Antidepressants in the UK

Here is an interesting question that came to my attention today (19th April 2012):

Chris Ruane (Vale of Clwyd, Labour)

To ask the Secretary of State for Health how many prescriptions for anti-depressant drugs were issued in each region of the UK in each of the last three years; and what estimate he has made of the proportion of the population issued with such prescriptions.

·                     Hansard source (Citation: HC Deb, 18 April 2012, c413W)

                    

And the answer was no less interesting:

Simon Burns (Minister of State (Health), Health; Chelmsford, Conservative)

Information is only available on prescription items dispensed in the community in England.

The following table shows the number of prescription items dispensed for drugs classified as antidepressant drugs in British National Formulary section 4.3 for the last three years.

	Number of prescription items (thousand)
2009	39,141
2010	42,788
2011	46,678
Source: Prescription Cost Analysis (PCA) system

Information on the number of patients prescribed a particular medicine (or class of medicine) is not collected. It is therefore not possible to estimate the proportion of the population in England that have received anti-depressant prescription items.

It may be the case that it isn’t possible to know what proportion of people living in England are taking antidepressants, but 46,678,000 last year is an awful lot of prescriptions nonetheless.  I wrote about this in my article called B’org Mentality.  The only point I would add here is that these figures indicate that the nation is not getting happier as the years go by.  Seven million more prescriptions were written in 2011 than a mere two years earlier.  That’s some progress.

For anyone struggling with this health issue, I'd recommend my article called Down in the Doldrums? for some tips on how to beat depression naturally.

A B’org Invitation to Thrive

I was invited to a friend’s house with a few others to view a DVD called Thrive last night (17th April).  Thank God for the good company.  Before you follow the link and waste your time, you may want to read my review.

First of all, instead of making me feel reassured, hopeful and peaceful as a picture of the human race thriving might otherwise do, this film pissed me off and motivated me to write this article.

The movie was narrated by (James) Foster Gamble, a VERY wealthy man connected to Proctor and Gamble (snappily known as P&G) ... him and his mannequin wife.  So very Borg-like, so perfect, so in control, so afraid, so ungrounded, so driven, etc etc...  I was unable to find much information about him on the Internet though except that he was brainwashed at Princeton University.

The DVD began with a lot of boring information about UFOs.  You see, when you’re part of the Elite aka Stratos Dwellers, it can get pretty lonely so you create ETs to keep you company.  This isn’t something I made up.  David Korten in his book, When Corporations Rule the World, (link is to my book review) talked about The Stratos Dwellers from a Star Trek episode and how it relates to the way civilisation is structured.  But for the rest of us down on the ground, outer space has its place and we have ours, may never the twain shall meet.

He even uses imagery in the film of him sitting above the world in outer space!

Also, when I did my law degree at the College of Law in Guildford, we used a computer program called ELITE (electronic legal interactive training environment).  Handy name because we were being groomed to serve the Elite, and most knew this but just went along with it because otherwise you might as well skip the career (and all the trimmings that come with it).

The movie progresses with a hodge-podge (in the UK, known as hotchpotch) of facts like the one that there are a few rich families with lots of power controlling what’s going on in the world today, especially because they control money, power (in a materialistic sense), and they’re trying to control food (this is my main beef).  It was a hodge-podge because nothing made any sense.  Sure the facts presented were mostly true in one form or another, but what was the point.  There was none unless you take it that continuing a consumerist life style (the so-called American Dream mentallity) is OK and even desirable.

I would have thought that some type of coherent message could have been delivered in two hours!  OK, he did say that all we need is access to free energy in the form of a technological gadget which the Elite are denying us, even though one form or another has been available for years.

Well, I think we have all the energy we need when we have our health, the sun, the earth, water and wind.  It is access to these things which is being denied that was not even mentioned in the film.  The information given was as unreal as the ET information that started out the film.  I got the impression that the film began with ET because if you could believe in UFOs, you’d have no trouble being sucked into believing the rest.

