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Medication Security Drop Box with Programmable Electronic Lock safely stores unused, expired or discontinued drugs being returned to the pharmacy. Editor's Note: This article is part of a technology assessment document prepared by the University HealthSystem Consortium (UHC) to assist members in assessing and deploying barcoding technology as a patient safety strategy. Research has shown that errors that occur earlier in the medication process are more readily detected (~50% are prevented during the ordering stage) while very few (An emerging information technology designed to address medication administration errors uses barcodes on both the medication and patient that are scanned at the point-of-care (POC) before administration. A summary of the barcode-assisted process for medication administration is shown in Figure 1. A typical procedure starts at the bedside with nurses scanning their own employee ID barcode, a barcode on the patient wristband, and a barcode on each medication package. However, not all ADEs are preventable, not all medication errors result in ADEs, and not all ADEs are serious. The push to use barcodes to improve medication administration safety has come from many organizations, including professional societies, hospital networks, industry consortiums, and patient safety groups. Insight into the current status of medication errors at academic medical centers can be derived from the UHC-compiled Patient Safety NetTM (PSN). More than 13,000 events related to medication use were noted in PSN, 11,633 of which were reported as medication errors. Reported medication errors are grouped according to the stage in the medication process in which they occurred (see Table 1).
Administration errors are more likely to reach the patient than errors that occur earlier in the medication process.
Steps to be taken in the pre-implementation phase include a thorough study of the current medication administration system and processes to delineate problems and issues and develop criteria for functionality of the final product.
In this pre-implementation phase, some institutions may choose to stage implementation of barcoding by first successfully barcoding patient IDs, followed by staff ID barcoding.
Despite the general acceptance that BCMA systems are valuable for patient safety, their use still has challenges, potential disadvantages, and may even introduce different types of errors. Procedures may contain loopholes that enable users to circumvent key steps, thus negating error safeguards. Barcode scanning can interrupt nurse workflow processes, leading to frustration and fatigue among staff. Barcode equipment must be reliable, readily available, and user-friendly to be used effectively. Barcode system approaches to complex IV solutions, nontypical formulations, and other pharmacy compounded products are still in the development phase.
A BCMA system is only one part of a comprehensive information technology-enabled medication system.
Radio frequency identification (RFID) tags have been considered as future replacements for the barcodes now placed on wristbands, staff IDs, and drug packages. The applications most likely to use RFID tags at an early date are labeling of blood products and IV bags. Barcode technologies are now being used for other healthcare applications outside of medication administration. Barcodes may also play an expanded role in the trend toward having a complete electronic health record (EHR). Thomas Ratko manages and prepares resources created by the technology assessment (TA) group, including High-Impact Technology Briefs, Web conferences, and other TA-related activities. When clinicians and LVTa€™s utilize and prescribe controlled substances within a facility, they must be aware of and adhere to the Federal and State regulations and policies that govern their use. A resource for personnel about the forms, instruction documents and other information available to help simplify compliance with the regulations and policy.
A controlled substance is a drug or chemical whose manufacture, possession and use are regulated by the Federal and State government. Controlled drugs are rated in the order of their abuse risk and placed in Schedules by the Federal Drug Enforcement Administration (DEA). The mission of the Drug Enforcement Administration (DEA) is to enforce the controlled substances laws and regulations of the United States. The New York Board of Pharmacy (NYBP) is the agency authorized by NY statute to regulate controlled substances in the State of NY.
Unit Registrant: A person who is appointed by the administrator to hold the DEA and NYSBP registrations for the Unit, exercises signature authority and approves or appoints the Location Registrants for the Unit. Location Registrant: A person, usually the principal investigator (PI) or lab supervisor, who obtains an NYSBP registration for the (lab) Location, supervises the Authorized Users and assures compliance with the controlled substances policy and regulations at the Location. Controlled substances must be properly handled at all stages of purchase, use, storage, transfer and disposal.
Unit Registrants and Location Registrants must understand the Unit and Location structure, registration process, roles and responsibilities. Everyone performing any activity with controlled substances must sign the Authorized Users Signature Log. The Authorized User Signature Log, like all controlled substance records, must be kept for a minimum of seven years. To pick up controlled substances, pharmacies require a copy of the DEA registration, the Authorized Users Signature Log and photo identification. After the DEA has approved your use of C-I or C-II controlled substances, they will send you the DEA Forms 222.
Store controlled substances requiring cold storage in a refrigerator or freezer with a locked door. Only Unit Registrants, Location Registrants and Authorized Users may use controlled substances. The person using the controlled substances must be the one to initial and date the disposition record for the particular action performed.
