The document summarizes strategies implemented in British Columbia to improve prescription drug utilization and their outcomes. It discusses policies such as outcome-based drug coverage, reference-based pricing, restricted access criteria, and therapeutic substitution that were introduced by the Therapeutics Initiative. Evaluations found these policies led to cost savings, changes in prescribing towards preferred drugs, and no increases in adverse health outcomes. However, the initiatives faced opposition from those with conflicts of interest, and changes to governance and funding now threaten the future of the Therapeutics Initiative's role in advising on drug policy in BC.
Introduction to Premarketing Phase
Limitation of Premarketing Phase and Importance of Phase IV period
Definition of DUS
History of DUS
Objectives of DUS
Types of Drug Use Information
Drug Utilization Cycle
Introduction to Premarketing Phase
Limitation of Premarketing Phase and Importance of Phase IV period
Definition of DUS
History of DUS
Objectives of DUS
Types of Drug Use Information
Drug Utilization Cycle
This presentation describes the objectives, approach and application of Drug Utilization studies in Pharmacotherapeutics. This emphasizes on how to conduct a drug utilization studies.
breif notes on what is pharmacoepidemiology, why do we need pharmacoepidemiology, whats is its aim and its main applications, advantages and disadvantages
This presentation describes the objectives, approach and application of Drug Utilization studies in Pharmacotherapeutics. This emphasizes on how to conduct a drug utilization studies.
breif notes on what is pharmacoepidemiology, why do we need pharmacoepidemiology, whats is its aim and its main applications, advantages and disadvantages
Presentación "Principios para una Prescripción prudente" en C Salud Montequin...Fernando Fabiani
Presentación de los "Principios para una Prescripción Prudente" en sesión de formación continuada del C de Salud de Montequinto usando para ello una adaptación de las diapositivas de @asunrosado del Congreso Samfyc 2012 y aportando las #rimasprescripcionprudente
Iniciativas por una prescripción prudente Presentacion al Master de Salud Publica. Facultad de Medicina. Universidad de Zaragoza. Rafael Bravo Toledo. Centro de Salud Linneo. Madrid. Abril 2016
An Essential Drug List, also known as a core drug list or medication list, is a carefully selected inventory of medications that are deemed essential for addressing the most prevalent health conditions within a specific population or country. It serves as a key component of national drug policies and pharmaceutical programs, ensuring the availability, accessibility, and affordability of essential medicines. The list is typically developed based on rigorous criteria, taking into consideration the medications' safety, efficacy, cost-effectiveness, and suitability for primary healthcare settings.
Rational Drug Therapy refers to the systematic and evidence-based approach to prescribing medications, aiming to maximize therapeutic benefits while minimizing the risk of adverse effects. It involves following established therapeutic guidelines and clinical protocols to ensure that medications are prescribed in a manner that is appropriate for the patient's condition, taking into account factors such as age, weight, co-existing conditions, drug interactions, and individual response. Rational drug therapy promotes the use of medications based on sound scientific evidence, emphasizing the principles of efficacy, safety, and cost-effectiveness to optimize patient outcomes and improve overall healthcare quality.
A study on prescription pattern and rational use of statins in tertiary care ...SriramNagarajan16
Objectives
Our objectives are to evaluate prescription pattern and rational use of statins in a tertiary care corporate hospital.
Methodology
It was a prospective observational study conducted for a period of 6 months and included various departments of 300
bedded multi specialty tertiary care corporate hospital. A total of 200 patients were included and the study criteria
was inpatients and induvial more than 18 years of either gender who are prescribed with HMG-CoA reductase
inhibitors.
Results
In the present study 200 patients belonged to the age group of above 18 years, out of which about 65% were male
and 35% were female. Atorvastatin (67%) was prescribed mostly and Rosuvastatin (29.5%) was also used.
Conclusion
It is finally concluded that Rational and prophylactic use of statins can reduce further complications of Diabetes
Mellitus (DM) and cardiac events.
Statins treatment is favourable in long term treatment of diseases, it is most effectively used in treatment of serious
disease conditions which has shown its immense therapeutic role in treatment
Epidemiology is the study of occurrence, distribution and determinants of health and
diseases or disorders in man and its application in controlling health problems.
Epidemiology has by tradition two major areas.
