Dosage Forms | |
amp | ampule |
buccal | buccal tablet |
cap | capsule |
Cm | cream |
el or elix | Elixir |
EC tab | Enteric-coated tablet |
expect | expectorant |
gtt | drops |
inj | injection |
lot | Lotion |
loz | Lozenge |
MDI | Metered Dose inhaler |
sol | solution |
spry | Spray |
supp | suppository |
susp | suspension |
syr | syrup |
tab | tablet |
tbsp | Tablespoon |
TDS | transdermal delivery system |
tsp | Teaspoon |
TPN | total parenteral nutrition |
pulv | poweder |
Ung or oint | ointment |
Friday, May 29, 2015
Dosage Forms Abbreviations
Route of Administration Abbreviations
Route of Administration | |
OD | Right Eye |
OS | Left Eye |
OU | Both Eyes |
AD | Right Ear |
AS | Left Ear |
AU | Both Ears |
PO | By Mouth |
SL | Sublingual |
NG or NGT | Feeding Tube through the nose into stomach |
IEN or NAS | by Nostril |
Bucc | Held Inside the Cheek |
S&S | Swish & Swallow |
HHN | Hand Held Nebulizer |
PR | Into the Rectum |
PV | Into the Vagina |
SubQ, SC, SQ | Immediately under the skin |
Top | Topical |
GT or PGT | Feeding Tube through the abdominal wall into stomach |
JT | Feeding Tube through the small Intestine |
IA | Into a(n) artery or joint |
IC | Into the heart muscle |
ID | Into the top layer of the skin |
IT | Into the Trachea |
IM | Into a muscle |
IV | Into a vein |
INH | Inhalant |
Frequency of Dosage Abbreviations
Also known as "Sig Codes", Prescription abbreviations are basically coded instructions from a health-care professional. The code is used to supply the words while Roman Numerals are sometimes used for the numbers. These should be memorized to prepare for the PTCB or ExCPT exams.
Frequency of Dosage | |
q | Every |
qH | Every Hour |
qAM | Every Morning |
qPM | Every Night |
qHs | Every Bedtime |
qD | Everyday |
qOD | Every Other Day |
qWK | Every Week |
qMO | Every Month |
q__o | (Q) 1°, 2°, 3°, 4°, (Every 4 Hours) |
q__H | Every__Hour (Every 4 Hours) |
BID | Twice a day |
TID | Three times a day |
QID | Four times a day |
X_D | Times_Day (3x a day) |
C | With |
AC | Before Meal |
PC | After Meal |
HS | At Bedtime |
PRN | As Needed |
UD | As Directed |
AA | Of Each |
QS | Quantity Sufficient |
ATC | Around the clock |
ad lib. | as desired |
STAT | Immediately |
|
Half Strength |
Thursday, May 28, 2015
Generic Medication Prefixes, Roots, & Suffixes Chart
Recognizing Generic Drug Names by Prefixes, Roots, and Suffixes:
Memorizing the top 200 drug names is one of the most challenging parts of studying for the PTCB of ExCPT exams.
In generic names, there are several prefix, root and suffixes that will help you to remember what the medication does.
The chart below lists some of the prefix, root and suffixes you will see when studying the top 200 drugs.
A prefix is placed at the beginning of a word to modify or change its meaning to "before." A Root is the central part of a word. Suffix is the ending part of a word that modifies the meaning of the word. Example: homeless. Root = 'home' and the suffix is 'less'.
Unfortunately, only a fraction of the top 200 drugs end in a common Generic Drug suffix. However, learning them may help you immensely to memorize the top 200 drugs.
There are plenty more common suffixes and prefixes in generic drug names. The above list is geared to apply to the Top 200 Drug name suffixes.
Memorizing the top 200 drug names is one of the most challenging parts of studying for the PTCB of ExCPT exams.
In generic names, there are several prefix, root and suffixes that will help you to remember what the medication does.
The chart below lists some of the prefix, root and suffixes you will see when studying the top 200 drugs.
A prefix is placed at the beginning of a word to modify or change its meaning to "before." A Root is the central part of a word. Suffix is the ending part of a word that modifies the meaning of the word. Example: homeless. Root = 'home' and the suffix is 'less'.
