World of Drug Information

World of Drug Information - Volume 8, Issue 4 - December 1997

In This Issue ...
 New IDIS Software/Articles-on-Disc  
 Current Clinical Issues  
 Key References 
 FDA Approvals 
 Search Tips 
 Staff Profile 

IDIS Windows® Debuts in 1998

Soon IDIS subscribers will have the option of using either IDIS Windows® or IDIS DOS retrieval software. Earlier this year IDIS subscribers were surveyed for their ability to use Windows® now and in the near future. The results clearly indicate that a wide majority of subscribers are ready for Windows® software. However, the survey also identified a core of institutions that will require a DOS version of IDIS. With this in mind, the IDIS staff in conjunction with Nexdata Solutions, Inc. has developed both Windows® and new DOS software for the database. We expect the new software to launch with the January 1998 update.


Powers Foss, Jennifer Cory, Stephen Haydel, Tom Evenson

Windows® will provide IDIS searchers with a full graphical user interface (GUI). The Windows® GUI search, retrieval and display features improve end-users' ability to extract relevant citations in a straightforward, easy-to-use format. Enhanced capabilities include:

The DOS software for the IDIS database is also new. While some of the above features are intrinsic with Windows® and will not be available in DOS, we have been able to achieve all the same basic search functions in the DOS format. These include the Boolean and proximity operands.

The Windows® and the DOS version of IDIS reside on the same compact disc. Thus DOS users are able to reinstall IDIS under Windows® whenever they have upgraded their system. The minimum system requirements for IDIS Windows® are:

The next step--IDIS Articles-on-CD

Both the new IDIS Windows® software and the new IDIS DOS software will be configured to link to article images. We are currently testing those links and establishing the production cycle and quality control steps for placing the IDIS database articles on compact disc as TIFF images. While we have proceeded as much as possible in parallel with the development of the Windows® software, some steps in establishing an articles-on-disc product inherently have to follow the search software development. We anticipate placing the articles-on-disc into monthly production in early 1998. For the first few months of production all subscribers will receive the articles-on-disc with their monthly updates. During this time, comments and evaluations from users will be critical. Articles-on-disc is an exciting enhancement for the IDIS database. We look forward to this next step in applying informatics technology to the IDIS database.

Hazel H. Seaba, Director

CURRENT CLINICAL ISSUES

Herbal Medicine

Therapeutic use of plants for the treatment of human illnesses dates back over many millennia. Evidence of their effectiveness in the diagnosis, cure and prevention of disease states exists in every culture throughout the world. Today "traditional medicine," characterized by the use of herbs and other natural products, still remains a regular component of health care in countries such as China, Japan, India, South America and Egypt. In the United States, where scientific methodologies are considered the foundation for effective and safe health care, this form of "alternative therapy" is not quite as readily accepted by most physicians. Since the last decade, however, herbal products used as therapeutic remedies are rapidly gaining popularity among health consumers.

What Is an Herbal Medicine?

Herb has various meanings, but in the context of this article it refers to "crude drugs of vegetable origin utilized for the treatment of disease states, often of a chronic nature, or to attain or maintain a condition of improved health" (Tyler, 1994). Herbal preparations called "phytopharmaceutical," "phytomedicinal" or "phytomedicine" are preparations made from different parts of herbs or plants. They come in different formulations and dosage forms including tablet, capsule, elixir, powder, extract, tincture, cream and parenteral preparations. Herbal products in their crude state are also used. A single isolate or active principle derived from plants such as digoxin or reserpine tablets is not considered herbal medicine. Herbal remedies are not to be confused with homeopathic preparations. Homeopathic medicine, founded in the eighteenth century by the German physician Samuel Hahnemann, also uses herbs and other natural products, but it is based upon the "law of similar" and the "law of dilution".

Is Herbal Medicine Indexed in the IDIS Database?

There is a wealth of nonscientific herbal medicine information readily available to the health consumer. Access to scientific literature is crucial to the pharmacist for his or her role as a drug information provider. The pharmacist, among all health care practitioners, is in the best position to provide information about "drug" safety and effectiveness. If an herb is used as a therapeutic agent, it should be considered a drug.

A "global search" with the terms Herbal Medicine* entered in the Global field of the Field Search template retrieves 369 Hits* (IDIS file 1985 through October 1997).

