ADVANCED DELIVERY DEVICES – Incorporating Patient-Centric Design Into a Novel Anti-Needlestick Safety Device
Historically, safety devices have been primarily added to prefilled syringes to meet anti-needlestick legislation around the globe. Today, we see a growing number of biotechnology drugs in pharmaceutical company pipelines that require devices to meet both healthcare practitioner and self-injecting patient needs. For example, patients with chronic diseases often suffer from impaired dexterity, making it difficult to perform an injection. And, many biologics have more complex properties, which make them harder to inject subcutaneously. Therefore, the design of a safety device to support biotechnology drugs must be able to address these requirements.
NEEDLESTICK SAFETY TODAY
The exposure of healthcare practitioners to bloodborne pathogens as a result of injuries caused by needlesticks are of a significant public health concern. The US Centers for Disease Control and Prevention (CDC) has estimated the number of sharps injuries in healthcare to be approximately 600,000 each year, with about half of those injuries occurring in US hospitals.1,2
Given the high incidence of needlestick injuries, we have seen an increase in legislation on a global scale. In 2000, the US enacted the Needlestick Safety and Prevention Act; in 2008, the Province of Ontario passed 474/07; Brazil passed rule Norma Regulamentadora NR32 in 2005; and Portaria MTE N.° 939 in November 2008 with a deadline to implement in October 2010.3-5 The EU passed a mandate 2010/32/EU that requires all EU member countries to address the danger of accidental sharps injuries (including needlesticks) by enforcing this legislation beginning May 13, 2013, and as a result, many member countries have passed new legislation.6 For example, Austria, Belgium, Finland, Germany, Hungary, The Netherlands, Norway, Poland, Slovenia, Spain, Sweden, and the UK have all subsequently finalized and passed needlestick safety legislation to support the May 2013 deadline. It is also anticipated that this increase in legislation will impact the presentation of injectables, especially those in prefilled syringes as although it does not specifically target the pharmaceutical manufacturer, many pharmaceutical companies are using this as an opportunity for brand differentiation as they are seeing value in offering safer injection presentations for end-users.
During a recent onsite seminar at the headquarters for BD Medical-Pharmaceutical Systems in Le Pont de Claix, France, Mrs. Stephanie McCarthy, a registered nurse from the Derby Hospitals NHS Foundation Trust in the UK emphasized the importance of hospital worker safety legislation to protect both healthcare workers and patients. Mrs. McCarthy also spoke regarding the costs for implementation of needlestick safety in the workplace and how they far outweigh the monetary and psychological costs of not introducing safety-engineered medical devices in the hospital.
INTUITIVE SAFETY DEVICE DESIGN
Several studies have confirmed that the safety aspect of an injection device is highly valued with nurses and self-injecting patients, and preferred over a bare prefilled syringe.7 However, it is very important that the correct device is selected. A passive safety technology has been shown to be the most effective as demonstrated by the Tosini study, a 2010 study conducted by GERES (Groupe d’Etude sur le Risque d’Exposition des Soignants), which confirmed that passive, fully automatic safety devices offer better protection against accidental needlestick injuries.8 The BD UltraSafe Passive™ Needle Guard (Figure 1) uses an innovative passive safety technology. The superiority of the passive safety technology arises because most needlestick injuries happen in the few moments after needle withdrawal.9 Because of this, it is critical that the needle is shielded right after the injection. Any extra steps required by the user may result in no activation of the safety mechanism, resulting in an unshielded and potentially infectious needle until disposal.
The growth in the biologic segment, estimated at $176.4 billion in sales for 2012, is driving the need for novel delivery systems.10 The majority of the over 550 biologics in development are monoclonal antibody therapies targeting chronic and auto-immune diseases, such as rheumatoid arthritis (RA), psoriasis, or multiple sclerosis (MS).11 These biologics are typically administered by a subcutaneous injection by the patient or caregiver at home rather than at a clinic or doctor office. This provides convenience for the patient while also reducing healthcare costs.
Many self-injecting patients suffering from chronic diseases may also suffer from reduced dexterity, making self-administration especially difficult. Self-injecting patients are trained when they receive treatment for the first time; however, intuitiveness and ease-of-use are essential factors in overall injection device design. To address this, many devices are provided in a variety of designs and different activation mechanisms to suit patient requirements.
In addition, biotech drugs, specifically monoclonal antibodies, can be quite viscous, which can then make them even more difficult to inject. This is especially true for patients who suffer from debilitating disease, such as RA. Furthermore, biologics often are administered in varying doses and volumes, requiring that the injection device design be able to support a range of fill volumes.
BD ULTRASAFE PLUS™ PASSIVE NEEDLE GUARD
BD Medical-Pharmaceutical Systems, Safety has developed a novel injection device, BD UltraSafe Plus™, based on the clinically proven BD UltraSafe Passive™ Needle Guard platform. The BD UltraSafe Passive™ Needle Guard, designed primarily for use in a clinical setting, has been marketed for over 12 years and successfully commercialized with over 30 different drugs.
The design of the BD UltraSafe Plus™ Passive Needle Guard (Figures 2 & 3) is to specifically support biotechnology drugs and provide improved handling, especially for those patients who prefer manual injection control. Specific features include the following:
• Extended built-in finger flanges and ergonomic plunger head provide a better feel for manual injection by the self-injecting patient (Figure 4).
• Robust plunger rod supports injection of viscous drugs.
• Larger drug inspection window improves drug visibility.
