1) CORRECT - Implementation: outcome desired; cuff inflation decreases the risk of aspiration; cuff position and pressure should be assessed frequently; swallowing and breathing will cause tracheostomy tube movement 2) Implementation: outcome not desired; accumulated oral secretions above the cuff will drain into the bronchi; increased risk of infection 3) Implementation: outcome not desired; cuff pressure should be less than 20 mm Hg (25 cm H2O); risk of trauma to trachea with higher pressures 4) Implementation: outcome not desired; increases the risk of trauma to lower airways. 1) Assessment: outcome not priority but may be appropriate; can be asked as part of assessment 2) Assessment: outcome not priority but may be appropriate; should be assessed for further teaching 3) CORRECT - Assessment: outcome priority; action of nicotine is vasoconstriction; increases heart rate and myocardial oxygen consumption; increased risk of angina and myocardial infarction 4) Assessment: outcome may be appropriate but not priority; gum is place between cheek and gums; may stain dental work. The nurse cares for a client with a history of type 1 diabetes mellitus who has just returned to the surgical acute-care unit after a right below-knee amputation.
The client's capillary blood glucose is 480 mg/dL. The postoperative orders indicate 6 units of regular insulin subcutaneously should be administered. Which of the following is the FIRST action the nurse should take? Check the client records to see if insulin was given prior to surgery. Administer the 6 units of regular insulin subcutaneously. Administer the insulin when oral fluids are tolerated.
Contact the healthcare provider. During the admission interview, the client reports a red, itchy raised rash on the chest and lip swelling after use of aspirin and penicillin. The admission orders include bed rest, soft diet as tolerated, naproxen (Naprosyn), and cefaclor (Ceclor). Which is the BEST description of expected breath sounds heard during auscultation?
Administer the Ceclor as ordered; do not administer the naproxen. Administer the naproxen as ordered; do not administer the Ceclor.
Administer both the Ceclor and naproxen as ordered; document the client's response. Do not administer the Ceclor or naproxen; notify the healthcare provider. The nurse is responsible for triage of injured residents of an apartment building that collapsed during a tornado.
Which client should the emergency personnel see FIRST? A 38-year-old client with potential fracture left femur. Blood pressure 110/78, pulse 92/minute, shallow respirations at 16/minute.
A 42-year-old client with ecchymotic areas on the left anterior and posterior chest. Blood pressure 142/90, pulse 88/minute, shallow respirations at 20/minute.
A 48-year-old client with severe head trauma. Blood pressure 168/52, pulse 58 per minute, irregular respirations at 12/minute. A 64-year-old client complaining of left hand and wrist pain asking, 'Where am I?' Blood pressure 128/72, pulse 88/minute, respirations unlabored at 16/minute. 1) Outcome not desired; requires frequent assessment of neuromuscular function and monitoring response to therapy 2) Outcome not desired; elderly clients are at risk for clostridium difficile infection due to antibiotic therapy; client would need frequent assessment and evaluation 3) CORRECT - Outcome desired; LPN/LVN can care for stable clients with expected outcomes; nothing in question indicates instability; as cerebral edema resolves, the condition will improve 4) Outcome: not desired; client requires frequent assessment and evaluation; WBC indicates possible infection. The nurse cares for a client during a 24-hour urine specimen collection.
Several hours later, the client tells the nurse that she has started to menstruate. Which action by the nurse is MOST appropriate? Inform the health care provider that the client is menstruating.
Send the urine collected prior to the onset of the client's menstruation to the lab. Insert an indwelling bladder catheter during the remainder of the collection period. Request a separate urine collection container from the laboratory to be used during the remainder of the urine collection period. The nurse instructs a client about include digoxin (Lanoxin), furosemide (Lasix), spironolactone (Aldactone), and a low-sodium diet. Which statement by the client indicates the need for further instruction? 'I should weigh myself every morning and call the health care provider if I gain more than a couple of pounds in a few days.'
'I should call the health care provider immediately if I start to feel nauseated or have difficulty breathing with normal activities.' 'I plan to use salt substitutes now that I have to limit my sodium intake.' 'I should read food and nonprescription medication labels to check the ingredients.' The nurse cares for a client scheduled for a femoral popliteal bypass procedure. When the nurse approaches the client with the informed consent form, the client says, 'I don't need to talk to anybody about this procedure. I already know everything I need to know about it.' Which response by the nurse is BEST?
'After I explain the operation to you, both of us will sign the form for legal purposes and it will be placed in your chart.' 'Tell me what the healthcare provider told you about the risks and benefits of this operation.' 'Can I answer any questions that you have about the procedure?' 'You should read all these materials to be sure that you understand everything about this procedure.'
1) Implementation: outcome not desired; nurse should not explain the procedure; the health care provider doing the procedure should explain the risks and benefits 2) CORRECT - Assessment: outcome desired; nurse should determine if client understands risks and benefits of the procedure before the client and nurse sign the informed consent form 3) Implementation: outcome not desired; yes/no question non-therapeutic response 4) Implementation: outcome desired but not priority; reading materials do not ensure that client understands risks and benefits of the procedure. A man scheduled for a vasectomy tells the nurse that he and his wife are involved in a monogamous relationship. Which statement by the nurse is BEST? 'You will need to wear a condom when having sexual intercourse for 6 weeks following the vasectomy.' 'No other form of birth control is necessary for you or your wife at this time.' 'You do not need to wear a condom when having sexual intercourse for the next few weeks, but your wife should use spermicidal jelly.' 'Always wear a condom when having sexual intercourse because not all vasectomies are successful.'
A 12-year-old diagnosed boy with a fractured right femur is placed in balanced suspension traction with a Thomas splint and Pearson attachment. The nurse is MOST concerned by which client statement? 'I will experience more muscle spasms and pain while my leg is in traction.' 'I can lift my body up while I grab the overhead trapeze and bend my left leg.'
'The health care provider told me it is okay to move the head of my bed up and down by myself.' 'I need to put the phone where I can reach for it without moving onto my side.' 1) CORRECT - Implementation: outcome not desired; muscle spasm should decrease with traction; if muscle spasm pain increases, the amount of traction weight should be assessed 2) Implementation: outcome desired; vertical movement is allowed as long as line of pull is maintained 3) Implementation: outcome desired; balanced suspension traction not affected by movement of bed; not affected by client movement unless line of pull affected 4) Implementation: outcome desired; can move up and down only, moving side-to-side changes line of pull of traction. 1) Assessment: outcome desired but not priority; question stem tells you that assessment has been done; changes in pulse, color, sensation should be reported immediately to the healthcare provider 2) CORRECT - Implementation: outcome priority and desired; diminished pulses indicates change in circulation 3) Assessment: outcome desired but not priority; should report changes in circulation 4) Assessment: outcome not desired; symptoms suggest changes in circulation to extremity; more important to report change in distal circulation. The nurse reviews medications with a 35-year-old female.
