Risk assessment of parenteral product preparation across secondary care acute trusts in the north of england

For personal use only. Not to be reproduced without permission of the editor
([email protected])
By Linda Hardy, BSc, MRPharmS, and Liz Mellor, MPharm, MRPharmS
acute trusts in the north of England.
In 1976,the Breckenridge reportnoted
the risks associated with the preparationof parenteral products in near-patientclinical areas.1 Since then, many adverse incidents have occurred following errors in the preparation and administration of par- enteral products.2 The incidence of errors in All 51 secondary care acute trusts in the area has been shown to be high and, although the minor, some errors will result in serious collection was carried out in three phases.
patient harm.3 The environment in wards in the locations where the preparation of par- Phase 1 The preparation of products in
enteral products has been carried out has eight high risk product categories (listed in in the north of England was reviewed.
been shown to be of variable quality and to Table 1, p59) were evaluated in Phase 1.
present a risk of product contamination.4,5 mission in its report,“A spoonful of sugar,” patient areas. Data collection was performed was that parenteral products should be pre- by pharmacy staff as a series of three 24h “snapshots” during the course of their regu- The identification and transfer to pharma- lar ward visits. Where near-patient clinical cy control of the preparation of all high-risk areas were not regularly visited (eg, theatre parenteral products is therefore a key target or X-ray departments), then special visits or for the NHS manufacturing and preparation liaison with staff working in these areas was arranged. During data collection, staff were asked to indicate the category of the product being prepared (eg, epidural) and, if possible, to identify the product itself (eg, diamor- gather data to enable broad, generalisable and staff at pharmacy parenteral preparation Bassetlaw Hospitals NHS Trust) and a large, in near-patient clinical areas per annum.
units about the number and types of prod- ucts they should be preparing, based on the relative risk potential for each product.
annual use figures, taking into account par- licensed centralised intravenous additive ticipation rates and the relative activity of units and unlicensed aseptic dispensing units different trusts using data based on finished operating under a “Section 10” exemption.) The intention was to answer the following: manufacturing and preparation services.
of adult and paediatric parenteral nutrition preparation units.Actual data were collected from batch production records.Adjustments for missing data were made, based on partic- Linda Hardy is project manager for reducing risk
with parenteral therapies and Liz Mellor is clinical
● What degree of overlap is there between governance lead pharmacist, both at Leeds Phase 2 The preparation in near-patient
Teaching Hospitals NHS Trust. Correspondence to clinical areas of 48 “high” or “high/ Linda Hardy at [email protected] medium” risk products, which are not part H O S P I TA L P H A R M A C I S T of any of the high risk product categories studied in Phase 1, was evaluated in Phase 2.
The products (listed in Panel 1) were select- Participation The participation rate varied
ed with reference to previous published5,6 between each data collection phase — the and unpublished risk assessment work car- highest was 82 per cent in Phase 1 and the ried out in a total of six trusts, including teaching and non-teaching hospitals. Thesedrugs were chosen not only because they Product preparation in near-patient
Drug name
Presentation
areas A summary of the number of prod-
high/medium risk but also because they are widely used in clinical practice. Two study categories (Phase 1) and the 48 named high aseptic managers from a variety of trusts, prepared in near-patient areas is set out in Following a pilot at Doncaster and Basset- of specific (a) epidural products (b) intrathecal products and (c) potassium-containing solu- collected from March to July 2005. Actual tions prepared in near-patient areas is given in Tables 2 (p60), 3 (p61) and 4 (p62–3).
were made in the same way as for Phase 1.
Phase 3 In Phase 3, the total output of
pharmacy parenteral preparation units was ● For cytotoxic products, the “Mito-in” evaluated. Data relating to the preparation of (a) non-parenteral nutrition adult products and (b) non-parenteral nutrition paediatric ● The other cytotoxic products prepared Data handling An Access database was
analysed. A series of reports was developed ● Preparation of adult parenteral nutrition Table 1: Summary of product preparation in near-patient clinical areas Product category
Number of doses Number of doses
collection
(Phase 1) or
prepared in near-
prepared in near-
product type
patient areas
patient areas
(actual data)
(estimated data)
Subtotal
1,227,325
Only doses described as “intraocular”, “intracameral” or “intravitreal” were included in the intraocular product category — doses described as “periocular” (eg, given by subconjunctival intavesicular, and desferrioxamine, which is H O S P I TA L P H A R M A C I S T consisted of the addition of vitamins andtrace elements to pre-made bags.
Table 2: Examples of epidural products prepared in ● For intraocular injections, cefuroxime near-patient clinical areas in trusts in the north of England chloride 0.9 per cent or balanced saltsolution, accounted for about 86 per Number prepared (per annum)
cent of products prepared in near-patient areas.
