Off-label drug use involves prescribing approved medications for indications, dosages, or patient populations that are different than what is specified in the drug's approved labeling. It occurs commonly where patients have been excluded from clinical trials. While it can provide early access to potentially valuable treatments, it also increases risks like adverse drug reactions. Regulatory guidelines on off-label use vary globally, and in India, off-label prescribing was previously illegal but amendments may have changed that. Drug repositioning, where existing drugs are tested for new uses, can be an efficient alternative to traditional drug development by building on existing safety data. Physicians are encouraged to base off-label prescribing decisions on credible evidence alone.
Post marketing studies of drug effects must then generally include at least 10,000 exposed persons in a cohort study, or enroll diseased patients from a population of equivalent size for a case–control study. A study of this size would be 95% certain of observing at least one case of any adverse effect that occurs with an incidence of 3 per 10 000 or greater (see Chapter 3). However, studies this large are expensive and difficult to perform. Yet, these studies often need to be conducted quickly, to address acute and serious regulatory, commercial, and/or public health crises. For all of these reasons, the past two decades have seen a growing use of computerized databases containing medical care data, so called “automated databases,” as potential data sources for pharmacoepidemiology studies.
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Post marketing studies of drug effects must then generally include at least 10,000 exposed persons in a cohort study, or enroll diseased patients from a population of equivalent size for a case–control study. A study of this size would be 95% certain of observing at least one case of any adverse effect that occurs with an incidence of 3 per 10 000 or greater (see Chapter 3). However, studies this large are expensive and difficult to perform. Yet, these studies often need to be conducted quickly, to address acute and serious regulatory, commercial, and/or public health crises. For all of these reasons, the past two decades have seen a growing use of computerized databases containing medical care data, so called “automated databases,” as potential data sources for pharmacoepidemiology studies.
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Definition and scope of Pharmacoepidemiology ABUBAKRANSARI2
In these slides I shared the information of definition and scope of pharmacoepidemiology. Types of studies - cohort studies, cross-sectional studies etc.
conversion from INTRAVENOUS TO ORAL DOSING----- design of dosage regimenpavithra vinayak
conversion from INTRAVENOUS TO ORAL DOSING----- TYPES OF IV TO PO THERAPY CONVERSIONS: MEDICATIONS INCLUDED IN AN IV TO PO CONVERSION PROGRAM: SELECTION OF PATIENTS FOR IV TO PO THERAPY CONVERSION: design of dosage regimen--clinical pharmacokinetics and therapeutic drug monitoring-- fifth pharm D notes
Pharmacovigilance is science of detection,
assessment, reporting and prevention of adverse
reactions to drug(s).
Major aims of pharmacovigilance are:
1. Early detection of hitherto unknown adverse
reactions and interactions
2. Detection of increases in frequency of (known)
adverse reactions
3. Identification of risk factors and possible
mechanisms underlying adverse reactions
4. Estimation of quantitative aspects of benefit/risk
analysis and dissemination of information needed to
improve drug prescribing and regulation.
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
Definition and scope of Pharmacoepidemiology ABUBAKRANSARI2
In these slides I shared the information of definition and scope of pharmacoepidemiology. Types of studies - cohort studies, cross-sectional studies etc.
conversion from INTRAVENOUS TO ORAL DOSING----- design of dosage regimenpavithra vinayak
conversion from INTRAVENOUS TO ORAL DOSING----- TYPES OF IV TO PO THERAPY CONVERSIONS: MEDICATIONS INCLUDED IN AN IV TO PO CONVERSION PROGRAM: SELECTION OF PATIENTS FOR IV TO PO THERAPY CONVERSION: design of dosage regimen--clinical pharmacokinetics and therapeutic drug monitoring-- fifth pharm D notes
Pharmacovigilance is science of detection,
assessment, reporting and prevention of adverse
reactions to drug(s).
Major aims of pharmacovigilance are:
1. Early detection of hitherto unknown adverse
reactions and interactions
2. Detection of increases in frequency of (known)
adverse reactions
3. Identification of risk factors and possible
mechanisms underlying adverse reactions
4. Estimation of quantitative aspects of benefit/risk
analysis and dissemination of information needed to
improve drug prescribing and regulation.
The safety monitoring in a clinical trail accompanies by common practices in safety monitoring, communicating safety information among stakeholders in a clinical trail.
2. Hospital Formulary.pdf unit 2 sem 7 b.pharmacyVedika Narvekar
Hospital formulary
Definition, contents of hospital formulary, Differentiation of hospital formulary and
Drug list, preparation and revision, and addition and deletion of drug from hospital
formulary
Introduction
Pharmacy & therapeutic committee (PTC)
Hospital formulary
Infection control committee
In these days of modern medicine, a large number of drugs are available for the treatment of a disease.
Considering the complexities surrounding their effective use, it is necessary for the hospital to establish a system to bring the best medicinal agents to the attention of the medical staff and help them in proper selection of therapeutic substances.
