Alcohol Withdrawal – Tremors start around 6 hours, seizures around 12 hours, but can occur 3-5 days later. Mortality can be as high as 35%. 3 Ts – Increase temp, tremor and tachycardia Treatment: correct electrolyte imbalances, benzos, can use propofol or barbiturates in refractory cases, magnesium, alpha 2 agonists, Beta blockers, calcium channel blockers Avoid: […]
Study Design
What Statistical Test To Use: I memorized this table and wrote it out on my noteboard during the test. It makes it easy to pick out which test without much mental effort Type of Data 2 Independent Samples“BETWEEN“ Related or Paired Samples“WITHIN“ 3 or More Independent Samples 3 or More Related Samples Measures of Correlation Prediction […]
Stages of Drug Development
Stages of Drug Development: 1 IND Animal tests 2 IND Review by FDA and local IRB Animal tests 3 Phase 1 Healthy volunteers, tests safety 4 Phase 2 Sick volunteers, tests effectiveness 5 Phase 3 Larger scale, test effectiveness and adverse effects 6 Post-marketing Review 7 NDA application 8 FDA Review and decision […]
Sleep Disturbances
Lifestyle Modifications: Maintain sleep schedule Do not go to bed unless tired Sleep long enough, but not too much Optimize bedroom lighting, temp and sound Develop a ritual Do not stay in bed for more than 15 minutes if you can’t sleep Don’t go to bed hungry. Only use the bedroom for sleep Avoid naps Avoid […]
Skeletal Muscle Relaxants
baclofen – seizure in overdose
Research Study Subjects -Informed Consent
Expedited IRB Review: Minimal or no risk Involve data, documents, specimens etc that have been collected for non-research purposes. IRB Exempt: Research in established or commonly accepted educational settings Use of educational tests where subjects cannot be IDed The use of texts and surveys if the subject is a public official under FOIA. Collecting or […]
QT Prolongation
Low Mg, Ca or K can all cause QT prolongation
Pulmonary HTN
Stages: No symptoms Symptoms with strenuous daily activities Symptoms with normal daily activities Symptoms at rest. Treatment: High dose CCBs Inhaled nitric oxide IV epoprostenol and IV adenosine ambrisentan, bosentan, macitentan, riociguat, sildenafil, tadalafil
Medication Errors
Medication Error Definitions: Mild: enhanced monitoring, no harm Moderate: active treatment required, enhanced monitoring, but no lasting harm Severe: patient harm that requires enhanced treatment and increased patient stay FDA’s Adverse Event Reporting System (FAERS): FAERS is a database that contains adverse event reports, medication error reports and product quality complaints resulting in adverse events that […]
Laws and Regulations to Know
This section is tricky. I recommend knowing a few laws and what they do. Food, Drug and Cosmetic Act (1938) – Give authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. Covers orphan drugs. The introduction of this act was influenced by the death of more […]