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CE ACCREDITED SEPTEMBER 2002

A UTHORS Gina Pugliese, RN, MS, Vice Presi- dent, Safety Institute, Premier Inc., Oak Brook, Illinois. She has no financial inter- Compliance With OSHA est to declare. Greg A. Lindquist, RPh, MBA, Direc- tor, Pharmacy, Premier Inc., Oak Brook, Illinois. He has no financial interest to Requirements for Sharps declare. Premier Inc., however, operates group purchasing programs with numer- ous medical product suppliers. Injury Prevention: The Role Tammy Lundstrom, MD, Vice Presi- dent, Chief Quality and Safety Officer, Detroit Medical Center, Detroit, Michi- gan. She has no financial interest to Of Pharmacy and Nursing declare. LEARNING OBJECTIVES NEEDS STATEMENT After completion of this program, par- ticipants should be able to: 1 Review the requirements of OSHA’s Since 1998, considerable public attention has been at the highest risk of exposure. Bloodborne Pathogens Regulations. focused on protecting healthcare workers from occu- Unlike the nursing staff, the pharmacy staff does 2 Outline the responsibilities for health- pational exposure to bloodborne pathogens. In con- not typically encounter sharps that have been contam- care professionals in pharmacy and junction with these efforts, the healthcare community inated with blood or other potentially infectious materi- nursing under OSHA’s Bloodborne has been actively working to implement the recent al. The pharmacy staff does, however, have much to Pathogens Regulations. Occupational Safety and Health Administration offer in reducing risks of occupational sharps injuries 3 Discuss the role of the healthcare (OSHA) regulations and corresponding federal legisla- to healthcare workers. The pharmacist has the exper- professional in supporting an institu- tion mandating the use of sharps safety devices. tise on dosage form options that will complement over- tion-wide bloodborne pathogens Much of the activity targeted at risk reduction has all risk reduction efforts. safety and compliance program. been focused on the identification, evaluation, and This article is intended to provide both pharmacists 4 Identify safety products and options implementation of devices with features that offer the and nurses with an overview of the evolution of the for pharmaceutical prefilled syringe potential to reduce sharps-related injury. Most of this bloodborne pathogens regulations, an appreciation presentations. work has been focused on devices that are considered for the issues involved in implementation of blood- high risk because of the potential for contamination borne pathogens compliance programs, and to offer with blood (eg, phlebotomy, I.V. access, and hypoder- insight on how the institution can be proactive in sup- mic products) and the education of clinicians who are porting efforts to reduce sharps injuries.

A CCREDITATION AND CREDIT INTENDED AUDIENCE DESIGNATION STATEMENTS Pharmacists and Nurses Continuing Pharmaceutical Education: METHOD OF PARTICIPATION AKH Consultant is approved by the Ameri- can Council on Pharmaceutical Education This activity should take approximately 1 hour to Jointly sponsored by (ACPE) as a provider of continuing pharmaceutical complete. The participant should, in order, read the education. objectives contained in this monograph, answer the AKH Consultant This program has been assigned the Universal 16-question multiple-choice post-test, and complete and McMahon Program Number 077-999-02-015-H04 and is accept- the evaluation on page 12. The evaluation form pro- able for 1.0 contact hour (0.1 CEU) in states that rec- vides each participant with the opportunity to com- Publishing Group ognize ACPE-approved providers. ment on the quality of the instructional process, the Continuing Nursing Education: This educational perception of commercial bias, and his or her views on activity for 1.0 contact hour is provided by AKH Con- future educational needs. To receive credit for this sultant. AKH Consultant is approved as a provider of activity, follow the instructions provided on the post- nursing continuing education credit through the fol- test. This credit will be valid through August 31, 2003. lowing boards of nursing: AL: #ABNP0229; CA: #CEP No credit will be given after that date. 12070; DE: #101; FL: #2851; IA: #277; KS: #LT0146- 0338; NV: #NV010295-3; WV: #WV096.0127.RN. Bloodborne Pathogens Regulations: History facilities and resulted in the commercial development of many new safety products, including sharps injury preven- 1990s: Early Initiatives tion devices. Although sharps injury prevention devices In the mid-1980s and early 1990s, reports of occupa- were becoming increasingly available for many clinical pro- tional HIV and hepatitis B infections among healthcare cedures, the momentum slowed in the late 1990s as man- workers resulting from percutaneous injuries with conta- aged care and healthcare reform initiatives intensified minated sharps were brought to public attention. These pressure to reduce costs and the shrinking healthcare infections occurred among frontline workers, as well as resources were spread over many other competing patient workers who may have been injured by sharps improper- and worker safety issues. ly disposed of in trash or laundry receptacles. Although many healthcare workers were no longer 1998-2001: A Sea of Change recapping needles and were disposing of sharps in The ongoing efforts of healthcare worker safety advo- strategically placed disposal units, healthcare worker cates resulted in new federal legislation and the enact- safety advocates pushed the Occupational Safety and ment of state laws to specifically address the use of sharps Health Administration (OSHA) for a standard that would safety devices. further reduce risk to workers. In 1991, OSHA issued the California became the first state to enact such legislation Bloodborne Pathogens Standard.1 with the signing of Bill No. AB 1208 by Gov. Pete Wilson on This standard required employers to establish and October 1, 1998. By the close of 2001, 21 states—California, maintain policies and procedures to prevent exposure to Tennessee, Texas, New Jersey, Georgia, Massachusetts, bloodborne pathogens and reduce sharps injuries to all New York, Ohio, West Virginia, Maryland, Alaska, Oklahoma, workers. This was accomplished through education Minnesota, Iowa, Connecticut, Maine, New Hampshire, efforts, risk reduction strategies, hepatitis B immuniza- Arkansas, Missouri, Rhode Island, and Pennsylvania—had tion, as well as documentation, evaluation, and medical passed legislation to address sharps safety. follow-up of workers after exposure to bloodborne On November 6, 2000, the federal “Needlestick Safety pathogens and other infectious materials. and Prevention Act” (HR 5178) was signed into law by These regulations were rapidly adopted by healthcare President Bill Clinton.2 This law directed OSHA to amend