One message that came through was that we should not be violent in our protest against the misery being created by these f****** (please excuse my language, but it was annoying).  This is clear evidence of the fact that the Stratos Dwellers live with fear every moment of their poor miserable lives.  I don’t envy them and all their so-called material wealth one bit.

Also, I was disappointed by Vandana Shiva being in the film.  She was used out of context and it shows how if you become well known and influential, you can be used by the enemy or perhaps she’s being sucked in and assimilated like so many others such as Whole Foods, The Body Shop, most charities (to name some organisations, but there are plenty of individuals too).

Just go and view a couple of episodes of the Farm Revealed and you’ll see where the young are being drawn today, not as a sinister thing, but as a matter of course.  The episodes are about cloning, GMOs, skin tags and other such things that also surface in the movie.

All the bits of intense information and elaborate technological visual effects made me think that it was an attempt to manipulate my mind, like a magic trick.  With his talk about Torus energy and a lot of other mumbo jumbo, I suppose some might be assimilated by it all.

However, Thrive is a load of rubbish.  I can’t say it strongly enough.  Don’t waste your time in watching it.

Photo credit: Thrive propaganda article

The B’org of Food Cuisine

Clarification of My Campaign Against the Adulteration of Food

In case you haven’t noticed, I’d like to point out that the modern kitchen is actually a laboratory because that is where the essence of much of today's food is formulated.  The one in the above picture is Munchy's in Malaysia.  How you feel about this will determine whether you like to eat real food or chemicals put together by man into food products.  People who profess to be plastic lovers often prefer manmade foods while the rest struggle to hold on to all that is natural.

However, at this stage of writing on this blog, I have realised that it is clear that the B’org of Food is simply stuck in a rut and are doing nothing but digging themselves in deeper.  They claim to be innovative, but in reality, they are stagnated.  The chains that bind big corporations are created by the market and the need to make money.  This is why our food is becoming more and more synthetic and difficult to understand.  Either we get our food supply out of the market or we’ll end up as a race of cyborgs, totally disconnected from Nature. Our spirituality may even be in jeopardy.  In other words, we’ll become as synthetic as the food that we eat.

I’ve written about baby formulas, feeding tube formulas, soup, yogurts, and breakfast cereals, but just about all food today is tainted by man’s manipulations with the ulterior goal of making a profit.  Not only that, chemicals are also commonplace in kitchens as cleaning products such as those used on floors and countertops.  This goes to show that money really is the root of all evil because making money and protecting health are incompatible with one another and our health is our greatest wealth.

Nature, Time and Patience are the three greatest physicians, and as it so happens, the three greatest chefs as well.

Greed, a honed Competitive edge and a Myopic view are the three top qualities of successful business people and also those in charge of formulating the B’org of food cuisine.

Many business people have no time or patience and, to varying degrees, know nature only for what they can take from it.  They require a sharp edge not to chop up the onions but to beat anyone else trying to take what they view with their myopic eyesight as important in nature.  They greedily take possession of physical components while destroying anything that gets in their way or threatens to lessen their coveted possessions.

I would also comment that there is a strong undercurrent of social cohesion that is keeping the B’org of Food strong.  It’s not cool to eat traditional foods and turn down offers of sugar laden starchy foods which are on offer just about everywhere you go in the UK and the US.  Just today, I was offered scones with jam and clotted cream.  What’s wrong with this I hear you say?  Without going into all the details, the scones are primarily wheat, the jam is chock full of sugar and the cream was made from pasteurised milk and unfermented.  As I adhere to the GAPS diet, I was slightly under attack by my colleagues for forgoing this afternoon tea delight.  Most people just don’t want to stand out from the crowd and so buy into what the B’org of Food has used billions in advertising and propaganda to promote.

Not being able to share in the food on offer is also a bit anti-social which is annoying.   I've been trying to make up for this lately by giving out samples of my homemade yogurt and kefir grains and finding other opportunities to share my cooking and baking.

