As an example, Dr. McNiel has written 3, scripts of OxyContin Opana's top rival through September of this year, which seems almost impossible even for a pain clinic. Endo's top ethics and compliance officer, not identified by name in the lawsuit, brushed off the warning. McNiel earlier this year and didn't find any evidence of suspected diversion.
McNiel surrendered his medical license last year after a series of sanctions by the state Board of Medical Examiners. He denied any wrongdoing. Endo pulled Opana from the market in under pressure from the U.
Food and Drug Administration. The lawsuit, which seeks unspecified damages, argues Opana caused more harm in Tennessee than any other state. Facebook Twitter Email. Buprenorphine is different from other opioids because it's a "partial opioid agonist," which means that when taken in proper prescribed doses, it should produce less euphoria and physical dependence, and therefore a lower potential for misuse.
It's also supposed to have a relatively mild withdrawal profile. However, if abused by crushing and snorting or injecting, it can suppress breathing and cause dizziness, confusion, unconsciousness and death. Subutex, the brand name for buprenorphine, is taken as a tablet placed under the tongue and allowed to dissolve.
The brand Suboxone is a combination of buprenorphine and naloxone, an opioid antagonist. Antagonists block the opiate receptors in the brain, keeping the narcotic from creating the high abusers crave.
Story highlights A nationwide shortage of injectable opioid painkillers has left hospitals scrambling for alternatives In some cases, this leads to dosage mistakes that may harm patients. The shortage, though more significant in some places than others, has left many hospitals and surgical centers scrambling to find enough injectable morphine , Dilaudid and fentanyl -- drugs needed for patients undergoing surgery, fighting cancer or suffering traumatic injuries.
The shortfall, which has intensified since last summer, was triggered by manufacturing setbacks and a government effort to reduce addiction by restricting drug production. As a result, hospital pharmacists are working long hours to find alternatives, forcing nurses to administer second-choice drugs or deliver standard drugs differently.
That raises the risk of mistakes -- and already has led to at least a few instances in which patients received potentially harmful doses, according to the nonprofit Institute for Safe Medication Practices , which works with health care providers to promote patient safety. Opioid history: From 'wonder drug' to abuse epidemic. In the institute's survey of hospital pharmacists last year, one provider reported that a patient received five times the appropriate amount of morphine when a smaller-dose vial was out of stock.
In another case, a patient was mistakenly given too much sufentanil, which is about 10 times more powerful than fentanyl, which was the ideal medication for that situation. In response to the shortages, doctors in states as far-flung as California, Illinois and Alabama are improvising the best they can. Some patients are receiving less potent medications like acetaminophen or muscle relaxants as hospitals direct their scant supplies to higher-priority cases.
Others patients are languishing in pain because preferred, more powerful medications aren't available, or because they have to wait for substitute oral drugs to kick in.
Read More. The American Society of Anesthesiologists confirmed that some elective surgeries, which can include gall bladder removal and hernia repair, have been postponed. In a Feb. Drug Enforcement Administration, a coalition of professional medical groups -- including the American Hospital Association, the American Society of Clinical Oncology and the American Society of Health-System Pharmacists -- said the shortages "increase the risk of medical errors" and are "potentially life threatening.
CNN Exclusive: The more opioids doctors prescribe, the more money they make. In addition, "having diminished supply of these critical drugs, or no supply at all, can cause suboptimal pain control or sedation for patients," the group wrote.
The shortages involve pre-filled syringes of these drugs, as well as small ampules and vials of liquid medication that can be added to bags of intravenous fluids. Drug shortages are common, especially of certain injectable drugs, because few companies make them. But experts say opioid shortages carry a higher risk than other medications. But in the late s, drug companies and doctors launched a war on the chronic pain often experienced by outpatients.
The main weapons in this war were old, generic opioids manufactured in novel configurations that allowed their makers to win lucrative patents. Cheap and easy to synthesize in the lab, fentanyl was refashioned in one newly patented form after another - as a lollipop, a fast-dissolving disc and a nasal spray.
After patents on prescription opioids elapsed, generic drugmakers have piled in to profit off volume sales. For the most part, the companies making injectables are not making prescription opioids. Still, large hospital chains and purchasing groups have enough market power to drive hard bargains, the FDA-led drug task force found.
Generic injectables are largely seen as interchangeable, so hospitals shop by price, not brand. That means hospitals are paying 3 cents per microgram for injectable fentanyl. Despite bargain-basement prices, drugs injected directly into the bloodstream are more expensive and more difficult to make than pills, which are mass produced.
Injectable drugs are made batch-by-batch, and the risks of contamination are greater. He and other injectable manufacturers told Reuters they remained in the U. When the novel coronavirus landed in the United States, the supply line for hospital opioids was still recovering from a setback three years earlier. By the summer, Pfizer warned of extended production delays as it sought to fix the problems, according to a letter the company sent to customers.
Purdue, for instance, had sharply reduced its injectable hydromorphone output over several years. The shortfalls across the country underscored the vulnerability of the injectables supply chain. In a February letter to U. Then Pfizer took an unusual step. In May and July of , the company sent out letters warning hospitals, doctors and pharmacists that cracked needle hubs and unspecified contaminants had been found in some glass syringes filled with morphine and hydromorphone after they had been shipped to hospitals.
In the letters, reviewed by Reuters, the company said that the contaminants could result in inflammation, tissue injury and respiratory problems. Endo said other painkillers such as Percocet and Endocet could be made at a separate facility in Huntsville, Alabama. The FDA said on Monday there was a small chance that stray pills from Endo could have gotten mixed in with a different medication during production.
Patients should stop taking their painkillers if any pills look different from the rest, the agency said.
0コメント