Legal and Regulatory Issues in Self-Care Practice

Legal and Regulatory Issues in Self-Care PracticeAnthony Pattin, PharmDAssistant Professor-ClinicalWayne State UniversityPHA 4010ObjectivesDiscuss the evolution and general effect of legislation that impacted the approval process and use of prescription drugs, OTC drugs, and dietary supplements in the United StatesUnderstand the drug approval process of nonprescription drugsDescribe the difference between the labeling requirements of prescription drugs, nonprescription drugs, and dietary supplementsDiscuss the components of the Drug Facts label and Supplement Facts labelUnderstand the meaning of a GRAS/E drugObjectivesGenerally describe the purpose of the OTC drug review processKnow what an OTC monograph is and what it representsUnderstand which governmental agency regulates the advertisement of nonprescription medications and dietary supplementsDiscuss what was accomplished by the DSHEA legislationKnow any specific labeling requirement mandated by DSHEAObjectives

http://www.en.berlin-chemie.lt/Company/Manufacturing

http://indiebusinessblog.typepad.com/indie_business/2007/07/cosmetics-label.html

http://blog.clickkingdom.com/2012/07/17/permission-based-marketing-vs-interruption-based-marketing/http://www.articles2day.org/2012/05/business-distribution-overview.htmlObjectives are to discuss the laws and regulations surrounding the manufacturing, labeling, distribution, and marketing of nonprescription (nonRX) medications. Also, talk about the difference between nonprescription medications and prescriptions medications. Within nonprescription meds we will briefly discuss supplements4Historical Development of OTC Regulation

http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM148055.pdfTime line of all the regulations we will discuss.5Pure Food and Drugs Act 1906

http://www.fda.gov/AboutFDA/WhatWeDo/History/ThisWeek/ucm117785.htmhttp://en.wikipedia.org/wiki/ToxicityKey- Manufacturers only had to show strength, quality and purity- these medications could still be unsafe and nonefficacious.6Federal Food, Drug, and Cosmetic Act (FDC) of 1938

http://www.sunstatessecurity.com/Our-Company/News.aspx?id=43Mandated safety7Durham-Humphrey Amendment to FDC 1951VS

http://www.uptowndrugs.com/pharmacy/otc.htmlhttp://whatyoudomatters.org/Substance_Abuse/Substance_Abuse/Prescription_Drugs.aspx1.Before this time manufactures were free to determine which category their drug product belonged2. Drugs that could be used safely without medical supervision and had labeling that included adequate directions for use could be marketed without a prescription3. Established two classes of drugs: prescription-only (Rx), nonprescription (nonRx, OTC- over-the-counter medication)

8kEfauver-Harris Amendment to FDC 1962AND

http://www.thephysiocompany.com/our-physiotherapy-services/massage/effective-massagehttp://www.sunstatessecurity.com/Our-Company/News.aspx?id=43All new drugs had to be safe and effective.As a result of this amendment the FDA undertook review of thousands of new drug products (including OTC drugs) that had been approved for only safety since 1938Products marketed before 1938 were exempted from the NDA requirement under a grandfather clause

9How are OTC Drugs ApprovedNDA

OTC Monographhttp://thedaily23.blogspot.com/2010/03/5-divination-methods-you-can-learn.htmlDrug Approval ProcessNDA

http://www.bizjournals.com/triangle/news/2012/05/29/tranzyme-puts-stop-to-gastro-drug-nda.html1. New chemical entities never before marked in the US would be classified as new drug, and in most cases, would be approved for prescription use only- persons, entities would use a new drug application to be able to sale and market the product. A manufacturer can also use this as a way to introduce a nonprescription medication product.