The client takes 200 mg carbamazepine (Tegretol) orally twice daily. The client asks the nurse about future pregnancies. Which statement by the nurse is MOST appropriate? 'If you take 5 mg folic acid daily while trying to conceive, you should be able to get pregnant.' 'It is recommended that you take carbamazepine suspension instead of the tablets when trying to get pregnant.' 'You should contact your health care provider and discuss your concerns about pregnancy.'
'If you avoid drinking grapefruit juice, there should be no problem with conception.' 1) CORRECT - Assessment: outcome expected; normal specific gravity of urine, normal hematocrit; specific gravity and hematocrit increase with dehydration 2) Assessment: outcome not expected; increased specific gravity of urine, increased hematocrit; suggests ongoing fluid volume deficit 3) Assessment: outcome not expected; decreased specific gravity of urine, increased hematocrit; does not indicate improvement 4) Assessment: outcome not expected; increased specific gravity of urine, decreased hematocrit; does not indicate improvement. The home care nurse is visiting an alert, oriented woman living with her daughter. The client is malnourished and has multiple bruises on her body, and the situation is reported to the appropriate authority. After counseling the client and daughter, the nurse notes the situation has not improved. The client decides to remain with her daughter. Which action, if taken by the nurse, is MOST appropriate?
Respect the client's decision to stay in her daughter's home. Insist the client move in with her other child. Begin guardianship procedures. Place live-in help in the home. 1) Implementation: outcome not desired; skin needs to be toughened if prosthesis is going to be used; no lotions, creams, or powders should be used unless prescribed 2) CORRECT-Implementation: outcome desired; bandages may be loose; expose to air 20 min/day; inspect residual limb for redness, irritation 3) Implementation: outcome not desired; the prone position will decrease the risk of flexion contractures 4) Implementation: outcome not desired; client can sit in straight back chair; time should be restricted to 1 hour or less. The school nurse teaches accident-prevention to the parents of school-aged children. Which statement, if made by a parent to the nurse, indicates teaching is effective?
'I'm going to make sure my child wears a helmet, shin guards, and gloves when he rides his bike.' 'I keep my guns and ammunition in a locked cabinet in the basement.' 'The next time we go to the park, I'm going to teach my child the correct way to climb on the monkey bars.' 'I'm going to make sure my wife and I observe our child when he plays outside with friends.' 1) Implementation: outcome not desired; only bicycle helmet is recommended; additional protective gear with skateboarding or rollerblading 2) Implementation: outcome not desired; guns and ammunition should be kept in separate locked areas 3) CORRECT-Implementation: outcome desired; injury prevention facilitated by age-appropriate safety education 4) Implementation: outcome not desired; school-aged children are developmentally ready for less supervision; parents should encourage interaction with peers.
The client is admitted to the hospital with chest pain when taking deep breaths and peripheral edema. The health care provider's order for the client reads; 'Digoxin 0.25 mg orally now. Repeat digoxin 0.25 mg orally in 12 hours.' Which action, if taken by the nurse, is MOST appropriate? Do not administer the second dose of digoxin.
Call the health care provider to clarify the order. Administer half the prescribed second dose of digoxin. Administer the first and second dose of digoxin as ordered. 1) Implementation: outcome not desired; medication should be given; if nurse questions the order, the health care provider should be contacted 2) Implementation: outcome not desired; unnecessary; 1 milligram of digoxin is a digitalizing dose; digitalizing dose is necessary to reach therapeutic blood levels 3) Implementation: outcome not desired; nurse can never change prescribed dose 4) CORRECT-Implementation: outcome desired; loading dose to achieve therapeutic blood levels; if loading dose not given, therapeutic levels are not reached for 6 days.
The nurse cares for clients on an acute-care surgical area. Which client should the nurse see FIRST? The LPN/LVN reports that a client who had a thoracotomy 2 days ago has clots in the chest drainage system. The nursing assistive personnel reports that a client who had a thyroidectomy 24 hours ago refuses to ambulate 30 minutes after receiving hydrocodone (Vicoden). The family of a client who had a small bowel resection 48 hours ago reports the client is more confused than yesterday. A client who had an ileostomy 3 days ago complains of 'aching legs.'
The nurse makes a follow-up phone call to the family of an infant receiving treatment for watery diarrhea after 7 days of amoxicillin (Amoxil) therapy. The nurse knows teaching is successful if the family makes which statement? 'We wear a fresh pair of clean gloves with each diaper change.' 'We are not allowing our other children to be in the same room with the baby.' The grandmother wears a mask when changing the baby's diaper. The mother wears an apron when changing the baby's diaper.
A 25-year-old woman is admitted to the labor unit for delivery of her first child. Her husband is coaching her during labor. During the transitional phase of labor, the client begins to scream and grab the side rails with each contraction. Which action, if taken by the nurse, is MOST effective? Offer the client pain medication before her next contraction.
Assist the client to a side-lying position with her knees flexed and a pillow between her legs. Establish eye contact with the client and breathe with her.
Suggest to the client that she watch television between contractions. 1) Implementation: outcome not desired; not used during transition; not effective and may interfere with mother's cooperation; may cause respiratory depression in infant 2) Implementation: outcome desired but not priority; priority action is to assist client to get control 3) CORRECT-Implementation: outcome desired and priority; slow breathing, reorient; model appropriate behaviors; this will assist client to get control and reduce muscle tension 4) Implementation: outcome desired but not priority; meet physical needs first. The client with with a 5-year history of alcohol abuse is treated in the emergency room for acute alcohol intoxication.
The client is agitated and verbally abusive. Admission orders include chlordiazepoxide (Librium) 50 mg IM or PO every 4-6 hours for agitation. Which action by the nurse is MOST appropriate? Place the client in chest restraints. Assist the client to the bathroom every 2 hours.
Assign a licensed practical nurse to stay with the client. Administer disulfram (Antabuse) 500 mg every 12 hours. 1) Implementation: outcome not desired; incubation period is 14-21 days, not communicable at this time; if woman develops rubella infection during the first trimester, abortion may be considered 2) CORRECT-Implementation: outcome desired; communicability is approximately 7 days before to 5 days following onset of rash; client needs to be evaluated 3) Implementation: outcome: not desired; vaccination contraindicated for pregnant women; increased risk of fetal complications 4) Implementation: outcome not desired; needs to be seen by the healthcare provider.
A 7-year-old boy is brought to the emergency room by his mother following a fall from his bicycle. X-ray reveals healed fractures of the ribs. The child's mother states, 'My son is such a careless child; he's always having accidents or fights with his brother.'
