In a 1999 report, nurses were surveyed anonymously about drug abuse and 20% admitted to misusing at least one prescription drug. In another 1999 report, nurses were surveyed anonymously about drug abuse, and 20% admitted to misusing at least one prescription drug. Easy access was highly correlated with drug misuse. Nurses reported to use: opioids 60%, tranquilizers 40%, sedatives 11%, amphetamines 3. 5%, and inhalants 1. 9%. Of the top 17 abused prescriptions in 2013, 16 of the drugs (94%) are classified as Schedule II, III, or IV medications including Ritalin, Oxycodone, Ativan, Vicodin, and Percocet.
Many providers are victims of drug abuse and divert drugs to maintain their habit. At a facility in Tennessee, a physician was abusing narcotic pain relievers, up to 100 tablets a day of Percocet, Vicodin, etc. There were no complaints from patients or staff, even though the physician demonstrated behavioral changes including dressing poorly, rounding at abnormal hours and not handling administrative duties. The physician’s father intervened and got the physician help. Since then, the physician has returned to practice successfully while remaining drug free.
Mayo Clinic reported the following examples where drug diversion was discovered at their facilities: ? A procedural sedation nurse assigned to administer opioids and sedatives to patients during colonoscopy was found to have a secret pocket sewn inside her uniform top, into which she dropped syringes of the potent opioid fentanyl and substituted them with syringes containing saline solution. ? A radiology technician who was positive for hepatitis C diverted unused fentanyl syringes intended for administration to patients causing 5 patients to be infected with hepatitis C virus.
A night custodian, while rummaging through sharps waste containers, revealed that he had been withdrawing and consolidating the miniscule remaining fentanyl vials, which he later use to support his addiction. An instance where diversion of a non-narcotic for personal use was seen when a nurse was discovered to divert furosemide from the automatic dispensing cabinet (ADC) because she had an eating disorder and took furosemide to assist with weight loss. All diversion should be handled consistently regardless of drug type. The facility reported the nurse to the police and the state board of nursing for theft.
The action became a permanent part of the nurse’s professional record. Someone who diverts drugs usually target on oral or injectable, brand name medications with the highest street value. The top diverted drugs for economic gain include Humira, Enbrel, Remicade, Copaxone. These drugs were included in the top 10 drugs with US quarterly sales over $1 billion. On August 2012, at the University of Miami Sylvester Comprehensive Cancer Center, a pharmacy technician stole non-narcotic medications including Neulasta and Aloxi over a 3 year period.
The technician would steal 4 Neulasta doses at a time at a cost of $2600 per dose. While the pharmacy’s focus was primarily toward narcotics, the lack of monitoring high cost medications led to UM losing over $14 million due to theft. Other generic medications are highly valuable as well including ketamine, midazolam, oxycodone and hydrocodone. Effective October 6, 2014, the Drug Enforcement Administration (DEA) rescheduling of hydrocodone combination products from Schedule III to Schedule II goes into effect, which can lead to an increase of diversion due to the lack of refills.
Prior to the rule, hydrocodone combination products had the ability to be refilled 5 times in a 6 month period. The common thread between these cases is the lack of controls of prescription drugs within the high risk areas of a healthcare facility including pharmacy storage and administration by staff and disposal. These high risk areas should be the focus of implementation and maintenance of control of all prescription drugs. Any drug can be abused or economic gain therefore selective monitoring of by drug type will not be as effective.
There may be capital limitations that may inhibit electronic surveillance of all drugs but there should be random audits of purchases compared to drugs administered to identify if there are drugs being diverted. There should be policies and procedures for handling controlled substances established and updated regularly. Policies and procedures should include areas addressing – Ordering controlled substances for pharmacy or facility with DEA Form 222 and Controlled Substance Ordering System (CSOS), reconciliation of drugs from wholesaler, storage and auditing of drugs in automated controlled drug cabinets (i. . Pyxis, Accudose, Omnicell), and distributing drugs including controls throughout the facility (i. e. operating rooms, outpatient facilities, patient care areas). Compounding records and documentation of waste is also important. Perform ongoing surveillance through constant monitoring of the following reports: ADC activity, anesthesia flow, operating room (OR) waste, abnormal usage and transaction. This is a sample of reports that can give valuable information on users and usage of medications throughout the hospital.
Scheduled and random audits of these and other reports can allow administration to be identifying potential drug diversion on a more proactive manner. Below are suggestions to reduce the potential of drug diversion. Easy access was highly correlated with drug misuse. When drug diversion occurs in hospitals and other healthcare facilities, the costs may be attributed to Medicare and Medicaid spending due to the costs of treating inpatients as well as outpatients. Under Medicare Part A, inpatient drug services are provided to qualified patients.
