Addendum to MCReview of AHFS DI Essentials
ROAD TEST FOR DRUG REFERENCES ON THE PDA
This Road Test is designed to convey and compare information from nine major drug PDA programs. Itincludes information from previous Road Tests published in the May/June 2003 and May/June 2004 issues.
We seek to include the most respected, technologically sophisticated drug database software for the
handheld from companies that appear invested in the future of medical computing for physicians. Theessential criterion for inclusion is that the software consists of physician-oriented content that is organizedinto individual drug monographs. Deliberately excluded are specialty drug or alternative medical references(unless they are part of the package reviewed). Another important criterion is that the software must beupdatable at least four times a year, either by visiting a Web site or by autosync over the Internet.
The Road Test is divided into four parts. Parts 1 and 2 examine the monographs’ content and
structure; Part 3 samples questions related to accuracy of information, and Part 4 samples new drugs andwarnings. In the first three parts, information begins with the current review on Essentials, after whichprevious Road Tests are reproduced for convenience and comparison. Due to the timely nature of Part 4content, only the current Essentials information is posted.
AHFS DI ESSENTIALS was obtained on or about March 19, 2005 and first
published here as an addendum to the May/June 2005 issue. Information on
was first published in May/June 2003 issue
and Drug Facts is identical (since both reference Facts & Comparison’s A to Z Drug Facts), althoughdifferent vendors (Skyscape and Unbound Medicine, respectively) formatted the content.
Essentials Road Test: Davis Liu, MD. Original Contributors: Arthur Chausmer, MD; Judy Knight, MD;Marjorie Lazoff, MD; Davis Liu, MD
ROAD TEST 1 – THOROUGHNESS OF EACH MONOGRAPH
In the original Road Test we assumed propranolol, a nonselective beta adrenergic antagonist (beta blocker) was representative of a typical monograph. We copied verbatim those portions of the monograph dealing with propranolol’s multiple FDA and nonFDA indications, its absolute and relative contraindications, and relatively complicated list of adverse reactions and side effects that range from trivial to significant. Although the content is identical, we abbreviated many of the terms and did not maintain the formatting.
The goal here is to give a sense of the approach and depth of content of each drug reference.
ESSENTIALS : Does not have a separate Indications section, but information is integrated in with Dosagesand Administration.
General – HTN, MI, angina, vascular HA; Ped Pts – HTN. cardiac arrhythmias, thyrotoxicosis;. Adults –HTN, angina (chronic stable angina, USA or Non-ST-Segment Elevation/Non-Q-Wave MI). cardiacarrhythmias – life-threatening arrhythmias or those occurring during anesthesia; VFib, MI; slowing ofventricular response during acute AFib; IHSS, pheochromocytoma – prior to surgery; adjunctive tx forinoperable pheo, vascular HA – prevention of common migraine;. MI – mortality reduction after AMI;essential tremor – routine Rx; intermittent Rx.
Cautions – C/I – Sinus bradycardia. Heart block > first degree. Cardiogenic shock. CHR (unless secondaryto a tachyarrhythmia treatable with propranolol). (See Cardiac Failure under Cautions.) Raynaud’ssyndrome. Malignant HTN. Bronchial asthma. (see Bronchospastic Disease under Cautions.) Concomitantthioridazine Rx. See Interactions: Specific Drugs. Pre-excited AFib or flutter.
