Pharm Lecture 1

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  1. What is psychopharmacology?
    Study of drugs to treat mental disorders
  2. What clinical psychologists should know about pharm.
    • -most mental health services are provided by non physician health professionals
    • -majority of psychotropic meds are prescribed by GPs not psychiatrists
  3. % of Rx written by psychiatrists for Lithium
  4. % of Rx written by psychiatrists for antipychotics
  5. % of Rx written by psychiatrists for antidepressants
  6. % of Rx written by psychiatrists for anxiolytics
  7. % of Rx written by psychiatrists for sedatives/hypnotics
  8. Why do non-psychiatrists prescribe more?
    • -high cost of psychiatrists
    • -healthcare/insurance may not cover psychiatrists
    • -more familiar with GP
    • -Psychiatrist has stigma...seen as personal failure
  9. How do psychologists monitor response to meds?
    • -are target sx improving?
    • -psychologists see pts more often than MD
    • -better position to observe, discuss, and work with pt regarding undesirable side effects and suggestions for managing side effects
    • -recommend reevaluation of drugs by MD
    • -make specific recommendations about type of drug to non psychiatrist MD
  10. Why therapists should learn about psychology.
    • Therapists need to communicate with doctors to help the client/patient manage their illness
    • -discuss diagnoses
    • -treatment plans
    • -best alternatives

    • Health maintenance organization (HMOs) therapists are responsible for
    • -Referring patients to physicians for medication
    • -Monitoring patient response to drug treatment
  11. Psychotherapist's Role
    • -Know when and how to refer patients to MDs (primary care physicians or psychiatrists) for psychotropic medication evaluation
    • -Monitor aspects of pharmacologic treatment in the context of psychotherapy

    • -Effectiveness of drug treatment in reducing target symptoms
    • -Desired therapeutic effect
    • -Side effects of drug treatment Typically undesirable effects of the drug

