Amanda Hesser

A drug is a substance or a composition presented like having properties curative, preventive or managed in order to establish a diagnosis. A drug is generally intended to cure, relieve or prevent human or animal Maladie S.

Official definition

The concept of drug is precisely defined in France by the L5111-1 article of the Public health code:

One understands by drug any substance or composition presented like having curative or preventive properties with regard to the human or animal Maladie S, like very produced being able to be managed with the man or the animal, in order to establish a medical diagnosis or to restore, correct or modify their organic functions. Are in particular regarded as drugs the products Diététique S which contain in their composition of chemical substances or biological not constituting themselves of the Aliment S, but whose presence confers on these products, either of the required special properties in therapeutic dietetics, or of the properties of meal of test. The products used for the disinfection of the buildings and the dental prosthesis are not regarded as drugs.

History

At the beginning of the XXe century, were regarded as drugs only one dozen molecules of synthesis, and a hundred natural products. At the beginning of XXIe century, we use hundreds of molecules of synthesis and it only remains very little of current remedies of exclusively natural origin. The XXe century saw the rise of the drugs containing molecules of synthesis produced by pharmaceutical laboratories. Recently the proteins, molecules of alive are used more and more like drug.

Action of the drug

Active ingredient and excipient

The drug is composed of two kinds of substances:

Of one or more Active ingredient S (it is often the active ingredient which is called the drug). (S) the active ingredients (S) is (are) made up (S) by a quantity of active molecules having a shown pharmacological effect and an interest also clinically shown Thérapeutique. It has to notice that any substance pharmacologically activates does not constitute necessarily the base of a drug and even less than one medicamentous therapy.
Of Excipient S which is inert auxiliary substances being used for the formulation of the galenic form. These excipients are generally inert substances on the pharmacological level. The excipients make it possible to formulate to it (S) principles (S) active (S), i.e. to present the active ingredient in a given galenic form. The formulation allows in addition to presenting the drug in the form most adapted for the route of administration desired and of if required if it were necessary, to modulate the escape velocity of the active ingredient towards the organization. As example of excipients one will quote: the Water and the Saccharose are the two excipients constituting simple syrup - or, for dry forms, the Amidon (S) modified (S) and the modified celluloses are agents of délitement used in dry forms (tablets, gélules.) to accelerate the disintegration (or in core disintegration) of those once arrived in the stomach. The excipients are known as inert or inactive. They are not always free from pharmacological effects on certain patients. Indeed, certain excipients are known to be at the origin of side pharmacological effects (allergic reactions or of intolerance) at a minority of particularly sensitive patients. One speaks then about excipient for “notorious purpose”. One will quote lactose among intolerant patients with lactose. The prescriber or the pharmacist will have to hold of it account at the time of the regulation and the delivery of the drug. This is very important nottamment during the substitution of a “princeps product” by a generic form (cheaper copy) which does not have necessarily the same excipients as the product of origin. This is one of the reasons for which a patient can not tolerate the generic products.

It has to notice that an active ingredient can be for example a product of contrast which is not intended to treat the patient but has to help to pose the diagnosis.

The galénique one or " art to formulate the médicaments" , will allow to present the active ingredient to different amounts and under various forms Galénique S (forms of administration of the active ingredient to the patient). One will speak about Comprimé S, Gélule S, of soft capsules, Suppositoire S of bulbs, drops (oral, ocular or nasal), of collutoires, eye lotions, pomades, freezing and creams, of transdermic solutions, ovules, plaster or devices etc One can thus classify the galenic forms by the route of administration to the patients for whom they were conceived. One will speak the injectable ones then (bulbs of solution or suspension, implants…) intended for the various parenteral ways (under cutaneous, intravenous intramuscular, will intra articular… These forms must be sterile, and apyrogenes, and sometimes isotonic. The other not-injectable liquid forms are intended for the oral ways (to be swallowed " per os" or sublingual, with enteric coating or disintegration fast), nasal, auricular and ocular, dermic but so transdermic (stamp or patch). There exist still forms for the way, rectal, ocular, auricular…

