Pubmed Direct To Set

PMID- 31361827
OWN - NLM
STAT- MEDLINE
DCOM- 20200127
LR - 20200127
IS - 1535-2900 (Electronic)
IS - 1079-2082 (Linking)
VI - 76
IP - 7
DP - 2019 Mar 19
TI - The opioid crisis: Origins, trends, policies, and the roles of pharmacists.
PG - 424-435
LID - 10.1093/ajhp/zxy089 [doi]
AB - PURPOSE: The purpose of this review is to (1) provide information concerning
the
opioid crisis including origins, trends, and some important related
laws/policies; and (2) summarize the current involvement and impact of
pharmacists in helping to address the crisis, as well as examine practices in
other healthcare disciplines from which pharmacists might derive guidance and
strategies. SUMMARY: Contributors to the opioid crisis included campaigns to
treat pain as a fifth vital sign and to use opioids in treatment of
non-cancer-related pain, as well as aggressive marketing of opioid analgesics
by
pharmaceutical companies. To address the crisis, numerous strategies have
been
implemented at the policy/legislative, health-system, and patient levels,
such as
prescription drug monitoring programs (PDMPs), increased regulation of pain
clinics, and expanded use of naloxone. Pharmacists have a critical role to
play
in interventions to address opioid misuse and reduce harm resulting from
misuse.
Such interventions include patient screening and risk stratification, patient
and
community education and outreach concerning appropriate pain management,
medication reviews/medication therapy management, education on safe storage
and
disposal, distribution of naloxone/opioid rescue kits and training on their
proper use, and referral of patients to addiction treatment, among other
strategies. CONCLUSION: Pharmacists have multiple, complex roles in
addressing
the opioid crisis. Outcomes of several studies provide substantial evidence
that
pharmacists can make an impact through appropriate pain management, use of
PDMPs,
opioid overdose prevention training, and medication reviews and counseling,
among
other interventions.
CI - © American Society of Health-System Pharmacists 2019. All rights reserved.
For
permissions, please e-mail: journals.permissions@oup.com.
FAU - Chisholm-Burns, Marie A
AU - Chisholm-Burns MA
AD - University of Tennessee Health Science Center College of Pharmacy, Memphis,
TN.
FAU - Spivey, Christina A
AU - Spivey CA
AD - Department of Clinical Pharmacy and Translational Science, University of
Tennessee Health Science Center College of Pharmacy, Memphis, TN.
FAU - Sherwin, Erin
AU - Sherwin E
AD - University of Tennessee Health Science Center College of Pharmacy, Memphis,
TN.
FAU - Wheeler, James
AU - Wheeler J
Tennessee Health Science Center College of Pharmacy, Knoxville, TN.
FAU - Hohmeier, Kenneth
AU - Hohmeier K
Tennessee Health Science Center College of Pharmacy, Nashville, TN.
LA - eng
PT - Journal Article
PT - Review
PL - England
TA - Am J Health Syst Pharm
JT - American journal of health-system pharmacy : AJHP : official journal of the
American Society of Health-System Pharmacists
JID - 9503023
RN - 0 (Analgesics, Opioid)
RN - 0 (Narcotic Antagonists)
RN - 36B82AMQ7N (Naloxone)
SB - IM
MH - Analgesics, Opioid/*adverse effects
MH - Counseling
MH - Direct-to-Consumer Advertising/legislation & jurisprudence
MH - Drug Utilization Review/organization & administration
MH - Health Policy
MH - Humans
MH - Inappropriate Prescribing/adverse effects/legislation &
jurisprudence/prevention
& control
MH - Medication Therapy Management/organization & administration
MH - Naloxone/therapeutic use
MH - Narcotic Antagonists/therapeutic use
MH - Opioid Epidemic/*etiology/prevention & control
MH - Opioid-Related Disorders/*epidemiology/etiology/therapy
MH - Pain Management/*methods
MH - Pharmaceutical Services/organization & administration
MH - Pharmacists/*organization & administration
MH - Prescription Drug Misuse/adverse effects/legislation &
jurisprudence/prevention &
control
MH - Professional Role
MH - United States/epidemiology
OTO - NOTNLM
OT - opioids
OT - pain management
OT - patient education
OT - pharmacists
OT - policy
OT - prescribers
EDAT- 2019/07/31 06:00
MHDA- 2020/01/28 06:00
CRDT- 2019/07/31 06:00
PHST- 2019/07/31 06:00 [entrez]
PHST- 2019/07/31 06:00 [pubmed]
PHST- 2020/01/28 06:00 [medline]
AID - 5382447 [pii]
AID - 10.1093/ajhp/zxy089 [doi]
PST - ppublish
SO - Am J Health Syst Pharm. 2019 Mar 19;76(7):424-435. doi: 10.1093/ajhp/zxy089.
PMID- 26541925
OWN - NLM
STAT- MEDLINE
DCOM- 20160216
LR - 20220311
IS - 0735-1097 (Linking)
VI - 66
IP - 19
DP - 2015 Nov 10
TI - The role of the clinical pharmacist in the care of patients with
cardiovascular
disease.
PG - 2129-2139
LID - S0735-1097(15)06275-0 [pii]
LID - 10.1016/j.jacc.2015.09.025 [doi]
AB - Team-based cardiovascular care, including the use of clinical pharmacists,
can
efficiently deliver high-quality care. This Joint Council Perspectives paper
from
the Cardiovascular Team and Prevention Councils of the American College of
Cardiology provides background information on the clinical pharmacist's role,
training, certification, and potential utilization in a variety of practice
models. Selected systematic reviews and meta-analyses, highlighting the
benefit
of clinical pharmacy services, are summarized. Clinical pharmacists have a
substantial effect in a wide variety of roles in inpatient and ambulatory
settings, largely through optimization of drug use, avoidance of adverse drug
events, and transitional care activities focusing on medication
reconciliation
and patient education. Expansion of clinical pharmacy services is often
impeded
by policy, legislation, and compensation barriers. Multidisciplinary
organizations, including the American College of Cardiology, should support
efforts to overcome these barriers, allowing pharmacists to deliver high-
quality
patient care to the full extent of their education and training.
CI - Copyright © 2015 American College of Cardiology Foundation. Published by
Elsevier
Inc. All rights reserved.
FAU - Dunn, Steven P
AU - Dunn SP
AD - University of Virginia Health System, Charlottesville, Virginia. Electronic
address: spdunn@virginia.edu.
FAU - Birtcher, Kim K
AU - Birtcher KK
AD - University of Houston College of Pharmacy, Houston, Texas.
FAU - Beavers, Craig J
AU - Beavers CJ
AD - UK HealthCare, University of Kentucky, Lexington, Kentucky.
FAU - Baker, William L
AU - Baker WL
AD - University of Connecticut School of Pharmacy, Storrs, Connecticut.
FAU - Brouse, Sara D
AU - Brouse SD
AD - UK HealthCare, University of Kentucky, Lexington, Kentucky.
FAU - Page, Robert L 2nd
AU - Page RL 2nd
AD - University of Colorado School of Pharmacy, Denver, Colorado.
FAU - Bittner, Vera
AU - Bittner V
AD - University of Alabama at Birmingham School of Medicine, Birmingham, Alabama.
FAU - Walsh, Mary Norine
AU - Walsh MN
AD - St. Vincent Heart Center, Indianapolis, Indiana.
LA - eng
PT - Research Support, Non-U.S. Gov't
PT - Review
PL - United States
TA - J Am Coll Cardiol
JT - Journal of the American College of Cardiology
JID - 8301365
SB - IM
MH - Cardiovascular Diseases/*drug therapy
MH - Humans
MH - *Medication Adherence
MH - Pharmacists/*standards
MH - *Pharmacy Service, Hospital
OTO - NOTNLM
OT - collaborative practice
OT - medication adherence
OT - medication therapy management
OT - team-based care
EDAT- 2015/11/07 06:00
MHDA- 2016/02/18 06:00
CRDT- 2015/11/07 06:00
PHST- 2015/04/22 00:00 [received]
PHST- 2015/09/08 00:00 [revised]
PHST- 2015/09/14 00:00 [accepted]
PHST- 2015/11/07 06:00 [entrez]
PHST- 2015/11/07 06:00 [pubmed]
PHST- 2016/02/18 06:00 [medline]
AID - S0735-1097(15)06275-0 [pii]
AID - 10.1016/j.jacc.2015.09.025 [doi]
PST - ppublish
SO - J Am Coll Cardiol. 2015 Nov 10;66(19):2129-2139. doi:
10.1016/j.jacc.2015.09.025.
PMID- 27123798
OWN - NLM
STAT- MEDLINE
DCOM- 20170922
LR - 20181113
IS - 1527-4160 (Print)
IS - 1527-4160 (Linking)
VI - 22
IP - 3
DP - 2016 May
TI - Buprenorphine Prescribing: To Expand or Not to Expand.
PG - 183-92
LID - 10.1097/PRA.0000000000000154 [doi]
AB - As a result of the prescription opioid epidemic in the United States, there
has
been an increasing need for effective treatment interventions, both
pharmacological and nonpharmacological. Buprenorphine has emerged as a
critical
component of the treatment of opioid use disorder, yet its adoption has not
been
without some concerns. This article first reviews the pharmacology, clinical
use,
and US legislative action related to buprenorphine, followed by a discussion
of
the misuse and diversion of buprenorphine in the United States as well as
internationally. We then explore the impact of buprenorphine abuse as well as
discussing strategies for its reduction, including changes in policy,
prescription and pharmacy monitoring, and continuing medical education for
guiding and improving clinical practice.
FAU - Li, Xiaofan
AU - Li X
AD - LI, SHORTER, and KOSTEN: Menninger Department of Psychiatry and Behavioral
Sciences, Baylor College of Medicine, Houston, TX SHORTER and KOSTEN: Michael
E.
DeBakey Veterans Affairs Medical Center, Houston, TX.
FAU - Shorter, Daryl
AU - Shorter D
FAU - Kosten, Thomas R
AU - Kosten TR
LA - eng
GR - IK2 CX000946/CX/CSRD VA/United States
GR - P50 DA018197/DA/NIDA NIH HHS/United States
PT - Research Support, N.I.H., Extramural
PT - Research Support, U.S. Gov't, Non-P.H.S.
PT - Review
TA - J Psychiatr Pract
JT - Journal of psychiatric practice
JID - 100901141
RN - 0 (Narcotic Antagonists)
RN - 40D3SCR4GZ (Buprenorphine)
SB - IM
MH - Buprenorphine/*therapeutic use
MH - Drug Prescriptions/*standards
MH - Humans
MH - *Legislation, Medical
MH - Narcotic Antagonists/*therapeutic use
MH - Opioid-Related Disorders/*drug therapy
MH - United States
PMC - PMC4852384
MID - NIHMS772734
COIS- The authors have no relevant affiliations or financial involvement with any
organization or entity with a financial interest or financial conflict with
the
subject matter or materials discussed in the manuscript. This includes
employment, consultancies, honoraria, stock ownership or options, expert
testimony, grants or patents received or pending, or royalties. Dr. Li
declares
no conflicts of interest.
EDAT- 2016/04/29 06:00
MHDA- 2017/09/25 06:00
CRDT- 2016/04/29 06:00
PHST- 2016/04/29 06:00 [entrez]
PHST- 2016/04/29 06:00 [pubmed]
PHST- 2017/09/25 06:00 [medline]
AID - 00131746-201605000-00004 [pii]
AID - 10.1097/PRA.0000000000000154 [doi]
PST - ppublish
SO - J Psychiatr Pract. 2016 May;22(3):183-92. doi: 10.1097/PRA.0000000000000154.
PMID- 31874070
OWN - NLM
STAT- MEDLINE
DCOM- 20210419
LR - 20210419
IS - 0163-7525 (Linking)
VI - 41
DP - 2020 Apr 2
TI - Comparative Approaches to Drug Pricing.
PG - 499-512
LID - 10.1146/annurev-publhealth-040119-094305 [doi]
AB - The United States relies primarily on market forces to determine prices for
drugs, whereas most other industrialized countries use a variety of
approaches to
determine drug prices. Branded drug companies have patents and market
exclusivity
periods in most industrialized countries. During this period, pharmaceutical
companies are allowed to set their list price as high as they prefer in the
United States owing to the absence of government price control mechanisms
that
exist in other countries. Insured patients often pay a percentage of the list
price, and cost sharing creates some pressure to lower the list price.
Pharmacy
benefit managers negotiate with drug companies for lower prices by offering
the
drug company favorable formulary placement and fewer utilization controls.
However, these approaches appear to be less effective, compared with other
countries' approaches to containing branded drug prices, because prices are
substantially higher in the United States. Other industrialized countries
employ
various forms of rate setting and price regulation, such as external
reference
pricing, therapeutic valuation, and health technology assessment to determine
the
appropriate price.
FAU - Kang, So-Yeon
AU - Kang SY
AD - Bloomberg School of Public Health, Johns Hopkins University, Baltimore,
Maryland
21205, USA; email: skang57@jhu.edu, gbai@jhu.edu, mdistef1@jhu.edu,
msocal1@jhu.edu, fyehia1@jhmi.edu, ganderson@jhu.edu.
FAU - Bai, Ge
AU - Bai G
Maryland
AD - Carey Business School, Johns Hopkins University, Baltimore, Maryland 21202,
USA.
FAU - DiStefano, Michael J
AU - DiStefano MJ
Maryland
FAU - Socal, Mariana P
AU - Socal MP
Maryland
FAU - Yehia, Farah
AU - Yehia F
Maryland
FAU - Anderson, Gerard F
AU - Anderson GF
Maryland
AD - School of Medicine, Johns Hopkins University, Baltimore, Maryland 21205, USA.
LA - eng
PT - Comparative Study
PT - Review
DEP - 20191224
PL - United States
TA - Annu Rev Public Health
JT - Annual review of public health
JID - 8006431
SB - IM
MH - Drug Costs/*legislation & jurisprudence/*statistics & numerical data
MH - Economics, Pharmaceutical/*legislation & jurisprudence/*statistics &
numerical
data
MH - Humans
MH - *Legislation, Drug
MH - United States
OTO - NOTNLM
OT - ability to pay
OT - access to pharmaceuticals
OT - drug innovation
OT - drug prices
OT - external reference prices
EDAT- 2019/12/25 06:00
MHDA- 2021/04/20 06:00
CRDT- 2019/12/25 06:00
PHST- 2019/12/25 06:00 [pubmed]
PHST- 2021/04/20 06:00 [medline]
PHST- 2019/12/25 06:00 [entrez]
AID - 10.1146/annurev-publhealth-040119-094305 [doi]
PST - ppublish
SO - Annu Rev Public Health. 2020 Apr 2;41:499-512. doi:
10.1146/annurev-publhealth-040119-094305. Epub 2019 Dec 24.
PMID- 30051225
OWN - NLM
STAT- MEDLINE
DCOM- 20181211
LR - 20210216
VI - 40
IP - 4
DP - 2018 Aug
TI - Pharmacovigilance in China: development and challenges.
PG - 823-831
LID - 10.1007/s11096-018-0693-x [doi]
AB - Background Rational drug use and drug safety are becoming increasingly
important
concerns in China with the increasing public access to drugs and the health-
care
system, and this has led to the development of pharmacovigilance in China.
Aim of
the review To provide a brief introduction about pharmacovigilance in China
in
terms of system development, utilization and challenges. Method Relevant
studies
on pharmacovigilance related to the study aim was undertaken through
literature
search to synthesize the extracted data. Results The creation and evolvement
of
China's pharmacovigilance system spans across 30 years since 1989. The system
consists of four progressing administrative layers: county, municipal,
provincial
and national levels. China has passed over 20 laws and regulations related to
pharmacovigilance covering the processes of drug development, manufacture,
distribution and use with the aim to guard drug safety. An online spontaneous
self-reporting Adverse Drug Reaction (ADR) Monitoring System was established
in
2003. ADRs are mainly reported by medical institutions, pharmaceutical
manufacturers, and drug distributors. Currently there is no mandatory ADR
reporting requirement for pharmaceutical manufacturers, and a proposed
regulation
under public comment will likely change this. China has started to build
active
pharmacovigilance surveillance programs in addition to the passive ADR
reporting
system. The China Food and Drug Administration has established the intensive
Safety Monitoring Program and the National Adverse Drug Reaction Monitoring
Sentinel Alliance Program based on electronic health records to further the
efforts of ADR reporting, monitoring and analysis. Conclusion The practice of
ADR
monitoring and pharmacovigilance in China have made great progress. More
efforts
are needed both in system building, and creation of laws and regulations to
strengthen the safe use of medicines.
FAU - Zhao, Ying
AU - Zhao Y
AD - Department of Pharmacy, Beijing Friendship Hospital, Capital Medical
University,
Beijing, China.
AD - Department of Pharmacy, Beijing Shijitan Hospital, Capital Medical
University,
Beijing, China.
FAU - Wang, Tiansheng
AU - Wang T
AD - Department of Epidemiology, University of North Carolina, Chapel Hill, NC,
USA.
FAU - Li, Guangyao
AU - Li G
AD - Department of Pharmacy, Beijing Shijitan Hospital, Capital Medical
University,
Beijing, China.
AD - School of Pharmaceutical Sciences, Peking University, Beijing, China.
FAU - Sun, Shusen
AU - Sun S
AUID- ORCID: 0000-0001-9014-7329
AD - College of Pharmacy and Health Sciences, Western New England University,
Springfield, MA, USA. ssun@wne.edu.
