General knowledge of drugsGeneral knowledge of drugs

Drug means a certain substance which is introduced into the Drug means a certain substance which is introduced into the living organism for living organism for medical purposesmedical purposes: for prevention, : for prevention, maintaining health, for improving the physical and mental state maintaining health, for improving the physical and mental state of human beings or desof human beings or deseeigned for diagnoses and for control of igned for diagnoses and for control of desedeseasesases..

This definitiThis definitioon involves:n involves:

The prevention (profilaxis)The prevention (profilaxis)

The diagnosis (recognition of illnesses)The diagnosis (recognition of illnesses)

The treatment (therapy)The treatment (therapy)

The Hungarian Pharmavopoeia define the „medical substances” The Hungarian Pharmavopoeia define the „medical substances” as substances responsible for the biological action, and as substances responsible for the biological action, and ingredients which have no biological activities (additives)ingredients which have no biological activities (additives)..

Classification of drugsClassification of drugs

Drugs can be divided into groups, according to their origin, the Drugs can be divided into groups, according to their origin, the strength of their activity, the pharmacological group, their use strength of their activity, the pharmacological group, their use and according to the way of their application.and according to the way of their application.

Classification of drugs on the basis of strengthClassification of drugs on the basis of strength

Drugs cause poisoning only in high quantity (dosis), are stored Drugs cause poisoning only in high quantity (dosis), are stored on open selfs of pharmacies, and they can be dispensed for on open selfs of pharmacies, and they can be dispensed for patients without prescriptions. patients without prescriptions.

Drugs designated by the symbol + have stronger activity.Drugs designated by the symbol + have stronger activity.

Drugs designated by the symbol Drugs designated by the symbol empty empty + are the + are the hhypnoticsypnotics or or sedatives.sedatives.

Drugs designated by the symbol ++ have very strong biological Drugs designated by the symbol ++ have very strong biological activity.activity.

Drugs designated by the symbol Drugs designated by the symbol empty empty ++ are ++ are narcoticsnarcotics..

they act on the central nervous system and after chronic they act on the central nervous system and after chronic use dependency is developed which destroys the use dependency is developed which destroys the

patients. patients.

Prescriptions and dispensing of drugs designated by the Prescriptions and dispensing of drugs designated by the symbols listed above (+, symbols listed above (+, emptyempty+, ++, +, ++, emptyempty++) must be ++) must be stored in closed cabinet and the narcotics must be stored stored in closed cabinet and the narcotics must be stored separately according to the laws.separately according to the laws.

The dispensing of drugs designated by crosses is limited, that The dispensing of drugs designated by crosses is limited, that means the prescription of a physician is necessary.means the prescription of a physician is necessary.

The highest limitations refer to the narcotics and poisoning The highest limitations refer to the narcotics and poisoning substances. They order needs a special requirements: substances. They order needs a special requirements: prescription with copy and all data of the patients including prescription with copy and all data of the patients including the diagnosis, etc. The prescriptions must be preserved as a the diagnosis, etc. The prescriptions must be preserved as a document.document.

Classification of drugs by their pharmacological actionClassification of drugs by their pharmacological action

According to the suggestion of the World Health According to the suggestion of the World Health Organisation (=WHO) the main activity of a drug can be Organisation (=WHO) the main activity of a drug can be described by a capital letter combined with three described by a capital letter combined with three number e.g. number e.g.

A 300 A 300 AntiepilepticsAntiepileptics

A 600A 600 Analgetics / anatipyreticsAnalgetics / anatipyretics

I 200I 200 Blood clotingsBlood clotings

I 210I 210 AnticoagulantsAnticoagulants

Classification of drugs by their useClassification of drugs by their use

The greatest part of drugs used The greatest part of drugs used for humans.for humans. The same The same quality of drugs must be used for animals, which has to be quality of drugs must be used for animals, which has to be marked marked „ad usum veterinarium„ad usum veterinarium”” (A.U.V.) which means for (A.U.V.) which means for veterinary use.veterinary use. Drugs may be stored only as long as they Drugs may be stored only as long as they meet the requirements described by the pharmacopoeia. meet the requirements described by the pharmacopoeia. Drugs may undergo transformation even under proper Drugs may undergo transformation even under proper storage condition, therefore they must be kept for a storage condition, therefore they must be kept for a limited time perios (limited time perios (expiration dateexpiration date).).

Classification of drugs by the place of applicationClassification of drugs by the place of application

On this basis drugs can be devided into two groups: drugs On this basis drugs can be devided into two groups: drugs for for local andlocal and for for generalgeneral administration.administration.

For exemple a powder administred on the surface of the skin For exemple a powder administred on the surface of the skin means a local (topical) use, on the contrary the use of an means a local (topical) use, on the contrary the use of an analgetic means a general action, independently from the analgetic means a general action, independently from the modes of their use.modes of their use.

Earlier there was an other way of classification: drugs for Earlier there was an other way of classification: drugs for externally (externally (ad usum externumad usum externum) and internally use () and internally use (ad usum ad usum internuminternum).).

Classification of drugs according to their origin may be:Classification of drugs according to their origin may be:

Chemical substances:Chemical substances:

Inorganic substances: e.g. sodium chloride, potassium Inorganic substances: e.g. sodium chloride, potassium iodids.iodids.

Organic substances: e.g. phenazone, salicylic acid, etc.Organic substances: e.g. phenazone, salicylic acid, etc.

Animal origin:Animal origin: pepsin pepsinee (manufactured from the stomach of pigs (manufactured from the stomach of pigs or from other animals), pancreatine, different serums etc.or from other animals), pancreatine, different serums etc.

Plant origin:Plant origin: vegetable drugs: chamomile, etc. vegetable drugs: chamomile, etc.

Synthetic or half synthetic origin.Synthetic or half synthetic origin.

Natural substances:Natural substances: purified alkaloids, glycosides, hormones etc. purified alkaloids, glycosides, hormones etc.