A proprietary medical product is a drug which has a trade name (which is the subject of a commercial property, trade name says also name of imagination). Each speciality is the subject of a recording near the authorities of health, which is prepared industrially according to very strict standards (good practices of manufacture) and is sold at a price determined by a pharmaceutical laboratory. Under its same name of mark, there exist various forms dosage forms and various specific conditionings, each one being the object of a specific recording. The same speciality could be possibly marketed under one or more names of mark and will remain protected as long as it will be the subject of an intellectual property and a protection of the intellectual and/or commercial rights (patent, commercial exclusiveness, license…). Once the lost intellectual property (exhaustion of the rights du/des patents) the drug can be marketed in forms known as generic (in addition to the existing commercial forms). Generic forms having to be bioéquivalentes with the first high-class product put on the market called still produced " princeps" or original speciality.

Pricipie of bioéquivalence| : two drugs containing the same quantity of active ingredient are known as Bioéquivalentes if, for the same group of individuals, their therapeutic effects are considered biologically equivalent. But as it is difficult and especially very expensive to test a therapeutic equivalence based of the clinical and/or biological tests, one tests in fact the variations of the plasmatic concentration of the active ingredient during consecutive time with the catch of the drug. The curve of biodisponibility is represented stalemate the plasmatic Concentration = F (T). It is the measurement of the surface under the curve which gives the biodisponibility of the active principa. Two drugs bioéquivalents give averages of surfaces under the curve (thus of plasmatic concentration in unchanged product = F (T)) who are equivalent in a population of a score of healthy individuals (this is true for the majority of the generic products). The problems of Bioéquivalence arise and in fact are encountered for not very soluble active ingredients (<1mg/ml) managed by oral way and for modified, called galenic forms form with release prolonged, called still forms delay, etc For forms in true solution (injectable IV in bolus) there exists by definition no difference of Bioéquivalence between forms since it is total (it is said whereas the biodisponibility is absolute) and equal to 1 whatever the injectable speciality. This would be similar for solutions oral, but less frequently used, bie that the biodisponibility remains relating to the stomachic transit of each individual and a window of absorption duodénale. The injectable ones with prolonged release (forms will intra muscular, articular, implants,…) can, on the other hand to show extremely different biodisponibilities between them and compared to form IV bolus. This not meaning necessarily primarily different therapeutic effects or necessarily superiors or inferiors. Starts the field of pharmacokinetic in connection with toxicity (animal and human) and the clinical studies ((animal and human).

Name of the drugs and DCI. More and more, one employs the DCI or “Name international non-proprietary” to identify and prescribe the drugs in general but especially the products become generic what corresponds in fact the use of the international name of the active molecule, name included in all the scientific publications. In example: acetylsalicylic acid (ASA por Acetyl Salicylic Acid) for Aspirine which is a trade mark of the Bayer firm.

Some definitions

Posology : it is the usual amount of the drug . It depends on the disease, the age of the patient, his weight and certain clean factors: renal function, hepatic function. It should not naturally be to in no case modified without a medical opinion or possibly of the pharmacist.
Pharmacokinetic : it is the speed to which the active molecule of the drug will be absorptive, distributed in the organization, metabolized (transformed), then eliminated from the organization. It conditions the method of catch: oral (by the mouth), intravenous…, the daily number of catches, their schedule, the amount day laborer (daily).
Indication : it is, or the diseases for which the drug is used.
Counter-indication : they are, or the situations, where the catch of the drug can appear dangerous. This last should not, consequently, not be given. One distinguishes the relative counter-indications where in certain cases, the benefit-risk ratio of the catch of the molecule remains acceptable, and the absolute counter-indications where the drug should not be taken, whatever the anticipated profit.

