Auxiliary Labels Flashcards
Federal law requires that schedule II, III, and IV drugs must have the following warning:
“Caution: Federal laws prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”
State law requirement for drugs that contain single or combination opioids. All opioid Rx bottles must contain the notice, “Caution: Opioid. Risk of overdose and addiction.”
This is an addiction to the cautionary statement required by federal law for schedule II, III, and IV drugs.
State law requirement to include for drugs that cannot be taken with alcohol. The following classes of drugs pose a substantial risk when taken in combination with alcohol. A pharmacist must include a warning on the Rx label for the following drugs:
- Disulfiram and other drugs (eg, chlorpropamide, metronidazole, tinidazole) which may cause a disulfiram-like reaction (avoid alcohol for 48 hours after last dose)
- Monoamine oxidase inhibitors
- Nitrates
- Cycloserine
- Antidiabetic agents (insulin, metformin, sulfonylureas)
- Any other drug which may pose a substantial risk: opioids, tramadol, benzodiazepines, barbiturates, non-benzodiazepine hypnotics, anticonvulsants, antipsychotics, some antidepressants, skeletal muscle relaxants
State law requirement to label include for drugs that can impair a person’s ability to drive or operate machinery. The following drug classes require a warning on the Rx label of the drug container:
- Muscle relaxants and analgesics with CNS depressant effects
- Antipsychotic drugs with CNS depressant effects
- Antidepressants with CNS depressants effects (eg, mirtazapine, trazodone)
- Antihistamines, motion sickness drugs, antipruritics, antiemetics, anticonvulsants, and antihypertensive drugs with CNS depressant effects
- All narcotics and controlled substances (schedules II-V) with CNS depressant effects (eg, hypnotics)
- Anticholinergic effects that may impair vision
- Any other drug which, based on the pharmacist’s professional judgment, may impair a patient’s ability to operate a vehicle or vessel (eg, dopamine agonists such as ropinirole)
Patients should be advised not to use these drugs during pregnancy or breastfeeding. This may be due to the risk of fetal injury, teratogenicity, or other exposure-related concerns.
- ACE inhibitors, renin inhibitors
- Angiotensin II receptor blockers
- Statins
- Warfarin
- Hormones (most, including estradiol, progesterone, raloxifene, testosterone, contraceptives)
- Isotretinoin and topical retinoids
- Paroxetine
- Valproic acid, carbamazepine
- Phenytoin, phenobarbital
- Lithium, topiramate
- NSAIDs
- Ribarivin
- Misoprostol, methotrexate
- Leflunomide, lenalidomide, thalidomide
- Dutasteride, finasteride
Check for peanut or soil allergy. Includes:
- progesterone (Prometrium only, not other formulations)
- clevidipine (Cleviprex)
- propofol
The Institute for Safe Medication Practices (ISMP) defines high-alert medications as those that have high risk of causing significant patient harm when they are used in error. Safeguards must be put in place to reduce the risk of errors, including the proper use of labeling.
- Adrenergic agonists (eg, epinephrine)- specify drug dose in mg. Note that epinephrine 1: 1,000 is 1 mg/mL and 1: 10,000 is 0.1 mg/mL.
- Adrenergic antagonists (eg, beta-blockers)- caution when converting from PO to IV. High risk for error due to differences in bioavailability.
- Sedatives (eg, midazolam, propofol)- these are common ICU medications used to keep patients comfortable on ventilators. Respiratory rate and mental status must be closely monitored.
- Antiarrthymics (eg, amiodarone, sotalol)- to be administered by protocol that defines dose or infusion rate and requirement for cardiac (ECG) monitoring.
- Anticoagulants (eg, heparin, argatroban, warfarin)- to be administered by protocol that includes required baseline labs (eg, INR, aPTT, CBC), state lab goals (indication based), frequency of monitoring labs and dose/rate adjustments based on lab values. Protocol should also include monitoring for symptoms of bleeding and reversal strategy.
