Tamsulosin and intraoperative floppy iris syndrome
From Mrs L. C. Titcomb, MRPharmS, and Dr J. L. Jones, MRPharmS
As specialist ophthalmic pharmacists, we have followed with interest the reclassification of tamsulosin from prescription-only to pharmacy medicine and its introduction as Flomax Relief MR for the treatment of symptoms of benign prostatic hyperplasia (BPH).
We wish to emphasise to those pharmacists recommending this product the importance of the frequent occurrence of difficulties encountered by ophthalmic surgeons undertaking cataract surgery on patients taking this drug.
Intraoperative floppy iris syndrome (IFIS) was first described in 20051,2 and is characterised by a flaccid and billowing iris, iris prolapse through a surgical incision and progressive pupil constriction. This may lead to increased procedural complications during cataract and other intraocular surgery.
IFIS is frequently seen in patients taking alpha-adrenoceptor blockers, particularly tamsulosin, which is a highly selective alpha-1a blocker. The alpha-1a receptor, as well as being the predominant receptor in the bladder neck and prostate, is the most abundant receptor in the iris mediating pupil dilation.
Although mention of IFIS during cataract surgery is made in the special warnings and precautions for use in the summary of product characteristics (SPC) for Flomax Relief MR, and is referred to in the patient information leaflet as a very rare side effect affecting less than 1 in 10,000 people, this is far from what is seen in clinical practice.
Since the syndrome was first reported, there have been many publications confirming the association between IFIS and tamsulosin treatment. In a review of this association published in 2009, Leibovici et al3 report the occurrence of IFIS in patients exposed to tamsulosin to be between 57 and 100 per cent compared with 0 to 5 per cent in those not exposed to the drug.
The age group of men suffering from BPH and that of those undergoing cataract surgery are similar and therefore we would expect a substantial number of patients treated with tamsulosin to present for cataract surgery. Pharmacists recommending over-the-counter tamsulosin to men who present with symptoms of BPH need to emphasise the importance of avoiding starting tamsulosin where cataract surgery is likely to be scheduled in the near future.
Whether bought OTC or obtained on prescription, it is vital that ophthalmologists are made aware that a patient is taking or has taken tamsulosin so that cataract surgery can be assigned to a surgeon experienced in dealing with IFIS as the syndrome has been reported after as short a period as two days of taking tamsulosin.4
As stated in the SPC for Flomax Relief MR and those of other brands of tamsulosin: “During preoperative assessment, cataract surgeons and ophthalmic teams should consider whether patients scheduled for cataract surgery are being or have been treated with tamsulosin in order to ensure that appropriate measures will be in place to manage the IFIS during surgery.”
We recommend that pharmacists working in ophthalmic surgical units bring the recent change in medicinal product classification of tamsulosin to the attention of staff involved in preoperative assessment to ensure that OTC use of this drug is not missed.
In addition, ophthalmic surgeons should be encouraged to report every case of alpha-blocker-induced IFIS using the yellow card system since it appears from the Medicine and Healthcare products Regulatory Agency’s adverse reaction data that it is currently grossly under-reported.
Lucy Titcomb
Chairman
Jacqueline Jones
Vice-chairman
UK Ophthalmic Pharmacy Group
References
1. Chang DF, Campbell JR. Intraoperative floppy iris syndrome associated with tamsulosin. Journal of Cataract and Refractive Surgery 2005;31:664–73.
2. Parssinen O. The use of tamsulosin and iris hypotony during cataract surgery. Acta Ophthalmologica Scandinavia 2005;83:624–6.
3. Leibovici D, Bar-Kana Y, Zadok D, Lindner A. Association between tamsulosin and intraoperative “floppy-iris” synd rome. Israel Medical Association Journal 2009;11:45–9.
4. Shah N, Tendulkar M, Brown R. Should we anticipate intraoperative floppy iris syndrome (IFIS) even with very short history of tamsulosin? Eye 2009;23:740.