First is the study of infectious diseases that spread to large populations, i.e., epidemics.
The second is the study of chronic diseases.
Epidemiological studies help to solve such health problems and provide a basis for
improving living conditions of the people.
During its progress and development, epidemiology has made available precise and
strict methodologies for the study of diseases.
Pharmacology is the study of the effects of drugs.
Clinical Pharmacology is the study of the effects of drugs in humans, It is traditionally
divided into two basic areas namely:
1. Pharmacokinetics
2. Pharmacodynamics.
Pharmacokinetics is the study of the relationship between dose administered of a drug
and the serum or blood level achieved, it deals with absorption, distribution, metabolism
and excretion.
Epidemiology is the study of the distribution and determinants of diseases in
populations.
Epidemics is the study of chronic/ infectious diseases in large populations.
Pharmacoepidemiology is the study of the use of and the effects of drugs in large
number of people.
It involves the examination of a single individual or large groups of people followed for
many years.
It involves gathering & analysis of information in order to identify possible causation &
related factors, that can be applied in clinical practice to group of people & also to
individuals undergoing treatment.
An introduction to medication therapy managementKabito Kiwanuka
Pharmacists: An Untapped Resource: Pharmacists receive more training on the safe, effective and appropriate use of medications than any other healthcare professional
El Estudio que Demostró el Control de la Industria de la Enfermedad sobre la Medicina
Este nuevo estudio, el primero en su tipo, comparó específicamente el nivel de publicidad farmacéutica con la cantidad y tipo de publicaciones acerca de suplementos alimenticios. Los autores revisaron un año de publicaciones de los 11 journals más grandes del mundo como por ejemplo el Journal of the American Medical Association, New England Journal of Medicine, British Medical Journal, Canadian Medical Association, Annals of Internal Medicine, Archives of International Medicine, Archives of Pediatric and Adolescent Medicine, Pediatrics and Pediatric Research y el American Family Physician.
Similar to C clausura outcomes_strategies_drug_utilization_wright_j (20)
C clausura outcomes_strategies_drug_utilization_wright_j
1. Outcomes of strategies
to improve drug
utilization in British
Columbia
James (Jim) Wright
Managing Director
Therapeutics Initiative
2.
3. Outline
My journey at the university
The Therapeutics Initiative (TI)
Strategies and outcomes
The Pharmaceutical Task Force and Academic
Review of TI
The problem and some potential solutions
Questions.
4. Warning
Information provided here about prescription
drugs that you may be taking could lead to
cognitive dissonance and affect your well being.
Viewer discretion is advised.
5. My journey at UBC
First Phase
1977 Assistant professor in Pharmacology &
Therapeutics and Medicine.
Clinical Pharmacologist – Clinical practice,
research and teaching.
1977-1983, MRC funded research into
mechanisms of adverse drug effects and drug
interactions.
6. My journey at UBC
Second Phase
In 1983 I began doing drug industry funded
clinical drug trials.
Between 1983 and 1994, I was principal
investigator for 15 trials with 15 different drug
companies.
7. My journey at UBC
Third Phase
In 1994 the Therapeutics Initiative was formed
and I was appointed the Clinical Managing
Director.
I stopped all drug industry funded research.
1994 to present -- main activity, Managing
Director of TI and Editor-in-Chief of Therapeutics
Letter.
2001, I was appointed Coordinating Editor of the
Cochrane Hypertension Review Group.
8. Therapeutics Initiative, 1994
(10 individuals)
Mission: To provide physicians and
pharmacists with up-to-date, evidence-based,
practical information on prescription drug
therapy.
First Task: To become expert in assessing
evidence from clinical trials of new drugs in
Canada, and to provide the evidence to
Pharmacare.
First policy decision: No conflicts of interest
were allowed.
9. What happened?
We became expert in critical appraisal and
assessment of evidence from clinical trials.
We got involved in the Cochrane Collaboration
and learned their methodology.
We hired experts in Health Technology
Assessment and Systematic Review.
10. Interventions implemented
Therapeutics Letter 6 times per year posted on
website and mailed to physicians and
pharmacists in BC.
Letters provided the best available evidence
about the benefits and harms of drugs and drug
classes.
Letters provided drug cost information.
11. What did the clinicians
think about the Letter?
Answered by regular surveys
12.
