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VOLUME 18 NO.2 FEBRUARY 2003
NEW DRUGS APPROVED BY THE FDA IN 2002
The
FDA approved 26 significant new molecular entities and biologicals in 2002. In
addition, significant new
dosage
forms of previously approved drugs and drug withdrawals are listed.
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NEW MOLECULAR ENTITIES |
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BRAND |
GENERIC |
COMPANY |
DESCRIPTION |
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Abilify |
aripiprazole |
Bristol-Myers Squibb |
An antipsychotic for the treatment of schizophrenia |
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Alinia |
nitazoxanide |
Romark Labs |
An antiparasitic agent for the treatment of diarrhea caused by Cryptosporidium parvum and Giardia lamblia in pediatric patients |
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Benicar |
olmesartan |
Sankyo |
An angiotensin II receptor blocker for the treatment of hypertension |
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Eloxatin |
oxaliplatin |
Sanofi-Synthelabo |
An antineoplastic for the treatment of metastatic colorectal cancer |
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Faslodex |
fulvestrant |
AstraZeneca |
An estrogen receptor blocker for the treatment of breast cancer |
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Hepsera |
adefovir |
Gilead |
A nucleotide analog for the treatment of chronic hepatitis B |
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Inspra |
eplerenone |
Pharmacia |
An aldosterone blocker for the treatment of hypertension |
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Orfadin |
nitisinone |
Swedish Orphan Int. |
An orphan drug to treat hereditary tyrosinemia type I (HT-1) |
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Relpax |
eletriptan |
Pfizer |
A 5-HT receptor agonist (triptan) for the treatment of migraine |
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Remodulin |
treprostinil |
United Therapeutics |
A vasodilator for the treatment of pulmonary arterial hypertension |
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Strattera |
atomoxetine |
Eli Lilly |
A norepinephrine reuptake inhibitor for the treatment of ADHD |
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Vfend |
voriconazole |
Pfizer |
An antifungal for treatment of aspergillosis and other severe infections |
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Xyrem |
sodium oxybate |
Orphan Medical |
Medical GHB for treating muscle weakness associated with narcolepsy |
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Zelnorm |
tegaserod |
Novartis |
5-HT4 partial agonist for constipation-predominant IBS in women |
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Zetia |
ezetimibe |
Merck/Schering |
An inhibitor of cholesterol absorption for the treatment of hyperlipidemia |
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SIGNIFICANT NEW BIOLOGICALS |
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BRAND |
GENERIC |
COMPANY |
DESCRIPTION |
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Bravelle |
urofollitropin |
Ferring |
Human follicle stimulating hormone for ovulation induction |
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Daptacel |
diphtheria/tetanus/ acellular pertussis |
Aventis (Canada) |
An additional DtaP vaccine for infants and young children. Licensed for use in the United States |
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Elitek |
rasburicase |
Sanofi-Synthelabo |
A urate oxidase enzyme to prevent tumor lysis syndrome in pediatric patients receiving chemotherapy |
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Forteo |
teriparatide |
Eli Lilly |
An injectable human parathyroid hormone for the treatment of osteoporosis |
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Humira |
adalimumab |
Abbott |
A monoclonal antibody for the treatment of rheumatoid arthritis |
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Neulasta |
pegfilgrastim |
Amgen |
Long-acting colony stimulating factor for prevention of infection |
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Pediarix |
DTaP, hep B, poliovirus vaccine |
SmithKline Beecham |
Combination diphtheria, tetanus, acellular pertussis, hepatitis B, and poliovirus vaccine for infants |
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Pegasys |
Peginterferon alfa-2a |
Roche |
Once-weekly therapy for the treatment of chronic hepatitis C |
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Rebif |
interferon beta-1a |
Serono |
An interferon for treatment of relapsing multiple sclerosis |
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SecreFlo |
secretin |
Chesapeake Bio. |
A hormone used to diagnose pancreatic dysfunction and gastrinoma |
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Zevalin |
ibritumomab tiuxetan |
IDEC |
a radiopharmaceutical for one type of non-Hodgkin's lymphoma |
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SIGNIFICANT NEW DOSAGE FORMS |
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BRAND |
GENERIC |
COMPANY |
DESCRIPTION |
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Actonel |
risedronate |
Aventis |
New once-weekly 35mg tablet for osteoporosis |