Administration of the drug

The drug can be managed:

in a total way (systemic): the active ingredient passes in the Sang and is transported everywhere in the organization, in order to reach its target:

oral administration known as per bone : compressed, syrup, gélule, drinkable solution, granulated
Suppository
stamp or patch transdermic (through the skin): for example to fight against the desire for smoking, or like anti-inflammatory drug or antidoulor (morphine)
the administration by parenteral way is made by means of an injection. It can be

Intraveineuse, in once one will say in bolus or by a slow Perfusion. The vein being able to be surface, usually with the arm ( peripheral venous way ) or deep ( central venous way ), generally on the level of the neck (jugular vein) or under the clavicle (vein under clavière). The intravenous way makes it possible to manage a product which must act very quickly (urgency) or a product badly tolerated with the risk to irritate the vein (phlebitis.
subcutaneous: under the Skin, frequently on the level of the belly or thighs (insulin)
intradermal: in the intramuscular derm
: in a muscle (thigh) for a product which must act slowly.

in a local way (topic): the active ingredient is brought directly to the place where it must act:

Pomade, dermic Cream, freezing dermic etc (cutaneous action or topic)
Aerosol (air Routes)
Eye lotion (eyes)

Therapeutic categories

See the detailed article: Categories of drugs

Among the drugs one finds families therapeutic:

the Anesthetic S to obtain local anesthesia or general, forms of it topics or injectable
the Analgésique S (Antalgique S), acting against the Douleur
the Antibiotique S, antimicrobic having an activity Bactériostatique and/or Bactéricide;
the Antidépresseur S, which treat the depression] (see psychotropic)
the Anti-diurétique S, which decrease the secretion of Urine (Diurèse);
the Anti-inflammatory drug S acting against the Ignition;
the Antihistamine S acting against the Allergy;
the Anti-hypertenseur S which fight against hypertension;
the Antipyrétique S acting against the Fever;
antiviral acting against the Virus;
antirétroviraux acting against the Retrovirus;
the Antitussif S which fight against cough
the Anxiolytique S, which reduce the anxiety (see psychotropic)
the Bronchodilatateur S, which will dilate the Bronche S;
the Diurétique S, which increase the secretion of Urine (Diurèse) and decreases the tension;
the Laxatif S, which stimulate the defecation;
psychotropic , for the treatment of the psychiatric diseases (of which Nerve sedative S, Anxiolytique S, Antidepressant S, etc);
the Sédatif S (calming), which decrease the activity of a body;
the Vasopresseur S, which make assemble the blood Pressure;
etc

that one could gather in 6 vaster categories:

Note: the Hypnotic S (sleeping pills) and the Anxiolytique S are sometimes gathered under the name of Psycholeptique S, term which is in fact rather vast. See the Classification according to Delay and Deniker (1957), validated by the world congress of psychiatry in 1961. Psychic sedatives, slowing down the activity of the nervous system: hypnotic (barbiturates); nerve sedatives; lithium salts; tranquillizing (anxiolytic), traditional sedatives (benzodiazepines) and antiepileptic.

This Classification according to Delay and Deniker (1957) was modernized later by Pelicier and Thuillier (1991).

Development of the drugs

For a use in human health and animal, discovery of a new molecule to the Marketing authorization while passing by the development of (S) (it) form (S) galenic (the drug delivered in dispensary), generally from 10 to 15 years ran out. One can describe the development process according to the following stages:

search for a molecule candidate to the statute of candidate drug according to several methods: data-processing modeling, sifting (screening), observation of traditional medicines (medicine man), study of the characteristics of the plants or natural substances (pharmacognosy), and sometimes the Chance (seredipity) of clinical observations.
the molecules candidates are then Brevet ées (= protection of the intellectual rights) for one 20 years maximum duration.
Study of the effect of the molecule in vitro (on micro-organisms in culture, animal bodies isolated or on biological receivers) then in vivo , i.e. on the live animal.
search for an adapted galenic form. One seeks as much as possible to obtain a stable oral form, this one being simplest to take by the future patient.
the last phases of research are the clinical studies:

phase 1: tests known as of safety on Healthy volonteer. One seeks to know pharmacokinetic molecule (i.e. the speed of absorption (= throughput speed in blood starting from an oral solution), the speed of metabolisation (biological transformation by the liver and other bodies), of distribution in various fabrics starting from the plasmatic compartment and the speed of elimination by the organization also called " clearance"). As it is not ethical to expose healthy volonteers to very active products (anti-cancer, antithyroïdiens, hormones, antibiotics…), this phase in this case is carried out on patients.
phase 2: tests known as of effectiveness on patient. One establishes the field (arranges) active amounts starting from the data obtained initially on animals, and one establishes the " range" active amounts without seeking to reach a maximum amount. This " range" will become gradually " the posologie" product for such indication. It is during these tests that one sees appearing the first side effects, which will be often the principal side effects of the product. If these effects are too important, the development of the product can be stopped if the therapeutic interest is not manifest.
phase 3: the drug whose interest was confirmed in phase 2 is compared with a drug of reference (or a placebo when there does not exist treatment of reference) in a broader clinical study. A randomization (drawing lot) is carried out to determine which arm of treatment will be the patient. The experimentation known as " double aveugle" is currently a standard (neither the patient, nor the doctor know if it is a drug or the placebo or the reference which is managed). These statistical methods are a pledge of rigor and quality of the data.

the data of animal toxicology and clinical safety ( safety = phase 2), the data clinical ( effectiveness) and the pharmaceutical data ( quality) are gathered in a file known as of recording which is deposited to obtain a Marketing authorization (AMM) at the European Agency (EMEA). If the authority judges (on file) that information deposited is sufficient, it authorizes the marketing of the drug in the approved clinical indications. If the authority estimates that a further information is necessary, it will require further information.
Generally, when it is about a drug containing a new molecule (NCE = New Compound Entity), this one is covered by intellectual property laws (patent). This property is obtained by the deposit of an patent application. This intellectual property runs over one period maximum from 18 to 20 years since the deposit of the patent application. At the end of a certain number of years, the Brevet of the molecule falls into the public domain, and thus opens the possibility of copy by generic medicines which them also must be the subject of recording. These products being primarily similar to the original products, only the pharmaceutical part is deposited to obtain a recording. One period known as of data protection the 5 years can be obtained from the authorities of health to prevent the generic copies of an original product, innovator who took a long time to be developed.
In France, an experimental drug is, according to the law (appendix I of the Decision of May 26th, 2006 modifying the decree of the modified May 10th, 1995 relating to the good practices of manufacture (drug company)) any active ingredient in a dosage form or placebo tested or used like reference in a biomedical research, including the drugs already profiting from a marketing authorization, but used or presented or conditioned differently from authorized speciality, or used for an indication not - authorized or in order to obtain further information on the form of the authorized speciality .

Regulation, Distribution

The drugs are prescribed by the Médecin S with their Patient S which will buy them at their Pharmacien.

Conditions of distribution

Certain drugs can be bought without ordinance (one speaks about Automédication); in France, when a drug is bought without being prescribed, it is not refunded by the Health insurance.

In the majority of the countries, a drug must have obtained a marketing authorization (AMM) to be sold. The AMM is known under name NDA (new drug application) in the United States and under NDS (new drug submission) in Canada.

Conditions of regulation, lists of drugs

The organizations of regulation of health draw up lists of drugs according to the risks which represent their catch.

For example, In France, there exist several lists of poisonous drugs, which can be acquired only on ordinance:

list I: dangerous drugs;
list II: drugs potentially dangerous, less toxic than those of list I;
Narcotic S: psychotropic substance able to cause a noxious dependence and effects on psychic and physical health

drugs with restricted regulation:

those which are reserved for the hospital use
those which can be prescribed only by one hospital doctor
those requiring a specific monitoring and a regulation by a doctor specialized

drugs of exception: particularly expensive drugs, they must be the subject of a specific follow-up and medical justifications for the assumption of responsibility.
restricted drugs and of exception.

the following table recapitulates these various cases (3 last columns being also with obligatory prescrition):

Balance paradoxical benefit/risk, side effects and

The profile of risk is especially related to the relation between the side effects and the neat disease.