I realise that there are many good-hearted people out there who are arguably a part of the market because they sell and prepare food for money and pay money to operate a business.  In Western countries, they are a small minority though and in other countries they are being forced away from the land and traditional customs.  They are for the most part all struggling and eventually will fall by the way side unless the monopolistic nature of the system is not dealt with.

In the meantime, please be reminded that every time, that is, every single time, you shop in Asda or eat at a McDonalds (or other such places) no matter how green they claim to be, you are supporting the system that lends towards us becoming cyborgs.  That is the underlying message of this blog.  That is the direction humanity is going in as a whole.  It’s up to each one of us to take control of our own life and live as close to nature as possible.  It is not for us to fight for or expect someone else to do for us.  It is for you to do for yourself, right now.

Good luck to us all! 

B’org Feeding Tubes

Most people with feeding tubes are at the mercy of the big organisation of food, aka the B’org of Food, because they rely on formulas made by transnational corporations.  I was unaware of the extent of the use of this medical treatment and feeding plan until recently.  As I work with a young man who has a PEG tube, I was inspired to do some research.  In the two months that I have known him, he’s been in hospital twice with digestive issues.  He had gall stones and then had his gall bladder removed.  Why you may ask does he suffer from digestive problems when he is being fed a well balanced, nutritional diet and unable to eat anything not prescribed by the doctor or dietician.  Even knowing what the B’org are like, I was amazed by what I found out for this article.

I would like to highlight that I did come across an exception to the rule in a blog article and would recommend it here as evidence that not everyone needing artificial assistance with feeding is having artificial food.

But alas, the evidence suggests that too many people are being sucked into the vortex, because the corporations that are involved in the production of the products used in feeding tubes are making lots of money out of it.

What is a PEG tube or G-tube? 

From Wiki:  A gastric feeding tube (G-tube or "button") is a tube inserted through a small incision in the abdomen into the stomach and is used for long-term enteral nutrition. One type is the percutaneous endoscopic gastrostomy (PEG) tube which is placed endoscopically. The position of the endoscope can be visualized on the outside of the patient's abdomen because it contains a powerful light source. A needle is inserted through the abdomen, visualized within the stomach by the endoscope, and a suture passed through the needle is grasped by the endoscope and pulled up through the esophagus. The suture is then tied to the end of the PEG tube that will be external, and pulled back down through the esophagus, stomach, and out through the abdominal wall. The insertion takes about 20 minutes. The tube is kept within the stomach either by a balloon on its tip (which can be deflated) or by a retention dome which is wider than the tract of the tube.

Who uses PEG tubes?

Surely, these tubes are not common you may think.  Possibly that would have been the case not long ago, but they are taking on a life of their own.  Despite some advice online to discourage their use, potential candidates are wide ranging and common:

Basically, they include:

• Babies with birth defects of the mouth, esophagus, or stomach (for example, esophageal atresia or tracheal esophageal fistula)
• Patients who cannot swallow correctly
• Patients who cannot take enough food by mouth to stay healthy
• Patients who often breathe in food when eating

A more extensive list such as this one for disability from Patient.co.uk expands on the type of patient that may be given a PEG. Please see this web page for references.

• Head and neck cancers. PEG has become the most acceptable and safest method for long term feeding support.  It is useful particularly when surgery is extensive and when combined with chemotherapy, radiotherapy or both.
• Malignant bowel obstruction including oesophageal cancer
• Neurological conditions are the most common indications for PEG and include:
• Stroke (usually the most common indication for PEG and often vertebrobasilar strokes)
• Disorders of swallowing
• Multiple sclerosis
• Neurosurgical disease
• Parkinson's disease
• Brain tumours
• HIV encephalopathy
• Neonatal encephalopathy
• Amyotrophic lateral sclerosis
• Dementia (in which use is common but controversial)
• Head injury patients
• AIDS and HIV encephalopathy (improves nutritional status but not survival)
• Crohn's disease
• Burns patients
• Neurological conditions are most commonly associated with such disability and constitute the most common indication for PEG. Its simplicity has led some to concern about use when there is little or no clinical benefit.