The place and way of application of formulated drugThe place and way of application of formulated drug

PlacePlace The way of The way of applicationapplication

The form of drugThe form of drug

Bucal (in mouth)Bucal (in mouth) Orally, under the Orally, under the tonguetongue

SubliSublinnqual tabletqual tablet

Oral, throughOral, through Orally Orally Solutions, pills, Solutions, pills, tablets, capsulestablets, capsules

Rectal (in rectum)Rectal (in rectum) RectallyRectally Tablets, supp.Tablets, supp.

In the vaginaIn the vagina VaginalVaginal Tablets, supp.Tablets, supp.

ParenterParenteraall ParenterallyParenterally Infusions, Infusions, injectionsinjections

iintra ntra mmuscular (im)uscular (im)

iintra venous (iv)ntra venous (iv)

iintra arterial (ia)ntra arterial (ia)

In the lungIn the lung InhalationInhalation AAerosolserosols

Cassification of formulated drugs Cassification of formulated drugs

Medicine mean formulated drugs prepared for medical Medicine mean formulated drugs prepared for medical treatment. In thestreatment. In thesee respect a biologically active substance is respect a biologically active substance is not a medicine, because it can not be used directly. not a medicine, because it can not be used directly.

Medicines may be in Medicines may be in undividedundivided (not for single use) and (not for single use) and devideddevided (for single use). The former may be a solution (for 2-4 days use) (for single use). The former may be a solution (for 2-4 days use) which will be redivided by the patients.which will be redivided by the patients.

The forms of medicines may be:The forms of medicines may be: powders powders tabletstabletspillspillssuppositoriessuppositoriescapsulescapsulescoated tabletscoated tablets

injections, etc.injections, etc.

Specialities may be according to the PharmacopoeiaSpecialities may be according to the Pharmacopoeiass registered registered specialities: specialities: galenic specialitiesgalenic specialities,, prepared according to the prepared according to the Formulae Normales (FoNo = the collection of official Formulae Normales (FoNo = the collection of official prescriprions), prescriprions), magistrally mademagistrally made specialitiesspecialities prepared occording prepared occording to the prescriptions of physicians.to the prescriptions of physicians.

Drugs and dosesDrugs and doses

In the single monographs of pharmacopoeias the „usual dose In the single monographs of pharmacopoeias the „usual dose range” or the usual doses are given for single (range” or the usual doses are given for single (pro dosipro dosi), daily ), daily ((pro diepro die) uses for adults using the medicament orally. There is ) uses for adults using the medicament orally. There is some substances where a period is stated over which the some substances where a period is stated over which the whole doses is given, for example daily doses the division of whole doses is given, for example daily doses the division of which is left to the physician.which is left to the physician.

If a drug is applied in an other way written by the If a drug is applied in an other way written by the pharmacopoeia a new dose for the new administration has to pharmacopoeia a new dose for the new administration has to be stated.be stated.

It must not be assumed that the doses indicate the greatest It must not be assumed that the doses indicate the greatest amount of drugs that may be given. The medical practioner will amount of drugs that may be given. The medical practioner will exercise his own judgment and act on his own responsibility in exercise his own judgment and act on his own responsibility in respect of the amount of any therapeutic agent, he may respect of the amount of any therapeutic agent, he may prescribe or administer or the frequency of its administration.prescribe or administer or the frequency of its administration.

WhenWhen however however an unusual large dose appears to have been an unusual large dose appears to have been prescribed, it is the responsibility of the pharmacist to satisfy prescribed, it is the responsibility of the pharmacist to satisfy himself, that the prescriber’s intention has been correctly himself, that the prescriber’s intention has been correctly interpreted. interpreted.

Specially named dosesSpecially named doses

Dosis curativa Dosis curativa = generally used dosis for curing= generally used dosis for curing

Dosis therapeuticaDosis therapeutica = generally used dosis= generally used dosis

Dosis medicinalis Dosis medicinalis = generally used dosis= generally used dosis

Dosis tolerataDosis tolerata = dosis which can be tolerated= dosis which can be tolerated

Dosis maximalis Dosis maximalis = the highest dosis over which toxic = the highest dosis over which toxic symptoms may appearsymptoms may appear

Dosis toxica minimaDosis toxica minima = dosis with minimal toxic effect= dosis with minimal toxic effect

According to our present knowledge the pharmacological According to our present knowledge the pharmacological activity based on the combination of drug molecules with the activity based on the combination of drug molecules with the molecules of the target organ (receptors).molecules of the target organ (receptors).

In this respect the concentration of the drug molecules will be In this respect the concentration of the drug molecules will be the highest in the tissue containing the receptors which is the highest in the tissue containing the receptors which is often called the site of action. To exert a certain often called the site of action. To exert a certain pharmacological effect it is necessary to bring the drug pharmacological effect it is necessary to bring the drug molecules to the receptor in a proper concentration.molecules to the receptor in a proper concentration.

The way of the drugs to the receptor is different depending The way of the drugs to the receptor is different depending upon the administration of the drug.upon the administration of the drug.

From the medicine administred orally the drug From the medicine administred orally the drug liberatesliberates and and than than absorbsabsorbs into the blood stream, and at the same time the into the blood stream, and at the same time the distributiondistribution, the , the biotransformationbiotransformation, , excretionexcretion is started. is started.

It is easy to understand that the action of the same drug will be It is easy to understand that the action of the same drug will be different if it is administered orally or parenterdifferent if it is administered orally or parenteraally.lly.

In the former case there is more or less lost in the consequence In the former case there is more or less lost in the consequence of liberation, dissolution.of liberation, dissolution.

The distribution and biotransformation influence the action of The distribution and biotransformation influence the action of drug independently from the administration. drug independently from the administration.

The applicability of a drug can be characterizes by the width of The applicability of a drug can be characterizes by the width of its action and by the therapeutic index.its action and by the therapeutic index.

The width of action of a drug The width of action of a drug == dosis tolerata – dosis curativa. dosis tolerata – dosis curativa.

The therapeutic index The therapeutic index == dosis curativa / dosis tolerata. dosis curativa / dosis tolerata.

ThThisis two concepts indicate the safety of the therapeutic two concepts indicate the safety of the therapeutic treatment. treatment.

