drug information paper

Drug Information Paper

You will need to prepare a written drug information paper that answers a question of interest to you. A drug information paper typically has three parts:

The introduction, where you give your reader background information about the medical condition and medication you will address in your paper.
The body of the paper, where you will summarize the methods and results of studies which have examined some aspect of drug's use for the medical condition with which you are concerned.
The conclusion, where you use the evidence presented in the body to formulate an answer to your drug information question.

Writing Level

For this exercise, assume that a physician has asked you a question and requested a written reply. You will thus write your paper at a level appropriate for a physician. This means that:

You can and should use technical words; medical jargon is appropriate to use when you are writing for highly-trained health care professionals. One caveat: you must understand the meaning of the words you use. Do not copy complex medical terms out of a resource unless you can explain in simpler language the essential information you are trying to relate.
In the background, you will outline the pathology behind or consequences of the medical condition and the pharmacology of the medication in much greater depth than you would were you writing for a lay individual. This means that you must use tertiary resources that explain the medical condition and medication in fairly extensive detail. Resources such as UpToDate and Drugdex will give you more extensive information than resources written for the lay public (e.g., MedlinePlus).

Choosing a Topic

Your topic will be written in the form of a question that a physician has asked you.

This question should be one sentence in length, and appear at the top of your paper after the word "Question:".
The question must be related to a medication of some type (this includes prescription, over-the-counter, and herbal products).
The question must also include the disease state or condition for which the drug is being used.

One type of question that makes an excellent topic for this kind of paper is asking about the effectiveness of a specific agent when used for a specific medical condition. There are many studies examining effectiveness of medications; indeed in order to bring a drug to market, a manufacturer is required to prove the drug's effectiveness in a clinical trial. There are not as many studies examining drug interactions, or drug mechanisms, so these topics are not be ideal for this type of paper. Examples of effectiveness-type questions used by past students include:

Does cinnamon help to lower blood sugar concentrations in patients with diabetes?
How effective is beta-interferon-1B for treating multiple sclerosis?

Another topic that works well for a drug information paper is examining an association between a drug and a health event. The association is examined by seeing if people taking the drug appear to be at higher risk of the adverse event than people not taking the drug. Examples of this type of question are:

Does ingestion of tomato products lower the risk of developing prostate cancer?
Does consumption of caffeine during pregnancy adversely affect the fetus?

The most challenging aspect of choosing a question is that, although it may be a very good question, there may be few or no studies on the topic for you to use in the body of your paper. In general, there will almost always be an adequate number of studies to answer questions relating to prescription medications. If you are considering a complementary or alternative medicine (CAM) topic, do run that topic by Dr. Elmer (if you are taking his class concurrently), Dr. Birchfield (who has a lot of experience evaluating literature on CAMs), or Dr. O'Sullivan (who may be able to tell you if past students have successfuly located studies on your proposed topic). Another way to check if your topic idea is viable is to do the secondary resources assignment early. It will help you locate available studies on a given topic. If you are doing this class concurrently with the CAM class, be aware that there are around 20 commonly used herbal topics that you are not allowed to use.

Reference Sources

You will need to use at a minimum three sources from the primary literature and three sources from the tertiary literature. It is traditional and logical to use the tertiary literature when preparing your introduction, and primary literature when writing the body of your reply.

The tertiary literature you use should be from reliable databases, with at least one from a drug database, such as Drugdex (Micromedex), Facts and Comparisons, or Natural Medicine Comprehensive Database, and at least one from a disease database, such as UpToDate, Harrison's, or the Merck Manual. Any of the resources noted in the tertiary resources lecture notes are reasonable candidates for additional references in the introduction. Also good for additional resources in the introduction are the web sites of disease state foundations/organizations, such as the American Diabetes Association (if your topic is related to diabetes), web sites from government organizations such as the National Heart, Lung, and Blood Institute, and recent reviews from the medical literature (you can find these via PubMed).

