podrían necesitar naloxona la tendrían a mano, si surten la receta. Pero no hay garantía de que lo hagan.

Una receta también puede ayudar a eliminar el estigma persistente de pedir una fármaco contra la sobredosis en el mostrador de una farmacia.

“Elimina los puntos de fricción”, dijo Davis. “Simplemente vas al mostrador y lo recoges”.

En un análisis de 2019, los farmacéuticos en los estados que requerían la receta conjunta de naloxona con opioides surtieron casi ocho veces más recetas de naloxona por cada 100,000 personas que los de los estados que no la requerían.

Missouri no tiene una ley de receta conjunta, pero el médico que ayuda a manejar el dolor a Danielle Muscato sugirió recientemente que llevara Narcan. La activista de derechos civiles de 38 años, que vive en Columbia, toma el opioide recetado tramadol y varios otros medicamentos para controlar su dolor lumbar severo y crónico. Está contenta de tener el aerosol nasal guardado en su bolso, por si acaso.

“Creo que es algo maravilloso” que la gente lo lleve y sepa cómo usarlo, dijo. “Ojalá esto fuera estándar en todas partes”.

Desde que entró en vigencia la ley de Nueva York, “definitivamente he visto un aumento de recetas que agregan naloxona a los opioides, especialmente si se trata de un pedido grande”, dijo Ambar Keluskar, gerente de farmacia de Rossi Pharmacy en Brooklyn.

Sin embargo, los pacientes no siempre entienden por qué lo obtienen, afirmó Toni Tompkins, farmacéutica supervisora de Phelps Hometown Pharmacy en la ciudad de Phelps, en el norte del estado de Nueva York.

Un caja de dos dosis de aerosol de naloxona generalmente cuesta alrededor de $150. El medicamento ahora está disponible en forma genérica, lo que puede reducir el costo de bolsillo. La mayoría de las aseguradoras lo cubren, aunque los pacientes suelen tener un copago.

Las personas sin seguro generalmente pueden obtener naloxona a través de programas estatales.

En Nueva York, las aseguradoras privadas están obligadas a cubrir la naloxona, y Medicaid también la cubre, dijo Monica Pomeroy, vocera del Departamento de Salud del estado. El Programa de asistencia de copago de naloxona (N-CAP) del estado cubre el costo de los copagos de hasta $40 para las personas con seguro, dijo Pomeroy.

Las personas sin seguro o aquellas que no han alcanzado su deducible pueden obtenerla gratis en uno de los sitios de prevención de sobredosis de opioides del estado.

En noviembre, la Administración de Alimentos y Drogas (FDA) anunció que está considerando que la naloxona esté disponible sin receta.

Aunque ofrecerla sin receta facilitaría la obtención del medicamento, a algunas personas les preocupa que el seguro no lo cubra. Además, “si un paciente simplemente lo recoge en algún lugar sin recibir orientación sobre cómo usarlo, eso podría ser un inconveniente”, dijo Anne Burns, vicepresidenta de asuntos profesionales de la Asociación Estadounidense de Farmacéuticos.

Algunos profesionales creen que se debe dispensar naloxona con cada receta de opioides, independientemente de los factores de riesgo. Así es en Rochester, Nueva York, y en los alrededores del condado de Monroe. En 2021, el ejecutivo del condado, Adam Bello, firmó la Ley de Maisie, que lleva el nombre de una niña local de 9 meses que murió después de tragarse una pastilla de metadona que encontró en el piso de la cocina de un vecino.

“Es horrible lo que pasó”, dijo Karl Williams, profesor de derecho farmacéutico y presidente de la junta de la Sociedad de Farmacéuticos del Estado de Nueva York. “Tal vez sea el próximo estándar que debería convertirse en ley”.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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NY Docs Are Now Required to Prescribe Naloxone to Some Patients on Opioid Painkillers

This strategy — now in place in at least 10 states — is part of an effort to curb accidental opioid overdose deaths by patients who take these powerful medications.

Without opioid painkillers to dull the ache in his knees and other joints, Arnold Wilson wouldn’t be able to walk half a block. The 63-year-old former New York City nurse has crippling arthritis for which he takes OxyContin twice a day and oxycodone when he needs additional relief.

For the past several years, he’s kept another drug on hand as well: naloxone, an overdose reversal drug often referred to by the brand name Narcan.