The biopharmacy deals with the drugs starting from the The biopharmacy deals with the drugs starting from the formulation until the drugs leaves the body. The formulation until the drugs leaves the body. The pharmacokinetic checks the blood levels during the pharmacokinetic checks the blood levels during the treatment and determines the start of the action as well treatment and determines the start of the action as well as the speed of elimination.as the speed of elimination.

Liberation, absorption, distribution, metabolism and Liberation, absorption, distribution, metabolism and eliminationelimination (abreviated as (abreviated as LADMELADME) are the ) are the basis of the basis of the drug safetydrug safety that means to insure the therapeutic that means to insure the therapeutic conceconcenntrtraation without any toxic effect.tion without any toxic effect.

Drug utilizationDrug utilization

It means the examination and evaluation of drug use. It means the examination and evaluation of drug use.

Main tasks in drug utilization.Main tasks in drug utilization.

- To monitor the quantity and ratios of drugs used in dTo monitor the quantity and ratios of drugs used in diifferent fferent pharmacological groups.pharmacological groups.

- To monitor the groups of drugs time to tTo monitor the groups of drugs time to tiime where the estimation me where the estimation seems to be necessary.seems to be necessary.

- To work out the way of control.To work out the way of control.

- To initiate and propagate principles concerning the economical and To initiate and propagate principles concerning the economical and safety drug use.safety drug use.

- The increase of drug consumption is 8-10 % per year, which The increase of drug consumption is 8-10 % per year, which includes the neincludes the neww drug preparations as well as the everage drug preparations as well as the everage consumption.consumption.

How could be influenced the sucreased drug consumption?How could be influenced the sucreased drug consumption?

- By regulation of dispensations (to obtain more current drugs after By regulation of dispensations (to obtain more current drugs after prescriptions). prescriptions).

- By increasing the drug prices.By increasing the drug prices.

- By improving the health informations (by initiation of healthy style By improving the health informations (by initiation of healthy style of life, changing of customs of fooding, the prevention of illnesses, of life, changing of customs of fooding, the prevention of illnesses, etc.).etc.).

Drug abuseDrug abuse

Prevention of drug abusePrevention of drug abuse

When the entire problem of drug abuse including alcoholism is When the entire problem of drug abuse including alcoholism is viewed in perspective, the percentage of individuals who viewed in perspective, the percentage of individuals who become compulsive drug user as a result of legitimate medical become compulsive drug user as a result of legitimate medical treatment, is extremely small.treatment, is extremely small.

Neverthless in the United State with the notable exception of Neverthless in the United State with the notable exception of alcohol and tobacco potent drugs are legally obtained only on alcohol and tobacco potent drugs are legally obtained only on the prescription of physicithe prescription of physiciaan or other licensed practicioner.n or other licensed practicioner.

Since the number of persons who may be predisposed to the Since the number of persons who may be predisposed to the abuse of drugs is far greater than the members of addicts, abuse of drugs is far greater than the members of addicts, physicians should consider the abuse potentphysicians should consider the abuse potentiial of the drugs al of the drugs they prescribe.they prescribe.

The high percentage of physicians, dentists and nurses who The high percentage of physicians, dentists and nurses who become addited to opioid and the vast number alcoholics become addited to opioid and the vast number alcoholics attest to the attest to the relationship between self medication and the relationship between self medication and the later development of compulsive drug abuse.later development of compulsive drug abuse.

Comission of Narcotic Drugs in the frame of the United Comission of Narcotic Drugs in the frame of the United Nations Organization (UNO)Nations Organization (UNO)

Confiscated narcotin drugs in 1983:Confiscated narcotin drugs in 1983:

2,2 t2,2 t morphinemorphine 6,1 t6,1 t heroineheroine

12 t 12 t cocainecocaine 84 84 t t opiumopium 242242 t t hasis hasis7000 7000 t t marihuanamarihuana

Price increases under the tradePrice increases under the trade

10 kg 10 kg opium opium 400 $400 $ (in Pakistan)(in Pakistan)

1 kg 1 kg morpine is produced morpine is produced 8 000 $8 000 $

hheroineeroine 200 000 $200 000 $

ddiluted 1 : 20 (5 % heroine) = 50 000 dosesiluted 1 : 20 (5 % heroine) = 50 000 doses

1,5 million $1,5 million $ (U.S.A.)(U.S.A.)

Besides morphine and its derivates, the metamphetamine Besides morphine and its derivates, the metamphetamine also known as crystal meth, it is the cheapest drug and can be also known as crystal meth, it is the cheapest drug and can be applied in dapplied in diifferent way it is capable to produce an enphoric fferent way it is capable to produce an enphoric feeling for as long as three hours, it has become known as feeling for as long as three hours, it has become known as poor man’s cocpoor man’s cocaaine.ine.

Drug Enforcement Agency estimates that approximately two Drug Enforcement Agency estimates that approximately two tons of methamphetamine are produced in U.S.A. annually.tons of methamphetamine are produced in U.S.A. annually.

Tolerance, physical dependence and abuse liabilityTolerance, physical dependence and abuse liability

The development of these with The development of these with rrepeated use is a epeated use is a charcharaacteristic feature of some drugs and cteristic feature of some drugs and the possibility of the possibility of developing physchological dependence on the effect of these developing physchological dependence on the effect of these drugs is one of the major limitation of their clinical use.drugs is one of the major limitation of their clinical use. This This ability to suppress withdrowal symptoms caused by ability to suppress withdrowal symptoms caused by withdrowal of other drugs.withdrowal of other drugs.

The degree to which it induces euphoria similar to that The degree to which it induces euphoria similar to that produced by morphine and other opioids.produced by morphine and other opioids.

The pattern of tThe pattern of tooxicity that occur when the dose is increased xicity that occur when the dose is increased beyond the usual therapeutic range. beyond the usual therapeutic range. Physical characteristicPhysical characteristic of the drug, such as water solubility and stability that may of the drug, such as water solubility and stability that may determine wether it is like to be abused by parenteral route. determine wether it is like to be abused by parenteral route.

Experiences seems to show that within a culture that Experiences seems to show that within a culture that accepts the use of some psychoactive agents total accepts the use of some psychoactive agents total prohibition of selected classes of drugs tend to produce a prohibition of selected classes of drugs tend to produce a shift toward the use of other agents.shift toward the use of other agents.