Finally, here is a list from the Nutricia, Advanced Medical Nutrition website which extends the possible scenarios for use even more:

Alzheimer's Disease, Cancer / Oncology, Cerebral Palsy, Critical Care: Burns etc, Crohn's Disease / IBD, Cystic Fibrosis, Dementia / Alzheimers, Diabetes, Gastrointestinal problems, Kidney / Renal Disease, Leg Ulcers / Wound care, Malabsorption / Maldigestion, Malnutrition / Undernutrition, Neurological : Multiple Sclerosis etc., Parkinson's Disease, Poor appetite / Anorexia, Respiratory Disease / COPD, Stroke / CVA, Surgery: Pre & Post Operative., Swallowing Problems / Dysphagia, Weight Loss in Older Adults

And specifically for the Nutrison Energy Multi Fibre product:

short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; disease related malnutrition.

Complications are many and besides those listed below, again from Patient.co.uk website, gall stones, constipation, coagulation in the digestive tract, e.g., due to drug interaction, and other ailments may develop with long term use due to ingesting the chemicals and processed stuff that is in commercial formulas.

Major complications

• Gastric perforation
• Gastrocolic fistula
• Internal leakage
• Dehiscence
• Peritonitis
• Aspiration pneumonia
• Subcutaneous abscess
• Buried bumper syndrome (migration of the internal bumper of the PEG tube into the gastric or abdominal wall).

Minor complications

• Tube problems:
• Tube blockages
• Tube dislodgements
• Tube degradation
• External leakage
• Unplanned removal
• Site infections (common but rarely serious)

The B’org of Food Formulas

At this point, it will probably come as no surprise that the commercial makers of the formulas used in PEG tubes are big multinationals.  After all, there is total control here.  No call for organic, non-GM, non-nano, etc etc.  They have carte blanche because most of the people involved in using these formulas have little say in the matter or think to challenge it.  I’m especially referring to how people succumb to the will of their doctor who will likely give advice to take one brand or another (probably after being wooed by the B’org of Food to do so). And many, like the young man I know, will never be able to eat normally again, so it’s for the remainder of their life, which could be a substantial amount of time as it so happens.

I had a hunch that Nestlé was up to something I had not thought of before and now I found a product to back this up, e.g., Nestlé Compleat tube feeding formula.  The following is off their website and I hate to bore my readers with more ingredients lists, but I find it so amazing that a doctor, for instance, could think that such products are good for someone suffering from an illness.  I think they would make a well person ill.  Notice the reference to semi-synthetic formulas (not my words).  Also, I can only wonder what the Microbial inhibitors are as I’m sure it’s a trade secret.  This does not impress me much since I go to a lot of trouble to grow microbes in my food with homemade yogurt, kefir and other fermented foods.  I’d be interested to find out what BENEFIBER is too, but again, it’s patented and likely to be a trade secret.

Compleat

Nutritionally Complete Blenderized Tube Feeding Formula

Compleat Formula is a blenderized tube feeding developed for patients with intolerance to semi-synthetic formulas. Formulated with chicken, peas, carrots, tomatoes and cranberry juice. The fiber blend with BENEFIBER® soluble fiber helps promote beneficial bacterial growth and normal bowel function.

