It took a high profile case such as the death of Michael Jackson to bring worldwide attention to the misuse and dangers of Propofol. Access and availability should be restricted, a move than will save lives

Over the years, there have been many case reports involving doctors and nurses abusing propofol, otherwise known as 'milk of amnesia'. However, they didn't attract any attention because the incidence was relatively low compared to other drugs such as opioids.

Until the recent death of Michael Jackson. The King of Pop had apparently been using propofol and toxicology reports found significant amounts of propofol along with other drugs.

So what is propofol?

Propofol is a short-acting sedative-hypnotic agent. It has become one of the most widely used anesthetic agents today. Its brand name is Diprivan, marketed by Astra Zeneca; however, generic versions are also available. It is primarily used in initiating or maintaining regional and general anesthesia during surgical procedures but is also used to induce sedation in patients on ventilators typically in intensive care units.

Propofol has become a popular anesthetic because its relatively 'short action' allows for a quick recovery, and is considered safe with minimal side effects. The most common side effects described are mood swings, dizziness, drowsiness; and lack of coordination. And it is also used extensively in veterinary medicine.

Propofol is a prescription drug and is not available over-the-counter. According to its package insert however, as approved by the U.S. FDA, propofol is only supposed to be administered by healthcare professionals trained in the administration of general anesthesia, such as anesthesiologists and certified registered nurse anesthetists (CRNA).

Propofol is not a controlled or 'schedule' drug, unlike many sedatives.  Under the U.S. Controlled Substances Act, certain drugs are controlled and classified into five different "schedules" depending on their medical use, safety and potential for abuse and addiction. Drugs which are highly addictive are classified as Schedule I (example: heroin) and then the schedule number increases with decreasing potency and dependence liability. Codeine found in cough syrups is a schedule V substance.

Controlled drugs, as the name suggests, are strictly regulated. In the U.S. they are regulated at the federal level by the Drug Enforcement Administration (DEA) and the U.S. Food and Drug Administration (FDA). Regulations are in place regarding their supply, distribution, storage and inventory in hospitals and pharmacies. Also regulated are the health professionals who are allowed to prescribe and administer these drugs.¹

Propofol abuse is on the rise but pales in comparison to other medications such as opioids and fentanyl. But the clinical use of propofol has significantly increased that incidence of dependence several fold.^2,3

Researchers at the University of Colorado surveyed 126 academic anesthesiology training programs in the U.S. and found the following:

• 18% of those surveyed admitted to have at least one case of propofol abuse or stealing during the past 10 years.
• Incidence of abuse was reported as 10 per 10,000 anesthesia providers per decade.
• Incidence of death among propofol users was 28%, many of whom were residents.⁴

So, why is propofol become one of the illicit prescription drugs of choice for both medical professionals and celebrities?

Propofol is easily available and accessible. Because it is not a controlled drug, every clinic, hospital and pharmacy has an ample supply of the drug, without checks and controls. There are no special precautions taken on the dispensing, prescription and storage of the drug. Any medical professional can have access to it.⁵

The University of Colorado survey revealed that "there was no established system to control or monitor propofol as is done with opioids at 71% of programs. There was an association between lack of control of propofol (e.g., pharmacy accounting) at the time of abuse and incidence of abuse at the program."

Propofol has become a popular recreational drug among medical professionals. Subanesthetic levels of propofol have been described to induce a “high” that is characterized by euphoria and sensitization.  Drug abuse is rampant among those people who are supposed to administer them, e.g. the medical professionals themselves and anaesthesiologists account for the majority.

According to Dr. Robert Hines of Department of Anesthesiology, Yale University School of Medicine, several factors contribute to the high incidence of abuse among anesthesiologists, namely; easy access, constant contact with drugs at the workplace and easy diversion.^6-8

Sleep disorders are very common especially among those who live a fast-paced, stressful lifestyle lifestyle especially celebrities and medical personnel. It is common knowledge that many Hollywood stars are hooked on prescription drugs and most of these drugs are sedatives and anti-depressants. Propofol seems to be one of the preferred drugs even though it is not indicated for insomnia.

