Dr. Bartlett New Drug Development and Prescription Writing Page 1 of 4
Total Page：16
File Type：pdf, Size：1020Kb
FUN2: 11-12:00 Scribe: Ashley Holladay Thursday, December 4, 2008 Proof: Brittney Wise Dr. Bartlett New Drug Development and Prescription Writing Page 1 of 4
I. Introduction[S1]: Talking about clinical cognitive thinking, writing scripts, how to safely use II. 4 Major Topics to cover [S2] a. New drug development- how get on market in the first place b. Unlabeled drug uses and what that means c. Drug use during pregnancy and FDA categories for that d. Controlled substances-specifics dealing with that because both optometrists and dentists will prescribe III. 2 Broad Categories for Drugs in US[S3,S4]: a. OTC- over the counter- sold without Rx regulated by FDA b. Legend- federal government prohibits without Rx- bear legend on the label of the product i. Controlled- Drug enforcement administration (DEA) regulates- have abuse and addiction potential ii. Non-controlled- will use on a daily basis in practice regulated by FDA IV. New Drug Development [S5] a. There are certain steps that a drug has to go through before it can go on the market b. Preclinical- lab tests, design, computer programs, conception, animal testing c. IND- investigative new drug designation- if drug looks promising. This is usually a quick turnaround of FDA approval. FDA approves and can begin human testing- transport across state lines, recruit human subjects. d. Phase I- interest around safety, not really concerned with whether or not it works. e. Phase II- larger scale- involve larger number of patients focus on efficacy and safety f. Phase III- pivotal study- even larger numbers of patients- lots of data- test to see if working for condition, side effects g. NDA- new drug application- submitted to FDA, turnaround time- average about 1 year, some drugs never approved h. Important for clinicians to understand about timeline and where certain drugs are i. [S6]- New Obesity Pills i. Pfizer, Merck, and UK drug company all have new drugs in the testing in different phases ii. Canavazoid receptor antagonist- block these receptors to regulate appetite j. Many clinical trials done at UAB [S7] k. Drug Approval Timeline [S8] i. Timeline in years- can last in average of about 4 years to IND (preclinical phase) ii. Takes a decade on average to get on the market iii. Sometimes phase IV studies are done after marketing (to test side effects)- post marketing surveillance studies iv. Patent expires after 20 years (from the time the patent issued, not the time the FDA approved) v. Philosophically most companies would like to have the patent issued as late in the process a possible. Most of the time this does not happen. They patent in the lab phase to protect the intellectual property. l. Standard Approvals [S9] i. How many new drugs coming on the market ii. About 12 months at the FDA for approval time iii. Standard NDA iv. BLA- biologic- genetically engineered drugs v. FDA approves 60-90 drugs per year vi. How many medications in the US- over 10,000 drug products commercially available V. Drugs With Unlabeled Uses [S10,S11] a. Label of a drug- package insert, legal document approved by FDA, for a certain clinical indication, for certain dosage, duration- proper utilization for that drug b. FDA can only approve what is submitted to them from the company (any other indication is off label i. Ex. A drug for asthma could be used to treat depression, but that was not what it was submitted to the FDA to treat- that would be an off-label or unlabeled use. c. Dosage/frequency or duration not in package insert not FDA approved- unlabeled use d. It is mportant for you to be familiar with label/ package inserts for drugs you are prescribing to your patients. e. Information a package insert contains [S12,S13]: i. brand and generic name of drug ii. chemical name iii. formulation (tablet, capsule, suspension, injection) iv. pharmacology v. mechanism of action vi. microbiology (if it is an antibiotic) vii. indications, contraindications FUN2: 11-12:00 Scribe: Ashley Holladay Thursday, December 4, 2008 Proof: Brittney Wise Dr. Bartlett New Drug Development and Prescription Writing Page 2 of 4 viii. precautions, adverse events, drug interactions f. [S14] Example of package insert for Prozac i. Black box warning- important to read- side effects and risks ii. Prozac- risk of suicidality g. Examples of Unlabeled Uses [S15] i. Misoprostol- prostaglandin analog. Prostaglandins are inflammatory mediators. This is given to patients who are on long term NSAID (Non Steroidal Anti Inflammatory Drugs) (Ibuprofen). When you take them long term there is a risk for peptic ulcers because you are