NHS Pharmaceutical Quality Assurance Service Safe Medication Bulletin

Transcription

1 NHS Pharmaceutical Quality Assurance Service Safe Medication Bulletin Divisional Contracts Wave 8b 33% (DCE and DSW) This Bulletin alerts users to products accepted for the National Contracts which have been assessed and categorised as having a HIGH or MEDIUM risk, or a LOW risk Pharmaceutical Quality Assessment (PQA) with Potential Acceptability Issues (PAIs). Due to the large number of items on this contract a separate appendix has been produced. This gives details of further items with a MEDIUM risk where users are likely already to be aware or where a photograph does not enhance the description, and LOW risk items with potential acceptability issues. All assessments are carried out in accordance with the risk assessment tool described in Quality Assurance and Risk Assessment of licensed medicines for the NHS published by the NHS Pharmaceutical Quality Assurance Committee (2 nd Edition 2010). Users should take appropriate action to ensure staff are made aware of this assessment and take reasonable precautions to reduce the risk of a medication error occurring. This list may not be comprehensive and users are requested to use the local reporting processes if a medication error risk due to similarity of presentation, packaging and labelling is identified. HIGH RISK Pharmaceutical Quality Assessment Product Supplier NPC Code Adrenaline solution for injection amp 500mcg/0.5ml (1:1000) Martindale DCD010 Etomidate injection 20mg/10ml Janssen DOA092 Glyceryl trinitrate injection 5mg/5ml Serono DBF227 Itraconazole solution ampoule and infusion bag 10mg/ml 25 ml Janssen DEB054 Methadone solution for injection ampoule 10mg/1ml Martindale DDG050 Methadone solution for injection ampoule 20mg/2ml Martindale DDG443 Methadone solution for injection ampoule 35mg/3.5ml Martindale DDG483 Methadone solution for injection ampoule 50mg/5ml Martindale DDG444 Paracetamol solution for infusion vial 1g/100ml B Braun DDG152 Paracetamol solution for infusion vial 500mg/50ml B Braun DDM009 Pharmaceutical Quality Assessment Product Supplier NPC Code Adrenaline solution for injection ampoule 1mg/10ml (1:10,000) Martindale DBP013 Alfentanil solution for injection ampoule 5mg/1ml Hameln DIF015 Amiodarone solution for injection prefilled syringe 300mg/10ml Martindale DBC044 Page 1 of 18