Prefix, Root, Suffix | Drug Class |
-artan | A2RB (Angiotensin 2 receptor blocker) |
-asone | Corticosteroid |
-azosin | Alpha Blocker |
-bital | Barbiturate (sedative) |
-caine | Local Anesthetic |
-cillin | Penicillin Antibiotic |
-cort- | Corticosteroid |
-cycline | Tetracycline Antibiotic |
-dipine | Calcium Channel Blocker |
-floxacin | Fluoroquinolone Antibiotic |
-itidine | H2Antagonist |
-lax | Laxative |
-mycin | Antibiotic; Antibacterial |
-nazole | Antifungal |
-olol | Beta Blocker |
-pril | Ace Inhibitor Angiotensin (Angiotensin Converting Enzyme) |
-pam | Benzodiazepines (Benzos) |
-profen | NSAID |
pred- | corticosteroid |
-razole | PPI = Proton Pump Inhibitor |
-romycin | Macrolide Antibiotic |
-semide | Loop Diuretic (water pill) |
-statin | Cholesterol (HG CoA Reductase Inhibitor) |
-thiazide | Thiazide Diuretic (water pill) |
-vir | Anti-Viral |
-zodone | Antidepressant |
-zolam | Benzodiazepines (Benzos) |
Unfortunately, only a fraction of the top 200 drugs end in a common Generic Drug suffix. However, learning them may help you immensely to memorize the top 200 drugs.
There are plenty more common suffixes and prefixes in generic drug names. The above list is geared to apply to the Top 200 Drug name suffixes.
Extended-Release Medications
These medication dosage forms are called extended-release, sustained release, long-acting, or controlled release. Although the exact meaning of these terms differ in some respects, each of these terms implies a gradual release of medication over a long period time.
CD | Controlled-diffusion |
CR | Controlled-release, continuous-release |
CRT | Controlled-release tablet |
LA | Long-acting |
SA | Sustained-action |
SR | Sustained-release, slow-relaese |
TD | Time-delay |
TR | Time-release |
XL | Extra-long |
XR | Extended-release |
Tuesday, May 26, 2015
Top 20 Most Commonly Diagnosed Conditions
Research data shows the top 20 most common conditions diagnosed by primary care and specialist physicians. Treatment and indications are also listed.
Condition | Indications | Treatment |
---|---|---|
High blood pressure (hypertension) | Blood pressure is a measurement of the force against the walls of your arteries as your heart pumps blood through your body. Hypertension is another term used to describe high blood pressure. |
|
Cholesterol, HDL, Hypercholesterolemia, Hyperlipidemia, Hyperlipoproteinemia, LDL | High amounts of cholesterol in the blood. High cholesterol can limit blood flow, increasing risk of heart attack or stroke. It's detected by a blood test. |
|
Type 2 diabetes Also called: adult onset diabetes | Diabetes means your blood glucose, or blood sugar, levels are too high. With type 2 diabetes, the more common type, your body does not make or use insulin well. |
|
Back pain | A common, painful condition affecting the lower portion of the spine. Pain: in the back, hip, leg, tailbone, or muscle and bone. Sensory: pins and needles or sensitivity to pain. Also common: leg numbness or muscle spasms |
|
Anxiety | Severe anxiety that lasts at least six months is generally considered to be problem that might benefit from evaluation and treatment. Each anxiety disorder has different symptoms, but all the symptoms cluster around excessive, irrational fear and dread. |
|
Obesity | A disorder involving excessive body fat that increases the risk of health problems. | The mainstay of treatment is lifestyle changes such as diet and exercise. |
Allergic rhinitis/ Seasonal allergies | An allergic response causing itchy, watery eyes, sneezing, and other similar symptoms. |
|
Reflux esophagitis/ Acid reflux | Digestive disease in which stomach acid or bile irritates the food pipe lining. |
|
Respiratory Diseases | A group of lung diseases that block airflow and make it difficult to breathe. |
|
Hypothyroidism /Underactive thyroid | A condition in which the thyroid gland doesn't produce enough thyroid hormone. | Levothyroxine (Synthroid) |
Visual Refractive Errors/ Farsightedness, Hyperopia, Myopia, Nearsightedness | Refractive errors are vision problems that happen when the shape of the eye keeps you from focusing well. | Eyeglasses, Contact Lenses, Refractive Surgery |
