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Tuesday 25 June 2019
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Council Directive 2010/32/EU: impact on pharmacy team

DIRECTIVE
Debra Adams RN PhD
Independent Consultant Advisor/Programme Specialist,
Healthcare Associated Infection,
NHS Midland and East,
St Chads, Hagley Road,
Birmingham, UK
Email: debra.adams@westmidlands.nhs.uk


Member States of the European Union (EU) have until 11 May 2013 to implement Council Directive 2010/32/EU. This article examines the issues surrounding sharps injuries and some of the implications for pharmacy teams

The National Audit Office in 2003 identified that sharps and needlestick injuries (NSI) accounted for 17% of accidents to NHS staff.(1) Sharps and NSI can transmit disease and therefore are a significant occupational hazard for healthcare workers (HCW). Between 1996 and 2009, there were 17 recorded cases of HCW sero-converting to hepatitis C in England following percutaneous exposure to a virus-infected patient.(2) Five cases of HIV sero-conversions resulting from percutaneous exposure were reported in HCW in the UK up until 2007, and none since 1999.(3)
In addition, the danger of an accidental NSI when working with hazardous drugs can present a significant health risk.
Over at ten-year period in an American nuclear medicine/pharmacy department, 41 nuclear medical technologists reported 27 radiotherapy-associated NSIs.(4)
Factors influencing injuries
Sharps and NSIs occur for a number of reasons, including: types of device used and procedures undertaken, lack of training on safe use and disposal of needles and sharps, and lack of knowledge of the consequences of such injuries. It is important to understand these areas to ascertain how best to reduce occupationally acquired sharps and NSIs in the healthcare setting. 
Who is at risk from sharps injuries?
From the data reported in 2007, the Health Protection Agency3 have identified that the professions most at risk from a sharps injury are:
  • medical/dental staff – 46% 
  • nursing staff – 44% 
  • professions allied to medicine (such as pharmacy) – 6% 
  • ancillary staff – 2% 
  • unknown – 1% 
While the evidence demonstrates that the risk of blood-borne virus (BBV)transmission to pharmacists is low, it remains necessary to protect them from exposure to transmission of infection, and to avoid exposure to other toxic medications such as cytotoxic chemotherapies and radiopharmaceuticals.
Legislation
All Member States of the EU will need to implement the Council Directive 2010/32/EU to prevent injuries and infections to HCW in both private and public domains, including prisons, as a result of sharps/NSI. This Directive applies to all workers in the hospital and healthcare sector, and all who are under the managerial authority and supervision of the employers. The purpose of this Directive is to:
  • achieve the safest possible working environment
  • prevent workers' injuries caused by all medical sharps (including needle-sticks)
  • protect workers at risk
  • set up an integrated approach establishing policies in risk assessment, risk prevention, training, information, awareness raising and monitoring
  • put in place response and follow-up procedures.
Implementing the Legislation
As identified, the key risks associated with sharps and NSI are both injury and the potential risk of BBV transmission from infected blood and body fluids. 
Key requirements that need to be implemented include: 
Risk assessment 
  • Undertake a risk assessment. Identify if there is a risk of injury, exposure to blood or other potentially infectious material from sharps or NSI, both within the department and when undertaking clinical visits?
  • Can the risk be eliminated or minimised? 
Risk elimination and prevention
  • Firstly, eliminate the unnecessary use of sharps 
  • Can the risk of exposure be reduced by using alternative devices or amending practices and procedures?

For example, medications that are dispensed from pre-filled syringes, such as low molecular weight heparin, will require the syringe/needle to be a safety engineered device (SED) where available. In addition, assess where there is a potential use for alternative practices, such as glass ampoule openers to protect from broken glass cuts, closed system drug transfer devices to mix medications and replacing glass products with plastic where suitable. 

Wittmann has developed a standardised risk assessment matrix for medical sharps which identifies the potential risks of BBV transmission associated with devices/procedures and the appropriate level of sharps safety required (Figure 1).(5) 
  • Ban the recapping of needles 
The preparation of medications such as cytotoxic chemotherapies and radiopharmaceuticals can be potential causes of exposure via NSI to the HCW.(4,6) Therefore, while preparation is undertaken in an aseptic suite utilising an aseptic non-touch technique, these procedures frequently involve the re-capping of needles. Under this legislation, the re-capping of needles is banned with immediate effect. Consequently, procedures will need to be reviewed and alternative products, such as blunt fill needles/filters and re-capping blocks, should be considered.
