FEDERAL REGULATION OF MEDICATION

you can disclose patient information if required by law or Medwatch to do so without violating HIPAA policy

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EPINEPRIN

COMBINATION PRODUCT (A DRUG OR A DEVICE) IN THIS CASE IT is considered a drug because it primary mechanism of action is a drug

how many phases are in the clinical trials?

4 phases not including the preclinicals

LABEL

A display of written, printed, or graphic matter upon immediate container of any article; and a requirement made by or under authority of the FDCA that any work, statement, or other information appearing on the label shall not be considered to be complies with unless such word, statement, or other information also appears on the outside container or wrapper, of any there be, of the retail package of such article, or is easily legible through the outside container or wrapper ANYTHING WRITTEN STICKER ON THE OUTSIDE OF THE BOTTLE

HYPO

A product claimed by a manufacturer to prevent pregnancy may not be a drug under B, since pregnancy is not a disease, however, under C it may be a drug because preventing a pregnancy means that the product INTENDS TO AFFECT THE FUNCTION OF THE BODY for it to be a drug it has to affect a DISEASE OR the FUNCTION OF THE BODY and make THERAPEUTIC CLAIMS see other hypo SLIDES

TWO MAJOR OFFENSES UNDER FDCA

ADULTERATION MISBRANDING VIOLATION ARE STRICT LIABILITY IN NATURE WHOLE SALERS HAS TO BE REGISTERED UNDER "Prescription Drug Market Act of 1967"

NON ACCOMPANYING is considered?

ADVERTISING

DRUG

ARTICLES RECOGNIZED IN THE US PHARMACOPEIA, official Homeopathic Pharmacopeia of the US, or official National Formulary, or any supplement to any of them

DRUG

BROAD MEANING addresses products intended for use with DISEASE recognized that even products not intended for used with diseases may still be drugs if they make a structure or function claim

PREGNANCY WARNING

CATEGORY: A- SAFE, ONLY A HANDFUL OF DRUGS, safe for the 1st trimester B- most of the drugs C D X- birth defect, FATAL RISK

TAMPERING

DEFINED IN THE ACT AS improper interference with the product for the purpose of making objectionable or unauthorized changes

PHASE III

Drug is tested for both safety and efficacy in hundreds or even thousands of patients clinical setting usually the study is double blinded(don't know anything) and compared with control group AFTER THIS PHASE THE NDA IS SUBMITTED TO FDA to see real life side effects and decides whether or not to approve the drug

MISBRANDING

RIGHT DRUG WITH A WRONG NDC

manufacture recall notices

IT CAN BE A LETTER, TELEGRAM, TELEPHONED, OR NOTIFIED BY SALES REPRESENTATIVE

IND APPLICATION

Its purpose is to protect the safety of the humans who will participate in the clinical trials and to ensure that the clinical studies are designed properly to prevent problems during the NDA REVIEW

ACCOMPaNYING is considered?

LABELING EXAMPLES ARE PACKAGE INSERTS

INFORMED CONSENT

MANDATED BY THE KEFAUVER HARRIS AMENDMENT FDA requires investigators to obtain the informed consent of the study subject or a representative for the administration of an experimental drug informs the subject about the risks, benefits and alternative treatments IRB approval of the study

what are the three procedural categories of SUPPLEMENTAL NEW DRUG APPLICATION??

PRODUCTION LABELING CHANGES MINOR CHANGES

PRESCRPTION DRUG ADVERTISING: MANUFACTURER TO PROFESSIONALS

TRUE STATEMENT AND BRIEF SUMMARY REQUIREMENTS REMINDER ADVERTISING ADVERTISING V. LABELING ADEQUATE PROVISION REQUIREMENT FOR BROADCAST MEDIA

HYPO

UNDER THE FDCA, A PHARMACIST WHO UNKNOWINGLY AND INNOCENTLY RECEIVES AN ADULTERATED OR MISBRANDED DRUG AND SUBSEQUENTLY SELLS IT TO A CONSUMER HAS VIOLATED THE FDCA

can an APPROVED DRUG BE A NEW DRUG?

YES IF: The drug contains a new substance, active ingredients, excipeint, carrier or coating there is a new combination of approved drugs the proportion of ingredients in combination is changed a new intended use for the drug the dosage, method or duration of administration or application is changed any changes in the drug that's already in the market

can a Pharmacy be deemed by a manufacturer??

YES, If a manufacturer repackages or compounds medications for sale under certain conditions drugs is adulterated if it contains an unsafe color additive, or if its strength, quality or purity differs from standards unless stated on the label

can a drug be adulterated under FDCA even though is is pure??

YES, when it is prepared, packed, or held in conditions where it may have been contaminated exposed to container that may have contaminated it or manufactured under conditions that do not conform the Current Good Manufacturing Practice (CGMP)

WHAT IS A DRUG?

a drug is defined as intended use such as THERAPEUTIC CLAIMS and structure/function claims and it has to have evidence of intended use

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a drug marketed BEFORE 1938 exempt from proving either safety or efficacy provided that it is marketed in accordance with the labeling requirements as then existed

NEW DRUG

a drug that is not generally recognized by qualified experts as safe and effective for use under the conditions recommended in the drug's labeling

COUNTERFEIT DRUGS

a drug which, or the container or labeling of which without authorization, bears the trademark, trade name, or other identifying mark, imprint , or device, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactures, processed, packed or distributed such drug and which thereby falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer processor, packer or distributor

SUPPLEMENTAL NEW DRUG APPLICATIONS

after the approval of an NDA, a manufacturer may not make any changes in teh drug or it production

