التجمع الصيدلي المصري الدواء باالسم العلمي قوانين العالم المحددة لصالحيات الصيادلة في صرف األدوية وفقا ألسمائها العلمية والتي تقر بشكل يشبه اإلجماع علي أحقية الصيدلي في اختيار الشركة المنتجة للدواء مع استثناءات ال تذكر أوال -قراءة في النظام االميريكي لصرف الدواء Generics Substitution مصطلح Generics Substitutionهو مصطلح عالمي يعني السماح للصيدلي بصرف الدواء المثيل دون الرجوع إلي الطبيب أو المريض والسبب المباشر في إعطاء هذه الصالحية للصيدلي هو ان هذا اإلجراء يحقق توفير المال للمريض األمريكي ويحقق مرونة في مزاولة مهنة الصيدلة للصيدلي األمريكي وتتفاوت حدود هذا اإلجراء من والية إلي أخري وتتسع مساحة حرية الصيدلي من مكان ألخر في الواليات المتحدة األمريكية حيث تبدأ من إعطاء كامل الحرية للصيدلي بصرف الدواء المثيل في معظم الواليات تحت أي ظرف من الظروف إلي وضع بعض الحدود في واليات أخري ومن أمثلة الحدود الموضوعة في بعض الواليات األمريكية (االستثناءات) كاألتي -1يمكن للطبيب أن يطلب من الصيدلي صرف دواء الشركة األم Brand Drugsأما ما عدا هذا فال يحق للطبيب رفض مستحضر أي شركة طالما أن الدواء المطلوب ليس من الشركة األم -2تستثني قوانين بعض الواليات األدوية ذات narrow therapeutic rangeمثل مادة الديجوكسين ومادة المورفين -3بعض األدوية التي تستخدم عن طريق االستنشاق بطريقة Metered Doseحيث تختلف قياسات كل جهاز عن آخر عند استخدامه -4أدوية الصرع وهذا االستثناء غير شائع في معظم الواليات إال انه موجود في بعضها وتم ذكره من قبيل األمانة العلمية -5بعض الواليات تلزم الصيدلي بالتبديل الجبري للدواء إذا كان الطبيب قد كتبه باسم تجاري وله مثائل أرخص والسؤال هنا لماذا تختلف الواليات في أنظمتها لصرف الدواء؟ القوانين توضع لعالج مشاكل واقعة وبناءا علي اختالف نوعية المشاكل من والية ألخرى تختلف النظم والقوانين فيها ونحن في مصر يجب أن نتخذ من اختالق قوانين صرف الدواء في الواليات األمريكية مدخال لصناعة نظام خاص بمصر يساعد علي حل مشاكلها الدوائية كما تقوم كل دولة بل كل والية بوضع النظام الذي يخدم مصالحها ويساهم في الحد من مشاكلها ملحوظة مهمة جدا ========== مصطلح (الدواء باالسم العلمي) هو وسيلة لتحقيق مصطلح متعارف عليه دوليا وهو ()Generics Substitution بمعني ان وسيلتنا لتحقيق مبدأ ( )Generics Substitutionهو أن نتخلى عن االسم التجاري سواء في الروشته أو علي غالف الدواء أو كالهما معا وإذا كانت بعض الدول ال تلزم الشركات أو األطباء باالسم العلمي فهذا الن مبدأ ( )Generics Substitutionيتم تحقيقه بدون اللجوء إلي ضرورة استخدام االسم العلمي حيث أن ثقافة المريض والطبيب تسمح هناك بذلك أما في مصر ومع سنوات من قدسية االسم التجاري لدي المريض والطبيب فان مبدأ ( )Generics Substitutionال يمكن ابدأ تحقيقه إال إذا تخلينا ولو لفترة انتقاليه عن االسم التجاري وذلك بكتابة الدواء باالسم العلمي وكما ذكرنا فان لكل دولة وكل والية نظامها الخاص في تحقيق مبدأ ()Generics Substitutionفإننا يحق لنا أن نخلق )Generics Substitution( ما يناسب ثقافتنا ويضمن تحقيق مبدأ هذه النصوص مصدرها مواقع رسمية للواليات األمريكية وتصف أنظمة صرف الدواء هناك Alabama Pharmacists shall select a pharmaceutically and therapeutically equivalent drug product containing the same active ingredient, or ingredients, and of the same dosage form and strength. http://www.albop.com • California Pharmacist may select another drug product with the same active chemical ingredients of the same strength, quantity, and dosage form, and of the same generic drug name. Drug product .selection is within the discretion of the pharmacist http://www.pharmacy.ca.gov/laws_regs/lawbook.pdf • Colorado The pharmacist may substitute an equivalent drug product if the substituted drug product is the same generic drug type and in the pharmacist's professional judgment, the substituted drug .product is therapeutically equivalent Therapeutically equivalent" or "equivalent" means those compounds containing the identical " • active chemical ingredients or identical strength, quantity, and dosage form and of the same generic drug type, which, when administered in the same amounts, will provide the same .therapeutic effect as evidenced by the control of a symptom or disease http://www.dora.state.co.us/Pharmacy/Statute.pdf • Connecticut The pharmacist may substitute a generic drug product with the same strength, quantity, dose, and dosage form as the prescribed drug product which is, in the pharmacist's professional opinion, therapeutically equivalent. When the prescribing practitioner is not reasonably available for consultation and the prescribed drug does not use a unique delivery system technology, the pharmacist may substitute an oral tablet, capsule, or liquid form of the prescribed drug as long as the form dispensed has the