Alfentanil 2.5mg in 0.1% bupivacaine 250ml ● Most of the preparation of eye drops in Clonidine 1.5 microgram/ml in bupivacaine 0.125% additions to balanced salt solution.
Clonidine 150–300 micrograms in bupivacaine 0.08% 500ml Clonidine 150–300 micrograms in bupivacaine 0.125% 250ml Product preparation in pharmacy par-
Clonidine 1 microgram/ml in levobupivacaine 0.125% enteral preparation units The total
Diamorphine 50mg in bupivacaine 0.1% 500ml parenteral preparation units in the north of England was 2,269,000 units per annum.
Parenteral nutrition output (Phase 1) was Diamorphine 5mg in bupivacaine 0.1% 400ml Diamorphine 5–10mg in bupivacaine 0.08% 500ml products (Phase 3) was 1,854,561; and pae- Diamorphine 30mg in bupivacaine 0.1% 500ml diatric non-parenteral nutrition products Diamorphine 20mg in bupivacaine 0.1% 500ml Diamorphine 20mg in bupivacaine 0.1% 250ml Diamorphine 10mg in bupivacaine 0.1% 250ml Discussion
It is clear that high risk products are still being prepared in near-patient clinical areas at hospitals in the north of England. The Fentanyl 0.8 microgram/ml in bupivacaine 0.1% extent of such preparation varies between Fentanyl 1,000 micrograms in bupivacaine 0.1% 250ml Fentanyl 2 microgram/ml in bupivacaine 0.1% Fentanyl 2 microgram/ml in bupivacaine 0.1% 100ml Relatively few parenteral nutrition feeds Fentanyl 2 microgram/ml in bupivacaine 0.1% 10–20ml bolus are prepared in near-patient clinical areas.
Fentanyl 2 microgram/ml in bupivacaine 0.15% 250ml However, that any are prepared in this way is Fentanyl 50 microgram in bupivacaine 0.125% 20ml of concern, because these products usually contain lipid emulsion and are infused over temperature, making them particularly sus- Methylprednisolone 80mg in levobupivacaine 0.5% 10ml Morphine/adrenaline/bupivacaine 0.25% mixtures in near-patient areas that ideally should not Pethidine 100mg in 50ml sodium chloride 0.9% be include cefuroxime intracameral injec- tion (in either sodium chloride 0.9 per cent Triamcinolone 40mg in bupivacaine 0.125% 20ml or balanced salt solution). This requires two dilution stages and seven manipulations, giv- ing it an overall risk score of 33 (a highscore) using the Newcastle Risk Assessment Data relate only to instances where it was possible to identify the product (and not just the product category) being prepared and totals are therefore not the same as in Table 1.
Use of this device is increasing because ofthe clinical need to administer the drug Table 3: Examples of intrathecal preparations prepared in close to the time of surgery,12 making it diffi- near-patient clinical areas at trusts in the north of England cult for pharmacy staff to provide theproduct in a ready-to-use format.
Number prepared
Apart from the Mito-in device, all prepa- (per annum)
ration of cytotoxics in near-patient areasoccurred in departments other than oncolo- Diamorphine 0.5–3mg in water for injections Diamorphine 5mg in water for injections 5ml duction in near-patient areas is minimal. On Diamorphine 300–500 micrograms in bupivacaine 0.5% plain or heavy the other hand, it is worrying, because staff Diamorphine 300 micrograms in bupivacaine 0.5% up to 4ml less likely to have the knowledge and skills Diamorphine 300 micrograms in bupivacaine heavy 0.5% up to 4ml required to handle cytotoxics safely and to Fentanyl 25–30 micrograms in bupivacaine 0.5% plain or heavy ensure that the drugs are provided in a suit- Fentanyl 25 micrograms in bupivacaine 0.5% up to 4ml Fentanyl 25–100 micrograms in bupivacaine heavy 0.5% Fentanyl 25 micrograms in levobupivacaine Variety of products prepared in near-
patient areas There is a wide variation
between trusts in the types of products being prepared in near-patient areas. For example, Morphine preservative free 10mg in 10ml sodium chloride 0.9% only five of the 40 different types of epidural Triamcinolone in lidocaine miscellaneous doses trust (diamorphine in bupivacaine, diamor- diamorphine 10mg in bupivacaine 0.1%500ml, Intrathecal chemotherapy injections are not included. Data relate only to instances where it was possible to identify the product (and not just the product category) being prepared and totals are 2 microgram/ml in bupivacaine 0.1%). Four therefore not the same as in Table 1.
different clonidine and local anaestheticmixtures and 32 different opiate and local Phase 1) doses per trust per annum are being anaesthetic solutions were reported.
guidelines from the National Patient Safety prepared in near-patient areas is of concern.