  • Improving education and awareness 
All staff should have access to training on the safe handling and disposal of sharps. The principles surrounding the safe use and disposal of sharps have been identified:(7,8)
– Handling of sharps should be kept to a minimum
– Syringes or needles are not dismantled by hand and are disposed of as a single unit straight into a sharps container for disposal 
– Sharps are not passed directly hand to hand
– Sharps containers are readily available as close as possible to the point of use (sharps trays with integral sharps boxes are a useful resource)
– Needles are never re-sheathed or recapped
– Needles are not broken or bent before use or disposal
– Arrangements should be in place to ensure the safe disposal and transport of sharps used in a community setting such as patients' homes
– All sharps containers should conform to UN standard 3291 and British Standard 7320
– Sharps containers are not filled to more than two-thirds of capacity
– Sharps containers are signed on assembly and disposal
– Sharps containers should be temporarily closed when not in use
– Sharps containers are stored safely away from the public and out of reach of children 
– Sharps containers should be disposed of every three months even if not full
– Staff should report sharps injuries in line with local reporting procedures and policies
– Staff should attend training on the safe use of sharps and SED
  • Reviewing staffing levels to ensure they are appropriate for the work level
  • Ensure personal protective equipment is available at the point of use
  • Ensure appropriate sharps disposal systems are available at the point of use
  • Ensure the organisation has developed an overall occupational exposure policy and that staff are aware of both it, and the actions they are expected to perform should such an incident occur. 
Training
  • Incorporate use, safe handling and disposal of sharps procedures
  • Improve occupational exposure awareness, such as risks associated with exposure to blood, body fluids, cytotoxic chemotherapies and radiopharmaceuticals
  • Recognise the importance of hepatitis B virus immunisation.
Pre-exposure vaccination to hepatitis B should be considered for all HCW who are at risk of exposure to the virus from contact with blood, bloodstained body fluids or tissue.(9) While pharmacists might not have everyday contact with patients/clients, they may be exposed to the risk of a downstream injury (an injury not occurring to the original user, for example, from a discarded needle in waste bag). Therefore, vaccination should be provided and uptake encouraged.
  • Encourage occupational exposure reporting. 
Under-reporting of sharps and NSIs may occur for several reasons, for example: staff finding the reporting procedure to be time consuming, staff being too busy, poor follow-up procedures, staff underestimating the risks associated with contaminated needlesticks or sharps, and fear that reporting might have negative repercussions for them professionally.(10.11)
Information
  • Inoculation injuries should be reported promptly and appropriately, and risks identified following a root cause analysis into each case. 
Awareness raising and monitoring 
  • Employers are responsible for ensuring all staff are aware of the risks associated with occupational exposure from inoculation injuries 
  • Furthermore, health monitoring and vaccination should be provided where available.
Measures post inoculation injury
Healthcare workers are potentially at risk from receiving an inoculation injury. It is therefore essential that any occupational exposure to blood, body fluids, cytotoxic chemotherapies or radiopharmaceuticals be treated immediately, irrespective of whether there is any known risk.
The Department of Health has advised encouraging the wound to bleed as the initial action following a sharps injury.(12) Sucking of the wound by mouth is not recommended. If exposure has occurred to the eyes or mouth, these areas should be copiously irrigated with water. If contact lenses are being worn, then eyes should be irrigated both before and after lens removal. 
Healthcare workers should then immediately follow local policy and protocol regarding receiving further expert advice in order to reduce their risks associated with potential viral transmission following the sharps or NSI. 
