Download Drug information - Millennium Organization

Introduction to the
Concept of
Medication Information
What is drug information ?
• It has different meanings to different
people depending on the context in which
it is used.
• information printed in a reference.
• verbalized by an individual that pertains to
drugs.
• medication information.
• The provision of medication information is
among the most fundamental
responsibilities of pharmacists.
Drug information specialist must be:
1- individual responsible for operating
the center
2- capable of storing information in the
center and retrieve, select and distribute
it to:
a-respond to specific questions,
b- help evaluation of drugs for use in
the hospital,
c- inform through newsletters of
current developments related to drugs
Information may be:
• Patient specific, as an integral part of
pharmaceutical care, or
• relative to a group of patients, such as
in the context of a disease management
program or publishing in a newsletter.
The Beginning
• In 1962, the first drug information
center opened at the University of
Kentucky Medical Center.
• to evaluate , compare drugs, and provide
the drug information for :
staff physicians , dentists and nurses.
 education of health professional
students including medicine, dentistry,
nursing, and pharmacy.
The goal was to influence pharmacy
students in developing their role as drug
consultants.
i- Decentralizing pharmacists
ii- Offering a clinical consultation service
iii- Providing services for a geographic area
through a regional center.
The development of drug information
centers and drug information specialists
was the beginning of the clinical pharmacy
concept.
Medication Information Services
1- Support for clinical services
i- Answering questions
ii- Developing principle guidelines for
medication use
2- Pharmacy and therapeutics committee
activity (P & T committee).
i- Development of medication use policies
ii- Formulary management
3- Publications-newsletter, journal columns.
4- Education-services (health professionals &
students).
5. Medication usage (practice, procedure, handle)
evaluation/ medication use (spend) evaluation
6. Investigational medication control
i. Institutional Review Board activities
(IRBs) IRBs are responsible for ensuring that research
ethics are followed in each institution
ii. Information for practitioners
7. Coordination of reporting programs
e.g., adverse medication reactions
8. Poison information
9. Expert testimony.
Development of information provision
1- The Medical Literature Retrieval and
Analysis System (MEDRALS) was
developed by the National Library of
Medicine in the early 1960s.
Although it provided a computerized form
of searching, requests for searches were
submitted by mail and results returned by
mail.
2- The ability to transmit such
information over telephone lines (on-line
technology) was not available until 1971
when MEDLINE was introduced and was
limited to libraries.
3- Nowadays information is easily
provided through telephones and online
connections.
The Evolution
• Majority of centers
(>80%) are located in
hospitals
• few (7%) are located in
colleges of pharmacy.
• 70% of which have
primarily educational
purposes.
The responsibilities of individual pharmacists
regarding the provision of drug information
have changed substantially over the years.
• Motivation for this change includes:
1- drug information centers and the clinical
pharmacy concept.
2- Study commission on Pharmacy
External official group or committee was
established to review the state of the
practice and education of pharmacists and
report its findings.
• Pharmaceutical care
term has broaden the
concept to involve patients in any environment not only
hospitals:
• It is defined as “the responsible provision
of drug therapy for the purpose of
achieving definite outcomes that improve a
patient’s quality of life.”
• Pharmacists involved in patient care areas
(e.g., hospitals, clinics, long-term care, home health care) answer
drug information questions, participate in
evaluating a patient’s drug therapy, and carry
out medication usage evaluation activities.
• The provision of medication information may be
1- on a one-on-one basis or
2- may occur using a more structured approach,
such as a presentation to a class of diabetic
patients or a group of nurses in the practice
facility.
Pharmacists in Community Settings
1. Counsel patients
2. Answer drug information questions
3. Review patient medication regimens for
potential problems
4. Participate in helping patients manage their
chronic diseases.
Factors Influencing the Evolution of
the Pharmacist’s Role as a
Medication Information Provider
1. Growth of information technology
2. Changes in the health care
environment with focus on evidencebased medicine and evaluation of
outcomes
3. The sophistication of medication
therapy
4. More knowledgeable patient
1- Integration of New Technologies
• Computer technology has changed drastically, however,
storing and retrieving data has become more manageable.
• The internet & World Wide Web provide a tool for sharing information &
allow the user to have easily access to the scientific literature,
government publications, items in the news, etc…….
• The information may be in textual form, or include graphics, video, or
sound.
• Pharmacist in a local community pharmacy or rural hospital can
communicate with health care professionals or their patients locally or
get medical data found in another country.