same strength, dose, and dose schedule and is therapeutically .equivalent to the drug prescribed Therapeutically equivalent" means drug products that are approved under the provisions of " • the federal Food, Drug and Cosmetics Act for interstate distribution and that will provide essentially the same efficacy and toxicity when administered to an individual in the same dosage regimen http://www.cga.ct.gov/2007/pub/Chap400j.htm#Sec20-619.htm • Florida Each community pharmacy shall establish a formulary of generic and brand name drug products which, if selected as the drug product of choice, would not pose a threat to the health .and safety of patients receiving prescription medication In addition the Florida Board of Pharmacy maintains a negative formulary available at • .https://www.flrules.org/gateway/RuleNo.asp?ID=64B16-27.500 A pharmacist may substitute a generically equivalent drug product listed in the formulary of .generic and brand name drug products for the brand name prescribed Generically equivalent drug product" means a drug product with the same active ingredient, " .finished dosage form, and strength http://www.leg.state.fl.us/statutes/index.cfm?mode=View%20Statutes&SubMenu=1&App_mode=Disp lay_Statute&Search_String=Pharmacy&URL=0400-0499/0465/Sections/0465.025.html Georgia A pharmacist may substitute a drug with same generic name in the same strength, quantity, dose, and dosage form as the prescribed brand name drug product which is, in the pharmacist's reasonable professional opinion, both pharmaceutically equivalent and therapeutically .equivalent )]http://www.lexis-nexis.com/hottopics/gacode/default.asp (See Title 26, Chapter 4. [§ 26-4-81 • Hawaii A pharmacist may substitute a therapeutically equivalent drug product listed in the current .state drug formulary In addition, pharmacists shall not substitute an equivalent generic product for any antiepileptic • prescription without consent of the prescriber and the patient or patient's guardian plus may not .substitute antiepileptic drugs without practitioner and patient consent See HRS Chapter 328 at • http://www.capitol.hawaii.gov/hrscurrent/Vol06_Ch0321-0344/HRS0328/HRS_0328-.htm http://gen.doh.hawaii.gov/sites/har/AdmRules1/11-33.pdf • Iowa The pharmacist may exercise professional judgment in the economic interest of the patient by selecting a drug product with the same generic name and demonstrated bioavailability as the one .prescribed for dispensing and sale to the patient The Iowa Board of Pharmacy advises the use of the Orange Book to determine therapeutic • equivalency.6 http://www.state.ia.us/ibpe/pdf/IC155A.pdf • http://www.legis.state.ia.us/IACODE/2003/155A/32.html#1 • Kansas A pharmacist may substitute with a generic product unless the FDA has determined that a drug product of the same generic name is not bioequivalent to the prescribed brand name prescription .medication http://www.kansas.gov/pharmacy/Rules&Regs.htm • Kentucky Kentucky Board of Pharmacy maintains a negative state formulary and a list of narrow .therapeutic index drugs not to be substituted The following drugs are noninter changeable unless the FDA considers them therapeutically • equivalent as published in the Orange Book: digitalis glycosides, antiepileptic drugs, antiarrhythmic agents, conjugated estrogens, esterified estrogens, warfarin anticoagulants, .theophylline products, and thyroid preparations http://www.lrc.state.ky.us/kar/201/002/116.htm • Michigan Pharmacists may substitute with a generically equivalent product, identical in dosage, form, and .content of active ingredients =http://www.legislature.mi.gov/(pec4oabmf23cgqykwgodjx45)/mileg.aspx?page • getObject&objectName=mcl-333-17755 Minnesota A pharmacist may substitute with a generically equivalent drug that, in the pharmacist's .professional judgment, is safely interchangeable with the prescribed drug http://www.revisor.leg.state.mn.us/stats/151/21.html • Montana A pharmacist may substitute with a drug product with the same generic name, strength, quantity, dose, and dosage form as the prescribed drug that is, in the pharmacist's professional .opinion, therapeutically equivalent, bioequivalent, and bioavailable http://data.opi.state.mt.us/bills/mca/37/7/37-7-505.htm • Nebraska Nebraska statues pertaining to drug product selection allow a pharmacist to substitute a drug product that