2.3.2012 Pharmacopoeia Rules for drug prescription Pharmacological databases Jan Juřica, PharmD., Ph.D. Pharmacology, definition, aims „pharmacon" + „logos" / „logia" Scientific discipline dealing with INTERACTIONS BETWEEN SUBSTANCES.. introduced into the organism from the environment ..AND THE LIVING ORGANISM on all levels of complexity: molecular cellular organ organism as a whole 1 Pharmacology • Pharmacodynamics - systematic study of the effects of drugs on living systems • Pharmacokinetics - systematic study of the effects of living systems on drugs Reasons tor drug administration • therapeutic \'J • diagnostic • preventive Therapeutic use: -suppression or mitigation of the cause or unpleasant symptom(s) of the disease -substitution of endogenous substance (hormones, vitamins, bile salts, HCI, etc.) -modulation of the organ function Therapeutic use of drugs can be: „empiric" or „aimed" performed on the base of knowledge of the mechanism of the therapeutic effect and/or adverse effects, comparison with the effect of other drugs.. „Evidence - based therapy" 2.3.2012 Reasons for drug administration Diagnostic use: - functional tests (dexamethazone, histamin) - substrates (markers, probe drugs) for biochemical examinations or phenotype determination (CYPs) Prevention / Prophylaxis: - vaccination - immunoprofylaxis - prophylaxis of myocardial infarction with ASA - prophylaxis of Str. endocarditis, meningitis with penicillin Drug Names • Chemical Name • Generic Name • Trade Name 3 2.3.2012 Chemical Name • describes its molecular structure and distinguishes it from other drugs §jpi • Chemical Name: 2-(diethylamino)-2',6'-acetooxylid monohydrochloride 4 2.3.2012 Generic name • often determined by the pharmaceutical company (investigator) • Generic Name: lidocaine hydrochloride • Officinal Name: Lidocaini Hydrochloridum (Czech Pharmacopoea 2009) • Brand (Trade) Name: Xylocaine® 5 Trade Name • or brand name - the manufacturer selects alone...can become a registered trademark • Pharma- Comp. is only one who can advertise and market the drug under that name International Nonproprietary Name • INN, also known as rINN, for recommended International Nonproprietary Name • official non-proprietary or generic name given to a pharmaceutical substance, as designated by the World Health Organization (WHO) • provides a standard name for each substance ~ IUPAC names in chemistry • WHO issues INN names in English, Latin, French, Russian, and Spanish • Arabic and Chinese versions, although not included in the original scheme, are now also being issued 2.3.2012 lUPAC name: N-(4-hydroxyphenyl)-acetamide INN: Paracetamol British Approved Name (BAN): Paracetamol United States Adopted Name (USAN): Acetaminophen Other generic names: N-acetyl-p-aminophenol, APAP, p-Acetamidophenol, Acetamol Proprietary names: Tylenol®, Panadol®, Panamax®, Perdolan®, Calpol®, Doliprane®, Tachipirina®, Benuron®, Atasol® Dosage Forms • drug substances are seldom administered alone, but rather as a part of a formulation in combination with one or more nonmedical agents that serve varied and specialized pharmaceutical functions 7 2.3.2012 Doses • DTS - dosis therapeutica singula • DTD - dosis therapeutica pro die • DMS - dosis maxima singula • DMD - dosis maxima pro die • ED50, LD50, TD50 Determining Drug Dose • Factors • Body Weight, Surface Area, Sex, Tolerance • Concomitant Drug Therapy • Time of Administration • Dosage Form and Route of Administration 8 r > How many ml of epinephrine solution can be injected to patient for the treatment of anaphylactic reaction? Aqueous solution : available in dilution 1:1000. A) calculate the min and max volume if the dose range is 0.1-0.5 mg B) calculate volume of solution for child weighing 25kg if the dose