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Alavert |
loratidine |
Wyeth |
New orally disintegrating tablets for OTC use |
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Altocor |
lovastatin |
Andrx |
Extended-release lovastatin for once-daily administration |
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Augmentin XR |
amoxicillin/clavulanate |
GlaxoSmith Kline |
New high-dose (1000mg/62.5mg), extended-release tablets for community-acquired pneumonia and acute sinusitis in adults |
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Avage |
tazarotene |
Allergan |
Retinoid to treat wrinkles |
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Avandamet |
rosiglitazone/metformin |
GlaxoSmith Kline |
Combination product for the treatment of type 2 diabetes |
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Avinza |
morphine |
Elan/Ligand |
Controlled-release oral morphine for once-daily administration |
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Celebrex |
celecoxib |
Pharmacia/Pfizer |
New 400mg capsules for use in patients with FAP |
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Cipro XR |
ciprofloxacin |
Bayer |
Once-daily 500mg tablets for uncomplicated UTI |
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Commit |
nicotine polacrilex |
GlaxoSmith Kline |
Nicotine lozenge for smoking cessation |
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Concerta |
methylphenidate |
McNeil |
New 27mg extended-release tablet for treatment of ADHD |
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Copegus |
ribavirin |
Roche |
An antiviral, used in combination with Pegasys, for hepatitis C |
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Finacea |
azelaic acid |
Berlex |
New gel formulation for the treatment of mild to moderate rosacea |
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Fluzone (pediatric) |
influenza vaccine |
Aventis Pasteur |
New preservative-free influenza vaccine for infants |
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Geodon |
ziprasidone |
Pfizer |
First atypical antipsychotic for injectable (IM) use |
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SIGNIFICANT NEW DOSAGE FORMS |
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BRAND |
GENERIC |
COMPANY |
DESCRIPTION |
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Lexapro |
escitalopram |
Forest |
The S-isomer of the antidepressant citalopram |
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Metaglip |
glipizide/metformin |
Bristol-Myers Squibb |
Combination tablet for the treatment of type 2 diabetes |
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Mucinex |
guaifenesin |
Adams Labs |
Extended-release 600mg tablets available OTC |
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Ortho Tri-Cyclen Lo |
norgestimate/ethinyl estradiol |
Ortho-McNeil |
New low-dose estrogen (25mcg) oral contraceptive |
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Paxil CR |
paroxetine |
GlaxoSmith Kline |
Once-daily, controlled-release 12.5, 25, and 37.5mg tablets |
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Prevacid SoluTab |
lansoprazole |
TAP |
New 15mg and 30mg tablets that disintegrate when placed on the tongue |
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Restasis |
cyclosporine |
Allergan |
Ophthalmic formulation to increase tear production |
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Ritalin LA |
methylphenidate |
Novartis |
Once-daily capsules for treatment of ADHD |
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Suboxone |
buprenorphine/naloxone |
Reckitt Benckiser |
New sublingual tablet for maintenance treatment of opiate addiction |
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Subutex |
buprenorphine |
Reckitt Benckiser |
New sublingual tablets for initial treatment of opiate addiction |
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Sustiva |
efavirenz |
Bristol-Myers Squibb |
Once-daily 600mg tablet for treatment of HIV |
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Testim |
testosterone gel |
Auxilium |
A topical gel for the treatment of hypogonadism |
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DRUG WITHDRAWALS |
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BRAND |
GENERIC |
COMPANY |
DESCRIPTION |
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aloe, cascara sagrada |
various |
OTC laxative products containing these ingredients are no longer recognized as being safe and effective |
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Lymerix |
Lyme vaccine |
GlaxoSmith Kline |
Withdrawn by company due to low demand for product |
Source: Supplement to Pharmacist’s Letter, Vol 19, No. 2
Note: Formulary status should be determined before prescribing these new agents
JCAHO NATIONAL PATIENT SAFETY GOALS - 2003
DRUG NAMES THAT LOOK AND SOUND ALIKE
Patient Safety Goal #2 requires organization to promote effective communication and to read back and verify the complete order when taking verbal or telephone orders. Just repeating the order is not enough. You must write down the complete order and then read it back, according to JCAHO. This practice does not only apply to medication orders, but to all verbal or telephone orders.