Warnings/Precautions – Warnings – Cardiac Failure – Poss precipitation of CHF. Avoid use in pts withovert CHF; may use cautiously in pts with inadequate myocardial function and, if necessary, in pts with well-compensated heart failure (e.g., those controlled with cardiac glycosides and/or diuretics). Adequate tx (e.g.,with a cardiac glycoside and/or diuretic) and close observation recommended if signs or sxs of impendingcardiac failure occur; if cardiac failure continues, D/C Rx, gradually if possible. Possible decreased exercisetolerance in pts with L vent dysfunction. Abrupt Withdrawal of Rx – Abrupt withdrawal of propranolol notrecommended as it may exacerbate angina symptoms or precipitate MI in pts with CAD. Gradually decreasedosage over about 2 wks and monitor pts carefully. If exacerbation of angina occurs or acute coronaryinsufficiency develops, reinstitute Rx promptly, at least temporarily, and initiate appropriate measures for themanagement of USA. Bronchospastic Disease – Possible inhibition of bronchodilation produced byendogenous catecholamines. Possible increased airway resistance and bronchospasm, particularly in pts with ahistory of asthma. Use with caution in patients with a hx of nonallergic bronchospasm (e.g., chronicbronchitis, emphysema). Use not recommended in pts with bronchial asthma. (see Cautions: C/I.) MajorSurgery – Possible increased risks associated w/ general anesthesia (e.g., severe hypotension, difficultyrestarting or maintaining heart beat) due to decreased ability of the heart to respond to reflex B-adrenergicstimuli. Use with extreme caution for mgment of arrhythmias occurring during anesthesia with myocardialdepressant anesthetics. (See Myocardial Depressant General Anesthetics under Interactions: Specific Drugs.)DM and Hypoglycemia – Possible decreased signs and sxs of hypoglycemia (e.g., tachycardia, palpitation, BPchanges, tremor). Possible hypoglycemia, especially in those undergoing dialysis, prolonged fasting, or severeexercise regimens. Use with caution in pts with DM. Thyrotoxicosis – Signs of hyperthyroidism may bemasked. Possible thyroid storm if Rx is abruptly withdrawn; carefully monitor pts having or suspected ofdeveloping thyrotoxicosis. Possible altered thyroid fxn test results. Bradycardia – Possible bradycardia,occasionally severe and accompanied by hypotension, syncope, shock, or angina. Severe bradycardiarequiring a demand PM has occurred in pts with WPW syndrome. Treat severe bradycardia with IM or IVatropine sulfate. If response is inadequate, consider cautious administration of IV isoproterenol. Possibledepressed SA node automaticity; use with caution in pts with sinus node dysfunction. AV Block – Possibleintensification of AV block, AV dissociation, complete heart block or cardiac arrest, especially in pts withpreexisting heart block caused by digitalis or other factors. Pheochromocytoma – To prevent severe HTN,institute alpha-adrenergic blocking agent Rx prior to the use of propranolol and continue during propranololRx. General Precautions – Hx of Anaphylactic Reactions – Possible increased reactivity to a variety ofallergens; pts may be unresponsive to usual doses of epinephrine used to treat anaphylactic rxns. OcularEffects – Possible dry eyes, generalized hyperemia of the conjunctivae, decreased tear production, and eyepain. Myasthenia Gravis – Myasthenic condition (e.g., ptosis, weakness of limbs, and double vision) reportedrarely with propranolol; use may be C/I in pts w/myasthenia gravis. Other Precautions – Shares the toxicpotentials of beta-adrenergic blocking agents; observe usual precautions of these agents. In addition, whenused in fixed-combination with hydrochlorothiazide, consider the cautions, precautions, andcontraindications associated with thiazide diuretics.
Common Adverse Effects – Bradycardia, N,V,D, epigastric distress, abdominal cramping, constipation,flatulence.