For intrathecal preparations, there seems Only one trust (Royal Liverpool and Broad- to be a greater degree of uniformity of for- green University Hospitals NHS Trust) has stopped the use of concentrated potassium- in bupivacaine heavy 0.5 per cent was used “where there is a requirement for potassium containing solutions in near-patient clinical by five trusts, with minor variations (for solution in a dilution which is not available commercially . . . the solution should be pre- It should be noted that, for cytotoxics, a phine) being used by another four trusts.
risk assessment carried out by Quality Con- possible”.9 Particular problems are encoun- trol North West concluded that provided the solutions of potassium chloride reported in Mito-in device (cytotoxic) is used in accor- use was 53 and this does not include unspec- phosphate solutions in near-patient areas, dance with its licence, its preparation in ified “miscellaneous” doses. As for all the because two different strengths of the con- near-patient clinical areas is associated with high risk category products, clinical review centrated solution from which dilutions are a medium (rather than a high) level of risk is needed to determine the need for such a diverse range of preparations and to assess this product in a pharmacy unit or depart- the potential for minimising risk by standar- data from the 41 trusts that participated in ment is therefore desirable, but not essential.
dising practice where possible. In particular, Table 4: Examples of potassium-containing solutions prepared in near-patient clinical areas at trusts in the north of England (continued on p63) Presentation
Number prepared (per annum)
Intravenous potassium chloride-containing solutions
Potassium chloride 100mmol in sodium chloride 0.9% 1,000ml
Potassium chloride 10mmol in glucose 10%/sodium chloride 0.18% 500ml Potassium chloride 10mmol in glucose 2.5 %/sodium chloride 0.45% 500ml Potassium chloride 10mmol in sodium chloride 0.45% 500ml Potassium chloride 120mmol in sodium chloride 0.9% 1,000ml Potassium chloride 120mmol in sodium chloride 0.9% 250ml Potassium chloride 13mmol in glucose 5% 500ml Potassium chloride 20–40mmol in sodium chloride 0.9% Potassium chloride 20–40mmol in glucose 5%/sodium chloride 0.45% Potassium chloride 20–40mmol in glucose 10% 500ml Potassium chloride 20–40mmol in glucose 5%/sodium chloride 0.45% 500ml Potassium chloride 20–40mmol in glucose 10%/sodium chloride 0.18% 500ml Potassium chloride 20–40mmol in glucose 5%/sodium chloride 0.45% 1,000ml Bag Potassium chloride 20–40mmol in Hartmann’s 1,000ml Potassium chloride 20–40mmol in sodium chloride 0.9% 500ml Potassium chloride 20–60mmol in glucose 5% 500ml Potassium chloride 20mmol in glucose 20% 500ml Potassium chloride 20mmol in sodium chloride 0.9% Potassium chloride 20mmol in glucose 10% 1,000ml Potassium chloride 20mmol in glucose 4%/sodium chloride 0.18% 1,000ml Potassium chloride 20mmol in glucose 4%/sodium chloride 0.18% 500ml Potassium chloride 20mmol in sodium chloride 0.45% 500ml Potassium chloride 20mmol in sodium chloride 0.9% 100ml Potassium chloride 30mmol in glucose 4%/sodium chloride 0.18% 500ml Potassium chloride 40mmol in sodium chloride 0.9% 50ml Potassium chloride 40mmol in glucose 5% 1,000ml Potassium chloride 40mmol in glucose 5% 100ml Potassium chloride 40mmol in sodium chloride 0.9% 250ml Potassium chloride 40mmol in sodium chloride 0.9% 100ml Potassium chloride 60mmol in dextrose saline 1,000ml Potassium chloride 60mmol in sodium chloride 0.9% 1,000ml Potassium chloride 80mmol in sodium chloride 0.9% 1,000ml Potassium chloride 80mmol in Hartmann’s 1,000ml Potassium chloride 80mmol in sodium chloride 0.9% 500ml Potassium chloride 10–20mmol in glucose 5% Potassium chloride 10mmol in 50ml sodium chloride 0.9% Potassium chloride 20mmol in 20ml sodium chloride 0.9% Potassium chloride 20mmol in sodium chloride 0.9% Potassium chloride 20–40mmol in 10–20ml sodium chloride 0.9% Potassium chloride 40mmol in sodium chloride 0.9% 40ml Potassium chloride 40mmol in sodium chloride 0.9% 50ml Potassium chloride 40mmol in sodium chloride 0.9% Intravenous potassium and phosphate-containing solutions
Potassium acid phosphate 20mmol in sodium chloride 0.9% 100ml
Potassium acid phosphate 9mmol in glucose 5% /sodium chloride 0.45% 500ml Bag Potassium acid phosphate solutions miscellaneous H O S P I TA L P H A R M A C I S T Table 4 (continued from p62): Examples of potassium-containing solutions prepared in near-patient clinical areas at trusts in the north of England Presentation
Number prepared (per annum)
Intravenous potassium and phosphate-containing solutions (contd)
Potassium acid phosphate 40mmol in sodium chloride 0.9% 60ml
Potassium phosphate 8.71% in water for injections 20ml Potassium solutions used in haemofiltration or dialysis fluids
Potassium chloride 10–80mmol in haemofiltration fluid
Potassium chloride 20mmol in Haemosol dialysis fluid 3 litres Potassium chloride 20mmol in Aqualact 5 litres Potassium chloride 25mmol in lactate-free haemofiltration fluid Potassium chloride 40mmol in haemofiltration fluid Potassium chloride 4mmol per litre in peritoneal dialysis solution Potassium chloride miscellaneous doses in haemofiltration fluid Data relate only to instances where it was possible to identify the product (and not just the product category) being prepared and totals are therefore notthe same as in Table 1.
