A. C. E. Inhibitors – Angiotensin Converting Enzyme Inhibitors block the conversion of angiotensin I to angiotensin II. Avoiding Angiotensin II may avoid increased blood pressure and vasoconstriction. They usually have the suffix “PRIL” A. 2. R. B. – Angiotensin 2 Receptor Blockers block Angiotensin 2 enzymes from specific receptor sites. Avoiding Angiotensin 2 activity helps prohibit vasoconstriction. They usually have the suffix “ARTAN” Anti-Biotics – Anti-Biotics inhibit the reproduction of new Bacteria cells.
There are several varieties and Drug Class Definitions of Anti-Biotics. Anti-Convulsants – Anti-Convulsants suppress the rapid firing of neurons in the nervous system (brain). Also known as Anti-epileptic drugs and Anti-Seizure drugs. Anti-Diabetics / Sulfonylureas – lower glucose levels in the blood. They are only used to treat Type II Diabetes. Benzodiazepines – Also know as “Benzos”. Benzos are used as anti-anxiety agents, muscle relaxants, sedatives, and hypnotics. They usually have the suffix “PAM”. Beta Blockers (B1) – Also known as Beta-adrenergic blocking agents.
Block adrenaline receptors, which are part of the central nervous system and mediate a “Fight or flight” response, which would cause actions in the heart. They usually have the suffix “OLOL”. Calcium Channel Blockers – Calcium channel blockers work by blocking calcium channels in cardiac muscle and blood vessels, thereby slowing down activity in the heart. Diuretics – Diuretics are primarily used to treat hypertension. They promote evacuation of water from the body, which decreases the load on the cardiovascular system.
HMG-CoA Reductase Inhibitors – Also known as Statins, They inhibit the body’s cholesterol production and usually have the suffix “STATIN”. NSAID – Non Steroidal Anti-Inflammatory Drugs are commonly used as pain killers and Fever Reducers. They are non-narcotic and can be sold OTC. Opioid – Opioids provide an analgesic effect by decreasing the perception of pain and increase pain tolerance. Proton Pump Inhibitors – Inhibit the action of the gastric proton pump, thereby reducing gastric acid production. They usually have the suffix “PRAZOLE”. S. S. R.
I – Selective Seratonin Re-Uptake Inhibitors increase the body’s Seratonin level by inhibiting its re-uptake into the Presynaptic cell. Commonly indicated as an Anti-Depressant. | Pharmacy Regulators and Agencies| F. D. A – Approves new drugs – Process new drug applications – regulates package inserts – Regulates advertising of drugs – issues recalls – Federal AgencyD. E. A – Federal agency – Enforces CSA (controlled substance act) – Track controlled substance manufactured and sold – Investigates all violations involving controlled substance – Issues DEA numberB.
O. P – Regulates licensing of Pharmacists – Regulates licensing of Pharmacy Techs – Set state laws/requirements – Outline the operating guidelines in the pharmacy – Investigate violations of the operating guidelines – Determine state regulated controlled substances – State agencyThe Joint Commission – Formerly JCAHO – Join Commission on Accreditation of Healthcare Organizations – Watches over Healthcare Organizations – Third party auditors/ regulators for insurance providersRemember who does what: – Ask if the question involves a controlled substance.
If it does, then the DEA will likely be the answer. If the question involved a drug that is not controlled, FDA will likely be the answer. If the question sounds state specific or involves licensing, then the BOP is likely the answer. D. E. AD. E. A Schedules Schedule 1- No accepted medical use. Extremely high potential for abuse. Ex- Heroin and MDMASchedule 2- Does have medical use. High potential for abuse. Ex- Oxycodone, codeine, RitalinSchedule 3- Does have medical abuse. Moderate abuse potential less than schedule 2.
Ex- Vicodin, Tylenol with codeine Schedule 4- Abuse potential exists less than schedule 3Ex- Ambien, Darvocent and LorazepamSchedule 5- Lowest abuse potential of the DEA schedule abuse potential exists, but less than schedule 4. Ex- Cough medicine with codeine or anti-diarrheals D. E. A Form 222 – Must be used whenever schedule 1 and 2 are bought, sold or transferred between pharmacies or distributors. the forms are only available through the DEA and errors are not acceptable on the form.
In case of an error, the form must be voided and kept on file and a new formed used. For schedule 3-5, a form 222 is not necessary. Refills – There are no refills allowed on schedule 2 drugs and schedule 2 drug prescriptions can not “called in” or transmitted electronically unless it is an absolute emergency and certain criteria is met. D. E. A Check Digit – Add together 1,3,5 digits – Add together 2,4,6 and multiply by 2 – Add totals and the last number in the total is the check digit D.
