RULES OF THE DRUG PRESCRIPTION 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.(correxit-corrected)na • written in a non-erasible manner • max. 2 kinds of medicines/Rx RULES OF DRUG PRESCRIPTION • refers to the valid Pharmaceuticals Act and from the related acts and regulations. Electronic Prescription • Physician • Central server for data storage (SÚKL) • Pharmacy • Patient + his password/PIN www.sukl.cz/erecept Common and E- prescription • 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) Expedition is bound upon prescription unbound upon Rx (OTC) only in pharmacies Both in pharmacies and in other places (supermarkets, petrol stations, etc „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“ 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 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 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) • 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 Rx for repeated issue REPETATUR 2x bis 3x ter 4x quater 5x quinquies 6x sexies 7x septies 8x octies 9x nonies 10x decies Inscriptio Personalia aegroti Invocatio Ordinatio Compositio (Praescriptio) Subscriptio Signatura Stamp, Physician identification Date Signature Symbols in Rx formulary I – fully paid by insuarance company C – partially paid by patient and insuarance comp. P – fully paid by patients Symbols on prescription „HRADÍ NEMOCNÝ/COSTS COVERED BY PATIENT“ - fully paid by patients (instead of I, C, P) „ZVÝŠENÁ ÚHRADA/INCR. RATE OF COVERING “ – drug has two different levels of payment from insuarance comp. „NEZAMĚŇOVAT/NOT TO BE SUBSTITUTED“ - physician specify „not to be substituted with generic medicine“ ! a) when max. dose was exceeded b) different indication from SPC (+ dg. number) dg. http://www.uzis.cz/cz/mkn/index.html „POHOTOVOST/EMERGENCY“ – Rx issued by emergency 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.I (unam) Amp. Orig. No. I (unam) Expeditiones originales numero duas – Exp.orig.No.II (duas) Tbl. orig. No. XXX (triginta) 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.II(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 IPP Ordinatio – = compositio + subscriptio + signatura • = 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 • remedium cardinale- component showing the major therapeutic effect • remedium adiuvans- supplementary substance improving the effect of the major active component or attenuating its adverse effects, • remedium corrigens - component modifying/ unpleasant taste and/or improving undesirable appearance and/or aroma of the preparation, • remedium constituens or vehiculum- pharmaceutical excipient Compositio • Doses – DTS • Exceeding of D max. ! • Doses always in units of grams • decimals ! • Doses of some drugs spec. in IU, ggts • Doses of vehiculum „q.s.“ Subscriptio detailed instructions for the pharmacy how to prepare fixed Latin abbreviations are being used Most often: Misce fiat (sg.) or Misce fiant (pl.) = 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 201 Mr. Ordinary Guy 220426/5698 Brno, Česká 2, 600 00 Acidi borici 2,0 Vaselini albi ad 100,0 M. f. ung. D.S. … MUDr. Radím Uzel 13. 2. 2011 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 Narcotic substances – §§ alfentanyl – §§ diphenoxylate – §§ fentanyl – §§ hydrocodone – §§ cocaine – §§ methadone – §§ morphine – §§ oxycodon – §§ oxymorfon – §§ pethidine – §§ sufentanyl – §§ remifentanyl – §§ tilidin – §§ opium crudum Psychotropic substances – § aphetamin – § buprenorfin – § phencyclidin – § flunitrazepam (Rohypnol) – § methamphetamin – § pentazocin – … 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 Examples Rp. Durogesic 25 g/h empl. EMP 5x2,5 mg (10 cm2) Emp. orig No. X (decem) D.S. … Transdermal patches Rp. Dolsin inj. INJ 10x1 ml 5% Amp. orig No. X (decem) D.S. … Injections Rp. MST Continus 10 mg tbl. ret. TBL RET 60x10 mg (miligrammata decem) Tbl. orig No. LX (sexaginta) D.S. … Tablets Rp. Valoron gtt. GTT 10 ml 10% Lag. orig. 10 ml No. I (unam) D.S. … drops Rp. Morphini hydrochloridi trihydrici 0,03 Lactosi q.s. M.f.pulv. D.t.d. No. XX (viginti) ad caps. gelat. D.S. … IPP Drug information databases Micromedex LEXICOMP EMA, FDA AISLP SPCs Drugs.com In Czech: AISLP Infopharm Pharmindex Vademecum Pharmindex Compendium Remedia Compendium