it is important for all pharmacy staff to fol- are several factors which may help to make low clinical governance principles and liaise capacity available within existing facilities.
with prescribers to ensure that high risk drugs or routes of administration are only used when there are no suitable, lower risk, products should be used. Before supplying or prescribing a “special” or extemporane- ously dispensed product pharmacists should satisfy themselves that there is a real clinical larger batch sizes and longer shelf-lives, staff in the risk assessment of product prepa- ration in near-patient clinical areas looks set to increase in the future. The results of this with the NPSA which is set to issue a bul- increasing efficiency within the existing letin on injectable medicines later this year.
This is likely to require trusts to risk-assess the preparation of all parenteral products used and to control all procedures that are found to be of high risk. Clinical and tech- prepared products. It is to be noted that nical pharmacy staff will have a role working with nursing and medical colleagues in the implementation of the requirements of the Modernisation of pharmacy prepara-
tion services All pharmacy aseptic units are
now required to have capacity plans for
Panel 2:The four central pillars of the NHS manufacturing pharmacy parenteral preparation services.To supply all the high risk products currentlyprepared in near-patient clinical areas in aready-to-use form from a pharmacy service, ■ National co-ordination — to create a and preparation capacity of approximately 50 per cent would be required. Modernisa- ■ Capital investment — to maintain and ■ Working with industry partners — to preparation services, along four central pil- lars (see Panel 2), will not be able to provide all of this increased capacity.13 Instead, there H O S P I TA L P H A R M A C I S T three days was analysed and, although there all participating trusts with an opportunity is nothing to suggest that any of these days (Royal Victoria Infirmary, Newcastle-upon- to review their own aseptic service provision Tyne), Ian Beaumont (Quality Control North preparation, it is possible that different results West, Stockport), Anne Black (Freeman Hos- would have been obtained had different days pital, Newcastle-upon-Tyne), Roger Brooks prepared in near-patient areas within the (Sheffield Teaching Hospitals), Roger Han- drugs was carefully chosen to suit trusts in NHS Trust), David Knass (Stepping Hill Hos- the project area as a whole. Individual trusts pital, Stockport), John Timmins (Sheffield Children’s Hospital NHS Trust) and Charlotte tion Board to support trust chief pharmacists appropriate to their needs, particularly those Gibb, Liz Kay and Diane Palmer (all at Leeds in this task.Work will also be undertaken to address the various issues this project identi- fied in each drug category. Links to current Hospital Pharmacist online
work of various clinical and technical groups Hospital Pharmacist is available online at will be established with the aim of develop- Conclusions
www.pjonline.com/hp/index.html
The website contains the current issue and an archive of back issues from January 2000 conducted in trusts in the north of England assessment process as part of this project and onwards.There are also links to the regular have found high risk areas of practice within features in Hospital Pharmacist (eg, (north), has generated data which are gener- addressed locally. Some trusts have already comments, careers, focus on technicians) Manufacturing and Preparation Service as a drawn up action plans in response to their findings. It is recommended that all trusts contributors to Hospital Pharmacist, Limitations Not all trusts in the project
practice and ensure that parenteral prepara- a link to The Pharmaceutical Journal careers area provided data, and so it was necessary to tion services are increasingly focused on the page and information on subscribing to the based on sound principles, might not accu- There is a diary page with reunions, branch rately represent the actual extent of product initiatives, with a multidisciplinary approach preparation in near-patient areas. In addi- at both levels will be needed to produce an (www.pjonline.com/diary).
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Source: http://media.dh.gov.uk/network/121/files/2011/03/Hardy-Mellors-Risk-Ass-Parenteral-Prod-Prep.pdf