misc 2-lame stuff Flashcards
what do all emulsions need
an antimicrobial agent because aqueous phase is favorable to growth
another name for pseudoplastic system, and what it refers to
shear thinning system- viscosity (part of non newtonian flow),-
2 types of flow and how they are different
newtonian=pure liquids and dilute solutions that viscocity is a single value and plot of their shear stress vs rate of shear is linear. Non means viscosity is not constant, and depends on shearing stress or force applied )ex/ suspension, emulsion, dispersions, ointments, creams)-further classified into 3 groups
what does “plastic system” refer to
substance that exhibits newtonian flow patterns after certain shearing stress, called yield value (becomes linear)
what does thixtropy refer to
principle that when shear or force is applied (ex/ shaking) a substance loses its consistency and it takes a finite time to recover. Ideal for dispersions
what are suractants
aka surface active agents- molecules or ions that adsorb at interfaces. Has a hydrophilic and hydrophobic part- reduce interfacial energy and lower surface tension. Can act as wetting agents, detergents, foaming agents, dispersing agents, solubilizers, emulsifying agents
process of particle size reduction
comminution
trituration
method of comminution where rubbing solid in mortar with pestle reduces size of particles. Can also e mixing two or more substances with mortar to intimately mix them
what is pulverization by intervention
uses recrystallization to obtain fine particles. First dissolve drug in suitable solvent (minimum amount of volatile solvent like alcohol), then incorporated into liquid or semisolid prep. IE particle reduction with the aid of a chemical that can later be removed (volatile substance)
what is levigation
reduce particle size by triturating in a mortor or spatulating on an ointment slab with a small amount of liquid or semi solid in which it is not soluble. Optimal liquid is viscous with low surface tension to improve ease of wetting solid.
common levigating agents
mineral oil and glycerin
geometric dilution
combining two or more powders of enequal quantities
how numbers relate to capsule size
biggest number (5) means smallest pill. 000 is largest (00 is largest capsule size for human use)
how should powder be packed in capsules
loosely or slightly packed- too packed makes it less easy to disperse
what is the max BUD for products containing water if stability is unknown
14 days
emulsion
2 phase system in which one liquid is dispersed in another in the form of small droplets
lotion
an emulsion liquid dosage form
what is the most common emulsion type
oil in water
ante area
area adjacent to clean room- may ahve lesser air cleanliness. Must be calss 8 or higher. Handwashing, gowning, etc is done here. Cardboard boxes and packing material should not be brought in
what level must a clean room be
6 or 7
what level must the critical area be
class 5 environment
another name for vertical flow hoods
biologic safety cabinets- can be used for any aseptic processing but are required for cytotoxic or hazardous drugs
volume limit for SQ injection
2.5ml
IM volume limits for adults and kids
adult- 2mL in deltoid, 5 mL in butt. Kids up to 3 years- 1mL in gluteus maximus (recommended spot) and only 0.5 if under 15yo in deltoid.
IV limit per day in adults
3L per day
age 6-15 yo- never inject more than this into msucle tissues
2mL (may be less depending on age and muscle)
calculating expiration date/shelf life
use 0.9 x C (90% of original concentration) and C1= original concentration, along with rate constant
BUD of non aqueous liquids and solids
25% remaining from expiry date OR 6 months (lesser)
formulations other than non aquous liquids and solids and liquids BUD
30 days or intended duration of therapy
pore size of filter to remove microorganisms (free of)
0.22
the larger the mesh# of a seive, the ___ (size) particles it makes
smaller- mesh # is a count of the # of openings across the seive per inch
what do deflocculating agents help with
preventing particle aggregation
kind of zeta potential (charge) when a system is flocculated (loose aggregates) and predominated by attractive forces
low
kind of zeta potential when a system is predominated by repulsive forces (deflocculated)
high
what is coacervation, and what is it AKA, and what is it used commonly for
adding electrolytes of non solvents to replace the drug in a dispersion medium and cause precipitation- aka salting out, used a lot in micoencapsulation (coating for slow release of drug)
what size are colloidal particles
1-500nm
what is an emulsion
dispersed system with at least 2 immiscible liquids (internal and external phase)
for IV admin, what type of emulsion MUST it be? what about IM?