Benefit ratio/risk

One takes into account the benefit ratio/risk: thus severe side effects will be accepted unquestionably better to escape a Cancer than to avoid the Douleur or the Obésité.

As regards doctor, this one must take into account in this report/ratio with the risk the duration of the treatment (cumulative effect), and not neglect the risk on the fetus when it is about an expectant mother (example: Thalidomide, better known under the name Softenon). The indications of posology and the side effects known must be indicated on the note accompanying the drug.

Moreover, legislative side, certain drugs are severely regulated and can be prescribed only under certain conditions (see Prescription, distribution).

Obligations of the laboratories

After the Marketing of the drug, the pharmaceutical laboratories have the obligation to make studies of Pharmacovigilance, i.e. to continue the study of the risks of the drug by collecting the whole of the side effects of the drug or to even carry out clinical studies to this end.

The collected data, concerning a great number of patients, are transmitted to the authorities of health which revalue the balance benefit/risk of the drug. It can come out from it from the serious effects which had not appeared at the time them clinical studies and thus carry out the laboratory or the authority to withdraw the drug.

undesirable Event medicamentous

These undesirable effects can be serious: undesirable Evénement engraves (EIG), that they are the fact of a medicamentous Erreur or not. See iatrogénèse.

Potential paradoxical effects

To prescribe a drug is not neutral: the induced effects are not always light, they can be serious.

The side effects can in their turn being badly interpreted, like symptoms of another thing, or of an aggravation of the state of the person… what complicates the situation singularly and to lead to additional regulations (unsuited!) with other side effects, and also with a dependence.

See for example for the soporific , whose French the large-scale consumers in the world are (3 times more than the British, or than German), the article on the hypnotic S

In the field of antibiotics, a on-regulation can lead, in the long term, with infections more difficult to treat because of selection of germs resisting antibiotics.

Environmental impacts or secondaries (via the food) of human or veterinary drugs (whose disturbing endocriniens) seems to be underestimated. Certain residues, via the urine and the excrements are not degraded by the purification plants or are introduced and already seem to pose problem, definitely detectable on the fertility of marine species or water fresh, in particular alive downstream from the discharge system of purification plants. Certain drugs (Chemotherapy, Disinfecting S) contain molecules which are not dégradables (Heavy metals). The detection and the filtration of these molecules are still at their beginnings.

Problems of refunding: access to the drug and overconsumption

For the countries having signed the Charter of the United Nations, the protection of the populations (safety, protection of health) vis-a-vis the daily accidents, diseases and catastrophes (calamities), is one of the functions of the State (articles 3,22 and 25 of the Universal declaration of the human rights of 1948).

Access to the drugs

It is thus of the responsibility for the State to ensure an access to the care, and in particular to the drugs, according to the health condition of the person and not of its incomes.

Two difficulties arise then:

financing;
regulation of medicamentous consumption.

So people do not have the means of buying drugs, the cost must thus be assured about it by the State, therefore by the taxes, social contributions S or Taxe S in one way or another (on the tobacco, alcohol, etc); it is about fact of a means of redistribution of the richnesses. The individuals having “sufficient” incomes, but not being able to cover very expensive care, can also contract a Assurance organizing the mutualisation of the risk.

Déresponsabilisation and serious consequences

That it is about an organization of State or private, an free access with the drugs (or a very reduced cost) presents a big risk of deresponsabilisation, at the same time patients and looking after, with for possible consequences:

a overcost without relationship with the needs for health:

in the world about half of the drugs is not used advisedly (in France, it is more half)
the drugs represent the share in the health expenditure which increases most quickly, in many countries, and in particular in France (approximately +6% per annum, in value).

