Pharmaceutical Compounding

Compounding  of pharmaceuticals is necessary if a drug is not manufactured, due to a discontinuation or shortage, to meet the clinical needs of a patient.  This may occur in a local pharmacy or in a hospital.  A few years ago, a tragedy was reported related to contaminated spine steroid injections compounded by the New England Compounding Pharmacy in Massachussetts. The compounding product had a widespread use throughout the US for lumbar spine injections for back pain. As a result of sloppy and unsafe practices, batches of the injection became  contaminated, and hundreds of patients developed fungal meningitis; 70 patients died. In addition to civil and regulatory lawsuits and sanctions, the pharmacists in charge have been charged in criminal court for placing patients live at risk.

Other contaminated injections, including eye drugs, have occurred in the past, but not to the far reaching effect of NECC. Other types of errors include the wrong chemicals used in the formulation, and an excessive (dose) amount or inadequate amount, due to ignorance or inexperience of those preparing the formulation.

As a rule, If product is available commercially, then a compounding product should not be used or made.

Manufacturer products are safer than compounded.

Urine Drug Screening

The first step to assessing whether someone has a drug in their system is often a urine drug screen.  Drug screens can be performed to test drug use after a crash, to test whether prospective employees are drug users, as part of compliance in a drug program, to determine possible impairment after a workplace accident, and in other civil and criminal situations.  Drugs of abuse typically tested are cocaine, methamphetamine, marijuana, phencyclidine, and morphine/opiates.  Urine drug screening detects whether certain drug classes are present, but generally cannot distinguish individual drugs.  So a test for morphine will also test positive for opiates, but not necessarily opioid medication. Advantages of urine drug screens are that they are inexpensive and non-invasive.  Other urine drug panels may be used to detect additional drugs in one class, or additional classes of medication.

Screens are used, and if positives are reported, they must be confirmed.

Urine drug screens are based on immunoassay technology, in which the binding of antibody to a certain part of a molecule characteristic of a drug class will trigger a change in the amount of light at a certain wavelength that is given off and detected.  In other words, the more times an antibody binds to drug molecules, the more the assay signal changes.  However, the antibody targets only a particular part of the drug molecule, and so it will bind anything which has that particular chemical structure.  This leads to cross-reactivity and false positives.  For this reason, any test which has medical or legal consequences or would impact someone greatly should be confirmed by a GC/MS test, which is much more reliable in identifying individual drugs. In part to reduce the possibility of false positives, the measured drug concentration must exceed an established cutoffs/minimum level to register as a positive test result.

When evaluating these cases, it is important to obtain all the lab reports to verify that the analysis was correct in identifying the drug.  It is necessary to verify that the proper lab protocols were followed. The subject/employee, patient, etc should be asked if taking ANY medications, prescription, over the counter, or supplements, as these exposures may explain positive findings.  Questionable lab reports should be reviewed by knowledgeable experts to determine if the results are accurate and lab protocols and standards are followed.

Drug Induced Falls

This is an important topic excerpted from our O’Donnell’s Drug Injury IVth Ed. book

Significant contribution to Falls

Use of medicines, such as tranquilizers, sedatives, or antidepressants. Even some over-the-counter medicines can affect balance and how steady you are on your feet.

In theory, ANY drug that causes one of the following effects can increase the risk of falling:

  • Drowsiness
  • Dizziness
  • Hypotension
  • Parkinsonian effects
  • Ataxia/gait disturbance
  • Vision disturbance

Greatest risk:

  • Sedative / hypnotics
  • benzodiazepines, especially long half life (Valium)
  • Blood pressure medicines  –  too much, get up too fast, dizzy and fall.
  • Alcohol plus any drug increasing fall risk – overall significantly greater fall risk.

Falls account for over 8 million hospital emergency room visits, representing the leading cause of visits (21.3%). Slips and falls account for over 1 million visits, or 12% of total falls. The CDC also reports that approximately 1.8 million people over the age of 65 were treated in an emergency room as a result of a fall. For people aged 65-84 years, falls are the second leading cause of injury-related death; for those aged 85 years or older, falls are the leading cause of injury-related death. Incidence of falls goes up with each decade of life.

Fractures are the most serious consequences of falls and occur in 5% of all people who fall.

Slips and falls are the leading cause of workers’ compensation claims and are the leading cause of occupational injury for people aged 55 years and older.

Half of all accidental deaths in the home are caused by a fall. Most fall injuries in the home happen at ground level, not from an elevation. Of all fractures from falls, hip fractures are the most serious and lead to the greatest health problems and number of deaths. The following statistics describe the slip-and-fall crisis affecting our nation’s elderly. Each year in the United States, one of every three persons over the age of 65 will experience a fall. Half of which are repeat fallers. According to the CDC In 2005, more than 15,000 people over the age of 65 died as a result of a fall. Up from 7,700 a decade earlier.

See Barbara Cadario and BC Falls and Injury Prevention Coalition. Drugs and the Risk of Falling: Guidance Document. Revised August 2011.  

Opiate Toxicity Video

Not a day goes by without multiple news reports about the opiate epidemic and opiate deaths in all walks of life. Dr. James J. O’Donnell has prepared a video explaining how opiates cause toxicity, specifically suppression of breathing, which is the mechanism of death in opiate toxicity and overdose.

This scenario presents in criminal law (drug induced homicide), as well as in civil/health care malpractice. Deaths occur on the street, in the hospital, and after discharge at home.

Drug Allergy Video

Allergic reactions can occur with any drug. Patients need to be constantly asked about allergic reactions, and notes/warnings/flags about allergies must be posted on all medical, health, pharmacy, and dental records. Some drugs cause allergies more than others, and patients with multiple allergies are at risk for more allergies and more severe reactions. Allergic reactions can be minor, a rash, itching, or severe/deadly, an anaphylaxis – unable to breath, loss of pulse, or severe swelling/ rash on the skin.

The minor reactions, with no prior reaction hisory, are unavoidable. They are important, and must be noted, because the second or subsequent exposures can result in a severe or deadly reaction. As a result of this, severe reactions are, in most cases, avoidable.

The video, presented by James T. O’Donnell Pharm D, discusses allergic reactions, risks, avoidance, and provides guidances for risk reduction of this very common and frequently deadly adverse drug reaction.

Pharmacist Errors

A recent front page story in the Chicago Tribune reporting more than 50% of pharmacists tested failed to detect and warn about dangerous drug interactions made national news, and calls by the Illinois Governor for increased enforcement of the Illinois Pharmacy Practice Act.

The video below on pharmacists errors is presented by James Thomas O’Donnell, a pharmacist who has served as a pharmacy college professor, the Founding Editor of the Journal of Pharmacy Practice, and a frequent consultant and expert witness in pharmacist error cases.

The type, frequencies and severity of errors are reviewed, and recommendations made to help individual patients avoid injury by pharmacist errors.

Ambien Sleep Driving

Ambien is a benzodiazepine-like drug (ie, Xanax) which is used as a sleeping pill. It induces a rapid descent into sleep. One of its classic side effects is anterograde amnesia. After taking the pill, the person may be awake and functional for some time before falling asleep, but they may have no recollection of that time afterwards. More importantly, after falling asleep, people get up, sleep walk, sleep cook, sleep drive, and even sleep-sex. People may Continue reading