O/w or serious embolization may occur. For IM it is usually w/o so that it can be sustained release
what kinds of surfactants are least irritating and have less incompatibilities
non ionic
what must preservatives be compatible with in emulsions
the external phase (ie if o/w, must be compatible with water phase)
what is a humectant and what is it good for
capable of absorbing water from air- reduce evaporation and prevent drying of a preparation
what is HLB a measure of
surfactants’ relative polarity (hydrophile-lipophile balance). Ranges from 1-50, most fall between 1-20. 10-20 means hydrophilic, 0-10 means lipophilic
when dispersed droplets move upward in an emusion it is called ___. downward?
up=creaming (o/w), down=sedimentation (w/o)
what it mottling
uneven colour distribution on a tablet
friability
ability of compressed tablet to withstand abrasion or crumbling
three major properties material must possess to compress into a tablet
fluidity, compressibility and minimal segregation. Usually granulation is required for this to occur
what are the 3 major methods of processing to produce compressed tablets
wet granulation, dry gran, direct compression
what is preferentially absorbed through passive diffusion across membranes- ionized or non?
non ionized. Weakly acidic drug is more unionized in low pH, vs basic in is more unionized in high pH
what is the kp value
partition coefficient- ability of drug to penetrate membranes. Kp=Coil/Cwater. If too low, drug wil stay in aq cavity, but if too high it may get stuck in lipid membrane when it gets in
what does extensive PPB do to a drug
prolongs T1/2
what is the rate limiting step in drug delivery for MR system
release from the dosage form, NOT the absorption
a drug is considered safe if its therapeutic index (LD 50/ED 50) is greater than or equal to
10
main advantage of capsules
number of drugs can be combined into one unit
what do wetting agents act as
a sufactant- decrease surface or interfacial tension
if an existing chemical drug is modified for changes in previously approved formulation (safety and or efficacy, dosing ie once daily to once weekly, less SE) is it a new drug?
yes
how long is the drug discovery process
10-15 years. 1-2 out of 10000 drugs in pre clinical testing make it to human testing
what is the cost to introduce a new drug to market
typically over 1 billion (1.3-1.6(
when does a patient expire after on a new drug
20 years- ie companies will have about 7-10 years to recoop costs
who is studied in: phase 1, 2 and 3 in clinical trials
1=healthy individuals, 2=people with the disease and look at dosing, 3= test on a wide patient pop
if there is a new drug designed to treat a life threatening illness, what can be done for approval?
FDA has a fast track/priority program
patent protection strategies
superior formulations, new route of admin, new use for drug, chiral switches,
what is the key to ensuring bioequivalence
dissolution testing. Remember, extent of absorption is important, but not rate. Rate has no effect on efficacy, so can be considered bioequiv even if rate of absorption differs
explain the precontemplation stage in models of change and some strategies
no intention of action in next 6 months. Increase awareness, don’t pressure the,
explain the contemplation stage in models of change and some strategies
intends to take action in next 6 months. Motivate, encourage, help make decisions
explain the preparation stage in models of change and some strategies
intends to take action in next 30 days. Assist in developing and implementing concrete plans and setting goals
explain the action stage in models of change and some strategies
changed behaviour for less than 6 months. Provide feedback, support, monitoring and follow up
explain the maintenance stage in models of change and some strategies
changed behaviour for more than 6 months. Assist with coping, reminders. It has now become a good habit for them
what is the threshold for non adherence
80%
mean vs count adherence
mean= average of all values. Count means assessing the number who were 80% or more adherenent, and taking the averages of the yes and no answers
what is primary non adherence
prescription is never filled
what is non persistence non adherence
d/c after at least one fill
what is poor execution non adherence
doesn’t comply with dosing instructions (doesn’t take enough)
when is the rate of non adherence highest
first year
what is PAS
our advocacy group. Voluntary organization
what is SCPP
our provinical regulatory authority. the group that holds us accountable- self regulatory body with primary purpose being to protect the public. Statutory organizations. Part of NAPRA- our larger regulatory body
what does NAPRA do
sets standards for all provincial and territorial pharmacy regulators
4 domains in the model standards of practice set out by NAPRA
expertise in meds and medication use, collaboration, safety and quality, professionalism and ethics
5 principles of medicare as defined by the canada health act
public administration, universality, portability (anywhere in canada), accessibility (reasonable access without barriers) and comprehensiveness (insure all medically necessary services from hospitals and Drs) (this is medicare in Canada as we know it)
what is a verbal prescription narcotic
single narc with at least two additional medical ingredients
direct to consumer advertising laws in canada
cannot mention a disease and site a specific brand name in an advertisement directed to the general public. Can be EITHER product specific (brief mention of brand name occurs), or informational (increase public awareness about disease and availability of treatment- ie ED)
amount of requried malpractice insurance
at least 2 million
how many managers must be practicing pharmacists
over 50%
when can you release information to a police officer
only if there is a warrant or imminent harm will come to patient or public
what is the only straight narcotic you don’t have to sales record
propxyphene
hierarchy of study designs
systematic review/meta analysis, RCT, cohort, case control, cross over, case report, authority/opinion
what is internal validity and what are the 3 major threats to it
are the results due to our intervention or something else? chance, confounding and bias
what is external validity
are the results generalizable (related to inclusion and exclusion criteria)
