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Pharm Blueprint Exam 1

Terms in this set (76)

-Preclinical investigation can be either in vitro or in vivo
-In vitro- a glass or plastic container (a test tube)
-In Vivo- in a living organism (mouse), this testing allows for some information on toxicity and dosing, once this is completed, researchers can determine if the drug should be tested on peoples

Clinical Research:
Phase 1-
Study Participants: 20 to 100 healthy volunteers or people with the disease/condition.
Length of Study: Several months
Purpose: Safety and dosage
Approximately 70% of drugs move to the next phase

Phase 2
Study Participants: Up to several hundred people with the disease/condition.
Length of Study: Several months to 2 years
Purpose: Efficacy and side effects
Approximately 33% of drugs move to the next phase

Phase 3-
Study Participants: 300 to 3,000 volunteers who have the disease or condition
Length of Study: 1 to 4 years
Purpose: Efficacy and monitoring of adverse reactions
Approximately 25-30% of drugs move to the next phase

Phase 4-
Study Participants: Several thousand volunteers who have the disease/condition
Purpose: Safety and efficacy

-Once a drug company has information that the new drug is safe and effective, it can file for marketing with the FDA
-The FDA reviews the information and either approves or requires more information before allowing the pharmaceutical company to market the drug to the public
-After a drug is approved, it may take months to several years in order to see a true picture of the drugs safety
-The FDA has reporting programs to allow for adverse reactions to be reported post-marketing
-Based on this information, new information can be added to a drug after it has been on the market, or a drug could be removed from the market due to safety concerns that were not evident during clinical trials
Right patient:
-Two patient identifiers must be used:
-Name and Date of birth or Medical record number
-New systems allow barcode scanning-must still ask patient to state their name and date of birth.

Right drug:
-Must have a prescription signed by a prescriber on the patient's case.
-Ensure it is the correct drug (generic names/brand name)
-Generic name is preferred on orders to help decrease medication errors
-If the order is unclear, contact the prescriber to clarify
-When we are administering the medications, we should be checking the label a minimum of 3 times to ensure the correct medication, dose and route are being administered.

Right does:
-Refer to the prescriber's order
-Use a drug reference manual to make sure it is a safe dose for this patient
-Calculate dosages based on mg order and form available
-Double check your math, looking for any errors that you might have made.

Right time:
-Facilities have protocols as to what time frame you may administer medications
-You have 6 patients, all of them have 0900 medications. Can you administer all medications to each patient at exactly 0900? No, so find out what the policy is at your facility
-Most often, an hour before and an hour after the medication is due is accepted, however, you must also consider what medications your patient is receiving. If it is something that can cause harm if not given exactly on time, you should still make it your priority to administer that medication ON TIME.

Right route and Form:
-This requires a complete order from a prescriber (if a route is not included, contact the prescriber and ask for a clarification).
-Never assume the route.

Right Documentation:
-Important for patient safety
-Widely known as the "sixth right".
-The nurse should document timely and include all pertinent information.

Right reason:
-Refers to using appropriate medications to treat patient problems.
-This is important if the doctor prescribes acetaminophen (brand name is Tylenol) for fever, it is not appropriate to administer it for pain. You would need to contact the prescriber and ask if the Tylenol can also be administered for pain. Also, the nurse should review the patient's history and ask the patient why they are on each medication.

Right Response or Right Evaluation:
-Refers to evaluating the patient's response to a medication, looking for desired and undesired responses.

Right to refuse:
-Refers to the patient's right to refuse any treatment that they wish, for any reason.
-We should never force a patient to take a medication or trick them into taking it by saying it is something else. If a patient refuses a medication, ask why they are refusing it, and re-educate the patient about the medication.
-If they still refuse, you must notify the prescriber and document the refusal.

Right assessment:
-Meaning that you perform the correct assessment prior to administering the medication.
-The right to a complete and clear order. If the order is not clear or complete, we have the right to ask for clarification. No one should make you feel bad for making sure your patient is safe by clarifying an order.

-The right to have the correct drug, route (Form), and dose dispensed. We always double check the medications that we obtain from the locked medication cabinets, patient medication drawers and pyxis systems. It is our right to have the correct drug, and if pharmacy stocked an incorrect drug (or even an expired drug), we have the right to contact and obtain the correct drug.

-The right to have access to information. Hospitals are required to have information about medications for nurses. When I was a brand-new nurse, we had a drug guide on the unit that we could use. It was a couple years old and they didn't replace it. Soon after, they got a new medication administration system, where you could click on the drug in the patient's record and access all the information about the drug. It was so nice to have that instead of the old drug guide.

-To have policies that guide safe medication administration practices. If a hospital puts in a policy that does not allow for safe medication practices, you have the right to advocate for a change in policy.

-The right to administer medications safely and to identify system problems. Think about the Dennis Quaid story. It was a system problem- the concentration of heparin should not have been stocked in a neonatal intensive care unit. The label on the heparins were very similar, making it easy to make the error. Better labelling was needed, and the hospital needed to pull that concentration of heparin from the stock in the NICU.