Osteoarthritis/ OA, degenerative joint diseas | A type of arthritis that occurs when flexible tissue at the ends of bones wears down. |
|
Fibromyalgia/myositis, neuritis, fibrositis | Widespread muscle pain and tenderness. |
|
Malaise and fatigue | Malaise is a generalized feeling of discomfort, illness, or lack of well-being. Fatigue (feeling tired) occurs with malaise in many diseases. Along with malaise, you can have a feeling of not having enough energy to do usual activities. | |
Joint Pain | Conditions that can lead to painful joints, include osteoarthritis, rheumatoid arthritis, bursitis, gout, strains, sprains, and other injuries. | Nonsteroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen or naproxen may help relieve pain and swelling. |
Acute laryngopharyngitis/ Laryngitis | An inflammation of the voice box from overuse, irritation, or infection. |
|
Acute maxillary sinusitis/ sinus infection | A condition in which the cavities around the nasal passages become inflamed. |
|
Major depression/ clinical depression | A mood disorder causing a persistent feeling of sadness and loss of interest. | Escitalopram (Lexapro), Selegiline (Eldepryl), Aripiprazole (Abilify), Bupropion (Wellbutrin), Imipramine (Tofranil-PM), Paroxetine (Paxil), Desvenlafaxine, Fluoxetine (Prozac), Trazodone (Desyrel), Nortriptyline (Pamelor), Buspirone, Amitriptyline, Fluvoxamine, Citalopram (Celexa), Venlafaxine (Effexor), Mirtazapine (Remeron), Sertraline (Zoloft), Duloxetine (Cymbalta) |
Acute bronchitis/ bronchial infection | Inflammation of the lining of bronchial tubes, which carry air to and from the lungs. |
|
Asthma | A condition in which a person's airways become inflamed, narrow and swell, and produce extra mucus. |
|
Monday, May 25, 2015
Guidelines for Filling Prescription Orders
Prescription Order Expiration Dates: A prescription order must be dated, and have an appropriate expiration date based on the type of drug ordered. If it's not filled in time, the script expires.
Refills: If refills are allowed by the prescriber, it will be noted on the prescription. However, there are boundaries and limitations.
Generic Substitutions: Generic drug substitutions may not be used unless the prescriber has authorized it. Generic substitutions may only be used if the prescriber has requested or authorized them.
DEA Controlled Drug Prescriptions Must contain:
Refills: If refills are allowed by the prescriber, it will be noted on the prescription. However, there are boundaries and limitations.
Generic Substitutions: Generic drug substitutions may not be used unless the prescriber has authorized it. Generic substitutions may only be used if the prescriber has requested or authorized them.
DEA Controlled Drug Prescriptions Must contain:
- Date of prescription issue
- Patient's name and address
- Practitioner's name, address, and phone number
- Drug name
- Drug strength
- Exact quantity prescribed
- Have a valid DEA Number
- Complete directions for use
- Number of refills authorized
- Dosage form and instructions
- Must be manually signed by the practitioner. No exceptions.
- May not be Faxed or Called in, except for a valid emergency.
- May not have any refills.
Prescription order expiration dates | Refills | |||
---|---|---|---|---|
Federal | State Ex. NY | Federal | State Ex. NY | |
DEA Sch II | No Expiration | 30 days | NO REFILLS ALLOWED | NO REFILLS ALLOWED |
DEA Sch III thru V | 6 Months | 6 Months | up to 5 times, but only 5 times | up to 5 times within 6 months |
Legend Drugs | 12 Months | No Expiration | up to 12 Months worth | up to 3 Months worth |
Friday, May 22, 2015
Routes of Medication Administration
A route of administration in pharmacology and toxicology is the path by which a drug, fluid, poison, or other substance is taken into the body. Routes of administration are generally classified by the location at which the substance is applied. Common examples include oral and intravenous administration. Routes can also be classified based on where the target of action is. Action may be topical (local), enteral (system-wide effect, but delivered through the gastrointestinal tract), or parenteral (systemic action, but delivered by routes other than the GI tract).