Thus at present, some opioid users shift to alcohol and Thus at present, some opioid users shift to alcohol and barbiturates in to no drug at all, but they often return to barbiturates in to no drug at all, but they often return to opioids whenever the liability increases.opioids whenever the liability increases.

The countries of the „gold triangle” Burma, Laos, Thailand The countries of the „gold triangle” Burma, Laos, Thailand and the countries of the „gold half-moon” Afganistan, and the countries of the „gold half-moon” Afganistan, Pakistan, Iran have produce the majority of opioids.Pakistan, Iran have produce the majority of opioids.

In South and Middle American countries e.g. Peru, Bolivia, In South and Middle American countries e.g. Peru, Bolivia, Columbia and Mexico cultivate and manufacture the cocain. Columbia and Mexico cultivate and manufacture the cocain. For a pharmacist it is necessary to define the constitutes of For a pharmacist it is necessary to define the constitutes of drug abuse, the extent of this problem and the role of drug abuse, the extent of this problem and the role of pharmacists.pharmacists.

It is important to know how the patients suffering from drug It is important to know how the patients suffering from drug abuse how can be recognised, to inform them the hazards of abuse how can be recognised, to inform them the hazards of using drugs for that purpose, and about the hazards of using drugs for that purpose, and about the hazards of injecting drugs, etc.injecting drugs, etc.

The introduction as well as the scope of health The introduction as well as the scope of health iinsurance, nsurance, while an international trend, has remained strictly a while an international trend, has remained strictly a separate national decision of the indivseparate national decision of the indiviidual country.dual country.

However the trade in opiates and other narcotic drugs However the trade in opiates and other narcotic drugs became a matter of international cooperation and decision.became a matter of international cooperation and decision.

In the In the early 19early 19thth century the English government, in order to century the English government, in order to retain the profitable trade in opium, overcame by force of retain the profitable trade in opium, overcame by force of arms attempts of the Chinese government to aliminate the arms attempts of the Chinese government to aliminate the import of the drug from English-dominated Indiaimport of the drug from English-dominated India.. Defeated Defeated in two so-called in two so-called opium warsopium wars (1839-1843 and 1856-1866), (1839-1843 and 1856-1866), the Chithe Chinnese government – to the lasting discredit of the ese government – to the lasting discredit of the EEnnglish – had to compensate the traders for their losses. glish – had to compensate the traders for their losses.

International Professional TrendsInternational Professional Trends

In the development of industrial pharmacy, of health insurance under In the development of industrial pharmacy, of health insurance under governmental control and of laws controlling dependency-producing governmental control and of laws controlling dependency-producing drugs, the pharmacists had to adapt as best they could to a given drugs, the pharmacists had to adapt as best they could to a given situation. However, there was a wide field left to the initiative of the situation. However, there was a wide field left to the initiative of the members of the profession that could be cultivated fruitfully on an members of the profession that could be cultivated fruitfully on an international basis.international basis.

Federation Internationale Pharmaceutique Federation Internationale Pharmaceutique F.I.P.F.I.P.

- - IInternational Congresses of Pharmacy continued to be held nternational Congresses of Pharmacy continued to be held every few years in various countries – every few years in various countries – no continuityno continuity

-- 1908 1908 Dutch Pharmaceutical Association proposal for Dutch Pharmaceutical Association proposal for organizing aorganizing a permanpermaneent international associationnt international association

- 1911 - 1911 Decision about placing the headquarters and the Decision about placing the headquarters and the secretariat at The Haguesecretariat at The Hague

-- 1912 1912 T The new International Pharmaceutical Federation he new International Pharmaceutical Federation became a federation of the important national became a federation of the important national pharmaceutical associations, dedicated to the pharmaceutical associations, dedicated to the furtherance of the profession and of pharmaceutical furtherance of the profession and of pharmaceutical knowledge, and seeking better collaboration and knowledge, and seeking better collaboration and understanding on issues of common concern.understanding on issues of common concern.

Sections (9) e.g. Documentation-, Academic-, OIndustrial-, Sections (9) e.g. Documentation-, Academic-, OIndustrial-, Medicinal plant-, Military-, etc.)Medicinal plant-, Military-, etc.)

Conferences – each year.Conferences – each year.It represents a majority of the world’s pharmacists.It represents a majority of the world’s pharmacists.

International Pharmaceutical Federation of StudentsInternational Pharmaceutical Federation of Students N.P.S.F. N.P.S.F. - 1949- 1949

((The 44The 44thth congress of FIP was organized in Budapest in 1984 congress of FIP was organized in Budapest in 1984))

Budapest’s Declaration:Budapest’s Declaration:

1.1. Drugs and other pharmaceutical products cannot be regarded Drugs and other pharmaceutical products cannot be regarded us goods. They provide the principal part of medical us goods. They provide the principal part of medical treatments.treatments.

2.2. Only experts are able to inform concerning the preparation Only experts are able to inform concerning the preparation constitution, pharmacological activity, side effects; etc.constitution, pharmacological activity, side effects; etc.

3.3. The pharmacist are experts on drugs.The pharmacist are experts on drugs.

The FIP called the attention of the governments, and theThe FIP called the attention of the governments, and the national and international organizations to the necessity of national and international organizations to the necessity of the knowledge of pharmacists and to that it is essential to the knowledge of pharmacists and to that it is essential to consult them before making decisions. consult them before making decisions.

Unification of Drug StandardsUnification of Drug Standards

To unify standards for drugs internationally has been a goal to To unify standards for drugs internationally has been a goal to which pharmacists and others in the health sciences return agwhich pharmacists and others in the health sciences return agaain in and again.and again.

1893:1893: in Chicago: the idea of an internationale code of potent in Chicago: the idea of an internationale code of potent medicaments. (18 countries agreed)medicaments. (18 countries agreed)

1906:1906: Protocole International (P.J. = International Formulary)Protocole International (P.J. = International Formulary)

1925:1925: The final protocol was signed (26 governments)The final protocol was signed (26 governments)

1937:1937: Technical Comission of Pharmacopoeial Experts Technical Comission of Pharmacopoeial Experts (unification of pharmacopoeias)(unification of pharmacopoeias)

1947:1947: W.H.O. ExpertW.H.O. Expert Committee on the Unification of Committee on the Unification of Pharmacopoeias.Pharmacopoeias.