2 Baclofen solution for injection 10mg/20ml Sun DJB023 Bupivacaine plastic solution for injection amp 25mg/10ml (0.25%) Mercury DOB146 Bupivacaine plastic solution for injection amp 50mg/10ml (0.5%) Mercury DOB160 Ciclosporin capsules 100mg Mylan DHB003 Ciclosporin capsules 25mg Mylan DHB004 Ciclosporin capsules 50mg Mylan DHB008 Dehydrated alcohol solution for injection amp 5ml Martindale DQK035 Diamorphine powder for solution for inj amp 100mg Actavis DDG004 Diamorphine powder for solution for inj amp 10mg Actavis DDG005 Diamorphine powder for solution for inj amp 30mg Actavis DDG006 Diamorphine powder for solution for inj amp 500mg Actavis DDG007 Diamorphine powder for solution for inj amp 5mg Actavis DDG008 Digoxin injection 500mcg/2ml Aspen DBA028 Dihydrocodeine solution for injection amp 50mg/ml 1ml Martindale DDG266 Docetaxel solution for infusion vial 80mg/4ml (DCE only) Accord DHC029 Dopamine solution for infusion amp 800mg/5ml Martindale DBG028 Esmolol solution for injection vial 100mg/10ml Baxter DBI001 Etomidate emulsion for injection amp 20mg/10ml BBraun DOA171 Fluconazole solution for infusion 400mg/200ml Bowmed DEB052 Furosemide solution for injection amp 50mg/5ml Mercury DBC002 Glucose 50% solution for infusion vial 50ml Hameln DIB459 Ibandronic acid solution for injection pfs 3mg/3ml Teva DFF088 Isosorbide dinitrate injection 1mg/ml 50ml Torbay DBF148 Isosorbide dinitrate injection 500mcg/ml 50ml Torbay DBF142 Magnesium sulphate solution for infusion amp 10% 10ml Martindale DIE051 Meropenem injection vial 500mg Fannin DEA072 Methadone solution for injection amp 50mg/1ml Martindale DDJ033 Methadone solution for injection amp 50mg/2ml Martindale DDJ034 Noradrenaline solution for infusion amp 2mg/2ml Hospira DBG050 Noradrenaline solution for infusion amp 4mg/4ml Hospira DBG051 Octreotide powder and solvent for suspen for injection vial 10mg Novartis DHC042 Octreotide powder and solvent for suspen for injection vial 20mg Novartis DHC043 Octreotide powder and solvent for suspen for injection vial 30mg Novartis DHC044 Ofloxacin intravenous infusion 2mg/ml 100ml Sanofi DEA272 Phenobarbital solution for injection amp 30mg/1ml Martindale DDH116 Phenobarbital solution for injection amp 60mg/1ml Martindale DDH029 Phenol oily solution for injection amp 5% 5ml Martindale DAG006 Phenytoin sodium sol for injection amp 250mg/5ml Fannin DDH032 Sodium bicarbonate solution for inj amp 8.4% 10ml Martindale DIB528 Sodium chloride glass 0.9% inj 50ml Hameln DIB575 Sodium picosulfate oral powder sachet 10mg Casen Fleet DAF079 Sodium valproate sol for inj amp 300mg/3ml Desitin DDH139 Terlipressin solution for injection amp 1mg/8.5ml Ferring DFE126 Tobramycin solution for injection amp 40mg/1ml Teva DOG003 Water for injection vial 100ml Hameln DJJ004 Page 2 of 18

3 Adrenaline solution for injection amp 500mcg/0.5ml (1:1000) Supplier: Martindale HIGH RISK Old style livery, box and ampoules, with other products very similar in appearance. This may lead to selection error. Strength as micrograms per ml is in very small font. PIL present in box now-gives likely dose and route of administration (IM) but no other technical information. Ampoules now labelled longitudinally. Contains sodium metabisulphite,as do other similar preparations. Etomidate injection 20mg/10ml Supplier: Janssen HIGH RISK Hypnomidate brand prominent and etomidate only in very small font on 2 faces. Peel off labels provided for syringes but these only state hypnomidate and not etomidate at all. Risk of inappropriate use. Glyceryl trinitrate injection 5mg/5ml Supplier: Serono HIGH RISK High risk because no technical information is present with the product - needs to be diluted and there are special requirements for administration. Brand name prominent. Page 3 of 18

4 Itraconazole solution ampule and infusion bag 10mg/ml 25 ml Supplier: Janssen HIGH RISK Pack containing concentrate (10mg/ml) and saline bag for dilution. Complicated instructions: bag will contain 250mg dose but only 200mg to be infused so infusion has to be stopped after 60 minutes therefore danger of overdosage. Also the 50ml saline is actually 52-56ml and hence the dose in 60ml will be between 185 and 195mg. Also complex flushing instructions following infusion Methadone solution for injection ampoule 10mg/1ml Methadone solution for injection ampoule 20mg/2ml Methadone solution for injection ampoule 35mg/3.5ml Methadone solution for injection ampoule 50mg/5ml Supplier: Martindale HIGH RISK Packaging very similar to other strengths in the range, although the 35mg and 50mg strengths are given in larger print. Ampoule labels all very similar - old style livery. Hence risk of incorrect selection. Expiry given as mth/year - not clarified in PIL. Back of box gives to keep out of reach of children, rather than reach and sight. Page 4 of 18