Route | Methods | Description | Advantages | Disadvantages |
---|---|---|---|---|
Oral | Oral | Through the mouth | It is convenient. It is the cheapest available route. It is easy to use. It is safe and acceptable. | Less amount of drug reaches the target tissue. Some of the drug is destroyed by gastric juices. Absorption has to take place which is slow, so is not preferred during emergencies. It might cause gastric irritation. It might be objectionable in taste. It might cause discoloration of teeth. |
Buccal | Inside the cheek | |||
Lingual | On the tongue | |||
Sublingual | Under gums | Rapid absorption takes place. Drug is dissolved easily. Drug enters the blood directly. Less first pass effect. Spitting out of the drug removes its effect. | This method is inconvenient. Irritation of the mucous membrane might occur. Person may swallow the drug. Might be unpleasant in taste. | |
Transmucosal | Across mucous membrane | |||
Enteral | Enteral | By way of the intestine | ||
Nasogastric (Tube) | A feeding tube inserted through the nose into the stomach (NG or NGT) | |||
Gastrostomy (tube), percutaneous endoscopic gastrostomy (tube) | A feeding tube inserted through the abdominal wall into the stomach (GT or PEG) | |||
Jejunostomy (tube) | A feeding tube inserted through the jejunum (small intestine) (JT) | |||
Inhalation | Inhalation | Drawn through the mouth into the lungs | Rapid absorption takes place. Rapid onset of action takes place. This route has minimum side effects. No first pass effect takes place. This method is easy. Fewer doses is required. | Special apparatus is required. Irritation of the respiratory tract may take place. Cooperation of the patient is required. Airway must be patent. |
Parenteral | Parenteral | By passing the gastrointestinal tract. Not delivered via the intestinal tract. | Parenteral route is rapid. It is useful for uncooperative patients. It is useful for unconscious patients. Inactivation by GIT enzymes is avoided. First pass effect is avoided*. Bioavailability is 100%. | Skill is required. It is painful. This method is expensive. It is less safe. |
Implant | A device inserted into or under the skin | |||
Intra-arterial | Into an artery (AI) | |||
Intra-articular | Into a joint (AI) | |||
Intracardiac | Into the heart muscle (IC) | |||
Intradermal | Into the top lay of the skin (ID) | |||
Intratracheal, endotrcheal | Into the trachea (IT) | |||
intramuscular | Into a muscle (IM) | Absorption is rapid than subcutaneous route. Oily preparations can be used. Irritative substances might be given Slow releasing drugs can be given by this route. | Using this route might cause nerve or vein damage. | |
Intraosseous | Into the marrow of a bone | |||
intraperitoneal | Into the peritoneal (abdominal) cavity | |||
Intrapleural | Into the pleura (sac that surround the lungs) | |||
intrathecal | Into space around the spinal cord | |||
intrauterine | Into the uterus | |||
intravenous | Into a vein (IV) | Immediate action takes place. This route is preferred in emergency situations. This route is preferred for unconscious patients. Titration of dose is possible. Large volume of fluids might be injected by this route. Diluted irritant might be injected. Absorption is not required. No first pass effect takes place.* Blood plasma or fluids might be injected. | There is no retreat. This method is more risky. Sepsis-Infection might occur. Phlebitis(Inflammation of the blood vessel) might occur. Infiltration of surrounding tissues might result. This method is not suitable for oily preparations. This method is not suitable for insoluble preparations. | |
intraventricular | Into the ventricles, or cavities, of the brain | |||
intravesicular | Into the urinary bladder | |||
intravitreal or intravitreous | Into the eye | |||
Subcutaneous | Immediately under the skin (SubQ, SC, SQ) | Absorption is slow and constant. It is hygienic. | It might lead to abscess formation. Absorption is limited by blood flow. | |
Nasal | Into the nose | |||
Ophthalmic | Into the eye | |||
Otic, aural | Into the ear | |||
Percutaneous | Through the skin | |||
Rectal | Through the anus into the retum | This route is preferred in unconscious or uncooperative patients. This route avoids nausea or vomiting. Drug cannot be destroyed by enzymes. This route is preferred if drug is irritant. | This route is generally not acceptable by the patients. Locally acting drugs include glycerin and Bisacodyl suppository. Systemic acting drugs include Indomethacin (anti inflammatory) and aminophyllin (bronchodilator). Retention enema is diagnostic and is used for finding the pathology of lower intestines. Drugs given by rectal route have 50% first pass metabolism.* | |
Topical | Applied to the skin or mucous membranes | |||
Transdermal | Through the skin | |||
Vaginal | Into the vagina |
*First Pass Effect: First pass effect is the term used for hepatic metabolism of drug when absorbed and delivered through portal blood. Greater the first pass effect, less amounts of the drug reach the systemic circulation.