Figure 1. Map of US indicating the 21 states (in green) that have passed sharps safety legislation. 2 the existing federal Bloodborne Pathogens Standard to expand the definition of “engineering controls” to include ‘As of June 2000, there have been 56 “needleless systems” and “sharps with engineered documented cases of HIV transmission to sharps injury protections,” require annual reviews of the healthcare workers, and an additional exposure control plan to include consideration of new technology, require a sharps injury log, and require 138 cases are considered possible employee involvement in product selection. occupational HIV transmissions.’ The passage of HR 5178 was significant in that it strengthened the 1991 federal bloodborne pathogens —Centers for Disease Control and Prevention regulation. The revised OSHA standard became effective in all 50 states on October 18, 2001, and in effect, creat- ed a federal mandate to have frontline healthcare workers evaluate and select safer products to protect themselves been 56 documented cases of HIV transmission to from accidental sharps injury. healthcare workers, and an additional 138 cases are considered possible occupational HIV transmissions. 2002–Present: Work in Progress The CDC also reports that the average risk of HIV trans- By 2002, healthcare employer obligations and inter- mission after a percutaneous (eg, needlestick) expo- pretation of the regulations are better understood. Many sure to HIV-infected blood is 0.3%. It may be higher, employers have taken action to comply with these new however, depending on the amount of blood present, regulations and have implemented programs to reduce the severity of the injury, and the stage of HIV infection needlestick injuries through a variety of strategies, includ- in the source patient. Although postexposure antiretro- ing the use of safety technology. While the boundaries for viral treatment is available, its effectiveness is limited by compliance have become better defined, technology a number of factors. These include the timing of drug solutions that can help create a safer workplace continue administration, resistance to antiretroviral agents, to evolve and improve. severe toxicity requiring discontinuation of treatment, and failures in response to treatment. • Hepatitis B: The Need for Safer Devices There has been a sharp decline in hepati- tis B virus (HBV) infections among healthcare workers. The Centers for Disease Control and Prevention (CDC) This is, in part, related to increasing pre-exposure vac- has estimated that more than 385,000 percutaneous cination rates with the highly effective HBV vaccine. injuries occur annually among healthcare workers from For nonimmunized individuals, the risk of acquiring needles and other sharps used in the healthcare setting.3 HBV infection from a percutaneous injury ranges from Published studies have noted that up to 70% of such 6% to 30%. Even in the nonimmune worker, postexpo- injuries are never reported.4 sure acquisition of HBV can be prevented through a In spite of the significant progress that has been made combination of immunoglobulin therapy and postex- to date, safety devices are not used in 100% of the situa- posure vaccination. tions where exposure to contaminated sharps may occur. • Hepatitis C: The average risk of acquiring hepatitis C There are many cited reasons for this, including the com- virus (HCV) infection from a needlestick injury is plexity of choosing a device that is most appropriate for the procedure and some resistance to change (because some safety devices create a need to change the tech- Table 1. Mechanism/Cause of Exposures nique for a particular procedure). In addition, technology For Hollow-Bore Needles has not advanced to the point where sharps with engi- neered safety protection are available for all types of pro- Mechanism/Cause of Exposure % of Exposures cedures performed in hospitals (eg, safety spinal needles Manipulating needle in patient 29 for performance of lumbar puncture, safety devices for Handling/passing device during or after use 10 drainage of fluid from deep body cavities). Recapping needle 5 The consequences of a needlestick injury can be deadly. The risk of developing an infection depends on Collision with co-worker 8 many factors, including the infection status of the source Cleanup 11 individual, the type of sharp involved, the amount of infec- During disposal 12 tious material involved, and the severity of the sharps Transit to or during disposal 12 injury. The risk of infection also varies by the specific type of bloodborne infection.5 Improper disposal 10 • HIV: The CDC reports that as of June 2000, there have Source: CDC’s National Surveillance System for Health Care Workers (NaSH) 3 made to reduce sharps injury in response to the growing body of data documenting the frequency of injury and The average risk of acquiring hepatitis C the increasing availability of sharps safety technology. The major changes included: virus infection from a needlestick injury 1. Amending the definition of “Engineering Controls” to is approximately 2.0%. include sharps with engineered sharps injury protection features and needleless systems [Section (b), Defini- tions]. “Engineering Controls” is an OSHA term for prod- ucts that will help prevent injury. The change in definition is meant to clarify and reinforce the need to assess and approximately 2.0%. The lack of both a vaccine and an select new safety technology. effective postexposure treatment makes HCV infection 2. The addition of language to the requirement for an annu- a serious risk for healthcare workers. al review of the Exposure Control Plan that explicitly requires the consideration of new technologies and doc- Sources and Causes of Injury umentation of their consideration and implementation According to data from the CDC’s National Surveillance [Section (c)(1)(ii)]. The Exposure Control Plan is the System for Health Care Workers (NaSH) and the Interna- employer’s policy manual defining what, when, and how tional Healthcare Worker Safety Center’s EPINet surveil- the employer will ensure that the bloodborne pathogens lance data, needles are the major cause of sharps-related regulations are implemented and that compliance is injuries—representing more than 50% of all percutaneous maintained. This includes device selection and imple- injuries (Table 1, page 3). Of these, hypodermic needles mentation processes. account for almost 30% of the injuries from needles. 