Every activity with controlled substances must be recorded on the disposition record, which is the primary record of all activities with controlled substances. For C-III, C-IV and C-V drugs, the total volume used on a daily basis may be recorded on the disposition record. In the instance of an animal surgery, the individual recorded dose can be the total per animal per anesthetic episode. The DEA requires the use of a Controlled Substance Disposition Record that contains all the required elements. Note that the disposition records are dedicated exclusively to tracking all controlled substances activities.
This example uses sodium pentobarbital, a C-II controlled substance, to demonstrate the more stringent record-keeping requirements. In this example, Lines 2-4 represent the use of sodium pentobarbital in three animals, each recorded individually. When controlled substances are diluted or combined, it must be recorded on the disposition record. When diluting (as in this example using sodium pentobarbital) or combining drugs (when using ketamine-xylazine or other drug combinations), it is necessary to record the amount used from the stock bottle(s) AND to record the amount of diluted or combined drugs used.
A sterile container and pharmaceutical grade diluents must be used when diluting or combining controlled substances for use in animals.
In the example, this 2.5 ml diluted sodium pentobarbital will also be recorded on the Controlled Substances Single Drug Disposition Record. Complete the required information at the top of the Controlled Substances Single Drug Disposition Record. In the body of the record, the columns on the left side pertain to use of the controlled substance and the columns on the right side could be used to record information relevant to your research.
In addition, to save time or minimize duplication of recording, researchers may choose to use the Controlled Substances Single Drug Disposition Record as a surgical or procedure record by adding other research elements to the record.
If your laboratory uses only the Single Drug Disposition Record as a controlled substance record, it is very important to clearly record all the controlled substances activities (receiving, using, diluting or combining, disposing and transferring) on the form. By recording the amount you put in the slurry bottle on both the disposition record and disposal record, you can easily track the controlled substance. Although it is not advised, it is possible to transfer controlled substances to another DEA registration. In this example, Line 8 records the transfer of one 50 ml bottle of sodium pentobarbital to another laboratory.
The DEA registration does allow facilities to register for pick up and disposal of expired, contaminated or excess controlled substances. The DEA website contains specific directions for the proper disposal of controlled substances.
Each disposal into the slurry bottle must be recorded on the disposal form, which is used to record amounts of expired or waste controlled substances for disposal.
The two-page Controlled Substances Disposal Form is required by DEA policy and is available on the DEA website.
Currently the DEA Form 41 (Registrants Inventory of Drugs Surrendered) is available in PDF format in two ways a€“ 1. All packages included on a single line should be identical in name, content and controlled substance strength.
Drugs should be shipped tape-sealed via prepaid express or certified mail (return receipt requested) to Special Agent in Charge, Drug Enforcement Administration, of the DEA District Office which serves your area.
To document the surrender of controlled substances which have been forwarded by registrants to DEA for disposal. Other Federal law enforcement and regulatory agencies for law enforcement and regulatory purposes. State and local law enforcement and regulatory agencies for law enforcement and regulatory purposes. Failure to document the surrender of unwanted Controlled Substances may result in prosecution for violation of the Controlled Substances Act. Under the Paperwork Reduction Act, a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.


The DEA policy requires that each Location using controlled substances must complete a annual inventory.
The recommended Controlled Substances Inventory Record contains the required elements from the DEA regulations. If you find a discrepancy between the amount of controlled substances in your safe and the amount recorded in your records, this discrepancy must be reported. The Location Registrant must provide a copy of the inventory to the Unit Registrant and file the original inventory with the Location records. If there is an obvious or suspected break-in to your safe or other diversion of controlled substances, immediately contact the Police. The Unit and Location Registrants must decide if it is necessary to use Form 106 to report the loss to the DEA. If there is consistent loss of controlled substance that can be explained, write a Memo to File for your controlled substance records the explains this consistent loss.
If a discrepancy cannot be reconciled or if there has been a diversion, it must be reported to the DEA using DEA Form 106. The Unit Registrant and Location Registrant must file a copy of the completed Form 106 with the controlled substance records.
In case of accidental loss of controlled substances due to spilling or breaking a container, use DEA Form 41.
DEA regulations have requirements for maintaining and retaining records about the use of controlled substances for research.
The person performing the tasks (receiving, using, diluting, disposing) is responsible for documenting information on the disposition record. It is highly recommended that records be maintained in a 3-ring binder so that nothing is lost or misplaced. Keep disposition records and other associated records at the Location for a minimum of 5 years according to the DEA. Most children with hydrocephalus need surgery to help the cerebrospinal fluid (CSF) drain from their head, using a shunt, to some other part of their body that can absorb the fluid.
