Term
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Definition
• An article recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States or official National Formulary
• An article that is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals
• An article, other than food, intended to affect the structure or function of the body of humans or any other animal
• Does not include devices |
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Term
| FederalFood,Drug,andCosmeticAct(FFDCA) of 1938 |
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Definition
• Replaced Pure Food & Drug Act
• Granted FDA authority to regulate food, drugs, and cosmetics
• Required proof of safety
• Labels must include adequate directions for use
• Removed requirement to demonstrate intent to defraud in drug misbranding cases
• Established good manufacturing practices (GMP) |
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Term
| Durham-HumphreyAmendment1951 |
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Definition
• Sale and use of prescription drugs must be under medical supervision
• Establish written prescription system through pharmacists |
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Term
| Kefauver-HarrisAmendments1962 |
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Definition
• Requires proof of safety and efficacy for drugs released since 1938
• Established guidelines for reporting of information about adverse reactions, clinical testing, and advertising of new drugs |
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Term
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Definition
• Rare disease defined as affecting <200,000 people in the U.S.
• Tax and licensing incentives to develop drugs for rare diseases |
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Term
| FDAModernizationActof1997 |
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Definition
• Fast track review for serious and life-threatening conditions
• Encourage pediatric studies
• Encourage studies of new indications for approved drugs |
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Term
| Patient Protection and Affordable Care Act of 2010 |
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Definition
• Stops agreements between manufacturers that limit competition from generic drugs
• Elimination of catastrophic threshold where patients paid all costs of prescription drugs out-of-pocket
• Opportunity to expand Medicaid coverage |
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Term
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Definition
• High potential for abuse
• No currently accepted medical use
• Not safe for use even under medical supervision |
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Term
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Definition
• High potential for abuse
• Accepted medical use
• May lead to severe psychological or physical dependence |
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Term
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Definition
• Low potential for abuse
• Accepted medical use
• May lead to limited physical dependence or psychological dependence |
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Definition
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Term
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Definition
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Term
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Definition
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Term
• C-II medication may be dispensed based on verbal prescriber orientation only in an “emergency situation”
• Quantity limited to minimum necessary for emergency period
• Prescription must be immediately reduced to writing with all necessary information (besides prescriber signature)
• Pharmacist must make best effort to verify that oral order is legitimate
• Written and signed prescription must be postmarked within seven days (note: many state laws require quicker turnaround time)
• If prescription is not received within required timeframe, the prescription is invalid and the pharmacist must notify the DEA |
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Definition
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Term
• Definition: the illegal acquisition of prescription drugs for personal use or profit
• Examples:
• Forging new prescriptions
• Altering existing prescriptions
• Stolen prescription pad used to write prescriptions for real or fictitious patients |
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Definition
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Term
• Store prescription pad in secure location
• Spell out quantities and refills, including zero refills
• Check prescription monitoring program, if available
• Electronic > printed
• Log out of electronic health record when not in use
