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General knowledge of drugs

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1 General knowledge of drugs
Drug means a certain substance which is introduced into the living organism for medical purposes: for prevention, maintaining health, for improving the physical and mental state of human beings or deseigned for diagnoses and for control of deseases. This definition involves: The prevention (profilaxis) The diagnosis (recognition of illnesses) The treatment (therapy) The Hungarian Pharmavopoeia define the „medical substances” as substances responsible for the biological action, and ingredients which have no biological activities (additives). Classification of drugs Drugs can be divided into groups, according to their origin, the strength of their activity, the pharmacological group, their use and according to the way of their application.

2 Classification of drugs on the basis of strength
Drugs cause poisoning only in high quantity (dosis), are stored on open selfs of pharmacies, and they can be dispensed for patients without prescriptions. Drugs designated by the symbol + have stronger activity. Drugs designated by the symbol empty + are the hypnotics or sedatives. Drugs designated by the symbol ++ have very strong biological activity. Drugs designated by the symbol empty ++ are narcotics. they act on the central nervous system and after chronic use dependency is developed which destroys the patients.

3 Prescriptions and dispensing of drugs designated by the symbols listed above (+, empty+, ++, empty++) must be stored in closed cabinet and the narcotics must be stored separately according to the laws. The dispensing of drugs designated by crosses is limited, that means the prescription of a physician is necessary. The highest limitations refer to the narcotics and poisoning substances. They order needs a special requirements: prescription with copy and all data of the patients including the diagnosis, etc. The prescriptions must be preserved as a document.

4 Classification of drugs by their pharmacological action
According to the suggestion of the World Health Organisation (=WHO) the main activity of a drug can be described by a capital letter combined with three number e.g. A 300 Antiepileptics A 600 Analgetics / anatipyretics I 200 Blood clotings I 210 Anticoagulants

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

6 Classification of drugs by the place of application
On this basis drugs can be devided into two groups: drugs for local and for general administration. For exemple a powder administred on the surface of the skin means a local (topical) use, on the contrary the use of an analgetic means a general action, independently from the modes of their use. Earlier there was an other way of classification: drugs for externally (ad usum externum) and internally use (ad usum internum).

7 Classification of drugs according to their origin may be:
Chemical substances: Inorganic substances: e.g. sodium chloride, potassium iodids. Organic substances: e.g. phenazone, salicylic acid, etc. Animal origin: pepsine (manufactured from the stomach of pigs or from other animals), pancreatine, different serums etc. Plant origin: vegetable drugs: chamomile, etc. Synthetic or half synthetic origin. Natural substances: purified alkaloids, glycosides, hormones etc.

8 The place and way of application of formulated drug
The way of application The form of drug Bucal (in mouth) Orally, under the tongue Sublinqual tablet Oral, through Orally Solutions, pills, tablets, capsules Rectal (in rectum) Rectally Tablets, supp. In the vagina Vaginal Parenteral Parenterally Infusions, injections intra muscular (im) intra venous (iv) intra arterial (ia) In the lung Inhalation Aerosols

9 Cassification of formulated drugs
Medicine mean formulated drugs prepared for medical treatment. In these respect a biologically active substance is not a medicine, because it can not be used directly. Medicines may be in undivided (not for single use) and devided (for single use). The former may be a solution (for 2-4 days use) which will be redivided by the patients. The forms of medicines may be: powders tablets pills suppositories capsules coated tablets injections, etc. Specialities may be according to the Pharmacopoeias registered specialities: galenic specialities, prepared according to the Formulae Normales (FoNo = the collection of official prescriprions), magistrally made specialities prepared occording to the prescriptions of physicians.