breaking down the stomach lining. Misoprostol is used to replenish the prostaglandins inhibits by the NSAIDS 1. Unlabeled use- induces labor. ii. Valium- labeled as muscle relaxor 1. Unlabeled use- panic attacks iii. Quinine- labeled use- for Chloroquine resistant malaria 1. Unlabeled use- treat night time leg cramps iv. Over time it is learned to use medications differently from package insert h. [S16] It is legal to use unlabeled uses as long as 3 caveats apply: i. There needs to be a scientific or medical rationale. (Does it make sense according to the mechanism of the drug?) There needs to be an explainable reason ii. There needs to be peer reviewed literature- Evidence based medicine. Good scientific support or a scientific study iii. There needs to be informed consent from the patient. The patient has to acknowledge that they understand that the drug is not FDA approved for the condition you are treated. This should be documented in the chart. i. Negative consequences[S17] i. Legal issues 1. Ex.[S18] Cephalon- drug company that makes Phentora (narcotic analgesic approved for cancer pain) Some doctors have been used to treat other types of pain and some patients have died when taking from unlabeled uses. 2. When there are bad side effects from an off label use it increases your medical legal exposure as a healthcare provider. So be careful when prescribing a drug off label. ii. Insurance companies might not pay if unlabeled use of a drug 1. Ex. [S19] Insurance company refused to pay for Avastin treatment (approved for colorectal cancer). Being used for brain cancer, uses in the eye. Insurance companies could decline to pay the bill (Cost is $8000 per dose every 2 weeks) VI. Drugs in Pregnancy [S20] a. Every FDA approved drug has pregnancy label b. Can have no controlled studies on this i. Animal studies and mechanisms of action ii. Make studies for risk to fetus c. Ask every female of child-bearing age if she is pregnant or plans to get pregnant d. 19 year old patient comes in for 2nd opinion [S21,S22] i. Cornea should not have blood vessels ii. Hazy- should be very clear iii. This patient has severe allergic condition iv. Has been using steroid eyedrop for past several months v. Patient is 4 months pregnant. e. [S23] The FDA assigns A, B, C, D, or X to a medication according to a presumed level of risk. A is safest. X drugs are the least safe. i. Don’t worry about this exact narrative definition on this slide. It is summarized on the next. ii. This is what to remember[S24] 1. A drugs- no risk to fetus. Some of these drugs are prescribed in prenatal vitamins (Vitamin B6 good for morning sickness, Levothyroxine- thyroid disease) 2. B drugs- no evidence of risk. Some antibiotics. Brimonodine variant of Quanidine. 3. C drugs- risk cannot be ruled out. 4. D drugs- definite risk. Tetracycline- dental implications- pigmentation of teeth and bone structure and decreased development 5. X drugs- very definite risk- medical malpractice. Isotretinoin- Accutane- for acne- associated birth defects. Misoprostol can induce a miscarriage. iii. Very important to remember these categories. FUN2: 11-12:00 Scribe: Ashley Holladay Thursday, December 4, 2008 Proof: Brittney Wise Dr. Bartlett New Drug Development and Prescription Writing Page 3 of 4 iv. A and B relatively safe. v. C rather not use vi. Avoid D. vii. Absolutely avoid X. viii. The safest thing to do is not to use any medication at all during pregnancy, but some chronic diseases have to be treated (asthma, high BP, thyroid, diabetes) ix. [S26]Some drugs have different categories depending on different trimesters 1. Ex. Ace inhibitors for high blood pressure. C in 1st trimester, D in 2nd and 3rd 2. Pregnancy labeling task force to make labeling more meaning. f. Epocrates.com good website for free drug information software. VII. Controlled Substances [S27] a. Drugs that have abuse and addiction potential- regulated by the DEA. b. You must be registered with the DEA to utilize controlled drugs. c. This is separate fee and registration process from your optometry or dental degree. d. This will give you a DEA number that you will put on the Rx. You do not preprint this on your Rx pad. e. It is required for controlled drug Rx. Some pharmacists require for all Rx not just controlled. f. If you preprint the DEA number on your Rx pad- risk for drug diversion (drugs diverted away from their legitimate clinical use- sold on street etc.) g. [S28] 5 Schedules/ Categories of Controlled Drugs Ranked- smaller the number, the greater the risk for addiction or abuse potential i. Schedule I- so risky no accepted medical use (heroin, LSD, marijuana) ii. Schedule II- high addiction/abuse potential, can use clinically iii. Schedule III- less abuse iv. Schedule IV- even less v. Schedule V- some of these can be sold OTC, just have to sign for them at the pharmacy (codine containing cough medicine, most states changed to Sched. III) h. [S29] Controlled drugs have a symbol- Roman numeral with the schedule number with a capital C in front of it or encircling it. i. Example of controlled substance symbols- oxycodone and Tylenol III with codeine j. Examples of schedules of controlled substances [S30]- Read examples straight from slight. i. Website on bottom DEA diversion- schedules are listed there k. Requirements for Sched. II [S31] i. Rx must be written in ink. ii. You cannot call in a Sched. II controlled drug Rx iii. The patient has to take it personally to the pharmacy iv. They cannot be refilled l. Requirements for Sched. III [S32] i. Can be called in. ii. Federal law allows to refill up to 5 times within 6 months. iii. Always expire within 6 months for all controlled drugs. Non controlled drugs expire after 12 months. m. [S33] Sched. V can be Rx or OTC depending on the state. Most states now have as Sched. III. n. [S34] Never prescribe for a drug addict or a fictitious patient (one that is not your own) o. Never prescribe for office use- there are order forms for stocking your office- optometrist rarely would do this. VIII. [S35] Take a look at these useful websites a. Updated daily b. Orange book- generic drugs. Category A- therapeutically equivalent IX. Rx Writing [S36] a. [S37] Prescription- communication between prescriber and the pharmacist who will fill the prescription b. Will talk about out- patient prescribing, not in hospital, because most will work in outpatient setting c. [S38] Written- most common d. Call (telephone)- limitation on schedule II controlled drugs i. Always have the pharmacist read the Rx back to you. Similar sounding drugs. Make sure there is no confusion. Decreases everyone’s liability. ii. [S39] Electronic Rx- becoming more popular- eliminates confusion, bad handwriting, correct dosage.
1. There may be automatic checks for drug interactions and allergies with the patient’s data. X. Format for writing Rx. a. [S40] If in multi-doctor practice- circle your name. Pharmacist may not be able to read your signature. b. Upper part of the Rx pad- demographic- name, address, date FUN2: 11-12:00 Scribe: Ashley Holladay Thursday, December 4, 2008 Proof: Brittney Wise Dr. Bartlett New Drug Development and Prescription Writing Page 4 of 4 c. [S41] Every Rx pad for Medicaid patients has to be tamper proof- federal law i. Void when photocopied ii. Void when erased or changed iii. Watermark iv. Have to have 2-3 of these methods d. Patient’s name and date- always e. Age- important for young and old patients (pediatric dose)- pharmacists can double check f. Address only required for controlled substances g. Rx- superscription- ancient Latin designation for recipe h. Well written Rx has 3 lines [S43] i. 1st line- inscription-name of medication- generic or trade name form, concentration or strength (may not have to specify if only one), formulation(capsule, tablet, opthalmic suspension, ointment) ii. 2nd line-subscription- how much medication you want the patient to take with them from the pharmacy at that time (10 ml, 100 tablet, usually no more than 30 day supply because of insurance limitations) #sign put in front by convention or disp (dispense) or nothing at all iii. 3rd line- signatura- label on the outside that will tell the patient how to use the medication (Latin and English) want this to be very clear to the patient (communicating to the patient how to use) - pharmacist has the authority to change the wording to make it clearer to the patient iv. Sig.: (label) reason for prescription on the label v. GT- drop vi. OU- both eyes vii. B.i.d.- twice a day viii. Then reason for the Rx ix. 2 signature lines 1. Dispense as written- trade name 2. Product selection- permits pharmacist to dispense the generic although you have written a trade name because the generic is therapeutically equivalent 3. [S44] There are insurance issues with this. Some insurance require generics. Clinicians may not be in entire control of what the patient ultimately gets. x. [S45] Ex. Tetracycline class 1. Take 1 capsule. PO- by mouth, always put PO for oral medication 2. Q means every xi. Make sure you write legibly. [S48] xii. [S49] Avoid decimals. If you use a decimal, put a “0” in front of it. Don’t want patient to end up with 10X the dosage. Never use a trailing “0” after a decimal. xiii. Commonly used Latin abbreviations- need to know all of these. [S50,S51,S52] xiv. [S57] important website for error prone abbreviations and Rx writing
[End 51:32]