PowerPoint to accompany Chapter 8 Part 2 Molecular Geometry and Bonding Theories.
Chapter 4 PowerPoint, Part 1
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Transcript of Chapter 4 PowerPoint, Part 1
Delivering and Dispensing Drugs
Food and Drug Regulation in the US
“And pursue with eagerness the fortunes of hope”
1905
Pure Food and Drug Act of 1906 (Wiley Law) Promotes accurate labeling and
purity of food and drugs Defines two bases for seizing a
product Adulteration Misbranding
Ruth de Forest Lamb: An American Chamber of Horrors
1937107 deaths. Could only be seized because it was labeled as an “elixir” but contained no alcohol.
Food, Drug and Cosmetic Act of 1938 Requires proof of safety prior to
marketing Requires pre-marketing approval by FDA Creates “new drugs” – those marketed
after 1938 Retains ability to seize drugs that are
Misbranded Adulterated
Carl Durham, R.Ph. Hubert Humphrey, R.Ph.
Caution: Federal law prohibits dispensing without prescription.
Phocomelia
Europe's deformed baby crop seen at 7,000
Sleeping pill deforms unborn child
Deformity drug's toll not final
Kefauver-Harris Amendments Improved informed consent for clinical
trials Established GMPs Teratology testing in animals Required proof of efficacy prior to
marketing DESI studies
FDA to control advertising of legend drugs
New Drugs
Drugs may not be introduced into commerce unless Proven safe and effective for intended
use Adequate labeling Meet current Good Manufacturing
Practices Produced by a registered
manufacturer
New Drug Development Process
Pre-clinical Testing• In vitro and in vivo animal testing
File IND (Investigational New Drug) Clinical Trials
• Phase I: healthy volunteers • Phase II: limited trials in patients with disease• Phase III: large-scale clinical trials
• Randomized• Double blind• Placebo-controlled
File NDA (New Drug Application)• Phase IV: post-marketing trials
Supplemental NDAs Prior approval supplement
Change in production or labeling Change being effected
Labeling changes that strengthen warnings
Limited changes to production Annual report
Minor changes
Abbreviated NDAs Used for generic drugs Demonstrate bioavailability and
bioequivalence May have different labeling than
innovator’s drug Doesn’t preclude dispensing for uses
not contained in the generic insert
FDA Ratings of New Drugs Chemical type
1. NCE2. New salt or ester3. New formulation4. New combination5. Duplicate of
another product6. Previously
marketed by same firm
Therapeutic PotentialP - Therapeutic
advance• No other effective
drugs• More effective or
safe• Other important
advantages
S - Similar to other drugs on market
FDA Jurisdiction Foods
Articles used for food or drink for man or other animals
Chewing gum Articles used for components of any
such article
FDA Jurisdiction Cosmetics
Applied to body Intended for cleansing, beautifying,
promoting attractiveness, altering appearance
Dalkon Shield 25 years of
litigation $2.6 billion
settlement trust
Demise of A.H.Robins Co.
FDA Jurisdiction Devices
Intended for diagnosis of disease or other conditions, or for cure, mitigation, treatment, or prevention of disease in man or animals.