10 Drugs and doses In the single monographs of pharmacopoeias the „usual dose range” or the usual doses are given for single (pro dosi), daily (pro die) uses for adults using the medicament orally. There is some substances where a period is stated over which the whole doses is given, for example daily doses the division of which is left to the physician. If a drug is applied in an other way written by the pharmacopoeia a new dose for the new administration has to be stated. It must not be assumed that the doses indicate the greatest amount of drugs that may be given. The medical practioner will exercise his own judgment and act on his own responsibility in respect of the amount of any therapeutic agent, he may prescribe or administer or the frequency of its administration. When however an unusual large dose appears to have been prescribed, it is the responsibility of the pharmacist to satisfy himself, that the prescriber’s intention has been correctly interpreted.

11 Specially named doses Dosis curativa = generally used dosis for curing Dosis therapeutica = generally used dosis Dosis medicinalis = generally used dosis Dosis tolerata = dosis which can be tolerated Dosis maximalis = the highest dosis over which toxic symptoms may appear Dosis toxica minima = dosis with minimal toxic effect According to our present knowledge the pharmacological activity based on the combination of drug molecules with the molecules of the target organ (receptors). In this respect the concentration of the drug molecules will be the highest in the tissue containing the receptors which is often called the site of action. To exert a certain pharmacological effect it is necessary to bring the drug molecules to the receptor in a proper concentration.

12 The way of the drugs to the receptor is different depending upon the administration of the drug.
From the medicine administred orally the drug liberates and than absorbs into the blood stream, and at the same time the distribution, the biotransformation, excretion is started. It is easy to understand that the action of the same drug will be different if it is administered orally or parenterally. In the former case there is more or less lost in the consequence of liberation, dissolution. The distribution and biotransformation influence the action of drug independently from the administration. The applicability of a drug can be characterizes by the width of its action and by the therapeutic index. The width of action of a drug = dosis tolerata – dosis curativa. The therapeutic index = dosis curativa / dosis tolerata.

13 This two concepts indicate the safety of the therapeutic treatment.
The biopharmacy deals with the drugs starting from the formulation until the drugs leaves the body. The pharmacokinetic checks the blood levels during the treatment and determines the start of the action as well as the speed of elimination. Liberation, absorption, distribution, metabolism and elimination (abreviated as LADME) are the basis of the drug safety that means to insure the therapeutic concentration without any toxic effect.

14 Drug utilization It means the examination and evaluation of drug use.
Main tasks in drug utilization. To monitor the quantity and ratios of drugs used in different pharmacological groups. To monitor the groups of drugs time to time where the estimation seems to be necessary. To work out the way of control. To initiate and propagate principles concerning the economical and safety drug use. The increase of drug consumption is 8-10 % per year, which includes the new drug preparations as well as the everage consumption. How could be influenced the sucreased drug consumption? By regulation of dispensations (to obtain more current drugs after prescriptions). By increasing the drug prices. By improving the health informations (by initiation of healthy style of life, changing of customs of fooding, the prevention of illnesses, etc.).

15 Drug abuse Prevention of drug abuse When the entire problem of drug abuse including alcoholism is viewed in perspective, the percentage of individuals who become compulsive drug user as a result of legitimate medical treatment, is extremely small. Neverthless in the United State with the notable exception of alcohol and tobacco potent drugs are legally obtained only on the prescription of physician or other licensed practicioner. Since the number of persons who may be predisposed to the abuse of drugs is far greater than the members of addicts, physicians should consider the abuse potential of the drugs they prescribe. The high percentage of physicians, dentists and nurses who become addited to opioid and the vast number alcoholics attest to the relationship between self medication and the later development of compulsive drug abuse.

16 Comission of Narcotic Drugs in the frame of the United Nations Organization (UNO)
Confiscated narcotin drugs in 1983: 2,2 t morphine ,1 t heroine t cocaine t opium t hasis t marihuana Price increases under the trade 10 kg opium $ (in Pakistan) 1 kg morpine is produced $ heroine $ diluted 1 : 20 (5 % heroine) = doses 1,5 million $ (U.S.A.)