of the problems involved in the medicamentous overconsumption, which itself creates overcosts of the health-care system, for example:

medicamentous interactions which can be serious (8000 décès/an according to the Ministry for French Health) and more generally:
medicamentous accidents more or less serious (13000 deaths proven per annum in France, and perhaps much more)
pharmacodépendance, of which it is very difficult to leave, as with hard drugs, for drugs as simple as of the soporific , even if they are taken over very a short duration
increasing resistance of the bacteria to the antibiotics, limiting more and more often our defense vis-a-vis the pathogenic bacteria. More than 3000 annual deaths by infections Nosocomiale S in France must with this impotence: a Staphylocoque gilded on 3 is from now on impossible to thwart, more than 50% of the pneumococci are resistant to penicillin.

the risk thus to more be able to finance really useful expenditure. The related spending with the lengthening of the lifespan, (whose Affections Long life (ALD) in France, which account for 60% of the expenditure of the Health insurance) increase and will continue to strongly increase, in the years to come. It is all the whole of the health-care system which is in question…

It is thus like if all, doctors and patients, we cut the branch on which we sat…

Vulgarizing of the drug, reduction in the cost, even exemption from payment

See the introduction of Edith Dufay, President of AAQTE, in the French dictionary of the medicamentous Error, 72 pages, SFPC:

… It takes shape behind these 4 reports an implicit but seldom proposed answer, with the perpetuation of the total distribution of the drug, the protected organization of the circuit of the drug in our health care institutions: the refusal, by the whole of the health professionals, the risk related to the drug.

Each one among us with the conviction to control the activities which fall on to him, because we have an individual operating process partitioned without external glance .

We also standardized the drug . Although it represents a therapeutic act impossible to circumvent, its balance benefit-risks is insufficiently evaluated and very often dedramatized until forgetting of it.

the reduction in the cost of the drugs, even their exemption from payment,… contribute certainly to this vulgarizing .

An interesting comparison to show the difference according to the developed countries: by anybody, the French consume 6 times more drugs than the Netherlands. In the Netherlands, 6 people out of 10 who leave a consultation do not have a Prescription of drugs, whereas the rate is of 0.25 out of 10 in France.

The warning of the experts of WHO

The experts of the World Health Organization (WHO) were not mistaken there, they emitted serious warnings: to promote the rational use of the drugs, it is to save lives and to make economies .

The question of refunding is thus a thorny problem, the research of balance between the free access to the care, the therapeutic choice (freedom of looking after, freedom of the patient), the equality in front of the care…

See the articles Social security and Health insurance.

What becomes the out-of-date drugs or not used in France?

It should be known that each year, the consumption of drugs Périmé S causes 22.000 Intoxication S!

So instead of throwing them to the dustbin (Pollution of the Environment), one turns over them to the Pharmacien, they can be Recyclé S in two manners.

If they are nonout-of-date, they are treated by association Cyclamed. Some are redistributed the most stripped with in France and in the third world by 11 humanitarian organizations (10 million boxes thus could be redistributed in 2002). If they are out-of-date, they are burned in Incinérateur S. packing are recycled; they account for 90% of the 70.000 tons annual of waste resulting from drugs produced in France.

See too

Internal bonds

French Agency of public health of the health products
Alicament
Chemotherapy
Bithérapie
Trithérapie
Generic medicine
Drug under ordinance
Regulation of drugs
Drugs and pregnancy
Side effect (medicine)
Undesirable effect
medicamentous undesirable Event (EIM) - Unfavourable Drug Vent (ADE)
medicamentous Error
medicamentous Interaction
Iatrogénèse
Overconsumption of drugs
Surprescription
Dependence
Sevrage
phytotherapeutic Liste of drugs withdrawn from the market
Traitement
medical Délégué
Produit forest, other that wood

External bonds

Databases or dictionaries

Editions of the VIDAL - Swiss Dictionary VIDAL
Compendium of the drugs.
Biam, the data bank automated on the drugs.
Theriaque.org, site of GIE SIPS (Information system on the health products)
Database of the pharmaceutical notes of French language

Industries

Companies of the Drug

History

drugs in the Hospitals of Roy Text of the middle of the XVIIIe century.

Others

French Dictionary of the medicamentous error, 72 pages, SFPC

Simple: Medication

Random links: