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Off label use

MUHS Pharmaceutical Medicine Class

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Off label use

  1. 1. 3/20/2018 1 OFF LABEL USE : An Overview Dr.RENJU.RAVI MD MUHS - MSc Pharmaceutical Medicine class
  2. 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. 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. 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
  5. 5. 3/20/2018 5 Medication error- treatment process related, not intentional Misuse, abuse - may be intentio nal or non- intentional, ‘off– label ‘use or medication error Compassionate use(?)- unauthorized drug, intentional Orphan disease t treatment- intentional Overlapping terms MUHS - MSc Pharmaceutical Medicine class
  6. 6. 3/20/2018 6 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. 7. 3/20/2018MUHS - MSc Pharmaceutical Medicine class 7 Clinical indications associated with on-label and off-label uses for top 14 drugs for-off-label-use-stanford-professor-says.html
  8. 8. 3/20/2018 8 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. 9. 3/20/2018 9 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. 10. 3/20/2018 10 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. 11. 3/20/2018 11 • 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. 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. 13. 3/20/2018 13 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. 14. 3/20/2018 14 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. 15. 3/20/2018 15 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. 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 16 Pros and cons of off-label use of drugs MUHS - MSc Pharmaceutical Medicine class
  17. 17. 3/20/2018 17 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. 18. 3/20/2018 18 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. 19. 3/20/2018 19 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
  20. 20. 3/20/2018MUHS - MSc Pharmaceutical Medicine class 20 THANK YOU