17 Besides morphine and its derivates, the metamphetamine also known as crystal meth, it is the cheapest drug and can be applied in different way it is capable to produce an enphoric feeling for as long as three hours, it has become known as poor man’s cocaine. Drug Enforcement Agency estimates that approximately two tons of methamphetamine are produced in U.S.A. annually. Tolerance, physical dependence and abuse liability The development of these with repeated use is a characteristic feature of some drugs and the possibility of developing physchological dependence on the effect of these drugs is one of the major limitation of their clinical use. This ability to suppress withdrowal symptoms caused by withdrowal of other drugs.

18 The degree to which it induces euphoria similar to that produced by morphine and other opioids.
The pattern of toxicity that occur when the dose is increased beyond the usual therapeutic range. Physical characteristic of the drug, such as water solubility and stability that may determine wether it is like to be abused by parenteral route. Experiences seems to show that within a culture that accepts the use of some psychoactive agents total prohibition of selected classes of drugs tend to produce a shift toward the use of other agents. Thus at present, some opioid users shift to alcohol and barbiturates in to no drug at all, but they often return to opioids whenever the liability increases.

19 The countries of the „gold triangle” Burma, Laos, Thailand and the countries of the „gold half-moon” Afganistan, Pakistan, Iran have produce the majority of opioids. In South and Middle American countries e.g. Peru, Bolivia, Columbia and Mexico cultivate and manufacture the cocain. For a pharmacist it is necessary to define the constitutes of drug abuse, the extent of this problem and the role of pharmacists. It is important to know how the patients suffering from drug abuse how can be recognised, to inform them the hazards of using drugs for that purpose, and about the hazards of injecting drugs, etc.

20 The introduction as well as the scope of health insurance, while an international trend, has remained strictly a separate national decision of the individual country. However the trade in opiates and other narcotic drugs became a matter of international cooperation and decision. In the early 19th century the English government, in order to retain the profitable trade in opium, overcame by force of arms attempts of the Chinese government to aliminate the import of the drug from English-dominated India. Defeated in two so-called opium wars ( and ), the Chinese government – to the lasting discredit of the English – had to compensate the traders for their losses.

21 International Professional Trends
In the development of industrial pharmacy, of health insurance under governmental control and of laws controlling dependency-producing 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 members of the profession that could be cultivated fruitfully on an international basis. Federation Internationale Pharmaceutique F.I.P. - International Congresses of Pharmacy continued to be held every few years in various countries – no continuity Dutch Pharmaceutical Association proposal for organizing a permanent international association Decision about placing the headquarters and the secretariat at The Hague The new International Pharmaceutical Federation became a federation of the important national pharmaceutical associations, dedicated to the furtherance of the profession and of pharmaceutical knowledge, and seeking better collaboration and understanding on issues of common concern. Sections (9) e.g. Documentation-, Academic-, OIndustrial-, Medicinal plant-, Military-, etc.)

22 Conferences – each year.
It represents a majority of the world’s pharmacists. International Pharmaceutical Federation of Students N.P.S.F. - 1949 (The 44th congress of FIP was organized in Budapest in 1984) Budapest’s Declaration: Drugs and other pharmaceutical products cannot be regarded us goods. They provide the principal part of medical treatments. Only experts are able to inform concerning the preparation constitution, pharmacological activity, side effects; etc. The pharmacist are experts on drugs. The FIP called the attention of the governments, and the national and international organizations to the necessity of the knowledge of pharmacists and to that it is essential to consult them before making decisions.

23 Unification of Drug Standards
To unify standards for drugs internationally has been a goal to which pharmacists and others in the health sciences return again and again. 1893: in Chicago: the idea of an internationale code of potent medicaments. (18 countries agreed) 1906: Protocole International (P.J. = International Formulary) 1925: The final protocol was signed (26 governments) 1937: Technical Comission of Pharmacopoeial Experts (unification of pharmacopoeias) 1947: W.H.O. Expert Committee on the Unification of Pharmacopoeias. 1955: Pharmacopoea Internationalis, first ed. In English, French and Spanish. 1967: Pharmacopoea. Internationalis, first ed. In English, French and second ed. The tendency toward international cooperation may be affected by regional as well as national differences. International Groups of Specialized Scope.