1955:1955: Pharmacopoea Internationalis, first ed. In English, French Pharmacopoea Internationalis, first ed. In English, French andand Spanish.Spanish.

1967:1967: Pharmacopoea. Internationalis, first ed. In English, French Pharmacopoea. Internationalis, first ed. In English, French and second ed.and second ed.

The tendency toward international cooperation may be affected The tendency toward international cooperation may be affected by by regionalregional as well as as well as national differences.national differences. International Groups International Groups of Specialized Scope.of Specialized Scope.

The World Health Organization (WHO)The World Health Organization (WHO)

After finishing the Second World War the United Nations After finishing the Second World War the United Nations Organization (Organization (UNOUNO) was founded in Los Angeles.) was founded in Los Angeles.

The World Health Organization (The World Health Organization (WHOWHO) was also established on ) was also established on 22nd of July 194622nd of July 1946 as the satellite organization of the UNO. as the satellite organization of the UNO.

From 26 members of the WHO it grew up to 132 up to now. From 26 members of the WHO it grew up to 132 up to now. HeadquarterHeadquarter of WHO: of WHO: GenevaGeneva. It has . It has 6 regional bureaus6 regional bureaus. The . The European one is in Copenhagen (Denmark). European one is in Copenhagen (Denmark). The aim of the WHO is The aim of the WHO is to contribute to improve the level of health of its member states,to contribute to improve the level of health of its member states, etc.etc.

Connecting to the pharmaceutical activity:Connecting to the pharmaceutical activity:

- To work out the numenklature and the revision of the - To work out the numenklature and the revision of the namesnames of medicines.of medicines.

- To standardize the drugs and biological products used - To standardize the drugs and biological products used in thein the medication and to edit the International medication and to edit the International Pharmacopoeias.Pharmacopoeias.

- - ToTo give advice and background for further give advice and background for further investigations. investigations.

Commission of Narcotic DrugsCommission of Narcotic Drugs

In 1912 in HagIn 1912 in Hagueue (first international conference on narcotic (first international conference on narcotic drugs)drugs)

Documents: Documents: Narcotic Drugs Agreement (Opium Agreement)Narcotic Drugs Agreement (Opium Agreement)(signed by 11 states. Hungary joined it in 1923)(signed by 11 states. Hungary joined it in 1923)

Unified agreement on narcotic drugs in New York Unified agreement on narcotic drugs in New York (1961). Accepted by 73 countries.(1961). Accepted by 73 countries.

The Agreement emphasizes:The Agreement emphasizes:

„…„…. . The use of narcotic drugs cannot be avoided in the The use of narcotic drugs cannot be avoided in the field of science and for the treatment of the sick, field of science and for the treatment of the sick, butbut at at the same time the drug abuse and the same time the drug abuse and dependence mean a dependence mean a big big danger and disasters both for the individuals and for danger and disasters both for the individuals and for the the whole societywhole society””

Therefore the production and the trade of these drugs are Therefore the production and the trade of these drugs are regulated very strictly.regulated very strictly.

The International Red CrossThe International Red Cross ++ ) )

The „Agreement of Geneva” was established in 1864 by the The „Agreement of Geneva” was established in 1864 by the representatives of 17 states. representatives of 17 states.

According to this agreement:According to this agreement:

- - wwounded men and sick people can not be ounded men and sick people can not be considered as enemy in case of war.considered as enemy in case of war.

- - vehicles transferring wounded men and people vehicles transferring wounded men and people working on them must be regarded as working on them must be regarded as

neutral.neutral.

In Honour of Switzerland the emblem of the Red Cross was In Honour of Switzerland the emblem of the Red Cross was chosen on the basis of the national emblem o Switzerland.chosen on the basis of the national emblem o Switzerland.

Headquarter of the International Red Cross is in Geneva.Headquarter of the International Red Cross is in Geneva.

Drug control and quality assuranceDrug control and quality assurance

- - The drug control is as old as drug manufacturing. The drug control is as old as drug manufacturing. The simplest tests for identity and purity were introduced The simplest tests for identity and purity were introduced at the beginning of the 19th century. The most important at the beginning of the 19th century. The most important quality tests used can be found in the Analytical.quality tests used can be found in the Analytical. Chemistry of Chemistry of FreseniusFresenius in 1829 which were translated to in 1829 which were translated to ddiifferent lafferent lannguages.guages.

- - Quantitative tests (assays). This sort of control appeared Quantitative tests (assays). This sort of control appeared inin the pharmacopoeias from the middle of the 19th century.the pharmacopoeias from the middle of the 19th century.

Development:Development: detedeterrmination of specific weight,mination of specific weight, g gravimetric, ravimetric, tittitrrimetric methods, compleximetric methods, complex examinations ofexaminations of

the biologicalthe biological activity,activity, bioequivalency.bioequivalency.

- - Inspection system (in Hungary in 1933)Inspection system (in Hungary in 1933)

EFTA – based Pharmaceutical Inspection ConveEFTA – based Pharmaceutical Inspection Convenntion tion

EFTA = European Free Trading Agency (1970)EFTA = European Free Trading Agency (1970)

WHO’s recommendations on WHO’s recommendations on Good Manufacturing Practices Good Manufacturing Practices (GMP)(GMP)

GMP convention:GMP convention: the mutual control and visiting the mutual control and visiting phpharmaceuticalarmaceutical phactories; including machines, buildings, phactories; including machines, buildings,

methodsmethods of control and the staff, including of control and the staff, including their education, etc.their education, etc.

Pharmaceutical literaturePharmaceutical literature

History of pharmaceutical literatureHistory of pharmaceutical literature

In most of the European countries, the first scientific In most of the European countries, the first scientific pharmaceutical knowledge came from Arabian sources. Original pharmaceutical knowledge came from Arabian sources. Original literature dealing with subjects of pharmaceutical interest, and literature dealing with subjects of pharmaceutical interest, and influencing pharmacy, began with general books on natural influencing pharmacy, began with general books on natural history that included pharmacy.history that included pharmacy.