Does not achieve its effect by chemical action or by being metabolized
FDA Jurisdiction
Drugs Listed in USP, NF, or HP Intended for diagnosis, cure, mitigation,
treatment, or prevention of disease in man or other animals
Articles (other than food) intended to affect the structure or function of body of man or animals
Intended to be used as component of the above
Adulterated Fails to conform to compendial
standards for purity, quality, strength, and appropriate assays
Failed to be stored under USP standards
Misbranded Incomplete labeling Misleading labeling
7-point OTC Label Name of Product Name and address
of manufacturer, packager, distributor
Net contents Active ingredients
and quantity of certain other ingredients
Name of any habit forming drug
Cautions and warnings
Adequate directions for use
Poison Prevention Packaging Act Requires child-resistant containers (CRCs)
on certain “household substances” Requires CRCs on all prescription drugs,
except for certain listed products Requires CRCs on specifically listed OTC
products Authorizes Consumer Products Safety
Commission to set standards for child-resistant packaging, or “special packaging” as its called in the Act
OTCs Requiring CRCs Aspirin, Acetaminophen NSAIDs Iron preparations >
250 mg elemental iron/pkg
Diphenhydramine > 66 mg/pkg
Lidocaine, Dibucaine
Minoxidil Methyl salicylate Ethylene glycol Methyl alcohol Hydrocarbons and
solvents NaOH, KOH
Tylenol in ChicagoExcedrin & Sudafed in WA
Tamper-resistant Packaging(Federal Anti-Tampering Act)
Indicator or barrier to entry If breached or missing provides visible
evidence of tampering Label statement describing barrier or
indicator Required for certain OTCs, devices, and
cosmetics Dentifrices, dermatologicals, lozenges,
and insulin are excluded
Dietary Supplement Health and Education Act New law - 1994 Allows certain claims to be made for
dietary supplements without violating FDCA
Dietary Supplements
Vitamin Mineral Herb or other botanical Amino acid
Dietary Supplements Substance to supplement diet by
increasing total dietary intake Concentrate, extract, metabolite,
constituent or combination of above
Dietary Supplements
Intended for ingestion Not represented for use as a
conventional food or sole item of a meal or diet
Labeled as a dietary supplement Deemed to be a food
Dietary Supplement Health and Education Act Pharmacists must use care in
making claims not otherwise allowed under this law
Labeling accompanying the product makes claims
Permitted Labeling under DSHEA
Label can claim benefit related to a classic nutritional
deficiency disease describe role of a nutrient intended to affect
structure or function of body characterize the mechanism of action describe general well-being gained from
consuming a nutrient Must state FDA has not evaluated claims
References and Nutrition Books
Articles, books, abstracts of peer-reviewed scientific publications may be sold or displayed Must be reprinted in their entirety Must be presented with other publications
to provide a balanced view Must be physically separate from product No information applied by sticker, etc.
Advertising and Labeling
May not make false, misleading, or unapproved claims for a product when you are the seller of the product
Specific assertions to purchasers may create warranties of fitness for a particular use
Information Required on Label of Legend Drug (Federal Law) the name and address of the dispenser the serial number date of the prescription or of its filling the name of the prescriber if stated in the prescription, the name of
the patient the directions for use and cautionary
statements, if any, contained in such prescription
21 USC 353 (b)(2)
Package Insert Warnings
CONTRAINDICATIONS
ADVERSE REACTIONS, PRECAUTIONS,WARNINGS
INDICATIONS
Patient Package Inserts Oral Contraceptives
Must supply both “brief” insert and complete insert with each dispensing
Must supply when requested On admission and q 30 d in hospital
Estrogen/Progestin Insert Same as for OCs
Other inserts/information should not be removed or covered over.
Patient may request professional package insert and is okay to give.
Unlabeled indications for approved drugs Labeling restricts manufacturers’ claims,
not prescribers’ use Labeling that CONTRAINDICATES a
particular use provides evidence that a pharmacist should not dispense the drug for that use or in that situation
It is permissible to dispense a generic for a use that is only in the labeling of the brand name drug
Information Required on Label of Legend Drug (WA) Complete directions for use (“UD” not valid) Expiration date Quantity dispensed Name and strength of drug Initials of pharmacist (can be in computer
system) “Warning: State or federal law prohibits
transfer of this medication to any person other than the person for whom it is prescribed.”