Which response by the nurse would be MOST appropriate? 'When I document information about these injuries, it will be on your son's hospital record forever.' 'How would you describe your son's relationship with his brothers and sisters?' 'What I see suggests that someone has been abusing your son.' 'I will need to talk to the nurse manager about this situation before you leave.' The home health nurse is planning client visits for the day.
Which of the following clients should the nurse see FIRST? A 70-year-old diabetic with fasting blood glucose readings of 240-260 mg/dL for 1 week. A 65-year-old discharged from the hospital 2 days ago following coronary artery bypass graft surgery (CABG).
A 55-year-old with congestive heart failure who gained 3 lbs in the last 24 hours. A 40-year-old with metastatic breast cancer complaining of pain unrelieved by pain medication. The home care nurse instructs the daughter of a client diagnosed with congestive heart failure. The daughter states her father is taking digoxin (Lanoxin) 0.25 mg and the healthcare provider just prescribed furosemide (Lasix) 40 mg. Which statement, if made by the daughter to the nurse, indicates teaching is successful? 'I'm glad that Dad doesn't have to change his diet.' 'Dad is going to have to eat more cottage cheese and add some more salt to his diet.'
'Dad must increase his intake of cheese and yogurt.' 'I should encourage Dad to eat more fresh fruits and vegetables.' A man is returned to his room in stable condition after a transurethral prostatectomy (TURP). He has continuous bladder irrigation through a 3-way urinary drainage catheter with a 30-mL balloon tip. Tension has been applied to the catheter. The client reports that he feels pressure in his bladder and rectum, and feels as though he has to urinate. Which action should the nurse take FIRST?
Check the patency of the catheter. Assess residual urine volume using bladder ultrasonography. Assess the amount of drainage in the urinary drainage bag.
Decrease the tension on the catheter. A nurse is performing triage in the emergency department. Which of the following clients should the nurse see FIRST? A client with an open fracture of the left femur. BP 110/60, P 86, R 20, T 99.2° F (37.3° C). A client complaining of a 'crushing' headache. BP 160/ 100, P 76, R 18, T 98.4° F (36.9° C).
A client with burns on the face, chest, and hands. BP 120/80, P 100, R 24, T 98.8° F (37° C). A client with type 1 diabetes. Blood sugar 480 mg/dL. BP 100/60, P 100, R 26, T 99.4° F (37.4° C).
The nurse presents a class on herbal medications at a community health care seminar. Which statement should be included in the class?
Select all that apply 1. (1.) The potency of herbal preparations varies between manufacturers.
(2.) The FDA tests and regulates herbal preparations. (3.) Herbal preparations are classified as dietary supplements. (4.) Ma huang contains ephedra and can be dangerous for people with high blood pressure. (5.) Herbal preparations are used in the treatment of immune system dysfunction.
(1.) CORRECT - read labels carefully to determine the exact amount of herbs in the preparation (2.) herbal preparations are classified as dietary supplements; adverse reactions may be reported after use (3.) CORRECT - the FDA does not research or regulate herbal preparations because they are classified as dietary supplements (4.) CORRECT - read labels carefully to determine what the herbal preparation contains (5.) label should state that the herbal preparation will 'decrease inflammation or support the immune system'; label cannot say that the preparation 'protects against cancer'. The nurse feeds the client in a chair when the client suddenly begins to choke on food.
The client is conscious but unable to speak. Which action is MOST appropriate for the nurse to take? Encourage the client to cough and breathe deeply. Leave the client in the chair and apply vigorous abdominal or chest thrusts from behind.
Return the client to the bed and apply vigorous abdominal or chest thrusts while straddling the client's thighs. Apply several vigorous back blows until the food dislodges. 1) Implementation: outcome not desired; more important to protect from injury during the seizure; no indication oxygen is needed 2) CORRECT-Implementation: outcome desired; protects client from injuries; stay with client 3) Implementation: outcome not desired; rectal diazepam used to treat status epilepticus in children; not indicated for single seizure 4) Implementation: outcome not desired; turn client to side after the seizure to reduce risk of aspiration; should protect extremities during seizure. The nurse describes to a male client how to collect a clean-catch urine for culture and sensitivity. Which explanation, if made by the nurse, is MOST accurate?
'The urinary meatus is cleansed with an antiseptic solution, and then a urinary drainage catheter is inserted to obtain urine.' 'You will be asked to empty your bladder one half-hour before the test; you will then be asked to void into a container.' 'Before voiding, the urinary meatus is cleansed with an antiseptic solution; urine is then voided into a sterile container; the container must not touch the penis.' 'You must void a few drops of urine, and then stop; then void the remaining urine into a clean container which should be immediately covered.'
An LPN/LVN informs the nurse that aspirin 325 mg was given to a client even though 80 mg aspirin had been ordered once daily. The LPN/LVN asks the nurse if it is necessary to complete a medication-error form since 'no harm was done.' Which statement, if made by the nurse, is BEST? 'What do you mean, 'no harm was done'? 'A medication-error form must be completed whenever the wrong preparation of a medication is given.'
'I will call the health care provider and ask what should be done to deal with this error.' 'It is not necessary to complete an incident report with over-the-counter medications.'
1) Assessment: outcome not priority; assessment of client must be done by nurse; question is not necessary 2) CORRECT-Implementation: outcome desired; contains full description of situation, error committed, condition of client, remedial steps taken; medication error form must be completed for all variances 3) Implementation: outcome not desired; it is a nursing responsibility; health care provider should be informed 4) Implementation: outcome not desired; always complete form for any medication error. The nurse counsels a woman at 36 weeks gestation who has attended childbirth class in preparation for labor and delivery. Which statement by the client requires an intervention by the nurse? 'I now know when to expect discomfort during labor and delivery and the things I can do to decrease the discomfort.' 'My husband is still concerned that he is not sure what to do during the labor process.' 'Even though I learned pain control techniques, I still may need some pain medication during labor and delivery.'
'The breathing patterns I learned in class will decrease the amount of time I spend in labor.' 1) Implementation: outcome desired; purpose of childbirth class is to eliminate fear of the unknown 2) Implementation: outcome not desired but not priority; focus of class is on fetus and mother; further assessment needed 3) Implementation: outcome desired; anxiety and pain reduction techniques included in class, but mothers are encouraged to use analgesia if needed 4) CORRECT-Implementation: outcome not desired; breathing techniques may decrease anxiety and pain but have no effect on time of labor. 1) Implementation: outcome desired; client is NPO before the procedure; risk of dye-induced nausea and vomiting; encourage fluid to decrease risk of dye-induced nephrotoxicity after the procedure 2) Implementation: outcome desired; photophobia common after subarachnoid hemorrhage 3) CORRECT-Implementation: outcome not desired and is priority; leg should be extended and in a neutral position after femoral angiogram 4) Assessment: outcome not desired but not priority; urine is concentrated; fluids encouraged to flush dye through kidneys. The nurse observes a student nurse caring for a client with a tracheostomy and humidified oxygen.
