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Drug Consult Example
Date and time requested: September 23, 2013 at 10:00 AM
Date and time answered: September 27, 2013 at 5:00 PM
Pharmacy has been consulted re: Are calcium supplements
associated with coronary heart disease in adult patients?
Background:
Calcium supplementation has long been recommended for
promoting bone health and is often utilized for the prevention
and treatment of osteoporosis.1 It has been reported that in the
older population close to 50% of men and 70% of women are
users of calcium supplements.1 In most adult patients, the
recommended daily allowance (RDA) of elemental calcium is
1000 mg. In females aged 51 and greater, the RDA is slightly
increased at 1200 mg.2 Calcium administration is generally well
tolerated with the most commonly occurring adverse effects
being gastrointestinal discomfort, constipation, flatulence and
nausea.3 Recently, there has been speculation about a
correlation between calcium supplementation and
cardiovascular risk. While some studies have reported
cardiovascular benefits such as improvements in blood pressure
and lipid panels, some concerning data linking calcium
supplementation to increased risk of stroke, myocardial
infarction and cardiovascular death has also been published.1 It
has been hypothesized that excess calcium intake via
supplementation may lead to cardiac calcium phosphate deposits
which are correlated with risk of atherosclerosis, coronary heart
disease and death.1
Literature Search Strategy:
A search was conducted using Ovid MEDLINE (2009 to
September week 2 2013). Terms searched included
supplemental calcium, calcium supplement, coronary heart
disease and cardiovascular disease. The Boolean operator OR
was first used to combine the terms supplemental calcium and
calcium supplement and then used again to combine the terms
coronary heart disease and cardiovascular disease. The Boolean
operator AND was subsequently utilized to combine the results
from supplemental calcium, OR calcium supplement, with
coronary heart disease OR cardiovascular disease. The search
was limited to the English language and humans and yielded 13
results. Of the 13 articles, 9 were excluded for being review
articles, 2 were excluded because they focused on dietary rather
than supplemental calcium intake and 1 was excluded for being
focused specifically on myocardial infarction and stroke. The
article to be discussed was chosen because it is relevant to the
topic as it looks specifically at cardiovascular risk related to
calcium supplementation in both men and women.
Results/Literature Analysis:
A prospective study was conducted to determine if calcium
intake was associated with risk of death from heart disease,
cerebrovascular disease or cardiovascular disease.1 Included
participants were male and female AARP members with ages
ranging from 50 to 71 years. Participants were geographically
located in 6 states (California, Florida, Louisiana, New
Jersey, North Carolina, and Pennsylvania) in addition to 2 cities
(Atlanta and Detroit). Patients were excluded if they did not
complete their own baseline questionnaire, if they had a history
of heart disease, stroke, diabetes, end-stage kidney disease or
cancer with the omission of skin cancer if it was not melanoma.
Patients were also excluded if their total dietary energy or
calcium intakes were excessive (as defined by interquartile
range calculations). In total 388,229 subjects were included in
trial analysis and were followed for a duration of twelve years.
While the above criteria did capture older adults which is a
population with prevalent use of calcium supplements, the ages
of enrolled patients does limit the external validity to apply
results to both younger and older patients. Exclusion criteria
did help improve internal validity of the study by excluding
some confounding conditions, but also by excluding those with
prior heart disease, we are prevented from making an
assessment as to whether or not calcium supplementation would
affect cardiovascular risk in those with a preexisting cardiac
condition. As heart disease is a top cause of mortality in this
country, this information would be valuable and further studies
in this population may be warranted. At baseline, patients were
asked to self-report three items. First, dietary calcium intake
was assessed by a food frequency questionnaire which
considered both portion sizes as well as frequency of ingestion
of each of 124 listed items during the course of the previous
year. Second, participants reported the frequency range (i.e. 1
to 3 times per week) as well as dose of any calcium supplements
taken. And third, regularity and variety of any multivitamins
taken was also reported. Based on the information provided,
investigators calculated each patient’s calcium intake by dietary
calcium alone, supplemental calcium alone (calcium supplement
plus multivitamin) and total calcium (dietary plus
supplemental). Overall 56% of women and 23% of men stated
they took individual calcium supplements, were non-Hispanic
white and had a lower consumption of alcohol, red meat and
total fat. Although investigators attempted to standardize the
self-reporting through a calibration method involving 24-hour
dietary recalls, a limitation to the study is that calcium intake
was not directly measured. In addition, it is possible that
patients were ingesting calcium in mediums not captured in the
questionnaires, such as in food items not contained on the list.
Study design may also have been improved upon if investigators
had collected information regarding duration of supplement use
to determine if any increased risks were associated with length
of use and also if there was a familial history of CVD.
Although authors of this study did not explicitly specify a
primary endpoint, the methods and objective were well defined.
Investigators were able to access the Social Security
Administration Death Master File and National Death Index
Plus to determine if a subject died, and if so, what the cause of
death was. Based on this information, as well as adjustments
made for patient demographics, lifestyle and dietary variance,
relative risks were estimated. Investigators estimated a 95%
accuracy rate when pulling data from these databases. Relative
risk is an appropriate method to determine level of association
in a prospective cohort study, but due to the method of data
collection, some error is inherent in study design. Study results
showed that men who took more than 1000 mg per day of
supplemental calcium in the form of both individual
supplements and multivitamins as compared to men with no
calcium supplementation had a 20% increased risk of
cardiovascular death (RR 1.20; 95% CI, 1.05-1.36). When
individual calcium supplements were considered without
multivitamins, men who took more than 1000 mg per day of
calcium had a 37% increased risk of death from heart disease
(RR 1.37; 95% CI, 1.06-1.77). In women, no associations were
seen between calcium supplementation and risk of
cardiovascular mortality. Additionally, no association was
found between dietary calcium intake and cardiovascular death.
Given the large amount of patients in the study, the long study
duration and the prevalence of calcium supplementation these
increases in relative risk are highly clinically relevant.
Recommendations/Summary:
Due to the elevated risk of cardiovascular death in men who
took more than 1000 mg per day of calcium supplementation,
doses in this range should be avoided. While these results were
not replicated in women, the authors of the study suggest that
we cannot rule out the possibility that that a true association
exists. Based on the above evidence I would recommend the
following in both male and female patients:
• Encourage patients to meet calcium requirements through
dietary intake. While dairy products are widely known to
contain high calcium content, alternatives to dairy include
collard greens, kale, soybeans, sardines and salmon. Calcium
fortified foods are also available such as orange juice, tofu and
cereals.4
• In patients unable to achieve adequate dietary intake, consider
calcium supplementation at a dose less than 1000 mg per day.
• Supplements should be administered in 2 to 4 divided doses of
no more than 600 mg per dose to ensure adequate absorption.5
• Example regimens:
o Ultra Strength TUMS® (1000 mg calcium carbonate; 400 mg
elemental calcium). Directions: Chew one tablet by mouth
twice daily.
▪ Least expensive alternative.5
▪ Absorption is best if taken with food, but may be reduced if
patient is taking drugs that decrease stomach acid.5
▪ Associated with more gastrointestinal upset than alternative
calcium formulations.5
o Citracal Regular® (500 mg of elemental calcium as citrate).
Directions: Take one tablet by mouth twice daily.
▪ May be taken without regards for food.5
▪ Preferred in users of proton pump inhibitors or H2 receptor
antagonists, as absorption is less dependent on pH and those
with histories of either GI upset from calcium carbonate or
kidney stones.5
• Patients requiring calcium supplementation, especially at a
dose greater than 1000 mg per day, should be monitored closely
for signs and symptoms of heart disease such as chest pain or
shortness of breath. Stress tests may be used to assess patients
for coronary heart disease at first sign of symptoms.
• Ensure adequate Vitamin D needed for calcium absorption
(RDA 600 units per day).2
Closing:
Thank you for the opportunity for this consult and please let me
know of any follow-up questions. I may be contacted via email
at xxxx .mcphs.edu.
Respectfully,
Your Name, PharmD candidate
References:
1. Xiao Q, Murphy RA, Houston DK, Harris TB, Chow WH,
Park Y. Dietary and Supplemental Calcium Intake and
Cardiovascular Disease Mortality. JAMA Intern Med.
2013:173(8):639-646.
2. Lexicomp Web site.
http://online.lexi.com.ezproxy.mcphs.edu/lco/action/home.
Accessed September 23, 2013.
3. Natural Standard Web site.
http://www.naturalstandard.com.ezproxy.mcphs.edu. Accessed
September 23, 2013
4. National Osteoporosis Foundation Web site.
http://www.nof.org/articles/886. Accessed September 24, 2013.
5. Dynamed Web site.
http://web.ebscohost.com.ezproxy.mcphs.edu/dynamed/search/b
asic Accessed September 25, 2014.
1
Last edited 4/9/08 1
QUICK REFERENCE CITATION FORMAT
For AMA Manual of Style, 10th ed, 2007
Listed below are some of the more commonly used citations
depicting the correct citation format;
however, these are examples only. More recent editions may
have been published. Refer to other
examples and explanations in AMA Manual of Style: A Guide
for Authors and Editors. 10th ed. New
York: Oxford Press;2007.
Article in Journals
Typical entry for journal article
Smith J, Canton EM. Weight-based administration of dalteparin
in obese patients. Am J Health-Syst
Pharm. 2003;60(7):683-687.
