Presentation on theme: "General knowledge of drugs"— Presentation transcript:
1General 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 drugsDrugs 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.
2Classification 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.
3Prescriptions 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.
4Classification 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 AntiepilepticsA 600 Analgetics / anatipyreticsI 200 Blood clotingsI 210 Anticoagulants
5Classification 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).
6Classification 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).
7Classification 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.
8The place and way of application of formulated drug The way of applicationThe form of drugBucal (in mouth)Orally, under the tongueSublinqual tabletOral, throughOrallySolutions, pills, tablets, capsulesRectal (in rectum)RectallyTablets, supp.In the vaginaVaginalParenteralParenterallyInfusions, injectionsintra muscular (im)intra venous (iv)intra arterial (ia)In the lungInhalationAerosols
9Cassification 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.
10Drugs and dosesIn 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.
11Specially named dosesDosis curativa = generally used dosis for curingDosis therapeutica = generally used dosisDosis medicinalis = generally used dosisDosis tolerata = dosis which can be toleratedDosis maximalis = the highest dosis over which toxic symptoms may appearDosis toxica minima = dosis with minimal toxic effectAccording 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.
12The 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.
13This 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.
14Drug 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.).
15Drug abusePrevention of drug abuseWhen 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.
16Comission 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 marihuanaPrice increases under the trade10 kg opium $ (in Pakistan)1 kg morpine is produced $heroine $diluted 1 : 20 (5 % heroine) = doses1,5 million $ (U.S.A.)
17Besides 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 liabilityThe 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.
18The 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.
19The 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.
20The 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.
21International 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 continuityDutch Pharmaceutical Association proposal for organizing a permanent international associationDecision about placing the headquarters and the secretariat at The HagueThe 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.)
22Conferences – 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.
23Unification 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.
24The 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.
25Commission 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.
26The 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.
27Drug 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 ConventionEFTA = 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.
28Pharmaceutical literature History of pharmaceutical literatureIn 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 literatureTreatises Herbals, Compendiums (XV, XVI, XVII. centuries)PharmacopeiasNational PharmacopeiasIn 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
29In Britain:. Pharmacopoeia Londinensis 1618; In Britain: Pharmacopoeia Londinensis ; The first British Pharmacopoeia 1864In Hungary1871 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
30AB-2 (Arzneibuch der DDR) 1975 DAB-9 (Deutsches Arzneibuch) 1986Farmakopea CCCP xUSP XXI United States Pharmacopoeia 1985European PharmacopoeiaMartindale 28. (Extra Pharmacopoeia) 1982Homoeopathic PharmacopoeiaManualesNational FormularyPharmaceutical Recipe BooksProceedingsYournals trade papers pharmacy pharm.chem scientific yournals pharmacognosy pharm.technology pharm industryF.I.P. yournals
31International 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.
32Ordering of drugsPrescriptionLatin language (internationally accepted)The form of a prescription.Inscriptio Title, name, etc. Invocacio Rp. Ordinatio or Praescriptio Subscriptio Signatura AdscriptioE.G X. Y., ……………..(name, adress, age, etc.)Rp. Mixturae sedativae FoNo dosim D.S. 2 spoonful, twice a daySignaturaAdscriptio ……… (notes of pharmacists etc.)
33Formula magistralesIndividual prescription of the physicianFormula officinalis Officinal drugs in PharmacopoeiasFormula NormalesFormula Normales VeterinarieFormula originales85 % of the total drugs Drugs prepared in pharmaceutical factories.E.g. Rp.Tablettae Dopegyt scatulam originalem No.I. (unam) D.s. 2 x 1 tabletFormula nosocomialis (Hospitale, etc.)Copia = copy of the prescription
34Preparation of Medicines Three levels according to the scale of preparationpreparation in public pharmaciesmanufacturing medicines in Galenic laboratories and in hospitalsmanufacturing of medicines by pharmaceutical industryPublic pharmacyPublic pharmacies, where medicines with or without prescription are dispensed.- ground units of drug supply establishments of the public health
35The 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 cleanerOrganisation of drug supplyWholesale campanies (Hungarodrug, etc.) Imported drugs (National Institute of Pharmacy)Store:- certain amount of drugs in the pharmacies.Statim order (urgent order)
36The sketch of a modern pharmacy StreetGreen partaseptic lab.laboratory for the preparation of drugsOFFICINAexpedition of drugsevaluation of drugscamera materialls(store for chemical)corridorofficestore for specialitiesgardrobesstore for crude drugs and other itemssocial roomcold roomwashing roomspecial storestore for drug cont.Pharmacy windowentryexit
37Administration 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
38LaboratoriesGalenic laboratoriespreparation of complex drugsspecial preparationsdistilled water (big quantities)infusionsHospital, etc. Laboratoriesspecial profile according to the specialization of the hospital or instituteClinical pharmacy.Pharmaceutical factoriesMain 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.
39Industrial drug production in Hungary History: more than 100 year’s tradition.Control: Hungarian Pharmaceutical Association+Ministry of Industry humanMinistry of Health (Serobacterial Products)Ministry of Food and Agriculture ( - „ - )veterinaryDigitalis, ergot, morphine alkaloids, steroid hormones, sulfonamide preparations, papaverine, etc.Research InstitutesResearch Institute for Pharmaceutical Industry Central Research Institute of Chemistry
40Hungarian Pharmaceutical Industry Chinoin Chemical and Pharmaceutical Works Ltd. (founded in 1910); BudapestChemical Works of Gedeon Richter (founded in 1901); BudapestEgis Pharmaceutical and Chemical Works; BudapestAlkaloida Chemical Works Kabay’s method: morphine (founded in 1927); TiszavasváriBiogal Pharmaceutical Works (founded in 1952); DebrecenHuman Institute of Serobacterial Production and ResearchPhylaxia Institute of Serobacterial Production and Research (veterinary)Reanal Factory of fine chemicals
41Some 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
42The 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 1000Between the World Wars First woman graduated Ratio of Female students has been increasing permenthy.
43The 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 incorporated1952 Faculty of Pharmacy was incorporated1969 The name of the University was changed to Semmelweis University of MedicineIntegration process – Semmelweis UniversityCollege of Health CareFaculty of DentistryFaculty of Health SciencesFaculty of MedicineFaculty of PharmacyFaculty of Physical Education and Sports SciencesSchool of Ph.D. students
44Ignaz 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.
45Nevertheless, 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.