Which of the following actions taken by the student nurse requires an intervention by the nurse? The student nurse sets the wall suction to 160 mm Hg pressure prior to suctioning. The student nurse increases the oxygen level to 100% prior to suctioning.
The student nurse uses a catheter half the size of the tracheostomy opening. The student nurse tells the client to breathe normally as the catheter is inserted. The nurse assesses the fetal monitor of a client in labor. Which fetal heart rate pattern requires an intervention by the nurse? A baseline rate of 140-150 between contractions with moderate variability. Consistent heart rate accelerations that coincide with fetal movements.
A heart rate that slows following the peak of the contraction and returns to baseline after the contraction ends. Gradual slowing of the heart rate that begins with the onset of the contraction and returns quickly to the baseline.
The nurse assesses the IV site before administering vancomycin. The nurse notes that the area around the IV infusion site is pale and feels cool. Which INITIAL action will the nurse perform? Remove the intravenous catheter and elevate the arm on 1 or 2 pillows. Begin the vancomycin infusion and reassess the infusion site in 15 minutes.
Withhold the vancomycin infusion and notify the healthcare provider. Apply warm, moist compresses to the infusion site for 30 minutes and then administer the medication. A 26-year-old woman comes to the emergency room for a possible ruptured ectopic pregnancy. On admission, the client's vital signs are pulse 90, blood pressure 110/70, respirations 20. A half-hour later, her vital signs are pulse 120, blood pressure 86/50, respirations 26.
Which of the following is the MOST appropriate initial action for the nurse to take? Administer pain medication. Increase the rate of the IV fluids. Ask the client to identify where she is. Check the client's white cell count. The nurse cares for a client with chronic renal failure who has an arteriovenous fistula in the left arm. Which of the following should be included in the care of the client?
Select all that apply 1. (1.) Assess and compare blood pressure in both arms. (2.) Auscultate for 'whooshing' sound over the fistula. (3.) Palpate for warmth and tenderness over the area of the fistula. (4.) Instruct the client to avoid getting the left arm wet. (5.) Instruct the client to sleep with the left arm in the dependent position. (6.) Instruct the client to avoid carrying heavy objects with the left arm.
(1.) no constriction of the arm with the fistula; may damage fistula (2.) CORRECT - Bruit should be heard over the area of the fistula due to increased blood flow; if no bruit heard, notify healthcare provider (3.) CORRECT - Increased risk of infection in the fistula area; possible infection should be reported to healthcare provider (4.) fistula is internal; no risk of infection from exposure to water (5.) no weight should be placed on the extremity with the fistula (6.) CORRECT - increases the risk of fistula damage. A 22-year-old woman at term comes to the hospital in labor. Two hours after admission, the client remains 4 centimeters dilated, and her contractions are weak. The healthcare provider orders oxytocin (Pitocin).
Which finding would require an intervention by the nurse? Contractions every 2 minutes, lasting 90 seconds. Contractions every 3-4 minutes, lasting 60 seconds. Fetal heart rate of 110 beats per minute at the peak of a contraction.
Fetal heart rate of 158 bpm at the end of a contraction. A woman is admitted to the hospital complaining of diarrhea and vomiting for 3 days. The blood pressure is 90/60, apical heart rate 96, and respiratory rate 22 with shallow respirations. Laboratory results include Na+ 147 mEq/L, K+ 5.6 mEq/L, hematocrit 52%, hemoglobin 14 g/dL. The client is receiving 5% dextrose in 0.45% normal saline with K+ 20 mEq at 125 mL/hr. Prior to calling the healthcare provider, it is MOST important for the nurse to take which of these actions? Change IV fluids to 5% dextrose in 0.45% normal saline.
Increase IV flow rate to 150 mL/hour. Check the hourly urine output. Observe the client for muscle weakness. 1) CORRECT- Assessment: outcome desired and priority; change in pupil size, shape, or reactivity is an early sign of increased intracranial pressure; report to healthcare provider immediately 2) Assessment: outcome not priority; increased temperature late sign of increased intracranial pressure; temperature elevation may be due to other injuries 3) Assessment: outcome not priority; changes in vital signs are late sign of increased intracranial pressure 4) Assessment: outcome desired but not priority; increased carbon dioxide level will increase intracranial pressure. The nurse plans care for a 4-year-old girl who has been sexually abused by her grandfather. Play therapy is scheduled as part of the treatment plan.
Which statement, if made by the child's parents, indicates understanding of the primary purpose of play therapy? 'The main goal of play therapy is for our child to deal with any anger that she has.' 'During these play sessions, our child will be encouraged to communicate at her own level.' 'Our child's developmental level will be evaluated by a child development specialist during these sessions.' 'The main purpose of play therapy is to determine exactly what type of abuse occurred.' The home care nurse performs a health screening at the local mall. The nurse knows that which of the following clients is at HIGHEST risk for developing a stroke?
A 32-year-old Caucasian female who has a history of type 1 diabetes mellitus and has used oral contraceptive for 8 years. A 49-year-old Caucasian male who works as an account executive at an ad agency and has a cholesterol level of 250 mg/dL.
A 56-year-old African-American female who consumes 1 to 2 alcoholic beverages weekly and has smoked cigarettes for 30 years. A 69-year-old African-American male who has a history of hypertension and is 30 pounds overweight. 1) Implementation: outcome not desired; cannot eat dairy and meat at the same meal; eat dairy 6 hours after meat meal 2) Implementation: outcome not desired; cannot eat pork products (bacon, ham, animal shortening, gelatin or foods containing gelatin, e.g., marshmallows) 3) Implementation: outcome not desired; cannot eat shellfish or scavenger fish; fish must have scales 4) CORRECT- Implementation: outcome desired; kosher diet follows Jewish law; no meat or poultry at the same meal as dairy, or using the same utensils; no pork products; no scavenger fish. A 52-year-old homeless woman is admitted to the psychiatric unit for treatment of chronic schizophrenia. The nursing assistive personnel reports to the nurse that when attempting to bathe the client, the client became uncooperative and demanded coffee and a snack. Which suggestion will the nurse give to the nursing assistive personnel?
Remind the client that too much caffeine is bad for her health. Tell the client that she may have coffee and a snack when her bath is complete. Remove the client from the bath and return her to bed. Get help from other staff members to complete the bath. QUESTION - Where do you find the PMI? STRATEGY - Picture the anatomy of the heart and its position in the body.
NEEDED INFO - PMI: forward thrust of left ventricle during systole produces normal pulsation on chest wall. Indicates size and position of heart. Should be felt in 5th intercostal space. If apical impulse appears in more than one intercostal space, may indicate ventricular enlargement.