Ind – *acute MI, angina, *anxiety, a fib, a flutter, *esophageal varices, HTN, IHSS, migraine prophylaxis,PSVT, pheochromocytoma, *portal HTN, post MI, *scleroderma renal crisis, thyrotoxicosis, tremor,*unstable angina, variceal bleeding prophylaxis (* - items are non-FDA approved ind). Medical Computing Review
CI/precautions – *abrupt discontinuation, *acute bronchospasm, asthma, *AV block, *bradycardia, breast-feeding, bronchitis, cardiogenic shock, cerebrovascular disease, COPD, depression, DM, elderly, emphysema,heart failure, hepatic disease, hyperthyroidism, hypoglycemia, hypotension, myasthenia gravis,pheochromocytoma, pregnancy, psoriasis, pulmonary disease, pulmonary edema, Raynaud’s disease, renalfailure, surgery, thyroid disease, thyrotoxicosis, tobacco smoking, vasospastic angina, ventricular dysfunction. (* - items are absolutely CI)
Adverse rxns – alopecia, AV block, bronchospasm, DM, diarrhea, exfoliative dermatitis, fatigue,hallucinations, heart failure, hyperglycemia, hypertriglyceridemia, hypoglycemia, hypotension, impotence,libido decrease, musculoskeletal pain, myalgia, nausea/vomiting, nightmares, pruritis, sinus bradycardia, skinhyperpigmentation, xerosis.
DRUG FACTS: (A2ZDrugs would have the same content, although organized differently)
Ind – Tx of HTN; angina pectoris; IHSS; MI; pheochromocytoma; migraine prophylaxis; essential tremor;some ventricular and supraventricular arrhythmias. Unlabeled Use(s): Tx of alcohol withdrawal syndrome;esophageal varices rebleeding in portal hypertension; anxiety; thyrotoxicosis symptoms.
CI – Hypersensitivity to beta-blockers; >1st degree heart block; CHF unless secondary to tachyarrhythmia oruntreated HTN treatable with beta-blockers; overt cardiac failure; sinus bradycardia; cardiogenic shock;untreated bronchial asthma or bronchospasm, including sever COPD.
Precautions – Abrupt withdrawal: A beta-blocker withdrawal syndrome (eg, HTN, tachycardia, anxiety,angina, MI) may occur 1 to 2 wk after sudden discontinuation of systemic beta blockers. If possible, graduallywithdraw therapy over 1 to 2 wk. Anaphylaxis: Deaths have occurred; aggressive therapy may be required. CHF: Administer cautiously in patients whose CHF is controlled by digitalis and diuretics. DM: May masksymptoms of hypoglycemia (eg, tachycardia, BP changes). May potentiate insulin-induced hypoglycemia. Nonallergic bronchospastic diseases: Give drug with caution in patients with bronchospastic diseases. PVD:May precipitate or aggravate symptoms of arterial insufficiency. Renal/Hapatic impairment: Reduce dose. Thyrotoxicosis: May mask clinical signs (eg, tachycardia) of developing or continuing hyperthyroidism. Abrupt withdrawal may exacerbate symptoms of hyperthyroidism, including thyroid storm. Wolff-Parkinson-White: In several cases, tachycardia was replaced by severe bradycardia requiring a demand pacemaker.
SE/Adverse rxns – CV: Bradycardia; hypotension; CHF; atrioventricular (AV) block; worsening angina;torsades de pointes; edema; peripheral ischemia. CNS: Depression; tiredness; fatigue; lethargy; sleepdisturbances; bizarre dreams; short-term memory loss; dizziness. Dermatologic: Rash; pruritus. EENT: Dryeyes; visual disturbances. GI: Dyspepsia; N&V; diarrhea; dry mouth. GU: Impotence; urinary retention;difficulty with urination. Hematologic: Agranulocytosis. Hepatic: Elevated LFTs. Metabolic:Hyperglycemia; hypoglycemia. Respiratory: Wheezing; dyspnea; bronchospasm; difficulty breathing. Other:Increased sensitivity to cold (Raynaud phenomenon); psoriasis-like eruptions; skin necrosis; SLE; decreasedexercise tolerance.