13. What was the impact on
prescribing of the first
20 Letters?
Answered using a randomised controlled trial.
14. Effect of periodic letters on evidence-based
drug therapy on prescribing behaviour: a
randomized trial
Dormuth CR, Maclure M, Bassett K, Jauca C, Whiteside C,
Wright JM (CMAJ 2004; 171(9): 1057-61)
The Therapeutics Initiative is funded by a grant from the Government of British Columbia
15. Methods
Physicians:
-Study population included 499 physicians from 24 local health
areas in British Columbia, Canada
Communities:
-Paired according to the number of physicians.
-One in each pair was randomly assigned to the intervention
group and the other to the control group
Source databases:
-Physician service records and drug claims records from the
British Columbia Ministry of Health
16. Methods
Analyses:
-Incidence of newly treated patients was measured
-For each drug group studied, patients were classified as being newly treated if none of
the drugs in the group were dispensed to them in the previous year.
17. Results
Table: Characteristics of treatment and control physicians
Treatment Control
Characteristic Group (n=258) Group (n=241)
Physicians:
% General Practitioners 89.9 90.4
Average age 45.6 46.2
% Males/Females 89/11 83/17
Patients:
Average age 35.5 (75.2) 35.0 (75.3)
% Males/Females/Unknown 46/52/2 (44/52/4) 46/52/2 (44/52/4)
Avg. no. visits / MD 6402 (1322) 6660 (1340)
Results in brackets are for subset of patient population 65 and older.
19. Interpretation
Printed letters distributed as a series regularly from a trusted
source has a modest desirable impact on prescribing to new
patients.
Further work needs to be done to determine the sustainability of
prescribing changes, and to determine what aspects of printed
letters elicit prescribing changes
20. What policies were
implemented?
Outcomes based coverage.
Funding of new drugs was based on the best
available evidence.
A new drug only became a full benefit if it
represented a therapeutic advantage or a cost
advantage over appropriate alternatives.
21. Examples of drug classes
affected by this policy
Non-steroidal anti-inflammatory drugs (Cox-2
selective NSAIDs).
Oral hypoglycemic drugs (glitazones and others).
Cholinesterase inhibitors for Alzheimers Disease.
22. What was the impact of
the outcome based
coverage policy?
26. What other policies were
implemented?
Reference based pricing of equivalent drugs
within a drug class.
Restricted access based on special authority
criteria.
Therapeutic substitution
27. Reference based pricing
January 1, 1997 least expensive ACE inhibitors
fully covered (captopril, quinapril, ramipril).
More expensive ACE inhibitors covered up to a
maximum of $27 per month (benazepril,
cilazapril, enalapril, fosinopril, lisinopril).
Patients on more expensive ACEI could pay the
difference or switch.
28. Outcomes of reference
pricing for angiotensin-
converting-enzyme inhibitors
Schneeweiss S, Walker AM, Glynn RJ, Maclure M,
Dormuth C, Soumerai SB.
N Engl J Med 2002;346:822-9
29. No increase in Emergency
Hospitalizations due to RP
Schneeweiss et al. N Engl J Med 2002
31. Reference pricing for ACEI
conclusions
18% of patients switched to lower cost
alternative.
Not associated with changes in physician visits,
hospitalizations or mortality.
Cost savings to drug funder of approximately $6
million per year.
32. What policies were
implemented?
Reference based pricing of equivalent drugs
within a drug class.
Restricted access based on special authority
criteria.
Therapeutic substitution
37. Why were the policies
successful?
The TI did not allow any conflicts of interest.
Establishing questions for review was an iterative
process.
Drug Assessment Working Group (DAWG)
followed Cochrane methodology.
DAWG improved critical appraisal skills and
assessing risk of bias over time.
38. Why were the policies
successful?
Researchers were contracted to independently
evaluate the impact on drug utilization and health
outcomes.
Ministry of Health personnel remained committed
to outcomes based coverage despite political
pressures.
39.
40. What did the TI team
learn?
All drugs with any effect have both benefits and
harms.
Drugs are less effective than what we thought was
true.
Drugs are more harmful than what we thought was
true.
In many instances we were shocked that Health
Canada had approved the drugs for market.
In most instances drugs are marketed without
knowing that the benefits outweigh the harms in
many if not all the clinical settings where they are
used.