• These techniques also ease the access to the patient’s medical records.
• Local area networks (LAN), palm top computers
search drug
information data bases as Physician’s Desk Reference (PDR).
• All this technology & information need skilled pharmacist.
2- Evidence-Based Medicine and Drug Policy Development
• Evidence-Based Medicine is an approach to practice and teaching
that connect current clinical research evidence with pathophysiologic
basis, professional expertise, and patient preferences.
• Evidence-Based Medicine techniques are used in the development of
therapeutic guidelines, clinical pathways, medication use evaluations, and
disease state management.
• Emphasizes the need for skilled pharmacist with solid understanding
of drug information concepts and be able to evaluate the medication
use issues for a group of patients, be able to search, retrieve, and
critically evaluate the scientific literature, and apply the information to
the targeted group of patients.
• All the drug analysis processes help to support the decision making
process in a managed care organization, where the outcomes can be used
to identify the effectiveness of pharmaceutical products and evaluate
pharmacoeconomics (cost, consequences, and efficiency) to help
services in achieving desired health outcomes.
3- Sophistication of Medication Therapy
•It is increasingly difficult for physicians & other health
professionals to keep up with all of the developments in
medication therapy, & keep this side by side to the required
information for their practice.
•Sophisticated level of medication therapy offers pharmacists
opportunity to assess the medication information needs of
professionals, patients, or family members.
• Pharmacists can provide literature to:
a- differentiate the choice of medications within a class,
b- suggest the appropriate information to help patients
correctly and safely by using more potent medications, &
address administration and delivery problems to avoid
medication therapy problems.
4- Consumerism
• Consumers have a growing desire for information about their
medications.
! increase in
improved
growth of
focus on
accessibility
the selfhealth care
of health
care
costs
information
movement
•These are some factors that have influenced patients to participate more
fully in health care decisions, including the selection and use of medications.
• Based on these needs, direct-to-consumer advertising (DTCA) campaigns
have appeared in virtually all mediums including magazines, television, and
radio. Gps as National Council on Patient Information and Education (NCPIE)
• “Medication information hotlines” established by pharmacists, enhance
the relationships between pharmacists, physicians, and patients, the 3 Ps.
Poison Control
• Poison information is a specialized area of medication
information with the practitioner typically practicing in
an accredited poison information center or an
emergency room.
• Its mission is to provide accurate and timely
information to enhance the quality of care of patients.
• In the P.I.C. most consultations are generated from the
public, while in DIC the health professionals generate most
consultations .
•These centers must be prepared to provide
information on management of any poison situation
including household products, therapeutic drugs
overdose, plants intoxication, envenomation with
different venomous animals, etc.
Drug Information Resources
Tertiary:
• Text books
•Full-text computer
data base
•Review articles
Secondary:
• Indexed data
• Abstracted data
Primary:
• Articles in medical
journals
Drug information: Is an information in text form or is a verbal information.
Index data, medicus: Provide only bibliographic information that is indexed by
topic.
Abstracted data: Provide a brief description of information contained in a specific
citation.
Adverse event: Harm in the patient administered medication, but not necessarily
caused by the medication. It's any injury caused by the drug.
Adverse drug reactions: It's any adverse event associated with the usage of the
drug
Bioequivalent: the presence of 2 drugs the 1st is used as standard & the 2nd is
compared with it in potency, side effect & …………..
Orphan drug status: drug used in treatment of rare diseases & the cost shouldn't
cover the cost of the production & researches.
Extemporaneous compounding: the compounding of drugs according to prescription.
Formulary: It's continuously revised list of medication that are available for using
within a hospital or institute
OBRA: Omnibus Budget Reconciliation Act.
It's a public law focused on drug benefits provided under medic aid & the law needs
the pharmacist to: Conduct drug use information. Review utilisation of the drug.
Review of the prescription to prevent drug interaction.
i- Adverse Event or Adverse Drug Reactions Resources
Adverse event: Harm in the patient administered medication, but not
necessarily caused by the medication (all aspects of care, including diagnosis and treatment,
failure to diagnose or treat, and the systems and equipment used to deliver care..
Adverse DRUG event: Harm caused by the use of a medication, may
include adverse drug reaction OR medication error.