Note: If the journal does not have a volume or issue number,
use the issue date.
Typical entry for journal with more than 6 authors (If more than
6 authors, list first 3, then et al)
Hunter DJ, Hankinson SE Jr, Laden F, et al. Plasma
organochlorine levels and the risk of breast cancer. N
Engl J Med. 1997;337(18):1253-1258.
Issue with supplement (the basic format)
Dworkin RH, Jolnson RW, Breuer J, et al. Recommendations for
the management of herpes zoster. Clinic
Infect Dis. 2007;44(1)(suppl 1):S5-S10.
Note: if there is no suppl number, leave it blank, e.g.,
(1)(suppl):S5-S10.
Editorials or letters (place the article type in brackets [ ])
Whitcomb ME. The April issue: required reading [editorial].
Acad Med. 2007;82(4):319-320.
Committee, group or organization
Council on Scientific Affairs. Scientific issues in drug testing.
JAMA. 1987;257(22):3110-3114.
No author
Pediatric studies become costlier; Congress may make them less
profitable. Prescr Pharm and
Biotechnol: Pink Sheet. 2007;69(12):23-24.
The choice of antibacterial drugs. Med Lett Drugs Ther.
1998;40(1023):33-42.
Drug Topics Red Book (update). May 2007;26(5):49.
Books
Book with one author or editor
Davis NM. Medical Abbreviations: 26,000 Conveniences at the
Expense of Communications and Safety.
12th ed. Huntingdon Valley, PA: Neil M.Davis Associates;
2005:173.
McEvoy GK, ed in chief, Snow ED, ed. AHFS: Drug
Information. Bethesda, MD: American Society of
Health-System Pharmacists; 2008:1125-1126.
Book with two or more authors/editors
Aronoff GR, Berns JS, Brier ME, et al. Drug Prescribing in
Renal Failure. 4th ed. Philadelphia, PA:
American College of Physicians; 1999:39.
Dukes MNG, Aronson JK, eds. Meyler’s Side Effects of Drugs.
14th ed. Amsterdam, Netherlands:
Elsevier; 2000:xvi-xvii.
Last edited 4/9/08 2
Chapter in book
Wallace RJ Jr, Griffith DE. Antimycobacterial agents. In:
Kasper DL, Fauci AS, Longo DL, Braunwald
E, Hauser SL, Jameson JL, eds. Harrison’s Principles of Internal
Medicine. 16th ed. New York, NY:
McGraw-Hill; 2005:946.
Note: See FAQ section for citing multiple pages of a book with
chapters.
Johannsen EC, Madoff LC. Infections of the liver and biliary
system. In: Mandell GL, Bennett JC, Dolin
R, eds. Mandell, Douglas, and Bennett’s: Principles and
Practice of Infectious Disease. Vol 1. 6th ed.
Philadelphia, PA: Elsevier; 2005:951-952.
Dowling TC, Comstock TJ. Quantification of renal function. In:
DiPiro JT, Talbert RL, Yee GC, Matzke
GR, Wells BG, Posey LM, eds. Pharmacotherapy: A
Pathophysiologic Approach. 6th ed. New York, NY:
McGraw-Hill; 2005:761.
Books complied by group, agency or committee (no author or
editor)
Drug Topics Red Book. Montvale, NJ: Thomson Healthcare;
2007:552.
United States Pharmacopeia Drug Information: Drug
Information for the Health Care Professional. Vol
1. 27th ed. Greenwood Village, CO: Thomson Micromedex;
2007:2514-2517.
Mosby’s Drug Consult. St. Louis, MO:Mosby; 2007:II-539–II-
540.
Physicians’ Desk Reference. 61st ed. Montvale, NJ: Thomson
PDR; 2007:678.
United States Pharmacopeia and National Formulary (USP 30-
NF 25). Vol 2. Rockville, MD: United
States Pharmacopeia Convention; 2007:1553-1554.
Stedman’s Medical Dictionary. 27th ed. Baltimore, MD:
Lippincott Williams & Wilkins; 2000:1784.
Serial Books that are updated (include no publication date, only
page number after colon)
Drug Facts and Comparisons. St. Louis, MO: Facts and
Comparisons:1904.
Tatro DS, ed. Drug Interaction Facts. St. Louis, MO: Facts and
Comparisons:397a.
Spechler SJ. Esophageal disorders. In: Dale CD, ed in chief,
Federman DD, founding ed. ACP Medicine.
New York, NY:WebMD Corp:4-I-5.
Note: cite like a book chapter; however, the 4-I-5 represents
section 4 (Gastroenterology), Chap I
(Esophageal Disorders) and the page number (5).
Other Published Material
Package Insert
Lamasil [package insert]. East Hanover, NJ: Sandoz
Pharmaceuticals Corp; 1993.
Newspapers
Steinmetz G. Kafka is a symbol of Prague today; also, he’s a T-
shirt. Wall Street Journal. October 10,
1996:A1, A6.
Last edited 4/9/08 3
Electronic Media
Online Package Insert
Byetta [package insert]. Amylin Pharmaceuticals, Inc., San
Diego, CA; October 2007.
http://pi.lilly.com/us/byetta-pi.pdf. Accessed March 18, 2008.
Note: the above is the official online package insert from the
manufacturer, not a patient
product/counseling notice. The date (October 2007) is the last
modification date, normally found at the
end of the package insert file.
Online Journals (journal article) on Internet
Seal A, Kerac M. Operational implications of using 2006 World
Health Organization growth standards in
nutrition programmes: secondary data analysis. BMJ. 2007;
334:733. http://www.bmj.com
/cgi/content/full/334/7596/733. Accessed April 12, 2007.
Note: the above citation is without page numbers; some online
journals have inclusive page
numbers, thus, use same format, but include pages after the
colon; e.g., :733-736.
PubMed Abstract Citation
Benedict NJ. Sitaxsentan in the management of pulmonary
arterial hypertension [abstract].
Am J Health Syst Pharm. 2007;64(4):363-368.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?
db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=1729
9175&query_hl=17&itool=pubmed_doc
sum. Accessed April 12, 2007. PMID:17299175.
Note: abstract is placed in brackets [ ] to indicated the citation
is solely an abstract; also, note that
the PMID (PubMed Unique Identifier) number is placed last.
IPA Abstract Citation
Schrimsher RH, Freeman MK, Kendrach M. A survey of drug
information resources in Alabama
pharmacy facilities [abstract]. Drug In J. 2006; 40(1);51-60.
http://web5s.silverplatter.com. Accessed
April 16, 2007. Accession Number:43-07214.
Note: abstract is depicted in brackets [ ] to indicated the
citation is solely an abstract; also, note
that the accession number is placed last. The PMID and
Accession number for both PubMed and IPA
uniquely identify the citations.
Epub Ahead of Print
Kozyrskyj AL, Ernst P, Becker AB. Increased risk of childhood
asthma from antibiotic use in early life
[published online ahead of print April 5 2007]. Chest. 2007.
http://www.chestjournal.org/papbyrecent.dtl.
Accessed April 16, 2007
Note: Ahead of Print citations can be difficult. If the volume,
issue number, date, or pages of the
print information are known, include what is known after the
journal title and year (e.g., Chest. 2007; vol
(issue #):page(s). If you were citing an Epub ahead of print
abstract from PubMed, the [abstract]
notation is placed after the journal title and before the period.
Internet-based Book (eBook)
Fields HL, Martin JB. Pain: pathophysiology and management.
In: Kasper DL, Fauci AS, Longo DL,
Braunwald E, Hauser SL, Jameson JL, eds. Harrison's
Principles of Internal Medicine. 16th ed. New
York, NY: McGraw-Hill; 2005.
http://www.netlibrary.com.ezproxy.samford.edu/Reader.
Accessed April
16, 2007:71-73.
General Internet
Note: the basic format for Web sites is: Author(s), if give and
many times there are none; title of the
specific item cited, if any; name of the Web site; URL;
published and/or update, if any; accessed date.
FDA/CEDR resources page. Food and Drug Administration Web
site. http://www.fda.gov/
cder/approval/index.htm. Accessed April 7, 2007.
Last edited 4/9/08 4
USPDI Updates On-line. Vol 1. Thomson Micromedex Web site.
http://uspdi.micromedex.com/.
Accessed June 23, 2006.
Clinical Pharmacology Web site.
http://cpip.gsm.com.ezproxy.samford.edu/. Accessed June 23,
2006.
Micromedex Healthcare Series Web site.
http://www.thomsonhc.com.ezproxy.samford.edu/
home/dispatch. Accessed Sep 23, 2006.
Facts & Comparisons. Facts & Comparisons Web site.
http://online.factsandcomparisons.
com.ezproxy.samford.edu/. Accessed June 23, 2006.
Newcomb K. Search engines come together on sitemaps auto-
discovery. SearchEngine Watch Web site.
http://searchenginewatch.com/showPage.html?page=3625565.
April 12, 2007. Accessed April 16, 2007.
Software (CD)
Note: Dates associated with various software may be updates or
file dates or some other indication of
currency.
Clinisphere [computer program]. Version 4.2. St Louis, MO:
Facts and Comparisons; Feb 03.
Clinical Pharmacology [computer program]. Version 2.07.