Although overdose deaths from illicit drugs sold on the street make headlines, the risk of overdose is just as real for patients who take opioids prescribed by their doctors.

“It gives me a sense of relief and security,” said Wilson, who keeps Narcan nasal spray in his car and at home. His pain management doctor at Montefiore Medical Center in the Bronx prescribed the opioids in 2013, after a bout with meningitis exacerbated joint problems Wilson had as a result of two brain aneurysms and several strokes. His doctor urged him to start carrying Narcan in 2017.

Naloxone, which begins to reverse an overdose within minutes, is typically administered by others. Though he’s never needed it, Wilson’s 18-year-old daughter knows how to use it. “I’ve instructed her how to do it, in case I’m lethargic,” he said. His girlfriend and friends know what to do, too.

A recently enacted New York law aims to ensure that naloxone is available if needed by people like Wilson who take prescription opioids.

Under the law, which took effect this summer, doctors must co-prescribe naloxone to certain patients who are at risk of an overdose when writing the patients’ first opioid prescription each year. Risk factors that would trigger the requirement include taking a high daily dose of an opioid (at least 90 morphine milligram equivalents, or MME); taking certain other drugs, like sedative hypnotics; or having a history of substance use disorder.

At least 10 other states have similar laws, according to research by the Network for Public Health Law.

“Sometimes patients, especially if they’ve been taking opioids for a long time, don’t understand the risks,” said Dr. Laila Khalid, co-director of the chronic pain clinic at Montefiore Medical Center. The clinic provides free naloxone to patients through the state’s opioid overdose prevention program.

Someone may forget the timing of their last dose and inadvertently take too much, for example, or have a few extra drinks at a party, Khalid said. Alcohol and some medications, like benzodiazepines, amplify opioids’ effects.

“Drug overdose deaths continue to climb, as they have nearly every year for more than two decades,” said Emily Einstein, chief of the Science Policy Branch at the National Institute on Drug Abuse. In 2021, Einstein noted, overdose deaths in the United States topped an estimated 100,000 for the first time, according to provisional data from the Centers for Disease Control and Prevention. According to this provisional data, Einstein said, the vast majority of those deaths — over 80,000 — involved opioids. While most opioid overdose deaths were attributable to illicit fentanyl, approximately 17,000 deaths involved prescription opioids, including methadone.

Naloxone, available as either a nasal spray or injection, is considered safe and causes few side effects. It’s not addictive. The CDC recommends that people at risk of overdose carry it with them so that a family member or bystander can administer it if necessary.

Experts in drug policy point to a key statistic that laws like the one in New York aim to address: In nearly 40% of overdose deaths, another person is present, according to the CDC.

If bystanders had had naloxone, “most of those people wouldn’t have died,” said Corey Davis, director of the Harm Reduction Legal Project at the Network for Public Health Law.

In every state, including New York, pharmacists are authorized to dispense naloxone, often under “standing orders” that allow dispensing without a prescription, typically to people who are at risk of overdose or are in a position to help someone at risk.

So then why require physicians to write scripts?

Mandating is more effective than recommending, experts said. By requiring physicians to prescribe the drug, more people who might need naloxone would have it on hand — if they fill the prescription. But there’s no guarantee they will.

A prescription can also help remove the lingering stigma of asking for an overdose drug at the pharmacy counter.

“It removes friction points,” said Davis. “You just drive through the window and pick it up.”

In a 2019 analysis, pharmacists in states that required co-prescribing naloxone with opioids filled nearly eight times as many naloxone prescriptions per 100,000 people as those in states that didn’t require it.

Missouri doesn’t have a co-prescribing law, but Danielle Muscato’s pain management doctor recently suggested she carry Narcan. The 38-year-old civil rights activist, who lives in Columbia, takes the prescription opioid tramadol and several other drugs to keep her chronic severe lower back pain in check. She’s glad to have the nasal spray tucked in her purse, just in case.

“I think it’s a wonderful thing” that people carry it and know how to use it, she said. “I wish this was standard everywhere.”

Since the New York law went into effect, “I have definitely seen an uptick of prescribers adding naloxone to opioids, especially if it’s a large order,” said Ambar Keluskar, pharmacy manager at Rossi Pharmacy in Brooklyn.

