PHRD4033 - Long Question Scenarios Exercise

PHRD4033 Exercise 9

Long Question Scenarios Exercise

BEFORE WORKING THIS EXERCISE – CAREFULLY REVIEW the Long Scenario Question EXAMPLE posted in Moodle. Questions like this will represent a large percentage of the OSDIE-2 grade.

For the following question, use these steps to retrieve and report information pertinent to the off-label use of a medication:

Use the 3-2-1 strategy to research and provide a response to the question, while documenting your search strategy throughout the process. Also, be sure cite (in-text numerical citations) your references as you work through the steps as described below.

STEPS

1. First, review ALL of the BIG FOUR tertiary resources and NO OTHERS for Ex. 9 and OSDIE-2.
   1. Use ALL/ONLY the BIG FOUR in the following SPECIFIC AREAS for this exercise and for OSDIE-2:

1. Micromedex – DrugDEX monographs – Therapeutic Uses
2. Facts – Off-Label Drug Facts
3. Clinical Pharmacology – monograph – Indications – Off-Label
4. Lexicomp – LexiDrugs monograph – Uses

1. Document your response to the question in the space provided as you review each resource. Though you must review all four resources, you may not find something useful in every one.
2. While searching within these tertiary resources, if an article is mentioned (cited) that may provide critical information for your answer, be sure to attempt to dig deeper and retrieve the fulltext of the article for the details. I will be checking for this. Remember if you use information from such an article, you must reference it.
3. It is entirely possible that there is no information to be found in ANY of the tertiary resources; if this is the case, document this in your response for each/all of the four resources. Step 2 has an additional requirement if this is the case.
1. Use secondary resources (Pubmed and IDIS only) to find at least one fulltext article (primary literature) that helps answer the question. Document any information or conclusions from this article for your response. IMPORTANT: If no information is found in ANY of the tertiary resources, you must find a minimum of TWO (2) fulltext articles to answer the question.
2. Document a detailed, reproducible Search Strategy throughout the entire process of reviewing resources:

Describe how you used the tertiary resources: how and where information was found; whether or not information was found. For instance, if you review Micromedex and find nothing, document in your response, “No information was found in Micromedex¹.

1. Describe how you used the secondary resources: Search terms, filters, linkouts, etc. What worked/didn’t work?
2. WORK CITED - Accurate AMA style referencing is not necessary for this exercise, but you must list all references used in numerical order. This is for ease of reference for the grader.
   1. List references in the order in which they appear in the response.
   2. When referencing any of the BIG FOUR tertiary resources used; just write the name (no full citation needed)
   3. List the citations (with PMID#) of all articles used in your response.
   4. Finally, use superscript numerical citations through out your response numbered in correspondence with the references in the WORKS CITED section.

Grading Expectations:

1. Grades will be determined by how well the above steps are followed to provide a thorough response to the question. Your response must answer the question and must be written in full sentences.
2. Remember to use the 3-2-1 method to search.
   1. Use ALL/ONLY the BIG FOUR as your tertiary resources
   2. Use ONLY Pubmed and IDIS as your secondary resources to find primary literature
3. For ease of grading, USE ONLY THE FOLLOWING SPECIFIC AREAS to find off-label uses within the tertiary databases:
   1. Micromedex – DrugDEX monographs – Therapeutic Uses
   2. Facts – Off-Label Drug Facts
   3. Clinical Pharmacology – monograph – Indications – Off-Label
   4. Lexicomp – LexiDrugs monograph – Uses
4. Document your search strategy as you go. You will be graded on details and reproducibility, but full sentences are not required.
5. Even if you do not find the answer in a resource or the full-text of an article, document everything you tried so that you will get full credit for your search strategy.
6. All articles will be verified as full-text; if a reference is just an article abstract, it will not count toward your article requirement in Step 2. You certainly may use information from an article abstract, but remember it will not count toward your full-text article requirement.
7. Always search databases (especially secondary) using generic drug names.
8. Safety – Describe tolerability, including any common adverse effects
9. Efficacy – Describe whether studies show if it works for the use in question.

Question:

A 45-year-old female has been diagnosed with aspirin-induced asthma (asthma-intolerant asthma). Her physician wants to treat her with Singulair (montelukast) to prevent aspirin-induced asthma; however, the manufacturer’s label does not provide for aspirin-induced asthma prophylaxis. He wants evidence to make the decision whether to use this medication for this patient.

Using the steps and expectations above, find information that will provide evidence for the use of montelukast for aspirin-induced asthma and answer the following questions (provide responses on the following pages):

1. What does the literature report about the efficacy (i.e., improved lung function, improved quality of life) of using montelukast to prevent of aspirin-induced asthma?

2. Describe the ages of the these patients that have been treated with montelukast, as reported in the literature:

3. Describe your search strategy according to Step 3 above (must be reproducible):

The following response will be provided to the doctor in the above scenario in response to her request:

Document your response to the above questions here:

According to Facts and Comparisons¹, patients with known aspirin sensitivity should continue to avoid these agents while being treated with Montelukast.

According to Micheletto C, Tognella S, Visconti M, et al under MICROMEDEX², they stated that Montelukast significantly improved signs and symptoms associated with persistent rhinitis in patients with aspirin-induced asthma (AIA). In a randomized, double-blind, placebo-controlled study, 36 non-smoking patients (aged 22 to 52) with AIA suffering from chronic nasal symptoms for approximately 3 years, received either montelukast (n=18) 10 milligrams (mg) or placebo (n=18) daily for 4 weeks.

Also according to Micheletto C³, their article found under PubMed, it states under their conclusion of their free article that “Montelukast 10 mg daily for 4 weeks, but not placebo, improves nasal function and nasal response to Aspirin substantially in ASA-sensitive asthmatics.”

Document search strategy on the following page…

Document your search strategy according to Step 3 above (must be reproducible):

1. Describe how you used the tertiary resources: how and where information was found; whether or not information was found.

1. Micromedex: found Drugdex monograph - Montelukast; then I did a search/(control find) on the monograph using the keyword: aspirin; you may also look under the “Therapeutic Use” tab. I found a randomized, double-blind, placebo-controlled study that is dealing with 36 non-smoking patients that are aged from 22-52.

Facts: Only found details about that if patient is sensitive to aspirin, it should be avoided while taking Montelukast to avoid further complications.

Clinical Pharmacology: NOTHING FOUND UNDER OFF-LABEL PERTAINING TO THE QUESTIONS

Lexicomp: found Lexidrugs monograph – NOTHING FOUND UNDER USES PERTAINING TO THE QUESTIONS.

2. Describe how you used all secondary resources: Search terms, filters, linkouts, etc. What worked/didn’t work?

Under PubMed, I used a single citation matcher for Micheletto and Montelukast and it went straight to the article I wanted to look at it. I also found the abstract and the full-article on this citation.

3. WORKS CITED: List ONLY those references that you used information to provide your response. Be sure your response has in-text superscript numerical citations corresponding with the numerical references below.

1. Facts and Comparisons

2. MICROMEDEX

3. Micheletto C, Tognella S, Visconti M, Pomari C, Trevisan F, Dal Negro RW. Montelukast 10 mg improves nasal function and nasal response to aspirin in ASA-sensitive asthmatics: a controlled study vs placebo. Allergy. 2004 Mar;59(3):289-94. PubMed PMID: 14982510