New Medicines Committee Briefing July Minims Povidone Iodine 5% w/v Eye Drops, Solution

Transcription

1 New Medicines Committee Briefing July 2013 Minims Povidone Iodine 5% w/v Eye Drops, Solution Minims Povidone Iodine 5% w/v Eye Drops is to be reviewed for use within: Primary Care Secondary Care Summary: Minims Povidone Iodine 5% w/v Eye Drops, Solution is licensed for cutaneous periocular and conjunctival antisepsis prior to ocular surgery to support post-operative infective control. 1 The European Society for Cataract & refractive Surgeons (ESCRS) Guidelines on prevention, investigation and management of post-operative endophthalmitis recommended that Clinicians should avoid use of large bottles of readily diluted povidone-iodine or chlorhexidine whenever possible, and use single-use sachets or vials instead, as both antiseptics can become contaminated with Ps. aeruginosa. 2 Minims Povidone Iodine 5% w/v Eye Drops, Solution was launched in the UK in December Currently at UHNS we use the unlicensed preservative free povidone iodine 5% 10ml bottle from Moorfield. In February 2013, there was a cluster of endophthalmitis which resulted in a visit from Health Protection Agency (HPA). HPA recommended during the visit that the department switch to the use of single dose povidone iodine eye drops. 1

2 Formulary application: Ophthalmology: Consultant submitting application: Dr Mohamed Musadiq (Consultant Ophthalmologist) Clinical Director supporting application: Gareth Rowland Dr Musadiq has requested that Minims Povidone Iodine 5% w/v Eye drops be considered for inclusion in the North Staffordshire Joint Formulary for use prior to ocular surgery. Dr Musadiq noted that currently they are using the unlicensed povidone iodine 5% preservative-free from Moorfields eye clinic London. Due to a cluster of endophthalmitis in February, Health Protection Agency has advised that they convert to single dose povidone iodine. Currently they treat 12 patients per day using the one bottle 10ml preservative-free while using different syringes per patient before and another bottle during the surgery. Endophthalmitis is an inflammatory reaction occurring as a result of intraocular colonisation by bacteria, fungi or rarely parasites. It can be exogenous (post-operative, post-traumatic) due to microbial contamination spreading from the ocular surface or open incision (wound) or contaminated instruments, intraocular lenses (IOLs) or intraocular foreign bodies or endogenous (septicaemia) in origin. The European Society for Cataract & Refractive Surgeons (ESCRS) Guidelines on prevention, investigation and management of post-operative endophthalmitis: 2 For peri-orbital skin antisepsis, a five to 10 per cent povidone-iodine solution is recommended which should be allowed to act for a minimum of 3 min, as the skin contains many sebaceous glands. If this is contraindicated (allergy or hyperthyroidism), an aqueous solution of chlorhexidine (0.05%) should be used instead. Clinicians should avoid use of large bottles of readily diluted povidone-iodine or chlorhexidine whenever possible, and use single-use sachets or vials instead, as both antiseptics can become contaminated with Ps. aeruginosa. In conclusion, it can be stated on the basis of the available clinical studies that only povidoneiodine in a concentration of five per cent in BSS or isotonic saline can be recommended at present as the pre-operative antiseptic of choice. It has not been established whether similar results can be obtained with a lower concentration, such as 2.5 or 1.25%. The Royal College of Ophthalmologists in their Cataract Surgery Guideline 2010: 3 A simple effective prophylactic measure in infection prevention has been Povidone iodine 5% aqueous solution irrigated into the conjunctival sac immediately pre-operatively. If local rates of endophthalmitis over a properly audited time frame are similar to those reported in the Bolton study (0.55%), then continuing with whatever preventative/prophylactic measures are in place would seem reasonable. 2

3 If local rates are higher than those reported in the Bolton study then intracameral cefuroxime may be added as part of a package of measures to lower endophthalmitis rates after a suitable analysis of processes has taken place. Current formulary status: The North Staffordshire Joint Formulary currently lists the following agents: Iodine Iodine Weak iodine solution and povidone-iodine Therapeutic class and mode of action 1 : Povidone iodine is an iodophore that has an established use as a broad-spectrum antiseptic, mainly for the treatment of contaminated wounds and for the preoperative preparation of the skin, mucous membranes and the ocular surface. The loose complex contains approximately 10% of active available iodine. Solutions of povidone iodine gradually release iodine to exert an antimicrobial effect against bacteria, fungi, viruses, and spores. Although povidone iodine is less potent than preparations containing free iodine, it is also less toxic. Povidone iodine is a complex of the polymer polyvinylpyrrolidone (povidone) with iodine which, after application, continues to deliver iodine to the ocular surface over the short time that the solution is in contact with the eye. After application, exposure of the ocular surface to iodine arises from the presence of free iodine in solution, and iodine bound to the polymer, which serves as a reservoir. As the preparation comes in contact with the eye, more and more iodine dissociates from the polymer. Licensed indication 1 : Minims Povidone Iodine 5% w/v Eye Drops, Solution is indicated for cutaneous peri-ocular and conjunctival antisepsis prior to ocular surgery to support post-operative infection control Dosage and administration 1 : Adults (including the elderly): Instil two to three drops of the solution onto the eye / eyes and leave for two minutes. Paediatric population: The adult dose may be used in neonates, infants, children and adolescents 3