Search terms entered in the Global field are cross referenced and searched in all fields including the Abstract field. This search is not specific but estimates IDIS coverage of the herbal medicine literature and provides examples of how herbal medicine is indexed.

Glancing at the search results, one can see that all aspects of herbal medicine are covered: overview, side effects, adulteration, pharmacokinetics, efficacy, interaction. Sixty-three percent of the 369 citations are reports or case reports. Close to twelve percent of the articles are classified as studies with only 8 randomized controlled studies. Several review articles and book reviews give basic information useful to the pharmacist with limited background in the field of herbal therapy (Bartram; Newall; Phillipson; Tyler, 1995, 1996). The result of this search is not surprising; most of the scientific phytomedicinal research is being done in Western European countries, especially in Germany.

A search conducted with the same terms against IDIS 1966-1984 database yields only 24 citations.

The substantial difference in the number of citations found between the two files (1985 through October 1997 and 1966-1984) can be explained by an increased awareness in phytomedicine by the medical community. Herbal Medicine was added as a valid drug term to the IDIS drug vocabulary in 1981 as interest increased in this form of alternative therapy. Since 1996, the addition of European Journal of Herbal Medicine and American Journal of Chinese Medicine to the IDIS journal list has contributed 31 citations to the database.

Which Phytomedicinals are Indexed in IDIS?

Thousands of herbal products are available worldwide. In some countries, herbal medicines are perceived as drugs and can be bought over the counter or prescribed by physicians. In the United States, herbal preparations are not classified as drugs by the Food and Drug Administration. In Germany, results of pharmacological research, clinical studies and bibliographic searches must be submitted to a special commission of the German Ministry of Health, Commission E, for risk-benefit evaluation before marketing authorization is granted.

In France, the sale of herbal medicines is under less stringent but more pragmatic regulations; an herb is considered a safe and effective drug if it can be "traditionally" proven safe and effective. Euphytose, a valerian based mild sedative drug introduced in France in 1927 can be 65% reimbursed by the "Securite Sociale" when it is prescribed by a physician, but it can also be bought without a prescription. Not all herbal medicines are reimbursable. Lenicalm, a linden tree and hawthorne composition, on the market since 1990 for mild insomnia is not reimbursable. In the United States, herbal preparations are not classified as drugs by the Food and Drug Administration (FDA). They are classified as "dietary supplements" with a few exceptions such as Capsicum, Elm Bark, Juniper, Karaya Gum, Psyllium and Witch Hazel. Over the years the United Stated Pharmacopoeia has included more than 600 herbals in its compendium.

A search of the terms Herb* Medicine* entered on the IDIS Thesaurus template retrieves 46 entries. The entries include:

Juniper - See HERBAL MEDICINES 9251000
Lappa Root - See HERBAL MEDICINES 9251000
Phytoestrogens - See HERBAL MEDICINES 9251000
Wormwood - See HERBAL MEDICINES 9251000

All are cross-referenced to the valid drug term HERBAL MEDICINES 9251000.

Each valid drug term in the IDIS database is assigned a modified American Hospital Formulary System (AHFS) drug number in which the first several digits serve as therapeutic class identifier. Herbal Medicines 9251000, a subcategory under the Unclassified Therapeutic Agents category 9250000, can be searched to show all the specific herbal drugs included in the subcategory.

A subcategory search conducted with 9251* entered on the Thesaurus template yields 118 entries including the 46 entries found from the previous thesaurus search. All of the 1990s' top selling herbs in the US such as Ginseng, Ginger, Echinacea, Garlic, Ginkgo and Aloe along with some more exotic herbs such as Betel, Kombucha and Mistletoe are listed with their unique specific drug code.

GINSENG 92510010
GINGER 92510009
GINKGO 92510034
ECHINACEA 92510019
GARLIC 92510008
ALOE 92510033
SAW PALMETTO 92510020
BETEL 92510043
KOMBUCHA 92510011
MISTLETOE 92510042

Herbal Side Effects Little is known about phytomedicine safety. There has been an increase in the number of side effects reported in the literature. Many cases, however, could have gone unreported because herbal medicine is usually self-prescribed and oftentimes ignored by health practitioners during the patient's care. Identifying adverse effects is further hindered because it is not always possible to assess the quality of certain herbal medicinal products.