24 The World Health Organization (WHO)
After finishing the Second World War the United Nations Organization (UNO) was founded in Los Angeles. The World Health Organization (WHO) was also established on 22nd of July 1946 as the satellite organization of the UNO. From 26 members of the WHO it grew up to 132 up to now. Headquarter of WHO: Geneva. It has 6 regional bureaus. The European one is in Copenhagen (Denmark). The aim of the WHO is to contribute to improve the level of health of its member states, etc. Connecting to the pharmaceutical activity: - To work out the numenklature and the revision of the names of medicines. - To standardize the drugs and biological products used in the medication and to edit the International Pharmacopoeias. - To give advice and background for further investigations.

25 Commission of Narcotic Drugs
In 1912 in Hague (first international conference on narcotic drugs) Documents: Narcotic Drugs Agreement (Opium Agreement) (signed by 11 states. Hungary joined it in 1923) Unified agreement on narcotic drugs in New York (1961). Accepted by 73 countries. The Agreement emphasizes: „…. The use of narcotic drugs cannot be avoided in the field of science and for the treatment of the sick, but at the same time the drug abuse and dependence mean a big danger and disasters both for the individuals and for the whole society” Therefore the production and the trade of these drugs are regulated very strictly.

26 The International Red Cross + )
The „Agreement of Geneva” was established in 1864 by the representatives of 17 states. According to this agreement: - wounded men and sick people can not be considered as enemy in case of war. - vehicles transferring wounded men and people working on them must be regarded as neutral. In Honour of Switzerland the emblem of the Red Cross was chosen on the basis of the national emblem o Switzerland. Headquarter of the International Red Cross is in Geneva.

27 Drug control and quality assurance
- The drug control is as old as drug manufacturing The simplest tests for identity and purity were introduced at the beginning of the 19th century. The most important quality tests used can be found in the Analytical. Chemistry of Fresenius in 1829 which were translated to different languages. - Quantitative tests (assays). This sort of control appeared in the pharmacopoeias from the middle of the 19th century. Development: determination of specific weight, gravimetric, titrimetric methods, complex examinations of the biological activity, bioequivalency. - Inspection system (in Hungary in 1933) EFTA – based Pharmaceutical Inspection Convention EFTA = European Free Trading Agency (1970) WHO’s recommendations on Good Manufacturing Practices (GMP) GMP convention: the mutual control and visiting pharmaceutical phactories; including machines, buildings, methods of control and the staff, including their education, etc.

28 Pharmaceutical literature
History of pharmaceutical literature In most of the European countries, the first scientific pharmaceutical knowledge came from Arabian sources. Original literature dealing with subjects of pharmaceutical interest, and influencing pharmacy, began with general books on natural history that included pharmacy. Forms of pharmaceutical literature Treatises Herbals, Compendiums (XV, XVI, XVII. centuries) Pharmacopeias National Pharmacopeias In Italy in 1499 (Nuovo receptario) : Pharmacopoea ufficiale del reguo d’Italia. In France: 1818 Codex medicamentarius seu pharmacopoeia Gallica. In Germany: Dispensatorium of Valerius Cordus 1546: XVII.c. Dispensatorium Brandenburgicum; : Pharmacopoea Germanica

29 In Britain:. Pharmacopoeia Londinensis 1618;
In Britain: Pharmacopoeia Londinensis ; The first British Pharmacopoeia 1864 In Hungary 1871 I. Hungarian Pharmacopoeia II. Hungarian Pharmacopoeia III. Hungarian Pharmacopoeia IV. Hungarian Pharmacopoeia V. Hungarian Pharmacopoeia Addendum VI. Hungarian Pharmacopoeia VII. Hungarian Pharmacopoeia (1,2,3,4,) 2003 VIII. Hungarian Pharmacopoeia (1,2,3a,3b,) Pharmacopoeia Nordica Pharmacopoeia Internationalis Europäisches Arzneibuch ( ) Compendium Medicamentorum (1970) ÖAB-9 Austrian P Pharmacopoeia Francaise VIII Pharmacopoeia Helvetica VI British Pharmacopoeia 1973