is 0.01 mg/kg C) calculate volume of epinephrine solution for the preparation of 500ml of infusion (dil. 1:100 000) by diluting the 1:1000 solution. How many ml of epinephrine solution can be injected to patient for the treatment of anaphylactic reaction? Aqueous solution in available in dilution 1:1000. A) calculate the min and max volume if the dose range is 0.1-0.5 mg 1:1000 = 1 mg in 1000 mg= in lg = in 1 ml aequous sol. --dose 0,1-0.5 mg = 0.1-0.5 ml r > How many ml of epinephrine solution can be injected to patient for the treatment of anaphylactic reaction? Aqueous solution in available in dilution 1:1000. Calculate volume of solution for child weighing 25kg if the dose is 0.01 mg/kg Dose = 0.25 mg; = 0.25 ml How many ml of epinephrine solution can be injected to patient for the treatment of anaphylaxictic reaction? Aqueous solution in available in dilution 1:1000. Calculate volume of epinephrine solution for the preparation of 500ml of infusion (dil. 1:100 000) by diluting the 1:1000 solution. = 1:100 000/1:1000 = 100. Dilution 100 x = 5 ml of 1:100 sol. into 495 ml of water or C*V = wl*Vl + w2*V2 0.00001*500 = 0.001*V1 + 0* (500-V1) 0.005=0.001V1 thus Vl=0.005/0.001= 5 ml > Pharmacopoeia > pharmacon = drug > poieo = prepare Substances in pharmacopoeia- called officinal drugs CESK.Y LÉKOPIS 2009 PharmDr. Jan Juřica, Ph.D. 1. DÍL Definition • basic reference work for pharmaceutical drug specifications • published by the authority of a government or a medical or pharmaceutical society • book containing directions for the identification of samples and the preparation of compound medicines • assures quality, efficacy, safety, standards 2.3.2012 Pharmacopoeias may be: •National e.g. Brazilian, British, Chinese, Indian, Japanese, Mexican, Spanish, United States •Regional e.g. European (Ph.Eur.) The 7th Edition of the European Pharmacopoeia •International The International Pharmacopoeia National and regional pharmacopoeias • Cover medicines used in the relevant country or region • Are legally binding "official" in the relevant country or region • Are prepared by a national or regional authority 12 International Pharmacopoeia A few dates... • The history of the International Pharmacopoeia dates back 1874... • -> 1948 First World Health Assembly established Expert Committee on Unification of Pharmacopoeia • -> 1950 WHA approved publication of Pharmacopoeia Internationalis International Pharmacopoeia ->implementation: "ready for use" by Member States "The Ph.lnt [... ] is intended to serve os source moteriol for reference or odoptotion by any WHO Member State wishing to establish pharmaceutical requirements. The pharmacopoeia, or any part of it, shall have legal status, whenever a national or regional authority expressly introduces it into appropriate legislation." [World Health Assembly resolution WHA3.10, WHO Handbook of Resolutions and Decisions, Vol. 1, 1977, p. 127] 2.3.2012 Scope since 1975 -> Model Lists of Essential Medicines -> Medicines recommended and specifications needed by WHO Programmes, e.g. to treat Malaria, TB, HIV/AIDS and -> Medicines for children! 14 International Pharmacopoeia A collection of monographs and requirements for: -> Drug substances -> Excipients -> Finished dosage forms -> General methods and requirements: dosage forms, e.g. tablets, liquid preparation for oral use dissolution testing -> Supplementary information, e.g. General guidelines for Chemical Reference Substances -> Infrared reference spectra Specifications of substances • Description, Chemistry, Solubility, Storage, Labelling • Definition, with information on polymorphism if relevant • Identification • Assay • Specific tests (sulphated ash, optical rotation, loss on drying...) • Related substances