A search with the drug code 9251* entered in the Drug field of the Field search template yields 587 citations.

A search with the code 9251* in the Drug field and Side Eff* in the Descriptor field from the Field Search template yields 378 citations.

By comparing the results of the searches, one can see that sixty-four percent of the citations found in IDIS reported a phytomedicine-induced side effect.

Herbal Medicine-Drug Interactions

The potential risk of an herbal medicine interacting with a prescribed drug is also a concern with the increased use of phytomedicines. Recently, several interactions have drawn the attention of the medical community.

Janetzky and Morreale reported a probable interaction between ginseng, one of the most popular herbs with multiple health claims, and warfarin, a drug with numerous well-recognized drug-drug interactions.

Several other drug-herbal interactions between Siberian ginseng and digoxin, ginseng and phenelzine and other MAO inhibitors were found in IDIS

A clinically significant interaction between warfarin and an herbal medicine containing Salvia miltiorrhiza roots causing clotting abnormalities was reported by Yu. A randomized, crossover study performed on eight healthy subjects reported no significant pharmacokinetic interactions between levofloxacin and three selected traditional herbal medicines. No differences were found in levofloxacin plasma concentration, area under the curve, terminal elimination half-life or renal clearance (Hasegawa).

A randomized, crossover drug-herbal interaction study was conducted in 22 healthy volunteers to investigate the effect of three major Chinese herbal medicines containing 60 to 66 mg of glycyrrhizin on the pharmacokinetics of prednisolone. The effect on prednisolone pharmacokinetics differed between the three preparations although they contained a similar amount of glycyrrhizin (Homma).

Herbal Medicine Adulteration

Standardized herbal preparations are becoming increasingly available. In some parts of the world where no government standards and quality control are enforced, adulteration and contamination pose safety as well as efficacy problems. The presence of adulterants such as arsenic, mercury, lead or prescription drugs in herbal medications can cause significant toxicity. Adulteration or contamination can be captured using IDIS descriptor CONTAMINATION 104. A search done with 9251* in the Drug field and contamination in the Descriptor field of the Field Search template yields 26 citations. Huang addressed this "public health concern" after finding that 23.70% of traditional Chinese medicines (total of 2,609 samples) collected over a year among eight hospitals in Taiwan were spiked with adulterants such as caffeine, acetaminophen, indomethacin, hydrochlorothiazide and other drugs.

Previously, an awareness call to the medical profession was made by Chan in his article published in The Lancet in 1993. Several cases of adulteration reported by Gertner alerted the physicians to the problems encountered by the presence of "undeclared" prescription drugs in Chinese herbal medicines.

Herbal Research

Garlic (Allium sativum), sometimes referred to as Nectar of the Gods (Lawrence Review of Natural Products), is one of the most versatile medicinal plants. Numerous scientific studies have been conducted to evaluate its various potential therapeutic effects. Garlic's beneficial effect in hypercholesterolemic and coronary heart disease subjects is shown in a randomized study by Adler and a double-blind, randomized, crossover study by Steiner. A meta-analysis of five randomized, placebo-controlled trials reported a "significant reduction in total cholesterol levels" in persons with cholesterol level greater than 200 mg/dL (Warshafsky). Another meta-analysis of eighteen trials concluded that there is "inadequate justification for garlic and related Allium" use to reduce cardiovascular risk (Kleijnen, 1989). Its cardioprotective effect has generated several letters to the editor in the Lancet. Its effect on platelet aggregation is well documented (Kiesewetter). Garlic's antibacterial, antifungal and antiviral properties have been studied in vitro (Delaha) and in vivo (Davis).

Resurgence of interest in extracts from St John's Wort leaves and flowering tops used as an antidepressant has been seen in recent years. St John's Wort (Hypericum perforatum) is used for the treatment of mild depression in Germany where its retail sales run about 92 million US dollars (HerbalGram). Results of a systematic review and meta-analysis of 23 randomized placebo-controlled trials of Hypericum extracts in depressed patients showed that St John's Wort extracts are statistically "superior than placebo and are as effective as the standard antidepressants" (Linde). St John's Wort pharmacokinetic studies are available. The National Institute of Mental Health and the Office of Alternative Medicine have cofunded a multi-center, randomized trial to be launched in 1998 that will compare Hypericum extract to a selected serotonin re-uptake inhibitor and a placebo (Holden).