Prescriptions and Labeling by prescriber Valid Rx (69.41.040)
Authorized prescriber Legitimate medical use
Label, when dispensed by prescriber (69.41.050) Name of prescriber Complete directions for use Name of drug, strength Name of patient Date Samples – Name of patient and prescriber
Requirements of a valid Rx Written for a patient By an authorized prescriber In the due course of medical
practice Bona fide prescriber-patient
relationship Within scope of prescriber’s practice
For a legitimate medical purpose
Authority to Prescribe A matter of state law Cannot delegate authority to prescribe
Exceptions: laws authorizing collaborative practice agreements
Generally, authority to prescribe includes authority to dispense
Only pharmacists, with specific exceptions (eg, Physician Assistants) can dispense a prescription by another prescriber
Agent of physician may communicate instructions
Randle v. California State Board of Pharmacy(49 Cal Rptr 485 (1966))
Patient would bring in receipt for $7.50 for office visit
Pharmacist would call office nurse and ask for approval to fill prescription for 60 ampoules of Methedrine (desoxyephedrine; methampetamine – not a CSA in 1966)
On 21 occasions, it was proved that physician was out of town, and that the pharmacist knew it
Pharmacist: “Well, I assumed the nurse had authorization to do so or she wouldn’t have done it”
Practitioners with Prescriptive Authority in WA Physicians
MD Osteopath (DO) Podiatrist
Dentists Veterinarians
Mid-level practitioners Nurse Practitioner Physician’s
Assistant Naturopath* Optometrist (OD)* Pharmacist* Midwife*
Prescriptions must be legible in WA
Complete directions for use – “UD” not allowed in WA BC pills – “As directed on dialpak” Written schedules – “As instructed
on written schedule from Dr.” Keep copy with original Rx Estimate days’ supply carefully
Coumadin – “Take 1 daily or as directed by physician.”
Telephoned, and FAXed Rx Reduce oral Rx to writing FAX treated like telephoned Rx
Must show date, time, phone #, and location of FAX machine on FAX
Not printed on thermal paper Verify unclear or suspicious orders
with prescriber
Electronic prescribing Must meet standards for security and
integrity Must be approved by Board – approved
systems listed on web site Staff must sign and adhere to security
and integrity policy and procedures Must allow for communicating
preferences for substitution Pharmacist responsible to for accuracy,
validity, and authenticity of the order
Drug Product Selection Generic substitution
Same chemical entity Same dosage form Bioequivalent
• Same AUC• Same Peak
Therapeutic substitution Same class Equivalent therapeutic effect
Substitution “Formularies” Negative formulary
A list of drugs that cannot be generically substituted
Usually “narrow therapeutic index” drugs
Positive formulary A list of drugs that may be generically
substituted Based on bioavailability data
The Orange Book
The Orange Book Approved Drug Products
Doesn’t cover drugs without NDA Generics listed must have approved
ANDA Therapeutic Equivalence Evaluations
A = products considered therapeutically equivalent to “reference” product
B = products not considered therapeutically equivalent
Reasons for “B” rating BC: Extended release formulations BD: Particular active ingredients with
documented problems BE: Delayed-release formulations BN: Aerosols or nebulized formulations BP: Particular active ingredients with potential
problems BR: Rectal formulations BS: Drug standards difficulties BT: Topical products BX: Insufficient data B*: Questions remain to be resolved
Three-character Codes
Used when two or more “reference” drugs are available which are not bioequivalent to each other
Adalat CC = AB1 Procardia XL = AB2 Nifedipine generic rated AB1 can be
exchanged for Adalat CC, and so on.