Patients don’t always understand why they’re getting it, though, said Toni Tompkins, supervising pharmacist at Phelps Hometown Pharmacy in the upstate New York town of Phelps.

A two-dose package of naloxone spray typically costs about $150. The medication is now available in generic form, which may reduce the out-of-pocket cost. Most insurers cover it, although patients typically owe a copayment. The uninsured can generally get naloxone through state programs.

In New York, private insurers are required to cover naloxone, and Medicaid also covers it, said Monica Pomeroy, a spokesperson for the state health department. The state’s Naloxone Co-Payment Assistance Program (N-CAP) covers the cost of copays up to $40 for those with insurance, Pomeroy said. Uninsured people or those with unmet deductibles can get it free at one of the state’s opioid overdose prevention sites.

In November, the FDA announced it is considering making naloxone available without a prescription.

Although offering it over the counter would make the drug easier to get, some people are concerned that insurance might not cover it. Further, “if a patient is just picking it up somewhere without getting any guidance on how to use it, that could be a downside,” said Anne Burns, vice president of professional affairs at the American Pharmacists Association.

Some professionals believe naloxone should be dispensed with every opioid prescription, regardless of risk factors. In Rochester, New York, and surrounding Monroe County, that’s what happens. In 2021, the county executive, Adam Bello, signed Maisie’s Law, named after a local 9-month-old girl who died after swallowing a methadone pill she found on a neighbor’s kitchen floor.

“It’s horrible what happened,” said Karl Williams, a pharmacy law professor and chair of the board of the Pharmacists Society of the State of New York. “Maybe it’s a next-level standard that should become law.”

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Patients Struggle to Find Prescription Opioids After NY Tax Drives Out Suppliers

The tax was touted as a way to generate funding for treatment programs across the state. But to avoid paying, scores of manufacturers and wholesalers stopped selling opioids in New York.

NEW YORK — Mike Angevine lives in constant pain. For a decade the 37-year-old has relied on opioids to manage his chronic pancreatitis, a disease with no known cure.

But in January, Angevine’s pharmacy on Long Island ran out of oxymorphone and he couldn’t find it at other drugstores. He fell into withdrawal and had to be hospitalized.

“You just keep thinking: Am I going to get sick? Am I going to get sick?” Angevine said in a phone interview. “Am I going to be able to live off the pills I have? Am I going to be able to get them on time?”

His pharmacy did not tell him the reason for the shortage. But Angevine isn’t the only pain patient in New York to lose access to vital medicine since July 2019, when the state implemented an excise tax on many opioids.

The tax was touted as a way to punish major drugmakers for their role in the opioid epidemic and generate funding for treatment programs. But to avoid paying, scores of manufacturers and wholesalers stopped selling opioids in New York. Instead of the anticipated $100 million, the tax brought in less than $30 million in revenue, two lawmakers said in interviews. None of it was earmarked for substance abuse programs, they said.

The state’s Department of Health, which has twice this year delayed an expected report on the impact of the tax, did not respond to questions for this story.

The tax follows strong efforts by federal and New York officials to tamp down the use of prescription opioids, which had already cut back some supply. Now, with some medications scarce or no longer available, pain patients have been left reeling. And the law appears to have missed its target: Instead of taking a toll on manufacturers, the greater burden appears to have fallen on pharmacies that can no longer afford or access the painkillers.

Among the companies that no longer sell opioids in New York is Epic Pharma. Independent Pharmacy Cooperative, a wholesaler, confirmed it no longer sells medications subject to the tax, but still sells those that are exempt, which are treatments for opioid addiction methadone and buprenorphine and also morphine. AvKARE and Lupin Pharmaceuticals said they do not ship opioids to New York anymore. Amneal Pharmaceuticals, which manufactures Angevine’s oxymorphone, declined to comment, as did Mallinckrodt.

Since the tax went into effect, Cardinal Health, which provides health services and products, published an extensive 10-page list of opioids it does not expect to carry. Cardinal Health declined to comment.

The New York tax is slowly gaining attention in other states. Delaware passed a similar tax last year. Minnesota is assessing a special licensing fee between $55,000 and $250,000 on opioid manufacturers. New Jersey Gov. Phil Murphy proposed such a tax this year but was turned down by the legislature.

