Alberto Coustasse, DrPH, MD, MBA, MPH

The FDA approved gabapentin in 1993 as a non-controlled substance and it has remained a non-controlled substance at the federal level.

The drug was created as an anticonvulsant and used to treat seizure disorders. The medication has also been used to treat hot flashes, neuropathic pain, pain, postoperative nausea, substance abuse issues, and vomiting.

It is estimated that approximately 1% of people in the United States misuse gabapentin.1 This fact has compelled certain states to generate legislative initiatives designed to monitor the use and/or reclassify gabapentin 3 In 2019, US pharmacies dispensed 69 million prescriptions for gabapentin.

Although gabapentin is not considered a controlled substance by the federal government, it does have a potential for abuse. As of September 2022, gabapentin was classified as a controlled substance in Alabama, Kentucky, Michigan, North Dakota, Tennessee, Virginia, and West Virginia.

 Adding gabapentin to the list of controlled substances has required providers to have a Drug Enforcement Administrationregistration number to prescribe it, adding another layer of restriction for its prescription and allowing for additional medication monitoring.

Gabapentin has known abuse potential and has been reported as an agent highly pursued for use in potentiating opioids. In an examination of opioid and gabapentin co-abuse, approximately 24% of patients with prescriptions for both gabapentin and opioids had at least 3 prescription claims surpassing specified dosage thresholds compared with the 3% and 8% of patients prescribed gabapentin or opioids alone, respectively.

 This co-abuse is of particular concern, as abuse of gabapentin in concert with opioids has been associated with a 4-fold raised risk of respiratory depression,

 which is the primary cause of death in opioid-related overdoses.

It has been suggested that gabapentin at doses exceeding 900 mg may lead to as much as a 60% augmentation in the likelihood of opioid-related death, comparable to misuse of opioids alone.

Gabapentin grew to 64 million prescriptions in the United States in 2016 from 39 million prescriptions in 2012,

 making it the 10th most prescribed medication that year.

 Gabapentin has been widely recognized as a drug related to opioid abuse in West Virginia.

 Studies have shown that gabapentin in toxicology reports constituted a considerable number of drug overdose deaths around the country, with West Virginia among the highest.

 The significant increase in gabapentin dispenses is thought to have been the result of efforts to reduce the abuse of Schedule II drugs, such as hydrocodone and oxycodone.

By 2017, West Virginia had taken notice of gabapentin misuse across the state. The Prescription Drug Monitoring Program (PDMP) is a database of controlled substance prescriptions maintained by each state that allows providers access to information on patient abuse behaviors for a quick and targeted response.

 West Virginia’s PDMP, called the West Virginia Controlled Substances Monitoring Program (WV CSMP), is supported by the West Virginia Board of Pharmacy and collects dispensing data for all Schedule II, III, IV, and V drugs. Although data regarding dispensing of gabapentin is not required to be maintained, the WV CSMP recognized the potential for this drug to be abused and started collecting data as of July 2017.

 The West Virginia Legislature also began reviewing issues with the significant increase in gabapentin prescriptions throughout the state and, by May 2018, took action to list it as a Schedule V drug.

Preliminary data from the WV CSMP showed a decline in the number of dispenses of gabapentin since these changes were implemented, with 73.8 million dispenses in 2021, down from 79 million in 2019.

 The decreases appeared across the state when examined by county, with some counties experiencing decreases of more than 30%. The reasons for this decrease are multifactorial and include a general increase in awareness of the addictive potential of gabapentin, limits on the length of time prescriptions are valid, and requirements to check the WV CSMP before prescribing. The most significant decrease in the dispensing of gabapentin occurred between 2018 and 2019, after the reclassification to Schedule V and the Opioid Reduction Act went into effect.

One study noted an increase in overdose deaths involving gabapentin as recorded in the State Unintentional Drug Overdose Reporting System, which tracks drug overdoses in 23 states, including West Virginia.

 The investigators did not, however, break down the data at the state level. Thus, while it is probable that there was an increase in overall gabapentin-related deaths, the trend in West Virginia alone appears to bemore positive.

The effectiveness of different strategies, such as policies regarding opioid abuse that regulate access to controlled drugs or the education of patients and prescribers and patients on the addictiveness of gabapentin or restricting supply, is still in question in West Virginia. Further analysis is needed to determine what methods and strategies in West Virginia and across the United States successfully reduce the rate of gabapentin misuse.

1. Pauly N, Delcher C, Slavova S, Lindahl E, Talbert J, Freeman P. Trends in gabapentin prescribing in a commercially insured U.S. adult population, 2009-2016. J Manag Care Spec Pharm. 2020;26(3):246-252. doi:10.18553/jmcp.2020.26.3.246

2. Anton RF, Latham P, Voronin K, et al. Efficacy of gabapentin for the treatment of alcohol use disorder in patients with alcohol withdrawal symptoms: a randomized clinical rial. JAMA Int Med. 2020;180(5):728-736. doi:10.1001/jamainternmed.2020.0249

3. Peckham AM, Ananickal MJ, Sclar DA. Gabapentin use, abuse, and the US opioid epidemic: the case for reclassification as a controlled substance and the need for pharmacovigilance. Risk Manag Healthc Policy. 2018;11:109-116. doi:10.2147/rmhp.S168504

