قراءة في النظام الاميريكي لصرف الدواء
Generics Substitution
مصطلح Generics Substitution هو مصطلح عالمي يعني السماح للصيدلي بصرف الدواء المثيل دون الرجوع إلي الطبيب أو المريض
والسبب المباشر في إعطاء هذه الصلاحية للصيدلي هو ان هذا الإجراء يحقق توفير المال للمريض الأمريكي ويحقق مرونة في مزاولة مهنة الصيدلة للصيدلي الأمريكي
وتتفاوت حدود هذا الإجراء من ولاية إلي أخري وتتسع مساحة حرية الصيدلي من مكان لأخر في الولايات المتحدة الأمريكية حيث تبدأ من إعطاء كامل الحرية للصيدلي بصرف الدواء المثيل في معظم الولايات تحت أي ظرف من الظروف إلي وضع بعض الحدود في ولايات أخري
ومن أمثلة الحدود الموضوعة في بعض الولايات الأمريكية (الاستثناءات) كالأتي
1-يمكن للطبيب أن يطلب من الصيدلي صرف دواء الشركة الأم Brand Drugs أما ما عدا هذا فلا يحق للطبيب رفض مستحضر أي شركة طالما أن الدواء المطلوب ليس من الشركة الأم
2-تستثني قوانين بعض الولايات الأدوية ذات narrow therapeutic range مثل مادة الديجوكسين ومادة المورفين
3-بعض الأدوية التي تستخدم عن طريق الاستنشاق بطريقة Metered Dose حيث تختلف قياسات كل جهاز عن آخر عند استخدامه
4-أدوية الصرع وهذا الاستثناء غير شائع في معظم الولايات إلا انه موجود في بعضها وتم ذكره من قبيل الأمانة العلمية
5- بعض الولايات تلزم الصيدلي بالتبديل الجبري للدواء إذا كان الطبيب قد كتبه باسم تجاري وله مثائل أرخص
ويسمح للصيدلي بالخروج عن هذه الاستثناءات وصرف الأدوية المثيلة إذا طلب منه المريض أن يعطيه الدواء ذو السعر الأقل وان دل هذا علي شيء فهو يدل علي انعدام قيمة هذه الاستثناءات وإمكانية الاستغناء عنها إذا اقتضت الحاجة لذلك
والسؤال هنا لماذا تختلف الولايات في أنظمتها لصرف الدواء؟
القوانين توضع لعلاج مشاكل واقعة وبناءا علي اختلاف نوعية المشاكل من ولاية لأخرى تختلف النظم والقوانين فيها ونحن في مصر يجب أن نتخذ من اختلاق قوانين صرف الدواء في الولايات الأمريكية مدخلا لصناعة نظام خاص بمصر يساعد علي حل مشاكلها الدوائية كما تقوم كل دولة بل كل ولاية بوضع النظام الذي يخدم مصالحها ويساهم في الحد من مشاكلها
ملحوظة مهمة جدا
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مصطلح (الدواء بالاسم العلمي) هو وسيلة لتحقيق مصطلح متعارف عليه دوليا وهو (Generics Substitution) بمعني ان وسيلتنا لتحقيق مبدأ (Generics Substitution) هو أن نتخلى عن الاسم التجاري سواء في الروشته أو علي غلاف الدواء أو كلاهما معا
وإذا كانت بعض الدول لا تلزم الشركات أو الأطباء بالاسم العلمي فهذا لان مبدأ (Generics Substitution) يتم تحقيقه بدون اللجوء إلي ضرورة استخدام الاسم العلمي حيث أن ثقافة المريض والطبيب تسمح هناك بذلك
أما في مصر ومع سنوات من قدسية الاسم التجاري لدي المريض والطبيب فان مبدأ (Generics Substitution) لا يمكن ابدأ تحقيقه إلا إذا تخلينا ولو لفترة انتقاليه عن الاسم التجاري وذلك بكتابة الدواء بالاسم العلمي
وكما ذكرنا فان لكل دولة وكل ولاية نظامها الخاص في تحقيق مبدأ (Generics Substitution)فإننا يحق لنا أن نخلق ما يناسب ثقافتنا ويضمن تحقيق مبدأ (Generics Substitution)
هذه النصوص مصدرها مواقع رسمية للولايات الأمريكية 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=Display_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
Oklahoma • 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
Oregon • “Therapeutically equivalent” means drugs that are approved by the FDA for 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=document-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
مجهود ضخم تلك التجميعه من كل تلك الولايات ….و تكمله للحديث اما في مصر فالصيدلي هيطلع عين امه لو طلع حاجه خلاف المكتوب وهذا تحزير هام جدا ونشكر حسن تعاونكم