Adverse DRUG reaction: Harm caused by the use of a medication at
normal doses, unexpected e.g. CHF from metoprolol
ii. Bioequivalence Resources
Pharmaceutical equivalence implies the same amount of the same active
substance(s), in the same dosage form, for the same route of
administration and meeting the same or comparable standards.Birkett 2003
“The absence of a significant difference in the rate and extent to
which the active ingredient or active moiety in pharmaceutical
equivalents or pharmaceutical alternatives becomes available at the site
of drug action when administered at the same molar dose under similar
conditions in an appropriately designed study.“ FDA
iii. Drug Interaction Resources
iv. Drug Use in Renal Failure Resources
v. Extemporaneous Compounding Resources
the compounding of drugs according to prescription.
• Extemporaneous Ophthalmic Preparations
• Pediatric Drug Formulations
•Remington’s Pharmaceutical Sciences
vi. Identification Resources for Tablet and Capsule Imprint
Codes
vii. U.S. Drug Identification Resources (Merck Index)
vii. Other Drug Identification Resources (BNF)
viii. General Drug Information Resources (AHFS Drug
Information: American Hospital Formulary Standards.)
ix. Geriatric Dosing Resources:
1- Geriatric Dosage Handbook
OBRA: Omnibus (collection, edition) Budget (financial statements, funds)Reconciliation
(settlement, declaration) Act (work, action…).
It's a public law focused on drug benefits provided under medic aid for all
patients, specially geriatrics.
x. Laboratory Tests
xi. Medical Resources
xii. Natural Product Resources
xix Sterile Drug Product
Resources
xx- Drugs in Pregnancy
and Lactation Resources
xiii. Over-the-Counter Drug Resources
xiv. Patient Counseling Resources
xv. Pediatric Dosing Resources
xvi. Pharmacology Resources
xvii. Pharmacotherapy Resources
xviii. Poison Control Information Resources
II- Secondary Resources
Indexed data
covers
Abstracted data
Biomedical Journals
Meetings
• They
Text books
Other
publications
are available via on-line vendors, CD-ROM format or
some systems as PubMed from the National Library of
Medicine (<<http://www.nlm.nih.gov>>).
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rosuvastatin and oxidative stress - Pu
Results: 1 to 20 of 50
1.
Effects of lipid-lowering therapy with rosuvastatin on kidney function and oxidative stress in patients
with diabetic nephropathy.
Abe M, Maruyama N, Okada K, Matsumoto S, Matsumoto K, Soma M.
J Atheroscler Thromb. 2011;18(11):1018-28. Epub 2011 Sep 15.
PMID: 21921413 [PubMed - in process] Free Article
Related citations
2.
Additive Effect of Homocysteine- and Cholesterol-Lowering Therapy on Endothelium-Dependent
Vasodilation in Patients with Cardiovascular Disease.
Wustmann K, Klaey M, Burow A, Shaw SG, Hess OM, Allemann Y.
Cardiovasc Ther. 2011 Jul 31. doi: 10.1111/j.1755-5922.2011.00272.x. [Epub ahead of print]
PMID: 21884007 [PubMed - as supplied by publisher]
Related citations
3.
Angiotensin-II and rosuvastatin influence matrix remodeling in human mesangial cells via
metalloproteinase modulation.
Solini A, Rossi C, Santini E, Madec S, Salvati A, Ferrannini E.
J Hypertens. 2011 Oct;29(10):1930-9.
PMID: 21881526 [PubMed - indexed for MEDLINE]
Related citations
J Atheroscler Thromb. 2011;18(11):1018-28. Epub 2011 Sep 15.
Effects of lipid-lowering therapy with rosuvastatin on kidney function and oxidative stress in patients with
diabetic nephropathy.
Abe M, Maruyama N, Okada K, Matsumoto S, Matsumoto K, Soma M.
Source
Division of Nephrology, Hypertension and Endocrinology, Department of Internal Medicine, Nihon University School of
Medicine, Tokyo, Japan. [email protected]
Abstract
AIM:
We aimed to assess the effects of rosuvastatin treatment on lipid levels, a biomarker of oxidative stress,
albuminuria, and kidney function in patients with diabetic nephropathy.