Time of Action using Different Routes of Administration
Route of Administration | Delay time for Action |
---|---|
Intravenous route | 30-60 seconds |
Intraosseous route | 30-60 seconds |
Endotracheal inhalation | 2-3 minutes |
Sublingual route | 3-5 minutes |
Intramuscular route | 10-20 minutes |
Rectal route | 5-30 minutes |
Ingestion | 30-90 minutes |
Medication Dosage Forms
The term dosage form can also sometimes refer only to the chemical formulation of a drug product's constituent drug substance(s) and any blends involved, without considering matters beyond that (like how it's ultimately configured as a consumable product such as a capsule, patch, etc.). Because of the somewhat vague boundaries and unclear overlap of these terms and certain variants and qualifiers thereof within the pharmaceutical industry, caution is often advisable when conversing with someone who may be unfamiliar with another person's use of the term.
Depending on the method/route of administration, dosage forms come in several types. These include many kinds of liquid, solid, and semisolid dosage forms. Common dosage forms include pill, tablet, or capsule, drink or syrup, and natural or herbal form such as plant or food of sorts, among many others. Notably, the route of administration (ROA) for drug delivery is dependent on the dosage form of the substance in question. A liquid dosage form is the liquid form of a dose of a chemical compound used as a drug or medication intended for administration or consumption.
A 1999 Food and Drug Administration Draft Guidance for Industry states: "A dosage form is the way of identifying the drug in its physical form. In determining dosage form, FDA examines such factors as (1) physical appearance of the drug product, (2) physical form of the drug product prior to dispensing to the patient, (3) the way the product is administered, (4) frequency of dosing, and (5) how pharmacists and other health professionals might recognize and handle the product."
Liquid Medication Dosage Forms | |
---|---|
Solutions | Aqueous (water-based) |
Gargles | |
Oral Rinses | |
Washes & Mouthwashes | |
Douches | |
Irrigants | |
Enemas | |
Sprays | |
Viscous (thick) aqueous | Syrups |
Jellies | |
Hydroalcoholic | Elixirs |
Spirits | |
Alcoholic | Collodions |
Spirits | |
Glycerites | |
Extractives | Extracts |
Tinctures | |
Emulsions | Fluidextracts |
Oil-in-Water | |
Suspensions | Magmas & Milks |
Gels | |
Mucilages |
Solid Medication Dosage Forms | |
---|---|
Tablets | |
Compressed | Suger-coated |
Film-coated | |
Enteric-coated | |
Sublingual | |
Buccal | |
Effervascent | |
Chewable | |
Vaginal | |
Capsules | Hard gelatin |
Soft gelatin | |
Lozenges | |
Supporites | Rectal |
Vaginal | |
Urethral | |
Semisolids | Oinments |
Creams | |
Pastes |
Miscellaneous Medication Dosage Forms | |
---|---|
Poweders | |
Granules | |
Inhalants | |
Aerosols | |
Shampoos & crème rinses | |
Wipes & scrubs | |
Transdermal patches | |
Implants |
Dosage Forms | Description |
---|---|
Capsules | Capsules are composed of a gelatin container. Caplet dosage forms are related closely to tablets, but they are smooth sided and are therefore easier to swallow. |
Lozenges & Troche | Lozenges and troches are other forms of tablets that are not meant to be swallowed but to dissolve in the mouth, which releases the medication more slowly. Troches are larger than normal-size tablets and are flat: they usually have a chalky consistency in order to dissolve in the mouth. |
Patches | Patches are solid pieces of material that hold a specific amount of medication to be released into the skin over time. |
Liquids | Liquids are composed of various solutions. |
Syrups are sugar-based solutions that have medication dissolved into them. | |
Elixirs contain dissolved medication in an alcohol base or water and alcohol base. | |
Sprays are composed of various bases such as alcohol or water in a pump dispenser. | |
Inhalants and aerosols need to be able to get medication directly to the source of inflammation. | |
Emulsions are a mixture of water and oil may be used with an emulsifier to bind the two together. | |
Suspensions are liquids that have very small, solid particles suspended in the base solution. | |
Enemas may be administered for two different reasons-retention or evacuation. | |
Semisolids | Semisolids contain solids and liquids, they normally are meant for topical application. |
Creams usually have medications in a base that is part oil and part water and is meant for topical or local use. | |
Lotions are thinner than creams because their base contains more water. They penetrate well into the skin and do not leave an oily residue after application. | |
Ointments contain medication in a glycol or oil base. Ointments can be used rectally, topically and as an ophthalmic agent. | |
Gels contain medication in a viscous liquid that easily penetrates the skin and does not leave a residue. | |
Pastes contain a lesser amount of liquid base than solids. They are used for topical application and are able to ab sorb skin secretions, unlike other topical agents. | |
Suppositories can be used rectally and vaginally. | |
Powders do not fit neatly into semisolids. Powders are solids, yet they are packaged in some forms that allow them to be sprayed similar to liquid dosage forms. | |
Injectables are used for rapid response. The onset of an injectable drug only takes a few minutes as opposed to the 45 minutes that oral medications can take to work. |
Thursday, May 21, 2015
Roman Numerals
Roman numerals
are used in Pharmacy by practitioners on prescription drug orders
and on packaging to designate DEA schedules for controlled substances.