4. Mattson CL, Chowdhury F, Gilson TP. Notes from the field: trends in gabapentin detection and involvement in drug overdose deaths — 23 states and the District of Columbia, 2019–2020. MMWR Morb Mortal Wkly Rep. 2022;71(190):664-666. doi:10.15585/mmwr.mm7119a3

5. Smith RV, Havens JR, Walsh SL. Gabapentin misuse, abuse and diversion: a systematic review. Addiction. 2016;111(7):1160-1174. doi:10.1111/add.13324

6. Collins S. More states make gabapentin a Schedule V controlled substance. Pharmacy Today. 2021;27(10):1. doi:10.1016/j.ptdy.2021.09.016

7. Karavolis ZA, Su AB, Peckham AM. State-level response to gabapentin misuse in the United States: implications and future direction. Am J Health Syst Pharm. 2022;79(9):e143-e148. doi:10.1093/ajhp/zxab486

8. Snoderly J. New laws on opioids and gabapentin go into effect. The Exponent Telegram. June 7, 2018. Accessed October 19, 2022. https://www.wvnews.com/theet/news/new-laws-on-opioids-and-gabapentin-go-into-effect/article_b9013859-8871-50e9-a460-2b69f3c4b73a.html

9. Peckham AM, Fairman KA, Sclar DA. All-cause and drug-related medical events associated with overuse of gabapentin and/or opioid medications: a retrospective cohort analysis of a commercially insured US population. Drug Saf. 2018;41(2):213-228. doi:10.1007/s40264-017-0595-1

10. Opioid overdose. World Health Organization. Updated August 4, 2021. Accessed September 9, 2022. https://www.who.int/news-room/fact-sheets/detail/opioid-overdose


11. Gomes T Juurlink DN, Antoniou T, Mamdani MM, Paterson JM, van den Brink W. Gabapentin, opioids, and the risk of opioid-related death: a population-based nested case-control study. PLoS Med. 2017;14(10):e1002396. doi:10.1371/jounral.pmed.1002396

12. Kuehn BM. Gabapentin increasingly implicated in overdose deaths. JAMA. 2022;327(24):2387-2387. doi:10.1001/jama.2022.10100

13. Delcher C, Pauly N, Moyo P. Advances in prescription drug monitoring program research: a literature synthesis (June 2018 to December 2019). Curr Opin Psychiatry. 2020;33(4):326-333. doi:10.1097/yco.0000000000000608

14. Slavova S, Miller A, Bunn TL, et al. Prevalence of gabapentin in drug overdose postmortem toxicology testing results. Drug and Alcohol Depend. 2018;186:80-85. doi:10.1016/j.drugalcdep.2018.01.018

15. Reynolds K, Kaufman R, Korenoski A, Fennimore L, Shulman J, Lynch M. Trends in gabapentin and baclofen exposures reported to U.S. poison centers. Clin Toxic (Phila). 2020;58(7):763-772. doi:10.1080/15563650.2019.1687902

16. Watson CJ, Ganetsky M, Burke RC, Dizitzer Y, Leventhal EL, Boyle KL. Impact of a mandatory prescription drug monitoring program check on emergency department opioid prescribing rates. J Med Toxic. 2021;17(3):265-270. doi:10.1007/s13181-021-00837-4

17. 2017 Controlled Substances Monitoring Program Annual Report. West Virginia Board of Pharmacy. 2017. Accessed September 19, 2022. https://www.wvbop.com/about/annualreports.asp

18. West Virginia Controlled Substance Monitoring Program Data Dashboard 2014 to 2021. West Virginian Board of Pharmacy. 2022. Accessed September 19, 2022. https://www.arcgis.com/apps/dashboards/4b314711d252496d941048cd4867ab85

Articles

Although the anticonvulsant is not considered a controlled substance, some state legislation focuses on monitoring the use of or reclassifying it.

Gabapentin Presents High Potential for Misuse

Under the Federal 340B Program, hospitals and eligible health care clinics that serve low-income or rural populations can qualify for federally negotiated manufacturer discounts on purchases of prescription drugs.

Approximately 50,000 entities participate in the 340B program, where pharmaceutical manufacturers are instructed to supply outpatient medications to participating providers at discounted rates of 20% to 50%.

 Participating hospitals depend on profits from the differential between their reimbursement for these drugs and the discounted rates they disburse to finance affordable patient care in underserved communities.

On June 15, 2022, the US Supreme Court ruled that major cuts to 340B payments were unlawful, an important victory for participating hospitals. But this win may be transitory, as the Supreme Court also gave the US Department of Health and Human Services (HHS) clear instructions on achieving its cost-cutting goals.

The Medicare statute lays out 2 options for HHS to calculate reimbursement rates.

 Under the first option, HHS may survey hospitals to determine drug acquisition costs, with reimbursement rates set at the average acquisition cost. HHS may then vary the average acquisition cost by hospital group, as indicated by survey data. Under the second option, HHS may survey drug manufacturers to determine their average sales price (ASP).

 Importantly, this second option does not explicitly give HHS the authority to vary the ASP by hospital group, though HHS has been given authority to adjust the ASP up or down as necessary to achieve statutory purposes.

From the statute’s passage until 2018, HHS exclusively used the second option, setting reimbursement rates at 106% of the ASP for all hospitals.5 Because 340B hospitals purchase drugs at a discount to the ASP, these hospitals received a payment that non-340B hospitals could not obtain. They achieved the same reimbursement rate as non-340B hospitals while enjoying significant cost savings. In 2018, HHS determined that because it had the authority to adjust drug reimbursement rates under the second option, it could vary reimbursement rates between 340B hospitals and non-340B hospitals as a cost savings measure. HHS argued that it had this authority even if it did not conduct the hospital survey as provided under the first option.