LA - eng
PT - Review
DEP - 20180726
PL - Netherlands
TA - Int J Clin Pharm
JT - International journal of clinical pharmacy
JID - 101554912
SB - IM
MH - *Adverse Drug Reaction Reporting Systems/legislation &
jurisprudence/organization
& administration
MH - China/epidemiology
MH - *Drug and Narcotic Control/legislation & jurisprudence/organization &
administration
MH - Drug-Related Side Effects and Adverse
Reactions/diagnosis/*epidemiology/prevention & control
MH - Government Regulation
MH - Humans
MH - Patient Safety
MH - *Pharmacovigilance
MH - Policy Making
MH - Program Evaluation
MH - Risk Assessment
MH - Risk Factors
OTO - NOTNLM
OT - Adverse drug reactions
OT - China
OT - Drug safety
OT - Pharmacovigilance
OT - Post-marketing monitoring
EDAT- 2018/07/28 06:00
MHDA- 2018/12/12 06:00
CRDT- 2018/07/28 06:00
PHST- 2018/01/13 00:00 [received]
PHST- 2018/07/12 00:00 [accepted]
PHST- 2018/07/28 06:00 [pubmed]
PHST- 2018/12/12 06:00 [medline]
PHST- 2018/07/28 06:00 [entrez]
AID - 10.1007/s11096-018-0693-x [pii]
AID - 10.1007/s11096-018-0693-x [doi]
PST - ppublish
SO - Int J Clin Pharm. 2018 Aug;40(4):823-831. doi: 10.1007/s11096-018-0693-x.
Epub
2018 Jul 26.
PMID- 26677894
OWN - NLM
STAT- MEDLINE
DCOM- 20160928
LR - 20220321
IS - 1330-0075 (Linking)
VI - 65
IP - 4
DP - 2015 Dec
TI - Practice implications and recommendations for managing codeine misuse and
dependence.
PG - 351-64
LID - /j/acph.2015.65.issue-4/acph-2015-0040/acph-2015-0040.xml [pii]
LID - 10.1515/acph-2015-0040 [doi]
AB - Codeine, a weak opiate, requires increased pharmacovigilance relating to
availability, heterogeneous nature of misuse, dependence and associated harm.
A
scoping review of literature on codeine was conducted using Arksey &
O'Malley's
framework (1). Databases searched included PubMed, EBSCO Host, Science
Direct,
EMBASE, PsycINFO, Cochrane library and Medline from 1994 to 2014. Follow-up
search strategies involved hand searching and searching of pharmaceutical,
health, medical and drug related websites. Initial zscreening identified
3,105
articles with 475 meeting the inclusion criteria. Eight broad categories
organised the literature, data charting and qualitative synthesis. This paper
presents implications for practice and makes recommendations to address these
issues. Themes identified relate to raising public and practitioner
awareness,
risk management, dispensing practices and monitoring and surveillance of
codeine.
Evidence to inform law enforcement, drug surveillance, public health
initiatives,
harm reduction approaches, pharmacy, clinical and treatment practices is
warranted.
FAU - Bergin, Michael
AU - Bergin M
FAU - Norman, Ian
AU - Norman I
FAU - Foley, Michelle
AU - Foley M
FAU - Harris, Richard
AU - Harris R
FAU - Rapca, Anna
AU - Rapca A
FAU - Rich, Eileen
AU - Rich E
FAU - Van Hout, Marie-Claire
AU - Van Hout MC
LA - eng
PT - Review
PL - Poland
TA - Acta Pharm
JT - Acta pharmaceutica (Zagreb, Croatia)
JID - 9303678
RN - 0 (Nonprescription Drugs)
RN - UX6OWY2V7J (Codeine)
SB - IM
MH - Analgesics, Opioid/*adverse effects
MH - Attitude of Health Personnel
MH - Codeine/*adverse effects
MH - Drug and Narcotic Control
MH - Health Policy
MH - Humans
MH - Nonprescription Drugs/*adverse effects
MH - Opioid-Related Disorders/diagnosis/epidemiology/*therapy
MH - Physician's Role
MH - Practice Guidelines as Topic
MH - *Practice Patterns, Physicians'/legislation & jurisprudence/standards
MH - Risk Assessment
MH - Risk Factors
MH - Substance Abuse Detection
EDAT- 2015/12/19 06:00
MHDA- 2016/09/30 06:00
CRDT- 2015/12/19 06:00
PHST- 2015/10/14 00:00 [accepted]
PHST- 2015/12/19 06:00 [entrez]
PHST- 2015/12/19 06:00 [pubmed]
PHST- 2016/09/30 06:00 [medline]
AID - /j/acph.2015.65.issue-4/acph-2015-0040/acph-2015-0040.xml [pii]
AID - 10.1515/acph-2015-0040 [doi]
PST - ppublish
SO - Acta Pharm. 2015 Dec;65(4):351-64. doi: 10.1515/acph-2015-0040.
PMID- 30236900
OWN - NLM
STAT- MEDLINE
DCOM- 20181005
LR - 20191210
IS - 0011-5029 (Linking)
VI - 64
IP - 10
DP - 2018 Oct
TI - Perspectives on the opioid crisis from pain medicine clinicians.
PG - 451-466
LID - S0011-5029(18)30108-1 [pii]
LID - 10.1016/j.disamonth.2018.07.002 [doi]
AB - Patients experiencing a terminal drug related event reflect a sentinel event.
If
this pharmacotherapy is a widely used agent, it may be viewed as a
catastrophic
problem. If patients are dying from illegal drug use when the medical
establishment fails them by withdrawing or minimizing their medically
prescribed
medication, then the burden rests with their health care providers,
legislation,
and insurance carriers to actively participate in a collegial fashion to
achieve
parity. Causing a decay in functionality in previously functional patients,
may
occur with appropriately prescribed opioid medications addressing non-cancer
pain
when withdrawing or diminishing either with or without patient consent. The
members of the medical profession have diminished their prescribing of
opioids
for their patients out of apparent fear of reprisal, state or federal
government
sanctions, and other concerned groups. Diminishing former dosages or deleting
the
opioid medication, preferably in concert with the patient, often results in
inequitable patient care. Enforcing sanctioned decreases or ceasing to
prescribe
from their former required/established opioid medications precipitate patient
discord. In absence of opioid misuse, abuse, diversion or addiction based
upon
medical "guidelines" and with a poor foundation of Evidence Based Medicine
the
CDC guidelines, it may be masked as a true guideline reflecting a decrement
of
clinical judgment, wisdom, and compassion. This article also discusses the
role
of pharmacy chains, insurance carriers, and their pharmacy benefit managers
(PBMs) contribution to this multidimensional problem. There may be a
potential
solution, identified in this paper, if all the associated political, medical
and
insurance groups work cohesively to improve patient care. This article and
the
CDC guidelines are not focused at hospice, palliative, end of life care pain
management.
CI - Copyright © 2018. Published by Elsevier Inc.
FAU - Jay, Gary W
AU - Jay GW
AD - Clinical Professor, Department of Neurology, University of North Carolina,
United
States.
FAU - Barkin, Robert L
AU - Barkin RL
AD - Professor, Rush University Medical College, Departments of Anesthesiology,
Family
Medicine, Pharmacology, Clinical Pharmacologist Department of Anesthesiology,
Pain Centers of Skokie and Evanston Hospitals, NorthShore University Health
System, IL, United States. Electronic address: rbarkin@rush.edu.
LA - eng
PT - Review
DEP - 20180918
PL - United States
TA - Dis Mon
JT - Disease-a-month : DM
JID - 0370657
RN - 0 (Analgesics)
SB - IM
MH - Analgesics/*adverse effects/therapeutic use
MH - Analgesics, Opioid/*adverse effects/therapeutic use
MH - Centers for Disease Control and Prevention, U.S./*legislation &
jurisprudence/organization & administration
MH - Drug Industry/economics
MH - Drug Misuse/mortality/statistics & numerical data
MH - Drug Overdose/epidemiology/mortality
MH - Evidence-Based Medicine/legislation & jurisprudence
MH - Female
MH - Health Personnel/legislation & jurisprudence
MH - Humans
MH - Insurance, Health/economics/legislation & jurisprudence/statistics &
numerical
data
MH - Male
MH - Opioid-Related Disorders/epidemiology/*mortality
MH - Practice Guidelines as Topic/standards
EDAT- 2018/09/22 06:00
MHDA- 2018/10/06 06:00
CRDT- 2018/09/22 06:00
PHST- 2018/09/22 06:00 [pubmed]
PHST- 2018/10/06 06:00 [medline]
PHST- 2018/09/22 06:00 [entrez]
AID - S0011-5029(18)30108-1 [pii]
AID - 10.1016/j.disamonth.2018.07.002 [doi]
PST - ppublish
SO - Dis Mon. 2018 Oct;64(10):451-466. doi: 10.1016/j.disamonth.2018.07.002. Epub
2018
Sep 18.
PMID- 32635876
OWN - NLM
STAT- MEDLINE
DCOM- 20210618
LR - 20210618
IS - 1462-2416 (Linking)
VI - 21
IP - 11
DP - 2020 Jul
TI - PARC report: a perspective on the state of clinical pharmacogenomics testing.
PG - 809-820
LID - 10.2217/pgs-2019-0193 [doi]
AB - In this Perspective, the authors discuss the state of pharmacogenomics
testing
addressing a number of advances, challenges and barriers, including legal
ramifications, changes to the regulatory landscape, coverage of testing and
the
implications of direct-to-consumer genetic testing on the provision of care
to
patients. Patient attitudes toward pharmacogenomics testing and associated
costs
will play an increasingly important role in test acquisition and subsequent
utilization in a clinical setting. Additional key steps needed include:
further
research trials demonstrating clinical utility and cost-effectiveness of
pharmacogenetic testing, evidence review to better integrate genomic
information
into clinical practice guidelines in target therapeutic areas to help
providers
identify patients that may benefit from pharmacogenetic testing and
engagement
with payers to create a path to reimbursement for pharmacogenetic tests that
currently have sufficient evidence of clinical utility. Increased adoption of
testing by payers and improved reimbursement practices will be needed to
overcome
barriers, especially as the healthcare landscape continues to shift toward a
system of value-based care.
FAU - Eichmeyer, Jennifer
AU - Eichmeyer J
AD - School of Allied Health Sciences, Boise State University, Boise, ID 83725,
USA.
FAU - Rogers, Sara
AU - Rogers S
AUID- ORCID: 0000-0002-9851-4151
AD - American Society of Pharmacovigilance, Houston, TX 77225, USA.
FAU - Formea, Christine M
AU - Formea CM
AD - Department of Pharmacy Services, Intermountain Healthcare, Salt Lake City,
UT 84123, USA.
AD - Center for Individualized Medicine, Mayo Clinic, Rochester, MN 55905, USA.
FAU - Giri, Jyothsna
AU - Giri J
AD - Center for Individualized Medicine, Mayo Clinic, Rochester, MN 55905, USA.
FAU - Jones, J Shawn
AU - Jones JS
AD - Department of Pharmaceutical Sciences, School of Pharmacy, Texas Tech
University
Health Sciences Center, Dallas, TX 75216, USA.
FAU - Schnettler, Erica
AU - Schnettler E
AD - OneOme, LLC, Minneapolis, MN 55413, USA.
FAU - Schmidlen, Tara
AU - Schmidlen T
AD - Genomic Medicine Institute, Geisinger, Danville, PA 17822, USA.
FAU - Glogowski, Emily
AU - Glogowski E
AD - GeneDx, Gaithersburg, MD 20877, USA.
FAU - Kurz, Raluca N
AU - Kurz RN
AD - Department of Health Policy and Management, Fielding School of Public Health,
University of California, Los Angeles, CA 90095, USA.
LA - eng
PT - Review
DEP - 20200708
PL - England
TA - Pharmacogenomics
JT - Pharmacogenomics
JID - 100897350
SB - IM
MH - Cost-Benefit Analysis/economics/legislation & jurisprudence
MH - Direct-To-Consumer Screening and Testing/*economics/*legislation &
jurisprudence
MH - Drug Labeling/economics/legislation & jurisprudence
MH - Humans
MH - Malpractice/economics/legislation & jurisprudence
MH - Pharmacogenomic Testing/*economics/*legislation & jurisprudence
MH - Precision Medicine/*economics
OTO - NOTNLM
OT - direct-to-consumer testing
OT - genetic testing
OT - liability
OT - malpractice
OT - patient access
OT - payers
OT - personalized medicine
OT - pharmacogenetics
OT - pharmacogenomics
OT - reimbursement
EDAT- 2020/07/09 06:00
MHDA- 2021/06/22 06:00
CRDT- 2020/07/09 06:00
PHST- 2020/07/09 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2020/07/09 06:00 [entrez]
AID - 10.2217/pgs-2019-0193 [doi]
PST - ppublish
SO - Pharmacogenomics. 2020 Jul;21(11):809-820. doi: 10.2217/pgs-2019-0193. Epub
2020
Jul 8.
PMID- 34521258
OWN - NLM
STAT- MEDLINE
DCOM- 20220210
LR - 20220902
IS - 1462-2416 (Print)
IS - 1462-2416 (Linking)
VI - 22
IP - 14
DP - 2021 Sep
TI - Engaging pharmacogenomics in pain management and opioid selection.
PG - 927-937
LID - 10.2217/pgs-2021-0044 [doi]
AB - Opioid misuse and mismanagement has been a public health crisis for several
years. Pharmacogenomics (PGx) has been proposed as another tool to enhance
opioid
selection and optimization, with recent studies demonstrating successful
implementation and outcomes. However, broad engagement with PGx for opioid
management is presently limited. The purpose of this article is to highlight
a
series of barriers to PGx implementation within the specific context of
opioid
management. Areas of advancement needed for more robust pharmacogenomic
engagement with opioids will be discussed, including clinical and economic
research needs, education and training needs, policy and public health
considerations, as well as legal and ethical issues. Continuing efforts to
address these issues may help to further operationalize PGx toward improving
opioid use.
FAU - Bright, David R
AU - Bright DR
AUID- ORCID: 0000-0002-2674-3705
AD - Department of Pharmaceutical Sciences, Ferris State University College of
Pharmacy, 220 Ferris Dr, Big Rapids, MI 49307, USA.
FAU - Petry, Natasha
AU - Petry N
AUID- ORCID: 0000-0001-5089-9286
AD - Department of Pharmacy Practice, College of Health Professions, North Dakota
State University, PO Box 6050, Fargo, ND 58108, USA.
AD - Sanford Imagenetics, 1321 W 22nd St, Sioux Falls, SD 57105, USA.
FAU - Roath, Eric
AU - Roath E
AD - SpartanNash, 1550 Gezon Parkway, Wyoming, MI 49509, USA.
FAU - Gibb, Tyler
AU - Gibb T
AD - Department of Medical Ethics, Humanities, & Law, Homer Stryker MD School of
Medicine, Western Michigan University, 1000 Oakland Drive, Kalamazoo, MI
49008,
USA.
LA - eng
PT - Research Support, N.I.H., Extramural
PT - Review
DEP - 20210915
TA - Pharmacogenomics
JT - Pharmacogenomics
JID - 100897350
SB - IM
MH - Analgesics, Opioid/*administration & dosage/adverse effects
MH - Humans
MH - Opioid-Related Disorders/epidemiology/*prevention & control
MH - Pain/drug therapy/epidemiology
MH - Pain Management/ethics/*standards
MH - Pharmacogenetics/methods/*standards
MH - Practice Guidelines as Topic/*standards
MH - Public Health Practice/ethics/legislation & jurisprudence/*standards
PMC - PMC8656342
OTO - NOTNLM
OT - opioids
OT - pain
OT - pain management
OT - pharmacogenetics
OT - pharmacogenomics
COIS- Financial & competing interests disclosure D Bright has conducted funded
research
with commercial pharmacogenetics companies and has a patent pending. N Petry
is a
co-investigator for RFA-HG-17-008 (PI: J Peterson/site PI: RA Wilke), an
NIH/NHGRI Administrative Supplement: A Depression and Opioid Pragmatic Trial
(ADOPT-PGx), which looks at gene-based dosing vs. standard of care for
post-operative opioids. The authors have no other relevant affiliations or
financial involvement with any organization or entity with a financial
interest
in or financial conflict with the subject matter or materials discussed in
the
manuscript apart from those disclosed. No writing assistance was utilized in
the
production of this manuscript.
EDAT- 2021/09/16 06:00
MHDA- 2022/02/11 06:00
CRDT- 2021/09/15 05:37
PHST- 2021/09/16 06:00 [pubmed]
PHST- 2022/02/11 06:00 [medline]
PHST- 2021/09/15 05:37 [entrez]
AID - 10.2217/pgs-2021-0044 [doi]
PST - ppublish
SO - Pharmacogenomics. 2021 Sep;22(14):927-937. doi: 10.2217/pgs-2021-0044. Epub
2021
Sep 15.
PMID- 30439632
OWN - NLM
STAT- MEDLINE
DCOM- 20190128
LR - 20190128
IS - 2212-1099 (Linking)
VI - 17
DP - 2018 Dec
TI - Drug Utilization Studies in Latin America: A Scoping Review and Survey of
Ethical
Requirements.
PG - 189-193
LID - S2212-1099(18)30233-4 [pii]
LID - 10.1016/j.vhri.2018.09.003 [doi]
AB - BACKGROUND: Drug utilization studies (DUSs) are increasingly being conducted
in
Latin America, especially in countries with a universal healthcare coverage,
to
inform policies and decision making. The need for an ethical framework
specific
to DUSs in Latin America has been recognized. OBJECTIVES: To describe the
ethical
and/or legal requirements applicable to DUSs in Latin American countries with
universal healthcare coverage. METHODS: We conducted a nonsystematic scoping
review on DUSs in this region, covering the period from January 1, 2012, to
July
1, 2017, and reviewed legislations and data protection requirements in each
country. We also surveyed 45 ethics committees and 22 key informants to
determine
specific ethical requirements for various types of DUSs differing in data
collection methods, study populations, and settings. RESULTS: Local
legislations
on DUSs are highly heterogeneous across Latin America. In Chile and
Guatemala,
authorization from the national health authority must be obtained for
accessing
clinical records, whereas in Argentina, no authorization is required for the
secondary use of existing data. In Argentina, Brazil, Costa Rica, Guatemala,
and
Peru, a national ethics committee approval is required in addition to a
site-specific approval. Requirements for patient informed consent also vary
across countries and depend on the type of DUS and study population.
CONCLUSIONS:
The lack of consensus in the legislative and ethical frameworks applicable to
DUSs across Latin America leads to operational challenges for the
implementation
of multinational studies. In many countries, absence of a framework leads to
precautionary stringent requirements, which restricts the feasibility of
DUSs.
CI - Copyright © 2018 International Society for Pharmacoeconomics and Outcomes
Research (ISPOR). Published by Elsevier Inc. All rights reserved.