Passive versus active SEDs
Passive SEDs do not require any additional actions by the user to activate the safety feature. Active SEDs require the user to activate the safety feature.(13) Active devices are only as good as the operator using them. If the operator fails, for whatever reason, to activate a safety feature, then the device is not protected and, therefore, the HCW is at risk from a sharp/NSI. It is essential that SEDs are appropriately evaluated by the clinical user using a recognised evaluation form, such as the one developed by Training for Development of Innovative Control Technologies14 prior to introduction to ensure that they meet user requirements, do not interfere with their original use and function and reduce risk of NSIs.(15) 
Examples of SED are shown in Figure 2. The main requirements of a needle SED are shown below.(14)
During use
  • The safety feature can be activated using a one-handed technique
  • The safety feature does not obstruct vision of the tip of the sharp
  • Use of this product requires you to use the safety feature
  • This product does not require more time to use than does a non-safety device
  • The safety feature works well with a wide variety of hand sizes
  • The device is easy to handle while wearing gloves
  • The device does not interfere with uses that do not require a needle
  • The device offers a good view of any aspirated fluid
  • The device will work with all required syringe and needle sizes
  • The device provides a better alternative to traditional recapping.
After use
  • There is a clear and unmistakeable change (audible or visible) that occurs when the safety feature is activated
  • The safety feature operates reliably
  • The exposed sharp is either permanently blunted or covered after use and prior to disposal
  • The device is no more difficult to process after use than are non-safety devices.
Training
  • The user does not need extensive training for correct operation
  • The design of the device suggests proper use
  • It is not easy to skip a crucial step in the proper use of the device.
The Health and Safety Executive has recently undertaken a systematic review of the efficacy of SEDs and their impact on sharps and NSIs.(16) Following the introduction of any SED, it is essential to ensure that continuing product reviews are undertaken. This will help to determine if there are any risks associated with use of the device. Adams and Elliott15 identified that some SEDs may cause splashing on activation. Roff and Health and Safety Laboratory also demonstrated that the activation of bench-top activated SEDs (devices which may be activated using surfaces such as tables or bedside lockers rather than by the operator's hand) may cause environmental contamination, which can accumulate on the surface near where the device has been activated.(17) Training is essential to ensure that HCW are aware of the risks associated with particular devices.
Financial costs
A study of the costs associated with implementation of SED to reduce the risk of NSIs was undertaken in 18 hospitals in Sweden.(18) The study demonstrated that the increased cost of the SED was offset by the reduction of costs associated with the investigation and treatment of a potential NSI. 
Failure to implement the Directive
Failure to implement the Directive will be seen as a criminal offence. In 2004, in the case of Skinner versus the Scottish Ambulance Service (Skinner v Scottish Ambulance Service 2004SC 790)(19) the Court took the view that the NHS refusal to introduce SEDs on cost grounds alone was a breach of employment and safety laws. More recently in 2010, The Worcestershire Acute Hospitals NHS Trust has been fined following an incident where a HCW contracted hepatitis C in 2007 from a NSI while taking blood from an infected patient. The issues highlighted were related to accessibility of sharps boxes, risk assessments and training/supervision. The Trust had been found to breach section 2 (1) of the Health and Safety at Work Act 1974 and regulation 6 of the Control of Substances Hazardous to Health Regulations 2002 and was fined £12,500 and ordered to pay £9000 costs.(20)
Conclusions
All HCW are at risk from sharps and NSIs. It is essential that pharmacists be protected from the risks associated with sharps and NSIs, risk of transmission of infection and toxic materials. Continuing implementation of safe working practices is paramount, as are risk assessment, risk elimination, training in use of devices and awareness of consequences of sharps and NSIs. Pharmacists have a pivotal role in assessing risks and evaluating any new SED introduced in their areas of practice. 
The Directive sets out the minimum standards required with regards to the Prevention from Sharps Injuries in the Hospital and Healthcare Sector;(21) at the time of writing this article the Health and Safety Executive (HSE) are consulting on the proposed regulations to implement Council Directive 2010/32/EU in the UK. 
Key points
  • Member States of the European Union (EU) have until 11 May 2013 to implement Council Directive 2010/32/EU – Implementing the Framework Agreement on Prevention from Sharps Injuries in the Hospital and Healthcare Sector.
  • Sharps and needlestick injuries (NSI) accounted for 17% of accidents to NHS staff.
  • The Directive aims to prevent healthcare workers' injuries caused by all medical sharps.
  • It is important that pharmacists are protected from the risks associated with sharps and
  • NSI, risk of transmission of infection and toxic materials
References
  1. National Audit Office. A Safer Place to Work: Improving the Management of Health and Safety Risks to Staff in NHS Trusts. http://tinyurl.com/bnd4zc9 (accessed 30 August 2012).