HHS determined that 340B hospitals would be reimbursed only 77.5% of the ASP, rather than the 106% non-340B hospitals received. This adjustment represented a $1.6 billion annual cut to 340B hospital reimbursements.

When the Supreme Court unanimously ruled that HHS incorrectly calculated the reimbursement rates, it was on the basis that HHS did not follow the correct procedure. Under the statute, if HHS surveys only drug manufacturers, it is free to adjust the reimbursement rates up or down, but it may not set different reimbursement rates for distinct groups of hospitals. HHS can vary reimbursement rates among hospital groups only if it surveys hospitals to determine the average acquisition cost.

The Supreme Court expressly endorsed HHS paying reduced reimbursements to 340B hospitals as long as HHS surveys hospitals for drug acquisition cost information.

 Consequently, 340B hospitals are not guaranteed to receive the drug reimbursement windfalls moving forward. Indeed, before the case was decided, HHS began surveying hospitals for drug acquisition costs.

 Although the survey was not complete, the calculation of 2020 reimbursement rates, reimbursements for 2021, 2022, and 2023 could be determined from the survey data.

More legal battles around the 340B Program are likely. Because the statute imposed specific requirements on HHS in conducting the hospital surveys,

 further litigation may be required to fully establish whether the 2020 survey sufficiently supports the differing reimbursement rates for 340B hospitals. The HHS Office of Inspector General is investigating several pharmaceutical companies for restricting contract pharmacies’ access to 340B drugs.

 The result of the investigations could be fines against these pharmaceutical companies, which will undoubtedly instigate lawsuits from drugmakers. The program’s lack of reporting requirements and transparency will continue to create additional concern and scrutiny. Details regarding the amounts being paid and saved and how those savings are used are required to determine whether the legislation’s 340B program goals are met.

Hospitals participating in the 340B program should be aware of the uncertainty in Medicare reimbursement when consid-ering funding. HHS has prioritized cost savings. However, the Supreme Court noted that the 340B drug reimbursement windfall offsets costs hospitals incur providing care to disadvantaged communities,

 including rural populations, as well as uninsured and underinsured patients.

One item to observe closely is the 2023 Outpatient Prospective Payment System proposed rule released by the Centers for Medicare & Medicaid Services (CMS).

 For 2023, CMS proposed a payment rate of ASP minus 22.5% for drugs and biologicals obtained through the 340B program.

 Therefore, the CMS payment plan in this proposed rule could shed some light on its approach, not only on future payments but also on remedying past underpayments.

1. American Hospital Association et al v. Becerra, secretary of Health and Human Services, et al. Supreme Court. October 2021. Accessed October 3, 2022. https://www.supremecourt.gov/opinions/21pdf/20-1114_09m1.pdf

2. Mulligan, K. The 340B drug pricing program: background, ongoing chal-lenges, and recent developments. USC Schaeffer Center for Health Policy & Economics. October 14, 2021. Accessed August 3, 2022. https://healthpolicy.usc.edu/research/the-340b-drug-pricing-program-background-ongoing-chal-lenges-and-recent-developments/

6. Medicare program: hospital outpatient prospective payment and ambulatory surgical center payment systems and quality reporting programs; final rule. Fed Regist. 2020;85(29):85866.

7. Health industry alert: Supreme Court upends Medicare 340B drug payment policy. Akin Gump Strauss Hauer & Feld LLP. June 22, 2022. Accessed July 29, 2022. https://www.akingump.com/a/web/uwpR8CtLJmX-5cqRZQkd8D6/452zq8/health-industry-alert.pdf

8. King R. HRSA Intends to fine 6 drugmakers over 340B contract pharmacy violations. Fierce Healthcare. September 23, 2021. Accessed August 15, 2022. https://www.fiercehealthcare.com/hospitals/hrsa-intends-to-fine-six-drug-makers-over-340b-contract-pharmacy-violations

10. CMS-1772-P. Hospital outpatient prospective payment- notice of proposed rulemaking with comment period (NPRM).Centers for Medicare & Medicaid Services. Accessed August 15, 2022. https://www.cms.gov/medicaremedicare-fee-service-paymenthos-pitaloutpatientppshospital-outpatient-regulations-and-notices/cms-1772-p

11. CY 2023 Medicare hospital outpatient prospective payment system and ambulatory surgical center payment system proposed rule (CMS 1772-P). Centers for Medicare & Medicaid Services. July 15, 2022. Accessed August 15, 2022 from https://www.cms.gov/newsroom/fact-sheets/cy-2023-medi-care-hospital-outpatient-prospective-payment-system-and-ambulatory-surgical-center.

 is an assistant professor of legal environment in the Department of Accountancy and Legal Environment at the Lewis College of Business at Marshall University College of Business in Charleston, West Virginia.

 is an associate professor of accounting at Brad D. Smith Schools of Business at Marshall University.

is a professor of health care management and administration at Marshall University Lewis College of Business.

Decision on payment reductions looks fleeting as ruling also provides HHS with instructions on cost-cutting goals.

Is the 340B Hospitals Battle at the Supreme Court Over?

The US health care system has encountered long-standing, complex challenges, including growing costs, overuse of care, staffing shortages, and supply chain weaknesses.

