Generic SSRI's - ethical?

r3nu4l

I know someone who has been taking generic SSRI's for a while now (citalopram 20mg). Each month she gets the prescription and every time the tablets have been manufactured by a different generics company.

Through talking to her about her therapy I've been amazed by the difference in her reaction to the tablets. They have the same active ingredients but are obviously different in formulation (I've seen the list of ingredients on the PIL).

As a result, every month there is an adjustment timeframe when she gets her new prescription. This means that there are a few days of the month when she either has the shakes, palpitations, sleepless nights, muscle spasms or feels extremely tired. She has told me that this results in inability to focus at work, increased feelings of anxiety and general malaise.

Now, obviously, SSRI's are prescribed for depression. Is it right that a depressed patient should recieve a 'different' generic every month and go through 3-4 days of readjustment? Why can't she receive the same generic every month?

In my opinion, I have no problem with generics but I can now see the argument that pharma companies put forward for respecting 'brand' privilege. While the FDA and EMEA will point at the generics and say that they are the same as the branded product, I don't see why different formulations of generics should be viewed as 'the same'. I would like to see pharmacists pay more attention to consistently providing generics produced by the same manufacturers to patients.

Is this possible? Anyone else feel that it's unethical to cause such distress to patients?

SomeDose

It would only be unethical if the healthcare professional ignores any such issues the patient may have and continues to prescribe / dispense without due consideration. To my knowledge, there's little evidence to suggest that there's an issue with patients receiving different generic preparations of citalopram (unlike say, lithium, which requires careful readjustments if different preparations are given). In other words, there's no reason to believe there is any difference in bioavailability and clinical equivalence between the various generics.

However, it sounds as if this is a fairly significant issue for the patient in question so it may be worth speaking to her GP or pharmacist and requesting the same brand/generic each month.

anotherlostie

How could the pharmacist be more consistent if the patient is going to a different pharmacy each month to collect their script?

I find it very hard to believe that there would be significant differences in bioavailability and pharmacokinetics between different brands of immediate release SSRI's, as citalopram is. You may see a difference in excipient name, I might see a difference between two ingredients that act in exactly the same way, or two different opacifiers where the difference is down to commercial choice by the generic manufacturer, and has no clinical impact. And if a patient is suffering in this way, why in the name of God would they not ask their GP to prescribe the drug by brand (even if it is a generic) rather than by name, so they would stay on the same version.

It is very easy to point fingers at others, but sometimes people need to take responsibility themselves, especially where it is very easy to do so.

Kevster

I have been taking an SSRI (Lexapro) for 4+ years now and it has been the same brand each and every time. As far as I was aware, the company of manufacture had no bearing on the chemistry of the drug. I mean, these drugs would have specific procedures to be followed during their manufacture. How could the end-product possibly be different?

r3nu4l

somedose and anotherlostie, you are saying exactly the same thing as the FDA, NICE and EMEA etc and you are right. Examine the kinetics, bioavailability, equivalence and you will get the same result as a branded product. However, that does not change anything for the individual in question. I'm not arguing branded against generic, I'm arguing against having one generic company's citalopram one month, another generic company's citalopram the next month and so on.

I really believe that this is something to do with the formulation. In other words, the concentration of all the different stearates, glycine derivatives etc.

Kevster, you are right, it should have no difference in the end but if you read the PILs you will see that each generic and the branded products all have different ingredients other than the bioactive ingredients. It is these ingredients I believe are causing the problem. They do not all have the same formulation ingredients and even the ingredients they have are at different concentrations when compared with one another. You are however wrong in saying the patient goes to a different pharmacy on every repeat. She does not, she has been to the same pharmacy every time.

Example, Say I dissolve a given drug in a saline solution and give it to you to drink. It makes you better. Now say I dissolve the same drug in concentrated hydrochloric acid. I measure the bioavilability, perform other studies and show that the overall concentration and action of the drug remain unchanged. You'd be badly damaged by drinking the acid but you might no longer have a headache

Okay, that's an extreme example but you may begin to see the picture. It is my firm belief that this is an issue for a lot of people but that they don't bother telling their doctors. The person I've been speaking to isn't going to ask her doctor to keep prescribing the same generic, she is going to just accept whatever packet is given to her. Most GP's would also give the same answer you guys are giving..."oh it can't be the drug!".