ePOCRATES: No separate listing for indications, but Dosing info provided for hypertension, angina, migraine headacheprophylaxis, SVTs, *portal hypertension, thyrotoxicosis and tetralogy spells (the latter two are listed underpediatric dosing and are not starred to indicate an unlabeled use)
CI – hypersen to drug/class/compound; asthma; sinus bradycardia, severe; AV block, 2nd or 3rd degree;cardiogenic shock; CHF; caution in elderly pts; caution if impaired liver function; caution if impaired renalfxn; caution if DM
Medical Computing Review
Adverse Rxs – Serious Rxns: CHF, bronchospasm, agranulocytosis, arrhythmias; Common Rxns:bradycardia, CHF, dizziness, insomnia, weakness, fatigue, hallucinations, nausea, vomiting, abdominal pain,diarrhea, constipation, pharyngitis, hypotension, rash, bronchospasm, alopecia, impotence
Ind – mgmt of HTN, angina, pheochromocytoma, essential tremor, tetralogy of Fallot cyanotic spells,arrhythmias (such as a fib and flutter, AV nodal re-entrant tachycardias, and catecholamine-inducedarrhythmias), prevention of MI, migraine headache, symptomatic treatment of IHSS. Unlabeled/Investigational – tremor due to Parkinson’s disease, ethanol withdrawal, aggressive behavior, antipsychotic-induced akathisia, prevention of bleeding esophageal varices, anxiety, schizophrenia, acute panic, gastricbleeding in portal HTN
CI – Hypersensitivity to propranolol, beta-blockers, or any component of the formulation, uncompensatedCHF (unless the failure is due to tachyarrhythmias being treated with propranolol), cardiogenic shock,bradycardia or heart block (2nd or 3rd degree), pulmonary edema, severe hyperactive airway disease (asthma orCOPD), Raynaud’s disease, preg (2nd and 3rd trimesters).
Warnings/precautions – administer cautiously in compensated heart failure and monitor for a worsening ofthe condition (efficacy of propranolol in CHF has not been demonstrated). Beta-blocker therapy should notbe withdrawn abruptly (particularly in patients with CAD), but gradually tapered to avoid acute tachycardia,HTN, and/or ischemia. Use caution in patient with PVD. Use caution with concurrent use of beta-blockersand either verapamil or diltiazem, bradycardia or heart block can occur. Avoid concurrent IV use of bothagents. Use cautiously in patients with DM, may mask prominent hypoglycemic sxs. May mask signs ofthyrotoxicosis. Can cause fetal harm when administered in preg. Use cautiously in hepatic dysfunction(dosage adjustment required). Use care w/anesthetic agents which decrease myocardial function. Preg risk C.
Adverse rxns – CV – bradycardia, CHF, reduced peripheral circulation, chest pain, hypotension, impairedmyocardial contractility, worsening of AV conduction disturbance, cardiogenic shock, Raynaud’s syndrome,mesenteric thrombosis (rare). CNS – mental depression, lightheadedness, amnesia, emotional lability,confusion, hallucinations, dizziness, insomnia, fatigue, vivid dreams, lethargy, cold extremities, vertigo,syncope, cognitive dysfunction, psychosis, hypersomnolence. Dermatologic – rash, alopecia, exfoliativedermatitis, psoriasiform eruptions, eczematous eruptions, hyperkeratosis, nail changes, pruritus, urticaria,ulcerative lichenoid, contact dermatitis. Endocrine & metabolic - hypoglycemia, hyperglycemia,hyperlipidemia, hyperkalemia. GI – diarrhea, N&V, stomach discomfort, constipation, anorexia. GU –impotence, proteinuria (rare), oliguria (rare), interstitial nephritis (rare), Peyronie’s disease. Hematologic –agranulocytosis, thrombocytopenia, thrombocytopenic purpura. Neuromuscular & skeletal