- Insulin- to be administered by protocol that includes initial infusion rate (for IV administration), blood glucose (BG), and potassium monitoring frequency, rate adjustment based on BG and when to notify the physician.
- Positive inotropes (eg, dobutamine, milrinone)- before administration and frequently during administration. Monitor BP, HR, hemodynamic parameters (if available) and urine output.
- Opioids (e.g. hydromorphone, fentanyl)- screen and monitor patietns at risk for oversedation and respiratory depression. A conversion support system should be used to help convert between agents. Use tall man lettering and separate look-alike/sound-alike agents.
- Electrolytes (eg, hypertonic saline, potassium)- to be administered by protocol with a max infusion rate and monitoring requirements. Should be prepared on the patient unit.
Neuromuscular blocking agents (cisatracurium, vecuronium, succinylcholine, rocuronium, pancuronium) can only be given to…
a patient who is already on BOTH an analgesic (e.g. fentanyl) and under deep sedation (e.g., propofol, midazolam) with pain and sedation assessed continuously.
Medications that are well known to cause blurry vision include anticholinergics (e.g. scopolamine), voriconazole (Vfend), telithromycin, and PDE-5 inhibitors (e.g. sildenafil). Alcohol and CNS depressants can cause blurry or double vision (diplopia) if toxic. Digoxin can cause yellow/green halos if toxic. Other drugs that can affect vision include:
- hydroxychloroquine
- tamoxifen
- amiodarone
- ethambutol
- isotretinoin
- isoniazid
- ivabradine
Avoid prolonged exposure to direct and/or artificial sunlight while using these medications due to increaesed skin sensitivity.
- Sulfa antibiotics
- Quinolones, tetracyclines
- Metronidazole, isoniazid
- Topical retinoids (newer one less risk), isotretinoin (oral)
- Ritonavir and few other HIV drugs
- NSAIDS (piroxicam, diclofenac, ibuprofen, naproxen)
- Diuretics
It is important to counsel the patient that they will need to use an alternative form of contraception to prevent unwanted pregnancy while taking this medication as it make make birth control pills less effective.
- Barbiturates (e.g., phenobarbital)
- St. John’s wort
- Ampicillin, tetracycline
- Rifampin, rifapentine, griseofulvin
- Bosentan
- Anticonvulsants (topiramate, lamotrigine, carbamazepine, primidone, phenytoin, oxcarbazepine)
- Some HIV drugs (some protease inhibitors, NNRTIs)
Persistent diarrhea due to colitis may occur weeks after using the medication. This should be reported to…
your doctor immediately as it can be a dangerous side effect. Includes clindamycin, quinolones, and broad-spectrum antibiotics
May cause discoloration of the urine, skin and sweat. May stain contact lenses and clothing.
- Entacapone, carbidopa/levodopa
- Metronidazole, rifampin
- Nitrofurantoin, phenazopyridine
- Sulfasalazine
- Doxorubicin, mitoxantrone
- Propofol
These medications are to be taken on an empty stomach. While 1 hour before or 2-3 hours after a meal is a standard time frame, individual medications may differ.
- Ampicillin, voriconazole
- Efavirenz (Sustiva/Atripla), didanosine (Videx)
- Bisphosphonates
- Captopril
- Iron (if tolerated), PPIs
- Levothyroxine
- Oxymorphone (Opana)
- Mycophenolate (CellCept), tacrolimus ER (Astagrf XL, Envarsus XR)
- Zafirlukast
These medications are to be taken with food.
- Carvedilol (Coreg), metoprolol tartrate (Lopressor)
- Lovastatin (with dinner)
- Fenofibrate and derivatives (Lipofen, Fenoglide)
- Niacin, gemfibrozil (Lopid)
- Metformin (IR with breakfast and dinner, XR with dinner)
- Itraconazole capsules
- Phosphate binders (when eating)
- NSAIDS, steroids
- Opioids (except Opana)