5 Paracetamol solution for infusion vial 1g/100ml Paracetamol solution for infusion vial 500mg/50ml Supplier: BBraun HIGH RISK NB BBraun have already taken steps to address all risks identified and a Low risk product will be available in early 2013 Risk of selection & administration error where whole bottles infused and/or both dose sizes are stocked. Total dose in total volume is stated at the bottom of the label. Qty/ml stated prominently at top of label. Doses differentiated by coloured strip across top of label which draws more attention to qty/ml (10mg/ml for both) than to the total dose. Both are in the same sized container. Stated only for patients ">33kg" and <33kg respectively rather than "greater than 33kg" and up to 33kg. Ecoflac bottles. Dose calculator & A4 poster provided. Market risk Adrenaline solution for injection ampoule 1mg/10ml (1:10,000) New Martindale packaging. Adrenaline (Epinephrine) 1:10,000 strength range of products are highlighted in pink. Ampoules are also new type labelling. Strength is stated as 1000 micrograms on outer carton and 1mg on ampoules. Potential for confusion. The 1 in 10,000 strength ampoules (100mcg/1ml, 500mcg/5ml, 1mg/10ml) are licensed for the intravenous route (IV) however if there is no venous access the intraosseous (IO) route is recommended. IO as an abbreviation for Intraossesous has potential to be confused with Intraocular Page 5 of 18

6 Alfentanil solution for injection ampoule 5mg/1ml Supplier: Hameln Classified as a medium risk PQA score because the warning, in small red print, that the product must be diluted before use is only on the back of the box and ampoule label. The requirement for dilution is not mentioned at all on the front of the box and this could lead to inappropriate administration. Not compared with other strengths in the range. Award made to lowest priced offer Amiodarone solution for injection prefilled syringe 300mg/10ml Standard Aurum plastic box although colour differentiation now used. Total dose only appears on the small seal label which is then not legible once this is broken. Syringe label and main label on box just states 30mg/ml. Syringe is not tamper evident and it is possible to reapply the seal on the box: this has led to issues in the past. Known issues about compatibility of these syringes and needle-free connectors. Adaptor required in some cases: this is not mentioned in the PIL. Various recalls and cautions in use issued due to labelling errors. Page 6 of 18

7 Baclofen solution for injection 10mg/2ml Supplier: Sun Total dose clearly marked but concentration not evident. Medium risk as there are several other concentrations of baclofen injection available. Ampoule labelled horizontally - cannot see critical information in one field of view. Labelled for intrathecal infusion. Award made to lowest price offer. Bupivacaine plastic solution for injection amp 25mg/10ml (0.25%) and 50mg/10ml (0.5%) Supplier: Mercury Poor differentiation between strengths especially so when ampoules out of carton. Risk of selection error. Ciclosporin capsules 100mg / 25mg / 50mg Supplier: Mylan MEDIUM RISK The generic name is much smaller than the brand name on both the blisters and the box. The BN and expiry date is printed on each blister, but on top of the original blister print. Difficult to read on some blisters. Unmarked capsules. Blister printing on all strengths is similar and patients could be on more than one strength, hence medium risk. Product contains small amounts of ethanol. (Up to 525mg ethanol/maximum dose). Bar code in space for dispensing label. Too large for most robots. Awarded to all suppliers Page 7 of 18

8 Dehydrated alcohol solution for injection amp 5ml Traditional Martindale livery on both carton and ampoules. Products look very similar to other Martindale products risk of selection error. Diamorphine powder for solution for inj amp 5mg/10mg/30mg/100mg/500mg Supplier: Actavis Box states to mix with requisite amount of water for injection but no further info given in PIL. This may cause delay in use/confusion for users as this user information is not provided with the product. Expiry given as mth/year and not clarified in PIL. Clearly labelled and strengths within range well differentiated by colour both on boxes and ampoule labels. 30mg,100mg and 500mg strengths also labelled as "high dose" and in red on box front. Tamper evident seal present. Market management Page 8 of 18