• Prescribe only to patients with active medical records (i.e., do not prescribe to friends or fellow staff) |
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Definition
| Prescription Fraud: Prevention |
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Term
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Definition
| absence of a significant difference in the rate and extent to which the active moiety in pharmaceutical equivalents becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study |
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Term
| Pharmaceutical Equivalents: |
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Definition
• Identical identity, strength, quality, purity, potency, and where applicable,
Content uniformity, disintegration times and/or dissolution rates
• Inactive ingredients and release mechanisms may vary
• Expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling |
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Term
| Generic Drugs: Bioequivalency |
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Definition
• Two one-sided test procedures, both with limit of 80%
• Always expressed as ratio of the average response for test/reference (125% is the reciprocal)
• Using ANOVA, the 90% confidence interval for geometric mean generic/innovator AUC and Cmax ratios must be entirely within 80–125%
• Absolute difference in AUC or Cmax >12% unlikely to pass
• Average difference is 3.5%, over 90% of products vary by less than 10% |
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Term
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Definition
• Biologic product that is highly similar to the FDA-approved reference biologic product
• Minor differences in clinically inactive components permitted
• No clinically meaningful differences between biosimilar and reference biologic product regarding safety, purity, and potency
• The product is the process |
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Term
| Biologics Price Competition and Innovation Act of 2009 |
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Definition
• Establishes standards for designating a biosimilar product as an interchangeable product
• Maybesubstitutedforthereferenceproduct without involvement of the prescriber (but state laws vary)
• Safetyandefficacyisexpectedtobethesame for the interchangeable product as the reference product
• Goal->increase patient access to therapies due to decreased cost |
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Term
| National Plan and Provider Enumeration System (NPPES) |
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Definition
• Provision of Health Insurance Portability and Accountability Act of 1996 (HIPAA)
• Assigns standard unique identifiers for health care providers and health plans called National Provider Identifiers (NPI)
• Provider name, type (NP), business practice location address, business mailing address, business practice phone number are publicly available
• You are responsible for updating NPPES within 30 days of any changes |
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Term
| What to include on a prescription |
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Definition
Your Name, Degree Office Address Office Phone
Patient Name Patient Address
Date Rx Written
Recommended: Allergies & DOB
Drug Name Dosage Form Strength Directions Quantity Optional: Indication Brand Medically Necessary
Refills
Your Signature Your License # NPI #
DEA # for controls |
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Term
| abbreviations (don't use) |
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Definition
ac
ante cibum
before meals
ad
aurio dextra
right ear
au
auris utrae
both ears
as
aurio sinister
left ear
atc
around the clock
bid
bis in die
twice daily
c
cum
with
cr
cream
daw
dispense as written
div
divide
g
gram
gr
grain
gtt
gutta
drop
h
hora
hour
hs
hora somni
at bedtime
npo
nil per os
nothing by mouth
od
oculus dexter
right eye
os
oculus sinister
left eye
ou
oculus uterque
both eyes
oz
ounce
pc
post cibum
after meals
po
per os
by mouth
pr
by rectum
prn
pro re nata
as needed
qam
quoque die ante meridiem
every morning
qd
quaque die
every day
qid
quater in die
four times a day
qod
every other day
qs
quantum sufficiat
a sufficient quantity
s
sine
without
sig
write on label
sl
sublingually
tbsp
tablespoon
tsp
teaspoon
troche
trochiscus
lozenge
tid
ter in die
three times a day
tiw
three times a week
top
topical
U
unit
ung
unguentum
ointment
USP
United States Pharmacopoeia
vag
vaginally
wc
with meals
wk
week |
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Term
| Poison Prevention Packaging Act of 1970 |
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Definition
• Hazardous products must be sold in child-resistant packaging
- Prevents 80% of children five and under from opening container
- Can be opened by at least 90% of adults
• Exceptions for specific products (e.g., sublingual nitroglycerin)