METHODS:
We conducted a prospective, open-label, parallel group, controlled study of 104 patients with diabetic nephropathy,
low-density lipoprotein cholesterol (LDL-C) levels of > 120 mg/dL, and well-controlled blood pressure who were
undergoing treatment with renin angiotensin system inhibitors. Patients were randomly assigned to two groups: the
rosuvastatin group (n = 52; 2.5 mg/day rosuvastatin, increased to 10 mg/day) and the control group (n = 52; no
rosuvastatin administered). We determined the efficacy of rosuvastatin by monitoring serum lipid profiles, high
sensitivity C-reactive protein (hs-CRP), malondialdehyde-modified LDL (MDA-LDL), and cystatin C levels. In addition,
urinary albumin, 8-hydroxydeoxyguanosine (8-OHdG) and liver-type fatty acid-binding protein (L-FABP) levels were
measured before and 6 months after rosuvastatin was added to the treatment.
RESULTS:
Rosuvastatin effectively reduced total cholesterol, LDL-C, triglycerides, non-high-density lipoprotein cholesterol
(non-HDL-C) levels, and the LDL-C/ HDL-C ratio in the rosuvastatin group. These parameters remained unchanged in
patients who were not treated with rosuvastatin. Although there was no significant change in the estimated
glomerular filtration rate level, serum cystatin C levels and urinary albumin excretion rates were significantly
decreased in the rosuvastatin group. In addition, rosuvastatin significantly reduced hs-CRP and MDA-LDL levels.
Moreover, urinary 8-OHdG and L-FABP levels at baseline (13.5±5.1 and 41.7±26.1 ng/mgCr, respectively) decreased
significantly at 6 months (11.5±4.0 and 26.9±13.4 ng/mgCr, respectively), and there was a significant correlation (r =
0.48, p < 0.01). Multivariate analysis revealed that albuminuria was significantly correlated with only rosuvastatin use
(p = 0.0006, R(2)= 0.53).
CONCLUSION:
Rosuvastatin administration reduced albuminuria, oxidative stress, and serum cystatin C levels, independent of blood
pressure and lipid levels.
PMID: 21921413 [PubMed - in process] Free full text
• Each Vendor provide access to numerous databases focused
on a variety of areas such as current affairs, business and
economics, social sciences and humanities, applied sciences and
biosciences.
• Cost of on-line access to secondary resources depends on
the vendor, time of day the search is conducted, data base
searched, citations printed, and other factors that vary with
the service accessed.
•Some examples of the 2ry resources:
1- Anti-infectives today: An indexing and abstracting
service that summarizes current literature on drug therapy
and management of infections. Available in newsletter and a
variety of electronic formats. Published monthly.
2- BIOSIS Previews
BIOSIS, Philadelphia. A major comprehensive resource that
covers all areas of biological research, including the
biomedical sciences. Meeting and conference citations include
the basic sciences; may be more comprehensive than
MEDLINE.
3- Index Medicus
U.S. Government Printing Office, Washington, D.C. An index
to the biomedical literature that references over 3000
journals. Note that this is a printed subset of MEDLINE.
4- MEDLINE
National Library of Medicine, Bethesda, MD. One of the most
expansive databases of biomedical information containing
approximately 370,000 references. Citations from 1966 to the
present can be searched for approximately 3500 journals. CDROM or via on-line services including the Internet as part of
PubM <<http://www. nlm,nih.gov>>.
Searching Computerized Databases
• Consider the question to be researched.
For example: Has diazepam been used rectally in pediatric
patients for the management of status epilepticus?
The question emphasizes four major points: (1) diazepam,
(2) pediatric usage, (3) rectal administration, and status
epilepticus.
• Pediatrics = child = infants, etc…, so one term in service
system may be another in other service systems .
• For databases available through National Library of
Medicine, index terms are called Medical Subject Headings
or MESH terms.
BOOLEAN OPERATORS are used to combine search terms.
Three Boolean operators are used routinely: AND, OR, and
NOT. In addition, some data bases have Boolean operators
known as WITH and NEAR.
III- Primary Literature
• Consists of research studies published in biomedical
journals, however, there are now some internet-only journals
• Primary literature provides details of research
methodology and scientific results that lead to therapeutic
conclusions, and it is more up-to-date than 3ry resources .
• 3ry and 2ry resources, however, consist of a review of
published primary literature that may be biased or
inaccurate, & one may get another conclusion from 1ry.
Pre-publication Servers
Electronic servers that publish non-reviewed research
example: NetPrints (http://clinmed.netprints.org/home.dtl).
The visitor is greeted by the following warning:
“Articles posted on this site have not yet been accepted
for publication by a peer reviewed journal.
They are presented here mainly for the benefit of fellow
researchers.
 Casual readers should not act on their findings, and
journalists should be wary of reporting them”.
An advantage of such servers is that negative results can be
published.
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