9 Digoxin injection 500mcg/2ml Supplier: Aspen Unit volume strength not present on cartons or ampoules just 0.5mg in 2ml and 500 micrograms in 2ml. Trade name Lanoxin dominant over INN, and the INN is particularly small on the ampoules Market management Dihydrocodeine solution for injection amp 50mg/ml 1ml Old style livery (but there is only one injectable Martindale dihydrocodeine product.) Ampoules, however, are in similar style to some other Martindale products especially when out of the box. Box gives to keep out of reach of children rather than reach and sight. Contains sodium metabisulphite. Docetaxel solution for infusion vial 80mg/4ml Supplier: Accord Unit strength does not appear on the vial and is only on one face of the carton, otherwise just labelled 80mg/4ml. Risk of dose calculation error. Plastic coated vial. Vials very tight to remove from tray, although therefore well protected in transit Market management Applies to DCE only Page 9 of 18

10 Dopamine solution for infusion amp 800mg/5ml Old style Martindale corporate packaging on box and ampoule, so product is poorly differentiated; the total dose is given but not strength. Risk also increased because "User Information Leaflet" is actually a PIL and there is no information with the product as to infusion preparation and rate. Market management Esmolol solution for injection vial 100mg/10ml Supplier: Baxter Strength only expressed in mg/ml - no mention of total dose in total volume. Generic name very small. No barcode. Etomidate emulsion for injection amp 20mg/10ml Supplier: BBraun Carton labelled on one side only. Two trays of 5 x 10ml glass ampoule, SPC, outer carton. Lipid emulsion of Etomidate must not be confused with other etomidate presentations (eg Hypnomidate which has a propylene glycol base) Page 10 of 18

11 Fluconazole solution for infusion 400mg/200ml Supplier: Bowmed Clearly labelled and differentiated by colour from other strengths in the range. The bag has an additive port, although the label states not to mix with other products - this may lead to inappropriate use. Also,only one package insert per box of 5 bags hence medium risk. Expiry is printed on the foil as month/year-not clarified in PIL. MA holder Villerton. Furosemide solution for injection amp 50mg/5ml Supplier: Mercury New Mercury Pharma livery. Clearly labelled for slow IV infusion but no technical information with product therefore Medium PQA. Glucose 50% solution for infusion vial 50ml Supplier: Hameln Only a single PIL in pack of 25 and no technical information. Vial label does not state for single use only and therefore risk of multiple use and contamination. Page 11 of 18

12 Ibandronic acid solution for injection pfs 3mg/3ml Supplier: Hameln Prefilled syringe with separate needle. Dose given as total qty/total volume only on carton, but qty/ml given on syringe barrel. Carton not labelled on 3 non-opposing sides. Syringe barrel not labelled longitudinally. Market risk Isosorbide dinitrate injection 1mg/ml 50ml Isosorbide dinitrate injection 500mcg/ml 50ml Supplier: Torbay New labelling, with strength now much clearer - given as mg/ml, total mg/total mls and %. Different strengths are in different colours. Expiry given as month/year and not clarified in PIL. PIL and SPC in box but only 1 copy of each per box of 10 vials. Generic name is not on 3 non-opposing sides of the box. Box probably too heavy for robots Magnesium sulphate solution for infusion amp 10% 10ml Old style Martindale livery. Labelled on one face of the pack only. Pack very similar to other Martindale products. Ampoule not labelled longitudinally and is similar to other Martindale products. Risk of selection error. Page 12 of 18

13 Meropenem injection vial 500mg Supplier: Fannin Product is made in Portugal and licensed in UK. Vial has only Suppliers name and country on, not PL number, which has potential to cause users to think it is not licensed in the UK. (PL number is on outer box of 10). Displacement values not given in leaflet or SPC. Extended stability data provided for 18 hours at 2-8C. Dissolution takes considerably longer than the 5 seconds indicated in the leaflet. Market risk Methadone solution for injection amp 50mg/1ml New style livery. Brand name Physeptone prominent hence medium risk PQA score. Well differentiated from the 25mg/ml 2ml product. Brand name prominent on ampoules but strength is clear. Expiry given as mth/yr - not clarified in PIL. Methadone solution for injection amp 50mg/2ml Brand name Physeptone prominent, hence medium risk PQA score, and 25mg/ml is given with the product name. The 50mg/2ml total content is highlighted but given elsewhere on the box. Ampoules are in the old style livery and so look very different to the 50mg/ml product. Expiry given as mth/yr - not clarified in PIL Page 13 of 18