For the Dietary Management of:

• Gluten Intolerance
• Cerebral Palsy
• Lactose Intolerance
• Constipation
• Diarrhea
• Semi-synthetic formula-related intolerance such as diarrhea, abdominal distention and nausea

Compleat Ingredients

Water, chicken puree (water, dehydrated chicken meat), cranberry juice cocktail (from concentrate), corn syrup, maltodextrin, sodium caseinate (milk), canola oil, pea puree (water, pea powder), carrot puree (water, carrot powder), tomato paste, partially hydrolyzed guar gum♦, potassium citrate, calcium phosphate tribasic, methylparaben†, potassium sorbate†, sodium chloride, hydroxylated soy lecithin, magnesium phosphate tribasic, choline chloride, carrageenan, sodium benzoate†, magnesium oxide, sodium ascorbate, alpha tocopheryl acetate, ferrous sulfate, zinc sulfate, niacinamide, calcium pantothenate, copper gluconate, BHA/BHT (to preserve freshness), vitamin A palmitate, manganese sulfate, pyridoxine hydrochloride, thiamine hydrochloride, riboflavin, chromium chloride, folic acid, biotin, potassium iodide, sodium molybdate, sodium selenite, phytonadione (vitamin K1), cholecalciferol (vitamin D3), cyanocobalamin (vitamin B12). Microbial inhibitors. BENEFIBER® soluble fiber. Product information and values are subject to change. Ingredient and nutrition information current as of April 2008.

Another formula that caught my eye is called Diabetisource AC Formula which it is claimed is designed to meet the unique nutritional needs of patients with diabetes and stress-induced hyperglycemia.  It also has a top secret (patented) microbial inhibitor.

Besides water, the main ingredient is cornstarch, which is another form, although perhaps lesser known, of sugar.    In fact, Wiki tells us that “starch is processed to produce many of the sugars in processed foods.”  Most sane people are aware that sugar causes insulin problems which are what diabetes is all about.  Another ingredient is medium chain triglycerides.  Mmm... I wonder how they are grown.

I’ll also include Jevity 1 Cal here because I think it is interesting that it is Halal and Kosher.  I wasn’t aware that these religious restrictions on foods applied to chemicals and sugars as shown in this ingredients list:

Water, Corn Maltodextrin, Corn Syrup Solids, Sodium & Calcium Caseinates, Soy Fiber, Soy Protein Isolate, Canola Oil, Corn Oil, Medium-Chain Triglycerides, Calcium Phosphate, Potassium Citrate, Magnesium Chloride, Soy Lecithin, Sodium Citrate, Ascorbic Acid, Choline Chloride, Magnesium Phosphate, Potassium Chloride, Carrageenan, Taurine, L-Carnitine, Zinc Sulfate, dl-Alpha-Tocopheryl Acetate, Ferrous Sulfate, Niacinamide, Calcium Pantothenate, Manganese Sulfate, Cupric Sulfate, Thiamine Chloride Hydrochloride, Pyridoxine Hydrochloride, Riboflavin, Vitamin A Palmitate, Folic Acid, Biotin, Chromium Chloride, Sodium Molybdate, Potassium Iodide, Sodium Selenate, Phylloquinone, Cyanocobalamin, and Vitamin D3.

Abbott Nutrition is the maker of Jevity 1 Cal  aka Abbott Laboratories.  I think it deserves a mention partly because they make Ensure, a line of well known meal replacement shakes which is what my mother took after she had surgery for stomach cancer.  Let me suffice to say that she became emaciated in a short time after this treatment and did not have a pleasant death.

The company's drug portfolio includes HUMIRA, a drug for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, moderate to severe chronic psoriasis and juvenile idiopathic arthritis; Norvir, a treatment for HIV; Depakote, an anticonvulsant drug; and Synthroid, a synthetic thyroid hormone.  

Also included is EAS aka Experimental and Applied Sciences, a very large producer of performance based nutritional supplements, i.e., for athletes.  So, Abbotts is making non food products for ingestion (what I refer to in an article about food law as ingestibles) for lots of people.

As a by the way, as recently as October 2011, this company got a slap on the hand (a fine of at least $1.3 BILLION) in the US for illegally marketing its Depakote epilepsy drug to the U.S. government and 24 states.  Who do you know who can afford to pay a fine like that and still be capable and allowed to continue trading?  Never mind that I don’t take their products, they’re still making me sick (when I think of them).