Maidenhair tree (Ginkgo biloba) products are among the most popular herbal dietary supplements in the US. In Germany, the extract from Ginkgo biloba leaves has been prescribed for circulatory system disorders and its retail sales run around 719 million US dollars a year. A review by Kleijnen and Knipschild (1992) summarizes the possible mechanisms of action, clinical pharmacokinetics, side effects and efficacy of Ginkgo biloba extract in the treatment of intermittent claudification and cerebral insufficiency. Substantial scientific data about Gingko biloba is available in the German literature. Recently, a placebo-controlled, double-blind, randomized trial, conducted in the United States, found that Ginkgo biloba extract is "safe and appears capable of stabilizing and improving the cognitive performance and the social function" in Alzheimer's and multi-infarct dementia patients (LeBars). Alzheimer's disease, characterized by a subtle onset and progressive loss of immediate memory and other cognitive functions due to a degenerative process of the cerebral cortex nerve cells, affects as many as four million persons in the US.

In Conclusion

Eighty percent of the world population is using some form of herbal medicine. In 1990, in the United States, one out of three Americans sought a complementary or alternative form of medicine. In 1992, the Office of Alternative Medicine, a component of the National Institutes of Health was created to "facilitate the evaluation of alternative medical treatment modalities" and to serve as a "public information clearinghouse" (Alternative Medicine Home Page).

Up-to-date information found in IDIS will support the pharmacists facing this new challenge--herbal medicine.

ThaiBinh TonThat, R.Ph., Pharm.D.

REFERENCES:

Adler AJ, Holub BJ. Effect of garlic and fish-oil supplementation on serum lipid and lipoprotein concentrations in hypercholesterolemic men. Am J Clin Nutr. 1997;65:445-450. (IDIS Article Number 381548)

Alternative Medicine Home Page [resource on World Wide Web]. URL:http://altmed.od.nih.gov/oam/about/general.shtml#purpose.

Bartram T. Encyclopaedia of herbal medicine. Eur J Herb Med. 1996;2:50. (IDIS article Number 367752)

Chan TYK, Chan JCN, Tomlinson B et al. Chinese herbal medicines revisited: A Hong Kong perspective. Lancet. 1993;342:1532-1534. (IDIS Article Number 322808)

Davis LE, Shen JK, Cai Y. Antifungal activity in human cerebrospinal fluid and plasma after intravenous administration of Allium sativum. Antimicrob Agts Chemother. 1990;34:651-653. (IDIS Article Number 264900)

Delaha EC, Garagusi VF. Inhibition of mycobacteria by garlic extract (Allium sativum). Antimicrob Agts Chemother. 1985;27:485-486. (IDIS Article Number 198568)

Gertner E, Marshall PS, Filandrinos D et al. Complications resulting from the use of Chinese herbal medications containing undeclared prescription drugs. Arthritis Rheum. 1995;38:614-617. (IDIS Article Number 347614

Hasegawa T, Yamaki KI, Muraoka I et al. Effects of traditional Chinese medicines on pharmacokinetics of levofloxacin. Antimicrob Agts Chemother. 1995;39:2135-2137. (IDIS Article Number 353850)

HerbalGram 1996:38:59.

Holden C. Random samples: NIH to explore St. John's Wort. Science. 1997;278:391.

Homma M, Oka K, Ikeshima K et al. Different effects of traditional Chinese medicines containing similar herbal constituents on prednisolone pharmacokinetics. J Pharm Pharmacol. 1995;47:687-692. (IDIS Article Number 355469)

Huang WF, Wen KC, Hsiao ML. Adulteration by synthetic therapeutic substances of traditional Chinese medicines in Taiwan. J Clin Pharmacol. 1997;37:344-350. (IDIS Article Number 385760)

Janetzky K, Morreale AP. Probable interaction between warfarin and ginseng. Am J Health-Syst Pharm. 1997;54:692-693. (IDIS Article Number 381389)

Kiesewetter H, Jung F, Jung EM et al. Effect of garlic on platelet aggregation in patients with increased risk of juvenile ischaemic attack. Eur J Clin Pharmacol. 1993;45:333-336. (IDIS Article number 323301)

Kleijnen J, Knipschild P, Ter Riet G. Garlic, onions and cardiovascular risk factors. A review of the evidence from human experiments with emphasis on commercially available preparations. Br J Clin Pharmacol. 1989;28:535-544. (IDIS Article Number 261219)

Kleijnen J, Knipschild P. Ginkgo biloba. Lancet. 1992;340:1136-1139. (IDIS Article Number 305011)

The Lawrence Review of Natural Product. 1994.