hard endpoints vs surrogate
hard=death, stroke, MI. Surrogate=BP (which can lead to an event)
what minimizes confounding
randomization
what minimizes chance
increasing sample size
block vs complete vs stratified randomization
complete has no limitations and may have unequal numbers between groups, block forces balanced number of subjects in each. Stratified uses similar characteristics to group and then randomize (ie all over 65 are randomized, then under 65, etc)
what does per protocol mean and what is the issue with it
only looks at subjects who completed study or followed protocol exactly- ITT looks at everyone and preserves value of randomization. Once randomized, should be analyzed
what does per protocol mean and what is the issue with it
only looks at subjects who completed study or followed protocol exactly- ITT looks at everyone and preserves value of randomization. Once randomized, should be analyzed
p value
less than 0.05 means there is a statistically significant different between groups(rejects null hypothesis)
what is attrition bias
part of selection bias- happens when people are lost to follow up
CI can show if there really is a ____. If it crosses the no difference threshold, then there is not difference. For means/proportions no difference is ___ vs relative risk or odds ration ____
statistical sig. 0, 1. ie if it crosses this line, it is not stat sig
what is “r” and what does it indicate
correlation coefficient- always bewteen -1 and 1. If 0= no correlation, if less than zero ie negative as one variable increases the other decreases, if positive they either increase or decrease together. If greater than 0.7 strong, 0.4-0.69 moderate, less than 0.4 weak
correlation implies causation- T/F
F
2 examples of observational studies
WHI and FHS
types of observational studies
case report, cross sectional, case control, cohort
case reports
narrative usually, suggest areas for further research or alarm, can help see trends but can’t confirm or prove anything. Series is a collection of these that can be used to form a hypothesis
do cross sectional studies (snapshot in time) look at proportion or incidence
only proportion/prevalence. Not incidence. Survey, chart review, etc how do these. Can look for associations
what is a case control study
observational retrospective study that looks at people with and without an outcome and compares, good for rare diseases and can establish association for further research, but really susceptible to confounding/bias
cohort study- what is it
groups (cohorts) compared according to exposure and followed over time to see if outcome occurs. Similar to RCT but don’t randomize subjects into group or assign exposure. Best type to find a valid association out of observational study types (highest level of evidence). Can be prospective or retrospective. Bias big concern with selecting groups differently
QALY equation
utility x survival time expected
SAP
Health Canada program, can request access to drugs unavailable in Canada, operates 24hrs/day 365, for patients with serious or life threatening conditions only for compassionate or emergency basis where conventional therapies don’t work or are unavailable. Will consider if drug shortage, negative review from health canada, medically necessary with no other reasonable alternatives
SAP- role of Dr
initiate request, provide supporting literature, provide progress reports to SAP upon request, ensure patient well informed or risk/benefit
who has the final word on whether or not a drug will be supplied with SAP
manufacturer.They can also impose restrictions. If give, must provide drug info
where can SAP meds be shipped to
only Dr office or hospital pharmacy
documentation at end of SAP
LOA (letter of authorization) must be kept for 25 years
look at ethical principles or moral rules first?
moral rules. then ethical principles, then ethical theories (consequential vs non)
pipeda and hipa- federal or provincial?
pip is fed, hipa is provincial
3 consent options under hipa
expressed, implied, deemed aka no consent
what are the 4 ps in marketing
product, price, place, promotion
what is porters analysis
assess risk and opportunity on market (helps develop strategic advantage over competitors); 5 forces are threat of new entrants or substitutes, bargaining power of suppliers or buyers, and rivalry among existing firms
what is SWOT
strengths weaknesses opportunities threats
what is another name for contingent work
floater- no contract for long term employment and hours of work can vary in a non systemic way
what is a primary stakeholder
participates in economic transactions with the organization
secondary stakeholder
does not engage in direct economic exchange with organization but is affected by or can affect its actions (ex advocacy group. gov, communities, etc)
4 main components of a business plan
operations, human resources, marketing, financial
what is the number one indicator of career success
work life balance
centralization vs decentralization
cent means formal decision making authority is held by a few people at the top, vs decent is it is dispersed through the organization
a balance sheet lists
assets (what the business owns or controls), equity (what is leftover for the owners-ie what you have invested) and liabilities (what it owes to outsiders -ie debt). Assets= liabilities + equity (ie total value is equal to what is owing and what you’ve already paid)
what is a long term asset vs current assets
won’t be turned into cash or be consumed within one year (property**, plant, building, equipment). Current assets are things like cash, accounts payable, etc- things that are cash or will turn into cash within one year
what are assets
something of value owned by the pharmacy
what are liabilities
debts incurred by the pharmacy
what is shareholders equity
the total net worth of the pharmacy (amount invested in it) aka stockholders or owners equity depending on context
income statement is aka
profit and loss statement
what is on the pharmacy income statement
gross profit, net income or loss, sales, operating expenses
what are the 3 additional ps when a product is a service
people, process, physical evidence
what are dividends
earnings of a business that are paid out to the owners
gross profit vs margin
same but profit is expressed as a number vs margin as a percent. measures profitability
naloxone schedule
1 (PDL) or if for emergency use is 2
