Implanon and use outside license

[BliarOut]

Does anyone know what the guidelines are for the use of Implanon outside it's terms of license in the UK?

The gf went to see a specialist GP at her surgery about having an implant and he was about as unhelpful as he could be

Basically she was on the mini pill years ago which stopped her periods and a practice nurse suggested she went on Implanon to minimise the side effects of her periods. When we were talking to the GP we mentioned that it wouldn't primarily be used for contraception and he suddenly seemed very anti and started talking about terms of license.

She's 45 (ah, just got a flea in my ear, she's 44!) so she would be outside the terms of license anyway as I understand it but are there any grounds for refusal under the UK license?

With hindsight it appears honesty wasn't the best policy

[Herbie58]

I've never heard of this before, but then at 44 most GPs don't like to prescribe the pill, as they recomend only using it for x no of years. As implanon is the same hormone principle I should imagine there are good medical reasons why he wouldn't want to prescribe it. Probably the same reasons it would be off licence.

There are a few GPs on PH, I'm sure one will be along to set the record straight soon!

[drfrank]

I've got to disagree !!

When it comes to health you have to honest with the doc, nurse or whoever. I'll never forget the idiot who said he had been fasting for an op when he hadn't and promptly aspirated (vomited and inhaled) his gastroc contents. Cue ICU and prolonged in patient stay, all of which could have been avoided had he been honest and had his op 6 hrs later.

Be honest....your life could be at stake !

[BliarOut]

Herbie58 said:

I've never heard of this before, but then at 44 most GPs don't like to prescribe the pill, as they recomend only using it for x no of years. As implanon is the same hormone principle I should imagine there are good medical reasons why he wouldn't want to prescribe it. Probably the same reasons it would be off licence.

There are a few GPs on PH, I'm sure one will be along to set the record straight soon!

I'm hoping so. There's no medical reason other than age, bp is fine and she's a non smoker. I think the GP was probably having a bad day. I've never come across a more obstructive person in the medical profession before and that includes doctor's receptionists

[Lois]

So is it for period control rather than contraception?
Depending on what the issues are, the mirena could be an option.

[BliarOut]

Yup, that would be the sole purpose, hence him wittering on about it's license.

That looks like a very good alternative if there's a problem, is it routinely available for period control?

[BliarOut]

LittleMiss said:

Is it possible he is concerned it will affect the process of the menopause given her age?

I don't believe so, he didn't ask if she smoked, didn't check her BP just started talking about terms of license (and a hysterectomy!).

He was probably having a bad day but he didn't come across very well at all.

My understanding is he can provide an implant as long as he explains to her that it might not work and puts a written note in her case files but I just wanted to fully understand the situation.

Shame he couldn't have been as helpful as Lois.

[BliarOut]

Thanks, I'm aware there may be contra indications, but that wasn't discussed. The GP was pretty much stuck on the issue of the license, not the clinical issues hence the question.

My only problem with Mirena is I will always have an image of a Vauxhall Meriva lurking inside her cervix for all eternity

[Lois]

BliarOut said:

Yup, that would be the sole purpose, hence him wittering on about it's license.

That looks like a very good alternative if there's a problem, is it routinely available for period control?

Yes, gynae clinics dole them out like sweets as they prevent many hysterectomies.

[Lois]

I've had a word with the other half who's an O&G doctor and he says from what you've said so far there's no reason why the doctor can't prescribe implanon.

Advantages:
Effectiveness not weight dependant
Not age dependant
Reduces Dysmenorrhoea
No evidence of a casual association for weight gain, mood swings, libido change or headaches.
Acne may improve
No worry about bone density changes
No worry about VTE risk (blood clots mainly in your leg)
Safe to use to menopause
No link to increase cancer risk

These are the only contraindications: (quote Mec 3+4 to your GP!!)
Current Breast Cancer ABSOLUTE 4
Current VTE on anticoagulants
Development of migraine with aura, IHD or CVA, whilst using Implanon
Raised BHCG due to trophoblastic disease
Previous Breast Cancer with no recurrence ≥ 5 years
Active liver disorders / tumours (monitor)
Unexplained vaginal bleeding

So basically your doctor was talking boswelox.

[Paul Dishman]

Prescribing outside the terms of the product licence means that the prescriber takes responsibility for any incident upon himself as the drug company will point to the licence and say "not us guv".

[Lois]

If you read this, the licence holder states that it is not off licence after 40...

A: Question
Is the use of Implanon outside the ages of 18-40 off licence?
B: Response
The summary of product characteristics (SPC) for Implanon indicates that the evidence regarding Implanon only applies to women between the ages of 18 and 40. The Clinical Effectiveness Unit (CEU) contacted the manufacturer’s information line in order to confirm that this does mean that the use of Implanon outside these age ranges is off licence. However clinicians can use their clinical judgement to use Implanon outside this age group.
According to the UK Medical Eligibility Criteria for Contraceptive Use (UKMEC), from menarche onwards the use of Implanon is a UKMEC category 1. This means that there are no restrictions for the use of the contraceptive method based on this age range.

http://www.fsrh.org/admin/uploads/No%202574.pdf

http://www.fsrh.org/admin/uploads/518_Contraceptio...

[BliarOut]

anonymous said:

[redacted]

Thanks very much for your help with this Lois, I think he was talking about it possibly being off license as I've had the snip so it's primary reason for use wouldn't be contraception. My point about being >40 was that they are probably prescribing for over forties routinely.

I know the clinic prescribes to a lesbian! and her fifteen year old daughter so they're not that rigid for all patients.

[Lois]

Ah right OK, important bit of info there!!

So if it's menorrhagia then Mirena is the best option anyway.
I don't quite understand the problem with the POP in the past though.

[BliarOut]

Cool and thanks again, she is going to speak to the practice nurse about it in the next couple of days once they get back to her