Tampa, FL: Gold Standard Multimedia; 2003.
CD-ROM on Book
Mosby's Drug Consult [CD-ROM]. St. Louis, MO: Mosby;
2006.
Software (Palm)
Note: All Palm software follows the same basic format: Name
of the company that licensed the software
usage (e.g., Lexi-Comp), name of book or database (Lexi-
Drugs, comp + specialties) [computer program].
compiler of database (Lexi-Comp, Skyscape); date and/or
version/date of program (Ver:4.0.46/
2003.8.31).
ePocrates (ePocrates Rx ) [computer program]. ePocrates, Inc;
Ver 6.12/Oct 1, 2003.
Lexi-Comp (Medical Abbreviations) [computer program]. Lexi-
Comp; Sep 22, 2003.
Skyscape (Dorland's Pocket Medical Dictionary) [computer
program]. Skyscape; Ver:4.0.46/2003.8.31.
Excel (Part of Microsoft Office Professional Edition) [computer
program]. Microsoft; 2003.
Databases
PDQ® - NCI's Comprehensive Cancer Database. Bethesda, MD:
National Cancer Institute; 2007.
http://www.cancer.gov/cancertopics/pdq/cancerdatabase
.Updated June 9, 2006. Accessed April 16, 2007.
Personal Communication, e.g., conversations, letters, email,
lectures, etc.
Place personal communication citation in the text with no
citation number, e.g., “In a conversation with
A.B. Smith, MD (March 2003)….” Or “According to a letter
from A.B. Smith, MD (March 2003)….” Or
“According to the manufacturer (A.B. Smith, PhD, oral
communication, March 2003), the drug was
approved in the US in March 2003.”
The author should give the date of the communication and
indicate whether it was oral or written;
furthermore, often the affiliation of the person is helpful to
better establish the relevance and authority of
Last edited 4/9/08 5
the citation. Citing lectures is the basically the same, e.g.,
“According to Dr. Schrimsher (PubMed
lecture, Sep 2003, Samford University, McWhorter School of
Pharmacy), controlled vocabulary should
always be used first prior to searching any database.”
FAQs (Frequently Asked Questions) regarding citations.
Can I cite an article that is in the reference section (or cited) of
the article I am currently reading?
Generally, you should not do this, that is, cite an article that is
cited within an another article.
The rule is to cite exactly where you are obtaining the material
and thus, pointing to the reader to
where the information is, in case the reader desires to read
and/or obtain the material you have
cited.
Where in the book is the best place to find the exact
authors/editors, publisher, date of publication, etc?
Generally, every book has a distinctive “title page” which
depicts authors or editors, publisher
and location, and edition. The date of publication (or copyright
date) is sometimes at the bottom
of the title page, but most often, it is the next page and the
exact location varies; however, for the
most part, it will appear as “©Copyright, 2002,” then the
publisher. If there is no clear
author/editor(s) on the title page, it is a good indication that the
publisher is the author. Editorial
staffs, associate editors, editorial assistants, are not considered
the editor, thus no author/editor
will be cited. For example, The Merck Index, 13th edition,
book lists an editorial staff of seven
persons, including a senior editor, editor emeritus, etc.,
however, none of these individuals would
be cited as the “editor.”
What is the rule for citing page numbers if the book uses
separate pagination within each chapter?
Follow the style used in the book; see the Mosby citation as an
example. To separate the "thru"
pages, use the "en dash" symbol (which is –).
How do I cite books with editor in chief?
If a book has only an editor in chief and no other editors, then
list only the editor in chief (ed in
chief). If a book lists an editor in chief, plus other editors (not
associate editors, but designated
editors), list the editors in order they appear on the title (or
other) pages. Normally, the editor in
chief will be listed first, followed by the other editors.
How do I cite software?
Software need not be cited in the reference section if it is
mentioned only in passing or is
available without charge via the Internet (e.g., shareware or
freeware). However, if the reference
is to using software for analysis purposes, e.g., SPSS or Excel,
then a citation must be included.
How do I cite an author that has “Junior” with their name?
Cite the name as follows: Wallace RJ Jr, Smith AB, Jones SU
III, …
Which city do I cite when the publisher lists several city
locations?
Cite the first city listed. For example, if New York, Paris and
London were listed as the
publisher’s locations, cite New York, which was the first
depicted on the title page of the book.
Must I use a registered trademark (®) when I cite/use that
particular item, e.g., drug brand name?
Guidance: The new AMA manual of style edition (10th)
specifically states that a trademark (e.g.,
®, TM or SM) should not be used in scientific journal articles
or references, but the initial letter
of a trademarked word should be capitalized.
How do I cite multiple page numbers using only one source?
The AMA Manual stipulates that if the author wants to cite
different places (or basically more
than one set of pages) in the text from the same source (of a
book only, not a journal article), the
Last edited 4/9/08 6
page numbers are included in the superscript citation and the
source appears only once in the list
of references. (This is not the same as inclusive pages, which is
explained below) Additionally,
when the source is listed in the references, no page numbers are
included after the publication
date (see next example regarding multiple pages in more than
one book chapter). For example:
Schrimsher6(p3),10 reported 10 drugs that have been withdrawn
by their manufacturers.
How to cite a book with two or more chapter authors and also
simultaneously citing multiple pages from
the same source ( book)
The AMA Manual does not illustrate a clear example regarding
this issue; thus, to cite multiple
pages from many (more than one) chapters by different authors,
list a separate citation for each
chapter cited.
For example, suppose I need to cite multiple pages from two
authored chapters in Nelson textbook
of pediatrics. And example of the running text:
Prober1(p751) examines several causes for infant central
nervous infections; furthermore,
Pickering2(pp765-767) found similar causes for pediatric
gastroenteritis.
-------------
References
1. Prober CG. Central nervous system infections. In: Behrman
RE, Kliegman RM, Jenson HB.
Nelson Textbook of Pediatrics. 16th ed. Philadelphia PA: W.B.
Saunders; 2000.
2. Pickering LK, Synder JD. Gastroenteritis. In: Behrman RE,
Kliegman RM, Jenson HB. Nelson
Textbook of Pediatrics. 16th ed. Philadelphia PA: W.B.
Saunders; 2000.
Note that both chapter citations come from the same source
(Nelson Textbook of Pediatrics) and both
would be listed separately in the reference section. Also,
neither lists page numbers after the publication
date because they are already shown with the citation number in
superscript in the body text.
Furthermore, this method applies only to citing multiple pages
from a single source.
What are inclusive pages?
Inclusive pages are pages with a dash between them, e.g., 10-
15. Inclusive pages are considered a
single cited entity, especially regarding books, which
essentially tells the reader that the
information cited is contained between the inclusive pages, and
that the reader would literally
have to read the inclusive pages to either find or understand
what is being cited. Inclusive pages
should not be confused with multiple page citations discussed
earlier, they are two separate
functions and purposes. Inclusive pages are generally used for
citing concepts, discussions, etc.
Do not substitute inclusive pages when you are essentially
referring to a paragraph or few
sentences on a single page. Pages cited should be as close as
possible to the actual material you
are referencing; furthermore, when citing inclusive pages, do
not omit any page digits after the
dash, e.g., 115-116.
Reproducing Tables and Figure
Copyright permission
If you (student) are going to recreate/reproduce a table or figure
from another source and insert it
verbatim (exactly as is) into you assignment paper, you do not
have to obtain copyright
permission from the copyright holder; however, you still have
to cite the source which the
table/figure came from and provide the copyright statement in
parenthesis. (See bottom of
example in Table 4 below.) The statement (If this paper were
submitted for publication,
copyright permission for reproduction of this table/figure would
have to be obtained.) must
be added.
Last edited 4/9/08 7
Citing
Citation(s) for the table/figure can be for the entire table or
portions of the table, using an
alphabetical order (a-z) footnote method. The superscripted
letters (see Table 4 below) are placed
in the title of the table if the entire table is verbatim from the
source; or if only a potion of the
table is from another source, eg, a cell or column, then place the
superscripted notation by that
cell, data point, or column, as appropriate. See page 90,
example, T7, AMA Manual of Style, 10th
ed, for other examples.
Table Footnotes
According to the new AMA manual of style, symbols as
footnotes in tables and figures are
no longer used. For both tables and figures, footnotes are now
indicated as superscript lowercase
letter in alphabetical order (a-z). According to the new AMA
manual, the font should be large
enough to see clearly, but without appearing to be part of the
actual data in the table/figure. Thus,
the first footnote would be superscripted a, then b, c...z. See
example in the below table regarding
footnotes. Table 4 has been reproduced with permission from
the Drug Information Journal ; the
table footnotes are fictitious, in that they were not in the
original data/publication. This is for
illustration purposes only.
Table 4. Availability of Personal Data (or Digital) Assistants
(PDAs) by Pharmacy Type (n=604)a
Resource
Name
Retail/
Community
(n=480)b
Hospital/Mental
Health
(n=74)
Other
(n=50)
Total
(n=604)
PDA Use Yes (count)
% Yes
82
17.1%c
24
32.4%
12
24.0%
118
19.5%
No (count)
% No
398
82.9%
50
67.6%
38
76.0%
486
80.5%
aData from Schrimsher, Freeman, Kendrach15
bTotals may not equal to 480 due to missing data/surveys.
cPercentages may not equal 100% due to unanswered/missing
data.