In order to ensure proper rationality in the use of drugs a “PHARMACY AND THERAPEUTIC COMMITTEE” need to be organized and constituted in a hospital.
It is an advisory group of medical staff and the administration of hospital on matters related to the therapeutic use of drugs.
FUNCTIONS
To advise the medical staff on usage of drugs.
To develop and compile formulary of drugs accepted for use in the hospital.
To plan/establish suitable educational programs.
To review adverse drug reactions.
To make recommendations concerning drugs to be stocked in hospital patient care areas.
To advise the pharmacy in the implementation of effective drug distribution and control procedures.
HOSPITAL FORMULARY
Hospital Formulary is defined as a list of drugs used in the hospital.
Formulary system is method whereby the medical staff of an institution, working through the PTC, evaluates, appraises, and selects from among the numerous available drug entities & drug products those that considered most useful in patient care.
Hospital Formulary - presentation gives the detail idea about Hospital formulary, its advantage, disadvantage, how to prepare Hospital formulary and much more. this will be useful for Pharm.D-IV YEAR students, which was in their Hospital pharmacy subject. regards APOLLOJAMES
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.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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Acute scrotum is a general term referring to an emergency condition affecting the contents or the wall of the scrotum.
There are a number of conditions that present acutely, predominantly with pain and/or swelling
A careful and detailed history and examination, and in some cases, investigations allow differentiation between these diagnoses. A prompt diagnosis is essential as the patient may require urgent surgical intervention
Testicular torsion refers to twisting of the spermatic cord, causing ischaemia of the testicle.
Testicular torsion results from inadequate fixation of the testis to the tunica vaginalis producing ischemia from reduced arterial inflow and venous outflow obstruction.
The prevalence of testicular torsion in adult patients hospitalized with acute scrotal pain is approximately 25 to 50 percent
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
Pulmonary Thromboembolism - etilogy, types, medical- Surgical and nursing man...VarunMahajani
Disruption of blood supply to lung alveoli due to blockage of one or more pulmonary blood vessels is called as Pulmonary thromboembolism. In this presentation we will discuss its causes, types and its management in depth.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
2. 3/20/2018
2
Definitions and overlapping terms
Types of ‘off-label‘ use and examples
Consequences following ‘off-label’ use
Regulatory and legal aspects
Drug repositioning
Summary
OUTLINE
MUHS - MSc Pharmaceutical Medicine class
3. 3/20/2018
3
Definitio
• the use of an authorised medicine by a
healthcare professional to treat a patient in a
way not covered by Marketing Authorisation
(MA) and detailed in the Summary of Product
Characteristics (SmPC) of the medicine
• prescribing currently available and marketed
medications but for an indication that has never
received regulatory approval
MUHS - MSc Pharmaceutical Medicine class
4. 3/20/2018
4
• does not have a Marketing Authorisation (MA)
• It can only be used in clinical studies or for
compassionate use/expanded access setting
• involves a medicine that is licensed (has an MA)
• is a medicine used in a different way than authorised
• when using a different dosing regime; for a different
indication/disease;
• when it is used for a different population, for example, using it for
paediatric (children) use, when the medicine is only intended for
use in adults
Unlicensed
medicines
Off-label
use
Eg.
Unlicensed medicines versus Off-label use
MUHS - MSc Pharmaceutical Medicine class
6. 3/20/2018
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Propranolol for Performance Anxiety
Clomiphene for Male Infertility
Quetiapine for Insomnia
Memantine for OCD
Clonidine for ADHD
Sildenafil for Female Sexual Arousal Disorder
Prazosin for Nightmares
List of off-label uses for prescription
drugs
MUHS - MSc Pharmaceutical Medicine class
7. 3/20/2018MUHS - MSc Pharmaceutical Medicine class
7
Clinical indications associated with on-label
and off-label uses for top 14 drugs
https://med.stanford.edu/news/all-news/2008/11/14-drugs-identified-as-most-urgently-needing-study-
for-off-label-use-stanford-professor-says.html
8. 3/20/2018
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A medication may not have been studied and approved for a specific
population
A life-threatening condition may motivate a HPC to give any treatment
that is logical and available, whether approved or not
If the pathophysiology of 2 conditions are similar, a physician may use
a medication approved for 1 of these conditions for both
If one medication from a class of drugs has approval, physicians
commonly use other medications in the same class without specific
regulatory approval for that use for the same indication
Factors motivating Off-label drug use
MUHS - MSc Pharmaceutical Medicine class
9. 3/20/2018
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prescription and use may be of benefit for a specific patient
Outcome of ‘off- label’ use (outside of formal clinical trials)
are of interest including for pharmacovigilance
Permits innovation in clinical practice
Offers early access to potentially valuable medication
Treatment in “orphan” conditions
‘Off- label‘ use or prescription: a bad thing?