-The right to stop, think and be vigilant when administering medications. Being a nurse is fast-paced and we are constantly pushed to do more with less. We must advocate for safe staffing that will allow for us to have the time to administer medications safely.
Errors can occur in any step of the medication process​:
-Prescribing (Most common area for errors and half of all preventable errors occur in this step) ​
-Transcribing (4th most common area) ​
-Dispensing (Third Common area) ​
-Administering (Second common area for errors to occur) ​

Causes of medication errors include the following areas:
Failed communication:
-This can be a result of poorly handwritten or verbal orders. It is best to clarify a poorly handwritten order than to try to guess what the order says. Verbal orders also are common areas that cause errors
-Misuse of zeroes in decimal numbers. Leading zeros should be used if the number is less than 1. For example, 0.5 mg instead of .5 mg. Trailing zeros should not be used. For example 1, instead of 1.0
-Use of apothecary measures (grains, drams) or package units (amps, vials, tablets) instead of metric measures (grams, milligrams, milliequivalents). If an order reads, "Give 2 tablets of acetaminophen PO every 6 hours," we would need to clarify the order. There are multiple doses of acetaminophen tablets and a mg order will be clearer. Instead, the order should read "Give 650 mg of acetaminophen PO every 6 hours"
-Misinterpreted abbreviations. Davis's Drug Guide has a list of commonly misinterpreted abbreviations. It includes more than what are on the Joint Commissions "Do not use abbreviation list". When it comes to nursing and writing medication orders or documenting in the medical records, I always say "when in doubt, write it out." The use of abbreviations can harm patients.

Poor distribution practices:
-Remember in the Dennis Quaid video that he mentions that the dose should not have been in the NICU? This is a poor distribution practice: keeping something in stock that is not likely to be given or is likely to be confused with another medication.

Dose miscalculations:
-As nurses, we are the last link in the chain before the patient gets the medication.
-Double check the dose calculations and make sure it is safe. Therefore, the dosage calculations information is so important for patient safety.

Drug packaging and drug delivery system:
-Again, in the Dennis Quaid video, he mentions the packaging was similar and that may have been a part of why the error occurred.

Lack of patient education:
-Involving the patient and providing clear education can help prevent medication errors. The knowledgeable patient can recognize when something has changed in his or her medication regimen and can question the health care provider
How medication errors are classified: ​
1. No error but circumstances could have led to an error​
2.Error occurred but no harm to patient​
3. Error caused harm​
4.Error resulted in death​

1. Multiple system check and balances​
2. Prescribers must write legible orders, or it must be entered electronically​
3. Consult pharmacists or recent drug references if any concern​
4. Check medication 3 times before administering​
5. Follow the "rights" of medication administration​
6. Only give medications you prepare
7. Avoid distractions

Responding and reporting​
1. If error does occur, it must be reported​
2. Assess the patient and address any urgent safety issues (can use charge nurse for assistance) ​
3. Once you have assured the patient is safe, you must notify the prescriber and nursing manager. If you cannot leave patient alone due to condition, another nurse can provide appropriate care to the patient while the nurse contacts the prescriber.​ It is best to notify the charge nurse prior to calling the prescriber in order to have someone available to help monitor the patient.
4. Follow-up procedures or antidotes may be prescribed​. The most important thing is patient
safety during this process. ​
5. Part of reporting is completing appropriate forms (such as an incident report). ​

1. Make sure it is accurate, thorough and objective​
2. Avoid judgmental words such as "error". ​
3. Chart factual information​
4. Note any observed changes in patient status (physical and mental) ​
5.Document that the prescriber was notified and any follow-up actions that were implemented​
6.Document ongoing monitoring of the patient​
-Instruct patient on the proper use of the metered-dose inhaler.
-There are 3 methods of using a metered-dose inhaler.
-Shake inhaler well.
(1) Take a drink of water to moisten the throat; place the inhaler mouthpiece 2 finger-widths away from mouth; tilt head back slightly. While activating the inhaler, take a slow, deep breath for 3-5 sec; hold the breath for 10 sec; and breathe out slowly.
(2) Exhale and close lips firmly around mouthpiece. Administer during second half of inhalation and hold breath for as long as possible to ensure deep instillation of medication.
(3) Use of spacer.
-Consult health care professional to determine method desired prior to instruction. Allow 1-2 min between inhalations. Rinse mouth with water or mouthwash after each use to minimize dry mouth and hoarseness. Wash inhalation assembly at least daily in warm running water.

-For use of dry powder inhalers, turn head away from inhaler and exhale (do not blow into inhaler). Do not shake. Close mouth tightly around the mouthpiece of the inhaler and inhale rapidly.

Steps for Using Your Inhaler
1. Remove the cap and hold inhaler upright.
2. Shake the inhaler.
3. Tilt your head back slightly and breathe out slowly.
4. Position the inhaler in one of the following ways as seen on the slide (A or B is optimal, but C is acceptable for those who have difficulty with A or B. C is required for breath-activated inhalers)
5. Press down on the inhaler to release medication as you start to breathe in slowly.
6. Breathe in slowly (3-5 sec).
7. Hold your breath for 10 sec to allow the medicine to reach deeply into your lungs.
8. Repeat puff as directed. Waiting 1 min between puffs may permit second puff to penetrate your lungs better.
9. Spacers/holding chambers are useful for all patients. They are particularly recommended for young children and older adults and for use with inhaled corticosteroids.

Avoid common inhaler mistakes.

Follow these inhaler tips:
• Breathe out before pressing your inhaler.
• Inhale slowly.
• Breathe in through your mouth, not your nose.
• Press down on your inhaler at the start of inhalation (or within the first sec of inhalation).
• Keep inhaling as you press down on inhaler.
• Press your inhaler only once while you are inhaling (one breath for each puff).
• Make sure you breathe in evenly and deeply.
• If you are using a short-acting bronchodilator inhaler and a corticosteroid inhaler, use the bronchodilator first, and allow 5 min to elapse before using the corticosteroid.