3. A new requirement to establish and maintain a sharps The CDC’s NaSH data indicate that for hollow-bore injury log, including details on the device and where needles, like hypodermic needles, the leading mecha- and how the injury occurred [Section (h)]. Previously, nism of injury is manipulating the needle in the patient.4 there was no requirement to log all injuries. The intent of A common factor in many of these injuries is an the log is to help identify trends in injuries that can be exposed needle. The use of safety devices that cover, tied to work practices or products in the hope of mak- shield, or encapsulate a needle after use has been ing changes that will improve safety and reduce injury. shown to reduce needlestick injuries to the worker han- 4. Creation of a new requirement mandating that non- dling and manipulating the device and may also reduce managerial employees involved in direct patient care risk to other workers who may be injured from improper participate in identification, evaluation, and selection of disposal practices.6-8 products. This requirement for “frontline worker” involvement was added to ensure that the selection of Federal Bloodborne Pathogens Regulations safer devices was more than a managerial exercise and to promote ownership of safety at the employee Workplace safety, which includes healthcare facilities, level to help ensure maximum compliance and safety. is regulated through OSHA. These regulations apply to These changes became effective on April 18, 2001, in all employees in the United States, with the exception of states under federal jurisdiction (on October 18, 2001, in state or federal workers who may be covered by individ- the state–OSHA plans), and have had far-reaching impli- ual state or federal agency-specific regulation. As noted, cations in the use and selection of safer sharps devices.9 the cornerstone of sharps device regulation is embodied in the OSHA Bloodborne Pathogens Standard (29 CFR Impact on Practice 1910.1030). This regulation specifies steps that employ- These regulations have a direct impact on departments ers must take to prevent employee exposure to blood- and units in which exposure to potentially contaminated borne pathogens in the workplace. Private employers in sharps is likely. Nurses’ potential for exposure is high all 50 states must comply with this regulation as a mini- because medication administration is a primary nursing mum requirement; 25 states have federal OSHA- activity. The direct impact on hospital pharmacies may be approved state plans that allow them to implement their limited because there is limited exposure to contaminated own regulations as long as they meet the federal stan- sharps in the pharmacy and because admixture or recon- dard as a minimum requirement. stitution involves clean needles. However, the pharmacist can play a significant role in supporting efforts to prevent Needlestick Safety and Prevention Act injury to healthcare workers who administer the medica- The “Needlestick Safety and Prevention Act” (HR tions dispensed by pharmacy. 5178) mandated several significant changes to the Historically, there have been a number of pharmaceu- Bloodborne Pathogens Standard. These changes were ticals available in prefilled syringe or cartridge form. 4 These prefilled presentations have been chosen over the years for a number of reasons, including convenience The pharmacist has unique knowledge and immediate access to a unit dose form that eliminates the need to draw a dose from a vial before administration. of dosage forms and delivery system These unit dose forms also reduced risk of medication options and can serve as a resource error (drawing up an incorrect amount), waste reduction, to identify products that represent risk, elimination of cross-contamination (ie, with multidose vials), and ease in billing and tracking, particularly with and recommend drug presentations to narcotics and other controlled substances. reduce risk. Since many of the drugs available in these dosage forms are not frequently administered—notable excep- tions are narcotics and low molecular weight heparin— they may be overlooked or not prioritized as sources of risk by infection control or other personnel with the notes that each device must be considered on its own merit responsibility for implementation of a sharps safety com- and ultimately in its ability to reduce workplace injuries.10 pliance program. One arena where this is particularly cru- Therefore, each employer must consider its own needs in cial is the selection of medication products to stock developing a bloodborne pathogens compliance program. “CODE BLUE” carts, as a code blue event is generally an To ensure uniform inspection procedures and to pro- emergency, and multiple parties are manipulating sharps vide guidance and interpretations of the revised stan- in a close field. dard, OSHA updated its compliance directive (CPL The pharmacist has unique knowledge of dosage 2-2.69) Enforcement Procedures for the Occupational forms and delivery system options and can serve as a Exposure to Bloodborne Pathogens on November 27, resource to identify products that represent risk, and rec- 2001.11 In this compliance directive, OSHA explains that ommend drug presentations to reduce risk. In addition, engineering controls (eg, sharps with engineered sharps the pharmacist’s involvement in medication error reduc- injury protection and needleless systems) and work prac- tion initiatives may involve the increased use of unit dose tice controls (eg, prohibiting the removal of contaminated drug presentations, such as prefills. In this case, it is needles by hand) shall be used to eliminate or minimize incumbent on the pharmacist to consider the safety employee exposures. needs of the clinicians administering the medications to In the compliance directive, OSHA provides a number avoid an inadvertent increase in sharps injury risk, while of specific interpretations and expectations for compli- attempting to reduce the risk of medication errors. ance. Examples: Engineering Controls and Work Practices— Compliance Requirements Section XIII, Subsection D, Paragraph 2, Paragraph (d)(2)(i) There are many factors to consider in developing a •The employer “must use engineering and work comprehensive program to comply with the bloodborne practice controls that eliminate occupational expo- pathogens regulations. An important component is to sure or reduce it to the lowest feasible extent.” conduct an assessment of all the clinical uses of contam- •“Where engineering controls will reduce employee inated sharps throughout the facility and then implement exposure either by removing, eliminating or isolat- procedures for the