There is much confusion between similar brand names, between similar generic names, and between similar brand and generic names. Such confusion is further compounded by illegible handwriting, incomplete knowledge of drug names, newly available products, similar packaging or labeling, and incorrect selection of a similar name from a computerized product list. In addition, many drug names may not sound alike as you read them or look-alike in print, but when hand written or communicated verbally, these names have caused or could cause a mix-up.
No drug name is without problems. Any name can be written or spoken poorly enough so that it can be mistaken for another. Listed in the accompanying table are drug names that can look and/or sound alike. Some are dangerously close, whereas others require incomplete prescribing information, poor communications skills, poor listening, and/or a lack of knowledge about the drugs for an error to result.
To reduce errors, practitioners must share the common goal of drug name safety with pharmaceutical manufacturers, the Food and Drug Administration (FDA), the World Health Organization (WHO), the United States Adopted Name Council (USANC), and the United States Pharmacopoeia (USP).
The potential for errors can be reduced by:
· Pretesting proposed names for error potential
· Careful selection of brand names and generic names by manufacturers, FDA, WHO, and USANC
· Legible handwriting
· Clear oral communications
· Writing complete drug orders
· Specifying the dosage form (eg, tablet)
· Specifying the drug strength (eg, 100mg)
· Specifying directions (eg, take one daily with breakfast)
· Specifying the purpose/indication (eg, take one daily with breakfast to control blood pressure)
· Printing orders for new or rarely prescribed drugs
· Using computer-generated orders
· For those involved in drug dispensing and administration, being aware of the drugs that are available and paying careful attention to the work at hand
· Knowing the patient's condition/problems, to ascertain if the drug name which has been read or heard is indicated
· Educating patients about their drug regimens (this serves as another final check that the prescription was properly read and dispensed)
The following partial list has been prepared to sensitize health professionals and their support personnel to the need for proper communication when writing, speaking, reading and hearing drug names.
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Aggrastat |
Aggrenox |
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Altace |
Artane |
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Amicar |
Amikin |
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Amlodipine |
Amiloride |
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Anaprox |
Avapro |
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Atrovent |
Alupent |
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Betapace |
Betapace AF |
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Buspirone |
Bupropion |
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Carafate |
Cafergot |
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Carboplatin |
Cisplatin |
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Cardene |
Cardura |
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Cardene SR |
Cardizem SR |
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Ceftin |
Cefzil |
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Celebrex |
Celexa |
Cerebyx |
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Clinoril |
Clozaril |
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Clonidine |
Klonopin |
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Cozaar |
Hyzaar |
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Dobutamine |
Dopamine |
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Doxorubicin |
Daunorubicin |
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Eldepryl |
Enalapril |
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Fioricet |
Fiorinal |
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Folic Acid |
Folinic Acid |
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Fosamax |
Flomax |
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Furosemide |
Torsemide |
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Glipizide |
Glyburide |
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Glucotrol |
Glucotrol XL |
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Haloperidol |
Halotestin |
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Hydralazine |
Hydroxyzine |
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Indinavir |
Denavir |
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Lamictal |
Lamisil |
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Lamictal |
Lomotil |
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Lasix |
Luvox |
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Losartan |
Valsartan |
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Lotrimin |
Lotrisone |
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Metroprolol |
Misoprostol |
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Narcan |
Norcuron |
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Nasalcrom |
Nasalide |
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Navane |
Norvasc |
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Nicoderm |
Nitroderm |
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Ocufen |
Ocuflox |
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OxyContin |
Oxycodone |
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Paxil |
Plavix |
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Percocet |
Percodan |
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Pravachol |
Propranolol |
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Primidone |
Prednisone |
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Prozac |
Proscar |
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Quinidine |
Quinine |
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Remeron |
Zemuron |
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Rifabutin |
Rifampin |
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Singulair |
Sinequan |
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Tiazac |
Ziac |
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Tramadol |
Toradol |
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Vioxx |
Zyvox |
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Xanax |
Zantac |
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Zoloft |
Zocor |
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Zyrtec |
Zyprexa |
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Adapted from: 1) USP Medication Error Reporting Program
2) Facts and Comparisons