In the past, doctors treated multiloculated hydrocephalus by placing a separate shunt in each pocket that held fluid. An endoscope being used to make a hole in the ventricle so the patient can avoid needing a shunt. For a small number of children, an endoscopic third ventriculostomy (ETV) surgery may be a treatment option. Children who have an ETV may avoid complications linked with shunts, such as getting infections or needing a shunt replaced (shunt revision). If your child's body isn't absorbing CSF well, a choroid plexus cauterization (CPC) may be a treatment option. In CPC, the neurosurgeon uses a flexible endoscope to reach the choroid plexus in the lateral ventricles each side of the brain. Seattle Children’s provides healthcare without regard to race, color, religion (creed), sex, gender identity or expression, sexual orientation, national origin (ancestry) or disability.
Roy Ilan knows that goodA communication is essential to promoting patient safety."There is ample evidence to suggest that a€™communication failuresa€™ are a major contributor to adverse events.
It was developed following surveys of members about their current practices and their future plans and after review of data gathered through the UHC that has led members to believe that this technology might be valuable in eliminating certain types of medication administration errors. By definition, these errors can occur at any stage in the medication process, which includes prescribing, order communication, product labeling, packaging, compounding, dispensing, distribution, and administration.
At its most basic level, barcode-assisted prevention of medication administration errors is predicated on verifying the "5 rights"; the right patient, right drug, right dose, right route, and right time. The barcodes may be linear (1-D), two-dimensional (2-D), or composite (combined 1-D and 2-D elements) (HIBCC 2005, UCC 2005). It is difficult, however, to cite a single number to define the extent of the medication error problem due to differences in institutions, study methodologies, error definitions, and other variables. For example, one study found that ~2% of admissions experienced a preventable ADE with an added cost per patient of ~$4,700 (JCAHO, 2004). In early 2004, it appeared that the Joint Commission on Accreditation of Healthcare Organizations (Joint Commission) would mandate that hospitals adopt the technology via implementation of Joint Commission National Patient Safety Goals (NPSGs) for 2005 (JCAHO, 2004).
The first prototype systems were developed in the early to mid-1990s and began to be disseminated in the late 1990s.
PSN is a real-time, Web-based adverse event reporting tool used by subscribing UHC members to report and evaluate patient safety and improve health care quality. Similar to data reported in the literature, UHC data suggest administration errors account for ~35% of all medication errors and 41% of errors causing harm. Initial studies often serve to determine the baseline number and type of medication errors that occur to compare them with those that occur after implementation of the barcode system. The involvement of end users in equipment selection is very important for obtaining cooperation and choosing important capabilities.
The complete system of the future will also incorporate CPOE, eMARs, and smart pumps to ensure patient safety from different aspects of the medication process. This technology has recently gained popularity in select applications, mainly inventory management.
In these cases, the cost of the product is much greater than the label cost, and there are some difficulties affixing a barcode to the shape of the product bag; these bags typically require a large amount of information beyond what the NDC code provides, and thus sometimes requires multiple, long barcodes that can be technically difficult to place and cumbersome to read.
The common perception is that the technology may be ready for POC applications in 3 to 5 years.
Probably the other most evolved and important application involves safety initiatives that target lab specimen identification. Since joining UHC in 1994, he has authored or contributed to more than 50 assessments and reports primarily involving medical devices, surgical procedures, diagnostic lab tests, and transfusion medicine technologies. Prior to joining UHC in 1993, Ratko was a senior research associate for the American Medical Association (AMA) in the Department of Immunology and Infectious Diseases. He is responsible for the development and direction of all UHC technology assessment efforts. This workshop is designed as an introduction to these regulations and policies, as well as to the paperwork and record keeping required for the use of controlled substances. The drugs with the highest abuse potential are placed in Schedule I, and those with the lowest abuse potential are in Schedule V. The DEA is responsible for suppressing illegal drug use and distribution by enforcing the Controlled Substances Act. The NYBP exists to protect the public from adulterated, misbranded and illicit drugs, and from unethical or unprofessional conduct on the part of pharmacists or other licensees. The DEA has a Standard Operating Procedure (SOP)Standard Operating Procedure (SOP)-->, that can serve as a reference. The Authorized Users Signature Log is one of the documents required by DEA policy that must be kept up-to-date and filed in your controlled substances records. Ensure this by providing an initialed and dated copy of the purchase receipt to the Unit Registrant. If a facility re-packages, compounds or dilutes controlled substances, appropriately label the re-packaged, compounded or diluted substance and store it in the safe.