41. What did we discover?
A novel way of measuring the net health effect
(benefits minus harms) of drugs in clinical trials.
Total serious adverse events are captured in all
clinical trials and represent a measure of total
mortality and serious morbidity.
42.
43. Who were happy about this
program?
Ministry of Health
Taxpayers
Most doctors
PATIENTS
44. Who was unhappy about
the program?
The elephants.
Some doctors (specialists) who were friends of
the elephants.
45. What should of happened?
Expansion of the reference based program to
new classes of drugs eg. Statins.
Continued development of the international
reputation of BC as a drug policy innovator.
Increased funding to the Therapeutics Intiative to
increase the expertise and ensure the long-term
future.
46. What Happened?
In October 2007 a Pharmaceutical Task Force was
announced by BC Health Minister with the following
objectives:
1. Identify and strengthen patient care and choice;
2. Optimize the decision-making process for what
drugs are covered under PharmaCare;
3. Improve the effectiveness of the Common Drug
Review process;
4. Enhance the effectiveness, transparency and
future role of the Therapeutics Initiative.
47. Nine member
Pharmaceutical task force
Chair, Don Avison,
President of the
University Presidents
Council. Board member
LifeSciences BC.
Robert Sindelar, Dean,
Faculty of
Pharmaceutical
Sciences, UBC. Board
member LifeSciences
BC.
Russell Williams,
president of Canada’s
Research-based
Pharmaceutical
Companies (Rx&D).
Susan Paish, Q.C., chief
executive officer,
Pharmasave Drugs
(National) Ltd.
David M. Hall, chief
compliance officer and
senior vice president of
Community Relations,
Angiotech
Pharmaceuticals.
2 Ministry of Health
members.
2 others.
48. PSF recommendations for TI
April 2008
#4 The Ministry of Health should establish a new
Drug Review Resource Committee to carry out
the drug submission review role currently
performed by the Therapeutics Initiative.
#12 Subject to Recommendation #4, if the
Therapeutics Initiative is maintained, action must
be taken in the following areas: improve the
governance, membership and accountability
standards; renew and revitalize the panel of
expert reviewers;
49. The Minister of Health accepted all the
recommendations of the Pharmaceutical Task Force
and set up a mechanism for their implementation.
50.
51. Academic review of TI
http://www.pharmacology.ubc.ca/
3 member external panel reviewed the TI over 2
days in October 2008.
Validated the roles and activities of the TI in drug
assessment, pharmacoepidemiology and
education.
Stable funding must be ensured. The present
funding is inadequate.
3 new permanent University F-slots should be
established.
52. What has happened?
The implementation of the Task Force
recommendations is nearly complete; it has been
costly for the government and extremely
disruptive for the TI.
In November 2009, Don Avison confirmed that
he was recently appointed as the Canadian
representative on Pfizer Global's International
Advisory Board. He did not respond to an e-mail
asking what he will be paid.
Don Avison received a Leadership award from
LifeSciences BC.
53. What has happened?
The TI’s advisory role to the BC Ministry of
Health is unlikely to continue in any meaningful
way.
The TI’s funding from the BC Ministry of Health is
uncertain.
54. What is wrong with the
prescription drug system?
The elephants (Brand Name drug companies)
are too wealthy and powerful.
Recommended reading: “The Corporation: The
pathological pursuit of profit and power”
“Capitalismo Canibal: La Corporacion, La
busqueda patologica de lucro y poder” by Joel
Bakan.
It is not the fault of the corporations.
Governments established the system that got us
here and must bring in regulations to correct it.
55. Ways to improve the
system.
Continue to educate prescribers and patients
about the benefits and harms of prescription drugs.
56. Definition of Advertising
“The science of arresting the human
intelligence long enough to get money
from it.”
Stephen Leacock
57. First regulatory step to
improve the system.
Ban all advertising, marketing, lobbying and
promotion by drug companies.
Ban must include physicians, pharmacists,
nurses, government officials, politicians and the
public.
This would encourage companies to transfer the
huge amounts of money they spend on
marketing to research and development.
58. Second regulatory step to
improve the system
Mandate that all Phase III and Phase IV clinical
trials be designed, conducted, analysed and
reported by independent academic researchers.
The funding for these trials would come from the
companies, but they would be prevented from
manipulating and biasing the results.