selection, evaluation, and adoption of ing the hazard, they must be used.” safety devices for each clinical use. This assessment •“[Removal of a contaminated needle] is best accom- should include all prefilled drug presentations. plished by using a sharp with engineered sharps The Bloodborne Pathogen Standard is a performance injury protection, which shields the sharp from expo- standard; it allows the employer the flexibility to imple- sure as soon as it is withdrawn from the patient.” ment a program that reduces risk to workers and takes Section XIII, Subsection D, Paragraph 2 into consideration the specific risks at each work site. Citations should be issued: This includes the type of clinical procedures being per- •“If a combination of engineering and work prac- formed, the preferences of the workers, and the types of tice controls … does not eliminate or minimize exposures that are occurring. OSHA does not make rec- exposure. …” ommendations for specific products or devices. •“When the compliance officer finds that an employ- The need for an employer to have flexibility in choosing er is using an engineering control, but believes the most appropriate safety device for the clinical situation another device would clearly be more effective … the is also supported by the CDC’s National Institute for Occu- compliance officer should consult with the Regional pational Safety and Health (NIOSH). In NIOSH’s Alert, Pre- Bloodborne Pathogens Coordinator to determine if a venting Needlestick Injuries in Health Care Settings, it violation of (d)(2)(i) exists.” 5 As noted above, OSHA’s compliance directs employ- •Indication of activation ers to reduce exposure to the “lowest feasible extent” with •Undefeatable the expectation that employers will use the most effective •Packaging technology to prevent and reduce injuries from contami- •Needle interchangeability nated sharps. OSHA has indicated that its goal is to elim- •Sharp covered permanently inate needlestick injuries by the year 2010. This goal is •Interference with procedure also supported by the CDC’s report “Healthy People •Right- or left-handed use 2010,” which establishes a more modest goal of a 30% reduction by 2010.12 Human Factors A recent General Accounting Office report pointed There are powerful human factors that must be con- out that safety devices may cost up to 3 1/2 times more sidered in a sharps safety program. Experience has than conventional devices.13 Although cost is cited by shown that there are many barriers to the adoption and some as a barrier to the adoption of new safety tech- use of safety products by clinicians, in spite of the docu- nology, the bloodborne pathogen regulation mandates mented risk of injury. Some of the most common barriers its use. The only acceptable exceptions are the lack of to successful conversion and implementation are: market availability of a safety device and the device’s •Resistance to change interference with a medical procedure that may com- • Easy access to conventional devices promise patient care. •Perception of low occupational risk of bloodborne Through the language of the regulation and the com- infections pliance directive, it is clear that safer sharps devices must • Incompatibility with other devices be used to minimize risk of injury to healthcare workers, •Inadequate training on new device or the employer may risk fines and penalties. Under the • Lack of complete institutional support law, OSHA is empowered to inspect the workplace at any A successful bloodborne pathogens safety program time for compliance with the regulations. The inspection must have a strategy that addresses all of these factors. may be part of a regularly scheduled OSHA inspection, A major component of any strategy must be an interdis- or may be a result of a worker complaint. In some areas ciplinary approach to identify, evaluate, and select safety of the country, both federal and state OSHAs have been products. Communication is also vital to educate employ- conducting random inspections for compliance with the ees, particularly those involved in direct patient care, that bloodborne pathogen standard. Employers that do not bloodborne pathogens exposure presents a real risk, and comply with the regulation can be cited and fined up to that the use of safety products is in their best interest. It is $70,000 for each violation. also important to communicate a similar message to departments that play a role in supporting a bloodborne Clinical Application of the Regulations pathogens safety program, such as the pharmacy, so that these departments are aware that they should maintain a There are a wide variety of factors to consider in evalu- stock of safety products and continually seek new and ating sharps injury prevention technology. The variety of improved safety technology.14,15 sharps technologies and the need to accommodate clin- Failure to consider and address these barriers can ical application and user preference can make the selec- doom even the best-intentioned efforts. This is an espe- tion of sharps safety technology somewhat complex. cially important message for the pharmacy, since any There are many categories of sharps devices to consider decisions to change product presentations made by the and multiple suppliers of technology in each category. pharmacist must be well coordinated with clinical end- The complexity is further compounded as there may be users and properly communicated; otherwise, they may little or no uniformity of technology among suppliers have a negative impact on the implementation of a safety because of the continuing product evolution and initiative, which could result in confusion, resistance, and improvement. The following list of factors should be con- ultimately, worker injury. sidered in evaluating safety technology in order to arrive Awareness of these factors, and an appreciation for the at an optimal solution that balances clinical preference complexity of the decision-making process, will optimize and clinical application.14 the process of recommending and selecting products to •Functional reliability improve safety and assure a comprehensive and effective •Suitability/range of uses compliance program. •Intuitiveness/ease of use •Active versus passive Sharps in the Pharmacy •Single-handed use •Hands remain behind sharp With OSHA’s focus on risk reduction, each department •Amount of change in technique required must evaluate products and work practices that present 6 Table 2. Examples of Drug Presentations To Be Assessed for Sharps Safety Needs Presentation Description *Examples of Application

