/
What Do We Know About the Mechanism of Action of Drugs in the Different Drug Classes? What Do We Know About the Mechanism of Action of Drugs in the Different Drug Classes?

What Do We Know About the Mechanism of Action of Drugs in the Different Drug Classes? - PowerPoint Presentation

catherine
catherine . @catherine
Follow
344 views
Uploaded On 2022-06-07

What Do We Know About the Mechanism of Action of Drugs in the Different Drug Classes? - PPT Presentation

MCPHS University International Center for Pharmaceutical Economics and Policy American Public Health Association Boston Nov 5 2013 Presenter Disclosures 1The following personal financial relationships with commercial interests relevant to this presentation existed during the past 12 ID: 914613

drugs moa atc therapeutic moa drugs therapeutic atc fda policy status subgroup classes 1980 100 preparations hypothesized 2013 phd

Share:

Link:

Embed:

Download Presentation from below link

Download Presentation The PPT/PDF document "What Do We Know About the Mechanism of A..." is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.


Presentation Transcript

Slide1

What Do We Know About the Mechanism of Action of Drugs in the Different Drug Classes? Assessment of Pharmaceuticals Approved by the FDA between 1980 and 2012

MCPHS University

International Center for

Pharmaceutical Economics and Policy

American Public Health Association, Boston, Nov. 5, 2013

Slide2

Presenter Disclosures

(1)The following personal financial relationships with commercial interests relevant to this presentation existed during the past 12 months:

Lita Araujo

No relationships to disclose

Slide3

Lita Araujo, MSSoeun Kwon, MSMichael Montagne, PhD

Enrique Seoane, PhD

MCPHS University

International Center for Pharmaceutical Economics and Policy

American Public Health Association, Boston, Nov. 5, 2013

Slide4

Outline Background

Objectives Data Sources and Methods Results Conclusions Policy Recommendations

Slide5

Background

Mechanism of action (MOA) describes a biochemical event indicative of a drug’s pharmacological activityFDA requires MOA on the drug’s label*MOA assists health providers to understand therapeutic applications and possible adverse reactions

* FDA. Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products - Content and Format. Feb 2009

Slide6

Objectives

Assessment of the MOA, as described in the product label, for the Anatomical Therapeutic Chemical (ATC) classes of new drugs and biologics approved by the FDA between 1980 and 2012

Slide7

Data Sources

Dailymed - National Institute of HealthDrugs@FDA - FDAPhysician's Desk Reference 1980-2013

Slide8

Methods

MOA classificationKnown, hypothesized, or unknownThree researchers classified the MOAWHO classification systemAnatomical main group (ATC-1) Therapeutic sub group (ATC-2)Chi-square

test to assess differences in proportions

Slide9

Defining Hypothesized MOAs

Equivocating Phrases

Remains to be fully established

Appears to be

Not determined

May be involved

Equivocating Words

Likely

Probably

PostulateSuggest

Slide10

Outline Background

Objectives Data Sources and Methods Results Conclusions Policy Recommendations

Slide11

Sample

902 new drugs and biologics approved by the FDA during 1980-2012 32 products were excluded870 products included in the study

Slide12

MOA Status

Known

579 (67%)

Hypothesized252 (29%)Unknown39(4%)

Slide13

MOA Status by Decade

Slide14

Chi-square test Orphan drugs vs. Non-orphan drugs

p-value 0.3877Marketed vs. Discontinued drugsP-value 0.0320By decade: 80’ p-value 0.0049

90’ p-value 0.0755

Slide15

MOA Status by Anatomical Group ATC-1

Slide16

MOA Status by Therapeutic Subgroup ATC-2Musculo-Skeletal System

Therapeutic

Subgroup

n

Known

Hypothesized

Unknown

Antigout Preparations

2

100.00%0.00%0.00%Muscle Relaxants12

91.67%8.33%0.00%Drugs for Treatment of Bone Diseases757.14%42.86%0.00%

Topical Products Joint /Muscular Pain10.00%100.00%0.00%Other Drugs Disorders Musc.-Skel. System20.00%

100.00%

0.00%

Antiinflammatory

and

Antirheumatic

Prods

16

0.00%

81.25%

18.75%

Slide17

MOA Status by Therapeutic Subgroup ATC-2Dermatologicals

Therapeutic

Subgroup

nKnownHypothesized

Unknown

Emollients

and

Protectives

1100.00%

0.00%0.00%Preparations Treat. of Wounds and Ulcers1100.00%0.00%0.00%Antipsoriatics

366.67%0.00%33.33%Antibiotics and Chemotherapeutics850.00%12.50%37.50%

Antifungals for Dermatological Use837.50%62.50%0.00%Corticosteroids, Dermatological Preps50.00%

100.00%

0.00%

Anti-Acne Preparations

4

0.00%

75.00%

25.00%

Other Dermatological Preparations

1

0.00%

0.00%

100.00%

Slide18

MOA Status by Therapeutic Subgroup ATC-2Nervous System

Therapeutic

Subgroup

nKnown

Hypothesized

Unknown

Other Nervous System Drugs

10

40.00%

50.00%10.00%Analgesics1323.08%

76.92%0.00%Psycholeptics2512.00%48.00%40.00%Anesthetics1010.00%

70.00%20.00%Anti-Parkinson Drugs1010.00%90.00%0.00%Psychoanaleptics263.85%84.62%

11.54%

Antiepileptics

16

0.00%

87.50%

12.50%

Slide19

Conclusions

An important number of therapeutic classes have a low proportion of known MOAsMany of the drugs belonging to those classes are used by large number of patientsThe lack of information about MOA could result in safety and efficacy problems

Slide20

Policy Recommendations

FDA could develop standardized template for product label with regard to MOAFDA could require compliance with its guidelines and template by manufacturersFDA could encourage manufacturers to continue collecting evidence post-marketing to confirm a drug’s MOA

Slide21

What Do We Know About the Mechanism of Action of Drugs in the Different Drug Classes? Assessment of Pharmaceuticals Approved by the FDA between 1980 and 2012

Lita Araujo, MS; Soeun Kwon, MS; Michael Montagne, PhD; Enrique Seoane, PhD

MCPHS University

International Center for

Pharmaceutical Economics and Policy

American Public Health Association, Boston, Nov. 5, 2013