MUHS - MSc Pharmaceutical Medicine class
10. 3/20/2018
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Therapeutic advances
are more rapid
compared to clinical
trial and regulatory
approval process
Once patents have
expired, no financial
motivation for
pharmaceuticals to
conduct trials for new
indications
Potential new
indication might not
be commercially viable
for the industry
Why do drugs remain off label???
MUHS - MSc Pharmaceutical Medicine class
11. 3/20/2018
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• Drugs given at doses other than those stated in
approved product information
Based on dose
• Drugs prescribed outside approved age rangeBased on age
• Drugs administered by unapproved route of
administration
Based on route
• Drugs used for indications other those stated in
approved product information
Based on indications
• Preparations of suspensions from capsules or
tablet; Using an oral preparation as a topical
agent
Modification of registered
medication
Types
MUHS - MSc Pharmaceutical Medicine class
12. 12
Obtaining written consent may be appropriate in some cases
Documentation of the consent process is recommended and,
As the medicine is being used off-label, additional information about
any uncertainties should be given
A healthcare professional’s decision whether to prescribe a medicine
off-label or not should be guided by evidence based medicine and
the best interest and medical needs of patients
3/20/2018MUHS - MSc Pharmaceutical Medicine class
Patient consent
13. 3/20/2018
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MUHS - MSc Pharmaceutical Medicine class
Professional conduct – controlled by Professional Conduct, Etiquette and
Ethics Regulations, 2017, ICMRPrescription of drugs
- Should not violate Drugs and Cosmetics Act (steroids, psychotropic
and narcotic drugs)
- Should not violate human rights
- Should not violate ICMR guidelines for research
no mention regarding “off-label” use
Regulatory guideline in India regarding off-label use
14. 3/20/2018
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MUHS - MSc Pharmaceutical Medicine class
Govt. of India, 2004 →
committee under Indian
Medical Association to make
specific guidelines
governing off-label drug use
Strongly favored off-label use of
drugs (if evidence based)
Indian law does not currently allow drugs to
be prescribed for indications for which they
have not been approved
Amendments to the
Indian Medical Council
Act 2 years ago made
off-label prescribing
illegal
Marketing such drugs by
pharmaceutical company is
considered as contravention of the
law and action is taken under the
Drugs and Magic Remedies
(Objectionable Advertisements) Act,
1954
BUT
Regulatory guideline in India
regarding off-label use
15. 3/20/2018
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MUHS - MSc Pharmaceutical Medicine class
Bavdekar SB, Sadawarte PA, Gogtay
NJ, Jain SS, Jadhav S. Offlabel drug use
in a Pediatric Intensive Care Unit.
Indian J Pediatr. 2009
Nov;76(11):1113-8
• Out of 2237 prescriptions in children , 1579 (70.58%)
were off-label in nature
Kharadi D, Patel K, Rana D, Patel V.
Off-label drug use in Psychiatry
Outpatient Department: A Prospective
Study at a Tertiary Care Teaching
Hospital. Journal of Basic and Clinical
Pharmacy 6.2 (2015): 45–9
• Of 250 patients in psychiatry OPD, 198 (79.2%)
received at least one off-label drug
What Is the current status in India???
16. Pros Cons
Early access to potentially valuable
medicine / may become standard of care
Increases likelihood of ADR
Tailor and improve individual patient care Easiest way for industry to bypass
approval process and expand market
Only choice in palliative settings / orphan
status
Medicolegal concerns
Pediatrics, geriatrics and obstetrics Increases healthcare costs
3/20/2018
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Pros and cons of off-label use of drugs
MUHS - MSc Pharmaceutical Medicine class
17. 3/20/2018
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MUHS - MSc Pharmaceutical Medicine class
Drug repositioning
• Drug repurposing, Drug reprofiling, Therapeutic
switching and Drug retasking
• It is the application of known drugs and compounds
to new indications (new diseases)
• Using drug repositioning, pharmaceutical companies
have achieved of number successes
• Example –Sildenafil in erectile dysfunction and
thalidomide in severe erythema nodosum leprosum
18. 3/20/2018
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MUHS - MSc Pharmaceutical Medicine class
Repositioned drug has already passed a
significant number of toxicity and other tests
Its safety is known
The risk of failure for reasons of adverse
toxicology are reduced
Advantage of drug repositioning over traditional
drug development
19. 3/20/2018
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MUHS - MSc Pharmaceutical Medicine class
Off-label drug
use involves
prescribing
medications for
an indication, or
using a dosage or
dosage form, that
has not been
approved by the
regulatory
approval
• Since the FDA
/DCGI does not
regulate the
practice of
medicine,
OLDU has
become
common
It occurs more
common in areas
in which the
patient population
is less likely to be
included in clinical
trials
Physicians should
prescribe
medications only
for indications - on
the basis of the
most credible
available evidence
Summary