Le Bars PL, Katz MM, Berman N et al. A placebo-controlled, double-blind, randomized trial of an extract of Ginkgo Biloba for dementia. JAMA. 1997;278:1327-1332. (IDIS Article Number 393113)

Linde K, Ramirez G, Mulrow CD et al. St John's wort for depression--An overview and meta-analysis of randomized clinical trials. BMJ. 1996;313:253-258. (IDIS Article Number 371610).

Newall CA, Anderson LA, Phillipson JD. Herbal medicines. A guide for health-care professionals. Eur J Herb Med. 1997;3:48-49. (IDIS Article Number 388305)

Phillipson JD. Pharmacy and herbal medicines. Hong Kong Pharm J. 1995;4:55-62. (IDIS Article Number 352788)

Steiner M, Khan AH, Holbert D et al. A double-blind cross-over study in moderately hypercholesterolemic men that compared the effect of aged garlic extract and placebo administration on blood lipids. Am J Clin Nutr. 1996;64:866-870. (IDIS Article Number 378078)

Tyler VE. Herbs of Choice: The therapeutic use of Phytomedicinals. Binghamton: Haworth Press; 1994.

Tyler VE. Herbal remedies. J Pharm Technology. 1995;11:214-220. (IDIS Article Number 354004)

Tyler VE. What pharmacists should know about herbal remedies. J Am Pharm Assoc. 1996;36:29-37. (IDIS Article Number 370769)

Warshafsky S, Kamer RS, Sivak SL. Effect of garlic on total serum cholesterol: A meta-analysis. Ann Intern Med. 1993;119:599-605. (IDIS Article Number 320675)

Yu CM, Chan JCN, Sanderson JE. Chinese herbs and warfarin potentiation by 'Danshen'. J Int Med. 1997;241:337-339. (IDIS Article Number 386596)

KEY REFERENCES

NEW DRUG SELECTED BIBLIOGRAPHY

This new drug bibliography provides a selection of key clinical studies, practice guidelines and reviews of new drugs approved by the FDA since July 1997. IDIS SYSTEM/CD-ROM was searched to retrieve key articles relevant to the new drugs and their approved uses.

Arbutamine HCl

Hendel RC, Kostuk W, Beanland RS et al. Comparison of tc-99m sestamibi perfusion imaging and ecocardiography using an arbutamine infusion for the detection of coronary artery disease. Am J Cardiol. 1997;79:1518-1521. (IDIS Article Number 387304). A randomized, crossover study of 38 patients in which the investigators sought to analyze the diagnostic value of arbutamine and technetium (Tc)-99m sestamibi perfusion imaging and directly compare perfusion imaging with echocardiography after arbutamine infusion.

Cohen JL, Chan KL, Jaarsma W et al. Arbutamine echocardiography: efficacy and safety of a new pharmacologic stress agent to induce myocardial ischemia and detect coronary artery disease. J Am Coll Cardiol. 1995;26:1168-1175. (IDIS Article Number 355701). A multicenter study that sought to determine the efficacy and safety of arbutamine echocardiography in inducing myocardial ischemia and detecting coronary artery disease in 143 patients with coronary artery disease documented by coronary angiography.

Kiat H, Iskandrian AS, Villegas BJ et al. Arbutamine stress thallium-201 single-photon emission computed tomography using a computerized closed-loop delivery system: multicenter trial for evaluation of safety and diagnostic accuracy. J Am Coll Cardiol. 1995;26:1159-1167. (IDIS Article Number 355700). A multicenter cohort study designed to evaluate the efficacy and safety of arbutamine when used in conjunction with thallium-201 single-photon emission computed tomography (SPECT) and to compare arbutamine stress and treadmill exercise thallium-201 SPECT for diagnostic sensitivity and myocardial perfusion pattern in 184 patients who underwent arbutamine stress testing.