Prefilled glass syringes Prefilled glass syringe containing a unit dose of Low molecular weight heparin, vaccines such as medication influenza, hepatitis B, pneumonia, Rh factor products

Prefilled glass cartridge systems Prefilled glass cartridge containing a unit dose of Narcotics, saline and heparin flushes, other generic medication, requiring a separate holder or handle in drugs order to deliver the contents (examples are Carpuject- and Tubex-type applications)

Prefilled plastic syringes Prefilled plastic syringes either commercially prepared Saline or heparin flush, antibiotics or filled in the pharmacy

*Examples are not intended to be inclusive

risk to the healthcare worker. In the pharmacy there is lit- duit of information from the clinicians, the pharmacy can tle risk of a contaminated sharps injury, but there are educate the pharmaceutical companies on the need for many product presentations that are dispensed from safety with all products that have the potential for injury to pharmacy that do represent risk for nurses and other workers during administration. involved in direct patient care. (Table 2) Because many “prefills” may be dispensed either irregu- Assessing Prefilled Syringes for Safety larly or infrequently, it is advisable for the pharmacy to check its inventory and document which drugs are stocked As noted earlier, assessing safety technology involves as “prefills.” After the prefilled products in the pharmacy matching the requirements of the regulations and the have been identified, the next step is to evaluate the safety realities of the clinical environment. Although OSHA options for each. Any products that are identified must be allows employers latitude in choosing technology by rec- evaluated by the frontline workers before adoption. ognizing that “no one medical device is appropriate in all Given the relationship with the pharmaceutical manufac- circumstances of use,” the employer remains obligated to turers, the pharmacy is in a unique position to identify safety reduce exposure to the “lowest feasible extent.”10 This cri- options for each prefilled drug and work proactively with the terion can only be met through a thorough evaluation of infection control or employee health department to assess available technology options coupled with clinical evalu- the current formulary of prefilled products and make recom- ation. Achieving this goal can be challenging because of mendations for selecting new drugs and presentations. the wide variety of technology options available and the The pharmacy is also in a position to create awareness unique nature of each clinical situation. Prefilled glass at the pharmaceutical company level regarding the need syringe presentations illustrate the complexity that can for safety on all prefilled offerings. By serving as a con- arise from this simple process.

Figure 2. Artist drawing of syringe with preattached needle. 7 Table 3. Prefilled Glass Syringes With Safety Devices Provided by the Manufacturer Company Drug Syringe Type Safety Device

Pharmacia Fragmin Preattached needle Preattached syringe-based passive/automatic safety mechanism

Sanofi-Synthelabo Arixtra Preattached needle Preattached syringe-based passive/automatic safety mechanism

Bayer BayRho-D, BayHep B, BayTet Preattached needle Preattached syringe-based active/manual safety mechanism

Ortho-Clinical Diagnostics RhoGAM, MICRhoGAM Preattached needle Preattached syringe-based active/manual safety mechanism

Amgen Neupogen, Neulasta Preattached needle Preattached syringe-based active/manual safety mechanism

GlaxoSmithKline Havrix, Engerix-B Luer lock Add-on needle-based active/ manual safety mechanism

Note: This list may not be complete and may not include all devices that are currently on the market. New products, applications, and safety devices are being introduced continuously. Companies should be contacted for complete product information.