Product Selection in WA
Two-line prescription blank, out of state ok to substitute unless “DAW” etc. is on Rx
Indicate on oral prescriptions if DAW or Substitution Permitted
Shall substitute unless patient requests otherwise
Must use therapeutically equivalent product of identical base or salt given in same regimen
May use any reliable information source to determine bioequivalence
Must pass on 60% of savings
Therapeutic Substitution in WA May do “Therapeutic Substitution” based
on prior authorization from prescriber Protocol, Exchange List, Formulary Per-prescription basis
Blanket prior authorization can be verbal, but are required to have documentation of authorization in the pharmacy
Substitution using prescriptive authority protocol is not really DPS, but prescribingRCW 69.41.100
Preferred Drug List: RxWashington.com Used for state-paid drug benefits plans Effective May 1, 2004 Pharmacists authorized to perform product
interchange using PDL on Rx’s from “endorsing prescribers” Prescriber may indicate DAW and non-PDL product
won’t need prior authorization Non-endorsing prescribers’ Rxs for non-preferred
drugs require prior authorization Refills of antipsychotics, antidepressants,
chemotherapy, HIV drugs, and immunosuppressive drugs exempt
Can you fill for quantities different than ordered? Cannot dispense more than the total
ordered including any refills Can use judgment for non-controlled drugs
Lipitor 10 mg #90, 1 daily• Insurance will only pay 30 days supply – ok to fill for 30,
and give 2 refills Lipitor 10 mg #30, 1 daily, Refill PRN
• Insurance will pay 90-day supply – ok to fill for 90 after first filling if patient tolerates drug
Elavil 10 mg #10, Refill 5x• Patient with history of suicide attempt – bad idea to
give more than 10 at a time
Not enough stock? Partial fill and order the rest – “Will call” Generally permitted by law
Restrictions for C-II drugs Problems with 3rd party payers and patient
doesn’t pick up remainder If put back in stock, must adjust patient profile May not be able to refund 3rd party General rule – don’t bill for full amount until it
has been given to the patient Problems with mailing unless patient has signed
a request
Secundum artem Circumstances may justify dispensing a
different strength or form than ordered Prednisone 10 mg #50, ½ tab daily Prednisone 5 mg #100, 1 tab daily
Levoxyl 225 mcg #30, 1 daily – doesn’t exist Levoxyl 113 mcg #60, 2 daily Levoxyl 200 mcg #30, 1 daily +
Levoxyl 25 mcg #30, 1 daily A wise pharmacist will inform prescriber of
these types of changes Be sure patient fully understands!
Refills of legend drugs All legend drugs expire after 1 year in WA Refill PRN = 1 year Refills must be consistent with directions If Rx expired, a refill should be treated as
a new Rx and given new number The full quantity of a prescription refill
may be dispensed up to the last day before the Rx expires
Legend Drugs Not Requiring CRCs Nitroglycerine SL SL, chewable
isosorbide 10 mg NaF 110 mg/pkg Cholestyramine and
colestipol powder Oral corticosteroids in
doses 105 mg of prednisone equiv.
Mebendazole 600 mg/pkg
K+ supplements 50 mEq/dose
EES granules 8 g/pkg, tabs 16 g
Aerosols for inhalation Pancrelipase OCs in memory aid
containers; MPG; other hormones
Sucrase solutions
Requirements for Containers At least 90% of adults, having been shown
how, can open within 5 minutes Not more than 20% of children < 5, having
been shown how, can open within 5 minutes Must meet USP standards for tightness, light
resistance May not be reused Because 1 in 5 children can open, by
design, never refer to these containers as “child-proof”
Exemptions and Waivers of CRC use Not required for institutionalized patients Prescriber may specify non-CRC on
individual prescriptions; no blanket waiver Patient or agent may request non-CRCs on
all prescriptions; blanket waiver Pharmacist may not designate him or
herself as patient’s agent Under federal law, waiver may be oral or
written WA: must be written
Liability Issues A child injured by a negligent act of a
pharmacist may be able to bring lawsuit after turning 18
Parents are not always legally able to waive child’s rights to sue
Some experts recommend that requests for non-CRCs include indemnification clauses
Accepting a waiver without warning patient of consequences to children may leave pharmacist exposed to liability
Some Realities Packages designed so that 90% of
adults can open IF SHOWN HOW Some packaging is particularly
suited to elderly Most common source of childhood
poisoning is a grandparent’s home or “Grandma’s purse”
Recalls
“Voluntary” for drugs FDA may initiate for devices or infant
formulas Wholesaler level Retail level Consumer level Product is considered misbranded or
adulterated - dispensing would violate FDCA
Recalls: Classes of Seriousness Class I - Likelihood of injury or death from
use of product; may include public warning
Class II - Temporary or reversible health problems from use of product
Class III - Use of product NOT likely to cause health problems
Market withdrawal - Minor health risk or minor FDA violation