Ind – (FDA) Angina, arrhythmias, essential tremor, HTN, IHSS, migraine, pheochromocytoma, post-MI(non-FDA) aggressive/agitated/violent behavior, anxiety disorders, CHF, GI bleeding, hyperthyroidism,neuroleptic-induced akathisia, tetralogy of Fallot
CI – Bronchial asthma or COPD, cardiogenic shock, hypersensitivity to propanolol, overt cardiac failure, 2ndand 3rd degree AV block, severe sinus bradycardia
Precautions – anesthesia/surgery (myocardial depression), avoid abrupt withdrawal, bronchospastic disease,cerebrovascular insufficiency, CHF, DM, hyperthyroidism/thyrotoxicosis, liver disease, myasthenicconditions, PVD, renal impairment. Medical Computing Review
Adverse effects – Common: bradycardia, AV block, cognitive dysfunction, cold extremities, depression,hypersomnolence, insomnia, paresthesias, psychosis, anorexia, N&V, dyspnea, wheezing, dermatitis, pruritus,urticaria. Serious: bronchospasm (rare)
Ind – (tab) HTN, angina, IHSS, migraine prophylaxis (inj/tab) arrhythmias (SVT, tachyarrythymia of digintoxication, resistant tachyarrythymia), reduction of CV mortality post-MI, essential tremors,pheochromocytoma
CI – cardiogenic shock, sinus bradycardia and >1st degree block, asthma, CHF (unless secondary totachyarrhythmias treatable w/propranolol)
Warnings/precautions – caution w/well-comp CHF, nonallergic bronchospasm, WPW Syndrome, hep orrenal dysfxn. Withdrawal before surgery controversial. May mask hypoglycemia or hyperthyroid sxs. Avoidabrupt discontinuation. May reduce IOP. Can cause cardiac failure.
Adverse rxn – bradycardia, CHF, hypotension, lightheadedness, mental depression, N&V, allergic rxns,agranulocytosis.
does not have a separate indications section in the medication
monograph, but integrates the indication in the dosing section.
FDA Approved Adult: HTN, angina, migraine prophylaxis, cardiac arrhythmia, MI, pheochromocytomasurgery. Unapproved adult: rebleeding esophageal varices. FDA Approved Peds: HTN. Unapproved peds:arrhythmia.
CI/precautions – (Under the subclass warning section) See also antihypertensive combinations. Abruptdiscontinuation may precipitate angina, myocardial infarction, arrhythmias, or rebound hypertension;discontinue by tapering over 2 weeks. Avoid using nonselective beta-blockers and use agents with beta1selectivity cautiously in asthma / COPD. Beta 1 selectivity diminishes at high doses. (Under drug-specificwarning section) No specific warning.
Adverse reactions – Serious: bronchoconstriction, masks hypoglycemic response and slow recovery, reboundhypertension/angina. Frequent: bradycardia, fatigue, dizziness, impotence. Medical Computing Review ROAD TEST 2 – DATA ORGANIZATION
This test presents the common template used for each monograph. The format is generally preserved, although a few headings were rearranged (such as dosage or brand names) to ease comparisons among references. Both Drug Facts and A2ZDrugs contain identical content, but since they arrange the content differently in their monographs, both templates are listed. Note that drug interactions here describe text information related to the particular drug, not the separate drug-drug interaction function that is bundled with several of these references:
ESSENTIALS: information & uses, dosage and administration, cautions, interactions, pharmacokinetics,actions and spectrum, advice to patients, preparations.
A2ZDRUGS : indications, action, CI, adverse rxns, route/dosage, preg, precautions, brand names, howsupplied, class, administration/storage, assessment/interventions, lab test interferences, overdosage, pt/familyeducation,
: description, indications (FDA and non-FDA), dosage (peds, adult, elderly, max limits, renal
and hepatic dosing), administration, CI/precautions, interactions, adverse rxns, classifications, preg/lactation.