  2. NHS Employers. The Management of Health, Safety and Welfare Issues for NHS Staff. 2005. Revised chapter on needlestick Injury, 2011. www.saferneedles.org.uk/news/pdf_articles/Needlestick_2011.pdf (accessed 30 August 2012).
  3. Health Protection Agency (HPA), Centre for Infections, National Public Health Service for Wales and CDSC Northern Ireland and Health Protection Scotland. Eye of the Needle: United Kingdom Surveillance of Significant Occupational Exposure to Bloodborne Viruses in Healthcare Workers. 2008. November. /www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1227688128096 (accessed 30 August 2012).
  4. Hung JC, Krause SJ, Schmit CL. Sensible approaches to avoid needle stick accidents in nuclear medicine. J Nucl Med Technol 1999;27:290–3.
  5. Wittmann A. In European Biosafety Network: Toolkit for implementation of the European directive on prevention of sharps injuries. (Council Directive 2010/32/EC) in Member States. 2011. www.europeanbiosafetynetwork.eu/EBN%20Toolkit%202011.pdf (accessed 30 August 2012).
  6. Health and Safety Executive. Information Sheet MISC615 Safe handling of cytotoxic drugs. www.hse.gov.uk/pubns/misc615.pdf (accessed 30 August 2012).
  7. Royal College of Nursing. Wipe it out: one chance to get it right. 2012. RCN, London. www.rcn.org.uk/__data/assets/pdf_file/0008/427832/004166.pdf (accessed 30 August 2012).
  8. National Institute for Health and Clinical Excellence. Infection: prevention and control of healthcare-associated infections in primary and community care. Clinical Guideline 139. 2012. www.nice.org.uk/nicemedia/live/13684/58656/58656.pdf (accessed 30 August 2012).
  9. Department of Health. Immunisation Against Infectious Disease. 2006;The Stationery Office, London. 
  10. Haiduven DJ et al. A survey of percutaneous/mucocutaneous injury reporting in a public teaching hospital. J Hosp Infec 1999;41(2):151–4. 
  11. Costigliola V, Letondeur C, Strauss K. Needlestick injuries in European nurses in diabetes. Diabetes Metab 2012;38:S10–S14.
  12. Department of Health. HIV Post-Exposure Prophylaxis: Guidance from the UK Chief Medical Officers' Expert Advisory Group on AIDS. 2008. The Stationery Office, London.
  13. Centers for Disease Control and Prevention. Workbook for Designing, Implementing, and Evaluating a Sharps Injury Prevention Program. 2008. www.cdc.gov/sharpssafety/pdf/sharpsworkbook_2008.pdf (accessed 30 August 2012).
  14. Training for Development of Innovative Control Technologies. Safety Feature Evaluation Forms. 1998. www.tdict.org/evaluation2.html (accessed 30 August 2012).
  15. Adams D, Elliott TS. A comparative user evaluation of three needle-protective devices. Br J Nurs 2003;12(8);470–4. 
  16. Health and Safety Executive. An evaluation of the efficacy of safer sharps devices: systematic review. 2012. www.hse.gov.uk/research/rrpdf/rr914.pdf (accessed 30 August 2012).
  17. Roff M, Health and Safety Laboratory. Splatter hazard from syringe needle protectors an unintended consequence. Presented at the British Occupational Hygiene Society. April 2011. www.bohs.org/uploadedFiles/Events/Past_Events/4b%20-%20M%20Roff.pdf. (accessed 30 August 2012).
  18. Glenngård AH, Persson U. Costs associated with sharps injuries in the Swedish health care setting and potential cost savings from needle-stick prevention devices with needle and syringe. Scand J Infect Dis 2009;41(4):296–302.
  19. Skinner v Scottish Ambulance Service 2004SC 790. Scottish Court Ruling; 8 July 2004. www.scotcourts.gov.uk/opinions/A32403.html (accessed 17 September 2012).
  20. Health and Safety Executive. 2010. www.hse.gov.uk/prosecutions/case/case_details.asp?SF=CN&SV=4206786 (accessed 17 September 2012).
  21. European Agency for Safety and Health at Work. Council Directive 2010/32/EU: implementing the framework agreement on prevention from sharps injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU. Official Journal of the European Union. 2010 June 01.

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