• Can dispense in alternate container per patient request |
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Term
| Prescriptions: Rational Prescribing |
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Definition
1. Diagnosis
2. Consider pathophysiology to devise targeted therapeutic plan
3. Define treatment goal
4. Select drug of choice
5. Select appropriate regimen taking into consideration concurrent medications
6. Age, weight, renal and hepatic function, cultural, socioeconomic, etc.
7. Formulate a monitoring plan
8. Patient education |
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Term
| Prescriptions: Patient Education |
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Definition
• Why they are on a medication/how it
relates to their goals
• How the medication works
• How they should take the medication
• What they should expect while on the medication (common side effects, when they should see improvement)
• When to call you/call for help |
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Term
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Definition
• Prescription never filled/picked up
• Patient does not take as prescribed
• Patient self-discontinues medication
• Patient takes medication inappropriately |
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Term
| Prescriptions: Medication Reconciliation |
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Definition
• Use a single pharmacy, preferably mail-order with automatic refills for chronic conditions
• Encouragepatientstokeepalistofall medications, diagnoses, and providers
• Specificallyaskaboutherbals,dietary supplements, and over the counter products
• Assess adherence and identify any barriers
• Review and update list at every visit |
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Term
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Definition
• Risk Evaluation and Mitigation Strategy
• FoodandDrugAdministrationAmendmentsAct of 2007
• Authority to require post-approval studies or clinical trials to examine a specific risk
• Unique plan for target drug depending on risk
• May include medication guide, notification letter, mandatory lab work, patient and/or prescriber program enrollment, distribution limited to specialty pharmacies |
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Term
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Definition
• 1999 Institute of Medicine “To Err is Human: Building a Safer Health System” report estimated up to 100,000 Americans die annually in hospitals as a result of preventable medical errors
• Solutions should focus on systems and processes over individuals
• Prescription error is any action or omission which may result in, or would
• Reasonably be expected to result in patient injury or death
• Near misses are opportunities to improve the system before an error reaches a patient |
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Term
| Medication Errors: Types of Error |
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Definition
- Diagnostic
• Error or delay in diagnosis
• Failure to employ indicated tests
• Use of outmoded tests or therapy
• Failure to act on results of monitoring or testing
- Treatment
• Error in the performance of an operation, procedure, or test
• Error in administering the treatment
• Error in the dose or method of using a drug
• Avoidable delay in treatment or in responding to an abnormal test
• Inappropriate (not indicated) care
- Preventive
• Failure to provide prophylactic treatment
• Inadequate monitoring or follow-up of treatment
- Other
• Failure of communication • Equipment failure
• Other system failure |
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Term
| Medication Errors: Strategies for Prevention |
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Definition
• User-centered design: make processes intuitive, force functions, keep high risk products out of reach
• Avoid reliance on memory: simplify processes, standardize where possible
• Create safe environment for work: work hour limits, adequate staffing, limit distractions
• Avoid reliance on vigilance: utilize checklists, rotate staff, automation
• Team training
• Patient-centered care
• Improve access to information |
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Term
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Definition
• Health on the Net certification of compliance with the code of conduct:
• Authoritative
• Complementarity
• Privacy
• Attribution
• Justifiability
• Transparency
• Financial disclosure
• Advertising policy
• Does not mean all content has been verified |
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Term
| Pregnancy and Lactation: Labeling |
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Definition
• Organogenesis occurs weeks 6–10->highest risk time for teratogenic effects from drug exposure
• 2/3 of pregnant women use at least one prescription drug, up to half are category C, D, or X
- Approximately 50% of pregnancies in the U.S. are unplanned
- 2/3 of prescription drugs are category C |
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Term
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Definition
• A: adequate and well-controlled studies have not shown a risk to the fetus in the fist trimester and there is no evidence or risk in the second or third trimester
• B: animal studies have not shown a risk to the fetus and there are no adequate and well-controlled human trials
• C: animal studies have demonstrated an adverse effect on the fetus and there are no adequate and well-controlled human trials
• D: there is evidence in humans that there is risk to the fetus
• X: there is human or animal data demonstrating fetal abnormalities such that the risks in pregnant women clearly outweighs any potential benefits |
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Term
| Pregnancy and Lactation: Labeling |
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Definition
Prior to 2014:
• A,B,C,D,X
• Allowed omission of information
• Not systemically absorbed
• Without adequate studies to demonstrate risk
• Absence of information for accidental exposures
• Do not describe nature, severity, timing, or incidence rate
• Lack information on treatability of potential fetal injury
December 3, 2014:
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Risk summary, clinical considerations, data
Applies to all drugs
Drugs approved before
June 29, 2001 do not have to add new labeling requirement, but must remove old pregnancy category within three years |
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Term
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Definition
• www.fda.gov/safety/medwatch
• FDA reporting system for adverse events
• Consumers and healthcare professionals can report/utilize the database
• Free alerts on FDA warnings, recalls, new drug approvals, etc.
• 1-800-FDA-1088 |
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Term
TF, a 57 year old man, recently filled a prescription for Percocet for a tooth extraction. He only took 2 tablets, then stopped because it made him sleepy and gave him a headache. He has a whole bottle left, and the pharmacy told him they can’t take back the remaining pills and refund him part of his copay. Instead, he is going to hold on to the Percocet in case he or someone else in his family needs some later.
How would you counsel TF? |
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Definition
| Narcotics should be discarded when they are no longer needed and should never be transferred to another person. Storing narcotics in the home is dangerous, especially if anyone in the home has a history of substance abuse. Many states have drop boxes for narcotics at places such as police stations. Alternatively, the patient can add water to dissolve the tablets then add a product such as cat litter/salt/etc to discourage people or animals from consuming the product. The container should be taped shut, placed in a non-transparent container such as an empty yogurt tub, then discarded in the trash (not recycling). |
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