Dolasetron Mesylate

Lofters WS, Pater JL, Zee B et al. Phase III double-blind comparison of dolasetron mesylate and ondansetron and an evaluation of the additive role of dexamethasone in the prevention of acute and delayed nausea and vomiting due to moderately emetogenic chemotherapy. J Clin Oncol. 1997;15:2966-2973. (IDIS Article Number 391211). In a multicenter, double-blind, randomized study of 696 eligible patients receiving moderately emetogenic chemotherapy, investigators compared the efficacy of dolasetron and ondansetron in controlling nausea and vomiting in the first 24 hours; evaluated efficacy when dexamethasone was added to either drug in the first 24 hours; and extended these comparisons over seven days.

Kris MG, Pendergrass KB, Navari RM et al. Prevention of acute emesis in cancer patients following high-dose cisplatin with the combination of oral dolasetron and dexamethasone. J Clin Oncol. 1997;15:2135-2138. (IDIS Article Number 387810). In a phase II study with 75 patients, investigators tested the ability of oral dolasetron 200 mg and dexamethasone 20 mg to prevent acute emesis in cancer patients receiving initial cisplatin at doses>/- 70 mg/m2.

Graczyk SG, McKenzie R, Kallar S et al. Intravenous dolasetron for the prevention of postoperative nausea and vomiting after outpatient laparoscopic gynecologic surgery. Anesth Analg. 1997;84:325-330. (IDIS Article Number 381725). A multicenter, randomized, double-blind, placebo controlled study that compared the efficacy and safety of three single intravenous doses of dolasetron mesylate salt (12.5, 25, or 50 mg) for the prevention of postoperative nausea and vomiting in 635 female patients undergoing outpatient laparoscopic gynecologic surgery.

Lerman J, Sims C, Sikich N et al. Pharmacokinetics of the active metabolite (MDL 74,156) of dolasetron mesylate after oral or intravenous administration to anesthetized children. Clin Pharmacol Ther. 1996;60:485-492. (IDIS Article Number 377405). A pharmacokinetic study that determined the pharmacokinetics of the active metabolite of dolasetron and assessed the safety and tolerability of dolasetron mesylate in 30 children undergoing elective surgery as inpatients.

Dempsey E, Bourque S, Spenard J et al. Pharmacokinetics of single intravenous and oral doses of dolasetron mesylate in healthy elderly volunteers. J Clin Pharmacol. 1996;36:903-910. (IDIS Article Number 376864). A randomized, open-label, crossover, pharmacokinetic study that assessed the pharmacokinetics of single intravenous and oral doses of dolasetron mesylate in 18 healthy volunteers over 65 years of age.

Hesketh P, Navari R, Grote T et al. Double-blind, randomized comparison of the antiemetic efficacy of intravenous dolasetron mesylate and intravenous ondansetron in the prevention of acute cisplatin-induced emesis in patients with cancer. J Clin Oncol. 1996;14:2242-2249. (IDIS Article Number 371421). A multicenter, randomized, double-blind study that assessed the comparative antiemetic efficacy of single-dose intravenous dolasetron mesylate and ondansetron in preventing cisplatin-induced nausea and vomiting in 609 cancer patients receiving first-course cisplatin chemotherapy.

Fenoldopam Mesylate

Pilmer BL, Green JA, Panacek EA et al. Fenoldopam mesylate versus sodium nitroprusside in the acute management of severe systemic hypertension. J Clin Pharmacol. 1993;33:549-553. (IDIS Article Number 316274). A multicenter, randomized, single-blind study that compared the effects of fenoldopam mesylate and sodium nitroprusside in 33 severely hypertensive patients.

Shusterman NH, Elliott WJ, White WB. Fenoldopam, but not nitroprusside, improves renal function in severely hypertensive patients with imparied renal function. Am J Med. 1993;95:161-168. (IDIS Article Number 318999). A comparative study that examined the effects of fenoldopam and sodium nitroprusside on blood pressure and renal function in 42 severely hypertensive patients of which 19 also had impaired renal function.