I think this is a real issue (it certainly is for the person in question), her body has to adjust to the new tablets every month. Therefore, I ask again is it ethical to continue prescribing different generics every month? right now the GP and pharmacist do not know there is an issue but if they are informed and continue to hand out different formulations every month then is that right?

Why not at least try the same generic for 4 months solid and see if the same adjustment time is needed?

anotherlostie wrote:

And if a patient is suffering in this way, why in the name of God would they not ask their GP to prescribe the drug by brand (even if it is a generic) rather than by name, so they would stay on the same version.

It is very easy to point fingers at others, but sometimes people need to take responsibility themselves, especially where it is very easy to do so.

You don't have much experience of dealing with depressed people on a day-to-day basis do you? These people are amongst the least likely to help themselves, simply because they don't know how to. In many cases they have spent a long time plucking up the courage to even see the doctor and admit they have a problem, nevermind going into in-depth discussion on their medication.

Kurtosis

It may be a case that the doctor and pharmacist do not realise there is any issue. Leaving aside the arguements over whether different generics can have different pharmacokinetics, there are a number of very simple solutions (which I know may be difficult for your friend due to the nature of the medication) depending on the situation.

If your friend is going to the same pharmacy each month, any pharmacist worth their salt should be dispensing the same generic each time, and if it is a case of different pharmacies, it is as easy as asking would it be possible to get *insert generic name* dispensed (it's a hugely common thing in pharmacies and any pharmacist should be more than happy to oblige).

If the doctor is prescribing different generics each time, a brief mention of "Could you prescribe this generic because I prefer it" should be all that is needed. A GP is going to realise that they may not be comfortable getting into an in-depth discussion about medication and should leave it at that.

r3nu4l

penguin88 wrote: »

If your friend is going to the same pharmacy each month, any pharmacist worth their salt should be dispensing the same generic each time.

That is what I would have thought but apparently not!! Every month it is one of 4 different generics (so far, 7 months in)!

If the doctor is prescribing different generics each time, a brief mention of "Could you prescribe this generic because I prefer it" should be all that is needed. A GP is going to realise that they may not be comfortable getting into an in-depth discussion about medication and should leave it at that.

I think the doctor is blameless (not that there is 'blame' to be had) here. He simply writes 'citalopram 20 mg' as per NHS guidelines for prescription of generics wherever is possible.

Regardless of pharmacokinetics etc I still ask the question, if a healthcare professional is aware that there may be a problem are they not obliged to act on the problem rather than point to regulatory bodies and say "They say there's no problem, therefore there isn't"?

This is partly hypothetical since in this case the GP is unaware of any potential issue.

Kurtosis

r3nu4l wrote: »

Regardless of pharmacokinetics etc I still ask the question, if a healthcare professional is aware that there may be a problem are they not obliged to act on the problem rather than point to regulatory bodies and say "They say there's no problem, therefore there isn't"?

You're 100% correct here, they are indeed obliged to act on the problem. I'm a pharmacy student and the amount of time and number of assignments on the subject of patient compliance is unreal. A healthcare professional's primary aim should be providing the best treatment for the patient, so not only does this mean giving them the right drugs but also making things as easy and convenient as possible for the patient so they will want to continue taking their medicines. We've had it drummed into us to dispense the same medicine the patient has gotten before, because even though there may or may not be any pharmacokinetic difference, if Mrs Murphy gets little pink tablets instead of her usual little blue tablets, she's quite liable to stop taking them!

If a doctor or pharmacist starts contending a patient's claim that taking different generics is having an effect on them, they obviously have their priorities wrong. Unless the patient has had a problem with one particular brand, there should be no reason to switch to another. Healthcare professionals should be trying to facilitate a treatment that suits the patient best, not making life difficult just for the sake of it.