COVID-19 revived these pressures, transforming the health care landscape. Medication and staffing shortages plague hospital systems, and pharmacies are not exempt. Most health systems have experienced high levels of pharmacy technician turnover, with most reporting a minimum turnover rate of 21% last year.

 In addition, medication shortages of critical medications and infusions create significant work-flow barriers that hospitals must address to ensure patient safety.

 In the face of these obstacles, health systems are turning to 503B compounding facilities to outsource pharmacy needs.

Before 2013, hospitals and surgical centers either compounded medications in house or depended on 503A pharmacies for compounded medications. However, to improve quality after high profile cases of infections from outsourced compounded products were reported, the Drug Quality and Security Act (DQSA) created FDA-registered 503B outsourcing facilities.

 Since 2013, 503B outsourcing facilities have produced and provided compounded sterile preparations in large quantities under DQSA. Registered 503B outsourcers must comply with federal and state guidelines, meet strict good manufacturing process standards, and be routinely inspected by the FDA.

However, pharmacy leaders are skeptical of this change in process and must do due diligence when selecting a 503B pharmacy before moving into an outsourcing relationship. A multidisciplinary team should undertake a standardized 503B vendor evaluation process to give administrative and clinical perspectives equal weight and minimize risk.

 The evaluation should include not only ensuring appropriate licensing and regulatory requirements but also asking probing questions regarding best practices, compliance, and quality assurance.

The first step in evaluating a potential 503B vendor is ensuring that it meets regulatory requirements. In October 2021, the FDA released updated draft guidance for 503B pharmacies recommending that health systems use FDA-registered 503B facilities.

 Although this recent guidance is only a recommendation, it ensures that health systems meet the requirements for minimizing the risk of contamination and risks associated with low compounding conditions. Because the FDA inspects registered facilities and other regulatory bodies, pharmacists can feel confident in the products they are receiving. The state board may require additional registration of boards of pharmacy (BoP). However, pharmacy leaders should double-check with their state BoP as found through the National Association of Boards of Pharmacy.

Before conducting the vendor interview, however, the multidisciplinary team should review all FDA inspection documents for the 503B facility and pay particular attention if an FDA Form 483 has been filed, as this indicates substandard conditions were found during inspection.

 Although an FDA Form 483 may not preclude a 503B vendor entirely, it does warrant consideration and may drive additional questions for the vendor. Other documents include audit documents, clean room certifications, and compounding and training records.

Within the compliance domain, questions revolve around shifting compounding regulations. If pharmacy leaders are screening vendors to ensure that they are considering only those that are FDA registered, this will alleviate considerable concerns within this domain. Questions may include how microorganisms and particles are monitored, what primary engineering controls are used, whether the environment is monitored, who the supplier or vendor of materials is, and how they are qualified.

Within the domain of quality assurance, the goal is to ensure that a 503B vendor is consistently producing high-quality compounds. A review of the local BoP may provide additional information on the status of the vendor facility and on disciplinary actions that have been taken.

Questions may include what the compounding process is, how employees are trained, what studies are performed to test the products, and what the quarantining process is.

The final domain for consideration is best practices. Although 503B vendors are relatively new to the health care world, the importance of authority, honesty, and transparency within the quality assurance department remains unchanged.

 Critical questions for this domain include what the authority and role of the quality assurance department are, what the process is for reporting adverse effects to patients, and whether the quality assurance department can reject or release the product.

Although evaluating a potential 503B vendor may seem daunting, the risks of entering a vendor agreement without a thorough review are far direr. Clinicians remain liable for the compounds and their prepa ration even if that service is outsourced.

 The focus on cost-effective care and patient safety has never been more monitored. A thorough evaluation of all potential 503B vendors is the best insurance against liability and the simplest way to ensure patient safety. COVID-19 will continue to affect the health care landscape for years. Outsourcing facilities can play a critical role in the hospital supply of ready-to-use sterile drug products.

1. Hospitals and health systems are experiencing severe shortage of pharmacy technicians. News release. American Society of Health-System Pharmacists. March 15, 2022. Accessed October 19, 2022. https://www.ashp.org/news/2022/03/15/hospi-tals-and%20health-systems-experiencing-severe-shortage-of%20pharmacy-technicians?loginreturnUrl=SSOCheckOnly

2. Narayanaswamy S, Gurz P, Niven K, Crozier L. Fluid shortages: current challenges in accessing a staple supply. Premier, Inc. April 18, 2022. Accessed October 19, 2022. https://premierinc.com/newsroom/blog/fluid-shortages-current-challenges-in-accessing-a-staple-supply

3. Information for outsourcing facilities. FDA. Updated March 29, 2022. Accessed October 19, 2022. https://www.fda.gov/drugs/human-drug-compounding/information-outsourcing-facilities 

4. Diorio L, Thomas D. Due diligence drives 503b vendor selection. Pharmacy Purchasing & Products. June 2022. Accessed October 18, 2022. https://www.pppmag.com/article/2935

5. Is your 503B outsourcing facility up to par? 17 vital questions for ASCs. Becker’s ASC Review. Accessed October 19, 2022. https://leiters.com/wp-content/uploads/2020/12/Is-your-503B-outsourcing-facility-up-to-par_Beckers-ASC-Leiters-March-2018.pdf

6. Hospital and health system compounding under section 503A of the Federal Food, Drug, And Cosmetic Act Guidance for Industry. FDA. October 6, 2021. Accessed October 19, 2022. https://www.fda.gov/regulatory-infor-mation/search-fda-guidance-documents/hospital-and-health-system-com-pounding-under-section-503a-federal-food-drug-and-cosmetic-act 

7. Jones S. Current good manufacturing practice (cGMP) in 503B outsourcing facilities: essentials of drug quality and patient safety. April 6, 2021. Accessed October 19, 2022. https://www.fagronsterile.com/newsroom/cgmp-503b-outsourcing

, is a clinical quality coordinator at Thomas Health System in Charleston, West Virginia.