Many patients have different requirements depending on their technique, injection site, and dexterity impairment. Therefore, there is not always a single device that meets all end-user requirements. BD offers many options for self-injecting patients, including the BD Physioject™ Autoinjector for patients who prefer automatic injection as well as the new BD UltraSafe Plus™ Passive Needle Guard for patients who may prefer more manual control over their injection. BD incorporates a rigorous human factors and patient-centric design approach to meet the needs of healthcare providers, patients, payers, and pharmaceutical companies.
The overall design of the BD UltraSafe Plus™ Passive Needle Guard was validated by performing handling studies with both nurses and self-injecting patients. In June 2012, a large clinical focus group was performed, which included 500 injections by self-injecting patients and nurses. Patients in this study suffered from RA, MS, cancer, Crohn’s, and asthma. These diseases can have very different effects on dexterity, thus it was important to test the design with a broad range of patients.
Results from the user study confirmed that the BD UltraSafe Plus™ Passive Needle Guard was intuitive and easy to use with a 100% activation success rate for all 500 injections.12 In addition, the added design features, such as the wider finger flanges and ergonomic plunger rod, were positively received by all users in providing additional injection support.
The results of the user study not only supported the added design features, but also the ability of BD UltraSafe Plus™ Passive Needle Guard to provide additional support in injecting drugs of higher viscosity. All users preferred to inject viscous solutions using BD UltraSafe Plus™ Passive Needle Guard than a standard prefilled syringe.13
ADD-ON FINGER FLANGES FOR INJECTION SUPPORT
The BD UltraSafe Plus™ Passive Needle Guard was designed with extended finger flanges to accommodate one full finger on each side of the device. There are, however, some patients who may prefer even wider finger flanges to support their injection. Given this requirement, BD Medical-Pharmaceutical Systems will offer specific add-on finger flanges to support the BD UltraSafe Plus™ device. Moreover, the design of this add-on finger flange will take into consideration particular shapes and textures that are perceived differently across various patient populations allowing for more disease-specific designs.
SUPPORTING MANUFACTURING CAPABILITIES
After the design of the BD UltraSafe Plus™ Passive Needle Guard was confirmed, we consulted with leading automation machine builders to ensure assembly of the BD UltraSafe Plus™ Passive Needle Guard was compatible with minimal modifications to existing or planned secondary packaging lines for the BD UltraSafe Passive™ Needle Guard device.
The BD UltraSafe Plus™ Passive Needle Guard is designed to be used in conjunction with 1.0-mL long prefilled syringes with staked needles, such as the BD Hypak™ or BD Neopak™ Glass Prefillable Syringe. The BD UltraSafe Plus™ Passive Needle Guard received 510(k) clearance as an anti-needlestick safety device in April 2013 and was commercially launched by a pharmaceutical company in 2013.
The market for biotechnology drugs continues to grow, and there is a need for pharmaceutical companies to offer injection devices that support both the complex properties of the biologic as well as the needs of the end-user who will be performing the injection. Patients, especially those with limited dexterity, have very specific needs and requirements for the injection device. Providing a prefilled syringe with a safety device specifically designed for patients who prefer manual injection control and for drugs with higher viscosity provides pharmaceutical companies with a viable option that supports both of these requirements.
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1. Center for Disease Control and Prevention Sharp Safety. Website: http://www.cdc.gov/sharpssafety/pdf/workbookcomplete.pdf.
2. Panlilio AL, Orelien JG, Srivastava PU, Jagger J, Coh RD, Cardo DM. The NaSH surveillance group, & the EPINet data sharing network. (2004). Estimate of the annual number of percutaneous injuries among hospital-based healthcare workers in the United States. Infect Control Hosp Epidemiol.1997-1998;25(7):556-562.
3. 106th Congress – Public Law 106-430, (2000). The Needlestick Safety and Prevention Act.
4. Ontario Needle Safety Regulation (O.Reg. 474/07) under the Occupational Health and Safety Act.
5. World Health Organization: New Legislation and regulation for safer needle devices in Brazil . Website: http://apps.who.int/occupational_health/publications ;
6. Directive 2010/32/EU https://osha.europa.eu/en/legislation/directives/sectorspecific-and-worker-related-provisions/oshdirectives/council-directive-2010-32 ;
7. Data on file.
8. Tosini W, et al. Needlestick injury rates according to different types of safety-engineered devices: results of a French multicenter study. Infect Control Hosp Epidemiol. 2010;31(4):402-407.
9. Hotaling M. The Need for Safety Devices: A Healthcare Perspective. PDA Prefilled Syringes Interest Group Workshop. Carlsbad, CA. 2010. Available by request.
10. Transparency Market Research: Biologics Market G7 Industry Size, Market Share, Trends, Analysis and Forecasts. 2012-2018.
11. Carlson . Pipeline bodes well for biologics growth. Gen Engin News. Online posting. June 15, 2011;31(12). http://www.genengnews.com/gen-articles/pipelinebodes-well-for-biologics-growth/3693/.
12. Data on file.
13. Data on file.
Sarah Baer is currently the Marketing Product Manager at BD Medical –Pharmaceutical Systems, Safety (formerly SafetySyringes, Inc.) with over 10 years of experience in the Biotechnology and Pharmaceutical industries. Before joining BD, Ms. Baer was a Senior Product Manager at Teva Pharmaceuticals in Irvine, California. Ms. Baer earned her MBA at San Diego State University and her BSc Biochemistry at McMaster University in Hamilton, Ontario, Canada.
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