Generally, all medications available in prefilled glass and require reconstitution. In other cases, it is the manu- syringes are intended for intramuscular or subcutaneous facturer’s choice to allow the clinician flexibility in needle injection, and therefore represent a bloodborne selection. In all cases, the clinician must add a needle to pathogens exposure risk for the caregiver administering make the injection. the dose. Thus, consideration of safety technology is At present, there are only a limited number of safety required under the bloodborne pathogens regulations. options available for prefilled glass syringe presentations. To begin an assessment of the safety options available Some are supplied preattached to the syringe barrel by for prefilled glass syringes, it is important to identify which the pharmaceutical manufacturer, while others are made drugs in the formulary are in prefilled presentations and available with an add-on device that is supplied separate- to subsequently differentiate the presentations that may ly from the syringe (Table 3). Some manufacturers do not be in prefilled glass syringes, prefilled glass cartridges, supply any safety device, in which case a separately pur- and prefilled plastic syringes—all of which may be chased add-on product should be considered (Table 4). stocked in the pharmacy. These distinctions are impor- The technologies for prefilled glass syringes are either tant because there are different safety options for each syringe-based, where the safety mechanism is incorporat- type of presentation. ed onto or into the syringe barrel, or needle-based, where As an example of the process for assessment and eval- the safety mechanism is incorporated onto the needle. uation of drug presentations and the need for sharps Until very recently, all of these safety technologies were safety options, the following discussion will be limited to active devices—manually activated through user interven- prefilled glass syringes. tion. Recently, however, 2 companies introduced passive, Prefilled glass syringes are available in 2 basic con- syringe-based technologies that automatically engage the figurations: safety device upon completion of the injection. Syringe with preattached needle: A glass syringe with a permanently attached, nonremovable needle. This Prefilled Syringes—Selection and Evaluation configuration offers no flexibility regarding needle selec- The selection of the sharps safety devices is based on tion and may pose a risk if an attempt is made to transfer numerous clinical and device characteristics, market contents to alternate syringe and needle presentation. availability, results of product evaluations, and ultimately, Syringe with Luer tip: A glass syringe with a Luer lock worker preferences. or Luer slip tip in place of the preattached needle. This Today, the selection and evaluation of needle safety configuration is sometimes required for long-term drug products for prefilled syringes involve assessing add-ons, stability issues related to interaction between the drug syringe-based manual and passive devices, manual nee- and the metal cannula, or the drug may be lyophilized dle-based alternatives, and perhaps even a return to vials, 8 Table 4. Sharps Safety “Add-On” Options For Prefilled Glass Syringes That May Be Obtained Separately Presentation Safety Option Comment

SafetyGlide Needle (Becton Dickinson)

Eclipse Needle (Becton Dickinson)

Needle-Pro (Portex, Inc.) Needle-based system requires manual activation Monoject Magellan Safety Needle (Tyco Healthcare/Kendall) Syringe with Luer tip Gettig Guard Safety Needle (Gettig Pharmaceutical Instrument Company)

Sterimatic Safety Needle (Sterimatic Medical Corp.) Needle-based passive/automatic system

SurGuard (Terumo Medical Corporation) Needle-based system requires manual activation

Syringe with preattached UltraSafe Needle Guard (SafetySyringes, Inc.) Syringe-based system requires manual needle activation

Note: This list may not be complete and may not include all devices that are currently on the market. New products, applications, and safety devices are being introduced continuously. Companies should be contacted for complete product information. All products need to be evaluated for use with prefilled syringes.

because not all pharmaceutical manufacturers have yet Another example is prefilled glass cartridge systems. chosen safety strategies for their products. Each drug The prefilled glass cartridge system is typically used for must be analyzed individually to determine what safety narcotics and other drugs to facilitate record keeping, options are available and whether there are differences in tracking, and billing. Manufacturers of these systems are technologies between manufacturers within a drug cate- now providing needleless versions that may be more gory. In the case of drugs with preattached safety tech- compatible with the I.V. systems in the institution but that nology, both the pharmacy and nursing’s role should be create other challenges when used for injection. Pharma- to identify options, work with users to evaluate those that cists and nurses should collaboratively determine best meet all clinical needs, and then ensure that the cho- whether it might be more effective to stock needleless sen products are always available. versions or the traditional needled forms, recognizing If add-on safety technologies are chosen, pharmacy that the user must have a needle for intramuscular and and nursing must participate in the analysis and evalua- subcutaneous injection purposes and that a safety strat- tion of the devices and work with other departments to egy must be identified for that needle. set up processes and procedures that will prevent the Safety products will present other considerations as well. use of the prefilled syringes without a needle safety For example, review of the impact that the added bulk will device. The establishment of a dispensing or stocking have on drug distribution strategies is crucial. For example, system that ensures the convenient and consistent avail- the addition of a safety device to a prefilled syringe may ability of the chosen safety device, along with the prefilled result in a need to reconfigure automated dispensing syringe, is vital to healthcare worker safety. equipment to accommodate the added bulk, or require the creation of an entirely new dispensing and stocking plan to Other Products, Other Considerations ensure that an add-on safety device is available when need- ed for all presentations without preattached safety technol- Besides prefilled syringes, there are other products in ogy. This system should have a mechanism to ensure that use throughout the institution that interface with pharma- the appropriate safety device is used. cy-dispensed medicines. For example, there are a variety In addition, safety technology may influence the way med- of I.V. access systems in use that do not require a needle. icines are chosen for the formulary. For example, risk con- These systems either use a blunt metal or plastic cannu- siderations arising from differences in safety technology la or adapt directly to a Luer lock tip. In these cases, the may play a role in formulary selection, whereas these con- pharmacy needs to work with the clinicians on the floor to siderations have not historically entered into decision mak- provide I.V. push-drug presentations in forms that are ing. The cost of these medicines is also likely to increase, as compatible with the chosen I.V. system. newer safety technology is adopted. The addition of safety 9 technology to a prefilled presentation adds manufacturing ety of reasons. Both pharmacy and nursing have been cost, some of which may be passed on to the pharmacy significantly impacted. Dosage forms of the medicines from the pharmaceutical company in the form of higher that are dispensed from the pharmacy will have an prices. In this case, the pharmacy budgets may need to be impact on the effectiveness of the overall safety program. adjusted accordingly. Specific practices related to nursing’s administration of parenteral medication also impact overall safety. Summary Therefore, it is incumbent on healthcare professionals to be aware of the requirements of the bloodborne In conclusion, the bloodborne pathogens regulations pathogens regulations and to work proactively with infec- have affected the use of sharps products by requiring the tion control or employee health to select drug presenta- use of safer sharps devices. These new devices have tions that will maximize compliance with the regulations resulted in substantial changes in clinical practice. These and, more important, help protect the health and safety of changes have often been difficult to implement for a vari- healthcare workers.