4 Method of administration: Wash hands thoroughly before use. Clean the area around the eyes with a sterile cotton swab Twist off the cap of the container to open it Do not touch the eye with the single-dose container nozzle. Gently instil 2 to 3 drops of the solution onto the eye / eyes Allow the solution to spread, by asking the patient to close their eyes and roll their eyes around Leave the drops on the eye / eyes for two minutes before rinsing: Using a suitable syringe, irrigate the eye / eyes thoroughly with sterile saline 0.9% w/v solution until the characteristic colour of the iodine solution disappears Presentation: A sealed polypropylene single-dose container fitted with a twist and pull off cap marked with PVI 5.0. Each single-dose container provides 0.5 ml of solution and is overwrapped in a polyethylene sachet. Special precautions for storage 1 : Store between 2 C and 8 C. The product may be stored without refrigeration at not more than 25 C for up to one month. Safety and adverse effects 1 : Contraindications: Hypersensitivity to iodinated povidone, to iodine or to any of the excipients; for intra-ocular or peri-ocular injection; Concomitant use with topical ophthalmic formulations containing mercury-based preservatives and Preterm neonates Adverse effects: Overdose: the most serious adverse reaction is hypersensitivity reaction (urticaria, Quincke s oedema, anaphylactic shock and anaphylactoid reaction) which is very rare. An overdose of Povidone Iodine Eye Drops Solution can be washed out of the eye with saline or water. Refer to the Summary of Product Characteristics for a full list of adverse effects. 4

5 Drug Interactions 1 : Povidone iodine is not to be used with other medicines that are intended for ocular administration, including other antimicrobial agents, because of the potential for antagonism or inactivation of povidone iodine. In particular, concomitant use with formulations containing mercury-based preservatives (which may be present in some ophthalmic medicines) must be avoided, due to the risk of formation of caustic compounds. When administered at volumes greater than those arising from single ocular instillation, povidone iodine may interfere with thyroid function tests. Pregnancy No effects during pregnancy are anticipated, since systemic exposure to iodine is negligible. Breast-feeding No effects on the breastfed new-born/infant are anticipated since the systemic exposure of the breastfeeding woman to iodine is negligible. Fertility No effects on fertility are anticipated, since systemic exposure to iodine is negligible. Cost analysis: Product Pack size Cost (incl. VAT) Cost per day/week Minim Povidone iodine 5% w/v eye drops 20 x 0.5 ml / Povidone iodine 5% eye drop (unlicensed) 10 ml / Estimated Cost: Currently 2 bottles of 10ml unlicensed povidone iodine 5% are used per day for 12 patients each clinic hence 10 bottles per week. Per week: 10bottles x 9.40 = Per month: 94 x 4weeks = Per year: 376 x 12months = 4, Switching to Minims Povidone Iodine 5% will imply 2 minims per patient (pre and during surgery) hence 60 patients (12patients x 5days) per week which is 120 minims. Per week: 120 minims = 6packs x =

6 Per month: x 4weeks = Per year: x 12months = 5, Expenditure at UHNS for a 12 months period (Jan Dec 2012) Product No of UHNS bottles Povidone iodine 5% eye drop (unlicensed) 504 4, References 1 Minims Povidone Iodine 5% w/v Eye Drops, Solution. Bausch & Lomb U.K Limited. Summary of Product 2 3 Characteristics. Date of first authorisation 03/10/2012. Accessed via: ESCRS Guidelines on prevention, investigation and management of post-operative endophthalmitis. August 2007 The Royal College of Ophthalmologists Cataract Surgery Guidelines. September 2010 Produced by Sr. Maria Chidiamara Njoku Primary Care/Secondary Care Interface Pharmacist University Hospital of North Staffordshire Telephone: Maria.Njoku@uhns.nhs.uk Produced for use within the NHS. Not to be reproduced for commercial purposes. 6