FAU - Bergamasco, Aurore
AU - Bergamasco A
AD - YOLARX Consultants, Paris, France.
FAU -
Arredondo Bisono, Teigna
AU -
Arredondo Bisono T
AD -
YOLARX Consultants, Paris, France.
FAU -
Castillon, Genaro
AU -
Castillon G
AD -
YOLARX Consultants, Montreal, QC, Canada.
FAU -
Moride, Yola
AU -
Moride Y
AD -
YOLARX Consultants, Paris, France; YOLARX Consultants, Montreal, QC, Canada;
Faculty of Pharmacy, University of Montreal, Montreal, QC, Canada. Electronic
address: yola.moride@umontreal.ca.
LA - eng
PT - Review
DEP - 20181112
PL - United States
TA - Value Health Reg Issues
JT - Value in health regional issues
JID - 101592642
SB - IM
MH - Drug Utilization/*ethics/*standards
MH - Humans
MH - Latin America/epidemiology
MH - Research Design/*standards
MH - Surveys and Questionnaires
MH - *Universal Health Insurance
OTO - NOTNLM
OT - drug utilization studies
OT - epidemiology
OT - ethical requirements
OT - ethics
OT - government regulation
OT - legislation
OT - policy
OT - real-world studies
EDAT- 2018/11/16 06:00
MHDA- 2019/01/29 06:00
CRDT- 2018/11/16 06:00
PHST- 2018/04/27 00:00 [received]
PHST- 2018/08/08 00:00 [revised]
PHST- 2018/09/05 00:00 [accepted]
PHST- 2018/11/16 06:00 [pubmed]
PHST- 2019/01/29 06:00 [medline]
PHST- 2018/11/16 06:00 [entrez]
AID - S2212-1099(18)30233-4 [pii]
AID - 10.1016/j.vhri.2018.09.003 [doi]
PST - ppublish
SO - Value Health Reg Issues. 2018 Dec;17:189-193. doi:
10.1016/j.vhri.2018.09.003.
Epub 2018 Nov 12.
PMID- 28925019
OWN - NLM
STAT- MEDLINE
DCOM- 20190401
LR - 20210109
IS - 0306-5251 (Print)
IS - 0306-5251 (Linking)
VI - 84
IP - 2
DP - 2018 Feb
TI - Inclusion of pregnant and breastfeeding women in research - efforts and
initiatives.
PG - 215-222
LID - 10.1111/bcp.13438 [doi]
AB - Pregnant and breastfeeding women have been rendered therapeutic orphans as
they
have been historically excluded from clinical trials. Labelling for most
approved
drugs does not provide information about safety and efficacy during
pregnancy.
This lack of data is mainly due to ethico-legal challenges that have remained
entrenched in the post-diethylstilbestrol and thalidomide era, and that have
led
to pregnancy being viewed in the clinical trial setting primarily through a
pharmacovigilance lens. Policy considerations that encourage and/or require
the
inclusion of pregnant or lactating women in clinical trials may address the
current lack of available information. However, there are additional
pragmatic
strategies, such the employment of pharmacometric tools and the introduction
of
innovative clinical trial designs, which could improve knowledge about the
safety
and efficacy of medication use during pregnancy and lactation. This paper
provides a broad overview of the pharmacoepidemiology of drugs used during
pregnancy and lactation, and offers recommendations for regulators and
researchers in academia and industry to increase the available
pharmacokinetic
and -dynamic understanding of medication use in pregnancy.
CI - © 2017 The British Pharmacological Society.
FAU - Illamola, Sílvia M
AU - Illamola SM
AUID- ORCID: 0000-0003-3245-1626
AD - Division of Clinical Pharmacology, Department of Pediatrics, University of
Utah
School of Medicine, Salt Lake City, UT, USA.
FAU - Bucci-Rechtweg, Christina
AU - Bucci-Rechtweg C
AD - Pediatric & Maternal Health Policy, Global Drug Regulatory Affairs, Novartis
Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
FAU - Costantine, Maged M
AU - Costantine MM
AD - Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine,
University of Texas Medical Branch, Galveston, TX, USA.
FAU - Tsilou, Ekaterini
AU - Tsilou E
AD - Obstetric and Pediatric Pharmacology and Therapeutics Branch at the Eunice
Kennedy Shriver National Institute of Child Health and Human Development,
Bethesda, MD, USA.
FAU - Sherwin, Catherine M
AU - Sherwin CM
AUID- ORCID: 0000-0002-0844-3207
AD - Division of Clinical Pharmacology, Department of Pediatrics, University of
Utah
School of Medicine, Salt Lake City, UT, USA.
AD - Department of Pharmacotherapy, University of Utah College of Pharmacy, Salt
Lake
City, UT, USA.
FAU - Zajicek, Anne
AU - Zajicek A
AD - Obstetric and Pediatric Pharmacology and Therapeutics Branch at the Eunice
Kennedy Shriver National Institute of Child Health and Human Development,
Bethesda, MD, USA.
LA - eng
PT - Review
DEP - 20171022
TA - Br J Clin Pharmacol
JT - British journal of clinical pharmacology
JID - 7503323
RN - 0 (Pharmaceutical Preparations)
SB - IM
MH - Biomedical Research/legislation & jurisprudence/*methods
MH - *Breast Feeding
MH - Clinical Trials as Topic/legislation & jurisprudence/*methods
MH - Drug-Related Side Effects and Adverse Reactions/*epidemiology
MH - Female
MH - Government Regulation
MH - Guidelines as Topic
MH - Humans
MH - Pharmaceutical Preparations/*administration & dosage
MH - Pharmacoepidemiology
MH - Pregnancy
MH - Pregnancy Complications/*drug therapy
MH - United States
MH - United States Food and Drug Administration
PMC - PMC5777434
OTO - NOTNLM
OT - breastfeeding
OT - clinical pharmacology
OT - drug utilization
OT - obstetric
OT - pregnancy
EDAT- 2017/09/20 06:00
MHDA- 2019/04/02 06:00
CRDT- 2017/09/20 06:00
PHST- 2017/06/05 00:00 [received]
PHST- 2017/09/01 00:00 [revised]
PHST- 2017/09/09 00:00 [accepted]
PHST- 2017/09/20 06:00 [pubmed]
PHST- 2019/04/02 06:00 [medline]
PHST- 2017/09/20 06:00 [entrez]
AID - BCP13438 [pii]
AID - 10.1111/bcp.13438 [doi]
PST - ppublish
SO - Br J Clin Pharmacol. 2018 Feb;84(2):215-222. doi: 10.1111/bcp.13438. Epub
2017
Oct 22.
PMID- 33751478
OWN - NLM
STAT- MEDLINE
DCOM- 20211020
LR - 20211123
IS - 1878-7649 (Print)
IS - 1878-7649 (Linking)
VI - 12
IP - 3
DP - 2021 Jun
TI - Interventions to optimize medication use in nursing homes: a narrative
review.
PG - 551-567
LID - 10.1007/s41999-021-00477-5 [doi]
AB - PURPOSE: Polypharmacy, medication errors and adverse drug events are frequent
among nursing home residents. Errors can occur at any step of the medication
use
process. We aimed to review interventions aiming at optimization of any step
of
medication use in nursing homes. METHODS: We narratively reviewed
quantitative as
well as qualitative studies, observational and experimental studies that
described interventions, their effects as well as barriers and enablers to
implementation. We prioritized recent studies with relevant findings for the
European setting. RESULTS: Many interventions led to improvements in
medication
use. However, because of outcome heterogeneity, comparison between
interventions
was difficult. Prescribing was the most studied aspect of medication use. At
the
micro-level, medication review, multidisciplinary work, and more recently,
patient-centered care components dominated. At the macro-level, guidelines
and
legislation, mainly for specific medication classes (e.g., antipsychotics)
were
employed. Utilization of technology also helped improve medication
administration. Several barriers and enablers were reported, at individual,
organizational, and system levels. CONCLUSION: Overall, existing
interventions
are effective in optimizing medication use. However there is a need for
further
European well-designed and large-scale evaluations of under-researched
intervention components (e.g., health information technology, patient-
centered
approaches), specific medication classes (e.g., antithrombotic agents), and
interventions targeting medication use aspects other than prescribing (e.g.,
monitoring). Further development and uptake of core outcome sets is required.
Finally, qualitative studies on barriers and enablers for intervention
implementation would enable theory-driven intervention design.
FAU - Spinewine, Anne
AU - Spinewine A
AUID- ORCID: 0000-0002-3836-2846
AD - Clinical Pharmacy Research Group, Louvain Drug Research Institute, Université
Catholique de Louvain, Avenue Mounier 72/B1.72.02, Woluwe-Saint-Lambert,
1200,
Brussels, Belgium. anne.spinewine@uclouvain.be.
AD - Pharmacy Department, CHU UCL Namur, Université Catholique de Louvain, Yvoir,
Belgium. anne.spinewine@uclouvain.be.
FAU - Evrard, Perrine
AU - Evrard P
AD - Clinical Pharmacy Research Group, Louvain Drug Research Institute, Université
Catholique de Louvain, Avenue Mounier 72/B1.72.02, Woluwe-Saint-Lambert,
1200,
Brussels, Belgium.
FAU - Hughes, Carmel
AU - Hughes C
AD - School of Pharmacy, Queen's University Belfast, Belfast, UK.
LA - eng
PT - Review
DEP - 20210309
TA - Eur Geriatr Med
JT - European geriatric medicine
JID - 101533694
RN - 0 (Antipsychotic Agents)
SB - IM
MH - *Antipsychotic Agents/therapeutic use
MH - *Drug-Related Side Effects and Adverse Reactions
MH - Humans
MH - Inappropriate Prescribing
MH - Nursing Homes
MH - Polypharmacy
PMC - PMC8149362
OTO - NOTNLM
OT - Implementation
OT - Interventions
OT - Medication optimization
OT - Nursing homes
OT - Older adults
OT - Potentially inappropriate prescriptions
COIS- The authors declare that they have no conflicts of interest.
EDAT- 2021/03/23 06:00
MHDA- 2021/10/21 06:00
CRDT- 2021/03/22 19:17
PHST- 2020/10/20 00:00 [received]
PHST- 2021/02/25 00:00 [accepted]
PHST- 2021/03/23 06:00 [pubmed]
PHST- 2021/10/21 06:00 [medline]
PHST- 2021/03/22 19:17 [entrez]
AID - 10.1007/s41999-021-00477-5 [pii]
AID - 477 [pii]
AID - 10.1007/s41999-021-00477-5 [doi]
PST - ppublish
SO - Eur Geriatr Med. 2021 Jun;12(3):551-567. doi: 10.1007/s41999-021-00477-5.
Epub
2021 Mar 9.
PMID- 30333932
OWN - NLM
STAT- PubMed-not-MEDLINE
LR - 20200929
IS - 2150-0878 (Print)
IS - 2150-0878 (Linking)
VI - 8
IP - 7
DP - 2017 Nov-Dec
TI - Integrating Biosimilars Into Oncology Practice: Implications for the Advanced
Practitioner.
PG - 688-699
AB - Biosimilar agents are biologic products that have been shown to be "highly
similar" to an already approved reference biologic product. Their integration
into clinical practice has the potential to significantly decrease costs for
patients, health-care systems, and insurance companies. Through legislation,
the
US Food and Drug Administration (FDA) approved the Biologics Price
Competition
and Innovation (BCPI) Act in 2009. In 2010, it was signed into law, allowing
for
an abbreviated pathway for biosimilar approval. This law implemented a
framework
for development and regulation of biosimilars for manufacturers and provided
guidance for the key submission components necessary to achieve final FDA
approval. Many factors will influence how biosimilars are integrated into
health-care systems and oncology clinics. As biosimilar utilization in the
United
States expands beyond supportive care, unique challenges will emerge. Patient
and
staff education will be at the forefront of the successful application of
biosimilar agents in oncology, and advanced practitioners will be in a unique
position to lead change. The goal of this article is to describe the chemical
and
clinical nature of biosimilars, review focus areas of interest for biosimilar
development in oncology, discuss implementation strategies for biosimilars,
and
provide techniques for patient education on biosimilars.
FAU - Campen, Christopher J
AU - Campen CJ
AD - Greenville Health System Cancer Institute-Pharmacy, Greenville, South
Carolina.
LA - eng
PT - Review
DEP - 20171101
TA - J Adv Pract Oncol
JT - Journal of the advanced practitioner in oncology
JID - 101550346
PMC - PMC6188098
EDAT- 2018/10/20 06:00
MHDA- 2018/10/20 06:01
CRDT- 2018/10/19 06:00
PHST- 2018/10/19 06:00 [entrez]
PHST- 2018/10/20 06:00 [pubmed]
PHST- 2018/10/20 06:01 [medline]
PST - ppublish
SO - J Adv Pract Oncol. 2017 Nov-Dec;8(7):688-699. Epub 2017 Nov 1.
PMID- 25174015
OWN - NLM
STAT- MEDLINE
DCOM- 20151222
LR - 20220317
IS - 1079-2082 (Linking)
VI - 71
IP - 18
DP - 2014 Sep 15
TI - The opioid abuse and misuse epidemic: implications for pharmacists in
hospitals
and health systems.
PG - 1539-54
LID - 10.2146/ajhp140157 [doi]
AB - PURPOSE: The current epidemic of prescription opioid abuse and misuse in the
United States is discussed, with an emphasis on the pharmacist's role in
ensuring
safe and effective opioid use. SUMMARY: U.S. sales of prescription opioids
increased fourfold from 1999 to 2010, with an alarming rise in deaths and
emergency department visits associated with the use of fentanyl, hydrocodone,
oxycodone, and other opioid medications. Signs and symptoms of opioid
toxicity
may include altered mental status, hypoventilation, decreased bowel motility,
central nervous system and respiratory depression, peripheral vasodilation,
pulmonary edema, hypotension, bradycardia, and seizures. In patients
receiving
long-term opioid therapy for chronic pain, urine drug testing is an important
tool for monitoring and assessment of therapy; knowledge of opioid metabolic
pathways and assay limitations is essential for appropriate use and
interpretation of screening and confirmatory tests. In recent years, there
has
been an increase in federal enforcement actions against pharmacies and
prescription drug wholesalers involved in improper opioid distribution, as
well
as increased reliance on state-level prescription drug monitoring programs to
track patterns of opioid use and improper sales. Pharmacies are urged to
implement or promote appropriate guidelines on opioid therapy, including the
use
of pain management agreement plans; policies to ensure adequate oversight of
opioid prescribing, dispensing, and waste disposal; and educational
initiatives
targeting patients as well as hospital and pharmacy staff. CONCLUSION:
Pharmacists in hospitals and health systems can play a key role in
recognizing
the various forms of opioid toxicity and in preventing inappropriate
prescribing
and diversion of opioids.
CI - Copyright © 2014 by the American Society of Health-System Pharmacists, Inc.
All
rights reserved.
FAU - Cobaugh, Daniel J
AU - Cobaugh DJ
AD - Daniel J. Cobaugh, Pharm.D., DABAT, FAACT, is Vice President, ASHP Research
and
Education Foundation, Bethesda, MD. Carl Gainor, J.D., Ph.D., is Clinical
Assistant Professor of Pharmaceutical Sciences, School of Pharmacy,
University of
Pittsburgh, Pittsburgh, PA. Cynthia L. Gaston, Pharm.D., BCPS, is Medication
Use
Policy Analyst, UW Health, Madison, WI. Tai C. Kwong, Ph.D., is Professor of
Pathology and Laboratory Medicine, University of Rochester School of Medicine
and
Dentistry, and Director, Hematology and Chemistry Labs, Strong Memorial
Hospital,
University of Rochester Medical Center, Rochester, NY. Barbarajean Magnani,
Ph.D., M.D., is Chair and Pathologist-in-Chief, Department of Pathology and
Laboratory Medicine, Tufts Medical Center, and Professor and Chair,
Department of
Anatomic and Clinical Pathology, Tufts University School of Medicine, Boston,
MA.
Mary Lynn McPherson, Pharm.D., BCPS, CPE, is Professor and Vice Chair,
Department
of Pharmacy Practice and Science, University of Maryland School of Pharmacy,
Baltimore. Jacob T. Painter, Pharm.D., M.B.A., Ph.D., is Assistant Professor
of
Pharmaceutical Evaluation and Policy, University of Arkansas for Medical
Sciences, Little Rock. Edward P. Krenzelok, Pharm.D., FAACT, FEAPCCT, DABAT,
is
Professor Emeritus, School of Pharmacy, University of Pittsburgh.
dcobaugh@ashp.org.
FAU - Gainor, Carl
AU - Gainor C
and
University of
Use
and
Hospital,
Department of
MA.
Department
of
is
FAU - Gaston, Cynthia L
AU - Gaston CL
and
University of
Use
and
Hospital,
Department of
MA.
Department
of
is
FAU - Kwong, Tai C
AU - Kwong TC
and
University of
Use
and
Hospital,
Department of
MA.
Department
of
is
FAU - Magnani, Barbarajean
AU - Magnani B
and
University of
Use
and
Hospital,
Department of
MA.
Department
of
is
FAU - McPherson, Mary Lynn
AU - McPherson ML
and
University of
Use
and
Hospital,
Department of
MA.
Department
of
is
FAU - Painter, Jacob T
AU - Painter JT
and
University of
Use
and
Hospital,
Department of
MA.
Department
of
is
FAU - Krenzelok, Edward P
AU - Krenzelok EP
and
University of
Use
and
Hospital,
Department of
MA.
Department
of
is
LA - eng
PT - Review
PL - England
TA - Am J Health Syst Pharm
JT - American journal of health-system pharmacy : AJHP : official journal of the
American Society of Health-System Pharmacists
JID - 9503023
SB - IM
CIN - Am J Health Syst Pharm. 2014 Sep 15;71(18):1537. PMID: 25174014
MH - Analgesics, Opioid/*adverse effects/therapeutic use/urine
MH - *Community Health Services
MH - Drug Monitoring
MH - Drug Overdose/*epidemiology
MH - Humans
MH - Opioid-Related Disorders/*epidemiology
MH - Pain Management
MH - Prescription Drug Misuse/*legislation & jurisprudence/*statistics & numerical
data
MH - Professional Role
MH - Substance Abuse Detection
EDAT- 2014/09/01 06:00
MHDA- 2015/12/23 06:00
CRDT- 2014/09/01 06:00
PHST- 2014/09/01 06:00 [entrez]
PHST- 2014/09/01 06:00 [pubmed]
PHST- 2015/12/23 06:00 [medline]
AID - 71/18/1539 [pii]
AID - 10.2146/ajhp140157 [doi]
PST - ppublish
SO - Am J Health Syst Pharm. 2014 Sep 15;71(18):1539-54. doi: 10.2146/ajhp140157.
PMID- 19952525
OWN - NLM
STAT- MEDLINE
DCOM- 20100225
LR - 20190724
IS - 0031-6903 (Print)
IS - 0031-6903 (Linking)
VI - 129
IP - 12
DP - 2009 Dec
TI - [Anti-doping reference for pharmacists].
PG - 1475-81
AB - In recent years, appropriate medication and guarantees of safety are being
sought
not only by medical circles but also by the world of sport. Under normal
circumstances, sport should be wholesome in both mind and body, but "doping"
by
the misuse and abuse of drugs and such is developing into a social issue.
This is
not just a result of the deliberate behavior of a certain number of people;
many
cases include use due to a lack of knowledge of drugs and doping, although
eventually the sanctions received are the same. Doping tends to be perceived
as
the problem of just a section of elite athletes, but since the introduction
of
doping control at the National Athletic Meet 2003, anti-doping measures
continue
to be a problem close at hand. In 2004, the World Anti-Doping Code came into
effect and subsequently not just the world of sport but various national
governments became deeply involved with anti-doping. Anti-doping guidelines
in
Japan were formulated by the Ministry of Education, Culture, Sports, Science
and
Technology in 2007, stipulating that doctors and pharmacists should be
proactive
in anti-doping activities. With the aim of eradicating doping, it was deemed
that
pharmacists can intervene by providing support regarding such issues as drug
enlightenment, consultation; the supply of drug information; database
production;
and therapeutic use exemption. It can be considered that pharmacists can
sufficiently use their knowledge and experience gained in these fields, and
that
such knowledge could lead to more appropriate drug use in sport.
FAU - Kasashi, Kumiko
AU - Kasashi K
AD - Department of Pharmacy, Hokkaido University Hospital, Sapporo, Japan.
kasashi@den.hokudai.ac.jp
LA - jpn
PT - English Abstract
PT - Review
PL - Japan
TA - Yakugaku Zasshi
JT - Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan
JID - 0413613
SB - IM
MH - Doping in Sports/legislation & jurisprudence/*prevention & control/trends
MH - Drug Information Services
MH - Drug Interactions
MH - Humans
MH - *Pharmacists
MH - *Professional Role
RF - 8
EDAT- 2009/12/03 06:00
MHDA- 2010/02/26 06:00
CRDT- 2009/12/03 06:00
PHST- 2009/12/03 06:00 [entrez]
PHST- 2009/12/03 06:00 [pubmed]
PHST- 2010/02/26 06:00 [medline]
AID - JST.JSTAGE/yakushi/129.1475 [pii]
AID - 10.1248/yakushi.129.1475 [doi]
PST - ppublish
SO - Yakugaku Zasshi. 2009 Dec;129(12):1475-81. doi: 10.1248/yakushi.129.1475.
PMID- 19371180
OWN - NLM
STAT- MEDLINE
DCOM- 20090812
LR - 20090417
IS - 1473-7167 (Linking)
VI - 9
IP - 1
DP - 2009 Feb
TI - Multifaceted national and regional drug reforms and initiatives in ambulatory
care in Sweden: global relevance.
PG - 65-83
LID - 10.1586/14737167.9.1.65 [doi]
AB - It is a continual challenge trying to improve the quality of prescribing
while
concurrently trying to address increasing pharmaceutical development,
utilization
and expenditure. National and regional reforms and initiatives in Sweden have
moderated growth in ambulatory drug expenditure to 2.7% per annum in recent
years
despite increasing volumes. National reforms include mandatory generic
substitution and value-based pricing alongside devolution of drug budgets to
the
regions. Regional initiatives include strengthening the role of the regional
Drug
and Therapeutic Committees, further budget devolution as well as strategies
incorporating prescribing guidance and monitoring coupled with financial
incentives. The extent and nature of the regional initiatives vary depending
on
their characteristics. In this article, we compare initiatives undertaken in
two
major counties, Stockholm and Ostergötland, and their outcomes. Outcomes
include
annual drug budget savings while achieving agreed quality as well as
increased
adherence to prescribing targets and guidance; the latter associated with
savings. Appraising these multifaceted reforms can provide guidance to other
countries and regions in view of their diversity. Future steps must
incorporate
measures to improve the utilization of new expensive drugs, which should
include
horizon scanning and forecasting activities as well as post-launch activities
involving monitoring of prescribing and registries. This may well require
cooperation with other European countries.
FAU - Godman, Brian
AU - Godman B
AD - Institute for Pharmacological Research Mario Negri, Milan, Italy.
godman@marionegri.it
FAU - Wettermark, Björn
AU - Wettermark B
FAU - Hoffmann, Mikael
AU - Hoffmann M
FAU - Andersson, Karolina
AU - Andersson K
FAU - Haycox, Alan
AU - Haycox A
FAU - Gustafsson, Lars L
AU - Gustafsson LL
LA - eng
PT - Review
PL - England
TA - Expert Rev Pharmacoecon Outcomes Res
JT - Expert review of pharmacoeconomics & outcomes research
JID - 101132257
RN - 0 (Drugs, Generic)
SB - IM
MH - Ambulatory Care/economics/*legislation & jurisprudence/*trends
MH - Budgets
MH - Cost Control/economics/*legislation & jurisprudence/*trends
MH - Drug Costs/legislation & jurisprudence/trends
MH - Drug Industry/education/legislation & jurisprudence
MH - Drug Prescriptions/*economics
MH - Drugs, Generic/economics
MH - Evidence-Based Medicine
MH - Health Care Reform/economics/*legislation & jurisprudence/*trends
MH - Health Expenditures
MH - Insurance, Health, Reimbursement
MH - Legislation, Drug/economics/trends
MH - Patient Education as Topic
MH - Pharmaceutical Preparations/standards
MH - Pharmacy and Therapeutics Committee
MH - Sweden
RF - 146
EDAT- 2009/04/18 09:00
MHDA- 2009/08/13 09:00
CRDT- 2009/04/18 09:00
PHST- 2009/04/18 09:00 [entrez]
PHST- 2009/04/18 09:00 [pubmed]
PHST- 2009/08/13 09:00 [medline]
AID - 10.1586/14737167.9.1.65 [doi]
PST - ppublish
SO - Expert Rev Pharmacoecon Outcomes Res. 2009 Feb;9(1):65-83. doi:
10.1586/14737167.9.1.65.
PMID- 15787955
OWN - NLM
STAT- MEDLINE
DCOM- 20050414
LR - 20181201
IS - 0887-378X (Print)
IS - 0887-378X (Linking)
VI - 83
IP - 1
DP - 2005
TI - Pharmacy utilization and the Medicare Modernization Act.
PG - 101-30
AB - To control expenditures and use medications appropriately, the Medicare drug
coverage program has established pharmacy utilization management (PUM)
measures.
This article assesses the effects of these strategies on the care of seniors.
The
literature suggests that although caps on drug benefits lower pharmaceutical
costs, they may also increase the use of other health care services and hurt
health outcomes. Our review raises concerns regarding the potential
unintended
effects of the Medicare drug program's PUM policies for beneficiaries.
Therefore,
the economic and clinical impact of PUM measures on seniors should be studied
further to help policymakers design better drug benefit plans.
FAU - Maio, Vittorio
AU - Maio V
AD - Department of Health Policy, Jefferson Medical College, Philadelphia, PA
19107,
USA. vittorio.maio@jefferson.edu
FAU - Pizzi, Laura
AU - Pizzi L
FAU - Roumm, Adam R
AU - Roumm AR
FAU - Clarke, Janice
AU - Clarke J
FAU - Goldfarb, Neil I
AU - Goldfarb NI
FAU - Nash, David B
AU - Nash DB
FAU - Chess, David
AU - Chess D
LA - eng
PT - Review
TA - Milbank Q
JT - The Milbank quarterly
JID - 8607003
SB - IM
CIN - Milbank Q. 2005;83(1):131-47. PMID: 15787956
MH - Aged
MH - Drug Prescriptions/economics
MH - Drug Utilization Review/legislation & jurisprudence
MH - Humans
MH - Insurance Benefits/legislation & jurisprudence
MH - Insurance Claim Review/*legislation & jurisprudence
MH - Insurance Coverage/legislation & jurisprudence
MH - Insurance, Pharmaceutical Services/*legislation & jurisprudence/statistics &
numerical data
MH - Medicare/economics/*legislation & jurisprudence/organization & administration
MH - Poverty/statistics & numerical data
MH - Privatization/economics/*legislation & jurisprudence/organization &
administration
MH - United States
PMC - PMC2690380
EDAT- 2005/03/25 09:00
MHDA- 2005/04/15 09:00
CRDT- 2005/03/25 09:00
PHST- 2005/03/25 09:00 [pubmed]
PHST- 2005/04/15 09:00 [medline]
PHST- 2005/03/25 09:00 [entrez]
AID - MILQ337 [pii]
AID - 10.1111/j.0887-378X.2005.00337.x [doi]
PST - ppublish
SO - Milbank Q. 2005;83(1):101-30. doi: 10.1111/j.0887-378X.2005.00337.x.
PMID- 21219120
OWN - NLM
STAT- MEDLINE
DCOM- 20110614
LR - 20110215
IS - 0300-7995 (Linking)
VI - 27
IP - 3
DP - 2011 Mar
TI - Generic drug approval: a US perspective.
PG - 541-5
LID - 10.1185/03007995.2010.548374 [doi]
AB - OBJECTIVE: Generic drugs are identical or bioequivalent versions of the brand
name drugs. They are the economic alternative of the costlier brand name
drugs.
This article presents a general overview of the procedure and regulatory
aspects
relating to generic drug approval in the US. METHODS: A computerized search
was
conducted to find literature on generic drug approval in the US. The
literature
was searched using the following key words: generic drug, brand name drug,
Hatch-Waxman Act, Medicare Act, NDA, ANDA, CTD and exclusivity. FINDINGS: The
search results were filtered for the literature describing and analyzing the
procedure and regulatory provisions for generic drug approval in the US.
After
the screening total 19 applicable literature remained. CONCLUSION: In the US
standardized procedures for the recognition of generic drugs have been laid
down
under the Drug Price Competition and Patent Term Restoration Act, 1984 (the
Hatch-Waxman Act). Provisions of this Act such as patent challenge, patent
term
extension and data exclusivity have created profound effects on the approval,
sale and distribution of the pharmaceuticals in the US. The Hatch-Waxman Act
is
an excellent piece of legislation that takes care of the rights of both the
brand
name and generic drug companies. This article presents only an overview of
generic drug approvals and for all practical purposes official resources
should
be referred.
FAU - Nagori, B P
AU - Nagori BP
AD - Lachoo Memorial College of Science and Technology (Pharmacy Wing), Jodhpur,
Rajasthan, India.
FAU - Mathur, V
AU - Mathur V
FAU - Garg, S
AU - Garg S
LA - eng
PT - Review
DEP - 20110110
PL - England
TA - Curr Med Res Opin
JT - Current medical research and opinion
JID - 0351014
RN - 0 (Drugs, Generic)
SB - IM
MH - Animals
MH - Chemistry, Pharmaceutical/*legislation & jurisprudence
MH - Drug Approval/legislation & jurisprudence/*methods/organization &
administration
MH - Drug Utilization Review/legislation & jurisprudence/methods/organization &
administration
MH - Drugs, Generic/*therapeutic use
MH - Humans
MH - Medicare/legislation & jurisprudence
MH - United States
MH - United States Food and Drug Administration/*legislation &
jurisprudence/organization & administration/trends
EDAT- 2011/01/12 06:00
MHDA- 2011/06/15 06:00
CRDT- 2011/01/12 06:00
PHST- 2011/01/12 06:00 [entrez]
PHST- 2011/01/12 06:00 [pubmed]
PHST- 2011/06/15 06:00 [medline]
AID - 10.1185/03007995.2010.548374 [doi]
PST - ppublish
SO - Curr Med Res Opin. 2011 Mar;27(3):541-5. doi: 10.1185/03007995.2010.548374.
Epub
2011 Jan 10.
PMID- 26178586
OWN - NLM
STAT- MEDLINE
DCOM- 20160212
LR - 20181202
IS - 0017-8748 (Linking)
VI - 55 Suppl 4
DP - 2015 Jul-Aug
TI - Triptans for Acute Migraine: Drug Class Review to Help Inform Policy
Decisions.
PG - 191-8
LID - 10.1111/head.12594 [doi]
AB - BACKGROUND/OBJECTIVE: In Ontario, triptans are publicly funded through the
Ontario Drug Benefit's Exceptional Access Program, a prior authorization
program.
However, it was unclear whether this listing aligned with current evidence of
safety and effectiveness for triptans in migraine. Using a comprehensive and
novel drug class review framework, we describe our review of triptans for the
management of acute migraine to evaluate the appropriateness of triptan
listing
on the public drug formulary in Ontario. METHODS: This supplement in Headache
highlights four key components of the triptan drug class review, including
findings from a qualitative analysis of patient and clinician perspectives, a
systematic review and network meta-analysis of clinical trial evidence, a
pharmacoepidemiologic analysis comparing utilization trends across Canada,
and a
reimbursement-based economic analysis. RESULTS: We found that triptans were
efficacious and safe for the treatment of acute migraine. However, Ontario
has
among the lowest rates of publically funded triptan use in Canada, which may
be
due to the highly restrictive nature of access to triptans in Ontario.
Expanding
access to triptans via a less restrictive listing (eg, Limited Use) would
potentially increase use by 20-fold, with increase in costs of approximately
220%. CONCLUSION: Based on findings from our multi-faceted review and after
stakeholder review and input from the Citizens' Panel, two policy options for
triptans were recommended for Ontario's publically funded drug program:
Limited
Use access or coverage via the Exceptional Access Program, both options
including
quantity limits of 12 units per month.
CI - © 2015 American Headache Society.
FAU - Knowles, Sandra
AU - Knowles S
AD - The Leslie Dan Faculty of Pharmacy, Toronto, Ontario, Canada.
AD - Keenan Research Centre of the Li Ka Shing Knowledge Institute, St. Michael's
Hospital, Toronto, Ontario, Canada.
FAU - Oh, Paul
AU - Oh P
AD - Toronto Rehabilitation Institute, University Health Network, Toronto,
Ontario,
Canada.
AD - Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Ontario,
Canada.
FAU - Gomes, Tara
AU - Gomes T
AD - Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada.
AD - Institute of Health Policy, Management, and Evaluation, Toronto, Ontario,
Canada.
AD - The Leslie Dan Faculty of Pharmacy, Toronto, Ontario, Canada.
AD - Keenan Research Centre of the Li Ka Shing Knowledge Institute, St. Michael's
Hospital, Toronto, Ontario, Canada.
CN - Ontario Drug Policy Research Network
LA - eng
PT - Review
PT - Systematic Review
DEP - 20150714
PL - United States
TA - Headache
JT - Headache
JID - 2985091R
RN - 0 (Tryptamines)
SB - IM
MH - Acute Disease
MH - Health Policy/*legislation & jurisprudence
MH - Humans
MH - Migraine Disorders/diagnosis/*drug therapy/*epidemiology
MH - Ontario/epidemiology
MH - Tryptamines/*therapeutic use
OTO - NOTNLM
OT - migraine
OT - public drug coverage
OT - triptan
EDAT- 2015/07/17 06:00
MHDA- 2016/02/13 06:00
CRDT- 2015/07/17 06:00
PHST- 2015/04/08 00:00 [accepted]
PHST- 2015/07/17 06:00 [entrez]
PHST- 2015/07/17 06:00 [pubmed]
PHST- 2016/02/13 06:00 [medline]
AID - 10.1111/head.12594 [doi]
PST - ppublish
SO - Headache. 2015 Jul-Aug;55 Suppl 4:191-8. doi: 10.1111/head.12594. Epub 2015
Jul
14.
PMID- 21332565
OWN - NLM
STAT- MEDLINE
DCOM- 20120514
LR - 20151119
IS - 0269-4727 (Linking)
VI - 37
IP - 1
DP - 2012 Feb
TI - The intended and unintended consequences of benzodiazepine monitoring
programmes:
a review of the literature.
PG - 7-21
LID - 10.1111/j.1365-2710.2011.01245.x [doi]
AB - WHAT IS KNOWN AND OBJECTIVE: Concern has been expressed regarding the
potential
over-prescription of benzodiazepines (BZDs) and their potential for misuse
and
abuse. Patterns of BZD use can be tracked by prescription monitoring
programmes
(PMPs). This study reviews the literature examining the impact of PMPs on the
use
of BZDs. METHODS: Studies published in English from January 1980 to April
2009
were identified though PubMed, EMBASE, IPA, CINHL and Web of Science using
MeSH
terms: 'Benzodiazepines' OR 'Benzodiazepines/supply and distribution' AND
('Social Control, Formal/legislation, jurisprudence'); Emtree terms: 'drug
control'/exp AND 'benzodiazepine derivative'/exp/mj. A broad search strategy
was
also used: benzodiazepines; triplicate prescription program; prescription
monitoring program; triplicate prescribing; and triplicate prescription
policy.
RESULTS AND DISCUSSION: This search identified 32 relevant articles that
addressed the impact of implementation of a PMP for BZDs in New York State in
1989. Overall, BZD prescribing declined following implementation, but the
decline
was not consistent across population groups. In particular, marginalized and
vulnerable populations, such as persons with chronic mental health disorders,
may
be disproportionately affected. WHAT IS NEW AND CONCLUSION: We provide a
critical
review of the impact of PMPs on the use of BZDs. PM decreases overall use of
BZDs, but may have unintended consequences that differentially impact certain
populations. Furthermore, research is warranted to understand better the
long-term costs and benefits.
CI - © 2011 Blackwell Publishing Ltd.
FAU - Fisher, J
AU - Fisher J
AD - College of Pharmacy, Dalhousie University, Halifax, NS, Canada.
judith.fisher@dal.ca
FAU - Sanyal, C
AU - Sanyal C
FAU - Frail, D
AU - Frail D
FAU - Sketris, I
AU - Sketris I
LA - eng
PT - Review
DEP - 20110217
PL - England
TA - J Clin Pharm Ther
JT - Journal of clinical pharmacy and therapeutics
JID - 8704308
RN - 12794-10-4 (Benzodiazepines)
SB - IM
MH - Benzodiazepines/adverse effects/*therapeutic use
MH - Drug Utilization
MH - Humans
MH - Mental Disorders/drug therapy/epidemiology
MH - New York
MH - Practice Patterns, Physicians'/*statistics & numerical data
MH - Substance-Related Disorders/*prevention & control
EDAT- 2011/02/22 06:00
MHDA- 2012/05/15 06:00
CRDT- 2011/02/22 06:00
PHST- 2011/02/22 06:00 [entrez]
PHST- 2011/02/22 06:00 [pubmed]
PHST- 2012/05/15 06:00 [medline]
AID - 10.1111/j.1365-2710.2011.01245.x [doi]
PST - ppublish
SO - J Clin Pharm Ther. 2012 Feb;37(1):7-21. doi: 10.1111/j.1365-
2710.2011.01245.x.
Epub 2011 Feb 17.
PMID- 24761815
OWN - NLM
STAT- MEDLINE
DCOM- 20150114
LR - 20140425
VI - 20
IP - 5
DP - 2014 May
TI - Assessing the present state and potential of Medicaid controlled substance
lock-in programs.
PG - 439-46c
AB - Nonmedical use of prescription medications--particularly controlled
substances--has risen dramatically in recent decades, resulting in alarming
increases in overdose-related health care utilization, costs, and mortality.
The
Centers for Disease Control and Prevention estimate that 80% of abused and
misused controlled substances originate as legal prescriptions. As such,
policymakers and payers have the opportunity to combat nonmedical use by
regulating controlled substance accessibility within legal prescribing and
dispensing processes. One common policy strategy is found in Medicaid
controlled
substance lock-in programs. Lock-in programs identify Medicaid beneficiaries
exhibiting high-risk controlled substance seeking behavior and "lock in"
these
patients to, typically, a single prescriber and pharmacy from which they may
obtain Medicaid-covered controlled substance prescriptions. Lock-in
restrictions
are intended to improve care coordination between providers, reduce
nonmedical
use behaviors, and limit Medicaid costs stemming from nonmedical use and
diversion. Peer-reviewed and gray literature have been examined to assess the
current prevalence and design of Medicaid lock-in programs, as well as the
current evidence base for informing appropriate program design and
understanding
program effectiveness. Forty-six state Medicaid agencies currently operate
lock-in programs. Program design varies widely between states in terms of
defining high-risk controlled substance use, the scope of actual lock-in
restrictions, and length of program enrollment. Additionally, there is a
remarkable dearth of peer-reviewed literature evaluating the design and
effectiveness of Medicaid lock-in programs. Nearly all outcomes evidence
stemmed
from publicly accessible internal Medicaid program evaluations, which largely
investigated cost savings to the state. Lock-in programs are highly prevalent
and
poised to play a meaningful role in curbing the prescription drug abuse
epidemic.
However, achieving these ends requires a concerted effort from the academic
and
policy communities to rigorously evaluate the effect of lock-in programs on
patient outcomes, determine optimal program design, and explore opportunities
to
enhance lock-in program impact through coordination with parallel controlled
substance policy efforts, namely prescription drug-monitoring programs.
FAU - Roberts, Andrew W
AU - Roberts AW
AD - UNC Eshelman School of Pharmacy, Campus Box 7573, Kerr Hall 2206, 301
Pharmacy
Ln., Chapel Hill, NC 27599. awroberts@unc.edu.
FAU - Skinner, Asheley Cockrell
AU - Skinner AC
LA - eng
PT - Review
PL - United States
TA - J Manag Care Spec Pharm
JT - Journal of managed care & specialty pharmacy
JID - 101644425
RN - 0 (Controlled Substances)
RN - 0 (Prescription Drugs)
SB - IM
MH - *Community Pharmacy Services/legislation & jurisprudence
MH - Controlled Substances/adverse effects/*supply & distribution
MH - *Delivery of Health Care/legislation & jurisprudence
MH - Drug and Narcotic Control
MH - *Drug-Seeking Behavior
MH - Health Policy
MH - Hospital Planning
MH - Humans
MH - *Medicaid/legislation & jurisprudence
MH - Prescription Drugs/adverse effects/*supply & distribution
MH - Program Evaluation
MH - Substance-Related Disorders/*prevention & control/psychology
MH - United States
EDAT- 2014/04/26 06:00
MHDA- 2015/01/15 06:00
CRDT- 2014/04/26 06:00
PHST- 2014/04/26 06:00 [entrez]
PHST- 2014/04/26 06:00 [pubmed]
PHST- 2015/01/15 06:00 [medline]
AID - 2014(20)5: 439-446 [pii]
AID - 10.18553/jmcp.2014.20.5.439 [doi]
PST - ppublish
SO - J Manag Care Spec Pharm. 2014 May;20(5):439-46c. doi:
10.18553/jmcp.2014.20.5.439.
PMID- 17714003
OWN - NLM
STAT- MEDLINE
DCOM- 20070918
LR - 20191110
IS - 0888-5109 (Print)
IS - 0888-5109 (Linking)
VI - 22
IP - 7
DP - 2007 Jul
TI - Adverse drug reactions and current state of drug regimen review in nursing
facilities: need for a change?
PG - 586-92
AB - OBJECTIVE: To review the salient issue of adverse drug reactions in nursing
facilities. SETTING: Nursing facilities across the United States. PRACTICE
DESCRIPTION: Federally mandated, retrospective drug regimen reviews (DRRs)
performed by consultant pharmacists are discussed as the impetus for change.
PRACTICE INNOVATION: A prospective process of medication therapy management
that
involves pharmacists interacting with the interdisciplinary care team is
described as a way to deliver high-quality, medication-related health care at
the
point of care. The paper presents the Fleetwood model as an exemplar of the
proposed care model and--as well as the recent revisions to the interpretive
guidelines for the State Operations Manual (SOM)--as a means of changing the
way
medication therapy management is deployed in nursing facilities. MAIN OUTCOME
MEASURES: Change in nursing facility pharmacy practice. RESULTS: In settings
where the Fleetwood model has been implemented, researchers have observed
numerous changes, including increased clinical involvement by dispensing and
consultant pharmacists, reduced time spent on traditional DRR, increased time
spent on pharmaceutical care planning, improved communication among the
interdisciplinary team, and more efficient processes within the nursing
facility
pharmacy. Changes in the Pharmacy Services Tags (F425, F428, F431) and
Unnecessary Medications Tag (F329) in the interpretive guidelines for the
SOM,
released by the Centers for Medicare and Medicaid Services, have significant
implications for the way consultant pharmacists practice. CONCLUSIONS:
Application of prospective medication therapy management, such as that
contained
in the Fleetwood model, and changes to the interpretive guidelines support
greater pharmacist involvement at the point of care, which has potential to
dramatically decrease adverse drug reactions in nursing facilities.
FAU - Bain, Kevin T
AU - Bain KT
AD - Department of Quality Outcomes, Omnicare Company, PA 19102, USA.
kbain@excellerx.com
LA - eng
PT - Review
PL - United States
TA - Consult Pharm
JT - The Consultant pharmacist : the journal of the American Society of Consultant
Pharmacists
JID - 9013983
SB - IM
MH - Adverse Drug Reaction Reporting Systems/legislation &
jurisprudence/*statistics &
numerical data/trends
MH - Drug Utilization Review/methods/*statistics & numerical data
MH - Guidelines as Topic/standards
MH - Humans
MH - Skilled Nursing Facilities/*standards
RF - 42
EDAT- 2007/08/24 09:00
MHDA- 2007/09/19 09:00
CRDT- 2007/08/24 09:00
PHST- 2007/08/24 09:00 [pubmed]
PHST- 2007/09/19 09:00 [medline]
PHST- 2007/08/24 09:00 [entrez]
AID - 10.4140/tcp.n.2007.586 [doi]
PST - ppublish
SO - Consult Pharm. 2007 Jul;22(7):586-92. doi: 10.4140/tcp.n.2007.586.
PMID- 15061684
OWN - NLM
STAT- MEDLINE
DCOM- 20040812
LR - 20220716
IS - 0114-5916 (Print)
IS - 0114-5916 (Linking)
VI - 27
IP - 5
DP - 2004
TI - The Xyrem risk management program.
PG - 293-306
AB - Sodium oxybate, also known as gamma-hydroxybutyric acid (GHB), was discovered
in
1960 and has been described both as a therapeutic agent with high medical
value
and, more recently, a substance of abuse. The naturally occurring form of
this
drug is found in various body tissues but has been studied most extensively
in
the CNS where its possible function as a neurotransmitter continues to be
studied. Sodium oxybate has been approved in different countries for such
varied
uses as general anaesthesia, the treatment of alcohol withdrawal and
addiction,
and, most recently, cataplexy associated with narcolepsy. During the 1980s,
easy
access to GHB-containing products led to various unapproved uses, including
weight loss, bodybuilding and the treatment of sleeplessness, sometimes with
serious long-term effects. The availability of these unapproved and
unregulated
forms of the drug led to GHB and its analogues being popularised as
substances of
abuse and subsequent notoriety as agents used in drug-facilitated sexual
assault,
or 'date rape', eventually leading to the prohibition of GHB sales in the US.
Legal efforts to control the sale and distribution of GHB and its analogues
nearly prevented the clinical development of sodium oxybate for narcolepsy in
the
US. However, following extensive discussions with a variety of interested
parties, a satisfactory solution was devised, including legislative action
and
the development of the Xyrem Risk Management Program. Amendments to the US
Controlled Substances Act made GHB a schedule I drug, but also contained
provisions that allow US FDA-approved products to be placed under schedule
III.
This unique, bifurcated schedule for sodium oxybate/GHB allowed the clinical
development of sodium oxybate to proceed and, in July 2002, it was approved
by
the FDA as an orphan drug for the treatment of cataplexy in patients with
narcolepsy as Xyrem(sodium oxybate) oral solution. To promote the safe use of
sodium oxybate, as well as alleviate concerns over possible diversion and
abuse
following product approval, a proprietary restricted drug distribution system
was
created, called the Xyrem Success Program. Components of the programme
include a
centralised distribution and dispensing system, a physician and patient
registry,
compulsory educational materials for patients and physicians, a specially
trained
pharmacy staff, a method for tracking prescription shipments, and an initial
post-marketing surveillance programme. The system has created a unique
opportunity to provide both physician and patient education and ongoing
patient
counselling, promoting greater drug safety and enhanced patient compliance.
FAU - Fuller, David E
AU - Fuller DE
AD - Orphan Medical Inc., Minnetonka, Minnesota 55305, USA.
FAU - Hornfeldt, Carl S
AU - Hornfeldt CS
FAU - Kelloway, Judy S
AU - Kelloway JS
FAU - Stahl, Pamela J
AU - Stahl PJ
FAU - Anderson, Todd F
AU - Anderson TF
LA - eng
PT - Review
PL - New Zealand
TA - Drug Saf
JT - Drug safety
JID - 9002928
RN - 0 (Illicit Drugs)
RN - 7G33012534 (Sodium Oxybate)
SB - IM
MH - Administration, Oral
MH - Drug and Narcotic Control/legislation & jurisprudence/*organization &
administration
MH - Humans
MH - Illicit Drugs/legislation & jurisprudence/*supply & distribution
MH - Product Surveillance, Postmarketing
MH - Risk Management/legislation & jurisprudence/*organization & administration
MH - Sodium Oxybate/administration & dosage/*supply & distribution/therapeutic use
MH - United States
RF - 37
EDAT- 2004/04/06 05:00
MHDA- 2004/08/13 05:00
CRDT- 2004/04/06 05:00
PHST- 2004/04/06 05:00 [pubmed]
PHST- 2004/08/13 05:00 [medline]
PHST- 2004/04/06 05:00 [entrez]
AID - 2752 [pii]
AID - 10.2165/00002018-200427050-00002 [doi]
PST - ppublish
SO - Drug Saf. 2004;27(5):293-306. doi: 10.2165/00002018-200427050-00002.
PMID- 24353049
OWN - NLM
STAT- MEDLINE
DCOM- 20140218
LR - 20220316
IS - 1551-7489 (Print)
IS - 1551-7489 (Linking)
VI - 9
IP - 5
DP - 2013 Sep-Oct
TI - Survey of naloxone legal status in opioid overdose prevention and treatment.
PG - 369-77
LID - jom.2013.0179 [pii]
LID - 10.5055/jom.2013.0179 [doi]
AB - OBJECTIVE: To survey the federal and state-by-state legal status for
prescribing,
dispensing, and administering naloxone injection. DESIGN: The survey was a
review
of legislation, which encompassed analyzing current and proposed laws
regarding
naloxone's role in opioid overdose prevention and treatment. MAIN OUTCOME
MEASURE(S): The primary study outcome was to evaluate the legal aspects of
current naloxone overdose prevention and treatment. Aspects of the
legislation
studied included Food and Drug Administration (FDA) regulatory status,
prescriber
authorization, prescription requirements, defining the patient, authority to
administer naloxone, status of lay person administration, and provisions for
Good
Samaritan protections from criminal and civil liability. RESULTS: To date, 10
states have legislation implementing opioid overdose prevention programs
including naloxone. Several states with high opioid overdose burdens are in
the
legislative process. Reasons for hesitation to initiate such programs include
fear of liability, a proxy endorsement for drug abuse, and apprehension of
increasing drug usage. CONCLUSIONS: A number of state legislatures have
passed
legislation permitting lay administration of naloxone to individuals in an
attempt to revive a person with an apparent opioid overdose. These emerging
state
policy initiatives parallel similar laws and regulations governing lay person
epinephrine administration for anaphylaxis and applying automated electric
defibrillators for sudden cardiac arrest. Public health initiatives
increasing
access to naloxone will likely continue in states with high opioid overdose
burdens. FDA approval of a new needle-free naloxone delivery system would
facilitate greater public access.
FAU - Hewlett, Leanne
AU - Hewlett L
AD - Department of Pharmacy Practice and Science, University of Kentucky College
of
Pharmacy, Lexington, Kentucky.
FAU - Wermeling, Daniel P
AU - Wermeling DP
AD - Professor, Department of Pharmacy Practice and Science, University of
Kentucky
College of Pharmacy, Lexington, Kentucky.
LA - eng
PT - Review
PL - United States
TA - J Opioid Manag
JT - Journal of opioid management
JID - 101234523
RN - 36B82AMQ7N (Naloxone)
SB - IM
MH - Analgesics, Opioid/*poisoning
MH - Drug Overdose/prevention & control
MH - Humans
MH - *Legislation, Drug
MH - Naloxone/administration & dosage/*therapeutic use
EDAT- 2013/12/20 06:00
MHDA- 2014/02/19 06:00
CRDT- 2013/12/20 06:00
PHST- 2012/10/29 00:00 [received]
PHST- 2013/01/02 00:00 [revised]
PHST- 2013/03/12 00:00 [revised]
PHST- 2013/05/29 00:00 [revised]
PHST- 2013/05/29 00:00 [accepted]
PHST- 2013/12/20 06:00 [entrez]
PHST- 2013/12/20 06:00 [pubmed]
PHST- 2014/02/19 06:00 [medline]
AID - jom.2013.0179 [pii]
AID - 10.5055/jom.2013.0179 [doi]
PST - ppublish
SO - J Opioid Manag. 2013 Sep-Oct;9(5):369-77. doi: 10.5055/jom.2013.0179.
PMID- 25747501
OWN - NLM
STAT- MEDLINE
DCOM- 20151228
LR - 20220311
IS - 0399-077X (Linking)
VI - 45
IP - 4
DP - 2015 Apr
TI - Inventory of antibiotic stewardship programs in general practice in France
and
abroad.
PG - 111-23
LID - S0399-077X(15)00018-9 [pii]
LID - 10.1016/j.medmal.2015.01.011 [doi]
AB - OBJECTIVES: The authors conducted a survey of measures implemented in France
and
abroad for a better use of antibiotics in general practice. METHODS: A
literature
review was conducted from January 2000 to July 2014. Emails were sent to
every
infectious diseases department, to all regional health authorities (ARS), to
the
health insurance offices (CPAM) with the highest and lowest antibiotic use,
and
to the ministry of health to make an inventory of all antibiotic stewardship
programs. The ministry of health, the board of general practitioners,
infectious
diseases specialists, pharmacists, and the medical and pharmacy schools of
the
nation's capital were contacted in 17 countries of Europe and North America.
RESULTS: The main measures implemented in France were training of healthcare
professionals, publishing guidelines, feedback to the practitioners on their
prescriptions, and availability of rapid diagnostic tests. Telephone networks
were created in some regions, such as Antibiolor or Medqual, to help
physicians
with antibiotic prescription. Many foreign countries issued pedagogical
material
to physicians, for patients to explain what to do in case of viral infection
or
delayed prescription. In Alberta (Canada), the government introduced an
optional
authorization for quinolones. In Denmark, the government temporarily
suspended
the reimbursement of some agents to preserve them according to bacterial
ecology.
In the United-Kingdom, the antibiotic susceptibility test report must include
less than 5 agents. CONCLUSIONS: The measures implemented in France and
abroad
were usually more persuasive than restrictive. But the bacterial resistance
crisis should lead to implementing more restrictive measures.
CI - Copyright © 2015 Elsevier Masson SAS. All rights reserved.
FAU - Wang, S
AU - Wang S
AD - Antibiolor, bâtiment des spécialités médicales Philippe-Canton, CHU de
Nancy-Hôpitaux de Brabois, 54511 Vandœuvre-lès-Nancy cedex, France.