, is a clinical associate professor, director of residencies, and the director of the Center for Pharmacy at Marshall University School of Pharmacy in Huntington, West Virginia.

 is a professor of health care management and administration at Marshall University Lewis College of Business in Huntington, West Virginia.

Complete due diligence before selecting a compounding pharmacy and establishing an outsourcing relationship.

Evaluate 503B Facilities for Outsourced Compounds

Radio frequency identification (RFID) is a technology that uses tags and readers to identify and collect asset information. In  pharmacies, this usually means RFID is used for high-cost equipment or pharmaceuticals. RFID applications have been in use for many years but recently gained traction in health systems. RFID is becoming particularly effective in drug inventory and automation applications, such as medication carousels and pick to-light systems.

Traditionally, the most popular use in pharmacy has been in code tray and box management applications.

 Between 2004 and 2009, RFID technology was actively pursued by pharmaceutical companies and wholesale distributors, which envisioned streamlining the inventory management process in their vast warehouses. However, costs and technical difficulties swung the pharmaceutical industry globally to deploying 2D barcodes for serializing products and tracking them through the supply chain. Passage of the Drug Supply Chain Security Act (DSCSA) in the United States in 2013 and the Falsified Medicines Directive in the European Union in 2011 locked in the path chosen by the industry.

The mention of the DSCSA highlights a critical element of this RFID movement: The technology can supply the same or even better anticounterfeiting and supply chain visibility that 2D barcode system delivers, including all data the law mandates. Technically, the FDA has required the use of 2D barcodes and human-readable product identification on packages so, at best, RFID would duplicate but not substitute the 2D barcodes.

RFID has many advantages over linear 2D barcoding. For example, a barcode on a medication bottle includes a stock-keeping unit that represents the National Drug Code and may contain other information, such as the expiration date, lot number, and package size. However, it does not change without being substituted with a new packet or sticker, needing a direct line of eyesight and human manipulation. The 2D barcode is limited in the number of characters it can maintain and can be difficult to read depending on the condition of the barcode. Furthermore, the 2D barcode is easily counterfeited, whereas an RFID tag is nearly unattainable to counterfeiting.

RFID uses radio waves for data collection and transfer and is considered a next-generation innovation for automatic data collection and asset tracking. It can capture data automatically and efficiently without human intervention. RFID technology sales for supply chain applications recorded $1.43 billion in 2019 and have continued to grow.

 Although the cost of the application is greater than barcode technology, there are many operational gains justifying the cost, including improved privacy, safety, and security.

Including RFID in pharmacy promotes inventory management and improves picking accuracy, identification, and safety. These systems enable real-time data use, which leads to the prevention of inventory loss and theft. In addition, integrating RFID-enabled systems with wholesalers and other inventory systems facilitates better inventory management, resulting in less overstock and improved operational efficiency.

With the rapid development of science and technology in health care, the market for high-value medical consumables also continues to advance. As consumables are more widely used, health systems can provide a higher level of care. In pharmacy, because of the high price and variety of high-value medications (often specialty drugs), it is critical to carry out efficient and traceable control of these products’ procurement, storage, allocation, user registration, and waste disposal. RFID systems enable visual information management of the whole process and allow a real-time 2-way traceability closed-loop management to secure the quality and safety of consumables. As a result, the RFID system recognizes the best information management of the whole process of high-value consumables application, approval, procurement, acceptance, warehousing, inventory management, and warehousing use. At the same time, it can instantly identify consumable information and carry out batch warehousing operations, which is convenient and fast, effectively reducing clinical workload and improving efficiency.

RFID technology is being used in prefilled syringes in acute and critical care settings. These ready-to-administer syringes can be combined with passive ultra high-frequency RFID tags, reader stations, and cloud-based registry to help clinics and hospitals automatically and individually identify each unique product.

 This has major safety implications, as the product can be identified, product quantity adjusted, and reordered without scanning the product.

As the use of RFID expands, these prod-ucts can be used to prevent missing medications in tube systems, improve materials management and the process of tracking of patients, and be embedded into labels and with pick-to-light technologies with RFID to enhance safety. Pharmacies play a crucial role in achieving an RFID-integrated health system to optimize patient outcomes, safety, and value in managing assets and inventory. Therefore, pharmacy managers should continue educating the pharmacy team and other professionals about the potential of RFID and support manufacturers and vendors to continue financing enhancements to improve operations and patient care using less manual information and more self-dependent workflows.