Forms of pharmaceutical literatureForms of pharmaceutical literature

TreatisesTreatisesHerbals, Compendiums (XV, XVI, XVII. Herbals, Compendiums (XV, XVI, XVII. ccenturies)enturies)

PharmacopeiasPharmacopeias

National Pharmacopeias National Pharmacopeias

In Italy in 1499 (Nuovo receptario) In Italy in 1499 (Nuovo receptario) 1892:1892:Pharmacopoea ufficiale del reguo d’Italia.Pharmacopoea ufficiale del reguo d’Italia.

InIn France: 1818 Codex medicamentarius seu France: 1818 Codex medicamentarius seu pharmacopoeia Gpharmacopoeia Gaallica.llica.

In Germany: Dispensatorium of Valerius CordusIn Germany: Dispensatorium of Valerius Cordus 1546:1546: XVII.c. Dispensatorium Brandenburgicum; XVII.c. Dispensatorium Brandenburgicum; 1865: 1865: Pharmacopoea GermanicaPharmacopoea Germanica

In Britain: In Britain: Pharmacopoeia Londinensis Pharmacopoeia Londinensis 1618;1618;The first British Pharmacopoeia The first British Pharmacopoeia 18641864

In HungaryIn Hungary

18711871 I. I. Hungarian Pharmacopoeia Hungarian Pharmacopoeia 18881888 II. II. Hungarian PharmacopoeiaHungarian Pharmacopoeia19101910 III. Hungarian PharmacopoeiaIII. Hungarian Pharmacopoeia19341934 IV. IV. Hungarian PharmacopoeiaHungarian Pharmacopoeia19541954 V. V. Hungarian PharmacopoeiaHungarian Pharmacopoeia19581958 AddendumAddendum19681968 VI. VI. Hungarian Pharmacopoeia Hungarian Pharmacopoeia 19871987 VII. Hungarian PharmacopoeiaVII. Hungarian Pharmacopoeia (1,2,3,4,)(1,2,3,4,)

20032003 VIII. VIII. Hungarian Pharmacopoeia Hungarian Pharmacopoeia (1,2,3(1,2,3aa,,3b3b,),)

Pharmacopoeia Pharmacopoeia NordicaNordicaPharmacopoeiaPharmacopoeia InternationalisInternationalisEuropäischesEuropäisches ArzneibuchArzneibuch (1974-78) (1974-78) CompendiumCompendium MedicamentorumMedicamentorum (1970)(1970)

ÖAB-9ÖAB-9 Austrian P.Austrian P. 19601960Pharmacopoeia FrancaisePharmacopoeia Francaise VIII. 1965VIII. 1965Pharmacopoeia HelveticaPharmacopoeia Helvetica VI. VI. 19711971British Pharmacopoeia British Pharmacopoeia 1973 1973

AB-2AB-2 (Arzneibuch der DDR)(Arzneibuch der DDR) 19751975

DAB-9DAB-9 (Deutsches Arzneibuch)(Deutsches Arzneibuch) 19861986

Farmakopea CCCP x.Farmakopea CCCP x. 19681968

USP XXI United States PharmacopoeiaUSP XXI United States Pharmacopoeia 19851985

European PharmacopoeiaEuropean Pharmacopoeia

MarMarttindale 28. (Extra Pharmacopoeia)indale 28. (Extra Pharmacopoeia) 19821982

HomoeopathHomoeopathicic Pharmacopoeia Pharmacopoeia

ManualesManuales

National FormularyNational Formulary

Pharmaceutical Recipe BooksPharmaceutical Recipe Books

ProceedingsProceedings

YournalYournalss trade paperstrade papers pharmacypharmacypharm.chempharm.chem

scientific yournalsscientific yournals pharmacognosypharmacognosy

pharm.technologypharm.technology pharm industrypharm industry

F.I.P. yournalsF.I.P. yournals

International PharmacopoeiasInternational Pharmacopoeias

TheThe International Pharmacopoeia (Pharmacopoeia International Pharmacopoeia (Pharmacopoeia Internationalis) edited by the Comission of the UNO (United Internationalis) edited by the Comission of the UNO (United Nations Organizations) and the Nations Organizations) and the European PharmacopoeiaEuropean Pharmacopoeia issued issued from 1974.from 1974.

The Compendium Medicamentorum was edited in German The Compendium Medicamentorum was edited in German and Russian. The 28th Extra Pharmacopoeia was published and Russian. The 28th Extra Pharmacopoeia was published first first in 1982 under the name MARTINDALE.in 1982 under the name MARTINDALE.

Ordering of drugsOrdering of drugs

PrescriptionPrescription

Latin languageLatin language (internationally ac (internationally acccepted)epted)

The form of a prescription.The form of a prescription.

InscriptioInscriptio Title, name, etc.Title, name, etc.InvocacioInvocacio Rp.Rp.OrdinatioOrdinatio or or PraescriptioPraescriptio SubscriptioSubscriptio

SignSignaaturaturaAdscriptioAdscriptio

E.G.E.G.X. Y., X. Y., ………… ……………..…..((name, name, adress, age, etc.)adress, age, etc.)

Rp.Rp. Mixturae sedativaeMixturae sedativaeFoNoFoNo dosimdosimD.S.D.S. 2 spoonful, twice a day2 spoonful, twice a day

SignaturaSignatura

Adscriptio ………..Adscriptio ………............(notes of pharmacists etc.)(notes of pharmacists etc.)

Formula magistralesFormula magistrales

IndividualIndividual prescription of the physician prescription of the physician

Formula officinalisFormula officinalis Officinal Officinal drugs in Pharmacopoeiasdrugs in Pharmacopoeias

Formula NormalesFormula Normales

Formula Normales Veterinarie Formula Normales Veterinarie

Formula originalesFormula originales

85 % of the total drugs.85 % of the total drugs. Drugs prepared in pharmaceutical factories.Drugs prepared in pharmaceutical factories.

E.g. Rp. E.g. Rp.

Tablettae DopegytTablettae Dopegytscatulam originalem No.I. scatulam originalem No.I.