Electronic
address: dr.wang.sophie@gmail.com.
FAU - Pulcini, C
AU - Pulcini C
Nancy-Hôpitaux de Brabois, 54511 Vandœuvre-lès-Nancy cedex, France; Service
de
maladies infectieuses, CHU de Nancy-Hôpitaux de Brabois, allée du Morvan,
54511
Vandœuvre-Lès-Nancy cedex, France; EA 4360 Apemac, université de Lorraine,
université Paris-Descartes, 9, avenue de la Forêt-de-Haye, CS 50184, 54505
Vandœuvre-lès-Nancy cedex, France.
FAU - Rabaud, C
AU - Rabaud C
Nancy-Hôpitaux de Brabois, 54511 Vandœuvre-lès-Nancy cedex, France; Service
de
maladies infectieuses, CHU de Nancy-Hôpitaux de Brabois, allée du Morvan,
54511
Vandœuvre-Lès-Nancy cedex, France.
FAU - Boivin, J-M
AU - Boivin JM
AD - CIC-P Inserm, CHU de Nancy, Hôpital Brabois, bâtiment Louis Mathieu, 54500
Vandœuvre-Lès-Nancy, France; Département de médecine générale, faculté de
médecine de Nancy, université de Lorraine, 9, avenue de la Forêt-de-Haye, BP
184,
54505 Vandœuvre-Lès-Nancy cedex, France.
FAU - Birgé, J
AU - Birgé J
Nancy-Hôpitaux de Brabois, 54511 Vandœuvre-lès-Nancy cedex, France.
LA - eng
PT - Review
DEP - 20150305
PL - France
TA - Med Mal Infect
JT - Medecine et maladies infectieuses
JID - 0311416
RN - 0 (Anti-Bacterial Agents)
SB - IM
MH - Anti-Bacterial Agents/*therapeutic use
MH - Bacterial Infections/diagnosis/drug therapy
MH - Canada
MH - Drug Information Services
MH - Drug Resistance, Multiple, Bacterial
MH - Drug Utilization/legislation & jurisprudence/statistics & numerical data
MH - Education, Medical, Continuing
MH - Europe
MH - France
MH - General Practice/*statistics & numerical data
MH - Government Programs
MH - Health Care Surveys
MH - Humans
MH - Inappropriate Prescribing/*prevention & control/statistics & numerical data
MH - Practice Guidelines as Topic
MH - Practice Patterns, Physicians'/*statistics & numerical data
OTO - NOTNLM
OT - Antibiotics
OT - Antibiotiques
OT - Bon usage
OT - General practice
OT - Misuse
OT - Médecine générale
OT - Mésusage
OT - Stewardship
EDAT- 2015/03/10 06:00
MHDA- 2015/12/29 06:00
CRDT- 2015/03/10 06:00
PHST- 2014/10/09 00:00 [received]
PHST- 2014/12/18 00:00 [revised]
PHST- 2015/01/28 00:00 [accepted]
PHST- 2015/03/10 06:00 [entrez]
PHST- 2015/03/10 06:00 [pubmed]
PHST- 2015/12/29 06:00 [medline]
AID - S0399-077X(15)00018-9 [pii]
AID - 10.1016/j.medmal.2015.01.011 [doi]
PST - ppublish
SO - Med Mal Infect. 2015 Apr;45(4):111-23. doi: 10.1016/j.medmal.2015.01.011.
Epub
2015 Mar 5.
PMID- 30181869
OWN - NLM
STAT- MEDLINE
DCOM- 20190918
LR - 20190918
IS - 2047-2994 (Linking)
VI - 7
DP - 2018
TI - Rationale and development of a business case for antimicrobial stewardship
programs in acute care hospital settings.
PG - 104
LID - 10.1186/s13756-018-0396-z [doi]
LID - 104
AB - BACKGROUND: Antimicrobial stewardship programs (ASPs) have been shown to
reduce
inappropriate antimicrobial use and its consequences. However, these programs
lack legislative requirements in many places and it can be difficult to
determine
what human resources are required for these programs and how to create a
business
case to present to hospital administrators for program funding. The
objectives of
the current paper were to review legislative requirements and outline human
resource requirements for ASPs, and to create a base business case for ASPs.
METHODS: A working group of antimicrobial stewardship experts from across
Canada
met to discuss the necessary components for creation of a business case for
antimicrobial stewardship. A narrative review of the literature of the
regulatory
requirements and human resource recommendations for ASPs was conducted.
Informed
by the review and using a consensus decision-making process, the expert
working
group developed human resource recommendations based on a 1000 bed acute care
health care facility in Canada. A spreadsheet based business case model for
ASPs
was also created. RESULTS: Legislative and /or regulatory requirements for
ASPs
were found in 2 countries and one state jurisdiction. The literature review
and
consensus development process recommended the following minimum human
resources
complement: 1 physician, 3 pharmacists, 0.5 program administrative and
coordination support, and 0.4 data analyst support as full time equivalents
(FTEs) per 1000 acute care beds. Necessary components for the business case
model, including the human resource requirements, were determined to create a
spreadsheet based model. CONCLUSIONS: There is evidence to support the
negative
outcomes of inappropriate antimicrobial use as well as the benefits of ASPs.
Legislative and /or regulatory requirements for ASPs are not common. The
available evidence for human resource recommendations for ASPs using a
narrative
review process was examined and a base business case modelling scenario was
created. As regulatory requirements for ASPs increase, it will be necessary
to
create accurate business cases for ASPs in order to obtain the necessary
funding
to render these programs successful.
FAU - Morris, A M
AU - Morris AM
AD - 1Department of Medicine, University of Toronto, Sinai Health System, and
University Health Network, Toronto, ON Canada.
FAU - Rennert-May, E
AU - Rennert-May E
AD - 2Department of Medicine, University of Calgary and Foothills Medical Centre,
Alberta Health Services, Calgary, AB Canada.
FAU - Dalton, B
AU - Dalton B
AD - Pharmacy Services, Foothills Medical Centre, Alberta Health Services,
Calgary, AB
Canada.
FAU - Daneman, N
AU - Daneman N
AD - 4Department of Medicine, University of Toronto and Sunnybrook Health Sciences
Centre, Toronto, ON Canada.
FAU - Dresser, L
AU - Dresser L
AD - 5Antimicrobial Stewardship, University Health Network, Toronto, ON Canada.
FAU - Fanella, S
AU - Fanella S
AD - 6Department of Pediatrics and Child Health and Medical Microbiology,
University
of Manitoba, Winnipeg, MB Canada.
FAU - Grant, J
AU - Grant J
AD - 7Department of Pathology and Laboratory Medicine, Vancouver General Hospital,
Vancouver, BC Canada.
FAU - Keynan, Y
AU - Keynan Y
AD - 8Departments of Internal Medicine, Medical Microbiology and National
Collaborating Center for Infectious Diseases, University of Manitoba,
Winnipeg,
MB Canada.
FAU - Le Saux, N
AU - Le Saux N
AD - 9Department of Pediatrics, University of Ottawa and Children's Hospital of
Eastern Ontario, Ottawa, ON Canada.
FAU - McDonald, J
AU - McDonald J
AD - 10Pharmacy Services, Children's Hospital of Eastern Ontario, Ottawa, ON
Canada.
FAU - Shevchuk, Y
AU - Shevchuk Y
AD - 11College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon,
SK
Canada.
FAU - Thirion, D
AU - Thirion D
AD - 12Faculté de pharmacie, Université de Montréal, Department of Pharmacy,
McGill
University Health Centre, Montréal, QC Canada.
FAU - Conly, J M
AU - Conly JM
AD - 13Departments of Medicine and Immunology, Microbiology & Infectious Diseases,
University of Calgary and Alberta Health Services, AGW5 Ground Floor SSB,
Foothills Medical Centre, 1403 29 St NW, Calgary, AB T2N 2T9 Canada.
LA - eng
PT - Meta-Analysis
PT - Review
DEP - 20180829
TA - Antimicrob Resist Infect Control
JT - Antimicrobial resistance and infection control
JID - 101585411
RN - 0 (Anti-Infective Agents)
SB - IM
MH - Anti-Infective Agents/pharmacology/therapeutic use
MH - *Antimicrobial Stewardship/legislation & jurisprudence/methods
MH - Cross Infection/*drug therapy/*microbiology
MH - *Emergency Medical Services
MH - Health Planning Guidelines
MH - Humans
MH - Models, Theoretical
PMC - PMC6114185
OTO - NOTNLM
OT - Antimicrobial resistance
OT - Antimicrobial stewardship
OT - Business case
OT - Human resources
COIS- Not applicable.Has been obtained by all authors.The authors declare that they
have no competing interests.Springer Nature remains neutral with regard to
jurisdictional claims in published maps and institutional affiliations.
EDAT- 2018/09/06 06:00
MHDA- 2019/09/19 06:00
CRDT- 2018/09/06 06:00
PHST- 2018/01/14 00:00 [received]
PHST- 2018/08/21 00:00 [accepted]
PHST- 2018/09/06 06:00 [entrez]
PHST- 2018/09/06 06:00 [pubmed]
PHST- 2019/09/19 06:00 [medline]
AID - 396 [pii]
AID - 10.1186/s13756-018-0396-z [doi]
PST - epublish
SO - Antimicrob Resist Infect Control. 2018 Aug 29;7:104. doi:
10.1186/s13756-018-0396-z. eCollection 2018.
PMID- 26301067
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20150824
LR - 20201001
IS - 2042-0986 (Print)
IS - 2042-0986 (Linking)
VI - 6
IP - 4
DP - 2015 Aug
TI - European Union pharmacovigilance capabilities: potential for the new
legislation.
PG - 120-40
LID - 10.1177/2042098615591802 [doi]
AB - European Directives and Regulations introduced between late 2010 and 2012
have
substantially overhauled pharmacovigilance processes across the European
Union
(EU). In this review, the implementation of the pharmacovigilance legislative
framework by EU regulators is examined with the aim of mapping Directive
2010/84/EU and Regulation EC No. 1235/2010 against their aspired objectives
of
strengthening and rationalizing pharmacovigilance in the EU. A comprehensive
review of the current state of affairs of the progress made by EU regulators
is
presented in this paper. Our review shows that intense efforts by regulators
and
industry to fulfil legislative obligations have resulted in major positive
shifts
in pharmacovigilance. Harmonized decision making, transparency in decision
processes with patient involvement, information accessibility to the public,
patient adverse drug reaction reporting, efforts in communication and
enhanced
cooperation between member states to maximize resource utilization and
minimize
duplication of efforts are observed.
FAU - Borg, John Joseph
AU - Borg JJ
AD - Medicines Authority, 203 Level 3, Rue D'Argens, Gzira, GZR 1368, Malta.
FAU - Tanti, Amy
AU - Tanti A
AD - Medicines Authority, Gzira, Malta.
FAU - Kouvelas, Dimitrios
AU - Kouvelas D
AD - School of Medicine, Aristotle University of Thessaloniki, Thessaloniki,
Greece.
FAU - Lungu, Calin
AU - Lungu C
AD - DDCS, Windhof, Luxemburg.
FAU - Pirozynski, Michal
AU - Pirozynski M
AD - Department of Anaesthesiology and Critical Care Medicine, Postgraduate
Medical
School, Warsaw, Poland.
FAU - Serracino-Inglott, Anthony
AU - Serracino-Inglott A
AD - Department of Pharmacy, University of Malta, Msida Malta.
FAU - Aislaitner, George
AU - Aislaitner G
AD - National Organisation of Medicines (EOF), Athens, Greece.
LA - eng
PT - Review
TA - Ther Adv Drug Saf
JT - Therapeutic advances in drug safety
JID - 101549074
PMC - PMC4530350
OTO - NOTNLM
OT - Pharmacovigilance and Risk Assessment Committee
OT - adverse drug reactions
OT - drug safety
OT - periodic safety update reports
OT - pharmacovigilance
OT - post authorization safety studies
OT - regulatory affairs
OT - signal detection
COIS- Conflict of interest statement: The author declares no conflicts of interest
in
preparing this article.
EDAT- 2015/08/25 06:00
MHDA- 2015/08/25 06:01
CRDT- 2015/08/25 06:00
PHST- 2015/08/25 06:00 [entrez]
PHST- 2015/08/25 06:00 [pubmed]
PHST- 2015/08/25 06:01 [medline]
AID - 10.1177_2042098615591802 [pii]
AID - 10.1177/2042098615591802 [doi]
PST - ppublish
SO - Ther Adv Drug Saf. 2015 Aug;6(4):120-40. doi: 10.1177/2042098615591802.
PMID- 28357892
OWN - NLM
STAT- MEDLINE
DCOM- 20180830
LR - 20191210
IS - 0897-1900 (Linking)
VI - 31
IP - 2
DP - 2018 Apr
TI - Suspected Synthetic Cannabinomimetic Intoxication: Case Series and Review.
PG - 238-243
LID - 10.1177/0897190017699761 [doi]
AB - PURPOSE: The purpose of this work was to retrospectively review patient cases
presenting to the University of Kentucky Chandler Medical Center (UKCMC)
emergency department (ED) with symptoms of suspected synthetic
cannabinomimetic
(SC) intoxication. These drugs, currently undetected by standard urine drug
screen tests, comprise a structurally diverse group of compounds designed to
mimic the psychoactive effects of Δ(9)-tetrahydrocannabinol (Δ(9)-THC), the
primary psychoactive cannabinoid in marijuana. SUMMARY: Fourteen cases of
suspected SC intoxication were identified between July 1, 2015, through
September
30, 2015. The median patient age was 25.5 years (range: 13-45 years), and
most
(64%) patients were males. The most common psychoactive symptom was agitation
(n
= 6, 42.9%), while the most common physical symptoms were altered level of
consciousness (n = 9, 64.3%) and mydriasis (n = 3, 21.4%). Most cases
resolved
without complication in 24 hours; 2 patients required hospitalization.
CONCLUSION: Recent legislation has failed to curb the public health concerns
emanating from SC misuse. Education about the risks of SC use along with
additional regulation may be required to remove the false sense of safety
that
some individuals, especially adolescents and young adults, may associate with
these compounds, which are often misconstrued as "herbal marijuana."
Clinicians
need to be prepared to identify and treat symptoms of SC intoxication as
incidents of toxicity continue to rise.
FAU - Baum, Regan A
AU - Baum RA
AD - 1 University of Kentucky HealthCare, Department of Pharmacy Services,
Lexington,
KY, USA.
AD - 2 University of Kentucky College of Pharmacy, Department of Pharmacy Practice
and
Science, Lexington, KY, USA.
FAU - Bailey, Abby
AU - Bailey A
AD - 1 University of Kentucky HealthCare, Department of Pharmacy Services,
Lexington,
KY, USA.
and
FAU - Chan, Ryan
AU - Chan R
and
FAU - Blumenschein, Karen
AU - Blumenschein K
AD - 3 University of Kentucky College of Pharmacy and Martin School of Public
Policy
and Administration, Lexington, KY, USA.
LA - eng
PT - Case Reports
PT - Review
DEP - 20170330
PL - United States
TA - J Pharm Pract
JT - Journal of pharmacy practice
JID - 8900945
RN - 0 (Cannabinoids)
RN - 0 (Illicit Drugs)
SB - IM
MH - Adolescent
MH - Adult
MH - Akathisia, Drug-Induced/*diagnosis/therapy
MH - Cannabinoids/*toxicity
MH - Consciousness Disorders/*chemically induced/*diagnosis/therapy
MH - Emergency Medical Services/trends
MH - Female
MH - Humans
MH - Illicit Drugs/*toxicity
MH - Male
MH - Middle Aged
MH - Retrospective Studies
MH - Young Adult
OTO - NOTNLM
OT - cannabinomimetic
OT - synthetic cannabinoid
OT - synthetic marijuana
EDAT- 2017/03/31 06:00
MHDA- 2018/08/31 06:00
CRDT- 2017/03/31 06:00
PHST- 2017/03/31 06:00 [pubmed]
PHST- 2018/08/31 06:00 [medline]
PHST- 2017/03/31 06:00 [entrez]
AID - 10.1177/0897190017699761 [doi]
PST - ppublish
SO - J Pharm Pract. 2018 Apr;31(2):238-243. doi: 10.1177/0897190017699761. Epub
2017
Mar 30.
PMID- 17915074
OWN - NLM
STAT- MEDLINE
DCOM- 20080110
LR - 20211020
IS - 1523-3812 (Print)
IS - 1523-3812 (Linking)
VI - 9
IP - 5
DP - 2007 Oct
TI - Why buprenorphine is so successful in treating opiate addiction in France.
PG - 358-64
AB - In France, all registered medical doctors have been allowed to prescribe
buprenorphine without any special education or licensing since 1995. This has
led
to a rapidly increasing number of opiate-dependent users under buprenorphine
treatment in primary care. French physician compensation mechanisms, pharmacy
services, and medical insurance funding all have contributed to minimizing
barriers to buprenorphine treatment. Approximately 20% of all physicians in
France are prescribing buprenorphine to treat more than one half of the
estimated
180,000 problem heroin users. Intravenous diversion of buprenorphine may
occur in
up to 20% of buprenorphine patients and has led to relatively rare overdoses
in
combination with sedatives, whereas total opiate overdose deaths have
declined
substantially. In France, buprenorphine maintenance treatment for problem
opiate
users was feasible and safe through office-based prescriptions in a relaxed
regulatory environment.
FAU - Fatseas, M
AU - Fatseas M
AD - Département d'Addictologie, Centre Carreire, 121 rue de la Béchade, 33076
Bordeaux Cedex, France.