is both chemically equivalent and bioequivalent except under certain circumstances .specified in the statues The Orange Book is not specifically required by statue or regulation, but it is the reference • commonly used to determine chemical equivalence and bioequivalence of drugs. http://www.dhhs.ne.gov/crl/statutes/Pharmacy.pdf • http://www.hhs.state.ne.us/crl/statutes/pharmstat.pdf • New Jersey The New Jersey Administrative Code 8:71-1.1 states that a drug product is interchangeable if it is listed in the New Jersey generic formulary or if it has a therapeutic equivalence rating of "A," .as identified in the Orange Book or FDA's "Drugs@FDA" website Note that the New Jersey generic formulary is outdated and has not been updated since about 6 • years ago.10 http://www.state.nj.us/oag/ca/pharm/pharmacy.pdf • http://www.state.nj.us/health/rules/njac8711.pdf • New York A pharmacist may substitute a generic equivalent product, provided the substituted drug product is contained in the list of drug products established pursuant to paragraph (o) of subdivision one of section two hundred six of the public health law. (Searchable online at ).http://www.op.nysed.gov/prof/pharm/article137.htm Each of the drug products on the list must be pharmaceutically and therapeutically equivalent • and shall not include any drug product which has been identified in the Orange Book as having .actual or potential bioequivalence problems http://www.op.nysed.gov/prof/pharm/article137.htm • North Carolina Equivalent drug product" means drug product which has the same established name, active " ingredient, strength, quantity, and dosage form, and which is therapeutically equivalent to the .drug product identified in the prescription The North Carolina Board of Pharmacy maintains a list of narrow therapeutic index drugs not • to be substituted. It is published in January of each year in the North Carolina Register. (List updated in March 2009 register). http://www.ncoah.com/rules/register/Volume23Issue17March22009.pdf The 2009 list of narrow therapeutic index drugs includes: carbamazepine (all oral dosage • forms), cyclosporine (all oral dosage forms), digoxin (all oral dosage forms), ethosuximide, levothyroxine sodium tablets, lithium (all salts, all oral dosage forms), phenytoin (all salts, all oral dosage forms), procainamide, tacrolimus (all oral dosage forms), theophylline (all salts, all oral .dosage forms), warfarin sodium tablets http://www.ncbop.org/LawsRules/Statutes.pdf • http://www.ncbop.org/LawsRules/Rules.pdf • North Dakota If a practitioner prescribed a drug by its brand name, the pharmacist may exercise professional judgment in the economic interest of the patient by selecting a drug product with the same generic name and demonstrated the therapeutical equivalency as the one prescribed for .dispensing and sale to the patient http://www.nodakpharmacy.com/NDBP/law/2008LegislativeChanges.pdf • Ohio Generically equivalent drugs contain identical amounts of the identical active ingredients that meet the identical compendial or other applicable standard of identity, strength, quality, and purity including potency, and where applicable, content uniformity, disintegration times, or .dissolution rates and have not been listed by the FDA as having proven bioequivalence problems http://www.pharmacy.ohio.gov/leglprac-070701.htm • It is unlawful for a pharmacist to substitute any like drug, medicine, chemical, or • .pharmaceutical preparation without the authority of the prescriber or purchaser http://www.ok.gov/OSBP/documents/law08.pdf • Oklahoma Therapeutically equivalent" means drugs that are approved by the FDA for " • Oregon interstate distribution and the FDA has determined that the drugs will provide essentially the .same efficacy and toxicity when administered to an individual in the same dosage regimen http://landru.leg.state.or.us/ors/689.html • Pennsylvania The Pennsylvania Board of Pharmacy maintains a list of narrow therapeutic index drugs not to .be substituted Drug products found by the FDA to have a narrow therapeutic range shall not be considered • .generically equivalent http://ecapps.health.state.pa.us/pdf/ddc/generic33.ps.pdf • http://ecapps.health.state.pa.us/pdf/ddc/nti.pdf • Rhode Island A pharmacist may substitute drugs containing all the same active chemical ingredients of the .same