Nutrison is what the young man I know with a PEG is fed.  To be honest, I can’t make head or tail out of this meal from the list of ingredients below.  It has a shelf life of a year, which can be said for very little of what I eat.  However, I would comment that the first most abundant ingredient after water is a type of sugar.  I think this would be up there with the more or less synthetic formulas.  This product seems to be able to keep him alive, but I think his chances of it improving his health in any way are nil.  He can’t speak much, except to say “Yeah”  and the occasional “see you later” when prompted.  He sits in a wheelchair most of the day, otherwise, he’s in bed.  He can't do anything for himself. Besides this formula dripping into his stomach all day long, he gets injections of drugs through the tube.  How did he get to be like this?  I don’t know.  But I do know that the medical treatment he is receiving is not helping to improve the situation.  Perhaps it is keeping him alive and in this condition and that is the ultimate goal.  It seems cruel somehow, his being totally dependant and there being no apparent hope of improvement.

Nutrison Ingredients

Water, maltodextrin, milk proteins, vegetable oils, dietary fibres (soy polysaccharides, resistant starch, inulin, arabic gum, cellulose, oligofructose), emulsifier (soy lecithin), di potassium hydrogen phosphate, tri potassium citrate, acidity regulator (citric acid), magnesium chloride, sodium chloride, tri sodium citrate, magnesium hydrogen phosphate, calcium hydroxide, choline chloride, carotenoids (contains soy) (b-carotene, lutein, lycopene), potassium hydroxide, sodium L-ascorbate, ferrous lactate, zinc sulphate, nicotinamide, retinyl acetate, copper gluconate, DL-a-tocopheryl acetate, sodium selenite, manganese sulphate, calcium D-pantothenate, chromium chloride, D-biotin, cholecalciferol, thiamin hydrochloride, pteroylmonoglutamic acid, pyridoxine hydrochloride, cyanocobalamin, sodium molybdate, riboflavin, sodium fluoride, potassium iodide, phytomenadione.

From Wiki about the corporation responsible for the production of Nutrison, Numico (or in full Koninklijke Numico N.V., Royal Numico N.V.), is a specialist baby food and clinical nutrition subsidiary of Groupe Danone. Products range from infant formula to specialised nutrition for babies with specific needs and for breastfeeding mothers. It also produces and markets special clinical nutrition, diet products and disease-specific nutrition. Its main brands are Nutricia, Milupa, Mellin, Cow & Gate, and Dumex.

The name "NUMICO", is formed by NUtricia, MIlupa and COw & Gate.

Numico has three divisions:

·         Baby Food

·         Clinical Nutrition

·         Research & Development

On 9 July 2007 it was reported by Reuters that Danone was planning to pay Numico €12.3 billion for the company and by the end of 2008, this was finalised.

That’s all for now folks.  It seems that I could go on a long time on this one, but I’ll leave it for you to investigate more for yourself if you have a stake in the issue.  According to Wiki, the principal competitors of Danone in this field are: Bristol-Myers Squibb Company; NBTY, Inc.; Nestlé S.A.; Heinz; Novartis; Leiner Health Products; Perrigo Company; Milnot Company; Sunrider Corporation; Nature's Sunshine Products, Inc.; and Twinlab Corporation.  So there’s lots more that could be said on this topic.

Photo credit:  Young girl with gastric feeding tube

Photo credit:  Nutrison Energy Multi Fibre Formula

EU Science for Environment Policy by AstraZeneca

Just a quick reminder to beware of so-called scientific studies being bandied about everywhere you look.  The one below had the logo of the European Commission on it which at first glance gives it credence despite the clarification that “contents and views included in Science for Environment Policy are based on independent, peer-reviewed research and do not necessarily reflect the position of the European Commission.”  Whether AstraZeneca is capable of producing independent, peer-reviewed research is in my mind very questionable.  After reading the rubbish report I wasn’t surprised to note the contact at the end though.

If this is the sort of information that politicians in Europe are basing decisions, no wonder biodiversity is still on the landslide.