DRUG FACTS : general, indications, CI, dosing (adult and peds), dosage forms/strengths, interactions,adverse rxns, precautions, action, lab test interferences, administration and storage, assessment andinterventions, overdosage, pt and family education. Natural Products: general, uses, SE, toxicology, history,botany, pharmacology.
ePOCRATES : dosing (adult, peds), CI; interactions; adverse rxns; mfr/cost info; preg, lactation, metabolism, excretion, DEA/FDA, drug class, mech of action
LEXI-DRUGS : (essential; comprehensive in bold): special alerts, restrictions, brand names (US, Canadian), synonyms, generic available, pharmacologic category, use (labeled, unlabeled/investigational), preg risk factor, preg implications, lactation, breast-feeding considerations, CI, warnings/precautions, adverse rxns, drug interactions (cytochrome P450 effect, increased effect/toxicity, decreased effect, etoh/nutrition/herb interactions, test interactions), stability, mech of action, pharmacodynamics/kinetics, dosing: (adults, elderly, pediatric, renal and hepatic impairment), dosing adjustment: toxicity, administration, reference level, dietary considerations, pt ed, nursing implications, overdosage/toxicology, additional information, anesthesia/critical care, comment, monitoring parameters, geriatric considerations, strengths/dosage forms. Specialty review adds: CV considerations, compatibility, mental health (effects on mental status, effects on psychiatric treatment, child/adolescent considerations), emetic potential, vesicant, BMT (comments, high dose, unique toxicity), physical assessment/monitoring, preg issues. International version includes drug names from around the world. : generic names, common trade names, class, dosage (peds, adult), dose adjustments,
administration, monitoring, how supplied, indications (FDA and non-FDA labeled), CI, precautions, adverseeffects (common, serious), drug interactions, preg category, breast feeding, notes [not personal]
: therapeutic category, how supplied, indications, dosing (adult, peds), CI, warnings and
precautions, preg/nursing, drug-drug interactions, adverse rxns, Black Box warnings, DEA class,manufacturer’s name, PDR page number
: all info, warnings, adult dosing, peds dosing, forms avail,
caut/notes, drug mech, advers rxn, cost. Medical Computing Review ROAD TEST 3 – ACCURACY OF INFORMATION
This section compares which of 11 identified beta-2 adrenergic agonists inhalers/nebulizers were included in the various programs. In a previous Road Test. we noted that, “including a drug makes the database more comprehensive—though not always. Here, listing a medication may reflect the database’s inclusion of international medications, with precautions taken so US physicians know not to prescribe them. It may also reflect a slow updating process on a discontinued product…”
Present: albuterol (Proventil, Ventolin), levalbuterol (Xopenex), salmeterol (Serevent)
Not Present: metaproterenol (Alupent), pirbuterol (Maxair), neither the inhalation or tablet form ofterbutaline (Brethine, Bricanyl), formoterol (Foradil). ASHF explains that all the monographs exceptpirbuterol are currently in DI and so will eventually become a part of Essentials. Pirbuterol is not includedin DI.
Appropriately not present: bitolterol, fenoterol, procaterol, isoetharine.
Since Essentials is a work in progress, only 3 of the 6 medications listed in DI have been made into Essentialmonographs. The final drug expected to be present, pirbuterol, is not included in DI and so would notappear in Essentials. No inappropriate drug is mentioned; terbutaline is available in Canada but is notincluded because it is no longer marketed in inhalation form in the US.
Three drug databases are geared for US physicians, and contained accurate information on beta agonists:CP OnHand, ePocrates, and mobilePDR. All had the same four drugs missing: the non-US fenoterol andprocaterol, and the no-longer marketed bitolerol and isoetharine. All three included only oral and injectableforms of terbutaline, not inhalation.
Lexi-Drugs is geared for all North American physicians, and from that perspective it too was accurate. Lexi-Drugs continues to list bitolerol because the drug is still available in Canada (in addition to other countries);the “US Brand Names” field is empty, indicating the medication is not available in the United States. Fenoterol, also available in Canada, is similarly listed.
MobileMDX carries international medications. To differentiate those not available in the US, the companyexplained that the drugs should not carry an FDA-approved Indication. But as of May 2, MobileMDX stilllisted bitolteral along with its trade name Tornalate, and the monograph still included FDA approvedIndication for asthma. The company acknowledged this was an error. MobileMDX continued to listterbutaline as an inhalant, again with the FDA approved Indication, although it is confusing since theIndication may as well apply to the oral and injectable forms. The company acknowledges the confusion.