CORRECT ANSWER - (3) The fifth intercostal space at the midclavicular line. (1) Wrong position. (2) Wrong position. (4) Incorrect.
1) Implementation: outcome not desired; should provide increased fluid intake 2) Implementation: outcome not desired; contains caffeine, which is a natural diuretic and stimulant; should avoid fluids containing caffeine 3) Implementation: outcome not desired; should provide increased fluid intake 4) CORRECT-Implementation: outcome desired; provides for increased fluid intake; lithium can cause nephrogenic diabetes insipidus; those on lithium experience thirst and polyuria; need 2,500-3,000 mL/day with adequate salt intake. The nurse reviews room assignments for 4 clients admitted to the unit. The nurse should question which room assignment? A child with chickenpox placed in a private room at the end of the hall.
A child with meningitis placed in a private room across from the nurses' station. A client with cellulitis of the right leg placed in a semi-private room with a client diagnosed with type 1 diabetes.
A client with essential hypertension placed in a semi-private room with a client who has pancreatitis. The health care provider (HCP) provider orders hydralazine 25 mg IM on call for a client before surgery. The LPN/LVN administers hydroxyzine 25 mg IM to the client. Which of the following is the MOST appropriate action for the nurse to take?
Document 'Hydralazine 25 mg ordered; hydroxyzine 25 mg given; HCP notified; blood pressure 130/84; pulse 86; respiration 12.' Document 'Hydroxyzine 25 mg given; hydralazine 25 mg ordered; HCP notified; vital signs stable.' Document 'Hydroxyzine 25 mg mistakenly given; hydralazine 25 mg ordered.' Document 'Hydroxyzine 25 mg given; incident report completed.' In preparation for a total laryngectomy, the nurse teaches a client how to support his neck after surgery. Which of the following demonstrations by the client indicates to the nurse that teaching is successful?
The client raises the elbows and places the hands behind the neck. The client places one hand on the forehead and the other hand on the back of the head. The client covers the ears with both hands and presses firmly. The client grasps the chin with one hand and places the other hand on the forehead.
1) Implementation: outcome may be desired but is not priority; varicella vaccine recommended for adults who are not immune to varicella or who are immunocompromised; need further assessment 2) Implementation: outcome desired but not priority; should be given earlier in the winter; yearly influenza vaccine recommended for older adults 3) CORRECT- Implementation: outcome not desired and is problem; vaccine 6 years ago or more needs to be repeated; elderly at great risk for streptococcal pneumonia 4) Implementation: outcome: needs follow-up but not of MOST concern. The nurse supervises care of clients on a postoperative surgical unit. Which of the following requires an immediate intervention by the nurse? The nursing assistive personnel (NAP) obtains vital signs on a client who had a bowel resection 24 hours ago. The NAP assists a client who had an above-the-knee amputation apply an elastic bandage to the residual limb. The NAP assists a client who had a stroke 3 days ago with feeding. The NAP assists a client who had a laparoscopic cholecystectomy 6 hours ago ambulate.
A client is admitted to a medical unit with a diagnosis of pneunocystis jiroveci pneumonia. A nurse from another client care area asks the nurse caring for this client about the client's condition. Which is the MOST appropriate statement for the nurse to make? 'I will give a brief report on the client's condition in private.' 'You can get an update by reading the client's chart.'
'I cannot discuss this client's condition with you.' 'Why do you want to know about this client's condition?' A unit of packed cells is ordered for a client who has an intravenous infusion of dextrose 5% in water in progress. Which of the following is the MOST important action for the nurse to take? Connect the packed red blood cells to the dextrose infusion. Remove the dextrose infusion and replace it with the packed red cells. Start a separate infusion of normal saline and use a 'Y' connector to infuse the blood.
Start an infusion of lactated Ringer's solution and use a 'Y' connector to infuse the blood. A 50-year-old man scheduled for a vasectomy asks the nurse if he will be able to have sexual intercourse when he recovers from the surgery. Which statement, if made by the nurse, would be MOST accurate? 'My understanding is that each case is different after this procedure.' 'There will be a short period of time during which you will be unable to sustain an erection.'
'Most couples find that their sexual activity is more spontaneous after a vasectomy.' 'This surgery should have no permanent effect on your sexual functioning.'
Start Preamble AGENCY: Drug Enforcement Administration, Department of Justice. ACTION: Final rule. SUMMARY: With the issuance of this final rule, the Administrator of the Drug Enforcement Administration reschedules hydrocodone combination products from schedule III to schedule II of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule II controlled substances on persons who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities with, conduct chemical analysis with, or possess) or propose to handle hydrocodone combination products. DATES: This rule is effective October 6, 2014.
Start Further Info FOR FURTHER INFORMATION CONTACT: Imelda L. Paredes, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202) 598-6812. End Further Info End Preamble Start Supplemental Information SUPPLEMENTARY INFORMATION: Outline I. Legal Authority II.
Background III. Determination To Transfer Hydrocodone Combination Products (HCPs) to Schedule II IV. Comments Received A.
Support of the Proposed Rule B. Request for Extended Comment Period C. Clarification of Affected Drugs and Substances D. Opposition to the Proposed Rule 1. Authority to Control Drugs or Substances 2.
Requirements Applicable to Prescriptions 3. Patient Access to Medicine 4. Impacts on Unique Populations 5.
Impacts on Long-Term Care Facilities (LTCFs) 6. Abuse Prevention 7. Diversion Prevention Start Printed Page 49662 8. Responsibilities of Pharmacists 9. Requirements Applicable to Manufacturers and Distributors 10. Economic Impact 11.
Proposed Alternatives V. Scheduling Conclusion VI. Determination of Appropriate Schedule VII. Requirements for Handling HCPs VIII.
Regulatory Analyses I. Legal Authority The DEA implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. Titles II and III are referred to as the “Controlled Substances Act” and the “Controlled Substances Import and Export Act,” respectively, and are collectively referred to as the “Controlled Substances Act” or the “CSA” for the purpose of this action. The DEA publishes the implementing regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), parts 1300 to 1321. The CSA and its implementing regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the illicit market while providing for the legitimate medical, scientific, research, and industrial needs of the United States.
Controlled substances have the potential for abuse and dependence and are controlled to protect the public health and safety. Under the CSA, every controlled substance is classified into one of five schedules based upon its potential for abuse, currently accepted medical use in treatment in the United States, and the degree of dependence the drug or other substance may cause.
The initial schedules of controlled substances established by Congress are found at (c), and the current list of all scheduled substances is published. Pursuant to (a)(1), the Attorney General may, by rule, “add to such a schedule or transfer between such schedules any drug or other substance if he (A) finds that such drug or other substance has a potential for abuse, and (B) makes with respect to such drug or other substance the findings prescribed by (b) for the schedule in which such drug is to be placed.” The Attorney General has delegated this scheduling authority to the Administrator of the DEA. The Administrator may initiate the scheduling of any drug or other substance (1) on her own motion; (2) at the request of the Secretary of the Department of Health and Human Services (HHS); or (3) on the petition of any interested party.
