Pharma supply chain ramps up technology to battle opioid epidemic

Hart is on the front lines of the fight against opioid abuse. As the spread of opioids continues to devastate cities, counties and states throughout the country, there has been a major push to pinpoint the vulnerabilities in a fragmented pharmaceutical supply chain to stem the flow of illicit prescription drugs.

Public officials and regulators are hopeful that an onslaught of lawsuits will hold bad actors accountable for neglecting red flags and recoup millions of taxpayer dollars spent in detaining, treating and rehabilitating opioid abusers.

At the same time, stakeholders throughout the industry are working to improve physician awareness and leverage emerging technology to slow the epidemic.

"It all comes down to monitoring and having the right tools in place," said Justin Schneider, vice president of clinical operations, pharmacy, cardiology, stroke and supply chain at Sinai Health System in Chicago. "Certainly there are different types of monitoring programs at the state and federal level, but it's clearly not enough because we see this crisis persist and grow."

The pressure to rein in the crisis, which claims about 91 American lives a day, builds as the death tolls—and related legal actions—mount. The lawsuits pursue different paths to curb opioid distribution—taking aim at distributors' and pharmacies' reporting practices and targeting manufacturers' marketing tactics.

From 2010 through 2015, the largest drug distributors sold more than 290 million opioids in Hamilton County alone, leading to an average of four overdoses a day in Cincinnati and totaling 174 heroin overdoses over six days in August 2016, according to a suit filed by Cincinnati authorities. A record 4,050 people died of drug overdoses in Ohio last year.

The cities of Cincinnati and Birmingham, Ala., are two of the latest municipalities that have filed lawsuits against AmerisourceBergen, Cardinal Health and McKesson Corp. for allegedly pushing through suspiciously large and frequent orders of opioids that they claim have fueled the epidemic. The Cherokee Nation filed a similar suit claiming that pharmacies like CVS Health habitually ignored red flags in questionable prescription orders that would require further investigation. They join a handful of other cities and counties, including several in Ohio and West Virginia, that lodged comparable complaints.

Cardinal Health said the lawsuits are misguided because the company does not manufacture the drugs or promote or prescribe prescription medications to the public and actively combats the diversion of opioids. While the U.S. Drug Enforcement Administration is working on a new monitoring guidance for suspicious prescriptions, there has been a lack of clarity about the reporting requirements under the Controlled Substances Act and how distributor responsibilities and expectations have shifted over time, some experts said.

"The role of pharmacies, PBMs, distributors and hospitals in how and when they alert the DEA isn't clearly defined," Schneider said.

South Carolina also recently sued drug manufacturer Purdue Pharma, which makes OxyContin and other opioids, claiming that Purdue misleads physicians and patients through allegedly deceptive marketing practices. The state alleged that the company created a public nuisance and violated unfair trade practices act by inflating the benefits of opioids and downplaying their addictive nature while discrediting the quality of newer drugs that deter abuse.

The DEA has tried to limit opioid distribution by curbing its quota system, which it sets to meet the medical, scientific, research, industrial, export and reserve demands. The agency institutes a quota system for controlled substances that was designed to limit the quantities of drug ingredients and eliminate diversion from "legitimate channels of trade." While the DEA has recently reduced its production quota of opioids by 25% or more last year, that isn't enough, public officials said. Consequently, that has made it difficult to source the drugs for those who truly need them and led to a surge in heroin use, critics said.

It was the first reduction of its kind in more than two decades, but DEA-approved opioid production volumes remain high—including a 55% increase in oxycodone levels in 2017 compared with 2007, according to a letter to the DEA signed by 16 senators.

Between 1993 and 2015, the DEA allowed production of oxycodone to increase 39-fold, along with drastic increases of other opioids, the letter said. The number of opioid prescriptions increased from 76 million in 1991 to more than 245 million prescriptions in 2014, resulting in a dramatic rise in overdoses.

"Further reductions, through the DEA's existing quota-setting authority, are necessary to rein in this epidemic," according to the senators, who also called for more transparency in the quota-setting process.

The Joint Commission released new pain assessment and management standards on Aug. 31 that will require hospitals to provide nondrug pain treatment options such as chiropractic therapy and give physicians and pharmacists access to Prescription Drug Monitoring Program databases. They must also better monitor high-risk patients who are prone to opioid addiction.

