Pharmaceutical & Medical Packaging News staff

Stakeholders should take action before electronic pedigree infrastructure emerges.

By Steve Wood
President and CEO, Covectra

Over the last few years, prescription drug diversion and abuse has grown at alarming rates, resulting in an increase in the number of deaths and hospitalizations. Opioid addiction and abuse has become one the nation’s most serious healthcare crises. More than 23,000 people die each year from prescription drug abuse—more than are killed in traffic incidents.

According to the White House Office of National Drug Control Policy (ONDCP), prescription drug abuse is the fastest-growing drug problem in the United States. It is categorized as a public health epidemic by the Centers for Disease Control and Prevention. Unfortunately, there is no sign of slowing with the number of frequent illicit pain medicine abusers currently estimated at approximately seven million people in the United States and growing at a rate of at least 15% per year.

Furthermore, legitimate pain patients are now being denied access to pain medications because physicians are becoming more reluctant to prescribe opioids out of fear of DEA sanctions. This growing epidemic requires attention on all levels, from government and the drug manufacturers, right down to law enforcement, pharmacists, physicians, and patients.

There are several factors contributing to this rapid increase in drug diversion and abuse. Diverters have recognized that more profit can be made in selling prescription drugs than with illicit drugs (like marijuana and cocaine). Secondly, prescription drugs are becoming increasingly available from neighboring countries such as Mexico and Canada and can be obtained for very low prices from the Internet. An increasing incidence of cargo theft has also boosted the sale of opioid products. Furthermore, medicine cabinets of family members or friends are relatively easy sources of these medications.

Current efforts to deal with the growing crisis of drug diversion and abuse include beefed up education programs for physicians who prescribe opioids and other controlled substances. Physicians are informed that some patients can become addicted to certain opioid medications after taking only four unit doses.

In order to reduce the availability of unused drugs in medicine cabinets, federal and state law enforcement agencies have implemented campaigns such as National Take-Back Day for disposing unused prescription drugs that could have been otherwise stolen and sold and/or abused. Community organizations and schools have also begun to develop educational programs to make parents and children aware of the growing prevalence and risk of prescription drug abuse by teenagers. And more than 40 states have implemented Prescription Drug Monitoring Programs (PDMPs), whereby physicians who prescribe medications enter the data into a statewide database. Theoretically, PDMP programs will detect incidents of a behavior called doctor shopping, where patients attempt to obtain prescriptions from multiple physicians for the same medication. Although PDMPs will detect some prescription drug abuse within one state, the monitoring stops at the state’s boundaries, because the data is not made accessible between states. And entry of data by physicians in many states is voluntary.

What else can be done? Given the number of stakeholders in our healthcare system—patients, payers, pharmacies, distributors, wholesalers, pharma manufacturers, hospitals, government agencies and law enforcement—this problem can only be solved by a partnership approach. Practical solutions must be developed, or they will never be adopted and implemented. All stakeholders have a responsibility to be open to the development and testing of technologies and methods that will stem this rising tide of prescription drug abuse.

Government agencies and healthcare industry associations are currently debating solutions such as electronic pedigree, which, if ever adopted, will realistically be years away. In the meantime, it is important that we begin seriously considering effective ways to combat this issue without an e-pedigree infrastructure.

SERIALIZATION AS A TOOL
Despite the delay in e-pedigree implementation, serialization of medications, particularly for controlled substances can be a highly useful and practical end-to-end solution for identifying those involved with diversion and abuse.

Serialization is the placement of a unique serial number on, ideally, all levels of packaging. At the point of packaging, the serial number is printed on the primary package, or in the case of some opioids on the unit-dose package (e.g., blister). The standard recommended by GS1 Healthcare is the 2-D bar code (otherwise known as Data Matrix), and also a human readable number, which is embedded in the 2-D bar code. When the bar code is scanned at the point of dispensing, there is now a technology to link the medication being dispensed to the patient receiving the drug. That information can be sent to and maintained in a database, which can then be referenced at a later date if the product is found on the street and suspected of being diverted. If this package is found in the hands of a possible unauthorized user, the serial number can be provided to personnel with proper authorization, who can input the serial number by either a scan of the bar code or entry of the human readable number into a web portal, and the patient to whom the product was dispensed will be identified. This patient identification must be protected in accordance with HIPAA and 42 CFR Part 2.

The supply chain for these medications can be made more transparent with the use of a Specialty Pharmacy Provider (SPP), which can be used to ship the medication directly to a clinic, physician’s office, or sometimes even directly to a patient. Package bar code scans and electronic signatures are obtained at each outgoing and incoming point, and these electronic signatures are input into the database. The costs for processing and shipping by SPPs are relatively higher than standard distribution companies, but the degree of control and transparency is much stronger.

For combating diversion, serialization can provide benefits to all “four P’s” of healthcare: physicians, payers, pharmacists, and patients. For example, physicians have become increasingly concerned about possible abuse of controlled medications that they are prescribing to patients. If each package is uniquely identified with a tracking number, particularly on the unit dose package (e.g., on each blister cell), patients can be instructed to periodically return to the physician’s office to account for all medications taken. If each unit dose is serialized, substitution of “borrowed” medications can be detected given that the unit dose and primary package levels have both been serialized and aggregated (digital linking of serial numbers on each level of packaging). This practice can serve as a deterrent to prevent patients from selling medications for which they can now be held accountable.

The payers’ (insurance companies, HMOs, etc.) benefit for the type of program described above can be substantial, given the cost of hospitalization and treatment for prescription drug abuse. The increased cost for serialization is a small fraction of the relative increase in the cost to private or public healthcare reimbursement organizations.

Patients who legally obtain controlled substances for treating their medical conditions are often victims of theft by family members, friends, or caregivers from their home medicine cabinets. Knowing that these drugs can be traced back to them will motivate the patients of record to store them with greater security; or, if one of these drugs is later found to be diverted, the patient will be able to identify possible suspects.

Pharmaceutical brand owners have now begun to recognize that physicians prefer to prescribe a medication that has better control over its supply chain and less risk of diversion. Further, payers, recognizing their costs to deal with victims of prescription drug abuse, have stated that they may grant a higher formulary position for a drug that is supported by an effective track-and-trace program.

Another great beneficiary of serialization of controlled substances is law enforcement. Currently, if diverters are apprehended with large quantities of drugs, it is virtually impossible to identify the source of these drugs. Drug diversion investigators can easily input the human readable serial numbers into a web portal and are be able to determine which pharmacy dispensed the product. Then, with a subpoena, information regarding the patient and prescribing physician can be obtained. If the package was stolen prior to arrival at a pharmacy, electronic-pedigree-derived information could reveal where in the supply chain the product was diverted.

Prescription drug diversion and abuse is a crisis that is affecting millions of people and their families, as well as causing great financial impact on the private and public sector. Serialization can provide traceability for the entire supply chain, even into the hands of the patients…or the diverters. A collaborative partnership of pharma companies, technology solution providers, and government agencies can stem the rapidly rising tide of prescription drug diversion and abuse.

Steve Wood is President and CEO of Covectra, a Massachusetts-based company with technology for combating prescription drug diversion and abuse, and counterfeiting, using serialization-based track & trace technologies and package security features.

Steve has acted as co-founder for a number of start-up companies in industries such as defense engineering, recording media, packaging machinery, and security technologies. He currently serves on the Boards of PharmoRx Therapeutics, an early-stage drug development company, and MedSentry, a developer of medical device technology for monitoring medication adherence. He can be reached at [email protected].