Drug Diversion: What Your Hospital or Pharmacy Can Do To Avoid Diversion Issues

Prescription drug diversion is defined as the  unlawful channeling of regulated pharmaceuticals from legal sources to the illicit marketplace (Suratt, Kurtz and Cicero, 2007).  The topic has been citied in many diverse publications from USA Today to trusted medical journals.  But is your hospital, pharmacy or clinic doing what is needed to control diversion?  A request by the University of Wisconsin under a Freedom of Information Act  uncovered that during 2000 through 2003 in 22 eastern states, there were a total of 12,894 theft/loss incidents reported to the DEA, involving some 28 million dosage units of controlled substances.  Almost 90% came from pharmacies.  Drug diversion is a $25 billion a year problem.

Here are six quick tips for pharmacy management.

• Background Check all employees with access to the pharmacy and license all personnel.

While you may completely trust your employees, you are not with your employees every day, every minute.  Employees with long lengths of service may have extenuating circumstances that lead to diversion – maybe recent financial issues, stress or even just unhappiness in their position.  Every employee that works in a pharmacy should have a background check prior to employment and the Human Resources department should conduct extensive background checks on all employees annually.  Any arrest and conviction of a felony, or misdemeanor drug charge should be the basis for termination.  Random 12 panel drug testing should also be part of both screening and ongoing employment.

Even if your state does not require all personnel working in the pharmacy to be licensed (refer to the State Board of Pharmacy for your state), all personnel should either be licensed or registered.  Pharmacists are required to be licensed.  Pharmacy technician are not required to be licensed in all states.  However, if you are in a state that does not require licensure, your technicians, at a minimum, should be required to pass the Pharmacy Technicians Certification Board exam (www.ptcb.org).  Other than pharmacists or licensed or registered pharmacy technicians, no other personnel (such as delivery personnel) should be allowed behind the pharmacy counter or in areas where drugs are stored.

• Secure all areas as much as possible.

With the technology available today, all access to pharmacies should be by biometric scanning (i.e. finger print or retina scanning).  Passwords, combination locks and card scanners are too easily passed on to employees or others not having a need to access the pharmacy area.  The worse yet are pharmacies that are still under “lock and key” entry methods.  It is relatively easy to make duplicates of door keys.  Keys are also a cumbersome method of entry with multiple entrances requiring numerous keys for entry by those who may or may not need pharmacy access.  Diversion can occur when management is not even able to enter the area without someone internally allowing entry due to a lock and key system.

In addition to the pharmacy, ensure that storage areas for all pharmaceuticals are well maintained with access to areas controlled through biometric scanning.  This should include areas such as Pyxis machines, Omnicells machines and drug storage areas.  Again, passwords should not be used for these machines; instead, nurses should be required to access these machines through biometric scanning.  Do not simply include areas that have actual pharmaceutical products.   Highly diverted products also include syringes, antiseptics and insulin test strips.

• Maintain operational cameras in sensitive areas.

Ensure that all areas where drugs are brought into your facility (loading docks, storage areas) have well positioned cameras.  Make sure that the area where drugs are taken out of wholesaler bins are under surveillance as well.  Omnicells and Pyxis machine areas, emergency room areas and operating room facilities should also be under camera surveillance.  Security personnel should have access to the cameras in these areas to make sure they are fully functional.  Surveillance tapes are critical when a reported diversion becomes known so that security personnel can check the tapes to see who had access to the area where the diversion occurred.

• Complete inventory management and controls should be in place.

It goes without saying that hospitals should have controls over inventory, including pharmaceutical products.  Every drug that comes into the facility should be immediately scanned and compared against purchase orders generated by the hospital’s wholesaler.  If items were purchased and not received, senior management in purchasing, operations, pharmacy and nursing should be immediately notified and resolution of the missing items should occur.  Visual inventories of all products on a random basis should occur by either pharmacy staff or security staff and compared against computerized inventory amounts.  Controlled drug inventories are required by the State Boards of Pharmacy.  However, today, controlled drugs are not the only drugs to worry about.  Antiretroviral (ARV) medications used for HIV/AIDs and many other high cost drugs, such as Sovaldi (cost of $1,000/tablet) are highly diverted.  Spikes in utilization/purchasing of any medication should be a “red flag” for diversion.  Hospitals can lose their ability to purchase through a wholesaler if the wholesaler believes your hospital system does not have adequate controls for the purchasing of controlled medications.

• Work with your Security Department/Security Department should work with you.

Most commonly, Directors of a hospital’s security program have some law enforcement background.  Ensure that at least one member of the Security Department is designated as a “Drug Diversion Officer (DDO).”  This security staff professional should have a rapport with the community to know current drug trafficking patterns and ensure that the source of drug trafficking is not your hospital, or if it, is there is a confidential informer who works with both your security department and law enforcement to detect and prevent further loss of inventory.  The DDO should also be responsible for random testing of Omnicell/Pyxis system inventory and perform checks and resolve any inconsistencies between what is visually in the Pyxis/Omnicell and what should be in the machine.  The DDO should also be called in to investigate all drug diversion reports and/or investigate and resolve all missing drugs within the enterprise, including reports of impaired staff.  Lastly, the DDO should work with pharmacy and other staff personnel to ensure that cameras and biometric scanners are working properly, areas are configured to minimize diversion opportunities (i.e. a storage areas/lockers for coats, purses and backpacks in the pharmacy are locked and away from drug storage areas).

• Work with your Compliance Department.

If drugs are diverted, notify the Compliance Officer immediately.  All hospitals and pharmacies are required to immediately complete a “Form 106” (http://www.deadiversion.usdoj.gov/21cfr_reports/theft/) upon the discovery of a significant loss of controlled drugs.  The pharmacist in charge should be aware of these procedures and should be able to assist with the compliance officer the completion of the Form 106.  In addition, your compliance department should assist in other areas with a potential for diversion such as misallocation of drugs for 340(b) pricing, should this situation apply to your hospital (i.e. you are a Disadvantage Share Hospital under Health Resource and Services Administration (www.hrsa.gov).

Pharmaceutical products are some of the most expensive purchases made by hospitals and can run into the hundreds of millions of dollars annually.  These valuable assets should be protected through a thorough review of hospital, pharmacy and clinic operating procedures and an audit of physical environmental protection devices.  In addition, staff suspect of drug diversion are not only a detriment to the financial health of the organization, but can be a danger to patients and other staff members.  A thorough drug diversion program will help keep the health of the hospital, both financial and physical health, in check.

References:

340(b) Pricing Updates, Health Resource and Services Administration, retrieved from www.hrsa.gov.

Inciardi, J.C., Surratt, H.L., Kurtz, S.P. and Cicero, T.J. (2007), Mechanisms of Prescription Drug Diversion Among Drug Involved and Club and Street Based Populations, Pain Medicine, 8:171-183.

Reports and Thefts, Drug Enforcement Administration, retrieved from http://www.deadiversion.usdoj.gov/21cfr_reports/theft/

Pharmacy Technician Certification Board, Continuing Education, retrieved from:  http://www.ptcb.org/renew/continuing-education

Susan Hayes has over 35 years’ experience in the health care and pharmacy benefit industries. She is a licensed pharmacy technician and is an Accredited Health Care Fraud Investigator.  She is a frequent lecturer on pharmacy topics and has been quoted in and authored numerous articles on pharmacy benefit programs. In June 2009, she testified to Congress on transparency issues in the pharmacy benefits industry. She has a Bachelor’s Degree in Criminal Justice from Northeastern Illinois University and is currently pursuing her Master’s Degree in Criminal Justice from Boston University, Metropolitan College.