(If this paper were submitted for publication, copyright
permission for reproduction of this
table/figure would have to be obtained.)
Explanations:
The superscript "a" acknowledges that data the complete data is
from another source; thus is the first
indicated. Furthermore, the citation number 15 would match
that citation number in the reference section.
Footnotes "b" and "c" are not cited because they are explanatory
notes for clarification or indicating
important information about the table to the reader.
The last notation in parenthesis (copyright permission) in the
example of Table 4 above is to be added for
each table or figure. This statement must be included if the
paper is any type of student paper,
assignment, which includes Phrd 615-616 projects. If this
statement is not included, then a permission
statement from the copyright holder must be indicated.
(The following permission statement is not part of the above
Table 4.) Data from Schrimsher R, Freeman,
MK, Kendrach, M: “A Survey of Drug Information Resources in
Alabama Pharmacy Facilities, Table 4
(Drug Inf J 2006; 40(1):56. Copyright 2006, Drug Information
Association.
Journal Abbreviations
Note: The article itself may have the abbreviation provided on
the first page of the article (usually at the
end of the abstract or at the bottom of the page in small print).
Last edited 4/9/08 8
The following process can be used to locate journal
abbreviations:
Journal abbreviations may be found in both IPA and PubMed
databases, assuming that the journal is
indexed in that database. Another good source is "WorldCat"
which has a link at the bottom of the
WWW Pharmacy Resources Web page, specifically, Use
WorldCat for journal abbreviations search: after
locating journal, scroll to "Other Titles" section.
RubricPPW 440 Patient Care Seminar 1Drug Consult Outcome/
Performance Criteria0123ScoreComments❏ Student did not
answer the drug consult question
❏ Student did not use primary literature to answer the drug
consult question (no meta-analysis)
❏ The submission exceeds the 3 page limit (excluding
references)
If any of these boxes are checked, an automatic zero will be
given.
Zero Items Checked <50% of items checked< 100% but ≥ 50%
of items checked100% of items checkedBiomedical Literature
(80%) Background:
❏ Orients audience to the situation and rationale for the paper
❏ Utilizes tertiary resources to provide drug background
❏ Utilizes tertiary resources to provide disease state
background (including current standard care)
Zero Items Checked <50% of items checked < 100% but ≥ 50%
of items checked100% of items checked Search Strategy:
❏ Database described ❏ Search terms described
❏ Dates of indexed databases ❏Number of articles identified
❏Criteria to select and exclude articles for the consult described
(only included RCT, no reviews, etc)
❏ Selected article is relevant and appropriate to scenario
Zero Items Checked <50% of items checked< 100% but ≥ 50%
of items checked100% of items checkedMethods: Group
allocation
Summarizes and critiques interventions and methods accurately.
Students will only get a check for each item if both summary
and critique are provided (e.g. Logical, described in sufficient
detail, based on standard methods/practices and/or using
validated scales methods) :
❏ Study design ❏ Inclusion criteria ❏ Exclusion criteria
❏ Statistical power, if provided
Zero Items Checked <50% of items checked < 100% but ≥ 50%
of items checked100% of items checked Methods: Study
intervention
Summarizes and critiques interventions and methods accurately.
Students will only get a check for each item if both summary
and critique are provided (e.g. Logical, described in sufficient
detail, based on standard methods/practices and/or using
validated scales methods) :
❏ Intervention ❏ Comparator ❏ Primary
endpoint ❏ Relevant secondary endpoints
❏ Scales/measures ❏ Follow-up period
Zero Items Checked <50% of items checked < 100% but ≥ 50%
of items checked100% of items checked Results: Statistical
Significance -
Summarizes (All information must be accurate to earn credit):
❏Provides actual results (proportion/mean/median) for each
group AND difference between intervention and comparator
groups for relevant primary/secondary endpoints
❏Provides statistical data (p values AND 95% confidence
intervals) for the relevant primary/secondary endpoints
❏ Interprets results (e.g., "intervention reduced the risk of
endpoint X by 50% versus control")
❏Critiques power of the study, if the study was underpowered
and failed to show statistical significanceZero Items Checked
<50% of items checked < 100% but ≥ 50% of items
checked100% of items checked Results - Clinical Significance -
Summarizes and critiques (All information must be accurate to
earn credit):
❏ Baseline demographics of included population
❏ Interprets NNT/NNH for any relevant endpoint (only if
endpoint is dichotomous and statistically significant)
❏ Critiques the 95% confidence interval, if available, for any
relevant endpoint discussed
❏ Critiques the clinical significance of the results, by weighing
potential benefits and harms of the intervention and dicusses
whether or not the results should affect clinical practice
Zero Items Checked <50% of items checked < 100% but ≥ 50%
of items checked100% of items checked Application:
Summary of the students' conclusion is:
❏ Accurate ❏ Complete
❏ Applied to specific patient/PICO question Zero Items
Checked <50% of items checked < 100% but ≥ 50% of items
checked100% of items checked Referencing:
Exact 10th edition AMA referencing format:
❏ No missing citations (all references appropriately cited in
text) ❏ Correct numbering
❏ Correct AMA format ❏ Appropriate in-text citationZero
Items Checked <50% of items checked < 100% but ≥ 50% of
items checked100% of items checked ERROR:#DIV/0!Section
Score Communication (20%) Format for the assignment is
followed:
❏ 12 Times New Roman font
❏ 1 inch margins
❏ Utilizes primary and tertiary literature to answer provided
question ❏ Uses correct headings Zero Items
Checked <50% of items checked< 100% but ≥ 50% of items
checked100% of items checkedClarity and Language:
❏ Generic drugs are lower case and brand names capitalized
The paper is free of:
❏ Spelling errors
❏ Grammar errors
❏ Use of unapproved abbrevations
❏ Use of language inconsistent with professional audience *(ex.
Personal pronouns)
>2 errors present<50% of items checked< 100% but ≥ 50% of
items checked0-2 errors presentERROR:#DIV/0!Section Score
ERROR:#DIV/0!Raw final score=[ Biomedical lit (__) x 0.8]
+[Communications (__) x 0.2] ERROR:#DIV/0!Final Score (out
of 100%)= [ (raw score /3) x 100]
Sheet10Yes01No323
Drug Consult Guidelines
1) Students assigned Drug Consult question
• Students will receive an email with their assigned drug consult
topic/question no later than October 1st
• Students are expected to research their assigned question and
answer the consult question before the assigned due date
• At least one piece of primary literature must be reviewed to
answer the consult question
i. Literature should be recent (ie: relevant to current practice)
and address the assigned question
ii. More than one piece of primary literature may be reviewed to
answer the consult question, but only one is required for this
assignment
iii. PLEASE NOTE: A meta-analysis will NOT be considered
acceptable primary literature for the purposes of this assignment
• Additional references (other primary, secondary, or tertiary)
should be used to provide adequate drug and disease state
background
• The maximum length allowed is 3 pages excluding the
references
2) Students are expected to review the Blackboard content on
how to write a drug consult response before writing their drug
consult
• A sample drug consult will also be made available. Please note
that this is only an example of a drug consult and may not
address all requirements indicated in the instructions and rubric.
3) Submit completed drug consult via Turnitin on Blackboard
by 11:59 pm on November 9, 2018
• Only ONE submission will be accepted. No re-submissions
will be allowed for revisions once a submission has been made.
4) If the drug consult is not answered, primary literature not
reviewed, or if the consult exceeds the 3 page limit, then it will
result in a zero for the assignment (see rubric for details)
Consult Components and Formatting
(see rubric and sample drug consult on Blackboard for more
details)
• Title
a. Date and time requested
b. Date and time answered
c. State the question to be answered in the consult
• Brief background
a. Why is the drug information question/topic important?
i. May include:
1. Review of pharmacology and/or pharmacokinetic profile
2. Why the current therapy is ineffective in achieving target
goals
3. Why current therapy may be less desirable to alternatives due
to toxic effects
4. Relevant disease state background
b. Applicability of selected medication(s) in the identified
disease state
• Literature search strategy
a. Describe what database(s) you searched, terms utilized (key
terms, MeSH headings, Emtree terms etc. ), limits employed
b. State the number of articles identified and describe the
criteria employed to both select and exclude the articles for the
drug consult (e.g. only included RCT; excluded editorials and
case reports)
• Methods of primary literature reviewed
a. Study design, inclusion/exclusion criteria, intervention,
comparator, primary/secondary endpoints, etc.
• Results
a. Include the population characteristics, result(s), statistical
significance, confidence interval, etc. and critique
• Recommendation (based on student’s interpretation of
literature results), stated in bullets and includes your
recommended dose, route, frequency, and monitoring
parameters
a. Based on the results reported
b. Not a re-reporting of authors’ recommendation
c. Bullet format
• References
a. Use at least 1 primary reference and supporting references for
background (note: most questions will require more than one
primary reference to answer completely).
• Format and Layout
• Typed and printed on paper with a maximum of 3 pages in
length (not including references), 12-font, single spaced, with
standard margins (1 inch)
• Spelling and grammar will be assessed; please proofread your
assignment
• References and citations for all assignments MUST follow the
American Medical Association (AMA) style requirements.
Access to the full online style guide is available through the
MCPHS libraries website.