Specifications of substances • Precise description of analytical methods • Impurities (chemical names, structures, origin) • Any relevant information on Performance testing (e.g. dissolution) Stability Validation of analytical methods International Pharmacopoeia current: 4th Edition + 1st Supplement -> Consolidated in : 2 Volumes Vol. 1: pharmaceutical substances (A-O) Vol. 2: pharmaceutical substances (P-X) + dosage forms + radiopharmaceuticals + methods of analysis + reagents 1st Supplement - new requirements and revisions A.BACAVIR SULFATE A. ÍCltH11NsOj.,H.30, Eu-|>iriľv jiiiiLcntar n CLwmii'iiL iiiinit. a bac w i r si.il fa é is ■. 1 f ,4i? V 4- ľ -- Ami no-^.ey.: loiwopylamlno^ŕŕ pu tín-9-;yl]-2-cycl-i[v nterv- I-nie lha m I Ivniisu Ifát; CaS Reg. No. 16S062-.SO-2 Chemical name in ». accordance with IUPAC nomenclature rules intnalty to that cblained with solution b. a.2 Carry out lbs teat aa described under,_ tb eccodibto a described above under eat a.i bui using -ih- b i esas the coaBrJ£ au balance. Spiajwjth van illi Moulin in :n i-.i T"-1 " ' ' " ' " »^ B-« .h^bro™^. in w Cross-reference /c [I.-* option White to almostwhii? powder SabLbUJty. I i- ■ I - soluble in water. Category. An li n; tri viral '.Muck- ^id* Ri v^r^ Tran^ Mplase Inhibitor). Sionipe. Ataoi I'ir :-u Ihir-: sh.-uld tv tapt in a ty.; 11-: losed container. Requirements DefiJUtLocL Abaca *ir aulfaie o nta i^^ i> t Ihi llian 59.0 * and not more than 101.0 of if.'MEIMN.i >.i1.Hi1S<.>j, calcula t-d wilb reference to tbe anhydroua aubata.no?. Manufacture. The producti'-n meth-'d v-alidated I'- demon^trak rhar the subataiice., if tested, would comply wilh a iioill of Dot more than (LS»far(lJt 4J)-sbacavdr nullU-ni>-1 i.t-iri;-' a :-uiluiif -.himl cbrocnatograpbric method. Ill hill'. *Kt* ■ Bilfaer teata a. b. □ and b or tests C. d and e may he applied a. Carry out teat a. 1 or. where uv de te.: li- hi i\ i> r ava ila hie. teat a.2 aULca^J Rtas tbeCOatillf.MJli\i:m-. i a mi".......i| :■: '.-il iiiih -.■ i|' dkhloromelhane R and J vi-lum^ of J-pnpan-il k as Uv im-hik |ih:i>' Apply aeparafcLy to tbe plate 5 ul of each of 2 Bolnbj cb in Dmbamol -.-nii^i ni ng (Aj 5 rag of tbe tat au balance per ml aod i.b s or\ahacavir mi I fate RSper ruLAffcr removing the plat from tbe cbrccnatosra ntric cbamter. alt™ ffifo drv encbausliveiv International chemical reference substance (ICRS) -a general methoc li Tlv üii^iiri'Unn mv-.Iitim íl.ŕi of a IS ua DermlsolutiotL when observed between 2]0and <......u < -.h ii n- myj mum or abou 129 ] nm: tbe specific e('^taj is between 599and44l nm. C. Cany oul üV etainim.....n ^ i.ksj.rihťiJ undťr I ■ -.|V-hn^> i- metry in Ihe m f rj ľ J it^iiin Tbe infrared íifv rpU- n spectrum iŕ-.ni-.ndym ^ i Linne apectrum d from abacaviraulfate RS orwjth ihe r^r^nct sprorm\ of abacavir aulfate. CAS number D. Determine tne aj tiuäü.Lj.a 10 mfc'mtsoiuiico and calculate with referent lo the anhydroua subatance; L E. a 10 nigral lutiom ykld:- reaction a eksai Ivd undvrJ i ■-* m-ial idenliScatioD teata. aacharacteriatLc of autfatea. Il.wy iLwtnLs. Use tjOg for ilv pri^u:.....n if rht til v lui ion y^ described under 2.2. '<• Li niir Ksr fir Iv aw ire r,-uv Ftocedure l; dettmLDe the heavy raetaLcoDtDl according to r-1- Ih- id a: n- it n> a iba n 20 .ug/g. —-■ ■ 11 -■ ■ -.1 :1s.: Nol raote than 2D [njv'g, W^ter. Determine y^ i.k^iii\\l uiuLt J ■■ I..........:m-m ■ l -i:n i hy ihe Karl Fiacber method, hfelhod a . Uae ].o s.<\ Hi. LMMihM:m-.t Tbe wa tr con ten t ia not mote 111: • 115111 ^ tu-lnk-d Miitrurn^. r.^rr.1 ouHIk tsl a^ dt^^■rikd uiiderX_ Ii■-1■ j i■ J i. hriini:iiii!'iirli- i.m w:- -\ n fcsj. itt I lumn 11 ^ cm a 4.6 idid), paded ■-1 ■ 11 - -. i ri hil. I -il i. .i ■ I fi| . Iir ili.ii- ■-■ i." .iIm Th-.' n> j^ik' ph=iw.