Drug Facts/A2ZDrugs (same content; see Review) are geared for US physicians, yet they listed bitolteral andterbutaline as an inhalant, and they were the only reference that included the nebulizer medicationisoetharine. Facts & Comparisons, the company that provides the content, told me that they will look into it.
Tarascon Pharmacopoeia still lists complete monographs for isoetharine even though the Red Book indicatesthe FDA discontinued the medication in May 2002 and bitolterol which has not been marketed in the USsince 2001. Fenoterol is noted to be available in Canada only and procaterol is not in the database. Medical Computing Review
In the original Road Test we noted whether hypokalemia was listed as a side effect, an adverse effect, or awarning. This is a relatively mild but potentially clinically important side effect of beta agonist therapy, asdocumented in several references (eg. UpToDate’s “Beta agonists in asthma,” “Acute administration andprophylactic use”, and “Sympathetic activity and potassium balance”). Because hypokalemia is included insome but not all package inserts, depending on the drug manufacturer, inconsistencies in listings withinthe monographs of a single reference may reflect a database that relies on inserts without re-review.
ESSENTIALS: Each of the three beta-agonists present in Essentials appropriately lists hypokalemia as apossible side effect.
Only CP OnHand and ePocrates noted hypokalemia in every beta agonist monograph they include.
The failure of the other references to consistently note this side effect cannot be explained away by a drug’srelative beta-2 selectivity, since all these references failed to note hypokalemia in both more and less selectiveagents. Omitting hypokalemia can most reasonably be explained by the reference relying on individualpackage insert information, rather than also considering pharmacologic information pertinent to all betaagonists.
Lexi-Drugs failed to note hypokalemia in four medications. (bitolterol, metaproterenol, terbutaline, andpirbuterol). The company explained, "Under our current surveillance mechanisms, monograph drafts areprepared and updated for individual drugs. We rely on a secondary review process for the standardization ofmonographs across individual drug classes. Although we have completed this process for a number of drugclasses (i.e., tendon rupture warning for the fluoroquinolones) this process has not been completed for allclasses of drugs. This is the case with beta agonists. The presentation of adverse cardiovascular effects andhypokalemia are inconsistent within these monographs. A review and standardization of warnings, adverseeffects, and toxicology will be addressed immediately with all beta agonists. You should notice updates andcorrections to these monographs on Thursday, May 15, 2003. In addition, we will expand our secondaryreview processes to limit these issues in the future."
MobileMDX also acknowledged its error in failing to note hypokalemia in bitolterol and metaproterenol. Thecompany explained that DrugPoints tend to stay close to package insert information, other than for unlabeledindications and MedWatch. However, another part of Micromedex’s drug database, Drug Consults, has beenaggressively updating issues over the past several months and its “Hypokalemia in Beta Agonists” was in theprocess of being prepared. I was told that once this Consult is available, its information will be incorporatedinto DrugDex, which includes DrugPoints and so mobileMDX.
Drug Facts and A2ZDrugs content is created by the company Facts & Comparisons and a Stanfordpharmacologist, David Tatro, PharmD. The content failed to note hypokalemia in isoetharine andmetaproterenol. Dr. Tatro will consider adding a notation.
MobilePDR failed to note hypokalemia in metaproterenol and pirbuterol, as this information was lackingfrom its sole source of information, package inserts.
Tarascon Pharmacopoeia: None of the beta agonists listed hypokalemia as a potential side effect. Medical Computing Review
In the original Road Test, we examined the monographs of three tumor necrosis factor (TNF) inhibitors: infliximab (Remicade), etanercept (Enbrel) and adalimumab (Humira). Due to their affect on the immune system, it is important that TNF inhibitors not be initiate treatment in patients withacute localized or chronic infection and that patients be carefully monitored for signs of new infection.