** Point Deductions for Absence, Tardiness or Late
Assignments, Plagiarism**
Drug consult: A student who submits their written assignments
after the due date/time will lose 10 points per day off the
written assignment grade until the assignment is submitted. (For
example, if an assignment is due at 11:59 pm on November 9th
and the student submits their assignment at 12:00 am on
November 10th, there will be a 10-point deduction. If they
submit their assignment at 12:00 am on November 11th, there
will be a 20-point deduction, etc.). Please refer to the course
syllabus for additional details.
Please refer to the course syllabus for any situations involving
submission errors or computer (IT) problems for more
information.
Any incident of plagiarism will result in a grade of zero for the
assignment. All suspected incidents of plagiarism will be
referred to the course coordinators. Please refer to the course
syllabus for more information.

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Drug Consult ExampleDate and time requested September 23, 2013 .docx

  • 1. Drug Consult Example Date and time requested: September 23, 2013 at 10:00 AM Date and time answered: September 27, 2013 at 5:00 PM Pharmacy has been consulted re: Are calcium supplements associated with coronary heart disease in adult patients? Background: Calcium supplementation has long been recommended for promoting bone health and is often utilized for the prevention and treatment of osteoporosis.1 It has been reported that in the older population close to 50% of men and 70% of women are users of calcium supplements.1 In most adult patients, the recommended daily allowance (RDA) of elemental calcium is 1000 mg. In females aged 51 and greater, the RDA is slightly increased at 1200 mg.2 Calcium administration is generally well tolerated with the most commonly occurring adverse effects being gastrointestinal discomfort, constipation, flatulence and nausea.3 Recently, there has been speculation about a correlation between calcium supplementation and cardiovascular risk. While some studies have reported cardiovascular benefits such as improvements in blood pressure and lipid panels, some concerning data linking calcium supplementation to increased risk of stroke, myocardial infarction and cardiovascular death has also been published.1 It has been hypothesized that excess calcium intake via supplementation may lead to cardiac calcium phosphate deposits which are correlated with risk of atherosclerosis, coronary heart disease and death.1 Literature Search Strategy: A search was conducted using Ovid MEDLINE (2009 to September week 2 2013). Terms searched included supplemental calcium, calcium supplement, coronary heart disease and cardiovascular disease. The Boolean operator OR
  • 2. was first used to combine the terms supplemental calcium and calcium supplement and then used again to combine the terms coronary heart disease and cardiovascular disease. The Boolean operator AND was subsequently utilized to combine the results from supplemental calcium, OR calcium supplement, with coronary heart disease OR cardiovascular disease. The search was limited to the English language and humans and yielded 13 results. Of the 13 articles, 9 were excluded for being review articles, 2 were excluded because they focused on dietary rather than supplemental calcium intake and 1 was excluded for being focused specifically on myocardial infarction and stroke. The article to be discussed was chosen because it is relevant to the topic as it looks specifically at cardiovascular risk related to calcium supplementation in both men and women. Results/Literature Analysis: A prospective study was conducted to determine if calcium intake was associated with risk of death from heart disease, cerebrovascular disease or cardiovascular disease.1 Included participants were male and female AARP members with ages ranging from 50 to 71 years. Participants were geographically located in 6 states (California, Florida, Louisiana, New Jersey, North Carolina, and Pennsylvania) in addition to 2 cities (Atlanta and Detroit). Patients were excluded if they did not complete their own baseline questionnaire, if they had a history of heart disease, stroke, diabetes, end-stage kidney disease or cancer with the omission of skin cancer if it was not melanoma. Patients were also excluded if their total dietary energy or calcium intakes were excessive (as defined by interquartile range calculations). In total 388,229 subjects were included in trial analysis and were followed for a duration of twelve years. While the above criteria did capture older adults which is a population with prevalent use of calcium supplements, the ages of enrolled patients does limit the external validity to apply results to both younger and older patients. Exclusion criteria did help improve internal validity of the study by excluding
  • 3. some confounding conditions, but also by excluding those with prior heart disease, we are prevented from making an assessment as to whether or not calcium supplementation would affect cardiovascular risk in those with a preexisting cardiac condition. As heart disease is a top cause of mortality in this country, this information would be valuable and further studies in this population may be warranted. At baseline, patients were asked to self-report three items. First, dietary calcium intake was assessed by a food frequency questionnaire which considered both portion sizes as well as frequency of ingestion of each of 124 listed items during the course of the previous year. Second, participants reported the frequency range (i.e. 1 to 3 times per week) as well as dose of any calcium supplements taken. And third, regularity and variety of any multivitamins taken was also reported. Based on the information provided, investigators calculated each patient’s calcium intake by dietary calcium alone, supplemental calcium alone (calcium supplement plus multivitamin) and total calcium (dietary plus supplemental). Overall 56% of women and 23% of men stated they took individual calcium supplements, were non-Hispanic white and had a lower consumption of alcohol, red meat and total fat. Although investigators attempted to standardize the self-reporting through a calibration method involving 24-hour dietary recalls, a limitation to the study is that calcium intake was not directly measured. In addition, it is possible that patients were ingesting calcium in mediums not captured in the questionnaires, such as in food items not contained on the list. Study design may also have been improved upon if investigators had collected information regarding duration of supplement use to determine if any increased risks were associated with length of use and also if there was a familial history of CVD. Although authors of this study did not explicitly specify a primary endpoint, the methods and objective were well defined. Investigators were able to access the Social Security Administration Death Master File and National Death Index Plus to determine if a subject died, and if so, what the cause of
  • 4. death was. Based on this information, as well as adjustments made for patient demographics, lifestyle and dietary variance, relative risks were estimated. Investigators estimated a 95% accuracy rate when pulling data from these databases. Relative risk is an appropriate method to determine level of association in a prospective cohort study, but due to the method of data collection, some error is inherent in study design. Study results showed that men who took more than 1000 mg per day of supplemental calcium in the form of both individual supplements and multivitamins as compared to men with no calcium supplementation had a 20% increased risk of cardiovascular death (RR 1.20; 95% CI, 1.05-1.36). When individual calcium supplements were considered without multivitamins, men who took more than 1000 mg per day of calcium had a 37% increased risk of death from heart disease (RR 1.37; 95% CI, 1.06-1.77). In women, no associations were seen between calcium supplementation and risk of cardiovascular mortality. Additionally, no association was found between dietary calcium intake and cardiovascular death. Given the large amount of patients in the study, the long study duration and the prevalence of calcium supplementation these increases in relative risk are highly clinically relevant. Recommendations/Summary: Due to the elevated risk of cardiovascular death in men who took more than 1000 mg per day of calcium supplementation, doses in this range should be avoided. While these results were not replicated in women, the authors of the study suggest that we cannot rule out the possibility that that a true association exists. Based on the above evidence I would recommend the following in both male and female patients: • Encourage patients to meet calcium requirements through dietary intake. While dairy products are widely known to contain high calcium content, alternatives to dairy include collard greens, kale, soybeans, sardines and salmon. Calcium fortified foods are also available such as orange juice, tofu and
  • 5. cereals.4 • In patients unable to achieve adequate dietary intake, consider calcium supplementation at a dose less than 1000 mg per day. • Supplements should be administered in 2 to 4 divided doses of no more than 600 mg per dose to ensure adequate absorption.5 • Example regimens: o Ultra Strength TUMS® (1000 mg calcium carbonate; 400 mg elemental calcium). Directions: Chew one tablet by mouth twice daily. ▪ Least expensive alternative.5 ▪ Absorption is best if taken with food, but may be reduced if patient is taking drugs that decrease stomach acid.5 ▪ Associated with more gastrointestinal upset than alternative calcium formulations.5 o Citracal Regular® (500 mg of elemental calcium as citrate). Directions: Take one tablet by mouth twice daily. ▪ May be taken without regards for food.5 ▪ Preferred in users of proton pump inhibitors or H2 receptor antagonists, as absorption is less dependent on pH and those with histories of either GI upset from calcium carbonate or kidney stones.5 • Patients requiring calcium supplementation, especially at a dose greater than 1000 mg per day, should be monitored closely for signs and symptoms of heart disease such as chest pain or shortness of breath. Stress tests may be used to assess patients for coronary heart disease at first sign of symptoms. • Ensure adequate Vitamin D needed for calcium absorption (RDA 600 units per day).2 Closing: Thank you for the opportunity for this consult and please let me know of any follow-up questions. I may be contacted via email at xxxx .mcphs.edu. Respectfully, Your Name, PharmD candidate
  • 6. References: 1. Xiao Q, Murphy RA, Houston DK, Harris TB, Chow WH, Park Y. Dietary and Supplemental Calcium Intake and Cardiovascular Disease Mortality. JAMA Intern Med. 2013:173(8):639-646. 2. Lexicomp Web site. http://online.lexi.com.ezproxy.mcphs.edu/lco/action/home. Accessed September 23, 2013. 3. Natural Standard Web site. http://www.naturalstandard.com.ezproxy.mcphs.edu. Accessed September 23, 2013 4. National Osteoporosis Foundation Web site. http://www.nof.org/articles/886. Accessed September 24, 2013. 5. Dynamed Web site. http://web.ebscohost.com.ezproxy.mcphs.edu/dynamed/search/b asic Accessed September 25, 2014. 1 Last edited 4/9/08 1 QUICK REFERENCE CITATION FORMAT
  • 7. For AMA Manual of Style, 10th ed, 2007 Listed below are some of the more commonly used citations depicting the correct citation format; however, these are examples only. More recent editions may have been published. Refer to other examples and explanations in AMA Manual of Style: A Guide for Authors and Editors. 10th ed. New York: Oxford Press;2007. Article in Journals Typical entry for journal article Smith J, Canton EM. Weight-based administration of dalteparin in obese patients. Am J Health-Syst Pharm. 2003;60(7):683-687. Note: If the journal does not have a volume or issue number, use the issue date. Typical entry for journal with more than 6 authors (If more than 6 authors, list first 3, then et al) Hunter DJ, Hankinson SE Jr, Laden F, et al. Plasma organochlorine levels and the risk of breast cancer. N Engl J Med. 1997;337(18):1253-1258. Issue with supplement (the basic format) Dworkin RH, Jolnson RW, Breuer J, et al. Recommendations for the management of herpes zoster. Clinic Infect Dis. 2007;44(1)(suppl 1):S5-S10. Note: if there is no suppl number, leave it blank, e.g., (1)(suppl):S5-S10. Editorials or letters (place the article type in brackets [ ]) Whitcomb ME. The April issue: required reading [editorial].
