Advice Pool - Health and Fitness

One of the commonest questions anyone working in the addiction field is asked is “How can I stop my wife/husband/partner from drinking so much?” Unfortunately the short answe

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

r to that is – you can’t. They will stop when it suits them, whether that is because they hurt so much or because circumstances change. That is painful to hear, but neverthe

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

less it is true.

There is some good news, however, and that is if you can’t actually stop them drinking then there are things that you can do, or stop doing, that will make i

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

t more likely that they will take action and/or seek help for their drinking. Below I have listed a number of things that you should avoid doing as they often have the opposi

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

te effect to intended, making the situation even worse. I will discuss the things that you should do in another article.

Don’t protect the drinker from the naturally occurri

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ng consequences of drinking. If they embarrass themselves don’t make excuses, or if they fall don’t pick them up. Only intervene if there is a danger of the drinker being in

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

jured. For most people this kind of ‘tough love’ is a difficult thing to do, just ignore a loved one when they are drunk goes very much against the grain. However, protecting

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

the drinker means that they never suffer the consequences and so are never aware of the severity of their drinking. Since many believe that problem drinkers only seek help w

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

hen they are hurting, so protecting the drinker only delays that time coming and that it could be argued is more cruel.

Don’t protect the drinker from other consequences. If

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

they take time off work through being too drunk or too hungover, don’t phone the boss and give an excuse. The problem drinker is only too happy for someone else to accept re

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

sponsibility whereas they need to accept responsibility for their own behaviour if they are to change.

Don’t collude with the drinker. If they spend all their money on drink

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

don’t lend them money or pay their debts. Again this is protecting and delays recognition of the extent of the problem.

Don’t join in and drink along with the drinker. It

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

may seem a natural thing to do – “if you can’t beat them join them” but this just makes the drinking behaviour appear to be normal, which of course it’s not. Besides if you t

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

ry and keep up you could end up needing help yourself, and one drunk is more than enough for any household.

Don’t scream and shout and nag about the drinking behaviour. This

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

just provides an excuse to drink even more. That is, the logic that is used here is “I drink because you nag” rather than “You nag because I drink”. Yea, I know that is not

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

logical but hey this is not about logic, its about drinking.

Don’t make threats and give ultimatums. Unless you are actually prepared to carry out these threats and ultimat

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

ums they will lose any power to influence the drinker. In fact, they may even provide an excuse for drinking, especially if there is a pattern of drinking to avoid stress and

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

painful circumstances. Therefore you could be left feeling even more frustrated than before.

Don’t cry and sulk and withdraw to punish the drinker. The drinker can again v

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

iew his as behaviour best avoided by getting drunk, perhaps with the immortal words “No wonder I drink, look at you!”.

Don’t try and have a meaningful conversation about the

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

drinkers behaviour or your lives together when the drinker is intoxicated. It is easy to get lured into a conversation – don’t. Wait till the morning or when they are sober.

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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