-> fi-r f.frilii:m iluli- hi •.• -ik-k-i • •< i mi *iuii ■ if Moht pho^ a -md Mobile phase b, ualng tbe following.conditional Mobile phase a: Q05 S-ioluli in -f ti\flu iri^^^licacid R. r. I -11 -11. ||-i:rv \i ^ vi lunvMif iiv i h:iii-11 R and IS volumea ofwafcr Inn inin ťoninupiLis i.- j.i 95 to 70 5 to-30 Linear gradient A, lu to 95 90 to 5 it turn i- ■ initial c- m p virion ■: ILV Hi k. H ľ! M I h '- |:i L 11| ■■ :: III I |^ I mi MU I :i|>.l M|, Ml......1 i-1:. II L |1||.V r:iaiľi :|l ^0 "CAs b detector uae an uJbravic-k■ sp;crrophi 'lometer a\ ar aw^u^ knŕjLli ■ í itllJUt inn ľripari i he- (■ d b wi nř stínili-iť m Uv di\Mluliui s-d^nl prípniid K diluting I ml ■I |iIm i-fihi iľM. j-, ni i - 111 Ts in ] ü t re of water I'm ^ iijijuri. 11 ih\4i|iv Im mt> 'f Ilv ii^i si.ii^i:uv^ in i hi di^^■lu■l■■^ ^ ľvni and dUut to SOD nil with IbesaiTK ^ Iv^nt ForsoLulico r2i dlLute 5.0 tnL of aolu Hon (li b so 0 nil v\Ih Uv d i^i lu li in solv; nr The n dilute s o ml of Lhiis > ■! urion !:■ so.-j nil »im 0» BBJie b Iv em r r .i-iuu-n ■ <> Iiíp-p-* • m. - i jI>k i»t .ouj'- i i .v. i- oj suita hULty RS i o nra in in^ ah-v.-ivi r ^ul 9-y I] cycIcpentyJIctiethanoL F. rr^cycJQpropy I- í*-1.1.1 ff.4J.i- 4-1 f. 1.1-di nv Uiy k Uiyl' <\ v |mt thy I! - > cycJopen bu-1-ylj-9i¥-pu rine-2.ŕrJiairiirie. A. (]-*, 4í>abacavi r sul fate i naiitii nk i \-.~-: und; r Manufacture], ABA^AVtRJ C6HPRESSf ABACA VIR TABLETS Category. Anbreboviral {Nucleoside Reverse Transcriptase Inhibitor]. Storage. Abacavir tablets should be kept in a welt-closed container. Labelling. The designst'on of the container of Abacavir tablets should state that the active ingredient is in the sulfate form and the quantity should b« indicated in terms of the equivalent amount of abacavir. Additional information. Strength in the cuixant iVHO Modal list of essentia) medicines: 300 mg of abacavir. Strength in the current WHO Model list of essential medicines for children: 300 mg of abacavir. - ■ >: - Hsat the plate tor a tew Examine the chiomatograiYi >n daylight. The principal spot obtained with solution A corresponds In position, appearance and intensity to that obtained wrth solution B. B See method A described under Assay. The retention time of the principal peak in the chroma to gram obtained with solution ill is similar to that in the ehromatogram obtained .itth solution (2). C. To« mg abacavir add 100 ml of w the filtrate to 50 ml with the same solvent. The -,■ ■ (1.6) of the resulting solution when observed between 220 ran and *?n rtm exhibits a maximum at about 291 nm, Requirements vitb the monograph for 'Tablets". Cross-reference to M ._.* - - * . . ? quantity or tn-s powdered tablets containing the equivalent or ttie Cjenerdl m0n0Cjr3Dh ' "1- °* abacavir add 5 ml Of water ft and shake, The resulting " " ' yields reaction A described under 2.1 General identification t^ste as characteristic of sulfates. Definition. Abacavir tabled contain Abacavir sulfate. They contain not less than 90.0ec and not more than 110.0° a of the amount of abacavir (Cl4HiaNsO) stated on the label. ■i: ■ -if ■* v tests • Either tests A. C and D. or tests B. C and D may be applied. A. Carry out test A.l or. where UV detection is not available, test A.2- A.l Carry out the test as described under. 