References 1. Occupational Safety and Health Administration. 29 CFR part 1910.1030. Occu- York City, March 1993–June 1994. MMWR. 1997;46:25-29. pational Exposure to Bloodborne Pathogens. Federal Register. 1991;56:64004- 8. Mendelson MH, Short LJ, Schecter CB, et al. Study of a needleless intermittent 65182. intravenous-access system for peripheral infusions: analysis of staff, patient, and 2. Needlestick Safety and Prevention Act: Federal Law 106-430; November 6, institutional outcomes. Infect Control Hosp Epidemiol. 1998;19:401-406. 2000; Washington DC. 9. Occupational Safety and Health Administration. Department of Labor: Occupa- 3. Panlilio AL, Cardo DM, Campbell S, et al. Estimate of the annual number of per- tional Exposure to Bloodborne Pathogens: Needlestick and Other Sharps cutaneous injuries in US healthcare workers. (Abstract S-T2-01). In: Program and Injuries: Final Rule. Federal Register. 2001;66:5318-5325. Abstracts of the 4th International Conference on Nosocomial and Healthcare- 10. NIOSH Alert: Preventing Needlestick Injuries in Health Care Settings. Washing- Associated Infections; March 5-9, 2000; Atlanta, Georgia: 61. ton, DC: National Institute for Occupational Safety and Health, Publication No. 4. Pugliese G, Salahuddin M. Sharps Injury Prevention Program: a Step-by-Step 2000-18; November 1999:10-13. Guide, Catalog No. 196311. Chicago, Ill: American Hospital Association; 1999:5- 11.OSHA Enforcement Procedures for Occupational Exposure to Bloodborne 8. Pathogens. Compliance Directive: 2-2.69. Washington, DC: Occupational Safety 5. Centers for Disease Control and Prevention. Updated US Public Health Service and Health Administration; November 27, 2001. Guidelines for the Management of Occupational Exposures to HBV, HCV, and 12. US Public Health Service: Healthy People 2010 Goals. Available at: http:// HIV and Recommendations for Postexposure Prophylaxis. MMWR. www.health.gov/healthypeople/document/html/objectives/20-10.htm 2001;50(RR11):1-42. 13.GAO. Needlestick Prevention. Washington, DC: US General Accounting Office, 6. Centers for Disease Control and Prevention. Evaluation of safety devices for pre- Publication No. GAO-01-60R; November 17, 2000. venting percutaneous injuries among healthcare workers during phlebotomy 14.Premier Safety Institute: “Improving Safety” [Sharps safety devices section]. procedures—Minneapolis–St. Paul, New York City, and San Francisco, 1993-95. Available at: http://www.premierinc.com/safety MMWR .1997;46:21-25. 15.Eck E, De Baun B, and Pugliese G. OSHA Compliance: Needlestick Prevention 7. CDC. Evaluation of blunt suture needles in preventing percutaneous injuries Requires Planning, Products and People. Infection Control Today. 2001;Aug:32- among healthcare workers during gynecological surgical procedures.—New 40.