30 AB-2 (Arzneibuch der DDR) 1975
DAB-9 (Deutsches Arzneibuch) 1986 Farmakopea CCCP x USP XXI United States Pharmacopoeia 1985 European Pharmacopoeia Martindale 28. (Extra Pharmacopoeia) 1982 Homoeopathic Pharmacopoeia Manuales National Formulary Pharmaceutical Recipe Books Proceedings Yournals trade papers pharmacy pharm.chem scientific yournals pharmacognosy pharm industry F.I.P. yournals

31 International Pharmacopoeias
The International Pharmacopoeia (Pharmacopoeia Internationalis) edited by the Comission of the UNO (United Nations Organizations) and the European Pharmacopoeia issued from 1974. The Compendium Medicamentorum was edited in German and Russian. The 28th Extra Pharmacopoeia was published first in 1982 under the name MARTINDALE.

32 Ordering of drugs Prescription Latin language (internationally accepted) The form of a prescription. Inscriptio Title, name, etc. Invocacio Rp. Ordinatio or Praescriptio Subscriptio Signatura Adscriptio E.G X. Y., ……………..(name, adress, age, etc.) Rp. Mixturae sedativae FoNo dosim D.S. 2 spoonful, twice a day Signatura Adscriptio ……… (notes of pharmacists etc.)

33 Formula magistrales Individual prescription of the physician Formula officinalis Officinal drugs in Pharmacopoeias Formula Normales Formula Normales Veterinarie Formula originales 85 % of the total drugs Drugs prepared in pharmaceutical factories. E.g. Rp. Tablettae Dopegyt scatulam originalem No.I. (unam) D.s. 2 x 1 tablet Formula nosocomialis (Hospitale, etc.) Copia = copy of the prescription

34 Preparation of Medicines
Three levels according to the scale of preparation preparation in public pharmacies manufacturing medicines in Galenic laboratories and in hospitals manufacturing of medicines by pharmaceutical industry Public pharmacy Public pharmacies, where medicines with or without prescription are dispensed. - ground units of drug supply establishments of the public health

35 The personal conditions of a working pharmacy
- manager pharmacist - pharmacists - pharmacy assistants they are qualified in three different directions: -- for dispensing drugs for analytical work for drug supply - administrator cleaner Organisation of drug supply Wholesale campanies (Hungarodrug, etc.) Imported drugs (National Institute of Pharmacy) Store: - certain amount of drugs in the pharmacies. Statim order (urgent order)

36 The sketch of a modern pharmacy
Street Green part aseptic lab. laboratory for the preparation of drugs OFFICINA expedition of drugs evaluation of drugs camera materialls (store for chemical) corridor office store for specialities gardrobes store for crude drugs and other items social room cold room washing room special store store for drug cont. Pharmacy window entry exit

37 Administration in pharmacies
- Examinations concerning the identify, purity of drugs; controls of pharmaceuticals Registration in the Book of Examination - Registration of medicines prepared in large scale Registration in the Book of Prepared Medicines - The order and the dispensation of narcotic drugs must be registrered up to date in the Book for Control of Narcotics - Control of poisoning drugs: the Book of Poisoning Substances

38 Laboratories Galenic laboratories preparation of complex drugs special preparations distilled water (big quantities) infusions Hospital, etc. Laboratories special profile according to the specialization of the hospital or institute Clinical pharmacy. Pharmaceutical factories Main fields of activities : new drug-development, new drug-forms, technological studies, research in order to improve drug-stability, -safety, -activity, -bioavailibility, etc. Good Manufacturing Practice = GMP (1969 – W.H.O.) In Hungary from 1976.

