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. Eu-|>iriľv imilentar n CLwmii'iiL name. Abů&svir sul fa é is ■. 1 f ,4i? V 4- ľ -- Ami no-^.ey.: loiTopylamlno^ŕŕ pu tín-9-;yl]-2-cycl-i[v nrtrv- I-nit Íha m I lvnii:.u Ifát; CaS rttg. No. 163062-50-2 Chemical name in ». accordance with IUPAC nomenclature rules intnalty to that colained with solution B. a.2 Cany out lbs teat aa described under,_ tbeccodiKosdescribed above under eat a.i bui uanj] ih- b i ejas the coanrj^ aubstauce. Spray with vanillins II" in :n i-.i T". I " ' ' " ' " »^ B-« .h^bro™^. in d^j^L cross-reference /c [I.-* lipcion. White to almostwhli? powder SaLubUJty. I i. ■ I. soluble in water. CptegHry. Anlirelroviral '.Muck- *-ide Rt v;^ Tran^ riplase- [nbi.bi.tor). Sionipje. Ahatsvir :-u Ihir-: shi-uid tv ktpt in a 1Pt losed container. Requirements DefiJUtLocL Aba^a *ir i^ulfatt o nta i^^ i> t Ihi llian 59.0 * aud notcnore than 101.0 of i c.' HE111N. ■ >.i1.HilS<.>J, i'Akul4 fe-d wLib reference to tbe anhydroua subabmcev Manufacture. Tht producti'-n nitth-'d ■-■:JiJ-ii^ J \<- dtnion^trak that the substance, if tested, would comply wLih a JiDiLI of not more than 0.5» for (LU 4i>abacavdr ;nanlinTKi using a :-uiluiif -.hiral chrcoiatograpbric method. Ill hill'. IfHts ■ Either teata a. B. 0 and B or LestsC. D and E may he applied a. Carry out teat a. ] or. where UV de rtt U- hi i\ i> r ava ila hie. teat a.2 ailica^J Rtastbecoatin*Vuii-^ni- ■ : ■ ■ ■ •. ■ -i miv.......if k <.■■ ii uitws ■ ■ f dk hlorome Lha ne k and J v.-lum^ of J-pn-pan-il k as Uv im-hik |ih:i>' Apply separately to tbe plate 5 iilcif each of 2 Bolutu cb in methaLDJ ■.■■mining (a) 5 rag of tbe tataubalance per raJ and i.B.■ nig ofahata vir mi I late RSper QiL. Affcr removing, the pLafe from tbe cbrocnakisrapttic cbambeL allow rfski drv exhaustive iv International chemical reference substance (ICRS) -a general methoc li Tht üiviiroUnn mv-.Iitim íL.ŕi of a 11 uě DermLsoLutiotL when observed between 210and <......u < -.h ii n- myj mum or about29]nm: tbe speclĚc e('^taj is between 399and441 nm. C. Carry oul uV ttamin;.....n ^ i.ksj.rihrd undťr I ■ -.|v-hn^> hue try in trv infruľj itťiiin Ttv- infrared iih> qUi- ii srtarum is-.-ui-.-udym ^illube apectrum d from abacavir aulfate RS orwith the r^r^nct sprorm\ tí abacavir aulfate. CAS number □. Determine tbe £i tiuäü.Lj.a 10 mfc'mL soLutico and calculate wi(b referent hrlv anhydroua subatance; L E. a 10 mg^ral ^ lurion yi^Mj- reaction a ckstri Nd und^rJ I --j ip-'ialidg-nLificatjon L?ata_ as character a be of autfatea. Iluvy iLwtuLs. Use lijg for ilv prt|\u:.....n if rht tsl v lui ion y^ described under 2.2. '<• Li niir Ksr f a lha n 20 ug/g. —-■ ■ 11 -■ ■ -.1 :1s.: Nol mote than 2D mg/g, W^ter. Determine y^ ■.kstiiivd uiuLt J ■■ I..........:m-m ■ l -i:n i hy ihe Karl Fi sober met bod. hfetboJA. Uae ].o g. ■ ■ I ■ li. LMMihM:m-.t The wa tr con tn t ia not more than 5 uv: ^ tu-lnk-d Miitrnnn^. r.'^rry ouI rht tsl a^ dt^^■rikd under^_ Ii■-1■ j i■ J i. hrnni:iiii!'iirli- w:- -\ n ks^ sti I lumn 11 ^ ten s 4.6 mm\ paded ■-1 ■ 11 - -. i ft .