11Goals of a NDA

http://www.nanotech-now.com/news.cgi?story_id=37543The goals of a NDA are to provide the FDA with enough information to determine if the drug is a) safe and effective for its proposed use; b) the benefit of the drug outweigh the risks c) the methods used in manufacturing are adequate to preserve the identity, strength, quality, and purity. After some time and expiration of the original companys patent a second manufacturer can make the product (this is how generic medications are approved). Those manufactures file a ANDA (abbreviated new drug application)- this eliminates duplicate testing. The second and subsequent manufacturer must prove bioequivalence to the original product. 12Drug Approval ProcessSwitch from Rx to nonprescription status

http://www.deaneanderson.com/how-to-beat-the-pants-off-your-competition/25-years-in-business1.After so much time- Rx drug can be switched to nonRx drug if safety is established. It is established as Generally Recognized as Safe and Effective GRAS/E.2. They may even consider safety and efficacy data from countries outside of the US in consideration of moving the medication from Rx to nonprescription statusRecent medications include Miralax13OTC monographGRAS/E

FDA approvalhttp://photobucket.com/images/NO+Sign+Red+slash/The OTC monograph developed for therapeutic classes of ingredients that are considered Generally regarded as safe and effective.2. A manufacturer that desires to make a product with an OTC monograph ingredient, do not have to apply to the FDA using a NDA/ or ANDA.3. Under the monograph, all safety and efficacy data of the ingredient and its nonprescription status are made publicly available.14OTC Monograph

http://www.drugsdb.eu/otc_drug.php?d=Antacid&m=The%20Kroger%20Co.&id=7b4d189d-89e6-4b18-980d-afa1b0655f90.xml

1. All the required labeling must be included on the label- for example, antacids must contain terms such as heartburn, indigestion, or sour stomach2. Monographs primarily address the active ingredient- manufactures can use whatever inactive ingredients they want, as long as they are proven safe. (Can you understand why there are many OTC products on the market that have the same ingredients in them?) Companies can pick and choose active ingredients from the monograph.

15

Labeling Issues1.Remember, OTC drugs are defined as drugs that are safe and effective for use by the general public without seeking treatment by a health professional. Due to that, it is important that they are labeled appropriately and provide adequate information for general use.

2.There is more concern because many drugs are switching from Rx to nonRx status which requires more sophisticated self-diagnostic, and self-monitoring evaluations.

3. Recognizing these concerns the FDA now requires a standardized format for the Drug Facts label (and a label such as on this slide is required on all products or it is considered misbranded

4. The label has easily understandable terms such as uses, instead of indication.- Also should be easy to read by persons > 65 (minimum typesetting)

5. You should be familiar with a Drug Facts label and what it contains.16Expiration Date labeling

http://www.1201tuesday.com/1201_tuesday/expiration-dates/

http://thriftywifey.com/smart-shopping/shopping-tools-and-downloads/expiration-sell-by-date-facts/Most nonprescription drug products require an expiration date on the label.If you use the product beyond this date potency, stability, and integrity of the product cannot be guaranteed. NonRx drug products that do not have a dosage limit and are stable for at least 3 years do not require a exp date on the labelSafety issues rarely arise from using a product that is slightly past the exp date, but the product may have reduced efficacy and the product should be discarded17

Drug Reclassification: Prescriptions-to-OTC- Switch

The drug is switched through the non prescription review process non government experts review drugs on the market before 1962, determine if appropriate for OTC status. Ongoing process, since 1970s - forty reclassifications have occurred

18

Drug Reclassification: Prescriptions-to-OTC- SwitchSupplemental NDA

The manufacturer requests the switch by submitting a supplemental application to its approved NDA over 700 OTC drugs on the market went through this process. Examples include analgesics, antihistamines, and antifungals

19

Drug Reclassification: Prescriptions-to-OTC- SwitchThird party payers petition FDA

A company, usually the manufacturer can petition the FDA to switch a drug or class of drugs to nonRX status. Recently third party-payers have advocated for this switch. The key is that the switch would not cause harm to the public. Recent examples have been the switch of some antihistamines such as Allegra , Claritin , and Zyrtec . 20

Drug Reclassification: Prescriptions-to-OTC- SwitchWhy?

This saves consumers millions of dollars in health care costs. It reduces physician visit, preventing unnecessary days off work, and decrease costs associated with advancement of a disease that is limited by nonRx medications.

