‫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