SomeDose

I really believe that this is something to do with the formulation. In other words, the concentration of all the different stearates, glycine derivatives etc.

It's possible it's due to the formulation, but lack of published evidence would suggest this is a very rare occurance. It may even be a placebo effect since she is aware that the products are different. The effects you describe are actually quite typical and well-recognised side-effects of SSRIs. Anyway, the reasons behind the effects are academic since the issue for the patient still remains - hence the need for this to be communicated to GP / pharmacist, possibly by a family member or close friend if possible.

penguin88 wrote: »

If a doctor or pharmacist starts contending a patient's claim that taking different generics is having an effect on them, they obviously have their priorities wrong. Unless the patient has had a problem with one particular brand, there should be no reason to switch to another. Healthcare professionals should be trying to facilitate a treatment that suits the patient best, not making life difficult just for the sake of it.

True. However, the usual reason for pharmacies supplying different generics month by month is down to the wholesaler i.e. the pharmacy orders 50 boxes of generic citalopram 20mg and will get products from x,y and z manufacturer depending on who the wholesaler is buying from at that particular time.

anotherlostie

I agree with what you are saying. One of my friends tells a story of when an elderly woman came into his pharmacy one evening looking for an emergency supply of an anti-hypertensive treatment, for one night, until she would get to her GP the next day. So he found out who she was, checked what she wanted and confirmed it against the records, and dispensed the tablet. Now 10 minutes later she arrived back in very concerned and told him he had given her the wrong tablet, and of course he nearly dropped. What happened? Well it was Monday night and he had given her a Sunday tablet from the blister....

If a placebo is powerful, then imagine the effect of getting a tablet that looks (slightly) different, and more importantly is packaged totally differently. Some patients will be affected by that.

In relation to the scholars telling you to dispense the same generics all the time, well maybe they should get out into the real world and see what manufacturers discontinuing lines , wholesalers going short stocked etc etc. means. And like I said before there is only so much the GP/ pharmacist can do IF THE PATIENT DOESN'T SAY THERE IS A PROBLEM.

Kurtosis

anotherlostie wrote: »

In relation to the scholars telling you to dispense the same generics all the time, well maybe they should get out into the real world and see what manufacturers discontinuing lines , wholesalers going short stocked etc etc. means. And like I said before there is only so much the GP/ pharmacist can do IF THE PATIENT DOESN'T SAY THERE IS A PROBLEM.

I agree totally, in an ideal world everyone could get the same generics each month, but it isn't always practical. I suppose their point was more that if at all possible, give the patient the same thing as before instead of doing a bit of eeny, meeny, miny, moe to decide what to give.

I think best practice would be if the generic someone had been taking previously was not available one month, the pharmacist should explain this to the patient and give them the opportunity to pipe up if they would not be happy to switch to an alternative.

Nonoperational

While I seriously doubt there is any real effect from the different brands of citalopram thats not the issue here. All it takes for this issue to be resolved is for the patient or someone connected to her to ring the doctor and tell him the situation or for the patient to chat to the pharmacist and tell them their needs. I've often seen notes on the patients records in pharmacies asking for one brand or another.

As for asking if writing citalopram 20 mg od on a script is ethical...of course its ethical. Its actually probably more ethical / ideal practice than writing cipramil or a specific brand of generic!

ronbyrne2005

Clearly Nocebo effect.
http://en.wikipedia.org/wiki/Nocebo
Generics are so widespread and common that any significant differences in blood levels and biochemical effects of generics would have been noted by academics/researchers by now.

r3nu4l

ronbyrne2005 wrote: »

Clearly Nocebo effect.
http://en.wikipedia.org/wiki/Nocebo
Generics are so widespread and common that any significant differences in blood levels and biochemical effects of generics would have been noted by academics/researchers by now.

It could very well be a nocebo effect. This particular person is a scientist herself so that would seem unlikely. However, given that her brain chemistry is not in balance a nocebo effect may be more likely! Interesting.