Tamsulosin not high on POM-to-P switch wish-list
From Mr G. P. Burke, MRPharmS
In general, I am a keen advocate of switches of prescription-only medicines to pharmacy medicines (POM-to-P switches). However, I believe reclassification of prescription medicines should be prioritised according to patient need and not motivated by fiscal gain by opportunistic pharmaceutical companies.
If one were to ask a group of pharmacists which prescription medicines they would have liked to see reclassified as pharmacy-only medicines, I am sure tamsulosin, an alpha-blocker with significant interactions and hypotensive effects, would not have appeared high on their wish-lists.
Flomax Relief (tamsulosin hydrochloride 0.4mg) is a treatment for short-term relief in men with benign prostatic hyperplasia (BPH). The manufacturer’s rationale for the switch was on the basis that men could play a more active role in their healthcare. My main concern is self-medicating with Flomax Relief could cause a delay in the investigation of a patient’s prostatic symptoms.
Prostate cancer, the most common cancer in men in the UK, can present with symptoms similar to BPH, a condition for which many pharmacists in my peer group do not believe they are appropriately trained to make an accurate diagnosis.
Despite the manufacturer’s stipulation for pharmacists to ask patients to visit their GP for confirmation of diagnosis, patients may continue to self-medicate, obtaining supplies from pharmacies, while an underlying prostate cancer progresses.
Perhaps it is time the Medicines and Healthcare products Regulatory Agency works to reclassify prescription drugs discerningly, according to patient need.
Gareth Burke
London
Flomax
Having dealt with my first Flomax relief while locuming last weekend, I can assure Mr. Burke that the patient I supplied will not be self-medicating for long - not at £7.99 for 14 capsules!
I too was apprehensive at first but it was actually quite a satisfactory experience for me and, I hope him.
It gave me a chance to check his blood pressure for instance, to help me decide whether he would be likely to tolerate the antihypertensive effects of an alpha-blocker. We talked for a good while about the need to see his GP because of the small risk of more serious underlying illness and also, that if he got on well with the medication, as an over-60 he could have it prescribed for free.
We talked about his general health, his concurrent medication, his symptoms etc etc. and also managed to solve a few other problems relating to managing his seasonal allergies and a recent skin problem.
I know this is out of the ordinary, and goodness knows what sort of support I could have offered if he had approached the pharmacy at a busy time rather than a quiet late evening. But still, it was relatively positive all things considered.
I would hope that everyone can at least offer a BP test before selling an alpha blocker though, whether the company material requires it or not.
Mr. Burke, what would you like to be switched from POM to P? I've long thought that conservative P availability of prednisolone for allergic reactions would save a few emergency doctor appointments or A and E visits.
Counter-productive comments
From Mr J. D. Thomas, MRPharmS
The recent comments of Christopher Chapple (PJ, 22 May 2010, p497) concerning over-the-counter sales of tamsulosin are counter-productive for preventive medicine and the continuing relationships between the pharmacy and medical professions.
From my own recent personal experiences, most men who visit community pharmacies with queries about lower urinary tract symptoms were accompanied or, indeed, brought by their spouses. They realise that pharmacists are more accessible and approachable than GPs.
Moreover, if pharmacists were to follow Professor Chapple’s diktat to supply tamsulosin only after a visit to the GP, this would be self-defeating for the long-suffering general public. I can just imagine a customer’s response if I were to suggest conservative management techniques such as using incontinence pads or bladder training. Modern-day pharmacists are a valuable repository of pharmaceutical information and advice.
Every one of the men who presented themselves to me with lower urinary tract symptoms and were suitable for tamsulosin were supplied with the smallest pack after a thorough consultation and professional pharmaceutical assessment. They were also told that they must, after finishing the course of treatment, consult their GP for further medical assessment.
All of the men and their spouses stated that, if it had not been for the awareness stimulated by the media, coupled with the ease of access of community pharmacies and the professional advice freely available there, they would have not sought any advice on this condition.
So, contrary to general medical opinion and Professor Chapple’s statements, the general public are trusting and grateful for the professional assistance of community pharmacists.
J. David Thomas
Patshull, Shropshire