In order to locate primary literature (for the body of your paper) you will need to use PubMed and at least one other indexing (secondary) source (EMBASE, IPA, Current Contents, Biosis, or Science Citation Index) and you must indicate at the end of each reference which secondary source you used to locate that reference. The primary literature you locate will be studies. A study is any kind of investigation. At least one of the studies must be a clinical trial. A clinical trial is a specific type of study, done specifically in humans, where investigators assign some subjects to a specific treatment and other subjects to a control (such as a placebo or another drug).

Length and Style

Do not use a cover sheet. Place your name at the top of the first sheet of your paper. Hit return twice, then write "Question:" and follow this with your drug information question. Format your question as a query sentence, not as a title (i.e., do not capitalize each important word in the question, left-justify the question rather than centering it, and make sure that your sentence ends with a question mark). Hit return twice and then write your Introduction header and begin your paper.

The finished paper should be 5-6 pages in length and typed double-spaced in 12-point font. It should contain an introduction (that is at least two paragraphs in length), the body of the paper (including one paragraph for each study you review), a summary or conclusion paragraph (where you summarize the evidence, answer the question, and provide appropriate and specific recommendations), and your reference list.

Your paper should be written in third person language only. Avoid using emotion-evoking words. Keep your wording objective. Your conclusion should be evidence-based and should clearly answer the question.

One publication which contains articles very similar in format to the paper you will write is The Annals of Pharmacotherapy. There are some copies of this journal in the student lounge. Every edition of this pharmacy journal contains 1-3 articles in a section called Drug Information Rounds. These articles are written in basically the same format as you are expected to use. Please look over the format and content (as well as type of question) used in these articles, if you would like to see an example.

Rough Drafts

You will complete two rough semi-drafts.

The first draft will be of the introduction alone. You will need to include references for the information - remember that these will be primarily tertiary resources, and that you need to consult at least one reputable pathophysiology reference and one drug reference (see reference sources above if you have questions about what is considered "reputable"). Your introduction will be evaluated for how well it introduces the topic, how well it prepares your reader for the body of your paper, whether at least 3 tertiary references are used (along with the proper reference format for those references), how smooth the writing flow is, your success in writing at the level of a physician, and whether your writing mechanics are acceptable.
The second rough draft will be a one-paragraph outline of the methods and the results in one of the studies you will include in the body of your paper. Please reference the paper after the paragraph, using the correct reference format. You will also need to turn in with the paragraph a paper copy of the study you outlined. This study will be returned to you when your paragraph is handed back. You will be graded on your ability to clearly and accurately convey the study methods and results in your own words and in a way that reflects your understanding of the information presented in class, the use of the proper reference format, and writing mechanics.

There is more information below on specifics of what to write about in the introduction and body paragraphs, so be sure to read this information before writing your rough draft.

Grading for Overall Paper

Papers will be graded on both content and mechanics, as follows:

4.0	Exemplary work. The introduction clearly presents the important issues involved in answering the drug information question. The response is complete as written and requires almost no revision. References exceed the minimum number. There are no misspellings or grammar errors. The style is appropriately written for a reader who is a trained health care professional.
3.0	Expected work. The introduction presents the important issues involved in answering the drug information question. The response is complete as written and requires only minimal revision. Referencess meet the minimum number. There are few misspellings or grammar errors. The style is appropriately written for a reader who is a trained health care professional.
2.0	Deficient work. The introduction presents at least one of the important issues involved in answering the drug information question, but not in a concise and clear manner. There are major format or content issues. The response is incomplete as written and requires a fairly extensive revision. References do not meet the minimum number. There are many misspellings and/or grammar errors. The style is inappropriately written for a reader who is a trained health care professional. A revision to correct deficiencies will be required.
1.0	Unacceptable work. A 3.0 is the maximum grade that can be earned on the rewrite of the paper.

Remember that the whole purpose of the rough drafts is to help you get a grade of 3.0 or higher on your finished paper.

The Introduction

Please use a header of either Introduction or Background.

The purpose of your introduction is to explain to your reader why the question you have asked is important and why the answer is not universally already known. You will need to present the issues which led you to the primary literature to seek an answer to the question.