39 Industrial drug production in Hungary
History: more than 100 year’s tradition. Control: Hungarian Pharmaceutical Association + Ministry of Industry human Ministry of Health (Serobacterial Products) Ministry of Food and Agriculture ( - „ - ) veterinary Digitalis, ergot, morphine alkaloids, steroid hormones, sulfonamide preparations, papaverine, etc. Research Institutes Research Institute for Pharmaceutical Industry Central Research Institute of Chemistry

40 Hungarian Pharmaceutical Industry
Chinoin Chemical and Pharmaceutical Works Ltd. (founded in 1910); Budapest Chemical Works of Gedeon Richter (founded in 1901); Budapest Egis Pharmaceutical and Chemical Works; Budapest Alkaloida Chemical Works Kabay’s method: morphine (founded in 1927); Tiszavasvári Biogal Pharmaceutical Works (founded in 1952); Debrecen Human Institute of Serobacterial Production and Research Phylaxia Institute of Serobacterial Production and Research (veterinary) Reanal Factory of fine chemicals

41 Some important pharmaceutical companies around the world
Abott Bayer A.G. Leverkusen (Germany) Biochemie GmbH Boehringer Ingelheim Ciba – Geigy Eli Lilly and Co. Glaxo Merck (Darmstadt) Hoffmann – la Roche Co. Ltd. Sandoz Sanofi Shering AG Searle Squibb Upjohn (Michigan) The Wellcome Foundation Limited Wyeth

42 The history of education in Hungary (1)
13th – 14th centuries Buda, Pécs, Pozsony (at the time when most famous and oldest medical schools of Europe operated in Salerno, Montpellier and Padua). 17th, 17th and early decades of the 18th centuries Turkish occupation, wars against the Habsburgs. Decline of higher education in Hungary. 1769 Establishment of the University of Nagyszombat (founded in by Archbishop Péter Pázmány) 1777 ‘Royal Institute’ status Reform The Institute moved to the capital Buda (Medical Faculty) The Institute moved to Pest (Medical Faculty) 1848/49 War of Independence (police supervision) . Improvement of the Faculty, new departmnents. Number of students exceeded 1000 Between the World Wars First woman graduated Ratio of Female students has been increasing permenthy.

43 The history of education in Hungary (2)
After World War II Faculty of Medicine became an independent medcal scholl. (Budapest University of Medicine) 1951 Faculty of Dentistry was incorporated 1952 Faculty of Pharmacy was incorporated 1969 The name of the University was changed to Semmelweis University of Medicine Integration process – Semmelweis University College of Health Care Faculty of Dentistry Faculty of Health Sciences Faculty of Medicine Faculty of Pharmacy Faculty of Physical Education and Sports Sciences School of Ph.D. students

44 Ignaz Philipp SEMMELWEIS ( ), a Hungarian obstetrician educated at the universities of Pest and Vienna, introduced antiseptic prophylaxis into medicine. In the 1840s, puerperal or childbirth fever, a bacterial infection of the female genital tract after child-birth, was taking the lives of up to 30% of women who gave birth in hospitals. Women who gave birth at home remained relatively unaffected. As assistant professor on the maternity ward of the Vienna General Hospital, Semmelweis observed that women examined by student doctors who had not washed their hands after leaving the autopsy room had very high death rates. When a colleague who had received a scalpel cut died of infection, Semmelweis concluded that puerperal fever was septic and contagious. He ordered students to wash their hands with chlorinated lime before examining patients; as a result, the maternal death rat was reduced from 12% to 1% in 2 years.

45 Nevertheless, Semmelweis encountered strong opposition from hospital officials and left Vienna in 1850 for the University of Pest. As a professor of obstetrics at the University of Pest Hospital, he enforced antiseptic practices and reduced the death rate from puerperal fever to 0,85%. However, Semmelweis findings and publications were resisted by hospital and medical authorities in Hungary and abroad. After a breakdown, he entered a mental hospital in Vienna, where he died of an infection contracted during an operation he had performed.

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