The Basics
A smaller number in front of a larger number means subtraction, all else means addition. For example, IV means 4, VI means 6.
You would not put more than one smaller number in front of a larger number to subtract. For example, IIV would not mean 3.
You must separate ones, tens, hundreds, and thousands as separate items. That means that 99 is XCIX, 90 + 9, but never should be written as IC. Similarly, 999 cannot be IM and 1999 cannot be MIM.
Sometimes you will see a numeral with a line over it. That means to multiply it by 1000. A numeral V with a line over it means 5000. This usage is no longer current, because the largest numbers usually expressed in the Roman system are dates.
The Basics
A smaller number in front of a larger number means subtraction, all else means addition. For example, IV means 4, VI means 6.
You would not put more than one smaller number in front of a larger number to subtract. For example, IIV would not mean 3.
You must separate ones, tens, hundreds, and thousands as separate items. That means that 99 is XCIX, 90 + 9, but never should be written as IC. Similarly, 999 cannot be IM and 1999 cannot be MIM.
Sometimes you will see a numeral with a line over it. That means to multiply it by 1000. A numeral V with a line over it means 5000. This usage is no longer current, because the largest numbers usually expressed in the Roman system are dates.
Symbols | |
---|---|
I | The numeral one. II is two, III is three. You seldom see IIII as 4, since IV can also mean 4, plus its shorter to write. |
V | The numeral 5. IV is 4, VI is 6, VII is 7, VIII is 8. |
X | The numeral 10. IX is 9, XI is 11, etc. |
L | The numeral 50. XL would be 40. |
C | The numeral 100. Think of Century having a hundred years. C is short for the Latin word Centum, but that's not very easy to remember. |
D | The numeral 500. |
M | The numeral 1000. |
Roman Numerals Chart 1-100 | |
---|---|
1 | I |
2 | II |
3 | III |
4 | IV |
5 | V |
6 | VI |
7 | VII |
8 | VIII |
9 | IX |
10 | X |
15 | XV |
20 | XX |
25 | XXV |
30 | XXX |
35 | XXXV |
40 | XL |
45 | XLV |
50 | L |
55 | LV |
60 | LX |
65 | LXV |
70 | LXX |
75 | LXXV |
80 | LXXX |
85 | LXXXV |
90 | XC |
95 | XCV |
100 | C |
Brand Name Drugs and Generic Drugs
The FDA approves all drugs that are available for distribution in the U.S. to assure that they are safe and effective.
Before a new drug is approved, the manufacturer must submit a New Drug Application (NDA) to the FDA. The NDA includes:
Generic drug companies must submit an Abbreviated New Drug application (ANDA). Generic manufactures must meet the same standards for:
Pharmacists are permitted to substitute the generic equivalent drug for the brand name unless the prescriber prohibits generic substitution.
Generic substitution is regulated by state laws. These laws and regulations set requirements for when pharmacists may or may not substitute therapeutically equivalent generic drugs for brand name drugs.
Indications of no substitution include:
Before a new drug is approved, the manufacturer must submit a New Drug Application (NDA) to the FDA. The NDA includes:
- Info about the drug
- Results from human clinical trials
- Results from animal clinical trials
- How drugs acts in the body
- How it is manufactured, processed and packaged
- The generic name for Lipitor is atrovastatin
- Pfizer developed atrovastatin
- Pfizer submitted a NDA to the FDA
- FDA approved atrovastatin
- Pfizer is granted patents for an average of 11 years.