Your introduction will generally be two paragraphs in length. It should provide information about the disease state or condition for which the drug is used and should also describe the pharmacology of a drug on which you are focusing. For example, if you were trying to answer the question, "Does the maternal use of caffeine during pregnancy adversely affect the child?" you might want to outline in the first paragraph information about the ubiquity of caffeine use, why pregnant women might consume caffeine, and adverse effects that can happen to the fetus during pregnancy. In the next paragraph you will outline how the pharmacologic effects of caffeine could decrease placental blood flow, leading to a relative hypoxemia and thus decreased fetal growth and/or development, or even cause fetal demise.

You will find that it is most logical to introduce the disease or condition in the first paragraph. Make good use of numbers to explain to your reader how prevalent the condition is—remember that you can get information about disease epidemiology from good review articles and also through the statistics links on Healthlinks. Be sure to explain clearly the pathophysiology/consequences of the condition, particularly that part of the pathophysiology/consequences that is affected by the drug you will describe in the second paragraph. Assume that the reader (a physician) can explain the condition in lay language, so provide details about the pathophysiology/consequences of the condition that the physician may not readily know.

It will then be logical to introduce the treatment for the condition in the next paragraph. Begin by outlining the different treatments used for that condition and then focus your reader on the specific treatment about which you will be providing evidence. If you can review what is known or theorized about the pharmacology of the active consitituents in the drug, it will help you maintain a professionally technical tone.

The last sentence in your introduction will transition your reader to the body of the paper. This sentence should make your reader want to examine the available evidence regarding the question. Do not

Answer your question in your transition sentence, in effect summarizing what your reader is about to read (why should the reader read any further if you have answered the question?).
Phrase the transition sentence as a question. Using phrases such as, "But what what does the primary literature say?" sound like you are trying to get the reader emotionally involved in the topic. Your reader is already intellectually interested in the topic, so such emotive phrasing is unhelpful.
Use the awkward, "This paper will examine..." transition wording. Assume that your reader knows what will be examined, since he or she posed the question. Instead, use wording that explains why it would be useful to the reader to examine evidence from the primary literature.

Remember that you are writing this for a physician, so you do not want to

Use the same words you would when explaining a medical concept to a lay individual.
Write colloquially (i.e., you write just like you speak). Avoid the incomplete sentences/phrases people often use when they speak.
Use emotion-evoking or vague phrases such as "suffer from," "exploded," "more and more," and "turning to." Journalists love to use such sensationalistic phrases, but they are at best misleading and at worst completely incorrect.

In summary, plan to reference at least one common medicine resource (such as Harrison's, UpToDate, or the Merck Manual) and one common drug resource (such as Drugdex, Facts and Comparisons, or Natural Medicine Comprehensive Database), You should cite a minimum of three resources in your introduction.

One thing you may be unsure of is where, when, and how to use citations. Please read the information on the citations and references web page.

The Body

Use the header Published Literature or Published Evidence for this section.

The body of your paper should contain a series of paragraphs outlining studies from the primary literature. A reasonable header for the body of your paper would be "Published Literature."

How do you summarize a study in one paragraph?