LABELING

all labels and other written, printed, or graphic matter, plus package drug insert upon any article or any of its containers or wrapper, or accompanying such article PACKAGE INSERTS AND THE DRUG, INFORMATION ACCOMPANYING THE DRUG IS LABELING ACCOMPNYING IS CONSIDERED LABELING NON ACCOMPANYING IS CONSIDERED ADVERTISING

DRUG

articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals

DRUG

articles intended to affect the structure or any function of the body of man or other animals or articles intended for use as a component of any articles specified above

COSMETIC

articles intended to be rubbed, poured, sprinkles, or sprayed on, introduced into or otherwise applies to the human body or any part thereof for cleansing beautifying, promoting attractiveness, or altering the appearance and article intended for use as a component of any such articles

MEDICAL DEVICES

criteria for classification into each of the three classes CLASS I--> pose the least potential harm CLASSII--> insuffecient to ensure safety and effectiveness CLASS III-->devices must have premarket approval because they are life supporting or life sustaining or they present a potential unreasonable risk of illness or injury reporting obligations of manufacturers, device-user facilities and distributors FDA authority require prescription: contact lenses, diaphragms FDAMA has removed the requirement that distributors must submit adverse event report to DEA however they sill have to maintaing records of adverse events

Tampering Resistant Package

defined as one having an indicator or barrier to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred

labeling of drugs must include:

drug indication side effects dosages routes methods frequency duration of administration contraindication other warnings

PRODUCT TAMPERING

federal offense to tamper with consumer products it requires certain OTC drugs, cosmetics, and devices be manufactured with tamper resistant packaging violation may result in misbranding and adulterated or BOTH

BLOCKBOX WARNING

notifying the product as suicidal and antidepressants risk benefit analysis the doctor needs to know may lead to death or serious injury notifies the doctor

PHASE 1

involves a small number of subjects investigators examine the drug toxicity, metabolism, bioavailability, elimination and other phamacological actions purpose is to detect ADVERSE EFFECTS, NOT EFFICACY

SOAP

is an EXCEMPTION, it is not a cosmetic BUT IF IT CONTAINS bENZYL PEROXIDE THEN It is considered as a DRUG

Device

is an instrument, apparatus, implement, machine, contrivance, mplant, vitro reagent, or other similar or related articles, including any component, part, or accessory, which is: recognized in the official National Formulary, or the US Pharmacopoeia, or any supplement to them intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment of prevention of disease in man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes

ADULTERATED DRUGS

it deals with a drug's strength, purity, and quality a drug maybe adulterated under FDCA even though it is pure

Product Recalls

it has three classes CLASS I CLASS II CLASS III

MEDWATCH

it not only provides reporting but also wealth and safety information on products accessible from its web this is VOLUNTARY NOT MANDATORY REPORT TO THE FDA for adverse events to report side effects or errors occured

NEW DRUG APPROVAL

no new drug can be LEGALLY MARKETED in interstate commerce unless it has been approved by the FDA FDA required drug manufacturers to apply for and receive FDA approval of a New Drug Application (NDA) it can be expensive and length process OBRA 90--> PATIENT COUNSEL

SECTION 505(A) OF FDCA

no person shall introduce into interstate commerce any new drug unless an application has been approved by the FDA interstate commerce is "trade between two states"

PHASE IV

postmarketing surveillance activities ( to see real life side effects) FDA required manufacturers to conduct clinical studies after the drug is approved the FDA may terminate testing of an IND at any time if studies show that the drug is too toxic under the agency's benefit/ risk ratio

CLASS III

recalls apply to products that are not likely to cause adverse health consequences

CLASS I

recalls are issued when there is a reasonable probability that the product will cause serious adverse health consequence or death

CLASS II

recalls occur when the product may cause temporary or medically reversible health consequence, but the probability of serious adverse consequences is remote

1938 FDCA

required drugs to be proved to be safe before the FDA granted marketing approval 1962 KEFAUVER HARRIS AMMENDMENT to FDCA required that drugs be proved not only safe but also effective

LABELING changes IN SUPPLEMENTAL NDA

strength warnings or dosage and administration, information, or for certain changes in manufacturing methods, facilities and controls, a change being effected supplement may be allowed allows manufacturer to implement the change before FDA approves it

MINOR CHANGES IN SUPPLEMENTAL NDA

such as editorial changes in the labeling or changes in container size

PRODUCTION CHANGE IN SUPPLEMENTAL NDA

synthesis of drug, manufacturing process of the drug most labeling a prior approval, supplement is required FDA must approve the change before the manufacturer can implement it

examples of DEVICES

tanning bed microwave band aid body scanner (aiport) scissors gloves injection see the slide

PHASE II

tested limited no. of patients who actually have the disease for which the drug is an intended treatment purpose is to determine EFFICACY of the drug and the dosages at which efficacy occurs pharmacological testing to determine the drug's safety

MISBRANDING

the LABELING SHALL: NOT BE FALSE OR MISLEADING provide established names of drugs listing of any active ingredient for both prescription and OTC drugs adequate directions for use direction under which a layperson can use a drug safely and for the purposes for which it is intended adequate information for use not be an imitation drug focused on the representation made by the manufacturer on the label or labeling THIS APPLIES TO BOTH MANUFACTURERS AND PHARMACIES

What happens when there is a PRODUCT RECALL?

the manufacturer is responsible for notifying the sellers of the recall the sellers are responsible for contracting the consumers pharmacist is responsible for knowing which drug products have been recalled

Adequate directions of use LABELING OF DRUGS MUST INCLUDE

the quantity of dosage for each intended use and for persons of different ages and physical conditions the frequency of administration or application the duration of administration or application the time of administration or application route or method of administration or application the preparation necessary for use (shaking)