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Pharmaceutical Manufacturing and Packing Sourcer

Track Back

Over the last few years, prescription drug diversion and abuse has grown at an alarming rate, resulting in an increase in the number of deaths and hospitalisations. Opioid addiction and abuse has become one of the most serious healthcare crises in the US, with more than 23,000 people dying each year from prescription drug abuse - more than are killed in traffic incidents. Desperate addicts rob pharmacists at gunpoint, and homes of patients being treated for chronic pain are now being broken into for the specific purpose of stealing opioid drugs. There are even threats of bombing in order to secure certain opioid products.

According to the White House Office of National Drug Control Policy (ONDCP), prescription drug abuse is the nation's fastest-growing drug problem, and is categorised as a public health epidemic by the Centers for Disease Control and Prevention. Unfortunately, there is no sign of this slowing, with the number of frequent illicit pain medicine abusers currently estimated at approximately seven million people, and growing at a rate of at least 15 per cent per year. Additionally, six out of every ten high school seniors have misused prescription drugs. Last year, over 1.2 million people were treated at hospital emergency rooms for prescription drug overdose. 20 per cent of people (48 million) over the age of 12 have used prescription drugs for nonmedical purposes. Furthermore, legitimate pain patients are now being denied access to pain medications due to the fact that physicians are becoming more reluctant to prescribe opioids for fear of Drug Enforcement Administration sanctions. This growing epidemic requires attention on all levels, from government and drug manufacturers right down to law enforcement, pharmacists, physicians and patients.

Prescription drug abuse affects not just the patient, but also family members, as well as employers. The staggering costs of healthcare in the US are being exacerbated by treating prescription drug abuse patients; the average cost to treat a prescription drug abuser are nearly nine times more than a non-abuser.

There are several factors contributing to this rapid increase in drug diversion and abuse. The diverters have recognised 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 neighbouring 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-to-access sources of these medications. Attention deficit hyperactivity disorder drugs can be obtained quite easily, especially during exam periods on campuses of colleges and boarding schools.

Tackling the Issue

Current efforts to deal with the growing crisis of drug diversion and abuse include beefed up education programmes 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, which resulted in the disposal of over 120 tons of unused prescription drugs that could otherwise have been stolen, sold and/or abused.

Additionally, community organisations and schools have begun to develop educational programmes to make parents and children aware of the growing prevalence and risk of prescription drug abuse by teenagers. Over 40 US states have implemented Prescription Drug Monitoring Programs (PDMPs), whereby physicians who prescribe medications enter the data into a state-wide database. Theoretically, PDMPs will detect incidents of a behaviour 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. Another factor limiting the success of PDMPs is that entry of data by physicians in many states is voluntary. In those states that have mandated, there is limited monitoring of the physicians to ensure that data is inputted on a timely basis.

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 implemented. Each of the shareholders listed above has 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 ePedigree, which, if ever adopted, will realistically be years away from utilisation. In the meantime, it is important that we begin seriously considering effective ways to combat this issue without an ePedigree infrastructure.

Serialisation as a Tool

Despite the delay in ePedigree implementation, serialisation of medications, particularly for controlled substances - the most common target for diverters - can be a highly useful and practical end-to-end solution for identifying those involved with diversion and abuse. Serialisation 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 (such as blister packaging).The standard recommended by GS1 Healthcare is the 2D (otherwise known as Data Matrix) barcode, and also a human readable number, which is embedded in the 2D barcode. When the barcode is scanned at the point of dispensing, the technology links 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 unauthorised user, the serial number can be provided to personnel with proper authorisation, who can input the serial number by either a scan of the barcode 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 barcode 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 via SPPs are relatively higher than standard distribution companies, but the degree of control and transparency is much improved.

Society Benefits

For combating diversion, serialisation can provide benefits to all four 'Ps' of healthcare: physicians, payers, pharmacists and patients. For example, physicians have become increasingly concerned about the 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 (on each blister cell, for instance), patients can be instructed to periodically return to the physician's office to account for all medications taken. If each unit dose is serialised, substitution of 'borrowed' medications can be detected, given that the unit dose and primary package levels have both been serialised and aggregated (serial numbers on each level of packaging are digitally linked).This practice can serve as a deterrent to prevent patients from selling medications for which they can now be held accountable.

The benefits to payers - such as insurance companies or health maintenance organisations - for the type of programme described above can be substantial, given the cost of hospitalisation and treatment for prescription drug abuse. The increased cost for serialisation is a small fraction of the relative increase in the cost to private or public healthcare reimbursement organisations.

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 patients to store them with greater security; or, if their drugs are found to have been diverted, the patient will be able to identify possible suspects.

Pharmaceutical brand owners have now begun to recognise that physicians prefer to prescribe a medication that can be better controlled within the supply chain and has less risk of diversion. Furthermore, payers, recognising their costs in dealing 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 programme.

Another great beneficiary of the serialisation of controlled substances is law enforcement. Currently, if diverters are apprehended with large quantities of drugs, it is virtually impossible to identify their source. Drug diversion investigators can easily input the human readable serial numbers into a web portal, and are then 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, ePedigree-derived information could reveal where in the supply chain the product was diverted.

Conclusion

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. Serialisation 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.

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Steve Wood is President and CEO of Covectra, a Massachusetts based company with technology for combating prescription drug counterfeiting, diversion and abuse, using serialisation based track and trace technologies and package security features. He was awarded a BS from the US Naval Academy in Annapolis, MD, and served in the US Naval Submarine Service and Naval Intelligence for seven years. Steve received his MBA from the Yale University School of Management, and has acted as co-founder for a number of start-up companies. 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.
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