The actual use of the controlled substances must be demonstrated by recording it in surgical, anesthetic, post operative or other experimental record. For a C-II controlled substance, remember that the total use for each animal must be recorded individually. When a drug combination is used, track the combination use separately from the stock bottle use. It is important to remember that with a C-II controlled substance like sodium pentobarbital you are required to record the drug use for each animal separately along with all patients. If this is done, file the original record with your research records and a copy in your controlled substances records.
Only transfer unopened bottles of controlled substances so that both parties are certain of the amount being transferred.
The receiving laboratory must record the 50 ml bottle in their disposition records, who they received it from and the DEA number. Substances to be disposed of must be kept in the safe until picked or disposal is authorized. It is also recommended that the amount placed in the slurry bottle is recorded on the disposition record. This is merely a service rendered to registrants enabling them to clear their stocks and records of unwanted items.
Public reporting burden for this collection of information is estimated to average 30 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An inventory is the comparison of the quantity of controlled substances in your safe with the quantity written in your disposition records.
The DEA Form 106 a€?Report of Theft or Loss of Controlled Substances must be used to file this report online.
An example would be loss in the hub of the needle that is consistent over a number of experiments. Rarely, treatment involves making a channel in the brain so CSF can flow through the brain a different way. The shunt is used to drain extra CSF from ventricles in your child's brain to some other part in their body. This controls the pressure in your child's head and keeps fluid flowing away from the brain only. This is called a ventriculoperitoneal (pronounced ven-trick-yoo-lo-pair-ih-tuh-NEE-ahl) shunt (VP shunt).
Then the neurosurgeon uses a rigid endoscope to go into the third ventricle and make a hole in the bottom of it. Financial assistance for medically necessary services is based on family income and hospital resources and is provided to children under age 21 whose primary residence is in Washington, Alaska, Montana or Idaho.


More than one type of barcode may be involved in the medication administration process (see Figure 2).
On the high end of estimates, one study that compiled data from 36 institutions reported 19% (~1 in 5) of the medication doses studied over a 4-day period involved medication errors (Barker et al., 2002).
An allergic reaction to a drug in a patient with no previously known allergies is an example of a non-preventable ADE. Extrapolated, this suggests an added cost of ~$2.8 million per year for a 700-bed teaching hospital. However, final wording of the NPSGs, approved in July 2004, did not specifically mention medication barcoding. A thorough study of the information system (IS) infrastructure is performed to determine current capabilities and map out future functionalities. There are a number of models, including outsourcing medication barcodes, using in-house repackaging with barcoding, relying on manufacturer pre-barcoding of unit dose packages, or employing a combination of these methods. Only after a successful pilot is functional for a specific period of time should the technology be rolled out on a larger scale.
A key generalized capability should be the ability of the system to provide information to the caregiver at the point of administration.
Pilot programs typically call for RFID labeling of bulk packages or pallets with the ultimate goal of individual package labeling. It is likely that most institutions planning medication administration safety initiatives will first use barcodes rather than RFID tags.
This involves patient identification at the POC (by reading a wristband barcode), obtaining the sample, and immediately identifying it with a portable printer-based label. Cummings' background includes a bachelor's degree in biomedical engineering from the University of Iowa and a doctorate in biomedical engineering from Northwestern University. Tom received his doctorate in pharmacology degree from the University of Illinois Health Sciences Center in Chicago, and his bachelor of science degree in microbiology from the University of Illinois Urbana-Champaign. Matuszewski received his bachelor of science and doctor of pharmacy degrees from the University of Illinois, where he is currently an assistant clinical professor, and a master of science degree in health systems management from Rush University, where he holds a faculty appointment as an associate professor.
The NYBP requires researchers using controlled substances to obtain an NYBP registration certificate. If there is high turnover in your facility, you may need to start a new log, but remember to keep the original document with your controlled substance records. However, the individual use must be recorded in a surgical, anesthetic or other medical record that is accessible. This would be analogous to a hospital pharmacy dispensing a drug and a clinician writing the use of the drug in the medical record. For C-II drugs, do not combine the total use per day in multiple animals, as you can for C-III through C-V drugs. Both the receiving and the supplying laboratories must record the transfer in their disposition records.
Because sodium pentobarbital is a C-II substance, a Form 222 order form must be used to make the transfer. That instruction directs the registrant to ship the drugs to the Special Agent in Charge of the DEA office that serves the registrant's area. That instruction directs the registrant to ship the drugs to the Special Agent in Charge of the DEA office that serves the registrant's area. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for this burden, to the Drug Enforcement Administration, FOI and Records Management Section, Washington, D.C. In some cases, the tube goes into an upper chamber in the heart (atrium) or into the lining of the lung instead. Surgery using an endoscope (endoscopy) requires smaller cuts (incisions) than open surgery. Most often it's done in children who have a narrow or blocked channel leading out of their ventricles (aqueductal stenosis).