Quetiapine Fumarate

Small JG, Hirsch SR, Arvanitis LA et al. Quetiapine in patients with schizophrenia: a high- and low-dose double-blind comparison with placebo. Arch Gen Psychiatry. 1997;54:549-557. (IDIS Article Number 388276). A six week multicenter, double-blind, placebo-controlled phase II study that evaluated high and low doses of quetiapine fumerate in 286 hospitalized patients with schizophrenia (DSM-III-R).

Herz MI, McIntyre JS, Charles SC et al. Practice guideline for the treatment of patients with schizophrenia. Am J Psychiatry. 1997;154:1-63. (IDIS Article Number 384054). This practice guideline was developed under the auspices of the Steering Committee on Practice Guidelines of the American Psychiatric Association and includes information on the use of quetiapine fumerate in patients with schizophrenia.

Ropinirole HCl

Adler CH, Sethi KD, Hauser RA et al. Ropinirole for the treatment of early Parkinson's disease. Neurology. 1997;49:393-399. (IDIS Article Number 390050). A six month randomized, placebo-controlled, double-blind study that assessed the efficacy and safety of ropinirole in 241 patients with early Parkinson's disease with limited or no prior dopaminergic therapy.

Tiagabine HCl

Gustavson LE, Boellner SW, Granneman GR et al. A single-dose study to define tiagabine pharmacokinetics in pediatric patients with complex partial seizures. Neurology. 1997;48:1032-1037. (IDIS Article Number 385235). An open-label study of 25 children with complex partial seizures that assessed the pharmacokinetics and safety of a single dose of approximately 0.1 mg/kg tiagabine.

Dodrill CB, Arnett JL, Sommerville KW et al. Cognitive and quality of life effects of differing dosages of tiagabine in epilepsy. Neurology. 1997;48:1025-1031. (IDIS Article Number 385234). This study reports cognitive and quality of life findings from a 16 week, large, multicenter, randomized, parallel, double-blind, add-on study in which three different doses of tiagabine were compared to placebo in patients with focal epilepsy whose complex partial seizures were difficult to control.

Ruth Calloway, R.Ph., M.S.

FDA DRUG/BIOLOGIC APPROVALS
Generic Name
(FDA Therapeutic Classification)

Trade Name

Sponsor

(Approval Date)

Valid IDIS Drug Term

Drug Number

(IDIS Citations)*

Indication/Use

Valid IDIS Disease Term

Modified ICD-9-CM Number

Arbutamine HCl
(1S)**

GenESA
Gensia Inc.
(Sept. 12)
ARBUTAMINE
12120024
(10 citations)
Aid in diagnosing the presence or absence of coronary artery disease in patients who cannot exercise adequately when used in conjunction with radionuclide myocardial perfusion imaging or echocardiography Diag Test-Stress, Cardiac
89.4
Dolasetron Mesylate
(1S)

Anzemet
Hoechst Marion Roussel
(Sept. 11)
DOLASETRON
56220021
(24 citations)
Prevention of chemotherapy-induced nausea and vomiting, and prevention of postoperative nausea and vomiting Nausea and Vomiting
787.0
Prophylaxis NEC
V07.
Fenoldopam Mesylate
(1S)

Corlopam
Neurex
(Sept. 23)
FENOLDOPAM
12120026
(63 citations)
In hospital, short-term (up to 48 hrs) use in the management of severe hypertension when rapid, but quickly reversible, emergency reduction of blood pressure is clinically indicated, including malignant hypertension with deteriorating end-organ function Hypertension
401.
Interferon Alfacon-1
Infergen
Amgen, Inc.
(Oct. 6)
INTERFERON ALFA
14000201
(2573 citations)
Treatment of chronic hepatitis C virus (HCV) infection in patients 18 years of age or older with compensated liver disease who have anti-HCV serum antibodies and/or the presence of HCV RNA Hepatitis, Viral NEC
070.
Irbesartan
(1S)

Avapro
Sanofi Pharmaceuticals Inc.
(Sept. 30)
IRBESARTAN
24080055
(5 citations)
Treatment of hypertension Hypertension
401.
Quetiapine Fumarate
(1S)