strength, quantity, and dosage form as the drug requested by the prescriber The director shall permit substitution of less expensive generic, chemical, or brand name drugs • and pharmaceuticals considered by the director as therapeutically equivalent and .interchangeable with specific brand name drugs and pharmaceuticals http://www.rilin.state.ri.us/Statutes/TITLE21/21-31/21-31-16.1.HTM • http://www2.sec.state.ri.us/dar/regdocs/released/pdf/DOH/5042.pdf • South Carolina A pharmacist may substitute a drug product of the same dosage form and strength which, in his .professional judgment, is a therapeutically equivalent drug product Therapeutically equivalent" means the same efficacy and toxicity when administered to an " • .individual in the same dosage form For the purpose of generic substitution, the FDA Approved Drug Products book (Orange • Book), The Red Book, The Blue Book, USP DI Volume III, or Facts and Comparisons' Bioequivalency Codes may be used as a guideline, but no one reference will be recommended by the Board for use (Policy and Procedure #087).12 There are categories of drugs that the Board does not recommend pharmacists to substitute, • and these include prescriptions for:12 1) Narrow therapeutic index drugs (e.g. lithium); 2) Premarin or Synthroid; 3)"Critical drugs" in the following categories: anticoagulants, anticonvulsants, anti-asthmatics (especially time-release products), insulin, and cardiac .glycosides A pharmacist is liable for substituting drugs not recognized by the FDA as bioequivalent (SC • Board of Pharmacy newsletter, May 1998).12 Substitution may not occur unless the pharmacist advises the patient or the patient's agent that • .the practitioner has authorized substitution and the patient, or patient's agent, consents http://www.scstatehouse.gov/code/t39c024.htm • South Dakota Equivalent drug product" is defined as a drug product that is considered to be therapeutically " equivalent to other pharmaceutically equivalent products as determined by the latest edition of .the Orange Book If the prescriber orders the drug by brand name, the pharmacist must inform the patient of the • selection of an equivalent drug product and of the patient's right to refuse the product selected.13 http://www.pharmacy.sd.gov provides a link to Chapter SDCL 36-11. See specific statutes 36-11-2; • .36-11-19, and 36-11-46 http://legis.state.sd.us/statutes/DisplayStatute.aspx?Type=Statute&Statute=36-11-2 • Tennessee A pharmacist may substitute A-rated products and use his judgment on unrated products .except for antiepileptic drugs used to treat patients with epilepsy or seizures A pharmacist must notify the patient or the patient's representative and the prescriber before • interchanging one manufacturer of an antiepileptic drug for another manufacturer of an antiepileptic drug in instances where the patient's epilepsy or seizures are currently being controlled on a specific drug, strength, dosage form, and dosing regimen from a specific manufacturer. This does not apply to prescriptions dispensed for inpatients of a hospital, nursing home or assisted care living facility, or for inpatients or residents of a mental health hospital or residential facility.14 • http://michie.lexisnexis.com/tennessee/lpext.dll/tncode/1d5dc/1d974/1d9b6/1d9cb?f=templates&fn=do cument-frame.htm&2.0#JD_53-10-203 Texas .A pharmacist may substitute A-rated products and use his judgment on unrated products Washington The pharmacist shall not dispense any product that in his/her professional opinion does not .meet adequate standards Pharmacists may utilize the following as the basis for their decisions on therapeutically • equivalent drug products: available drug product information from federal and state agencies, official compendia, and drug manufacturers, or other scientific or professional resources, or the Orange Book as a board approved reference for a positive formulary of therapeutically .equivalent products within the limitations stipulated in that publication Refer to WAC 246-899-030 Product Selection Responsibilities for requirements for generic • substitution. http://apps.leg.wa.gov/WAC/default.aspx?cite=246-899-030 Refer to RCW 69.41.190 Preferred drug substation-Exceptions-Notice for requirements for • generic substitution for state purchases health care plans. http://apps.leg.wa.gov/RCW/default.aspx?cite=69.41.190 