  • 8. Acad Med. 2007;82(4):319-320. Committee, group or organization Council on Scientific Affairs. Scientific issues in drug testing. JAMA. 1987;257(22):3110-3114. No author Pediatric studies become costlier; Congress may make them less profitable. Prescr Pharm and Biotechnol: Pink Sheet. 2007;69(12):23-24. The choice of antibacterial drugs. Med Lett Drugs Ther. 1998;40(1023):33-42. Drug Topics Red Book (update). May 2007;26(5):49. Books Book with one author or editor Davis NM. Medical Abbreviations: 26,000 Conveniences at the Expense of Communications and Safety. 12th ed. Huntingdon Valley, PA: Neil M.Davis Associates; 2005:173. McEvoy GK, ed in chief, Snow ED, ed. AHFS: Drug Information. Bethesda, MD: American Society of Health-System Pharmacists; 2008:1125-1126. Book with two or more authors/editors Aronoff GR, Berns JS, Brier ME, et al. Drug Prescribing in Renal Failure. 4th ed. Philadelphia, PA: American College of Physicians; 1999:39. Dukes MNG, Aronson JK, eds. Meyler’s Side Effects of Drugs. 14th ed. Amsterdam, Netherlands: Elsevier; 2000:xvi-xvii.
  • 9. Last edited 4/9/08 2 Chapter in book Wallace RJ Jr, Griffith DE. Antimycobacterial agents. In: Kasper DL, Fauci AS, Longo DL, Braunwald E, Hauser SL, Jameson JL, eds. Harrison’s Principles of Internal Medicine. 16th ed. New York, NY: McGraw-Hill; 2005:946. Note: See FAQ section for citing multiple pages of a book with chapters. Johannsen EC, Madoff LC. Infections of the liver and biliary system. In: Mandell GL, Bennett JC, Dolin R, eds. Mandell, Douglas, and Bennett’s: Principles and Practice of Infectious Disease. Vol 1. 6th ed. Philadelphia, PA: Elsevier; 2005:951-952. Dowling TC, Comstock TJ. Quantification of renal function. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM, eds. Pharmacotherapy: A Pathophysiologic Approach. 6th ed. New York, NY: McGraw-Hill; 2005:761. Books complied by group, agency or committee (no author or editor) Drug Topics Red Book. Montvale, NJ: Thomson Healthcare; 2007:552. United States Pharmacopeia Drug Information: Drug Information for the Health Care Professional. Vol 1. 27th ed. Greenwood Village, CO: Thomson Micromedex; 2007:2514-2517.
  • 10. Mosby’s Drug Consult. St. Louis, MO:Mosby; 2007:II-539–II- 540. Physicians’ Desk Reference. 61st ed. Montvale, NJ: Thomson PDR; 2007:678. United States Pharmacopeia and National Formulary (USP 30- NF 25). Vol 2. Rockville, MD: United States Pharmacopeia Convention; 2007:1553-1554. Stedman’s Medical Dictionary. 27th ed. Baltimore, MD: Lippincott Williams & Wilkins; 2000:1784. Serial Books that are updated (include no publication date, only page number after colon) Drug Facts and Comparisons. St. Louis, MO: Facts and Comparisons:1904. Tatro DS, ed. Drug Interaction Facts. St. Louis, MO: Facts and Comparisons:397a. Spechler SJ. Esophageal disorders. In: Dale CD, ed in chief, Federman DD, founding ed. ACP Medicine. New York, NY:WebMD Corp:4-I-5. Note: cite like a book chapter; however, the 4-I-5 represents section 4 (Gastroenterology), Chap I (Esophageal Disorders) and the page number (5). Other Published Material Package Insert Lamasil [package insert]. East Hanover, NJ: Sandoz Pharmaceuticals Corp; 1993. Newspapers
  • 11. Steinmetz G. Kafka is a symbol of Prague today; also, he’s a T- shirt. Wall Street Journal. October 10, 1996:A1, A6. Last edited 4/9/08 3 Electronic Media Online Package Insert Byetta [package insert]. Amylin Pharmaceuticals, Inc., San Diego, CA; October 2007. http://pi.lilly.com/us/byetta-pi.pdf. Accessed March 18, 2008. Note: the above is the official online package insert from the manufacturer, not a patient product/counseling notice. The date (October 2007) is the last modification date, normally found at the end of the package insert file. Online Journals (journal article) on Internet Seal A, Kerac M. Operational implications of using 2006 World Health Organization growth standards in nutrition programmes: secondary data analysis. BMJ. 2007; 334:733. http://www.bmj.com /cgi/content/full/334/7596/733. Accessed April 12, 2007. Note: the above citation is without page numbers; some online journals have inclusive page numbers, thus, use same format, but include pages after the colon; e.g., :733-736.
  • 12. PubMed Abstract Citation Benedict NJ. Sitaxsentan in the management of pulmonary arterial hypertension [abstract]. Am J Health Syst Pharm. 2007;64(4):363-368. http://www.ncbi.nlm.nih.gov/entrez/query.fcgi? db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=1729 9175&query_hl=17&itool=pubmed_doc sum. Accessed April 12, 2007. PMID:17299175. Note: abstract is placed in brackets [ ] to indicated the citation is solely an abstract; also, note that the PMID (PubMed Unique Identifier) number is placed last. IPA Abstract Citation Schrimsher RH, Freeman MK, Kendrach M. A survey of drug information resources in Alabama pharmacy facilities [abstract]. Drug In J. 2006; 40(1);51-60. http://web5s.silverplatter.com. Accessed April 16, 2007. Accession Number:43-07214. Note: abstract is depicted in brackets [ ] to indicated the citation is solely an abstract; also, note that the accession number is placed last. The PMID and Accession number for both PubMed and IPA uniquely identify the citations. Epub Ahead of Print Kozyrskyj AL, Ernst P, Becker AB. Increased risk of childhood asthma from antibiotic use in early life [published online ahead of print April 5 2007]. Chest. 2007. http://www.chestjournal.org/papbyrecent.dtl. Accessed April 16, 2007 Note: Ahead of Print citations can be difficult. If the volume, issue number, date, or pages of the print information are known, include what is known after the journal title and year (e.g., Chest. 2007; vol
  • 13. (issue #):page(s). If you were citing an Epub ahead of print abstract from PubMed, the [abstract] notation is placed after the journal title and before the period. Internet-based Book (eBook) Fields HL, Martin JB. Pain: pathophysiology and management. In: Kasper DL, Fauci AS, Longo DL, Braunwald E, Hauser SL, Jameson JL, eds. Harrison's Principles of Internal Medicine. 16th ed. New York, NY: McGraw-Hill; 2005. http://www.netlibrary.com.ezproxy.samford.edu/Reader. Accessed April 16, 2007:71-73. General Internet Note: the basic format for Web sites is: Author(s), if give and many times there are none; title of the specific item cited, if any; name of the Web site; URL; published and/or update, if any; accessed date. FDA/CEDR resources page. Food and Drug Administration Web site. http://www.fda.gov/ cder/approval/index.htm. Accessed April 7, 2007. Last edited 4/9/08 4 USPDI Updates On-line. Vol 1. Thomson Micromedex Web site. http://uspdi.micromedex.com/. Accessed June 23, 2006. Clinical Pharmacology Web site. http://cpip.gsm.com.ezproxy.samford.edu/. Accessed June 23, 2006.