Under Medicare Part B, outpatient drug services are covered. Once healthcare workers divert drugs provided by Federal/State health insurance programs, this also impacts the bottom line of the drug spend. There is another type of drug diversion that impacts the Medicare/Medicaid drug spend, drug diversion through the 340B program. In 1992, Section 340B of the Public Health Service Act (Federal Register 2010), requires drug manufacturers participating in the Medicaid Drug Rebate Program to sign an agreement with the Secretary of Health and Human Services.
This agreement limits the price manufacturers may charge certain covered entities for covered outpatient drugs. The resulting program is called the 340B Program. The program is administered by the Office of Pharmacy Affairs (OPA), a part of the federal Health Resources and Services Administration (HRSA)/Department of Health and Human Services (HHS). Qualifying covered entities are discounted up to 50% off the average wholesale price for their outpatient and over the counter drug spend.
Medicare Part B pays hospitals for outpatient drugs provided incident to physician services. Medicare Part D pays for 340B drugs that are covered under the program. In 2013, 340B spend by qualifying providers was $7. 1 billion. Medicaid pays for 340B outpatient drugs for their patients covered under the program. Under the 340B program, drug diversion is defined as a 340B drug provided to an individual who is not an eligible outpatient of that entity, and/or dispensed in an area of a larger facility that is not eligible (e. g. an inpatient service, a non-covered clinic).
Examples of drug diversion include: dispensing 340B drugs at ineligible sites, not monitoring and correcting inventory, dispensing 340B drugs written by ineligible providers and dispensing 340B drugs to non-eligible patients at a contract or onsite pharmacy . Currently, there are no statistics illustrating the cost of drug diversion within the program, however if we estimate 10% of the drugs dispensed was diverted, that would yield a waste of 7. 1 million dollars annually. The 340B program provides the discounted drug program to covered entities.
Covered entities are defined by HRSA include federally qualified health center lookalike programs; certain disproportionate share hospitals and critical access hospitals owned by, or under contract with, State or local governments; and several categories of facilities or programs funded by Federal grant dollars, including federally qualified health centers, AIDS drug assistance programs, hemophilia treatment centers, STD and TB grant recipients, and family planning clinics. Eligible patients under the program include patients who receive health care services other than drugs from the 340B covered entity.
The only exception is patients of State-operated or –funded AIDS drug purchasing assistance programs. Currently, the 340B program is administered and monitored through HRSA. In 2012, HRSA performed 51 risk based audits that included 450 outpatient facilities and 400 contract pharmacies. Of these 51 audits, 45 were risk-based and 6 were targeted. In 2013, HRSA last announced that 94 audits were underway, which included 700 outpatient facilities and 1930 contract pharmacies. During these audits drug diversion, duplicate discounts and ineligible sites/providers were the common areas of noncompliance.
A duplicate discount occurs when a drug purchased with a 340B discount is also subject to a state Medicaid rebate. Examples of duplicate discounts include: billing Medicaid contrary to HRSA Medicaid exclusion file listing, 340B drugs used for Medicaid patients at contract pharmacy with no arrangement to prevent duplicate discounts, Medicaid claims incorrectly coded when provided to the state, incorrect Medicaid or NPI in HRSA Medicaid exclusion file and outpatient sites incorrectly listed on HRSA Medicaid exclusion file.
The number of covered entity sites enrolled in the 340B program has doubled from 8,605 in 2001 to 16,572 in 2011. From 2005-2011, the number of hospitals participating nearly tripled, from 591 to 1,673, and the number of hospital sites (almost quadrupled, from 1,233 to 4,426. In October 2014, there were a total of 28,306 340B registered sites with 14,236 non-hospital sites with over $7. 5 billion in 340B purchases . With these current sites and more sites qualifying annually, HRSA has the challenge in enforcing 340B compliance.
Noncompliance to 340B program impacts the bottom line of the Medicaid patients because the more diversion that occurs, drug manufacturers increase their prices to both public and private insurers leading to an increase in rates and charges to patients. If HRSA was able to enforce 340B regulations and audit all hospitals on a continuous basis, there would be fewer cases surrounding duplicate discounting, drug diversion and ineligible site/providers. Manufacturers also can audit the covered entities to ensure that they are not engaging in drug diversion or duplicate discounting.
If informal negotiations fail, a manufacturer may seek OPA permission to conduct an audit, OPA response to request (within 15 days), and Manufacturer provides Covered Entity with notice of Audit. A Chicago hospital was selected by pharmaceutical company Lilly to undergo a 340B audit where they found 340B drugs valued over $750,000 to be diverted to inpatients erroneously. The hospital and Lilly settled for $175,000 in repayment, however this open the door for other manufacturers to conduct audits on this same hospital to recoup 340B funds that were diverted during this same time.
This was a financial strain to the hospital because the funds recovered are not eligible for insurance so the funds must be paid through its cash reserves usually within 60 days of settlement. With these types of drug diversion through abuse, resale, recreation or the 340B program, the Federal/State health insurance programs are heavily financially impacted. There are measures to reduce drug diversion by patients and practitioners which will reduce the financial loss.