The first sentence should include such information as the year the study was published, the type of study, the geographical setting, the number of subjects, and the study objective. It is unnecessary to use the first author's name followed by "et al;" use of the first author's name to describe a study is generally discouraged by medical writing experts. This first sentence should be followed by the citation number in superscript (after the period at the end of the sentence).
After the first sentence should come two to three (2 -3) sentences summarizing the study methods. Note which drugs were compared and for how long (if the study is comparative). Also emphasize any notable methodologic aspects of the study that were particularly well done or that may have biased the results. Consider subject selection and measurement methods.
The results should then be summarized in two to four (2-4) sentences that report raw numbers as well as statistical significance. Try to limit your result information to the most important (as you see it) 2-3 pieces of information found in the results. Be sure that your summary contains the most interesting point that you gained from reviewing the journal article. This point may not be an important part of the results, but it should be something about the study that you felt was very educational, either in a positive or negative way.
In one sentence summarize the conclusion of the study investigators.
If you feel comfortable doing so, then you can follow with a few evaluative comments. Evaluative comments are optional at this point in your education. Be certain that any evaluative comments are supported by information in your study summary. If you choose to make evaluative statements, you should try to make at least one positive and one negative comment about each study you review in order to give your reader the feeling that you are objective. Occasionally, you will review a study that was exceptionally well done or particularly heinous. In these cases you may not be able to think of any notable study limitations or strengths (respectively). In this case it is okay to be one-sided in your evaluation, but be sure you provide balanced commentary for the other studies you review or else your reader will suspect you of interpretation bias.
The final statement in your paragraph should give your reader an idea of how the study fits into the answer to the drug information question.

This should give you a paragraph for each study that contains approximately 6-13 sentences.

Example paragraph for a study examining rheumatoid arthritis treatments:

A blinded, randomized, comparative, controlled trial published in 1996 examined the efficacy of three second-line drug regimens in 102 moderately severe rheumatoid arthritis patients at Omaha, Nebraska rheumatology clinics.¹ Patients who had failed at least one of the single-drug, second-line antirheumatic agents were randomized to methotrexate alone, hydroxychloroquine plus sulfasalazine, or methotrexate plus hydroxychloroquine plus sulfasalazine. Patients were titrated to maximum methotrexate therapy (17.5mg/week) over nine months and then were only allowed to remain in the trial over the remaining 15 months if they consistently displayed a 50% reduction in baseline symptoms. Survival analysis was used to compare between-group dropout rates. The three-drug group had a statistically-significantly higher number of patients (24 of the original 31 patients: 77%) left in the trial at the end of the second year when compared to the two-drug group (14 of the original 35: 40%), and the one-drug group (12 of the 36 patients: 33%). The investigators concluded that the three-drug regimen had greater efficacy than the other regimens. Since there is a paucity of studies examining the efficacy of multi-drug therapy in the treatment of moderately severe arthritis, this study was a laudable attempt to further define the answer to the regimen-of-choice question. Additionally, although it was not the primary study objective, the value of dose escalation (i.e. dosing up to 17.5mg weekly) for methotrexate patients who are non-toxic at lower doses (e.g. 7.5mg weekly) and not achieving acceptable efficacy, was well-illustrated. That said, the investigators may have biased the results slightly away from the methotrexate group because their inclusion criteria included failure to respond to single-drug treatment 9which is often methotrexate) and toward the 3-drug group since patients who had previously used (and failed?) 2- or 3-drug therapy were excluded. This trial, then, does not yet answer the question of the initial treatment of choice for rheumatoid arthritis patients not responding adequately to NSAID therapy.

The conclusion

Use the header Conclusion or Summary for this section.

In your conclusion you will need to summarize the evidence you have reviewed and use it to form an evidence-based answer to the question posed at the start of your paper. Your recommendation should be practical, clear, and specific. If you are going to recommend the use of a drug in a particular disease state, it is best to also provide the dose, route, frequency, duration of therapy, and monitoring parameters, if appropriate. Remember not to say, "I recommend..." Instead, you will want to say what the evidence appears to support (for example, "There is inadequate evidence available to support the use of gorillacillin for acne"). Your conclusion will be judged on whether or not you answered the question, and whether or not your answer was evidence-based. It is traditional to use a header of "Conclusion" or "Summary" for your conclusion.