FAU - Auriacombe, Marc
AU - Auriacombe M
LA - eng
PT - Review
PL - United States
TA - Curr Psychiatry Rep
JT - Current psychiatry reports
JID - 100888960
RN - 0 (Narcotics)
RN - 40D3SCR4GZ (Buprenorphine)
SB - IM
MH - Buprenorphine/administration & dosage/poisoning/*therapeutic use
MH - Cause of Death
MH - Cross-Sectional Studies
MH - Drug Approval/legislation & jurisprudence
MH - Drug Overdose/mortality
MH - Drug Prescriptions/statistics & numerical data
MH - Drug Utilization/statistics & numerical data
MH - Feasibility Studies
MH - France
MH - Heroin Dependence/rehabilitation
MH - Humans
MH - Long-Term Care/statistics & numerical data
MH - Narcotics/administration & dosage/poisoning/*therapeutic use
MH - National Health Programs/legislation & jurisprudence
MH - Opioid-Related Disorders/*rehabilitation
MH - Primary Health Care/legislation & jurisprudence
MH - Substance Abuse, Intravenous/rehabilitation
RF - 53
EDAT- 2007/10/05 09:00
MHDA- 2008/01/11 09:00
CRDT- 2007/10/05 09:00
PHST- 2007/10/05 09:00 [pubmed]
PHST- 2008/01/11 09:00 [medline]
PHST- 2007/10/05 09:00 [entrez]
AID - 10.1007/s11920-007-0046-2 [doi]
PST - ppublish
SO - Curr Psychiatry Rep. 2007 Oct;9(5):358-64. doi: 10.1007/s11920-007-0046-2.
PMID- 15700904
OWN - NLM
STAT- MEDLINE
DCOM- 20050317
LR - 20081121
IS - 1088-0224 (Print)
IS - 1088-0224 (Linking)
VI - 11 Spec No
DP - 2005 Jan
TI - The effect of access restrictions on the vintage of drugs used by Medicaid
enrollees.
PG - SP7-13
AB - OBJECTIVE: To examine the extent to which recent Medicaid drug access
restrictions, such as preferred drug lists (PDLs), may affect the vintage (or
time since Food and Drug Administration approval) of 6 types of drugs used by
Medicaid beneficiaries. STUDY DESIGN: Retrospective claims database analysis
using National Drug Code pharmacy claims data. METHODS: A regression model
was
developed to analyze the effect that Medicaid access restrictions had on the
vintage of medications prescribed in 6 different therapeutic categories. A
"difference in differences" approach was used to compare the change in
vintage of
medications prescribed in Medicaid versus non-Medicaid patients between the
January-June 2001 and July-December 2003 study periods. RESULTS: The results
of
the regression model showed that PDLs increased the age of Medicaid
prescriptions
by less than 1 year for drugs in 5 of the 6 therapeutic classes analyzed. In
the
case of pain management medications, the increase was more than 1.2 years.
CONCLUSIONS: The results of the regression model suggest that Medicaid drug
access restriction programs (e.g., PDLs) have resulted in an increase in the
age
of drugs prescribed for Medicaid beneficiaries versus non-Medicaid patients.
Since previous research has suggested a clinical and economic advantage to
utilizing newer versus older drugs, further research should be conducted to
explore how these medication restriction policies may unduly affect Medicaid
beneficiaries compared with privately insured patients.
FAU - Lichtenberg, Frank R
AU - Lichtenberg FR
AD - Graduate School of Business, Columbia University, New York, NY 10027, USA.
frank.lichtenberg@columbia.edu
LA - eng
PT - Review
PL - United States
TA - Am J Manag Care
JT - The American journal of managed care
JID - 9613960
RN - 0 (Drugs, Essential)
MH - Drug Prescriptions/*classification
MH - Drug Utilization/economics/*trends
MH - Drugs, Essential/economics/*supply & distribution
MH - Formularies as Topic
MH - Gatekeeping
MH - Health Services Accessibility/economics/*trends
MH - Humans
MH - Insurance Claim Review
MH - Medicaid/*legislation & jurisprudence
MH - Retrospective Studies
MH - United States
RF - 6
EDAT- 2005/02/11 09:00
MHDA- 2005/03/18 09:00
CRDT- 2005/02/11 09:00
PHST- 2005/02/11 09:00 [pubmed]
PHST- 2005/03/18 09:00 [medline]
PHST- 2005/02/11 09:00 [entrez]
AID - 2795 [pii]
PST - ppublish
SO - Am J Manag Care. 2005 Jan;11 Spec No:SP7-13.
PMID- 22166932
OWN - NLM
STAT- MEDLINE
DCOM- 20120821
LR - 20220311
IS - 0031-6970 (Linking)
VI - 68
IP - 5
DP - 2012 May
TI - Off-label use of anti-cancer drugs between clinical practice and research:
the
Italian experience.
PG - 505-12
LID - 10.1007/s00228-011-1173-6 [doi]
AB - BACKGROUND: Off-label use is the practice of prescribing a drug outside the
terms
of its official labeling. Worldwide, about 20% of the commonly prescribed
medications are off-label, and the percentage increases in specific patient
populations, such as children, pregnant women, and cancer patients. Off-label
use
is particularly widespread in oncology for many reasons, including the wide
variety of cancer subtypes, the difficulties involved in performing clinical
trials, the rapid diffusion of preliminary results, and delays in the
approval of
new drugs by regulatory organizations/agencies. OBJECTIVE: The aim of this
article is to describe the use of off-label drugs in oncology, with an
emphasis
on the role of the world's leading regulatory agencies and an assessment of
current Italian legislation. CONCLUSION: Off-label drug utilization is
essential
in oncology when based on evidence. However, off-label drugs must be
prescribed
in accordance with existing national laws and only when the potential benefit
outweighs the potential toxic effects.
FAU - Lerose, Rosa
AU - Lerose R
AD - Hospital Pharmacy, IRCCS Centro di Riferimento Oncologico di Basilicata, Via
Padre Pio 1, 85028 Rionero in Vulture, PZ, Italy. rosalerose@libero.it
FAU - Musto, Pellegrino
AU - Musto P
FAU - Aieta, Michele
AU - Aieta M
FAU - Papa, Carla
AU - Papa C
FAU - Tartarone, Alfredo
AU - Tartarone A
LA - eng
PT - Review
DEP - 20111214
PL - Germany
TA - Eur J Clin Pharmacol
JT - European journal of clinical pharmacology
JID - 1256165
RN - 0 (Antineoplastic Agents)
RN - 0 (Drugs, Investigational)
SB - IM
MH - Antineoplastic Agents/adverse effects/economics/*therapeutic use
MH - Compassionate Use Trials/adverse effects/legislation & jurisprudence
MH - Drug Approval/legislation & jurisprudence
MH - Drug Costs
MH - Drugs, Investigational/adverse effects/economics/therapeutic use
MH - European Union
MH - Evidence-Based Medicine/legislation & jurisprudence
MH - Government Agencies
MH - Humans
MH - Italy
MH - Legislation, Drug
MH - Neoplasms/*drug therapy/economics
MH - *Off-Label Use/economics/legislation & jurisprudence
MH - Reimbursement Mechanisms
EDAT- 2011/12/15 06:00
MHDA- 2012/08/22 06:00
CRDT- 2011/12/15 06:00
PHST- 2011/08/03 00:00 [received]
PHST- 2011/11/15 00:00 [accepted]
PHST- 2011/12/15 06:00 [entrez]
PHST- 2011/12/15 06:00 [pubmed]
PHST- 2012/08/22 06:00 [medline]
AID - 10.1007/s00228-011-1173-6 [doi]
PST - ppublish
SO - Eur J Clin Pharmacol. 2012 May;68(5):505-12. doi: 10.1007/s00228-011-1173-6.
Epub
2011 Dec 14.
PMID- 19302916
OWN - NLM
STAT- MEDLINE
DCOM- 20090512
LR - 20220408
IS - 0149-2918 (Print)
IS - 0149-2918 (Linking)
VI - 31
IP - 2
DP - 2009 Feb
TI - Estimates of pediatric medication use in the United States: current abilities
and
limitations.
PG - 436-45
LID - 10.1016/j.clinthera.2009.02.003 [doi]
AB - BACKGROUND: Resources are available for measuring adult medication use, but
similar resources have not been fully developed for measuring pediatric use.
Policy decisions require an understanding of the population affected, the
number
of children, their ages, sex, geographic distribution, race and ethnicity,
and
insurance status, as well as trends over time. OBJECTIVE: In this article,
databases providing information about prescription drugs used in the United
States are reviewed with respect to pediatric populations. METHODS: A series
of
searches were conducted in MEDLINE using these terms: frequency, prevalence,
drug
utilization, children, pediatric, drug usage, medications, and prescriptions.
Authors of selected articles were interviewed to identify salient issues in
the
measurement of pediatric medication use. Preliminary analysis of several
databases followed within the context of government implementation of the
Best
Pharmaceuticals for Children Act. This was followed by further MEDLINE
searches
and synthesis of the literature. RESULTS: Databases with information about
pediatric population medication use included 7 with outpatient data and 4
with
inpatient data. Outpatient data were available from government and private
sources, but inpatient data were available from private sources only. Three
of
the government and 1 of the private databases with outpatient data had sample
sizes of several thousand, too small to allow analysis of frequency trends in
pediatric populations or subpopulations, in which many drugs are used by
fewer
than 0.01% of patients. CONCLUSIONS: Sample size needs are greater when
measuring
pediatric medication use because the overall level of use is lower among
children
than adults. Databases resulting from hospital quality efforts,
conglomeration of
pharmacy benefit records, and standardization of state Medicaid records offer
opportunities to describe prescription medication use in samples of several
hundred thousand to several million children but will require dedicated
resources.
FAU - Lasky, Tamar
AU - Lasky T
AD - Department of Pharmacy Practice, College of Pharmacy, University of Rhode
Island,
Kingston, Rhode Island 02881, USA. tlasky@mail.uri.edu
LA - eng
PT - Review
PL - United States
TA - Clin Ther
JT - Clinical therapeutics
JID - 7706726
RN - 0 (Prescription Drugs)
SB - IM
CIN - Clin Ther. 2009 Jul;31(7):1615; author reply 1615-6. PMID: 19695411
MH - Child
MH - Databases, Factual/*statistics & numerical data
MH - Drug Utilization/statistics & numerical data
MH - Health Policy
MH - Humans
MH - Pediatrics
MH - Prescription Drugs/*administration & dosage/adverse effects
MH - Sample Size
MH - United States
RF - 65
EDAT- 2009/03/24 09:00
MHDA- 2009/05/13 09:00
CRDT- 2009/03/24 09:00
PHST- 2008/12/15 00:00 [accepted]
PHST- 2009/03/24 09:00 [entrez]
PHST- 2009/03/24 09:00 [pubmed]
PHST- 2009/05/13 09:00 [medline]
AID - S0149-2918(09)00046-0 [pii]
AID - 10.1016/j.clinthera.2009.02.003 [doi]
PST - ppublish
SO - Clin Ther. 2009 Feb;31(2):436-45. doi: 10.1016/j.clinthera.2009.02.003.
PMID- 28694146
OWN - NLM
STAT- MEDLINE
DCOM- 20180510
LR - 20220409
IS - 1043-6618 (Linking)
VI - 123
DP - 2017 Sep
TI - Can causality assessment fulfill the new European definition of adverse drug
reaction? A review of methods used in spontaneous reporting.
PG - 122-129
LID - S1043-6618(17)30521-2 [pii]
LID - 10.1016/j.phrs.2017.07.005 [doi]
AB - Causality assessment is a fundamental biomedical technique for the signal
detection performed by Pharmacovigilance centers in a Spontaneous reporting
system. Moreover, it is a crucial and important practice for detecting
preventable adverse drug reactions. Among different methods for causality
assessment, algorithms (such as the Naranjo, or Begaud Methods) seem for
their
operational procedure and easier applicability one of the most commonly used
methods. With the upcoming of the new European Pharmacovigilance legislation
including in the definition of the adverse event also effects resulting from
abuse, misuse and medication error, all well-known preventable causes of
ADRs,
there was an emerging need to evaluate whether algorithms could fulfill this
new
definition. In this review, twenty-two algorithmic methods were identified
and
none of them seemed to fulfill perfectly the new criteria of adverse event
although some of them come close. In fact, several issues were arisen in
applying
causality assessment algorithms to these new definitions as for example the
impossibility to answer the rechallenge question in case of medication error
or
AEFI (Adverse Event Following Immunization). Moreover, the exact conditions
at
which events occurred, as for example dosage or mode of administration should
be
considered to better assess causality in conditions of abuse/overdose, or
misuse
as well as in conditions of lack of expected efficacy reports for
biotechnological drugs and adverse event occurring after mixing of vaccines.
Therefore, this review highlights the need of updating algorithmic methods to
allow a perfect applicability in all possible clinical scenarios accordingly
or
not with the terms of marketing authorization.
CI - Copyright © 2017 Elsevier Ltd. All rights reserved.
FAU - Mascolo, Annamaria
AU - Mascolo A
AD - Department of Experimental Medicine, Section of Pharmacology L. Donatelli,
University of Campania 'L. Vanvitelli', Naples, Italy; Campania Regional
Centre
for Pharmacovigilance and Pharmacoepidemiology, University of Campania 'L.
Vanvitelli', Naples, Italy. Electronic address:
annamaria.mascolo@unicampania.it.
FAU - Scavone, Cristina
AU - Scavone C
Centre
Vanvitelli', Naples, Italy.
FAU - Sessa, Maurizio
AU - Sessa M
Centre
FAU - di Mauro, Gabriella
AU - di Mauro G
Centre
FAU - Cimmaruta, Daniela
AU - Cimmaruta D
Centre
FAU - Orlando, Valentina
AU - Orlando V
AD - Center of Pharmacoeconomics (CIRFF), Department of Pharmacy University of
Naples,
'Federico II', Naples, Italy.
FAU - Rossi, Francesco
AU - Rossi F
Centre
FAU - Sportiello, Liberata
AU - Sportiello L
Centre
FAU - Capuano, Annalisa
AU - Capuano A
Centre
LA - eng
PT - Review
DEP - 20170708
PL - Netherlands
TA - Pharmacol Res
JT - Pharmacological research
JID - 8907422
SB - IM
MH - *Algorithms
MH - Drug-Related Side Effects and Adverse Reactions/*etiology
MH - Europe
MH - Humans
MH - Product Surveillance, Postmarketing
OTO - NOTNLM
OT - Adverse drug reaction reporting system
OT - Adverse event definition
OT - Algorithmic method
OT - Causality assessment
OT - Pharmacovigilance legislation
EDAT- 2017/07/12 06:00
MHDA- 2018/05/11 06:00
CRDT- 2017/07/12 06:00
PHST- 2017/04/26 00:00 [received]
PHST- 2017/06/07 00:00 [revised]
PHST- 2017/07/05 00:00 [accepted]
PHST- 2017/07/12 06:00 [pubmed]
PHST- 2018/05/11 06:00 [medline]
PHST- 2017/07/12 06:00 [entrez]
AID - S1043-6618(17)30521-2 [pii]
AID - 10.1016/j.phrs.2017.07.005 [doi]
PST - ppublish
SO - Pharmacol Res. 2017 Sep;123:122-129. doi: 10.1016/j.phrs.2017.07.005. Epub
2017
Jul 8.
PMID- 1094825
OWN - NLM
STAT- MEDLINE
DCOM- 19750905
LR - 20001218
IS - 0002-9289 (Print)
IS - 0002-9289 (Linking)
VI - 32
IP - 2
DP - 1975 Feb
TI - Review of computer applications in hospital pharmacy practice.
PG - 165-73
AB - A comprehensive literature review of the applications of computers in
hospital
pharmacy practice is presented. Articles are categorized as: accounting and
drug
usage review; purchasing and inventory control; controlled substances;
outpatient
services;drug distribution; drug information; and clinical services.
FAU - Knight, J R
AU - Knight JR
FAU - Conrad, W F
AU - Conrad WF
LA - eng
PT - Review
PL - United States
TA - Am J Hosp Pharm
JT - American journal of hospital pharmacy
JID - 0370474
RN - 0 (Narcotics)
SB - IM
MH - Accounting
MH - *Computers
MH - Drug Interactions
MH - Information Systems
MH - Medication Systems, Hospital
MH - Narcotics
MH - Outpatient Clinics, Hospital
MH - Pharmaceutical Preparations/administration & dosage
MH - Pharmacy Administration
MH - United States
RF - 111
EDAT- 1975/02/01 00:00
MHDA- 1975/02/01 00:01
CRDT- 1975/02/01 00:00
PHST- 1975/02/01 00:00 [pubmed]
PHST- 1975/02/01 00:01 [medline]
PHST- 1975/02/01 00:00 [entrez]
PST - ppublish
SO - Am J Hosp Pharm. 1975 Feb;32(2):165-73.
PMID- 12187524
OWN - NLM
STAT- MEDLINE
DCOM- 20021010
LR - 20220409
IS - 0353-9504 (Print)
IS - 0353-9504 (Linking)
VI - 43
IP - 4
DP - 2002 Aug
TI - Comparative approaches to pharmaceutical price regulation in the European
Union.
PG - 453-61
AB - AIM: To review pharmaceutical price regulation methods in countries of the
European Union (EU), in terms of the anticipated impact of regulation on
pharmaceutical expenditures and evidence of actual outcomes. METHOD: An
extensive
search was performed of medical and economic studies on regulatory
interventions
specifically targeting pharmaceutical prices in EU countries, published
between
January 1990 and April 2002. Both peer-reviewed and "gray" literature were
systematically reviewed. RESULTS: Four principle approaches to pharmaceutical
price regulation with some methodological differences were identified in EU
countries, as follows: fixed pricing, cost-effectiveness pricing, profit
controls, and reference pricing. Actual evidence of the impact of price
regulation was limited in many of these countries. Cross-country comparisons
suggested that limiting the rise of pharmaceutical prices did not equate to
controlling the rise of pharmaceutical expenditures because of the volume
effect
of utilization. CONCLUSIONS: Supply-side regulation without the simultaneous
use
of demand-side incentives and volume controls does little to control the rise
in
pharmaceutical expenditures. The types of needed demand-side controls depend
on
the context of the individual country, on political priorities, and on the
type
of supply-side regulation in place.