This action was initiated by a petition to reschedule hydrocodone combination products (HCPs) from schedule III to schedule II of the CSA, and is supported by, inter alia, a recommendation from the Assistant Secretary for Health of the HHS and an evaluation of all relevant data by the DEA. This final action imposes the regulatory controls and administrative, civil, and criminal sanctions of schedule II controlled substances on any person who handles, or proposes to handle, HCPs. Background Hydrocodone was listed in schedule II of the CSA upon the enactment of the CSA in 1971. Public Law 91-513, 84 Stat. 202(c), schedule II, paragraph (a), clause (1) (codified at (c)); initially codified in DEA regulations at (b)(1)(x) (36 FR 7776, April 24, 1971) (currently codified at (b)(1)(vi)). At that time, hydrocodone was listed in schedule III of the CSA when formulated with specified amounts of an isoquinoline alkaloid of opium or one or more therapeutically active nonnarcotic ingredients.
91-513, 84 Stat. 202(c), schedule III, paragraph (d), clauses (3) and (4) (codified at (c)); initially codified at (e) (3) and (4) (36 FR 7776, April 24, 1971) (currently codified at (e)(1) (iii) and (iv)). Any other hydrocodone single-entity products or combinations of hydrocodone with other substances outside the range of specified doses are listed in schedule II of the CSA. Determination To Transfer Hydrocodone Combination Products (HCPs) to Schedule II Pursuant to (a), proceedings to add a drug or substance to those controlled under the CSA, or to transfer a drug between schedules, may be initiated on the petition of any interested party. The DEA received a petition requesting that HCPs be controlled in schedule II of the CSA. In response, in 2004, the DEA submitted a request to the HHS to provide the DEA with a scientific and medical evaluation of available information and a scheduling recommendation for HCPs, pursuant to (b) and (c). In 2008, the HHS provided to the DEA its recommendation that HCPs remain controlled in schedule III of the CSA.
In response, in 2009, the DEA requested that the HHS re-evaluate their data and provide another scientific and medical evaluation and scheduling recommendation based on additional data and analysis. On July 9, 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act (, 126 Stat.
993) (FDASIA). Section 1139 of the FDASIA directed the Food and Drug Administration (FDA) to hold a public meeting to “solicit advice and recommendations” pertaining to the scientific and medical evaluation in connection with its scheduling recommendation to the DEA regarding drug products containing hydrocodone, combined with other analgesics or as an antitussive. Additionally, the Secretary was required to solicit stakeholder input “regarding the health benefits and risks, including the potential for abuse” of HCPs “and the impact of up-scheduling these products.” Accordingly, on January 24 and 25, 2013, the FDA held a public Drug Safety and Risk Management Advisory Committee (DSaRM) meeting, at which the DEA made a presentation. The DSaRM Committee included members with scientific and medical expertise in the subject of opioid abuse, and a patient representative. Members included Start Printed Page 49663representatives from the National Institute on Drug Abuse (NIDA) and the Centers for Disease Control (CDC). There was also an opportunity for the public to provide comment.
The DSaRM voted 19 to 10 in favor of recommending that HCPs be placed into schedule II. According to the FDA, 768 comments were submitted to the FDA by patients, patient groups, advocacy groups, and professional societies. Upon evaluating the scientific and medical evidence, along with the above considerations mandated by the FDASIA, the HHS on December 16, 2013, submitted to the Administrator of the DEA its scientific and medical evaluation entitled, “Basis for the Recommendation to Place Hydrocodone Combination Products in Schedule II of the Controlled Substances Act.” Pursuant to (b), this document contained an eight-factor analysis of the abuse potential of HCPs, along with the HHS's recommendation to control HCPs in schedule II of the CSA. The HHS stated that the comments received during the open public hearing and submitted to the docket, and the discussion of the DSaRM members of the FDA DSaRM meeting provided support for its conclusion that: (1) Individuals are taking HCPs in amounts sufficient to create a hazard to their health or to the safety of other individuals or to the community; (2) there is significant diversion of HCPs; and (3) individuals are taking HCPs on their own initiative rather than on the basis of medical advice from a practitioner licensed by law to administer such drugs. The HHS stated that it gave careful consideration to the fact that the members of the DSaRM voted 19 to 10 in favor of rescheduling HCPs from schedule III to schedule II under the CSA.
The HHS considered the increasing trends, the public comments, the recommendation of the DSaRM, the health benefits and risks, and the information available about the impact of rescheduling, and concluded that HCPs have high potential for abuse. After a review of the available data, including the scientific and medical evaluation and the scheduling recommendation from the HHS, the Administrator of the DEA published in the Federal Register a notice of proposed rulemaking (NPRM) entitled “Schedules of Controlled Substances: Rescheduling of Hydrocodone Combination Products from Schedule III to Schedule II” which proposed to reschedule HCPs from schedule III to schedule II of the CSA., Feb. Both the DEA and HHS eight-factor analyses, as well as the DEA's Economic Impact Analysis (EIA), were made available in their entirety in the public docket for this rule (Docket No. DEA-389) and are available at under “Supporting and Related Material.” The proposed rule provided an opportunity for interested persons to file a request for hearing in accordance with DEA regulations by March 31, 2014. No requests for such a hearing were received by the DEA. The NPRM also provided an opportunity for interested persons to submit written comments on the proposal on or before April 28, 2014.
The DEA specifically solicited comments on the economic impacts of rescheduling with a request that commenters describe the specific nature of any impact on small entities and provide empirical data to illustrate the extent of such impact. Comments Received The DEA received 573 comments on the proposed rule to reschedule HCPs. Fifty-two percent (52%) (298 comments) supported, or supported with qualification, controlling HCPs in schedule II of the CSA. Forty-one percent (41%) (235 comments) opposed rescheduling HCPs into schedule II.
Seven percent (7%) (40 comments) did not take a definitive position regarding rescheduling of HCPs. Comments were submitted by a variety of individuals, including among others: Federal and State Government officials, manufacturers, distributors, pharmacies, surgeons, emergency physicians, dentists, physician assistants, nurse practitioners, pharmacists and pharmacy students, ultimate users of HCPs, and members of the general public.