CSF flows out of this hole and reaches the normal places around the brain where it is absorbed. This article focuses on barcode technologies applied at the administration stage of the process. At this time, there are many different codes and symbologies that are not yet standardized, and each has advantages and disadvantages. These errors included wrong time (43%), omission (30%), wrong dose (17%), and unauthorized drug (4%). Furthermore, missing a medication dose or providing the dose late may result in no discernible morbidity.
However, even if one determines the rate of medication administration errors resulting in significant injury or death is very small, it remains a significant problem owing to the high number of medication administrations that occur annually.
This figure does not include the significant costs of defending against malpractice claims stemming from preventable inpatient ADEs (Rothschild et al., 2002). One reason for the omission included the inability to determine a time frame for which it would be reasonable for hospitals to reach the standard.
A manufacturer's estimate in the summer of 2003 suggested that about 300 of the nation's 6,600 hospitals had BCMA systems (130 of which were Veterans Administration [VA] hospitals. The following analyses were excerpted from all events in PSN recorded between October 2002 and March 2004. Barcoding of medications is a complicated logistical problem that will require significant pharmacy space, time, and effort. Further, one manufacturer of automated drug dispensing cabinets has introduced a cabinet that keeps track of RFID labeled packages sitting within its shelves. Since these safety initiatives involve a paradigm change in administration processes, this tends to transcend any one technology involved in the process; thus, it is recommended that institutions begin their implementation without waiting for RFID technology.
He is also an affiliate clinical assistant professor of pharmacy practice at Midwestern University. Toward efficient medication error reduction: error-reducing information management systems. The SOP defines the person who is responsible for each of the activities related to using controlled substances.
Registrants should send the forms to DEA as detailed in instruction number 3, and await instructions on how to proceed. This second version is not recommended; fewer errors occur if the form is entered online and then printed. The goal of putting in a shunt is to drain the CSF that your child's body makes each day (about a pint).
Depending on your child's brain structures and age, the neurosurgeon may talk with you about doing an ETV instead of putting in a shunt. CPC may lower the level of fluid enough that your child's body can keep up with absorbing it.
Communication starts to erode in situations in which there is a lack of empathy, respect and trust. Linear barcodes are the most common; for medications they typically contain the 10-digit National Drug Code (NDC) number that identifies the manufacturer, product, and package size. On the other hand, error events involving cardiovascular drugs can result in serious complications secondary to bradycardia or hypotension, errors involving central nervous system (CNS)-acting agents can result in serious complications from oversedation and respiratory depression, errors involving anticoagulants may result in bleeding episodes, errors involving insulin can lead to a hypoglycemic episode, and errors involving chemotherapy agents can lead to bone marrow depression and toxicity (Kanjanarat et al., 2003).
The IOM report estimated that 3.75 billion drug administrations were given to patients in hospitals in 1998. In this phase, a multidisciplinary committee is formed that consists of members from nursing, pharmacy, IT, and administration.
It was also suggested that the ability to customize the type of information provided was very important; one example is the ability to turn off certain prompts or warnings that are deemed unnecessary or that are impeding workflow efficiency with little gain in patient safety. In another example of disseminating RFID technology, drug manufacturers have RFID tagged select drug packages, such as oxycontin and Viagra, in an effort to thwart counterfeiting schemes.
If RFID matures to the point of viability, it may be possible at some future date to substitute RFID tags for barcodes and RFID scanners for barcode scanners with little interruption to the process. Most BCMA manufacturers also have, or are planning to have, a module for lab specimen identification. Numerous other applications can be envisioned where information that should be in the patient record is input by staff via a barcode scanner. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. However, a hospital may use its own smaller, unique code to point to a much larger descriptor of the coded item contained in a relational database. A comprehensive review of medication error studies cited in the Institute of Medicine (IOM) 2000 report on errors in the U.S. Similarly, some manufacturers began with the lab application as their main product and are now branching into the medication administration application.
Alternatively, the 2-D symbologies can contain more information, such as the lot number and expiration date of the product. Successful implementation may depend on the input provided early on from this committee, particularly input from end users. Any further inquiries concerning these drugs should be addressed to the DEA District Office which serves your area. The IOM report further estimated that 770,000 patients are injured and ~7,000 die each year due to medication errors.
Comparison of methods for detecting medication errors in 36 hospitals and skilled-nursing facilities.



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