1. Focus on radio frequency identification technology. American Society of Health-System Pharmacists Foundation. Accessed September 11, 2022. https://www.ashpfoundation.org/research/technology-innovations

2. Basta N. RFID on the rise again in pharma. Pharmaceutical Commerce. June 17, 2021. Accessed September 8, 2022. https://www.pharmaceuticalcom-merce.com/view/rfid-on-the-rise-again-in-pharma

3. Product identifiers under the Drug Supply Chain Security Act: questions and answers. FDA. June 2021. Accessed September 11, 2022. https://www.fda.gov/media/116304/download

4. Falsified medicines. European Commission. Accessed September 11, 2022. https://health.ec.europa.eu/medicinal-products/falsified-medicines_en

5. Coustasse A, Kimble CA, Stanton RB, Naylor M. Could the phar-maceutical industry benefit from full-scale adoption of radio-frequency identification (RFID) technology with new regulations? Perspect Health Inf Manag. 2016;13(Fall):1b.

6. RFID in healthcare market size - global industry, share, analysis, trends and forecast 2022 - 2030. Acumen Research and Consulting. September 2022. Accessed October 12, 2022. https://www.acumenresearchandconsulting.com/radio-frequency-identification-rfid-in-healthcare-market

7. Seckman C, Bauer A, Moser T, Paaske S. The benefits and barriers to RFID technology in healthcare. Healthcare Information and Management Systems Society. June 26, 2017. September 11, 2022. https://www.himss.org/resources/benefits-and-barriers-rfid-technology-healthcare

8. Cheng J, Wen C, Jiang S, et al. Construction and application of SPD automated management module for interventional high-value consumables based on RFID sensors. J Sensors. 2022. doi:10.1155/2022/2184694

9. The value of RFID-enabled medications. Fresenius Kabi. April 4, 2022. Accessed September 8, 2022. https://www.healthcareitnews.com/news/value-rfid-enabled-medications

10. Genixus introduces new propofol RTA syringe. OR Today.August 12, 2022. Accessed September 8, 2022. https://ortoday.com/genixus-introduces-new-propofol-rta-syringe/

Technology gains traction in health-system pharmacies for drug inventory and to automate applications.

Radio Frequency Identification Enhances Patient Safety

With the Affordable Care Act in 2010 came interoperability and meaningful use requirements. Part of these requirements included the implementation of electronic medical records (EMRs), which was a crucial part of achieving these standards.

With EMRs, prescribers began sending electronic prescriptions.

EMRs can provide advanced decision support when writing prescriptions, and they include features such as auto populating the quantity prescribed, formulary information, therapeutic duplications, warnings about interactions and other potential clinical or regulatory issues. This system results in enhanced patient care and a more streamlined dispensing process. In addition, electronic prescriptions for controlled substances (EPCS) has become more widely used as a tool to combat the opioid epidemic.

Some critical goals of EPCS have been to eliminate paper prescriptions by allowing providers to prescribe electronically, making them digital, legible, more secure, and trackable for both pharmacists and providers.

This also has allowed prescriptions to become more readily retrievable in electronic archives for audits or drug utilization reviews, which makes the handling of controlled substance prescriptions more efficient. 

With EPCS, states began implementing prescription drug monitoring programs (PDMPs), which are electronic databases that track controlled substance prescriptions. Now PDMPs can support authorities’ and providers’ timely information about patient and prescribing behaviors that contribute to opioid abuse and facil-itate a directed and resourceful response. PDMPs have allowed providers to review the patient’s history prior to authorizing a prescription. PDMPs have grown from 35 states in April 2011 to 49 states, the District of Columbia, and Guam in 2022.

In addition, the Centers for Medicare & Medicaid Services implemented a mandate for electronic prescribing that started on January 1, 2022. This mandate required all controlled drugs covered by Medicare Part D to be dispensed through EPCS.

Many local and state laws have been implemented to better track controlled substance prescriptions using e-prescribing technology and PDMPs.8 The National Association of Boards of Pharmacy system has facilitated the transfer of the PDMPs across state lines, and many states now have working interfaces to make multistate data retrieval easier. 

To limit the likelihood of drug abuse and diversion, the Drug Enforcement Administration (DEA) has acknowledged the importance of ensuring that the rules regulating electronic prescriptions do not unintentionally enable abuse and diversion.

 As a result, the DEA’s Interim Final Rule on EPCS went into effect in June 2010, allowing for e-prescribing and laying out the rules for its use in the United States.

 Pharmacies, pharmacy system vendors, prescription system application vendors, and providers were all subject to the rules. 

EPCS aimed to reduce prescription opioid addiction, abuse, diversion, and death.

 Additionally, EPCS can improve efficacy, quality, and safety and ultimately help reduce workload in the dispensing phase.

EPCS can also improve efficiency, quality, and safety. EPCS has enhanced patient management and reduced prescription fraud associated with paper prescriptions.

 EPCS has gained popularity because of its ability to detect and prevent opioid diversion by removing paper prescriptions and allowing cross referencing of PDMP databases.

 With up to 9% of opioid paper prescriptions suspected of being forged or fraudulent, the widespread use of EPCS has had an overall substantial influence on opioid prescribing.

EPCS has reduced stealing prescription pads or printing them and writing illegitimate paper prescrip-tions, altering a legitimate prescription to obtain a higher dose or more dosage units (eg, changing a 10 to a 40), and altering a prescription record at the pharmacy to hide diversion from a pharmacy stock, according to the DEA.

The results of a case study conducted at Yale New Haven Health System  between February 2017 and August 2017 showed that the median number of opioid pills prescribed per surgery was reduced from approx-imately 30 pills before the prescription default modifi-cation to approximately 20 pills following the change in the prescription default.