Seroquel
Zeneca Pharmaceuticals
(Sept. 26)
QUETIAPINE
28160834
(24 citations)
Treatment of manifestations of psychotic disorders Schizophrenia NEC
298.
Ropinirole HCl
(1S)

Requip
SmithKline Beecham
(Sept. 19)
ROPINIROLE
28280011
(13 citations)
Treatment of signs and symptoms of idiopathic Parkinson's disease Parkinson's Disease
332.
Tiagabine HCl
(1S)

Gabitril
Abbott Labs
(Sept. 30)
TIAGABINE
28122034
(31 citations)
Adjunctive therapy in adults and children 12 yrs of age and older in the treatment of partial seizures Epilepsy, Part W Impair Consc
345.4
Epilepsy, Part No Impair Consc
345.5
*Through November 1997 Update. Complete bibliographic citations will be provided upon request.
**(1S) New Molecular Entity given standard review by FDA.

SEARCH TIPS

In the IDIS database, can I find if an article has an erratum or other type of correction?

The IDIS database allows you to find corrections to the original articles already in the database. The corrections are submitted by the original author(s) or the journal publisher. In 1993 the disease term CORRIGENDUM Z100. was added for articles that require corrections. The corrigendum term includes erratums, addendums, retractions or notes of plagiarism. The index records from 1986 to the present use the corrigendum term. The type of correction is listed in the title field followed by the microfiche number for the original article or correction.

For example:

Article Number: 384000

Title: THE BRITISH GUIDELINES ON ASTHMA MANAGEMENT. 1995 REVIEW AND POSITION STATEMENT (ERRATUM) ( MN 389227)

The subscriber can find the original article by looking at article microfiche 384000 and find the erratum on microfiche 389227.

Index records prior to 1986 include the word erratum in the title to denote a correction, but do not include the microfiche number or the corrigendum term. The database currently has over 2,000 index records that use the term corrigendum.

Mary Ann Cull, R.Ph.

How can I unlock the secrets of Indexing Notes?

Indexing Notes is a tool to help you define your search strategy according to the IDIS indexing guidelines. This tool facilitates searches by providing information and examples explaining the guidelines which apply to certain population groups and concepts. Application of the information will help you construct specific and streamlined search strategies, even when searching complicated topics.

A good example of the type of information you will find in the Indexing Notes is "population tags". Certain population groups have been assigned indexing "tags". If you would like to find articles relating to drug use in a particular population, such as in pregnancy, in athletes or in a particular age group, use Indexing Notes to find indexing information as well as the valid search term. For instance, type age, and press <Enter>. This will take you to general indexing information and the following tags:

V28. Fetus: Conception < age < Birth
V39. Neonate: Birth < age < 4 wks
V85. Pediatric: 4 wks < age < 12 yrs
V21.1 Puberty and Adolescence: 12 yrs < age < 19 yrs
V86. Geriatric: age > 65yrs

When you wish to conduct a search relating to pediatrics, entering V85. into the Disease field will limit your search to articles pertaining to that age group.

Other concepts, such as toxicity, treatment of a side effect, TPN, or fetal effect, can also be found in Indexing Notes. Simply enter the word or phrase, such as fetal effect, and <Enter>. You will find information outlining the indexing guidelines for this concept, and also several specific examples of their usage.

As you use Indexing Notes and become more familiar with the search terms, you will find that you save time and effort in retrieving the specific topics you require.

Nicola Sarrazin, R.Ph., Pharm.D.


STAFF PROFILE

Nicola Sarrazin, R.Ph., Pharm.D., is a staff pharmacist who joined DDIS in May of 1997. Her responsibilites include indexing journal articles for the IDIS database and supplying information to IDIS subscribers. Nickie has a B.A. in Anthropology and Asian Studies, and also a Pharm.D., both from the University of Iowa.

Originally from Maine, Nickie has resided in Iowa for the past 20 years and enjoys visiting family and friends "out east". Traveling, reading and gardening are some of her interests.


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Iowa Drug Information Service
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Iowa Drug Information Network
Telephone: 319-335-4199
U.S. Toll-Free: 800-791-7055
Fax: 319-335-4440
E:Mail: IDIN@uiowa.edu
Web Site: http://idin.idis.uiowa.edu

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Iowa City, IA 52242-5000 USA

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