In 2010, Florida implemented legislation mandating that pain management clinics register with the state, adopt minimum safety standards including use of counterfeit-proof prescription pads and submit to annual inspections.

The changes came after a crackdown on wholesalers in the state that were supplying pill mills. Pharmacists in Florida now have to enroll in substance abuse and prevention classes when renewing their licenses, said Wayne Russell, vice president of pharmacy at Premier.

Specialized training also should be required for physicians prescribing drugs like fentanyl, experts say. The doctors would have to sign documents saying where they have completed the training and that they recognize the risks.

To further limit the spread of opioids, their uses should also be narrowed from the "open-ended" chronic long-term pain treatment to cancer and traumatic injuries, and the drugs should be administered in a controlled hospital setting, they said.

Until recently, pharmacists relied on their intuition and network of other pharmacists they would call if a suspicious prescription surfaced. Today, nearly all prescription pads are tamper-proof, if physicians haven't already transitioned to electronic prescribing. More Cincinnati doctors are using e-prescribing, said Hart, who lauded the trend. And more states are also using interstate communication systems that track the types of prescriptions and where they are filled.

The Ohio Automated Rx Reporting System is one of the statewide databases that collect real-time information on controlled substances sold to pharmacies, including when and where they are dispensed. The statewide databases feed into an interoperable communication system called PMP Interconnect that connects pharmacists throughout the country to track usage, prescribing and dispensing patterns. The prescription monitoring program, headed by the National Association of Boards of Pharmacy, was started in 2011 and is online in 42 states, with more in the queue.

Providers in 27 states have also integrated PMP Gateway into their EHR systems, bringing prescription-usage and -filling trends to their fingertips. It alerts physicians when a patient has received several opioid prescriptions over a short period of time, among other behaviors.

These types of systems are vital in curbing the number of counterfeit prescriptions, advocates argue. Some 33,000 illegal online pharmacies are operating at any given time, driven by attractive profit margins and fragmented regulations, according to the Alliance for Safe Online Pharmacies. A new push for ".pharmacy" domains has helped patients identify legitimate sources for online drugs, said Libby Baney, ASOP's executive director.

Arming providers, pharmacists and law enforcement with interoperable data is crucial and those throughout the industry should be encouraged or even compelled to buy in, Baney said.

"Policy and enforcement have not kept pace with the consolidation of the supply chain and distribution of medicines, particularly with online sales," she said. "We need to harmonize domestic and international regulations and increase transparency."

But the databases are not a panacea, critics warn, and much more needs to be done to improve coordination among regulators and those in the drug supply chain.

Under the recently implemented Drug Supply Chain Security Act, manufacturers will need to create individual serial numbers for every prescription, which ideally would help determine where the drugs came from and how they got to the patient.

"We will start to get a lot more visibility in not only the flow of these drugs but understand who held them and where they traveled along the supply chain, said Paul Cianciolo, who heads health systems development for TraceLink, a company that provides a digital track-and-trace network for the pharmaceutical supply chain.

Outside of litigation and adapting regulations that aim to pinch opioid diversion, there has been progress in the adoption of e-prescriptions, stepped-up efforts to inform physicians about better prescribing habits and alternative paid treatments, as well as an increase in the number of PBMs, pharmacies, providers and wholesalers that are restricting the volume of opioids they dole out. Yet, they have to strike a delicate balance between restricting the harmful drugs while still allowing access to those who need them.

Salt Lake City-based Intermountain Healthcare is looking to cut the number of opioids prescribed for acute pain across its entire system by 40% by the end of next year. PBMs and pharmacies are following suit with similar programs, but providers worry that restricting opioids could hinder patient care. In the Chicago area, DuPage Medical Group's physicians are exploring ways to limit post-operative pain through different types of treatment, said Michael Kasper, CEO of the largest independent physician group in Illinois.

But it will take some time for the pending lawsuits, new regulations and safer prescribing habits to catch up, pharmacist Hart said.

"It's probably going to get worse before it gets better," she said. "Fentanyl is killing the majority of the people here (in Cincinnati). Until we get less people on opioids and heroin and get them into treatment, the safe prescribing habits will need time to catch up. I see that as maybe 10 years down the line."

Hart also helps run two drug rehabilitation facilities that provide naloxone for addicts, one of which helps young families navigate recovery. "That is really difficult because the kids pay a high price," she said. "We need to do more."​