-. hii. I - ii i. .i ■ I i-i . Iir iii-ii- ■. ■-■ i." . ■ Th* n> tiik ph-i^.^ fi-r f.rgili<.'ni iluli- hi •.• -ik-k-i • •< i mi *iuii ■ if Moht pho^ a -ind SfobiLe ptase B, using tbe following.conditions: StobiLe phase- a: 0.05 S-ioluli in -f triflu iri^^^licacdd R. r. I -11 -11. | |-i:rA- \i v. iunv\ of vtti rhan-il R and IS vodumea ofwatr Inn ll'lil'l MoNJepduseB CrjUMHOtE 95 to 70 5 to-30 Linear gradient A, lu to 95 90 to 5 ítNrn i- ■ initial imp virion ■: ILV Hi k. H ľ! M I |i '- |:i L III I I llll llU L :i|>.l l||. 1.1 1......1 |V. II L |H|.y r:iaiľi :|l ^0 t.a! b defectcc uae an ultraviotr sp£crroph .lomerír a\ ar a w.^ia; knřjUi ■ í about 254 um. ľripari rlK (■ d h wi nř stínili-iť m Uv iIi\mIuUui sd^nl pripn/id K dilurinp I ml ■i |iIm i-fihi iľM. j-, ni i - 1440ft-11 TS in 1 ü t re of water ľ-u :v lu Iii in ■ 11 ihwuiliv Im mt> i-f Uv ii^i si.ii^i:u>.^ in i hi di^^■lu■l■■^ ^ ľvni y nil dUut to SOD ml with Lbe saint ^ Iv^nr ForsoLulico (2) dlLute 5.0 mLof aolutlon (I) h 5i) (.■ nil wi th d i^i lu U .n s&Wi nr The n d i Iuk s ■> m I of U-ü^ > 4 urion !:■ íO.O nil »im ilv earn* a> tľ*nL r r .<-iuü--n ■ *< -iiü-r* • m. - i jI>k i»t .ouj'- i i .v. i- rj suita hlllfy RS i ci nra in in^ ab.-v.-ivi r ^ul i^u:ikiy j'iL i iy-.h if ^ ■ iui ■■ in^-11 .l i j .■ ú nJ n.mnú ■ ■ in Uv i h r- iiti-ii-if.rj ph ii i-yi-km ľ'ínniiiK- ilv iihuit: -. hl ■ niy !■ oraní for any estraueous peaks and disregard Ibeton' -i.....limp |» :ik> i-bserved lu the .hn-myiiONim i-Niuivd ^ i Ih * dulion (1). In the chroma logjam obtained wiih solulion (hj, tbe impurity peaks are elutd at tbe f- ii h i nf. r;k k m ii n w irh re fire ivt r- ■ a ha^-ivi r i k k nrii -n time about 19 niinuk'M impurity i nf> til -1 n. impui i ly 11 u hi-ui i ■ i =: iiyi|-h in h.1 I: :ili- -ul I |> i impurity B aboul 1 '■: impurity ľ'íiboul 1.?. Tbe tc-atia notvand unLesi tbe E-ioLution between tbe pea hs o irre :■■ poniJiny ii - ■:ihii.;H' n a nd impurity D is at Leaat 1.5. In the chroma h vinili nivuivd ^ilh solull n . I . ilv art a of any individual peak corresponding b impurity C, d, E, B, ccFia not greater than u. h timea tbe area of tbe principal pea k otvuivd ^ i Ih ^Hulico (2) (0.3*). Tbe area of any olber Impurity peak is not pester than 0.1 timea tbe area of the principal peak- htained with aolutlon 12) fO.]*.j. jbe sum of chs arta^ of aii psaks, other than the principal peat is not greater tK-in Ih,- nr,- :i i f Uv print i pa I pv :d: ■ iblai rvd wi Ui s- 4 urion (2J (.1*X 11 i ;;.-.'J <.\ ;Jiv peak wi±i an area Leas Iban 0.01 Hmea the area of the principal peak obtained w[tb solution (2) (0D5*j. iV*iiiy_ Ciisíolvŕ ati:*il 0.V.O j.. accurakly wtiglvd in SO ml ifwakr and titrate wiUi sodium hydrcwlde iO.l moL/l)\'5, ck Ľ nni ni n^ tht ind-poinl pi é n ĽcimetricaLty. 4. B. ŕŕ-cycJopropy P 1R ,4í* 41 [<.% s-diactrino-ť-chloro-4-p^1 rimidi m11-ty | nitthyl |- j- ip;<. loptnten-l-ylj-^íf-pu n'ue-2,i i h I -. 