The DEA also received comments from a number of national and regional trade associations with memberships comprised of manufacturers and distributors, pharmacists, pharmacies, physicians, pain specialists, doctors of optometry, physician assistants, nurse practitioners, and long term care facilities (LTCFs). In addition, the DEA received comments from patient advocacy groups. The 5 commenter categories with the most submissions were physicians (13%; 73 comments); mid-level practitioners (5%; 31 comments); pharmacists and pharmacy students (21%; 122 comments); the general public (44%; 250 comments); and ultimate users (6%; 35 comments). As discussed above, 52% of all commenters (298 of 573 comments) supported, or supported with qualification, controlling HCPs in schedule II of the CSA.
The majority of those supporting the rule were members of the general public and physicians. Comments submitted by the general public comprised 62% of the total 298 comments that supported, or supported with qualification, the rescheduling. Seventy-four percent (74%) (184 of 250 comments) of all comments submitted by the general public were in support, or supported with qualification, the rescheduling. Comments by physicians comprised 14% of the total 298 comments that supported or supported with qualification rescheduling.
Fifty-six percent (56%) (41 of 73 comments) of all comments submitted by physicians were in support, or supported with qualification, rescheduling. Forty-one percent (41%) of commenters (235 of 573 comments) opposed the proposal to reschedule HCPs from schedule III to schedule II of the CSA. The majority of those opposed to rescheduling HCPs were pharmacists, pharmacy students, and ultimate users. Pharmacists and pharmacy students comprised 31% of the total 235 comments submitted in opposition to the rule. Sixty percent (60%) (122 comments) of all comments submitted by pharmacists and pharmacy students were in opposition to the rule. Comments from ultimate users comprised 14% of the total 235 comments in opposition to the rule.
Ninety-one percent (91%) (32 of 35 comments) of all comments submitted by ultimate users were in opposition to rescheduling. Further discussions of these comments are included below.
Support of the Proposed Rule Two hundred ninety-eight commenters (52%) supported, or supported with qualification, controlling HCPs in schedule II of the CSA. Forty-one percent (41%) of commenters opposed controlling HCPs in schedule II, and 7% of commenters Start Printed Page 49664did not have a clearly defined position either in support or in opposition to the rescheduling.
The majority of those supporting the rule were members of the general public (62%) and physicians (14%), with 74% of comments from the general public supporting, or supporting with qualification, and 56% of comments from physicians supporting, or supporting with qualification, making HCPs schedule II controlled substances. Manufacturers, pharmacists, mid-level practitioners, pharmacy students, and trade associations also expressed support for the rule. Of all comments submitted, in support and opposition, 40% of pharmacists, 9% of ultimate users, and 78% of the general public were in support.
The State Attorney General and a U.S. Senator from the State with last year's highest per capita rate of prescription drug overdose in the nation wrote in strong support of rescheduling HCPs.
The State Attorney General wrote that, “This reclassification is not only justified given the high abuse and addiction potential of hydrocodone prescription painkillers., it is necessary to combat the drug abuse epidemic that is destroying so many communities. I urge you to proceed with your rulemaking without delay. The abuse of hydrocodone is an urgent problem that necessitates urgent action.” The U.S. Senator wrote that, “rescheduling hydrocodone combination drugs would be a tremendous step forward in the fight to curb the prescription drug abuse epidemic that has ravaged.
our country. It will help prevent these highly addictive drugs from getting into the wrong hands and devastating families and communities. I urge the DEA to move quickly in finalizing its regulations so that we are able to save hundreds of thousands of lives.” Two U.S. Senators from two other States, wrote a joint comment in support of rescheduling, stating that: “As members of the Judiciary Committee and senators from states hit particularly hard by the opioid epidemic, we are well aware of the alarming rates of diversion and prescription drug abuse,” and “we fully support DEA's efforts to combat this nationwide public health crisis.” All three Senators expressed their desire that patients maintain access to legitimate care. A major component of the rescheduling of HCPs was to evaluate their abuse potential as required under (b)(2). Many commenters indicated support for controlling HCPs in schedule II based on the scientific evidence demonstrating the high abuse potential of HCPs, evidence that HCPs may lead to severe psychological or physical dependence, history and current pattern of abuse, significance of abuse, and risk to the public health and safety.
Of the total 47 commenters who referenced the scientific, medical, and epidemiological data that was used to support the statutory requirement under (b)(2) for control of HCPs in schedule II of the CSA, 29 agreed with the data used to support control of HCPs in schedule II. Nineteen commenters specifically discussed the eight-factor analysis that was conducted in support of rescheduling HCPs into schedule II. Ten of those 19 commenters were in agreement with the DEA's analysis. Nine of the commenters who cited the DEA's eight-factor analysis indicated that the presented evidence was congruent with the requirements for placing a drug or other substance into schedule II of the CSA. (One commenter, while in agreement with the conclusion of the eight-factor analysis, did not favor rescheduling HCPs.) Commenters generally agreed that there is psychological and physical dependence associated with HCPs that support placement into schedule II. For example, one commenter stated that rescheduling HCPs from schedule III to schedule II “would be in the best interest of the general public” because he has personally witnessed the increase in abuse of prescription pain medication over the course of his 45-year career as a pharmacist.
Additional supportive comments included that the mechanism of action of hydrocodone is identical to oxycodone and morphine, both in schedule II as combination and single-entity products. Some commenters indicated that lower doses of hydrocodone in HCPs do not lower abuse and therefore agreed with the transfer to schedule II. Other commenters mentioned that HCPs are metabolized to hydromorphone, a schedule II opioid, and also have similar mechanisms of action to other schedule II opioids including oxycodone, morphine, and fentanyl, suggesting that abuse potential would be comparable. Some of the commenters indicated that HCPs are more likely to be abused due to their greater availability. Many of the commenters cited one of their primary reasons for supporting the rule was that it would lead to tighter regulation of HCP prescriptions. For example, one commenter stated: “Hydrocodone combination products should not be available with multiple refills on a single prescription and need to be prescribed more cautiously.” Similarly, another commenter stated: “Rescheduling HPCs sic would directly address the problem of `leftover' pills in parents sic medicine cabinets, and would keep kids safe.
Furthermore, lowering the quantity a doctor can prescribe will decrease the number of drugs that are sold on the street, which will in turn decrease crime and decrease HCP abuse overtime sic.” Many of the commenters wrote of their personal experiences with loved ones who suffer or had suffered with abuse and addiction, including many youths and young adults who have tragically died as a result of HCPs or other prescription opioids. The commenters wrote that the path to abuse and addiction was varied—sometimes beginning with a practitioner prescribing HCPs, and other times by recreational use of pills that were available for them to access as a result of practitioner overprescribing. Many of these commenters believe that controlling HCPs as a schedule II controlled substance will impose controls necessary to prevent the abuse and diversion of HCPs. DEA Response: The DEA appreciates the comments in support of this rulemaking. Request for Extended Comment Period The DEA received two comments requesting that the DEA reopen the period for public comment.