14 Noradrenaline solution for infusion amp 2mg/2ml Noradrenaline solution for infusion amp 4mg/4ml Supplier: Hospira Glass ampoules in plastic tray. Products clearly labelled and differentiated from each other. The expiry date is ambiguous but clarified in leaflet. There is no PL number or manufacturers name/logo on the ampoules which could lead to problems with traceability in event of recall. Ofloxacin intravenous infusion 2mg/ml 100ml Supplier: Sanofi Total dose in infusion vial not recorded on carton. Writing on vial itself (which does include total dose) is in green ink. Brand name Tarivid prominent throughout Octreotide powder and solvent for suspen for injection vial 10mg / 20mg/ 30mg Supplier: Novartis Improved packaging with colour differentiation between strengths. Brand name Sandostatin LAR is prominent, with generic name in smaller print. This is a depot injection, and IM use is only given in small print on the back of the box although is clear on vial label(preparations for use via other routes exist).instructions for use provided for HCP with PIL. Fridge item but this is only given in small print on the back of the box (expensive item if stored incorrectly). Page 14 of 18

15 Phenobarbital solution for injection amp 30mg/1ml and 60mg/1ml Boxes clearly labelled and well differentiated. However, ampoules are extremely similar, with the strength only given in very small print. Hence risk of incorrect selection if out of the box. Contains propylene glycol. Phenol oily solution for injection amp 5% 5ml New livery. Concentration expressed only as total dose in total volume, not quantity per ml. Expiry date is ambiguous. Otherwise clearly labelled. Phenytoin sodium sol for injection amp 250mg/5ml Supplier: Fannin 1) Product licence number is added as a sticky label 2) Total quantity (250mg / 5ml) and the ampoule size (5ml) only appears on one face of the box in very small print: the rest of the labelling just says 50mg/ml. Market management Page 15 of 18

16 Sodium bicarbonate solution for inj amp 8.4% 10ml Old style Martindale livery, similar in appearance to other products in range. This may lead to selection error. Product name and details on front of box only. PIL does not contain any technical info (box gives dose: see enclosed PIL, but the PIL gives that doctor will know the dose.) Sodium chloride glass 0.9% inj 50ml Supplier: Hameln Only a single PIL in pack of 25 and no technical information. Does not state For single use only on vial and therefore risk of multiple use and contamination. Sodium picosulfate oral powder sachet 10mg Supplier: Casen Fleet Citrafleet product. Active ingredient does not appear on any of the primary faces of the carton. No strength on the carton: only appears on the sachet. Dosage information for children is not provided. Page 16 of 18

17 Sodium valproate sol for inj amp 300mg/3ml Supplier: Desitin Glass ampoule - not labelled longitudinally. Generic name does appear on 3 nonopposing sides, but on one it is in very small print. PIL in box with limited technical information which may be insufficient if product was to be diluted in advance. Expiry date ambiguous and is not clarified in the PIL. Terlipressin solution for injection amp 1mg/8.5ml Supplier: Ferring Strength stated as 0.12mg/ml - inappropriate use of decimal point (risk of misreading as 12mg/ml). Generic name not well displayed. Point break ampoules - opened easily, but no instructions in SPC or pack for healthcare professional, nor for diluent, compatibility or stability. Ampoules not labelled longitudinally. Tobramycin solution for injection amp 40mg/1ml Supplier: Teva Medium MEPA because the ampoules are point-break and proved to be quite difficult to open, with a risk of loss of solution and harm to hands. There were no instructions on how to open the ampoules. Page 17 of 18

18 Water for injection vial 100ml Supplier: Hameln Only a single PIL in pack of 25. Label states For use as a diluent or dissolvent (not a recognised word). Does not state for single use only on vial and therefore risk of multiple use and contamination. Page 18 of 18