ESSENTIALS : Appropriately, all three warn about not starting therapy in patients with infection, andmonitoring patients for infection.
All programs except Drug Facts and A2ZDrugs clearly warned against initiating treatment in infectedpatients in all their monographs on TNF inhibitors; neither package made any mention of any risk ininitiating treatment in already-infected individuals. However, all programs clearly warned about monitoringpatients for new infections while undergoing treatment with TNF inhibitoris.
Because neither Drug Facts nor A2ZDrugs contained this warning, the content publisher, Facts andComparisons (F&C) was approached first. F&C referred the information to Dave Tatro, PharmD, theclinical editor and author of the content A to Z Druge Facts. In a phone conversation he acknowledged “thewording in the monographs was not as clear as it might have been.” He will reevaluate the monographs fromthat perspective.
2b) TNF Inhibitors: Pharmaceutical Information
Some drug information is important for non-clinicians, such as nurses and pharmacists involved with storage, reconstituting, and administrating subcutaneous or intravenous medications, or for clinicians wishing a more comprehensive understanding of a medication. Does each monograph note that the preparations must be refrigerated? (Reference: Drug Label Storage for Humira, Enbrel and Remicade (online reproductions above)).
ESSENTIALS : All three indicate appropriate storage instructions.
Four databases—CP OnHand, Drug Facts, A2ZDrugs, Lexi-Drugs, and mobileMDX—noted this in theirmonographs. The two databases that focus on concise physician-relevant prescribing (ePocrates) andspecifically outpatient information (mobilePDR), did not.
Tarascon: Infliximab (Remicade) monograph does not list refrigeration; the other two medications do, underthe caution/notes section. Medical Computing Review ROAD TEST 4 – FDA NEW DRUGS, WARNINGS AND UPDATES
See Nov/Dec 2004 issue limitations, and the results of most recent Road Test. As with the other drug handheld products, we testedhow Essentials handles the latest FDA approvals and warnings. However, this cannot be consideredcomparable with past Road Tests because not all the other programs were subjected to the same query,which took place 6-20 months after the other programs. For the original Road Test, see the May/Juneand the May/June 2004
As of March 19, 2005, neither telithromycin (Ketek, approved April 2004) nor duloxetine (Cymbalta,approved August 2004) were included in Essentials. Both are in DI: telithromycin was added in November2004 and revised in February 2005, and duloxetine was added in January 2005.
Natalizumab (Tysabri), a disease-modifying immunosuppressant for use alone or in combination with otheragents to decrease the frequency of exacerbations in relapsing remitting multiple sclerosis, was approvedNovember 24, 2004. As of March 19, 2005, there was no entry or monograph in Essentials. According toAHFS, a full monograph appeared in DI in February 2005.
Subsequently, the FDA issued a public announcement regarding natalizumab (http://www.fda.gov/cder/drug/advisory/natalizumab.htm) on February 28, 2005, notifying that the manufacturer is voluntarilysuspending marketing and dosing in clinical trials due to postapproval cases of progressive multifocalleukoencephalopathy, a rare, serious progressive disease that affects the nervous system and causes irreversibleneurologic deterioration and death. As of March 19, the announcement was not noted in DI.
In October 2004, rofecoxib (Vioxx) was recalled. There is a Caution icon embedded in the monograph inEssentials that, when clicked, states that Vioxx was recalled.
In December 2004, the FDA updated the information regarding the use of estradiol transdermal system(Estraderm, among others), warning of associated risks of dementia, cardiovascular disorders and breastcancer, and that it is contraindicated in patients with liver disorder or disease. While the entry in Essentialsdoes have the appropriate changes in the Cautions section, the Estraderm entry is linked to the generalestradiol monograph and is not specific for the Estraderm patch.
Also in December, the FDA updated information regarding tamoxifen (Nolvadex) to warn about the risk ofuterine malignancies, and this is appropriately noted in Essentials. Medical Computing Review
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