1-^,1 ""i in-laver ■-■ - ■■ -,- -n- gnh... using silica R£ as the coating substance and a mixture of 8- volumes, of dichloromethane R. 2 volumes of 2-propanol P as the mobile phase. Apply separately to the plate 5 pi of each of the following 2 solutions in methanol R. For solution i Aj shake a quantity of the tablets containing the equivalent of 25 mg of abacavir with S ml. f Iter, and use the clear filtrate. For solution (B) use £ mg of abacavir sulfate R£ per ml. After removing the plate from the chromatographic chamber, allow it to dry exhaustively m an or in a current of cool air. Examine the chi omatogi am in ulb aviolet light (254 nm). The principal spot obtained with solution A ton-esppnds in position, appearance and intensity to that obtained with solution B. A.2. Cairy out the test 3? ceccs-ired l'-; = ! : 1 ■■ _ ~|- ■■- a e-ctjie^Blflfl^flbi- using the conditions described above under tact A. 1 but using silica gel R5 as the coating substance. Spray ivrth Related substances. Carry out the test as described under 1,14.4 conditions as described under Assay method A. Piepaje the following solutions in the dissolution solvent prepared by diluting 1 ml of phosphoric acid [" 1440 g/l) TS in 1 litre of water R. For solution (1) transfer a Quantity of the powdered tablets containing the equivalent of 10 mg of abacavir m the dissolution solvent and dilute to 50.0 ml with the same solvent. For solution (2j dilute 5.0 ml of solution (1) to 50.0 ml with the dissolution solvent. Then dilute 5.0 ml of this solution to 50.0 ml with the same solvent. For solution (3) dissolve 5 mg of abacavir sulfate for system suitability RS (containing abacavir sulfate and impurities B to F) in the dissolution solvent and dilute to 25 ml with the same solvent. Inject separately 20 pi each of solution (1). (2) and (3) and of dissolution solvent in the chromatographic system. Examine the blank chroma to gram for any extraneous peaks and disregard the corresponding peaks observed in the ehromatogram obtained with solution {1). In the chiomatogram obtained with solution (3). the impurity peaks are e'uted at the following relative !*etention with reference to abacavir (retention time about IS minutes): impurity C about 0.7; impurity D about 1.07; impurity E about 1.10; impurity B about 1.1: impurity F about 1.7, The test is not valid unless the resolution between the peaks due to abacavir and impunty D is at least 1.5. Established by WHO COLLABORATING CENTRE FOR CHEMICAL REFERENCE SUBSTANCES -> 155 International Infrared Reference Spectra (125 published in Ph.Int. 4th Ed. Suppl. 1) ;.....: \ \ / \ ji i : ' l 1 \ / ■ -, 1 * \ i l \ 1 ' f 1 1 l| 1 ; 1 1 /l r 4000.0 5600 3200 1S00 1400 1000 1S00 1*00 1400 1100 1000 SOO 600 400.0 PHARMACOPOEIA BOHEMICA > 3 volumes + CD, 2009 > Translation of 7th ed. of Eur. Pharmacopoieia > Issued by The Czech Ph. Comm. Of Ministry of Health >Vol. 1 General methods and requirements >Vol. 2 Monographs A-N > Medicines, excipients >Vol. 3 - Monographs N-Z > Medicines, excipients National part - General methods and requirements - Tables (I-XII) > Medicines, excipients Drug dosology in paediatrics. Doses divided into 3 age groups 0-1 1-6 6-15 Calculation according to the body surface body surface[nv] Dose for children =-------------------------- x adult dose 1,73 7* age (yrs) + 45 • Body surface [m2] = ------------------------- 100 PHARMACOPOEIA • WHAT we can not find there ! -pharmacological properties of drugs, their pharmacodynamics, pharmacokinetics - indications, contra-indications - toxic effects 2.3.2012 PRESCRIPTION • official document compiled in accordance with fixed rules. • written in Latin • must have all parts filled up, must be legible • corrections should be signed by the physician following the abbreviation corr.(correx/^corrected)na • written in a non-erasible manner • max. 2 kinds of medicines/Rx 21 2.3.2012 RULES FOR DRUG PRESCRIPTION • refers to the valid Pharmaceuticals Act and from the related acts and regulations. Electronic Prescription • Physician • Central server for data storage (SUKL) • Pharmacy • Patient + his password/PIN 22 2.3.2012 Common and E- prescription Kdd pojitfowny OECEPT U£| lj seric 0356523 PF]]i . jmä ■■• Cislo pojiJtence i ''an ■ Bydlljtft HdraSa] I Ü Q Q 4 :V 11 Can* ■ 7 ir^-iA rpj'Bxp.orio^Nii.TH III»*) 1— D.S. 1.1.1 llcl DEOXVMYKfOK_Ujl |#»f| 5 rpj p,s. l.o.