(unam)(unam) D.s. 2 x 1 tablet D.s. 2 x 1 tablet

Formula nosocomialisFormula nosocomialis(Hospitale, etc.)(Hospitale, etc.)

CopiaCopia = copy of the prescription = copy of the prescription

Preparation of MedicinesPreparation of Medicines

Three levelsThree levels according to the scale of preparation according to the scale of preparation

- preparation in preparation in public pharmaciespublic pharmacies

- manufacturing medicines in manufacturing medicines in Galenic laboratoriesGalenic laboratories and in and in hospitalshospitals

- manufacturing of medicines by pharmaceutical industry manufacturing of medicines by pharmaceutical industry

Public pharmacyPublic pharmacy

PPublic pharmacies, where medicines with or without ublic pharmacies, where medicines with or without pprescription rescription are dispensed.are dispensed.

- ground units of drug supply- ground units of drug supply- establishments of the public health- establishments of the public health

The personal conditions of a working pharmacyThe personal conditions of a working pharmacy

- m- manager pharmacist anager pharmacist

- p- pharmacistsharmacists

- p- pharmacy assistantsharmacy assistantsthey are qualified in three dthey are qualified in three diifferent directions:fferent directions:

---- for dispensing drugsfor dispensing drugs

-- -- for analytical workfor analytical work-- -- for drug supply for drug supply

- a- administrator dministrator - - cleanercleaner

Organisation of drug supplyOrganisation of drug supply

Wholesale campanies Wholesale campanies (Hungarodrug, etc.)(Hungarodrug, etc.)Imported drugs Imported drugs (National Institute of Pharmacy)(National Institute of Pharmacy)

Store:Store:

- c- certain amount of drugs in the pharmaciesertain amount of drugs in the pharmacies..

Statim order (urgent order)Statim order (urgent order)

StreetStreet

Green partGreen part

aseptic lab.aseptic lab.laboratory for the laboratory for the

preparation of drugspreparation of drugsOFFICINAOFFICINA

expedition of expedition of drugsdrugsevaluation of drugsevaluation of drugs

camera materiallscamera materialls

(store for chemical)(store for chemical)

corridorcorridor

officeoffice

store for specialitiesstore for specialities gardrobesgardrobes

store for crude drugs and store for crude drugs and other itemsother items

social roomsocial room

cold roomcold room washing roomwashing room

special storespecial store

officeoffice store for drug store for drug cont.cont.

The sketch of a modern pharmacyThe sketch of a modern pharmacy

Pharmacy Pharmacy windowwindow

entryentry

exitexit

Administration in pharmaciesAdministration in pharmacies

- - Examinations concerning the identify, purity of drugs; Examinations concerning the identify, purity of drugs; controls of pharmaceuticals.controls of pharmaceuticals. Registration in the Registration in the BBoook of Examinationok of Examination

- - Registration of medicines prepared in large scaleRegistration of medicines prepared in large scale Registration in the Registration in the Book of Prepared MedicinesBook of Prepared Medicines

- - The order and the dispensation of narcotic drugs must The order and the dispensation of narcotic drugs must be registrered up to date in the be registrered up to date in the Book for Control of Book for Control of NarcoticsNarcotics

- - Control of poisoning Control of poisoning ddrugs: the Book of Poisoning rugs: the Book of Poisoning SubstancesSubstances

LaboratoriesLaboratories

Galenic laboratoriesGalenic laboratories

• preparation of complex drugspreparation of complex drugs

• special preparationsspecial preparations

• distilled water (big quantities)distilled water (big quantities)

• infusionsinfusions

HospitalHospital, etc. , etc. LaboratoriesLaboratories

• special profile according to the specialization of the special profile according to the specialization of the hospital or institutehospital or institute

Clinical pharmacyClinical pharmacy..

Pharmaceutical factoriesPharmaceutical factories

Main fields of activities : new drug-development, new drug-Main fields of activities : new drug-development, new drug-forms, technological studies, research in order to improve forms, technological studies, research in order to improve drug-stability, -safety, -activity, -bioavailibility, etc.drug-stability, -safety, -activity, -bioavailibility, etc.

Good Good ManufacturingManufacturing PracticePractice = GMP (1969 – W.H.O.)= GMP (1969 – W.H.O.)

In Hungary from 1976.In Hungary from 1976.

Industrial drug production in HungaryIndustrial drug production in Hungary

History: more than 100 year’s tradition.History: more than 100 year’s tradition.

Control: Control: Hungarian Pharmaceutical AssociationHungarian Pharmaceutical Association

++

Ministry of IndustryMinistry of Industry humanhuman

Ministry of Health (Serobacterial Products)Ministry of Health (Serobacterial Products)

Ministry of Food and Agriculture ( - „ - )Ministry of Food and Agriculture ( - „ - )

veterinaryveterinary

Digitalis, ergot, morphine alkaloids, steroid hormones, Digitalis, ergot, morphine alkaloids, steroid hormones, sulfonamide preparations, papaverine, etc.sulfonamide preparations, papaverine, etc.

Research InstitutesResearch Institutes

Research Institute for Pharmaceutical IndustryResearch Institute for Pharmaceutical IndustryCentral Research Institute of ChemistryCentral Research Institute of Chemistry

Hungarian Pharmaceutical IndustryHungarian Pharmaceutical Industry

ChinoinChinoin Chemical and Pharmaceutical Works Ltd.Chemical and Pharmaceutical Works Ltd.(founded in 1910); Budapest (founded in 1910); Budapest

Chemical Works of Gedeon RichterChemical Works of Gedeon Richter(founded in 1901); Budapest(founded in 1901); Budapest

EgisEgis Pharmaceutical and Chemical Works; BudapestPharmaceutical and Chemical Works; Budapest

Alkaloida Alkaloida Chemical Works Chemical Works Kabay’s method: morphineKabay’s method: morphine(founded in 19(founded in 192727); Tiszavasvári); Tiszavasvári

BiogalBiogal Pharmaceutical WorksPharmaceutical Works(founded in 1952); Debrecen(founded in 1952); Debrecen

HumanHuman Institute of Serobacterial Production and Institute of Serobacterial Production and ResearchResearch

PhylaxiaPhylaxia Institute of Serobacterial Production and Institute of Serobacterial Production and ResearchResearch

(veterina(veterinarry)y)

ReanalReanal Factory of fine chemicalsFactory of fine chemicals

Some Some important pharmaceutical companies around the worldimportant pharmaceutical companies around the world

AbottAbott

Bayer A.G. Leverkusen (Germany)Bayer A.G. Leverkusen (Germany)

Biochemie GmbHBiochemie GmbH

Boehringer IngelheimBoehringer Ingelheim

Ciba – Geigy Ciba – Geigy

Eli Lilly and Co.Eli Lilly and Co.