 Prescriptions issued for 30 pills were reduced from 39.7% before the EPCS to 12.9% after the EPCS adoption, whereas prescriptions written for 12 pills rose from 2.1% before EPCS to 24.6% after EPCS. The number of prescriptions written for 20 tablets increased significantly from 12.2% before EPCS to 19.6% after EPCS. After acquiring EPCS, the total opioid prescription was reduced by 34.41 morphine milligram equivalents. 

In another study done at a dental facility in New York, over 3 months before the required PDMP and between December 1, 2013, and February 28, 2014, after PDMP implementation, the most prescribed opioid analgesics were codeine, hydrocodone, and oxycodone.

 Following the mandated PDMP’s introduction,  there was a general trend toward fewer opioid prescriptions and more nonopioid analgesic prescriptions by the end of the trial, with the total number of opioid analgesics prescribed over 3 months dropping from 5096 to 1120 pills, a 78% decrease in absolute numbers.

EMRs, EPCS, and PDMPs have become essential tools in health care. They have curbed prescription errors, facilitated monitoring prescribed controlled substances, increased safety, and reduced possible abuses. In addition, EMRs and EPCS have provided a complete record of controlled substance prescriptions, monitoring both patients and physicians. These have been essential tools for law enforcement initiatives, public health agencies, and pharmacists to combat the opioid epidemic that has affected millions of Americans.

1. What is the Affordable Care Act? Department of Health and Human Services. August 4, 2017. Accessed July 9, 2022. https://www.hhs.gov/answers/health-insurance-reform/what-is-the-affordable-care-act/index.html

2. Computer provider order entry: the basics. HealthIT.gov. March 21, 2018. Accessed July 9, 2022. https://www.healthit.gov/faq/what-computerized-provider-order-entry

3. Chiu AS, Jean RA, Hoag JR, Friedman-Weiss M, Healy JM, Pei KY. Association of lowering default pill counts in electronic medical record systems with post-operative opioid prescribing. JAMA Surg.2018;153(11):1012-1019. doi:10.1001/jamasurg.2018.2083 

4. Blumenthal D, Tavenner M. The “meaningful use” regulation for electronic health records. New Engl J Med.2010;363(6):501-504. doi:10.1056/NEJMp1006114 

5. CDC. Leveraging Prescription Drug Monitoring Program (PDMP) data in overdose prevention and response. 2021. Accessed July 2, 2022. https://www.cdc.gov/drugover-dose/pdf/Leveraging-PDMPs-508.pdf

6. Prescription drug monitoring programs: state-by-state overview. Federation of State Medical Boards. Accessed July 2, 2022. https://www.fsmb.org/siteassets/advocacy/key-is-sues/prescription-drug monitoring-programs-by-state.pdf

7. Federal and state regulations. Imprivata. Accessed July 9, 2022. https://www.imprivata.com/federal-and-state-regulations

8. Everson J, Cheng AK, Patrick SW, Dusetzina SB. Association of electronic prescribing of controlled substances with opioid prescribing rates. JAMA Netw Open.2020;3(12):e2027951. doi:10.1001/jamanetworkopen.2020.27951

9. Abramson EL, Bates DW, Jenter C, et al. Ambulatory prescribing errors among community-based providers in two states.J Am Inform Assoc.2012;19(4):644-648. doi:10.1136/amiajnl-2011-000345

10. Danovich D, Greenstein J, Chacko J, et al. Effect of New York state electronic prescribing mandate on opioid prescribing patterns. J Emerg Med. 2019;57(2):156-161. doi:10.1016/j.jemermed.2019.03.052 

11. Kaushal R, Kern LM, Barrón Y, Quaresimo J, Abramson EL. Electronic prescribing improves medication safety in community-based office practices. J Gen Intern Med. 2010;25(6);530-536. doi:10.1007/s11606-009-1238-8 

12. Fischer MA, Stedman MR, Lii J, et al. Primary medication non-adherence: analysis of 195,930 electronic prescriptions. J Gen Intern Med. 2010;25(4):284-290. doi:10.1007/s11606-010-1253-9 

13. Gawande AA. It’s time to adopt electronic prescriptions for opioids. Ann Surg. 2017;265(4):693-694. doi:10.1097/SLA.0000000000002133

14. Achar S, Sinha N, Norcross W. The adoption and increased use of electronic prescribing of controlled substances. J Med Reg.2021;107(2):8 16.doi:10.30770/2572-1852-107.2.8

15. Rasubala L, Pernapati L, Velasquez X, Burk J, Ren YF. Impact of a mandatory prescription drug monitoring program on the prescription of opioid analgesics by dentists. PloS One.2015;10(8):e0135957 doi:10.1371/journal.pone.0135957

 is a professor of healthcare management and administration at Marshall University Lewis College of Business in Charleston, West Virginia.

is vice president of pharmacy operations at HealthTrust Supply Chain in Largo, Florida.

 is an associate professor of pharmacy practice, administration, and research, director of experiential  learning, and manager of clinical support services at Marshall University School of Pharmacy in Huntington, West Virginia.

Eliminating paper prescriptions allows for greater legibility, security, trackability for pharmacists and providers. 

Controlled Substances Prescribing Goes Electronic

 With EMRs, prescribers began sending electronic prescriptions.

EMRs can provide advanced decision support when writing prescriptions, and they include features such as auto populating the quantity prescribed, formulary information, therapeutic duplications, warnings about interactions, or other potential clinical or regulatory issues. This system results in enhanced patient care and a more streamlined dispensing process. In addition, electronic prescriptions for controlled substances (EPCS) has become more widely used as a tool to combat the opioid epidemic.