^ Ico 12 hodin —staffs Wimen' a jirwro LACINA M1LOSLAV MUDr . .lis.,, pa|islfince 1MCCIIM FIL'j POfi Tfii. Pffio fl fjp.crlg.He. I Uuial U.S. 7 \ a KBATt reKOOjf Ä/1 KORYLM PJH VbL HUB 10 Enji.ortij.Ko.: [una™' D.S. flic pothafcv EKMlI MFMOCNt Ii; mil ii 3 J«.01.2011 HUD:. Hilo^Uv LACINA www.sukl.cz/erecept 23 • Ready-made preparations (RMP)- final preparations made by pharm. companies, ready to be issued by the pharmacy to patients without any further modifications • Individually prepared preparations (IPP) - prepared in the pharmacies on the base of individual medical prescriptions Drug preparations Covered by insuarance company (fully) Covered by patient + ins. comp. (in part) Covred by patient (fully) Both in pharmacies and in other places (supermarkets, petrol stations, etc Expedition is bound upon prescription unbound upon Rx (OTC) only in pharmacies 1 earmarked drugs" (since 1998): act 378/ 2007,106/2008 Sb., „about good pactice of the sellers of earmarked drugs and about the specialized education of sellers of earmarked drugs" 2.3.2012 RECEPT Série O Příjmení a jméno Rodné číslo Bydliště (adresa) GO lip. ?Ip1 IB Dne: Cena razítko zdrav, zafčenf jmenovka a podpis lékaře Bez data vystaveni", razítka smluvního zafeení, jmenovky a podpisu lékaře recept neptaK! Prescription composition • Inscriptio the heading of the prescription • Personalia aegroti patient s personal data (name, surname, birth number and domicile). • Invocatio - induced by the abbreviation Rp. (recipe take). • Ordinatio - the actual prescription of the healing preparation = compositio + subscriptio + signatura 25 2.3.2012 compositio • RMP - the trade name in the nominative, specification of pharmaceutical dosage form, dose and package • IPP — list of pharmacopoeial (officinal) names of substances in the genitive of singular + dosages subscriptio • RMP — how many packages should be issued • IPP — how the preparation should be made of the prescribed components • signatura — instructions how the preparation should be used by the patients. • date • the stamp of the health facility, the identification of the physician, and the physician s personal signature 26 Validity of Prescription • Common Rx - 14 days • ATB - 5 days • ATB topically - 14 days • Narcotics, Psychotropics -14 days • Rx for repeated issue - 6 moths, max 1 Year • Rx issued by emergency next day after the Rx issue (= max. 48 h) • Date - Rx not valid if missing • Validity may be prologned by physician (pollen vaccines- allergology) Rx for repeated issue • Max. no. of medicines usually for 3 months (= usually max. 3 packages) • If more packages to be issued-*„Rx. for repeated issue" • 6 months of validity if not specified differently • Max. number of issues has to be specified 2.3.2012 REPETATUR 2x bis 3x ter 4x quater 5x quinquies 6x sexies 7x septies 8x octies 9x nonies lOx decies Příjmení a jméno _i ByciHštd (adresa) ■ fi ij Bcí dala vystaven/, razítka smluvního zařízení, jmenovky a podpisu Itíkaře recepl r>ept;i1i! 28 Symbols in Rx formulary ! - when max. dose was exceeded ® - physician specify „not to be substituted with generic medicine" „PERICULUM IN MORA" - emergency situation,when normal form is not available RMP • introduced into the marked under their trade names • ready to be issued by the pharmacy to patients without any further modifications • are manufactured in charges(= amount of product manufactured in one production cycle) • charge number must be given on the package of the preparation • longer usable life than IPP (on the outer and inner package -"Exspir./ Exp./ Best before") PRAESCRIPTIO • the trade name in the nominative • specification of pharmaceutical dosage form, dose and package • If not specified - the lowes strenght and smallest package is issued SUBSCRIPTIO • how many original packages (ampules, tablets) Expeditionem originalem numero unam -Exp.orig.No.l (unam) Amp. Orig. No. I (unam) Expeditiones originales numero duas -Exp.orig.No.il (duas) Tbl. orig. No. XXX (triginta) 2» SIGNATURA • necessary data, which inform patient about the proper use of the preparation respecting the optimum dosage scheme Rp. BRUFEN 400 por. tbl. flm. Tbl.100x400mg Exp.orig.no. Il(duas) D.S. 1-3 tablets/day IPP prepared in the pharmacies on the base of individual medical prescriptions (magistraliter) enables individualization of prescriptions 3-8 % of receipts ^ (e.g. ophthalmology, dermatology, ORL, dentistry). Risk of incompatibilities and mistakes in prescription and preparation 2.3.2012 IPP Ordinatio - = compositio + subscriptio + siqnatura • = compositio composition of preparation = list of pharmacopoeial (officinal) names of substances in the genitive of singular + dosages e.g. Paracetamoli 0.5 Morphini hydrochloridi trihydrici 0.03 32 2.3.2012 Compositio • remedium cordinole- component showing the major therapeutic effect • remedium adiuvans- supplementary substance improving the effect of the major active component or attenuating its adverse effects, • remedium corriqens - component modifying/ unpleasant taste and/or improving undesirable appearance and/or aroma of the preparation, • remedium constituens or vehiculum- pharmaceutical excipient • Doses - DTS • Exceeding of D max. ! • Doses always in units of grams • Use decimals ! • Doses of some drugs spec, in IU, ggts • Doses of vehiculum „q.s." 33 2.3.2012 Subscriptio detailed instructions for the pharmacy how to prepare fixed Latin abbreviations are being used Most often: Miscefiat (sg.) or Miscefiant (pi.) = mix to make e.g. M. f. sol./ung./oculogutt. Signatura detailed instructions for the patient how to use the medicine or drug is prescribed for the physician's use Ad usum medici, Pro medico, Pro ordinatione 34 2.3.2012 201 ^ j ' RECEPT séneO N < I por. e.| Příjmení a jméno Mr. Ordinary Guy Rodné číslo i , 220426,5698 | f. Bydliště (adresa) Brno, Česká 2, 600 00 Acidi borici Vaselini albi M. f. ung. D.S. ... 2,0 ad 100,0 m 13, 2. 2011 Dne: MUDr. Radím Uzel Cena razítko zdrav, zařízeni jmenovka a podpis lékaře Bez dala vyslavení, razítka smlrjvnrno zařízení, jmenovky a podpisu lékaře recepl neplatí! Drugs of abuse and psychotropic substances • §§ - Drugs of abuse group I very strong narcotic effect e.g. fentanyl, morphine, cocaine, methadone • § psychotropic substances, group II strong psychotropic effect e.g. amphetamin, flunitrazepam 35 2.3.2012 Narcotic substances - §§ alfentanyl - §§ oxycodon - §§ diphenoxylate - §§ oxymorfon - §§ fentanyl -§§ pethidine - §§ hydrocodone - §§ sufentanyl - §§ cocaine - §§ remifentanyl - §§ methadone -§§ tilidin - §§ morphine -§§ opium crudum Psychotropic substances - § aphetamin - § buprenorfin - § phencyclidin - § flunitrazepam (Rohypnol) - § methamphetamin - § pentazocin 36 Rules for prescription • prescribed on prescriptions and/or order forms with an oblique blue stripe • very strict accounting • three copies • only one preparation • number of doses in package • 14 days of validity 2.3.2012 Example BS Transdermal Rp. patches Durogesic 25 jig/h empl. EMP 5x2,5 mg (10 cm2) Exp. orig No. II (duas) D.S. ... Rp. Injections Dolsin inj. INJ 10x1 ml 5% Exp. orig No. I (unam) D.S. ... 38 Rp. IPP Morphini hydrochloridi trihydrici 0,03 Lactosi q.s. M.f.pulv. D.t.d. No. XX (viginti) ad caps, gelat. D.S. ... Drug information databases Micromedex EMA Databases in Czech language: AISLP Pharmindex Vademecum Pharmindex Compendium Remedia Compendium