GlaxoGlaxo

Merck (Darmstadt)Merck (Darmstadt)

Hoffmann – la Roche Co. Ltd.Hoffmann – la Roche Co. Ltd.

SandozSandoz

SanofiSanofi

Shering AGShering AG

SearleSearle

SquibbSquibb

Upjohn (Michigan)Upjohn (Michigan)

The Wellcome Foundation LimitedThe Wellcome Foundation Limited

WyethWyeth

The history of education in Hungary The history of education in Hungary (1)(1)

1313thth – 14 – 14thth centuries centuriesBuda, Pécs, PozsonyBuda, Pécs, Pozsony(at the time when most famous and oldest medical schools of (at the time when most famous and oldest medical schools of Europe Europe operated in Salerno, Montpellier and Padua).operated in Salerno, Montpellier and Padua).

1717thth, 17, 17thth and early decades of the 18th centuries and early decades of the 18th centuries Turkish Turkish occupation, wars against the Habsburgs.occupation, wars against the Habsburgs. Decline Decline of higher education in Hungary.of higher education in Hungary.

17691769 Establishment of the Establishment of the University of NagyszombatUniversity of Nagyszombat (founded in (founded in 1635 1635 by Archbishop by Archbishop Péter PázmányPéter Pázmány))

17771777 ‘Royal Institute’ status‘Royal Institute’ statusReform.Reform. The The Institute moved to the capital Institute moved to the capital BudaBuda (Medical Faculty) (Medical Faculty)

17841784 The Institute moved to The Institute moved to PestPest (Medical Faculty) (Medical Faculty) 1848/49 War of Independence (police supervision)1848/49 War of Independence (police supervision)

. . .. ..

Improvement of the Faculty, new departmnents.Improvement of the Faculty, new departmnents.Number of students exceeded 1000Number of students exceeded 1000

Between the World WarsBetween the World Wars First First woman graduated.woman graduated. Ratio of Ratio of Female students has been increasing permenthy. Female students has been increasing permenthy.

The history of education in Hungary The history of education in Hungary (2)(2)

After World War II.After World War II.Faculty of Medicine became an independent medcal scholl.Faculty of Medicine became an independent medcal scholl.(Budapest University of Medicine)(Budapest University of Medicine)

19511951 Faculty of Dentistry was incorporatedFaculty of Dentistry was incorporated

19521952 Faculty of Pharmacy was incorporatedFaculty of Pharmacy was incorporated

19691969 The name of the University was changed to The name of the University was changed to Semmelweis Semmelweis University University of Medicineof Medicine

20002000 Integration process – Integration process – Semmelweis UniversitySemmelweis University

College of Health CareCollege of Health Care

Faculty of DentistryFaculty of Dentistry

Faculty of Health SciencesFaculty of Health Sciences

Faculty of Medicine Faculty of Medicine

Faculty of PharmacyFaculty of Pharmacy

Faculty of Physical Education and Sports SciencesFaculty of Physical Education and Sports Sciences

School of Ph.D. studentsSchool of Ph.D. students

Ignaz Philipp SEMMELWEIS (1818-1965)Ignaz Philipp SEMMELWEIS (1818-1965), , a Hungarian obstetrician educated at the a Hungarian obstetrician educated at the universitiuniversitiees of Pest and Vienna, introduced s of Pest and Vienna, introduced antiseptiantisepticc prophylaxis into medicine. In the prophylaxis into medicine. In the 1840s, puerperal or chi1840s, puerperal or chilldbirth fever, a dbirth fever, a bacterial infection of the female genital bacterial infection of the female genital tract after child-birth, was taking the lives tract after child-birth, was taking the lives of up to 30% of women who gave birth in of up to 30% of women who gave birth in hospitals. Women who gave birth at home hospitals. Women who gave birth at home remained rremained reelatively unaffected. As assistant latively unaffected. As assistant professor on the maternity ward of the professor on the maternity ward of the Vienna General Hospital, SVienna General Hospital, Seemmelweis mmelweis obsobseerved that women examined by student rved that women examined by student doctors who had not washed their hands doctors who had not washed their hands after leaving the autopsy room had very after leaving the autopsy room had very high death rates.high death rates.

When a colleague who had received a scalpel cut died of When a colleague who had received a scalpel cut died of infeinfecction, Semmelweis concluded that puerperal fevetion, Semmelweis concluded that puerperal feverr was was septic and contagious.septic and contagious. He orderHe ordereed students to wash their hands d students to wash their hands with chlorinated lime before ewith chlorinated lime before exxamining patients; as a result, the amining patients; as a result, the maternal death rat was reduced from 12% to 1% in 2 years.maternal death rat was reduced from 12% to 1% in 2 years.

Nevertheless, Semmelweis encountered strong opposition Nevertheless, Semmelweis encountered strong opposition from hospital offfrom hospital offiicials and left Vienna in 1850 for the cials and left Vienna in 1850 for the University of Pest. University of Pest.

As a professor of obstetrics at As a professor of obstetrics at the University of Pest Hospital, the University of Pest Hospital, he enforced antiseptic he enforced antiseptic pracpracttices and reduced the ices and reduced the death rate from puerperal death rate from puerperal fever to 0,85%. However, fever to 0,85%. However, Semmelweis findings and Semmelweis findings and publications were resisted by publications were resisted by hospital and medhospital and mediical cal authorities in Hungary and authorities in Hungary and abroad. After a breakdown, he abroad. After a breakdown, he entered a mental hospital in entered a mental hospital in Vienna, where he died of an Vienna, where he died of an infection contracted during an infection contracted during an operation he had performed.operation he had performed.