- Once the patent expires other drugs companies may apply for approval of generic or copies of the drug.
Generic drug companies must submit an Abbreviated New Drug application (ANDA). Generic manufactures must meet the same standards for:
- Manufacturing
- Quality
- Labeling
- They do not need to repeat the original research.
- Must show bioequivalence to the brand name drug.
Pharmacists are permitted to substitute the generic equivalent drug for the brand name unless the prescriber prohibits generic substitution.
Generic substitution is regulated by state laws. These laws and regulations set requirements for when pharmacists may or may not substitute therapeutically equivalent generic drugs for brand name drugs.
Indications of no substitution include:
- “Dispense as written”
- “DAW”
- “no substitution”
- “do not substitute”
- “DNS”
Controlled Substances
Controlled substances are subject to stricter controls through Federal and State laws and regulations due to their potential for misuse, abuse, diversion, and addiction.
The Federal law regulating controlled substances is the Controlled Substance Act.
The Law and its regulations controls over the manufacture, import, export, distribution, ordering, dispensing and prescribing of controlled substances.
Pharmacies must comply with both State and Federal controlled substance laws.
Schedules of Controlled Substances
The Federal Controlled Substance Law created five classifications for controlled substances numbering I, II, III, IV, and V.
A drug is placed into a controlled Schedule based on certain criteria, such as it’s potential for abuse or addiction and its medical use.
Schedule I is the most restrictive and Schedule V is the least restrictive of the controlled substances.
Labeling Controlled Substances
The symbol that indicates a controlled substance is the capital letter “C” with the appropriate roman numeral placed inside the “C” symbol.
Dispensing Controlled Substances
For a controlled substance prescription to be valid, it must be prescribed by a licensed prescriber for a legitimate medical purpose in the normal course of the prescriber’s professional practice.
The prescribing practice must be registered with the DEA and be licensed to prescribe controlled substances by the state. Controlled substances prescription must contain:
Schedule V prescriptions may be refilled more than five times, but have a six-month the limit on refills.
Schedule II prescriptions may not be refilled and are not transferable between pharmacies.
Federal law allows schedule III, IV, and V prescriptions to be transferred from one pharmacy to another for refill (if the state permits).
Pharmacies are required to maintain complete and accurate records for all controlled substances that they purchase , receive, distribute or dispense.
Federal law requires that pharmacy to keep controlled substance records for two years and have them readily available for DEA inspection if requested. Examples of records include:
The Federal law regulating controlled substances is the Controlled Substance Act.
The Law and its regulations controls over the manufacture, import, export, distribution, ordering, dispensing and prescribing of controlled substances.
Pharmacies must comply with both State and Federal controlled substance laws.
Schedules of Controlled Substances
The Federal Controlled Substance Law created five classifications for controlled substances numbering I, II, III, IV, and V.
A drug is placed into a controlled Schedule based on certain criteria, such as it’s potential for abuse or addiction and its medical use.
Schedule I is the most restrictive and Schedule V is the least restrictive of the controlled substances.
Labeling Controlled Substances
The symbol that indicates a controlled substance is the capital letter “C” with the appropriate roman numeral placed inside the “C” symbol.
Dispensing Controlled Substances
For a controlled substance prescription to be valid, it must be prescribed by a licensed prescriber for a legitimate medical purpose in the normal course of the prescriber’s professional practice.
The prescribing practice must be registered with the DEA and be licensed to prescribe controlled substances by the state. Controlled substances prescription must contain:
- The date issued
- The patients full name & address
- The practitioners name, address & DEA registration number
- The drug name
- Strength
- Dosage form
- Quantity prescribed
- Direction of use
- Number of authorized refills
- Signature of prescriber
Schedule V prescriptions may be refilled more than five times, but have a six-month the limit on refills.
Schedule II prescriptions may not be refilled and are not transferable between pharmacies.
Federal law allows schedule III, IV, and V prescriptions to be transferred from one pharmacy to another for refill (if the state permits).
Pharmacies are required to maintain complete and accurate records for all controlled substances that they purchase , receive, distribute or dispense.
Federal law requires that pharmacy to keep controlled substance records for two years and have them readily available for DEA inspection if requested. Examples of records include:
- Invoices
- Receipts of purchases
- Inventory of records
- Records of transfer
- Patient info
- Prescriber info
- Pharmacy ID
- Prescription info