The company that makes the first point of sale within New York pays the tax. That isn’t always the drugmaker. It can mean wholesalers selling to pharmacies here are assessed, explained Steve Moore, president of the Pharmacists Society of the State of New York.

Independent Pharmacy Cooperative said about half its revenue from opioid sales in New York would have gone to taxes.

Mark Kinney, the company’s senior vice president of government relations, said the law is putting companies in a very difficult position.

When wholesalers like IPC left the opioid market, competitive prices went with them.

Without these smaller wholesalers, it’s hard for pharmacies to go back to other wholesalers “and say, ‘Hey, your prices aren’t in line with the rest of the market,’” Moore said.

Indeed, nine independent pharmacies told KHN that when they can get opioids they are more expensive now. They have little choice but to eat the cost, drop certain prescriptions or pass the expense along.

“We can trickle that cost down to the patient,” said a pharmacist at New London Pharmacy in Manhattan, “but from a moral and ethics point of view, as a health care provider, it just doesn’t seem right to do that. It’s not the right thing to ask your patient to pay more.”

In addition, Medicare drug plans and Medicaid often limit reimbursements, meaning pharmacies can’t charge them more than the programs allow.

Stone’s Pharmacy in Lake Luzerne was losing money “hand over fist,” owner Leigh McConchie said. His distributor was adding the tax directly to his pharmacy’s cost for the drugs. That helped drive down his profit margins from opioid sales between 60% and 70%. Stone’s stopped carrying drugs like fentanyl patches and oxycodone, and though that distributor now pays the tax itself, the pharmacy is still feeling the effects.

“When you lose their fentanyl, you generally lose all their other prescriptions,” he said, noting that few customers go to multiple pharmacies when they can get everything at one.

If pharmacies have few opioid customers, those price hikes have less impact on their business. But being able to manage the costs is not the only problem, explained Zarina Jalal, a manager at Lincoln Pharmacy in Albany. Jalal can no longer get generic oxycodone from her supplier Kinray, though she can still access brand-name OxyContin. New York’s Medicaid Mandatory Generic Drug Program requires insurers to provide advance authorization for the use of brand-name prescriptions, delaying the approval process. Sometimes patients wait several days to get their prescription, Jalal explained.

“When I see them suffer, it hurts more than it hurts my wallet,” she said.

One of Jalal’s customers, Janis Murphy, needs oxycodone to walk without pain. Now she is forced to buy a brand-name drug and pays up to three times what she did for generic oxycodone before the tax went into effect. She said her bill since the start of this year for oxycodone alone is $850. Lincoln Pharmacy works with Murphy on a payment plan, without which she would not be able to afford the medication at all. But the bill keeps growing.

“I’m almost in tears because I cannot get this bill down,” she said in a phone interview.

Several pharmacists raised concerns that patients who lose access to prescription opioids may turn to street drugs. High prescription prices can drive patients to highly addictive and inexpensive heroin. McConchie of Stone’s Pharmacy said he now dispenses twice as many heroin treatment drugs as he did a year ago. Former opioid customers now come in for prescriptions for substance use disorder.

Trade groups and some physicians and state legislators opposed the tax before it went into effect, voicing concerns about a slew of potential consequences, including supply problems for pharmacists and higher consumer prices.

New London Pharmacy said one of its regular distributors stopped shipping Percocet, a combination of oxycodone and acetaminophen. Instead, the pharmacy orders from a more expensive company. The pharmacist estimated that a bottle of Percocet for which it used to pay $43 now costs up to $92.

“Even if we absorb the tax, we’re not getting a break from reimbursements either,” a pharmacist who spoke on the condition of anonymity explained, adding that insurance reimbursements have not increased in proportion to rising drug costs. “We’re losing.”

Latchmin Raghunauth Mondol, owner of Viva Pharmacy & Wellness in Queens, has also seen that problem. The pharmacy used to be able to purchase 100 15-milligram tablets of oxycodone for $15, but that’s now $70, she said, and the pharmacy is reimbursed only about $21 by insurers.

Other opioids are just not available.

Mondol said she has been unable to obtain certain doses of two of the most commonly prescribed opioids, oxycodone and oxymorphone — the drug Angevine was on.

After Angevine lost access to oxymorphone, his doctor put him on morphine, but it does not give him the same relief. He’s been in so much pain that he stopped going to physical therapy appointments.

“It’s a marathon from hell,” he said.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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