One of the commenters specifically requested that the comment period be reopened for a minimum of 180 days. The stated justification of one of the commenters was that “the current period is utterly inadequate to large segments of the population who have had no meaningful notice, have extremely limited internet access in small time periods through use of computers at public libraries and are particularly at risk from harm if this rule is adopted.” Both requests for extended comment periods were accompanied by meaningful comment along with the request for extension. DEA response: The Administrative Procedure Act does not set a minimum length of time for public comment.; Phillips Petroleum Co. E.P.A., 803 F.2d 545, 558-59 (10th Cir. 1986) (upholding the EPA's refusal to extend the 45-day comment period on an NPRM, noting that courts have uniformly upheld comment periods of 45 days or less) (internal citations omitted).
However, both Executive Orders 12866 and 13563 provide that agencies should afford the public a comment period of at least 60 days. The DEA published in the Federal Register the NPRM proposing to reschedule HCPs into schedule II of the CSA on February 27, 2014.
The Start Printed Page 49665DEA provided 60 days for interested persons to submit written comments (either online or through the mail) on the proposal. The comment period closed April 28, 2014. Seven hundred twenty-four submissions on the associated docket at were submitted by the close of the comment period. Several paper submissions duplicating electronic submissions were received via the mail as well. (The 724 number differs from the finalized number of 573 comments received because, as alluded to above, many commenters submitted multiple, duplicate submissions.
Multiple submissions of exactly identical comments submitted by the same person or entity are considered by the DEA as only a single, submitted comment.) Based on the following considerations, the DEA declines to reopen the period for additional public comment. The Federal Register is published daily, Monday through Friday, except official holidays, by the Office of the Federal Register, National Archives and Records Administration, under the Federal Register Act (44 U.S.C. Section 7 of the Federal Register Act provides that publication in the Federal Register constitutes constructive notice to persons subject thereto or affected thereby. The Federal Register is published in paper and on microfiche. It is also available online at no charge. The NPRM was also available on to enable the public to conveniently access the proposal and the supporting materials.
Of additional consideration, on the same day as publication in the Federal Register, the DEA issued a press release stating that the Administration had published in the Federal Register an NPRM to move HCPs from schedule III to schedule II (available at ). The press release advised individuals where a complete copy of the NPRM could be obtained as well as how they could submit comments in response to the proposal. The DEA accepted written comments submitted either through Regulations.gov or through the mail. In accordance with the Administrative Procedure Act, the DEA's published NPRM included “the terms or substance of the proposed rule” and “a description of the subject and issues involved.” (b)(3). The quality and quantity of the responses received in response to the published NPRM, as well as the variety of respondents, including those advocating on behalf of persons residing in LTCFs and other populations that may potentially feel distributional regulatory impacts, demonstrate to the DEA that there has been an adequate opportunity for meaningful public participation by interested persons in accordance with the Administrative Procedure Act.
(c); Idaho Farm Bureau Fed'n v. Babbitt, 58 F.3d 1392, 1404 (9th Cir.
1995) (holding that comments discussing the proposed action and supporting data were evidence that the public had obtained and reviewed the information and thus adequate opportunity for public comment had been given). The DEA notes that the submission by a nurse located in Australia shows that the published NPRM was widely read and reviewed. In addition, those commenters requesting additional time for comment accompanied their request for an extension with substantial comment on the rule. This demonstrates to the DEA that adequate notice and opportunity for meaningful comment was provided by the DEA on this rulemaking. Clarification of Affected Drugs and Substances The DEA received some comments, though limited in number, indicating it would be helpful to provide detailed discussion of what products are affected by this rule. One commenter specifically requested clarification as to whether the action would apply to cough syrups that contain hydrocodone.
The second commenter requested the DEA not change the schedule of Zohydro TM ER. The third commenter requested that Zogenix, the manufacturer of Zohydro TM ER, be “allowed to bring their new drug to market.” DEA response: This rulemaking action affects hydrocodone combination products, which are those substances described in (e)(1) (iii) and (iv). All other products containing hydrocodone are already controlled in schedule II of the CSA and are not impacted by this action.
Icd 10 Code For Failed Trial Of Labor
Zohydro TM ER does not meet the definition of either (e)(1) (iii) or (iv); it is currently a schedule II controlled substance under (b)(1)(vi) and is not affected by this action. Other than Zohydro TM ER, all pharmaceuticals containing hydrocodone currently on the market in the United States are HCPs and are subject to this rulemaking. Hydrocodone is the most frequently prescribed opioid in the United States with nearly 137 million prescriptions for HCPs dispensed in 2013. IMS Health, National Sales Perspective TM (NSP). There are several hundred brand name and generic hydrocodone products marketed with the most frequently prescribed combination being hydrocodone and acetaminophen (e.g., Vicodin®, Lortab®).
Currently marketed HCPs approved as cough suppressants include Hycodan®, Mycodone®, Tussionex®, Pennkinetic®, Tussigon®, and several generics. Opposition to the Proposed Rule Two hundred thirty-five commenters (41% of all commenters) opposed the proposal to reschedule HCPs from schedule III to schedule II of the CSA. Many comments submitted in opposition came from pharmacists, including pharmacy school students/interns (31%); the general public (23%); and ultimate users (14%).
Of all comments submitted, in support and in opposition, 60% of pharmacists were opposed; 22% of the general public were opposed; and 91% of ultimate users were opposed. These commenters opposed the rescheduling HCPs for a variety of reasons. As discussed in a memorandum of understanding entered into by the Food and Drug Administration (FDA), and the National Institute on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS in carrying out the Secretary's scheduling responsibilities under the CSA, with the concurrence of NIDA.
What Is Failed Trial Of Labor
50 FR 9518, Mar. The Secretary of the HHS has delegated to the Assistant Secretary for Health of the HHS the authority to make domestic drug scheduling recommendations.
58 FR 35460, July 1, 1993. In the United States there are currently no approved, marketed, products containing hydrocodone in combination with other active ingredients that fall outside schedule III of the CSA. Further, until recently, there were no approved hydrocodone single-entity schedule II products. In October 2013 the FDA approved ZohydroTM.
ER, a single-entity, extended release schedule II product. ER was launched on March 3, 2014.
Accordingly, all of the historical data regarding hydrocodone from different national and regional databases that support this rule should refer to HCPs only, regardless of whether the database utilizes the term “hydrocodone” or “hydrocodone combination products.”. For purposes of performing regulatory analysis, the DEA uses the definition of a “practitioner” as a physician, veterinarian, or other individual licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice, but does not include a pharmacist, pharmacy, or hospital (or other person other than an individual). For the purposes of performing regulatory analysis, “mid-level practitioner” means an individual registered with the DEA as a “mid-level practitioner” but does not include practitioners as defined above. Examples of mid-level practitioners include, but are not limited to, health care providers such as nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists and physician assistants.