    -Monitor and foster medication compliance
  12. When to refer for psychotropic med eval
    • When serious psychiatric symptoms are present that significantly and negatively impact the patient’s ability to function in everyday life activities
    • -Mental Status changes or low score on MSE
    • -When there is evidence that pharmacologic treatment can relieve significant symptoms and promote more adaptive daily functioning
  13. Specific times when patients SHOULD be referred for psychotropic treatment
    • Presence of psychotic symptoms
    • Presence of manic behavior
    • Presence of vegetative sx
    • presence of ritualistic compulsions that sig impact everyyday life funct.
  14. Specific times when patients MAY be referred for psychotropic treatment
    • Presence of severe social phobia
    • Presence of ADHD
    • Presence of Tourette’s syndrome or other tic disorder
    • Presence of explosive, aggressive behavior that is of new onset or out of character
    • When psychotherapy has been unsuccessful in treating any of the following
    • Depression
    • Anxiety
  15. Presence of psychotic sx
    • Positive symptoms of psychosis,
    • Disorganized speech/thinking,
    • Catatonic behavior.
  16. presence of manic beh
    • Grandiosity
    • Psychomotor agitation
    • Decreased need for sleep
    • Pressured speech
    • Flight of ideas; racing thoughts
    • Euphoric mood
    • Impulsive behavior
  17. presence of vegetative sx
    • Change in appetite
    • Weight loss or gain without intent
    • Alteration in sleep pattern (oversleeping or early morning awakening)
    • Psychomotor retardation
    • Persistent fatigue and low energy
  18. General Principles for Psychopharmacologic Treatment
    • Accurate diagnosis
    • Caution on assuming it was done correctly (or done at all)Identification of target symptoms likely to respond to drug treatment
    • Monitor functional status of patient in carrying out daily life activities
    • Medical causes of psychological symptoms must be ruled out.
    • Substance abuse/dependence as causes of psychological symptoms must be ruled out
  19. General Principles for Psychopharmacologic Treatment (2)
    • Other medical disorders can influence psychotropic drug selection
    • Monitor for drug-drug interactions
    • Personal and family history of medication responsiveness
    • Polypharmacy (use of multiple medications) undertaken with caution
    • Life circumstances may be impacted by drug side effects
  20. General Principles for Psychopharmacologic Treatment (3)
    • Cost of the drug
    • Dosing frequency
    • Are generic equivalents appropriate?
    • Awareness of potential drug-food interactions
    • Prescribe only the number of pills that it is safe for the patient to have available
  21. Stages and Goals of Psychopharmacologic Treatment
    • Three stages of pharmacologic treatment:
    • Acute Stage
    • Continuation Stage
    • Maintenance Stage
  22. Acute Stage
    • Patient is presenting with severe symptoms that are very disruptive to their everyday functioning
    • The goal at this stage of drug therapy is to reduce symptoms and do it as quickly and safely as possible
  23. Continuation Stage
    • Relapse Prevention
    • Focus is to prevent patients from prematurely discontinuing medication, and having another episode of illness
    • Goal is to prevent acute relapse after the person has manifested initial clinical improvement
    • A risky stage of treatment because after initial improvement in symptoms, people who are feeling better tend to stop their medications
    • This is known as being asymptomatic
    • Important to support patients in the maintenance and continuation of medication in order to prevent relapse
  24. Maintenance Stage
    • Goal is to prevent future episodes of the disorder
    • In some disorders it is critical that the person maintain their pharmacological intervention indefinitely
    • Again, asymptomatic is key issue of concern here
    • Examples: Bipolar I, Schizophrenia, residual stage/phase
  25. When is maintenance program appropriate?
    • Not all disorders require long term drug treatment
    • Anxiety disorders often require only short term use of medication to help manage the symptoms (if any), plus psychotherapy to help the person develop appropriate coping skills. Some disorders may require constant medication
    • Cost-Benefit Analysis:
    • Decision to provide maintenance pharmacologic treatment for a disorder is based upon multiple factors that need to be considered and discussed with the patient and any other mental healthcare providers
  26. Factors Influencing Maintenance Treatment
    • Length of time between episodes of illness
    • Severity and destructiveness of the illness episodes
    • How quickly and easily an episode of the disorder can be brought back under control
    • Rapidity with which illness episodes begin
  27. Factors Influencing Maintenance Treatment
    • Patient’s capacity for self awareness or insight regarding symptomology
    • Toxicity (and side effect profile) of the drug being prescribed
    • Whether other alternative preventive approaches might reduce the risk of another illness episode
    • Compliance or adherence to medication (or polypharmacy) regimen
  28. Meication Compliance
    • Type of Medicine % of Doses Taken
    • Treat Physical Illness 76
    • Antipsychotic 58
    • Antidepressant 65
  29. Non-compliance with Psychotropic Drug Regimen
    • 25 to 50% of patients are NOT compliant with dose or timing of psychotropic medications
    • Minor instances of non-compliance for most medications
    • Missing/omitting a dose because of forgetting
    • Mistiming doses
    • Delaying doses or taking them early
  30. Non-compliance with Psychotropic Drug Regimen(2)
    • Major instances of non-compliance
    • Refusing to take the prescribed drug or stopping without consulting MD
    • Taking less than the prescribed amount regularly skipping doses
    • Taking the medication occasionally
    • When symptoms are severe or troublesome
    • Taking more of the drug per dosetaking the drug at shorter intervals than prescribed
  31. Reasons for Psychotropic Medication Non-Compliance
    • Disorder reasons
    • Symptoms of a disorder that requires drug treatment may keep the patient from complying
    • Paranoia
    • Denial
    • Cognitive impairment/disorganization
    • Attitudinal factors
    • Negative attitude toward authority
    • Fear of the addictive potential of psychotropics
    • Oversensitivity to perceived loss of control
    • Confirmation of scary belief that they are “crazy”
    • May have to give up the “sick role” if they improve
  32. Reasons for Psychotropic Medication Non-Compliance (2)
    • Values
    • Family, religious and cultural attitudes, values, and beliefs
    • Pragmatic Reasons
    • Lack of knowledge about how?, when?, why?
    • Lack of structure
    • Develop system for remembering to take meds Polypharmacy