E. A Controlled Drugs – Schedule 2:Percocet- Oxycodon + APAP – Pain ReliefOxycontin- Oxycodone – Pain ReliefConcerta- Methylphensdate – ADHDAdderall – Amphetamine + Dextroamphetamine – ADHDVyvanse- Lisdexamfetamine – ADHDDuragesic- Fentanyl Patch – Pain ReliefMethadose- Methadone- Opoid Recovery – Schedule 3:Vicodin- APAP+Hydrocodone – Pain ReliefTylenol 3- Codeine+APAP – Pain ReliefSuboxone- Buprenorphine – Opoid RecoveryTussionex- Hydrocodone+Chlorpheniramine – Cough suppresent+ Antihist.
-Schedule 4:Xanax- Alrazolam – BenzoAmbiem- Zolpidem – Sleep AidKlonopin- Clonazepam – BenzoAtivan- Lorazepam – BenzoDarvocet- Propoxyphene+APAP – Pain ReliefValium- Diazepam – BenzoRestoril- Tamazepam – Sleep Aid Adipex- Propoxyphene+APAP – Appitite SupressantLunesta- Ezopiclone – Sleep AidSoma- Carisoprodol – Muscle RelaxerGuidelines for Filling Prescription Orders Prescription order expiration dates – Prescription order must be dated, and it has an appropriate expiration date bases on the type of drug ordered.
If its not filled in time, the script expires. DEA Sch 2- NO Experation DEA Sch 3-5 – 6 Months Legend Drugs- 12 MonthsRefills – If refills are allowed by the prescriber, it will be noted on the prescription. However, there are boundaries and limitations. These are the guidelines: DEA Sch 2- No Refills Allowed DEA Sch 3-5 – Up to 5, but only 5 times* Legend Drugs- up to 12 months worth*If a patient has a ssh 3-5 prescription with 5 refills of 100, but can only afford 50 at a time, they will only get a 250 total (not 500) period.
Each time a refill is redeemed, that refill is then voided. So, if you are authorized a refill of 100, but only get 50, you then forfeit the other 50. DEA Controlled Prescription – Must contain at least: – Date of prescription issue – Patient’s name and address – Practitioner’s name, address, and phone number – Drug name – Drug Strength – Dosage form and instructions – Exact quantity prescribed – Complete directions for use – Number of refills – Valid DEA numberSchedule 2 Drug Prescriptions also: – Must be manually signed by practitioner.
No exceptions. – May not be Faxed or Called in, except for a valid emergency. – May not have any refills FDA Recall DefinitionsFDA Recalls Class – Class one – Would be used in a case where there is a probability that, the use of or exposure to violative product will cause serious adverse health consequences or death. – Class two- Cause temporary health problems and probability of serious health adverse health consequences is remote. – Class three- Not likely to cause adverse health consequences, but has violated some FDA regulation.
Other Actions – FDA market withdrawal- When a product has a minor violation that would not be subjected to FDA legal action. Manufactures must remove product from distribution markets or correct the violation. – Medical Device Safety Alert- Used for medical apparatus equipment. When medical device may present an unreasonable risk of substantial harm. FDA- New Drug Application (NDA) Process New Drug Development -Pre-Clinical -Animal Testing -Investigations new drug review (IND) – Review of pre-clinical trial results – Determination of safety to use on humans – Authorization to ship across state lines.
New Drug Clinical Trials -Phase 1 – Involves a small number of healthy volunteers (25-100) – Safety tolerated dosage determined – Identification of major side effects – Emphasis on safety and maximum tolerated dosages. -Phase 2 – Involves many volunteers (100-3000) – Emphasis on the drug effect against what its designed to treat. – Effects compared with patients unknowingly taking placebos – Study of different populations and different dosages. – Testing the drug in combination with other drugs. – Final phase before presenting to FDA for approval.
New Drug Post Approval Trails -Phase 4 – Ongoing/Post approval trials. – Health-care professionals to report any adverse findings – Phase last eternally, as long as drug is on marketFederal Food and Drug Act of 1906 – AKA Pure Food and Drug Act – Provided authority for federal inspection of meat products and prohibits sale of adulterated food. – Required that “Secret Elixirs” containing ingredients like: Cocaine, Heroin, Morphine, and Alcohol are labeled with correct information about ingredients as well as dosages.
Narcotic Tax Act of 1914 – AKA as the Harrison Narcotic Act – Provieded authority for internal revenue service to collect tax on opiates be registered with the IRS. – Emphasis was on attempting to control the massive flow of opiates in order to protect the public from rising addiction. Federal Food, Drug and Cosmetic Act of 1938 – AKA FDCA 1938 – Replaced he food and drug act of 1906 – Provided better clarification about misbranding definitions – Provided better clarification about adulteration definitions – Gave the FDA authority to require adequate testing of new drugs for safety.