Although these medications are readily available over the counter after the switch, many third party payers discontinue coverage for these medications.21Other classes of MedicationBehind-the-counter drugsSudafedPlan BSchedule V products Marketing Issues

Product line extensions can be new strengths, formulations, combinations of ingredients, and even a totally different therapeutic entityCan create consumer confusion and inappropriate drug selectionManufacturers hoping to capitalize on brand loyalty

Must pay attention to brand name, boil ease- doesnt have active ingredient, but they advertise as boil ease (mostly just petroleum jelly)23Dietary Supplements

http://dangerouslee.biz/2012/05/18/would-you-consume-baby-flesh-to-increase-stamina/

http://images.yourdictionary.com/ingest

http://healthblog.ivlproducts.com/blog/liquid-health-vitamins

Burden shifted to FDA to prove if UNSAFEhttp://topnews.net.nz/category/companies/fda

Dietary Supplements

http://www.shopping.com/Eas-Eas-100-Whey-Protein-Dietary-Supplement-Chocolate-2-Lbs/info

Regulated under the federal Dietary Supplement Health and Education Act of 1994 (DSHEA)Provides formal definition of a dietary supplementIs a product (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredientsA vitamin, mineral, amino acid, an herb or botanical, a concentrate, metabolite, extract or combination of the products mentioned, or a substance for the use to supplement the diet by increasing the total daily intake

25

Dietary Supplements:Good Manufacturing Practicehttp://www.americaneliquidstore.com/pages/certifications/iso-9001-2008-gmp.htmlhttp://www.medipro.com.my/about6.htmlIn 2007 the FDA issued a final rule on proposed changes to GMP standards for DS (dietary supplements). Standards mandated products be free of adulterants or impurities and must be labeled accurately. The hope was to set limits on the amount of metals, bacteria, and pesticides that are sometime found in dietary supplements.26Dietary Supplements: LabelingRegulated by

http://greenpiece1.wordpress.com/2010/12/21/the-ftc%E2%80%99s-green-guides-and-the-future-of-eco-logos/Federal Trade Commission (FTC) regulates advertising claims made in print or broadcastFDA regulates claims found on packaging, package labels, inserts, and other promotional materialsAll labels must list: 1) the name of the product as well as the word supplement 2) the net quantity of contents3) the manufacturers, packers, distributors address4) Directions for use

27

Dietary Supplement: LabelingNot allowed to claim: diagnose, cure, mitigate, treat, or prevent diseaseProduct considered misbranded if:Do not follow label requirementsDo not list the name or place of business of manufacturerFail to list accurate statement regarding quantity of the contentshttp://www.clker.com/clipart-no-sign-x.htmlDS are not allowed to make __________ that their product will diagnose, cure, mitigate, treat, or prevent diseaseDS are considered misbranded ifDo not follow __________ requirementsDo not list name or place of business of manufacturerFail to list accurate statements regarding __________ of the contents

29Dietary Supplement: LabelingHealth Claim- describes the relationship between a food, food component, or DS ingredient, and the resulting reduction in risk of disease or health-related problem (about decrease risk of disease)Examples___________________________________________________________________________________________________________________________________________________________________________________________Dietary Supplement: LabelingStructure Function claims- describes how a product may maintain normal healthy structure or function of the body without discussing a specific diseaseExamples____________________________________________________________________________________________Dietary Supplement: LabelingNutrient Claim- describe the amount of a nutrient or dietary supplement in a product

Example______________________________________________________________________________

ReferencesBernstein IB, Rickert ED. Legal and regulatory issues in self-care pharmacy practice. In: Berardi RR, Ferreri SP, Hume AL, Kroon LA, Newton GD, Popovich NG, et al, eds. Handbook of Nonprescription Drugs. 16th ed. Washington DC: American Pharmacists Association; 2009Dietary supplements. US Food and Drug Administration. Web site http://www.fda.gov/food/dietarysupplements/default.htm. Accessed August 8, 2012