10 Post-Test Choose the single-letter response that best answers the question or completes the sentence.

1. Which of the following bloodborne pathogens can be 9. Active sharps safety technology is characterized by transmitted to healthcare workers from a contaminat- automatic activation of the safety guard as part of the ed sharps injury? technique of the procedure being performed. a. hepatitis B virus a. true b. hepatitis C virus b. false c. HIV d. all of the above 10. Which of the following mechanisms is responsible for the majority of needlestick injuries from hollow-bore 2. Which of the following bloodborne pathogen infec- (eg, hypodermic) needles? tions can be prevented with pre-exposure vaccination? a. collision with a co-worker a. hepatitis B virus infection b. cleanup after the procedure b. hepatitis C virus infection c. manipulation of needle in patient c. HIV d. improper disposal d. all of the above e. recapping of needle 3. Which of the following factors may increase the risk of 11. When safety options are evaluated for prefilled syringe transmission of HIV through a needlestick injury from presentations, the newest technology should always an HIV-infected source patient? be selected. a. injury from a hollow blood-filled needle a. true b. stage of HIV infection in the source patient b. false c. severity of the injury d. all of the above 12. Which of the following need to be considered, within the context of a bloodborne pathogens safety pro- 4. Under the OSHA Bloodborne Pathogens Regulations, gram, with any change of drug presentation that which of the following factors is not appropriate justifi- involves the use of a sharp for administration? cation for failure to use engineering controls to pro- a. frontline clinician preference tect healthcare workers from sharps injury? b. resistance to change a. cost c. impact on clinical practice b. interference with medical procedure or patient care d. type of safety technology c. lack of market availability e. all of the above d. no documented needlestick injuries for a particular pro- cedure 13.Prefilled drug presentations may present a risk of injury to workers if they are not used with sharps 5. OSHA Bloodborne Pathogens Regulations require injury prevention features/device. frontline worker input for the selection and evaluation a. true of all sharps safety products. b. false a. true b. false 14.Safety technology for prefilled syringes is currently available: 6. Pharmacy personnel are generally at high risk for a a. preattached to the syringe barrel by the manufacturer contaminated sharps injury. b. supplied by the pharmaceutical manufacturer as an add- a. true on b. false c. available separately from nonpharmaceutical companies d. all of the above 7. Which of the following statements best summarizes the pharmacy’s role in a bloodborne pathogens com- 15. The adoption of sharps safety technology and prod- pliance program? ucts can affect the pharmacy directly by: a. The bloodborne pathogens regulations do not apply to a. decreasing the price of prefills pharmacy so there is no need for any involvement. b. reducing the size and bulk of drug presentations when b. Pharmacy should be directly involved due to the risk of preattached safety technology is added a contaminated sharps injury during drug admixture. c. requiring pharmacy to become active in taking mea- c. Pharmacy can play an important role in the identification sures to identify prefilled presentations with needles and of drug presentations that represent a sharps injury risk. coordinate risk reduction with clinicians d. The drug presentation decisions made by pharmacy d. exposing pharmacy to risk of needlestick injury have no impact on bloodborne pathogens safety. 16.Future decisions on drug formularies may include 8. Passive sharps safety technology is characterized by consideration of safety technology and compliance automatic activation of the safety guard as part of the with bloodborne pathogens regulations. technique of the procedure being performed. a. true a. true b. false b. false

11 CE Post-test Compliance With OSHA Requirements for Sharps Injury Prevention: The Role of Pharmacy and Nursing —Release September 1, 2002—

A 70% successful completion of this examination will provide the 1. The objectives of the program were achieved participant with 1.0 credit hours. The evaluation form and post-test a. Strongly agree b. Agree must be filled out completely for you to receive credit. Statements c. Disagree d. Strongly disagree of credit will be issued within 4 weeks of submission of post-test Comments: and evaluation. This credit is valid through August 31, 2003. ______Please complete the response form and mail to the attention of: ______2.The program was a valuable learning experience for me: a. Strongly agree b. Agree c. Disagree d. Strongly disagree Comments: ______SELECT AND CIRCLE THE SINGLE BEST ANSWER 3. The authors were effective in the presentation of the content: 1. a b c d a. Strongly agree b. Agree 2. a b c d c. Disagree d. Strongly disagree 3. a b c d Comments: 4. a b c d ______5. a b ______6. a b 4.The information was covered in sufficient detail: 7. a b c d a. Strongly agree b. Agree 8. a b c. Disagree d. Strongly disagree 9. a b Comments: 10. a bcde ______11. a b ______12. a bcde 5. The information presented was without promotional or com- 13. a b mercial bias: 14. a b c d a. Strongly agree b. Agree 15. a b c d c. Disagree d. Strongly disagree 16. a b Comments: ______AKH Consultant is approved by the American Council ______on Pharmaceutical Education (ACPE) as a provider of continu- 6.The examination was representative of the material presented: ing pharmaceutical education. This program has been assigned the Universal Program Number 077-999-02-015-H04. a. Strongly agree b. Agree AKH Consultant is approved as a provider of nursing c. Disagree d. Strongly disagree continuing education credit through the following boards Comments: of nursing: AL: #ABNP0229; CA: #CEP 12070; DE: ______#101; FL: #2851; IA: #277; KS: #LT0146-0338; NV: ______#NV010295-3; WV: #WV096.0127.RN. 7. My future educational needs include: ______

R EGISTRATION: Name License # or last 4 digits of SS# Pharmacist / Nurse / Other Street Address______City______State______Zip______Phone Number______Fax Number______E-mail ______Postmark date or fax date is official completion date The actual amount of time I spent on this activity was: ____hours____minutes SIGNATURE: 12 #236