    • Complicated regimens that are hard to follow
  33. Reasons for Polypharmacy
    • Presence of more than one disorder
    • Need for second medication to augment treatment effectiveness because a single agent does not provide significant symptom improvement
    • Need for combined therapy because treatment with two agents is more effective than treatment with either one alone
    • Provision of temporary relief of symptoms until another other drug intervention can take effect
    • Drug treatment of the side effects of the first medication
    • Documented need for multiple medications to treat a specific disorder
  34. Controlled Substances: Schedule I Drugs
    • Controlled Substances Act
    • Substances that have a high potential for abuse, no currently acceptable medical use in treatment, and which lack any accepted safe use under medical supervision
    • Production of these drugs is controlled
    • Examples include heroin, all hallucinogens, marijuana, and hashish
  35. Schedule II drugs
    • Substances that have a high potential for abuse with severe liability to cause psychic or physical dependence, but have some approved medical use with severe restrictions
    • Production of these drugs is controlled
    • Examples include opium, morphine, codeine, other narcotics (oxycodone), barbiturates, cocaine, amphetamine/ methamphetamine, and phencyclidine (PCP)
  36. Schedule III drugs
    • Schedule III Drugs have some potential for abuse, but less than I and II
    • Example: hydrocodones, benzodiazepines (diazepam or Valium), some barbiturates
    • Potential for abuse of Schedule IV drugs is less than Schedule III;
    • Schedule V is less than IV
    • All Schedule III-V drugs have accepted medical uses and production is not strictly controlled
  37. Bringing a drug to market
    • Prescription medications
    • Controlled by Food and Drug Administration (FDA)~ 3,000 different drugs
    • Over the Counter drugs
    • Not regulated, but can be pulled by FDA~300,000 different drugs
    • Dietary Supplements
    • Vitamin and herbal supplements
    • Note that these are still drugs
    • May not be psychoactive, though
  38. Process of drug testing
    • First step is preliminary determination of toxic effects
    • Use 2 or more animal species to determine
    • LD50 lethal dose in 50% of population
    • May see as TD50 for toxic dose
    • Need to determine what is toxic (maybe it isn’t)
    • Test on pregnant animals to determine teratogenic effectsLonger term studies for chronic problems to simulate duration used with humans
    • This takes 1-5 years
  39. Drug Testing step
    • Testing must identify...
    • Composition of new compound
    • Identify chemical structure
    • Purification of active ingredients
    • Be specific about what we are saying is causing this change to occur
    • THEN get permission from FDA to use on humans for testing
  40. Submit Investigational New Drug (IND) to FDA
    • Patent clock starts NOW for new drugpermission from FDA to use on humans for testing
    • Note that we have already spent a lot of money on first step in research and development of identifying our drug to get the IND
    • Now we begin
    • Phase 1-3 trials
  41. Phase 1 Trial
    • 20-80 healthy volunteers (prison inmates, med students)
    • Absorption rates
    • Side effects
    • Therapeutic index
    • Schedule of administration
    • Takes approx. 1.5 years
  42. Phase 2 Trial
    • Test on affected population
    • Must be free of other health problems
    • Double-blind studies
    • Both assure high internal validity
    • Done with 200-300 participants
    • Takes approx. 2 years
  43. Phase 3 Trial
    • Examine with 1000-3000 patients
    • Look for
    • Safety
    • Effectiveness
    • Dosage
    • Side effects
    • Takes approx. 3.5 years
    • Phases 1-3: 2-10 years
    • Most psychopharmacological agents (psychotropic drugs) will take 8-10 years
  44. Clinical Studies for Prescription Drugs
    • If all goes well
    • Submit New Drug Application to FDA
    • Very few reach this point
    • FDA reviews to determine readiness for commercial marketing
    • 2 mos to 7 years
  45. Clinica Studies for Rx Drygs (2)
    • For every 5,000 compounds evaluated in IND testing 5 enter all levels of trials1 gets FDA approval
    • Process costs $125,000,000 to $300,000,000 in research and development
  46. Phase 4 Trial
    • Not really a trial
    • “Open Trial” while the drug is in public use
    • This is when long-term effects are seen
    • Long term usage
    • Drug interactions
    • Adverse reactions, allergies
    • Drug companies do not know about these problems because they don’t occur until now
  47. MedWatch -phase 4
    • MedWatch
    • Federally funded program
    • Physicians VOLUNTARILY report adverse effects from drugs used by patients“safety alerts, recalls, withdrawals, and important labeling changes that may affect the health of all Americans are quickly disseminated to the medical community and the general public via web site”
  48. Serzone example
    • Black box warning example:Serzone
    • Put on by FDA
    • Now, pulled from market voluntarily
  49. Patents
    • Patent is granted for 20 years
    • Patent begins with initial drug testing (IND)
    • Once drug goes to market, clock has already been running many years
    • This is when drug company recoups costs incurred in research and development
    • Once patent expires drug goes to generic form
  50. Generic Equivalents
    • 1984: FDA required bioequivalency
    • Chemically and pharmacologically equivalent
    • These are much less expensive
    • Can be compounded by other companies (Walgreen’s) or by pharmacist
    • There are some considerations here…
  51. Generic Equivalents (2)
    • These are not always equivalent
    • “Inactive ingredients” do not have to be the same
    • These are not necessarily inactive or inert at all
    • These binding agents or enteric coatings affect the drug
    • These can change where the drug is primarily dissolved and absorbed
    • How the body interacts with drug and the other chemicals
    • FDA allows higher variance in generics
    • Can vary by 20% from dosage on label
    • Some drugs we can see lower for generic:
    • Significant difference in maximum drug concentrations
    • Significant difference in amount of drug absorbed
    • Lower plasma concentrations
    • Differences in absorption rates
    • Some studies have shown higher relapse rates
  52. FDA drugs safe?
    • Relatively
    • All have side effects
    • Some have abuse potential
    • Some have OD potential
    • Remember drug interactionsTCAs are very dangerous BZDs in combination with ETOH
    • Remember that it takes time to know some of the real effects of these drugs
    • Think “Phase 4 trial” here
    • Especially with new drugs
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Pharm Lecture 1
2012-04-20 21:06:36

Lecture 1
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