On 6^th March, I’ll be attending a Castle Debate in London on the environmental issues, law and policy for chemicals in the environment and hope to write up a more interesting article then.

23 February 2012

To cite this article/service:

"Science for Environment Policy": European Commission DG Environment News Alert Service, edited by SCU, The University of the West of England, Bristol. European Commission DG ENV News Alert Issue 274 23 February 2012

 A recent study has considered the levels at which active pharmaceutical ingredient (API) residues are safe when released into water bodies from drug manufacturing plants. It proposes that environmental reference concentrations and maximum tolerable concentrations are adopted for each API.

New approach to risk assessing pharmaceutical emissions

Pharmaceuticals and compounds
derived from medicines have been found in the environment over recent decades using better detection techniques. The most widespread route by which they enter the environment is from sewage containing residues excreted by people who have taken medicines. In addition, unused medicines are frequently thrown away down toilets or sinks.

A further source of pharmaceutical contamination are the effluents from drug manufacturing plants, The authors identify these as having the potential, if not controlled, to cause localised ‘hotspots’ of pharmaceuticals which could adversely affect the local receiving environment.

The environmental risk assessment of a substance is typically based on the concentration of the substance in the environment that is predicted to have no harmful effects over time, i.e. the PNEC (predicted no-effect concentration). This is compared with the predicted environmental concentration (PEC). The environmental reference concentration (ERC) approach proposed by the authors for APIs is based on established environmental quality standard concepts currently used in much national and international legislation. The ERC concept is similar to that of a PNEC. The ERC is defined as ‘the average concentration of an API in the receiving surface water environment that, based on current scientific knowledge, would be unlikely to result in any adverse long-term effects’. For each API, the study calculated four ERCs: ERCaquatic, intended to protect freshwater organisms, such as algae, invertebrates and fish; ERCmarine to protect marine organisms; ERCpredator to protect predators that eat fish, such as otters; and ERChuman to protect people. Typically, the lowest ERC for each API is used to set discharge standards at individual manufacturing sites.

Four MTC values, MTCaquatic, MTCmarine, MTCpredator and MTChuman were also calculated. The MTC is defined as ‘the maximum concentration of an API in surface waters which can be tolerated for short-term exposures’ (typically less than 24 hours). Whereas ERCs are designed to protect the environment and human health from long-term effects of APIs, MTCs are intended to protect against short-term higher emissions of APIs into the environment which often occur during the manufacture of drugs in batches or when machinery is cleaned between batches.

A comparison of the ERC and MTC values for 30 APIs revealed wide ranges, e.g. for ERCs from less than 0.1 ng/l to more than 10 μg/l. Significantly, different values were found for drugs that act in a similar manner, e.g. the ERCs for three beta-blockers ranged across two orders of magnitude. A wide range of ERCs was also found for four APIs that act differently on hormonal systems. This suggests that toxicity and ecotoxicity values should be determined for each API and not assumed to be similar to those for other drugs with the same mode of action or in the same class.

In some cases, ERCaquatic was not necessarily the lowest value, implying that people or fish-eating predators could be more sensitive to specific APIs than aquatic species. At some sites, where there are particular environmental concerns, such as the presence of wading birds, it might be necessary to look particularly closely at avian toxicology and exposure before deciding on the most relevant ERC.

The authors stress that emission control measures, such as cleaning techniques and waste disposal, should be tailored to the individual sites and the different APIs. Expert judgement will often be needed to decide the most appropriate risk management strategies for the different sites.

Source:
Murray-Smith, R.J., Coombe, V.T., Grönlund, M.H. et al. (2011) Managing Emissions of Active Pharmaceutical Ingredients from Manufacturing Facilities: An Environmental Quality Standard Approach. Integrated Environmental Assessment and Management. DOI: 10.1002/ieam.1268.

Contact:
richard.murray-smith@astrazeneca.com

Theme(s):
Chemicals, Risk assessment, Water