The Durham-Humphery Amendment of 1951 – Created a distinction between “OTC” and “Legend Drugs” – Legend drugs can only be dispensed with a valid prescription – Requires legend drugs to carry the statement: “Caution: Federal Law prohibits dispensing without a prescription. ” – Most people refer to legend drugs simply as “Prescription Drugs” – The emphasis on this act was to insure safety thru qualified medical supervision. The Kefauver-Harris Amendment of 1962 – AKA “Drug Efficacy Amendment” – Required drug manufactures to provide proof of the effectiveness and safety of their drugs before approval.
– Required drug advertising to be more closely regulated and disclose accurate information about side effectsThe Bureau of Narcotics and Dangerous Drug (BNDD) – Predecessor agency of the DEA – In 1973 the BNDD merged into the DEA – DEADrug Abuse Prevention/Controlled Act of 1970 – AKA Controlled Substance Act (CSA) – Completely replaced the Harrison Act – Required the use of DEA numbers – Required comprehensive record keeping the transaction tracking – Enforced by the DEA under the US Dept.
of JusticePoison Prevention Packaging Act of 1970 -AKA PPPA – Designed to reduce the risk of children ingesting dangerous substances – Required locking caps on most prescriptionsCombat Methamphetamine Epidemic Act 2005 – Enacted to regulate the OTC sales of pseudo ephedrine – Identity and address of each purchaser to be kept for two years – Daily sales of regulated products not to exceed 3.
6 grams – 30 day purchase limit not to exceed 9 grams – 30 day purchase via mail order not to exceed 7. 5 gramsNational Drug Code (NDC)National Drug Code – System used to identify legend drugs. Part of the drug listing act of 1972 requires manufactures of drug products to assign a unique number to each product based on the individual drug type, strength, packaging size and where it was manufactured. 0339-4164-06 -First Segment- Identifies the drug manufactures.
This number is unique to the maker or re-packaging of the product- Second segment of the NDA identifies the product-Third segment of the NDA identifies the packaging Dosage FormsEnteral Medications – Enteral medications are given orally and pass through the GI tract to be absorbed into the bloodstream and metabolized by the liver. This includes oral, naso-gastric, and rectal routes. Parenteal Medications – Are injected or placed into the body tissues and do not pass through the liver before entering the bloodstream.
This can include injections, topical and inhalation routes. Generally in pharmacy, parenteral refers to injection. Topical and inhalation routes are separated into their own routes of administration. Injectable Drugs – Are usually in the form of solutions or powders, which are mixed with a sterile diluent to render an injectable solution. Inhalation – Routes of administration are inhaled through the mouth or the nose and usually act directly on the respiratory system before entering into the bloodstream.
They are often used to treat respiratory diseases, but gases are inhaled for general anesthesia as well. Topical – Dosages are applied to the skin surface or a mucous membrane. Oral Suspensions – Drugs mixed with but not completely dissolved into liquid. Needs to be shaken before use. Syrups – Contain a high concentration of sucrose or sugar to sweetenElixirs – Between 5-40% alcohol Tinctures -17-80% alcoholEmulsions -Suspension involving one liquid in a second liquid with which the first will not mix. oil and water.
Pharmacology – Study of how a chemical will react with or affect a patientPharmacokinetics – How the patients body will process a drugPharmacokinetics Basic Components – i Absorbs – ii Distributes – iii Metabolize (ADME) – iv Eliminate Zero Order Kinetics- Gauge the speed at which the drug is broken down by the bodyMATHLiquids 1cc- 1ml 3tsp- 1tbsp 5ml- 1tsp 2tbsp- 1oz 15ml- 1tbsp 16oz- 1pt 30ml- 1oz 2pt- 1qt 480ml- 1pt 4qt- 1gal 3785ml- 1gal 1liter- 1000mlMass/Dry/Solids 1Kilogram- 1000 Grams 1kg- 2.
2lbs 1Gram- 1000Milligram 1lbs- 454gm 1Milligram- 1000Micrograms 1oz- 30gm 16oz- 1lbInsulin Units100IU- per/ml100Int’l units- per milliliterTemperatureC= (F-32)x(5/9)F= Cx(9/5)+32Clark’s RuleAdult dose x (weight? 150)= Child’s DoseYoung’s RuleAdult Dose x (Age ? (Age+12))Intravenous CalculationsVolume? Time= RateRateXTime= VolumeVolume? Rate= TimeIV Infusion Set CalculationsVolume (mL) X Drop FactorMinutes (gtt/ml)Concentration Percentage CalculationsV/V 1ML 100ML Volume Percentage (liquid)W/W 1GM 100GM Weight Percentage (Dry)W/V 1Gm 100ML Weight/Volume PercentageBSABSA(m? )=[(inchesxLBS)? 3131]. 5|