FAU - Mrazek, Monique F
AU - Mrazek MF
AD - LSE Health and Social Care, London School of Economics and Political Science,
Houghton Street, London, WC1B 4BP, UK. M.F.Mrazek@lse.ac.uk
LA - eng
PT - Comparative Study
PT - Review
PL - Croatia
TA - Croat Med J
JT - Croatian medical journal
JID - 9424324
SB - IM
MH - Cost Control/legislation & jurisprudence
MH - Cost-Benefit Analysis
MH - Drug Costs/*legislation & jurisprudence
MH - Drug Industry/legislation & jurisprudence
MH - Europe
MH - European Union
MH - Health Expenditures/*trends
MH - Health Policy
MH - Humans
MH - *Legislation, Pharmacy
MH - Prescription Fees/*legislation & jurisprudence
MH - Rate Setting and Review/legislation & jurisprudence
RF - 51
EDAT- 2002/08/21 10:00
MHDA- 2002/10/11 04:00
CRDT- 2002/08/21 10:00
PHST- 2002/08/21 10:00 [pubmed]
PHST- 2002/10/11 04:00 [medline]
PHST- 2002/08/21 10:00 [entrez]
PST - ppublish
SO - Croat Med J. 2002 Aug;43(4):453-61.
PMID- 12611195
OWN - NLM
STAT- MEDLINE
DCOM- 20030326
LR - 20061115
IS - 0040-5957 (Print)
IS - 0040-5957 (Linking)
VI - 57
IP - 5
DP - 2002 Sep-Oct
TI - [Social pharmacology: a new topic in clinical pharmacology].
PG - 420-6
AB - Social Pharmacology, a new field in Clinical Pharmacology, describes the
relationships between Society and Drugs. Topics of Social Pharmacology are
first,
the social consequences of populations' exposure to drugs and, secondly, the
social factors explaining drug use behind clinical or rational explanations.
Social Pharmacology also investigates the reasons for prescription, delivery,
consumption and self-medication of drugs (behind clinical or rational
factors).
The paper discusses the role of the different players of Social Pharmacology
in
the field of drug development, evaluation, prescription and consumption. For
example, the pharmaceutical industry should play an important role in the
discovery of new medically and socially "desirable" drugs. Drug companies are
also involved in this field for drug information to doctors but also
patients.
Regulatory agencies are concerned by social factors involved in drug
approval,
regulation of the maximal level of drug use, application and transferability
of
clinical trials to daily clinical practice. Social Pharmacologists also
investigate the factors (others than clinical or rational) regulating drug
use.
Drug consumption varies according to social characteristics of physicians
(sub-speciality, medical education, cultural origin, etc) or patients
(gender,
age, education, country, kind of work, social status etc). Relationships
between
drugs and religion make up a large chapter of Social Pharmacology. Other
topics
in Social Pharmacology involving other health professionals (pharmacists),
lawyers and the media are also discussed. Finally, drugs should be considered
as
important social markers of population behaviour. The role of the Social
Pharmacologist is to identify these social and irrational factors governing
drug
use in order to adapt and rationalize drug utilization in daily clinical
practice.
FAU - Montastruc, J L
AU - Montastruc JL
AD - Laboratoire de Pharmacologie Médicale et Clinique de la Faculté de Médecine
de
Toulouse, Toulouse, France. montastruc@cict.fr
LA - fre
PT - English Abstract
PT - Review
TT - La Pharmacologie Sociale: une nouvelle branche de la Pharmacologie Clinique.
PL - France
TA - Therapie
JT - Therapie
JID - 0420544
SB - IM
MH - Drug Therapy
MH - Government Agencies
MH - Humans
MH - Legislation, Pharmacy
MH - Pharmacy/*trends
MH - Research
MH - Social Medicine/*trends
RF - 27
EDAT- 2003/03/04 04:00
MHDA- 2003/03/27 05:00
CRDT- 2003/03/04 04:00
PHST- 2003/03/04 04:00 [pubmed]
PHST- 2003/03/27 05:00 [medline]
PHST- 2003/03/04 04:00 [entrez]
PST - ppublish
SO - Therapie. 2002 Sep-Oct;57(5):420-6.
PMID- 7591549
OWN - NLM
STAT- MEDLINE
DCOM- 19951205
LR - 20190920
IS - 0266-4623 (Print)
IS - 0266-4623 (Linking)
VI - 11
IP - 3
DP - 1995 Summer
TI - Pharmacists as agents of change for rational drug therapy.
PG - 485-508
AB - We analyze what is known and unknown about the contribution of the pharmacist
as
patient educator, physician consultant, and agent to affect patient outcomes
in
ambulatory settings. The need for pharmacist services is discussed, as are
the
theoretical underpinnings and quality of the scientific evidence to support
their
efficacy. The analysis is conducted in the context of a shift in pharmacists'
roles from product to patient orientation as well as recent U.S. legislation
mandating enhanced pharmacists' roles via drug utilization review for all
Medicaid patients. We conclude with a research and action agenda, calling for
stronger research designs in evaluating pharmacists' interventions. The
shifting
paradigm in the pharmacy profession, coupled with the implementation of the
Omnibus Budget Reconciliation Act of 1990, provide unique opportunities for
rigorous evaluations of pharmacists as agents of change for rational drug
therapy.
FAU - Lipton, H L
AU - Lipton HL
AD - University of California, San Francisco, USA.
FAU - Byrns, P J
AU - Byrns PJ
FAU - Soumerai, S B
AU - Soumerai SB
FAU - Chrischilles, E A
AU - Chrischilles EA
LA - eng
PT - Review
PL - England
TA - Int J Technol Assess Health Care
JT - International journal of technology assessment in health care
JID - 8508113
SB - IM
MH - Ambulatory Care
MH - *Drug Information Services
MH - Drug Therapy/*standards
MH - Drug Utilization Review
MH - Humans
MH - Organizational Innovation
MH - Patient Compliance
MH - *Patient Education as Topic
MH - *Pharmacists
MH - Quality of Health Care
MH - United States
RF - 138
EDAT- 1995/01/01 00:00
MHDA- 1995/01/01 00:01
CRDT- 1995/01/01 00:00
PHST- 1995/01/01 00:00 [pubmed]
PHST- 1995/01/01 00:01 [medline]
PHST- 1995/01/01 00:00 [entrez]
AID - 10.1017/s0266462300008692 [doi]
PST - ppublish
SO - Int J Technol Assess Health Care. 1995 Summer;11(3):485-508. doi:
10.1017/s0266462300008692.
PMID- 19930010
OWN - NLM
STAT- MEDLINE
DCOM- 20100723
LR - 20131121
IS - 0959-5236 (Linking)
VI - 28
IP - 6
DP - 2009 Nov
TI - Linked electronic medication systems in community pharmacies for preventing
pseudoephedrine diversion: a review of international practice and analysis of
results in Australia.
PG - 586-91
LID - 10.1111/j.1465-3362.2009.00051.x [doi]
AB - INTRODUCTION AND AIMS: Pseudoephedrine is a precursor often diverted into the
illegal manufacture of amphetamine type substances (ATS). The aim of this
study
was to evaluate the effectiveness of a linked electronic medication recording
system (LEMS) established in Australian pharmacies in 2005 for preventing the
diversion of pseudoephedrine. DESIGN AND METHODS: The number of illegal ATS
laboratories detected in each jurisdiction of Australia from 1996-1997 to
2004-2005 were analysed by linear regression nationally and by each
jurisdiction.
The statistical significance of seizures in 2005-2006 was based on the
comparison
of the observed value to the 95% prediction confidence intervals calculated
from
the historical data for each jurisdiction and nationally. RESULTS: Pharmacies
in
Queensland commenced an LEMS in late 2005 to minimise retail pseudoephedrine
diversion. The number of ATS laboratories seized in 2005-2006 in Queensland
was
significantly lower (P < 0.05) than predicted by historical data. For all
other
jurisdictions and nationally the totals of laboratories seized in 2005-2006
were
not significantly different from predicted values. DISCUSSION AND
CONCLUSIONS:
The significant decline in ATS illegal laboratories seized in Queensland in
2005-2006 suggests the effective use of LEMS in pharmacies to minimise
pseudoephedrine diversion. In order to evaluate a national LEMS, more
frequent
data on numbers of linked pharmacies, ATS laboratories seized and indicators
of
pseudoephedrine sales and misuse are required. Testing the use of LEMS by
pharmacies for preventing the diversion of other medicines seems appropriate.
FAU - Berbatis, Constantine G
AU - Berbatis CG
AD - School of Pharmacy, Curtin University of Technology (Western Australia),
Perth,
Australia. berbatis@git.com.au
FAU - Sunderland, Vivian Bruce
AU - Sunderland VB
FAU - Dhaliwal, Satvinder S
AU - Dhaliwal SS
LA - eng
PT - Review
PL - Australia
TA - Drug Alcohol Rev
JT - Drug and alcohol review
JID - 9015440
RN - 7CUC9DDI9F (Pseudoephedrine)
SB - IM
MH - Amphetamine-Related Disorders/epidemiology/prevention & control
MH - Australia/epidemiology
MH - Community Pharmacy Services/*standards/trends
MH - Electronic Health Records/*standards/trends
MH - Electronic Prescribing/standards
MH - Humans
MH - *Internationality/legislation & jurisprudence
MH - Pseudoephedrine/*adverse effects
RF - 24
EDAT- 2009/11/26 06:00
MHDA- 2010/07/24 06:00
CRDT- 2009/11/26 06:00
PHST- 2009/11/26 06:00 [entrez]
PHST- 2009/11/26 06:00 [pubmed]
PHST- 2010/07/24 06:00 [medline]
AID - DAR051 [pii]
AID - 10.1111/j.1465-3362.2009.00051.x [doi]
PST - ppublish
SO - Drug Alcohol Rev. 2009 Nov;28(6):586-91. doi: 10.1111/j.1465-
3362.2009.00051.x.
PMID- 9433037
OWN - NLM
STAT- MEDLINE
DCOM- 19980220
LR - 20071115
IS - 0194-7648 (Print)
IS - 0194-7648 (Linking)
VI - 18
IP - 4
DP - 1997 Dec
TI - The pharmacist's duty under OBRA-90 standards.
PG - 475-509
FAU - Brushwood, D B
AU - Brushwood DB
AD - Pharmacy Health Care Administration, College of Pharmacy, University of
Florida,
Gainesville 32610-0496, USA.
LA - eng
PT - Review
PL - United States
TA - J Leg Med
JT - The Journal of legal medicine
JID - 8000151
SB - IM
MH - Drug Utilization Review/*legislation & jurisprudence
MH - Humans
MH - *Legislation, Pharmacy
MH - *Liability, Legal
MH - Malpractice/*legislation & jurisprudence
MH - Medicaid/*legislation & jurisprudence
MH - Patient Education as Topic
MH - United States
RF - 137
EDAT- 1998/01/20 00:00
MHDA- 1998/01/20 00:01
CRDT- 1998/01/20 00:00
PHST- 1998/01/20 00:00 [pubmed]
PHST- 1998/01/20 00:01 [medline]
PHST- 1998/01/20 00:00 [entrez]
AID - 10.1080/01947649709511046 [doi]
PST - ppublish
SO - J Leg Med. 1997 Dec;18(4):475-509. doi: 10.1080/01947649709511046.
PMID- 16336281
OWN - NLM
STAT- MEDLINE
DCOM- 20060317
LR - 20151119
IS - 0269-4727 (Print)
IS - 0269-4727 (Linking)
VI - 30
IP - 6
DP - 2005 Dec
TI - Samples: to use or not to use?
PG - 505-10
FAU - Daugherty, K K
AU - Daugherty KK
AD - Department of Pharmacy Practice, Ferris State University, Grand Rapids, MI
49506,
USA. daugherk@ferris.edu
LA - eng
PT - Review
PL - England
TA - J Clin Pharm Ther
JT - Journal of clinical pharmacy and therapeutics
JID - 8704308
SB - IM
MH - Documentation
MH - *Drug Utilization
MH - Humans
MH - *Marketing/legislation & jurisprudence
MH - Pharmaceutical Preparations/supply & distribution
MH - Practice Patterns, Physicians'
RF - 20
EDAT- 2005/12/13 09:00
MHDA- 2006/03/18 09:00
CRDT- 2005/12/13 09:00
PHST- 2005/12/13 09:00 [pubmed]
PHST- 2006/03/18 09:00 [medline]
PHST- 2005/12/13 09:00 [entrez]
AID - JCP691 [pii]
AID - 10.1111/j.1365-2710.2005.00691.x [doi]
PST - ppublish
SO - J Clin Pharm Ther. 2005 Dec;30(6):505-10. doi: 10.1111/j.1365-
2710.2005.00691.x.
PMID- 12762101
OWN - NLM
STAT- MEDLINE
DCOM- 20030805
LR - 20191210
IS - 1073-1105 (Print)
IS - 1073-1105 (Linking)
VI - 31
IP - 1
DP - 2003 Spring
TI - Maximizing the value of electronic prescription monitoring programs.
PG - 41-54
FAU - Brushwood, David B
AU - Brushwood DB
AD - University of Florida College of Pharmacy, USA.
LA - eng
PT - Legal Case
PT - Review
PL - England
TA - J Law Med Ethics
JT - The Journal of law, medicine & ethics : a journal of the American Society of
Law,
Medicine & Ethics
JID - 9315583
MH - Chronic Disease
MH - Confidentiality
MH - Drug Monitoring
MH - *Drug Prescriptions
MH - Drug Utilization Review/legislation & jurisprudence/*methods
MH - Drug and Narcotic Control/*legislation & jurisprudence
MH - Government Programs
MH - Humans
MH - Medical Records Systems, Computerized/*legislation & jurisprudence/*standards
MH - Outcome Assessment, Health Care
MH - Pain/drug therapy
MH - Palliative Care
MH - Policy Making
MH - Risk Management
MH - Substance-Related Disorders/prevention & control
MH - United States
RF - 83
OID - KIE: 111280
OTO - KIE
OT - Health Care and Public Health
OT - Legal Approach
GN - KIE: KIE Bib: patient care/drugs
EDAT- 2003/05/24 05:00
MHDA- 2003/08/06 05:00
CRDT- 2003/05/24 05:00
PHST- 2003/05/24 05:00 [pubmed]
PHST- 2003/08/06 05:00 [medline]
PHST- 2003/05/24 05:00 [entrez]
AID - 10.1111/j.1748-720x.2003.tb00058.x [doi]
PST - ppublish
SO - J Law Med Ethics. 2003 Spring;31(1):41-54. doi:
10.1111/j.1748-720x.2003.tb00058.x.
PMID- 15344676
OWN - NLM
STAT- MEDLINE
DCOM- 20041102
LR - 20051116
IS - 1086-5462 (Print)
IS - 1086-5462 (Linking)
VI - 87
IP - 6
DP - 2004 Jun
TI - A review of controlled substances.
PG - 186-8
AB - Physicians who understand the Controlled Substances Act and their regulations
will have fewer complications and problems. The tracking/monitoring system
helps
protect physicians and their patients from problems with abuse and diversion.
The
understanding that pharmacists are utilizing their skills everyday in
reviewing a
patient's pharmaceutical history and aiding the patient will no doubt
encourage
increased interaction among the healthcare fields and increase the quality of
treatment for the patient.
FAU - Doig, Ian
AU - Doig I
AD - Department of Pharmacy, University of Rhode Island, USA.
FAU - Cordy, Cathy
AU - Cordy C
LA - eng
PT - Review
PL - United States
TA - Med Health R I
JT - Medicine and health, Rhode Island
JID - 9603446
SB - IM
MH - Drug Utilization/legislation & jurisprudence
MH - Drug and Narcotic Control/*organization & administration
MH - Humans
MH - United States
RF - 7
EDAT- 2004/09/04 05:00
MHDA- 2004/11/04 09:00
CRDT- 2004/09/04 05:00
PHST- 2004/09/04 05:00 [pubmed]
PHST- 2004/11/04 09:00 [medline]
PHST- 2004/09/04 05:00 [entrez]
PST - ppublish
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PMID- 4573778
OWN - NLM
STAT- MEDLINE
DCOM- 19730702
LR - 20181130
IS - 0018-5973 (Print)
IS - 0018-5973 (Linking)
VI - 47
IP - 7
DP - 1973 Apr 1
TI - Annual administrative reviews: pharmacy.
PG - 153-5 passim
FAU - Black, H J
AU - Black HJ
LA - eng
PT - Review
PL - United States
TA - Hospitals
JT - Hospitals
JID - 0374657
SB - IM
MH - Ambulatory Care
MH - Computers
MH - Costs and Cost Analysis
MH - Drug-Related Side Effects and Adverse Reactions
MH - Economics, Hospital
MH - Education, Pharmacy
MH - Education, Pharmacy, Continuing
MH - Hospital Administration
MH - Information Systems
MH - Infusions, Parenteral
MH - Medication Systems, Hospital
MH - United States
MH - Workforce
RF - 87
EDAT- 1973/04/01 00:00
MHDA- 1973/04/01 00:01
CRDT- 1973/04/01 00:00
PHST- 1973/04/01 00:00 [pubmed]
PHST- 1973/04/01 00:01 [medline]
PHST- 1973/04/01 00:00 [entrez]
PST - ppublish
SO - Hospitals. 1973 Apr 1;47(7):153-5 passim.
PMID- 392655
OWN - NLM
STAT- MEDLINE
DCOM- 19800324
LR - 20081121
IS - 0034-1193 (Print)
IS - 0034-1193 (Linking)
VI - 67
IP - 3
DP - 1979 Sep
TI - [Prescription in general practice. Critical review].
PG - 297-312
FAU - Taylor, R J
AU - Taylor RJ
LA - ita
PT - Review
TT - La prescrizione nella pratica medica generica. Rassegna critica.
PL - Italy
TA - Recenti Prog Med
JT - Recenti progressi in medicina
JID - 0401271
SB - IM
MH - Drug Prescriptions
MH - *Drug Utilization
MH - *Family Practice
MH - Humans
MH - Pharmacy Administration/legislation & jurisprudence
MH - *State Medicine/economics
MH - Substance-Related Disorders
RF - 63
EDAT- 1979/09/01 00:00
MHDA- 1979/09/01 00:01
CRDT- 1979/09/01 00:00
PHST- 1979/09/01 00:00 [pubmed]
PHST- 1979/09/01 00:01 [medline]
PHST- 1979/09/01 00:00 [entrez]
PST - ppublish
SO - Recenti Prog Med. 1979 Sep;67(3):297-312.

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