4ÍT.i-4-1 ií- d iiiľľii ni-"H- pu rin-^-y 11- j-tycl 9-y I] tyckpentyllmetbanoL F. A^cycJopropy p í*.m i ff.4J.i- 4-1 P. 1.1-di iiy Uiy k Uiyl' <\ v Iitp. thy 11 - 2- cycJopeu tu-1-yL)-9ŕŕ-pu rine-2.ŕrHdiamine. a. (4í>abaca vi r stil fatt nuitii nk i \-.~-: unde r Manufacture], ABA^AVIRj. 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 th* current 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 h>w Examine the chromatogp am >n daylight. The principal spot obtained with solution A corresponds In position, appearance and intensity to that obtained with 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 with solution (2). C. To« mg abacavir add 100 ml of w the Filtrate to 50 ml with the same solvent. The ^h-=.-1 . g ■ f 1.6) of the resulting solution when observed between 220 ran and nm exhibits a maximum at about 291 nm, Requirements vitb che monograph for 'Tablets". Cross-reference to M ._.* - - * . . ? quantity of the powdered tablets containing the equivalent or ttie Cjenerdl m0n0Cjr3Dh ' "1- °* abacavir add 5 ml Of water R and shake, The resulting " " ' yields reaction A described under 2.1 General identification t^ste as ch»"actonstic of sulfates. Definition, Abacavir tablets contain Abacavir sulfate- They contain not less than 90.0Bn and not more than 110.0° a of the amount of abacavir I Cl4HiaNsO) stated on the label. Identity 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 dichloro methane 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 RS per ml. After removing the plate from the chromatogi-aphic chamber^ allow it to dry exhaustively m an or in a current of cool air. Examine the chi omatogi am in ulti aviolet light (254 nm). The principal spot obtained with solution A con-esponds in position, appearance and intensity to that obtained with solution B. A.2. Cairy out the test ce;c;-L-=-d L'-- = ! 1 1 ■■ _ ~|- ■■- a e-cJ^rOjT^lcij^njh^. using the conditions described above under test A. 1 but using silica gel R5 as the coating substance. Spray ivith Related substances. Carry out the test as described under 1.14.4 conditions as described under Assay method A. Pi^paie 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 mt 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 ^*ith the same solvent. For solution (3) dissolve 5 mg of abacavir sulfate for system suitability FtS (containing abacavir sulfate and impurities B to F) in the dissolution solvent and dilute to 25 ml with the same solvent. Inject separately 20 ul each of solution (1). {2) and (3) and of dissolution solvent in the chromatographic system. Examine the blank ehromatogram 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 !*etenb"on 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 1.3: impurity F about 1.7, The test is not valid unless the resolution beh.een the peaks due to abacavir and impuiity 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 i'l r 4000.0 5600 3200 2S00 2400 2 000 1S00 1*00 1400 1200 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/Y-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