Reference list

Links to expected formats for references are on the main PHARM 500 home page. Please do not use Endnote style or function for your references. Do not use a footnote style, either. Your reference style should look like this:

References

Sobel JD, Kaye D. Urinary tract infections. In: Mandel: Principles and Practice of Infectious Diseases [Internet]. New York (NY): Churchill Livingston; c2000 [cited 2005 Sep 26]. Available from: http://www.mdconsult.com/
Hooton TM, Stamm WE. Recurrent urinary tract infection in women. In: UpToDate [Internet]. Wellesley (MA): UpToDate, Inc; c2005 [updated 2005 Feb 14; cited 2005 Sep 26]. Available from: www.uptodateonline.com
Gingrich CL. Bacterial infections of the urinary tract in women. In: Rakel RE, Bope ET, eds. Conn's Current Therapy. [Internet] Philadelphia (PA): W.B. Saunders; c2005 [cited 2005 Sep 26]. Available from: http://home.mdconsult.com/
Cranberry. In: Review of Natural Products. [Internet] St. Louis (MO): Facts and Comparisons; c2005 [updated 2005 Jul; cited 2005 Sep 26] Available from:http://online.factsandcomparisons.com/
Cranberry. In: Natural Medicines Comprehensive Database [Internet]. Stockton (CA):Therapeutic Research Faculty; c1995-2005 [cited 2005 Sep 26].Available from: http://www.therapeuticresearch.net/
Briggs S, Rouse JE. Cranberry. In: Alternative Medicine Evaluation [Internet]. Greenwood Village (CO): Thomson MICROMEDEX; c1974-2006 [cited 2005 Sep 26].Available at: http://www.thomsonhc.com/
Cranberry (Vaccinium macrocarpon) and Urinary Tract Infection. [Internet] Bethesda (MD): National Institutes of Health (US); c2003 [modified 2004 Feb 5; cited 2005 Sep 26]. Available at: http://nccam.nih.gov/research/concepts/consider/cranberry.htm
Can your diet prevent a urinary tract infection? [Internet] Santa Fe (NM): Web-based Health Education Foundation; c2005. [upated 2003 Apr 17; cited 2005 Sep 26]. http://www.healthandage.com/
Lowe FC, Fagleman E. Cranberry juice and urinary tract infections: what is the evidence? Urology 2001; 57:407-13. (PubMed)
Kontiokari T, Sundqvist K, Nuutinen M, Pokka T, Koskela M, Uhari M. Randomised trial of cranberry-lingonberry juice and Lactobacillus GG drink for the prevention of urinary tract infections in women. BMJ 2001;322:1571-5. (Current Contents)
Schlager TA, Anderson S, Trudell J, Hendley JO. Effect of cranberry juice on bacteriuria in children with neurogenic bladder receiving intermittent catheterization. J Pediatr 1999;135:698-702. (PubMed)
Reid G, Hsiehl J, Potter P, Mighton J, Lam D, Warren D, Stephenson J. Cranberry juice consumption may reduce biofilms on uroepithelial cells: pilot study in spinal cord injured patients. Spinal Cord 2001;39: 26-30. (Current Contents)
Avorn J, Monane M, Gurwitz JH, Glynn RJ, Choodnovskiy I, Lipsitz LA. Reduction of bacteriuria and pyuria after ingestion of cranberry juice. JAMA 1994;27:751-4. (PubMed)
Terris MK, Issa MM, Tacker JR.Dietary supplementation with cranberry concentrate tablets may increase the risk of nephrolithiasis. Urology 2001;57:26-9. (EMBASE)

The first nine references provided general background information and were cited in the introduction. Note that references 7 and 8 are internet sites and are given as examples of the correct format for citing something located on the web. Reference 9 is a review article. The remaining five articles were studies and were outlined in the body of the paper.

Note that for the journal articles, the title of the journal article is abbreviated. If you are unsure of the correct journal title abbreviation, you can find it via PubMed. Go to the journals database and type in the full name of the journal. You will find the correct abbreviation on the "MEDLINE abbr:" line.

One last thing...

We hope those of you who do phenomenal jobs on your drug information paper, and who tackle a topic that is probably of interest to many pharmacists, will strongly consider submitting your paper to the Washington State Pharmacy Association (WSPA), to consider publishing it in Washington Pharmacist. This would give you a publication on your resume, and would allow pharmacists over the state to benefit from the outstanding work you did researching the answer to the question.

Questions about the drug information paper? Please email the coursemaster.

Last updated 27 November 2007