  • 14. Micromedex Healthcare Series Web site. http://www.thomsonhc.com.ezproxy.samford.edu/ home/dispatch. Accessed Sep 23, 2006. Facts & Comparisons. Facts & Comparisons Web site. http://online.factsandcomparisons. com.ezproxy.samford.edu/. Accessed June 23, 2006. Newcomb K. Search engines come together on sitemaps auto- discovery. SearchEngine Watch Web site. http://searchenginewatch.com/showPage.html?page=3625565. April 12, 2007. Accessed April 16, 2007. Software (CD) Note: Dates associated with various software may be updates or file dates or some other indication of currency. Clinisphere [computer program]. Version 4.2. St Louis, MO: Facts and Comparisons; Feb 03. Clinical Pharmacology [computer program]. Version 2.07. Tampa, FL: Gold Standard Multimedia; 2003. CD-ROM on Book Mosby's Drug Consult [CD-ROM]. St. Louis, MO: Mosby; 2006. Software (Palm) Note: All Palm software follows the same basic format: Name of the company that licensed the software usage (e.g., Lexi-Comp), name of book or database (Lexi- Drugs, comp + specialties) [computer program]. compiler of database (Lexi-Comp, Skyscape); date and/or version/date of program (Ver:4.0.46/
  • 15. 2003.8.31). ePocrates (ePocrates Rx ) [computer program]. ePocrates, Inc; Ver 6.12/Oct 1, 2003. Lexi-Comp (Medical Abbreviations) [computer program]. Lexi- Comp; Sep 22, 2003. Skyscape (Dorland's Pocket Medical Dictionary) [computer program]. Skyscape; Ver:4.0.46/2003.8.31. Excel (Part of Microsoft Office Professional Edition) [computer program]. Microsoft; 2003. Databases PDQ® - NCI's Comprehensive Cancer Database. Bethesda, MD: National Cancer Institute; 2007. http://www.cancer.gov/cancertopics/pdq/cancerdatabase .Updated June 9, 2006. Accessed April 16, 2007. Personal Communication, e.g., conversations, letters, email, lectures, etc. Place personal communication citation in the text with no citation number, e.g., “In a conversation with A.B. Smith, MD (March 2003)….” Or “According to a letter from A.B. Smith, MD (March 2003)….” Or “According to the manufacturer (A.B. Smith, PhD, oral communication, March 2003), the drug was approved in the US in March 2003.” The author should give the date of the communication and indicate whether it was oral or written; furthermore, often the affiliation of the person is helpful to better establish the relevance and authority of
  • 16. Last edited 4/9/08 5 the citation. Citing lectures is the basically the same, e.g., “According to Dr. Schrimsher (PubMed lecture, Sep 2003, Samford University, McWhorter School of Pharmacy), controlled vocabulary should always be used first prior to searching any database.” FAQs (Frequently Asked Questions) regarding citations. Can I cite an article that is in the reference section (or cited) of the article I am currently reading? Generally, you should not do this, that is, cite an article that is cited within an another article. The rule is to cite exactly where you are obtaining the material and thus, pointing to the reader to where the information is, in case the reader desires to read and/or obtain the material you have cited. Where in the book is the best place to find the exact authors/editors, publisher, date of publication, etc? Generally, every book has a distinctive “title page” which depicts authors or editors, publisher and location, and edition. The date of publication (or copyright date) is sometimes at the bottom of the title page, but most often, it is the next page and the exact location varies; however, for the most part, it will appear as “©Copyright, 2002,” then the publisher. If there is no clear author/editor(s) on the title page, it is a good indication that the publisher is the author. Editorial staffs, associate editors, editorial assistants, are not considered
  • 17. the editor, thus no author/editor will be cited. For example, The Merck Index, 13th edition, book lists an editorial staff of seven persons, including a senior editor, editor emeritus, etc., however, none of these individuals would be cited as the “editor.” What is the rule for citing page numbers if the book uses separate pagination within each chapter? Follow the style used in the book; see the Mosby citation as an example. To separate the "thru" pages, use the "en dash" symbol (which is –). How do I cite books with editor in chief? If a book has only an editor in chief and no other editors, then list only the editor in chief (ed in chief). If a book lists an editor in chief, plus other editors (not associate editors, but designated editors), list the editors in order they appear on the title (or other) pages. Normally, the editor in chief will be listed first, followed by the other editors. How do I cite software? Software need not be cited in the reference section if it is mentioned only in passing or is available without charge via the Internet (e.g., shareware or freeware). However, if the reference is to using software for analysis purposes, e.g., SPSS or Excel, then a citation must be included.
  • 18. How do I cite an author that has “Junior” with their name? Cite the name as follows: Wallace RJ Jr, Smith AB, Jones SU III, … Which city do I cite when the publisher lists several city locations? Cite the first city listed. For example, if New York, Paris and London were listed as the publisher’s locations, cite New York, which was the first depicted on the title page of the book. Must I use a registered trademark (®) when I cite/use that particular item, e.g., drug brand name? Guidance: The new AMA manual of style edition (10th) specifically states that a trademark (e.g., ®, TM or SM) should not be used in scientific journal articles or references, but the initial letter of a trademarked word should be capitalized. How do I cite multiple page numbers using only one source? The AMA Manual stipulates that if the author wants to cite different places (or basically more than one set of pages) in the text from the same source (of a book only, not a journal article), the Last edited 4/9/08 6 page numbers are included in the superscript citation and the
  • 19. source appears only once in the list of references. (This is not the same as inclusive pages, which is explained below) Additionally, when the source is listed in the references, no page numbers are included after the publication date (see next example regarding multiple pages in more than one book chapter). For example: Schrimsher6(p3),10 reported 10 drugs that have been withdrawn by their manufacturers. How to cite a book with two or more chapter authors and also simultaneously citing multiple pages from the same source ( book) The AMA Manual does not illustrate a clear example regarding this issue; thus, to cite multiple pages from many (more than one) chapters by different authors, list a separate citation for each chapter cited. For example, suppose I need to cite multiple pages from two authored chapters in Nelson textbook of pediatrics. And example of the running text: Prober1(p751) examines several causes for infant central nervous infections; furthermore, Pickering2(pp765-767) found similar causes for pediatric gastroenteritis. ------------- References 1. Prober CG. Central nervous system infections. In: Behrman RE, Kliegman RM, Jenson HB. Nelson Textbook of Pediatrics. 16th ed. Philadelphia PA: W.B. Saunders; 2000. 2. Pickering LK, Synder JD. Gastroenteritis. In: Behrman RE,
  • 20. Kliegman RM, Jenson HB. Nelson Textbook of Pediatrics. 16th ed. Philadelphia PA: W.B. Saunders; 2000. Note that both chapter citations come from the same source (Nelson Textbook of Pediatrics) and both would be listed separately in the reference section. Also, neither lists page numbers after the publication date because they are already shown with the citation number in superscript in the body text. Furthermore, this method applies only to citing multiple pages from a single source. What are inclusive pages? Inclusive pages are pages with a dash between them, e.g., 10- 15. Inclusive pages are considered a single cited entity, especially regarding books, which essentially tells the reader that the information cited is contained between the inclusive pages, and that the reader would literally have to read the inclusive pages to either find or understand what is being cited. Inclusive pages should not be confused with multiple page citations discussed earlier, they are two separate functions and purposes. Inclusive pages are generally used for citing concepts, discussions, etc. Do not substitute inclusive pages when you are essentially referring to a paragraph or few sentences on a single page. Pages cited should be as close as possible to the actual material you are referencing; furthermore, when citing inclusive pages, do not omit any page digits after the dash, e.g., 115-116.