Refer to RCW 69.41.120 on Prescription to contain instruction as to whether or not a • therapeutically equivalent generic drug may be substituted. http://apps.leg.wa.gov/RCW/default.aspx?cite=69.41.120 ثانيا –النظام األوروبي Greece 2012-2-20 اليونان تقر مشروعا يلزم األطباء بكتابة الدواء باالسم العلمي Prescription by INN Returns to Top of Agenda The Greek Ministry of Health (MoH) has published a new draft law on various issues relating to the country's National Healthcare System, with particular reference to the provision of medicines. The full draft law can be accessed, in Greek, here. Within this new draft law, there are some major changes planned, which have already started to cause consternation and elicit strong opposition from the medical community in Greece. Among the main regulations set down in the new draft law are the following: Doctors prescribing for patients insured under the EOPYY and the Social Security Institute (F??) are obliged to use the international non-proprietary name (INN) of a drug, and not the brand name. Pharmacists dispensing these prescriptions on behalf of those insured under the EOPYY or F?? are obliged to dispense the cheapest product that has the INN written on the prescription in the specified dosage and formulation. The electronic recording of all prescription drugs dispensed in pharmacies becomes mandatory, whether the prescriptions are handwritten or electronically written. Greece's National Organisation for Medicines has a list of active substances that doctors must use on prescriptions, as well as therapeutic categories. http://www.ihs.com/products/global-insight/industry-economic-report.aspx?id=1065932338 بلجيكا The legislation provides the opportunity for doctors and dentists to prescribe medicines in INN. They can therefore ignore the different names and packages of medicines containing the same active ingredient, the same dose and same route of administration. In this matter pharmacists give advice about rational use of medicines, price comparison and choice of appropriate packaging. To help them in their mission, the Federal Agency for Medicines and Health Products (FAMHP) wrote a note to set in operation the "INN prescription” law. A file containing the different INN groups, provisionally in pdf format, is available on the website of the Belgian Centre for Pharmacotherapeutic Information (BCPI). An easily searchable database will be shortly developed by the BCPI. http://www.fagg-afmps.be/en/items-HOME/INN_precsription دولة اوروبيه26 جدول وصفي لكتابة وصرف الدواء في Country INN prescribing Generics Substitution Country Austria No - No - Luthuania Belgium Yes Indicative No - Cyprus Czech Repubilc Yes Indicative Yes Indicative Latvia Yes Indicative Yes Indicative Denmark No - Yes Generics Substitution INN prescribing Yes obligatory Yes Indicative Luxembourg Yes Indicative No - Yes Indicative Yes Indicative Malta Yes Indicative Yes Obligatory Obligatory Netherland Yes Indicative Yes Indicative Yes Indicative Yes Indicative Estonia Yes Obligatory Yes Indicative Poland Finland Yes Indicative Yes Obligatory Portugal Yes Obligatory Yes Indicative France Yes Indicative Yes Indicative Romania Yes Obligatory Yes Indicative Germany Yes Indicative Yes Obligatory Spain Yes Indicative Yes Indicative Greece No Indicative No - Sweden No Indicative Yes Obligatory Hungary Yes Indicative Yes Indicative Slovakia Yes Indicative Yes Obligatory Ireland Yes Indicative No - Slovenia Yes Indicative Yes Indicative Italy Yes Indicative Yes Indicative UK Yes Indicative No - مصدر هذا الجدول http://www.gabionline.net/Reports/Survey-on-rational-use-of-medicines-in-27-EU-Members-States قراءة في الجدول السابق ) يعني أن الطبيب يصف الدواء باالسم العلمي(العالميINN prescribing مصطلح يعني أن الصيدلي يتاح لها حرية استبدال اسم تجاري باخر دون الحاجة للرجوع الي الطبيبGenerics Substitution مصطلح تقريبا كل دول أوروبا تمنح الصيدلي صالحية اختيار الدواء المثيل من أي شركة وتختلف طريقة تفعيل هذه الصالحية من دولة الخري نجد مثال في الغالبية العظمي من دول االتحاد األوروبي ان األطباء اعتادوا عرفا او إلزاما علي كتابة التذكرة باألسماء العلمية بينما في السويد والدنمارك فان الطبيب ال يكتب الوصفة الطبية باالسم العلمي إال ان الصيدلي يستطيع بشكل إلزامي للطبيب أن يصرف الدواء المثيل ولكل ما تقدم فان صيادلة مصر مصرون ان يتحرروا ن هذا النظام الشاذ لتداول الدواء وان ينتقلوا الي تداوله باالسم العلمي