Some critical goals of EPCS have been to eliminate paper prescriptions by allowing providers to prescribe electronically, making them digital, legible, more secure, and track-able for both pharmacists and providers.

This also has made prescriptions more readily retrievable in electronic archives for audits or drug utilization reviews, which makes the handling of controlled substance prescriptions more efficient. 

With ECPS, states began implementing prescription drug monitoring programs (PDMPs), which are electronic databases that track controlled substance prescriptions. Now PDMPs can support authorities’ and providers’ timely information about patient and prescribing behaviors that contribute to opioid abuse and facilitate a directed and resourceful response. 

PDMPs have allowed providers to review the patient’s history prior to authorizing a prescription. PDMPs have grown from 35 states in April 2011 to 49 states, the District of Columbia, and Guam in 2022.

Many local and state laws have been implemented to better track controlled substance prescriptions using e-prescribing technology and PDMPs.

The National Association of Boards of Pharmacy system has facilitated the transfer of the PDMPs across state lines, and many states now have working interfaces to make multistate data retrieval easier. 

 As a result, the DEA’s Interim Final Rule on EPCS went into effect in June 2010, allowing for e-prescribing and laying out the rules for its use in the United States.10 Pharmacies, pharmacy system vendors, prescription system application vendors, and providers were all subject to the rules. 

Additionally, EPCS can improve efficacy, quality, and safety and ultimately help reduce workload in the dispensing phase.

EPCS has gained popularity because of its ability to detect and prevent opioid diversion by removing paper prescriptions and allowing cross-referencing of PDMP databases.

With up to 9% of opioid paper prescriptions suspected of being forged or fraudulent, the widespread use of EPCS has substantially influenced opioid prescribing.

EPCS has reduced stealing prescription pads or printing them and writing  illegitimate paper prescriptions, altering a legitimate prescription to obtain a higher dose or more dosage units (eg, changing a 10 to a 40), and altering a prescription record at the pharmacy to hide diversion from a pharmacy stock, according to the DEA.

The results of a case study conducted at Yale New Haven Health System between February 2017 and August 2017 showed that the median number of opioid pills prescribed per surgery was reduced from approximately 30 pills before the prescription default modification to approximately 20 pills following the change in the prescription default.

Prescriptions issued for 30 pills were reduced from 39.7% before the EPCS to 12.9% after the EPCS adoption, whereas prescriptions written for 12 pills rose from 2.1% before EPCS to 24.6% after EPCS. The number of prescriptions written for 20 tablets increased significantly from 12.2% before EPCS to 19.6% after EPCS. After acquiring EPCS, the total opioid prescription was reduced by 34.41 morphine milligram equivalents.

In another study done at a dental facility in New York, over 3 months before the required PDMP and between December 1, 2013, and February 28, 2014, after PDMP implementation, the most prescribed opioid analgesics were codeine, hydrocodone, and oxycodone.15 Following the mandated PDMP’s introduction, there was a general trend toward fewer opioid prescriptions and more nonopioid analgesic prescriptions by the end of the trial, with the total number of opioid analgesics prescribed over 3 months dropping from 5096 to 1120 pills, a 78% decrease in absolute numbers.

is a professor of healthcare management and administration at Marshall University Lewis College of Business in Charleston, West Virginia.

is an associate professor of pharmacy practice, administration, and research, director of experiential learning, and manager of clinical support services at Marshall University School of Pharmacy in Huntington, West Virginia.

3. Chiu AS, Jean RA, Hoag JR, Friedman-Weiss M, Healy JM, Pei KY. Association of lowering default pill counts in electronic medical record systems with postoperative opioid prescribing. JAMA Surg.2018;153(11):1012-1019. doi:10.1001/jamasurg.2018.2083

5. CDC. Leveraging Prescription Drug Monitoring Program (PDMP) data in overdose prevention and response. CDC; 2021. Accessed July 2, 2022. https://www.cdc.gov/drugoverdose/pdf/Leveraging-PDMPs-508.pdf

6. Prescription drug monitoring programs: state-by-state overview. Federation of State Medical Boards. Accessed July 2, 2022. https://www.fsmb.org/siteas-sets/advocacy/key-issues/prescription-drug-monitoring-programs-by-state.pdf

9. Abramson EL, Bates DW, Jenter C, et al. Ambulatory prescribing errors among community-based providers in two states. J Am Inform Assoc.2012;19(4):644-648. doi:10.1136/amiajnl-2011-000345

12. Fischer MA, Stedman MR, Lii J, et al. Primary medication non-ad-herence: analysis of 195,930 electronic prescriptions. J Gen Intern Med. 2010;25(4):284-290. doi:10.1007/s11606-010-1253-9 

14. Achar S, Sinha N, Norcross W. The adoption and increased use of electronic prescribing of controlled substances. J Med Reg.2021;107(2):8-16. doi:10.30770/2572-1852-107.2.8

15. Rasubala L, Pernapati L, Velasquez X, Burk J, Ren YF. Impact of a manda-tory prescription drug monitoring program on the prescription of opioid analgesics by dentists. PloS One.2015;10(8):e0135957 doi:10.1371/journal.pone.0135957

Eliminating paper prescriptions allows for greater legibility, security, trackability for pharmacists, providers.