  • 21. Reproducing Tables and Figure Copyright permission If you (student) are going to recreate/reproduce a table or figure from another source and insert it verbatim (exactly as is) into you assignment paper, you do not have to obtain copyright permission from the copyright holder; however, you still have to cite the source which the table/figure came from and provide the copyright statement in parenthesis. (See bottom of example in Table 4 below.) The statement (If this paper were submitted for publication, copyright permission for reproduction of this table/figure would have to be obtained.) must be added. Last edited 4/9/08 7 Citing Citation(s) for the table/figure can be for the entire table or portions of the table, using an alphabetical order (a-z) footnote method. The superscripted letters (see Table 4 below) are placed in the title of the table if the entire table is verbatim from the source; or if only a potion of the table is from another source, eg, a cell or column, then place the superscripted notation by that cell, data point, or column, as appropriate. See page 90, example, T7, AMA Manual of Style, 10th
  • 22. ed, for other examples. Table Footnotes According to the new AMA manual of style, symbols as footnotes in tables and figures are no longer used. For both tables and figures, footnotes are now indicated as superscript lowercase letter in alphabetical order (a-z). According to the new AMA manual, the font should be large enough to see clearly, but without appearing to be part of the actual data in the table/figure. Thus, the first footnote would be superscripted a, then b, c...z. See example in the below table regarding footnotes. Table 4 has been reproduced with permission from the Drug Information Journal ; the table footnotes are fictitious, in that they were not in the original data/publication. This is for illustration purposes only. Table 4. Availability of Personal Data (or Digital) Assistants (PDAs) by Pharmacy Type (n=604)a Resource Name Retail/ Community (n=480)b Hospital/Mental Health (n=74) Other
  • 23. (n=50) Total (n=604) PDA Use Yes (count) % Yes 82 17.1%c 24 32.4% 12 24.0% 118 19.5% No (count) % No 398 82.9% 50 67.6% 38 76.0% 486
  • 24. 80.5% aData from Schrimsher, Freeman, Kendrach15 bTotals may not equal to 480 due to missing data/surveys. cPercentages may not equal 100% due to unanswered/missing data. (If this paper were submitted for publication, copyright permission for reproduction of this table/figure would have to be obtained.) Explanations: The superscript "a" acknowledges that data the complete data is from another source; thus is the first indicated. Furthermore, the citation number 15 would match that citation number in the reference section. Footnotes "b" and "c" are not cited because they are explanatory notes for clarification or indicating important information about the table to the reader. The last notation in parenthesis (copyright permission) in the example of Table 4 above is to be added for each table or figure. This statement must be included if the paper is any type of student paper, assignment, which includes Phrd 615-616 projects. If this statement is not included, then a permission statement from the copyright holder must be indicated. (The following permission statement is not part of the above Table 4.) Data from Schrimsher R, Freeman, MK, Kendrach, M: “A Survey of Drug Information Resources in Alabama Pharmacy Facilities, Table 4 (Drug Inf J 2006; 40(1):56. Copyright 2006, Drug Information Association. Journal Abbreviations Note: The article itself may have the abbreviation provided on the first page of the article (usually at the
  • 25. end of the abstract or at the bottom of the page in small print). Last edited 4/9/08 8 The following process can be used to locate journal abbreviations: Journal abbreviations may be found in both IPA and PubMed databases, assuming that the journal is indexed in that database. Another good source is "WorldCat" which has a link at the bottom of the WWW Pharmacy Resources Web page, specifically, Use WorldCat for journal abbreviations search: after locating journal, scroll to "Other Titles" section. RubricPPW 440 Patient Care Seminar 1Drug Consult Outcome/ Performance Criteria0123ScoreComments❏ Student did not answer the drug consult question ❏ Student did not use primary literature to answer the drug consult question (no meta-analysis) ❏ The submission exceeds the 3 page limit (excluding references) If any of these boxes are checked, an automatic zero will be given. Zero Items Checked <50% of items checked< 100% but ≥ 50% of items checked100% of items checkedBiomedical Literature (80%) Background: ❏ Orients audience to the situation and rationale for the paper ❏ Utilizes tertiary resources to provide drug background ❏ Utilizes tertiary resources to provide disease state background (including current standard care)
  • 26. Zero Items Checked <50% of items checked < 100% but ≥ 50% of items checked100% of items checked Search Strategy: ❏ Database described ❏ Search terms described ❏ Dates of indexed databases ❏Number of articles identified ❏Criteria to select and exclude articles for the consult described (only included RCT, no reviews, etc) ❏ Selected article is relevant and appropriate to scenario Zero Items Checked <50% of items checked< 100% but ≥ 50% of items checked100% of items checkedMethods: Group allocation Summarizes and critiques interventions and methods accurately. Students will only get a check for each item if both summary and critique are provided (e.g. Logical, described in sufficient detail, based on standard methods/practices and/or using validated scales methods) : ❏ Study design ❏ Inclusion criteria ❏ Exclusion criteria ❏ Statistical power, if provided Zero Items Checked <50% of items checked < 100% but ≥ 50% of items checked100% of items checked Methods: Study intervention Summarizes and critiques interventions and methods accurately. Students will only get a check for each item if both summary and critique are provided (e.g. Logical, described in sufficient detail, based on standard methods/practices and/or using validated scales methods) : ❏ Intervention ❏ Comparator ❏ Primary endpoint ❏ Relevant secondary endpoints ❏ Scales/measures ❏ Follow-up period Zero Items Checked <50% of items checked < 100% but ≥ 50% of items checked100% of items checked Results: Statistical Significance - Summarizes (All information must be accurate to earn credit): ❏Provides actual results (proportion/mean/median) for each group AND difference between intervention and comparator groups for relevant primary/secondary endpoints ❏Provides statistical data (p values AND 95% confidence
  • 27. intervals) for the relevant primary/secondary endpoints ❏ Interprets results (e.g., "intervention reduced the risk of endpoint X by 50% versus control") ❏Critiques power of the study, if the study was underpowered and failed to show statistical significanceZero Items Checked <50% of items checked < 100% but ≥ 50% of items checked100% of items checked Results - Clinical Significance - Summarizes and critiques (All information must be accurate to earn credit): ❏ Baseline demographics of included population ❏ Interprets NNT/NNH for any relevant endpoint (only if endpoint is dichotomous and statistically significant) ❏ Critiques the 95% confidence interval, if available, for any relevant endpoint discussed ❏ Critiques the clinical significance of the results, by weighing potential benefits and harms of the intervention and dicusses whether or not the results should affect clinical practice Zero Items Checked <50% of items checked < 100% but ≥ 50% of items checked100% of items checked Application: Summary of the students' conclusion is: ❏ Accurate ❏ Complete ❏ Applied to specific patient/PICO question Zero Items Checked <50% of items checked < 100% but ≥ 50% of items checked100% of items checked Referencing: Exact 10th edition AMA referencing format: ❏ No missing citations (all references appropriately cited in text) ❏ Correct numbering ❏ Correct AMA format ❏ Appropriate in-text citationZero Items Checked <50% of items checked < 100% but ≥ 50% of items checked100% of items checked ERROR:#DIV/0!Section Score Communication (20%) Format for the assignment is followed: ❏ 12 Times New Roman font ❏ 1 inch margins ❏ Utilizes primary and tertiary literature to answer provided question ❏ Uses correct headings Zero Items
  • 28. Checked <50% of items checked< 100% but ≥ 50% of items checked100% of items checkedClarity and Language: ❏ Generic drugs are lower case and brand names capitalized The paper is free of: ❏ Spelling errors ❏ Grammar errors ❏ Use of unapproved abbrevations ❏ Use of language inconsistent with professional audience *(ex. Personal pronouns) >2 errors present<50% of items checked< 100% but ≥ 50% of items checked0-2 errors presentERROR:#DIV/0!Section Score ERROR:#DIV/0!Raw final score=[ Biomedical lit (__) x 0.8] +[Communications (__) x 0.2] ERROR:#DIV/0!Final Score (out of 100%)= [ (raw score /3) x 100] Sheet10Yes01No323 Drug Consult Guidelines 1) Students assigned Drug Consult question • Students will receive an email with their assigned drug consult topic/question no later than October 1st • Students are expected to research their assigned question and answer the consult question before the assigned due date • At least one piece of primary literature must be reviewed to answer the consult question i. Literature should be recent (ie: relevant to current practice) and address the assigned question ii. More than one piece of primary literature may be reviewed to answer the consult question, but only one is required for this assignment iii. PLEASE NOTE: A meta-analysis will NOT be considered acceptable primary literature for the purposes of this assignment • Additional references (other primary, secondary, or tertiary) should be used to provide adequate drug and disease state background • The maximum length allowed is 3 pages excluding the
  • 29. references 2) Students are expected to review the Blackboard content on how to write a drug consult response before writing their drug consult • A sample drug consult will also be made available. Please note that this is only an example of a drug consult and may not address all requirements indicated in the instructions and rubric. 3) Submit completed drug consult via Turnitin on Blackboard by 11:59 pm on November 9, 2018 • Only ONE submission will be accepted. No re-submissions will be allowed for revisions once a submission has been made. 4) If the drug consult is not answered, primary literature not reviewed, or if the consult exceeds the 3 page limit, then it will result in a zero for the assignment (see rubric for details) Consult Components and Formatting (see rubric and sample drug consult on Blackboard for more details) • Title a. Date and time requested b. Date and time answered c. State the question to be answered in the consult • Brief background a. Why is the drug information question/topic important? i. May include: 1. Review of pharmacology and/or pharmacokinetic profile 2. Why the current therapy is ineffective in achieving target goals 3. Why current therapy may be less desirable to alternatives due to toxic effects 4. Relevant disease state background b. Applicability of selected medication(s) in the identified disease state • Literature search strategy a. Describe what database(s) you searched, terms utilized (key terms, MeSH headings, Emtree terms etc. ), limits employed b. State the number of articles identified and describe the
  • 30. criteria employed to both select and exclude the articles for the drug consult (e.g. only included RCT; excluded editorials and case reports) • Methods of primary literature reviewed a. Study design, inclusion/exclusion criteria, intervention, comparator, primary/secondary endpoints, etc. • Results a. Include the population characteristics, result(s), statistical significance, confidence interval, etc. and critique • Recommendation (based on student’s interpretation of literature results), stated in bullets and includes your recommended dose, route, frequency, and monitoring parameters a. Based on the results reported b. Not a re-reporting of authors’ recommendation c. Bullet format • References a. Use at least 1 primary reference and supporting references for background (note: most questions will require more than one primary reference to answer completely). • Format and Layout • Typed and printed on paper with a maximum of 3 pages in length (not including references), 12-font, single spaced, with standard margins (1 inch) • Spelling and grammar will be assessed; please proofread your assignment • References and citations for all assignments MUST follow the American Medical Association (AMA) style requirements. Access to the full online style guide is available through the MCPHS libraries website. ** Point Deductions for Absence, Tardiness or Late Assignments, Plagiarism**
  • 31. Drug consult: A student who submits their written assignments after the due date/time will lose 10 points per day off the written assignment grade until the assignment is submitted. (For example, if an assignment is due at 11:59 pm on November 9th and the student submits their assignment at 12:00 am on November 10th, there will be a 10-point deduction. If they submit their assignment at 12:00 am on November 11th, there will be a 20-point deduction, etc.). Please refer to the course syllabus for additional details. Please refer to the course syllabus for any situations involving submission errors or computer (IT) problems for more information. Any incident of plagiarism will result in a grade of zero for the assignment. All suspected incidents of plagiarism will be referred to the course coordinators. Please refer to the course syllabus for more information.