There have been hints that propofol is not as safe and harmless as it seems even before 'Michael Jackson'.

Because it is a short-acting drug, several doses may be needed each day and can easily lead to overdose which can be life-threatening. According to MSNBC, the U.S. FDA has received “an increasing number of reports about fatalities linked to propofol in recent years: 43 in 2008 and 35 in 2007, up from an average of 22 per year over the decade before that“.^9-10

The American Association of Nurse Anesthetics (AANA) and the American Society of Anesthesiologists (ASA) have been very vocal about the abuse and dangers of propofol. As early as 2004, the AANA issued a position statement regarding the access to and administration of propofol. "Whenever propofol is used for sedation/anesthesia, it should be administered only by persons trained in the administration of general anesthesia, who are not simultaneously involved in these surgical or diagnostic procedures. This restriction is concordant with specific language in the propofol package insert, and failure to follow these recommendations could put patients at increased risk of significant injury or death".¹¹

The ASA "hopes that the tighter controls and monitoring that accompany scheduling will reduce the potential for abuse, although ASA members recognize that such action will not completely prevent all problems associated with the misuse of propofol".¹²

And a joint ASA and AANA statement expressed concerns that even medical professionals not trained in anaesthesiology get to administer the drug..."regulatory agencies, insurance companies, and various non-anesthesia professionals have downplayed the dangers of propofol, virtually treating its use as so easy, anyone can do it".¹³

How do we turn it around?

It's pretty obvious. Regulate it. In 2010, under pressure the Drug Enforcement Administration (DEA) responded by proposing to make propofol a schedule 4 drug. In response the American Veterinary Medical Association (AVMA) lobbied extensively against controlling propofol on the basis of interference in their daily use of propofol. You would still think that this would be a no brainer, but think again. As of 2012, propofol is still not a 'schedule' drug.^14-16

The Bottom Line

It took a high profile case such as the death of Michael Jackson to bring worldwide attention to the misuse and dangers of propofol.

Come on DEA, do your job. Access and availability of propofol should be restricted, a move than can save lives. But then again business interests trump just about everything or do they?

Published September 29, 2009, updated August 13, 2012

References

1. The Controlled Substances Act, U.S. DEA
2. Belluck P et al, With High-Profile Death, Focus on High-Risk Drug, The New York Times August 6, 2009
3. Wilson C et al, The abuse potential of propofol., Clin Toxicol (Phila). 2010 Mar;48(3):165-70
4. Wischmeyer PE et al, A Survey of Propofol Abuse in Academic Anesthesia Programs, Anesth Analg 2007; 105:1066-1071
5. McKenzie J, More Medical Professionals Abusing Propofol, ABC News Aug 21, 2009
6. McAuliffe PF, Second-hand exposure to aerosolized intravenous anesthetics propofol and fentanyl may cause sensitization and subsequent opiate addiction among anesthesiologists and surgeons, Med Hypotheses, 2006;66(5):874-82
7. Hines R, Substance Abuse in Anesthesia Providers: An Update, Refresher Course, Yale University School of Medicine
8. Fullerton-Batten J, The Junkie in the O.R. Men's Health, Men's Health 2008
9. DEA may limit drug eyed in Jackson case, MSNBC, July 15, 2009
10. Kirby RR et al, Death from Propofol: Accident, Suicide, or Murder? Anesth Analg 2009; 108:1182-1184
11. Position Statement Number 2.14. Securing Propofol, June 2009
12. ASA Supports DEA Proposal to Schedule Propofol, American Society of Anesthesiologists, November 21, 2010
13. AANA-ASA Joint Statement Regarding Propofol Administration, American Society of Anesthesiologists, April 29, 2004
14. Schedules of Controlled Substances: Placement of Propofol Into Schedule IV, Federal Register, October 27, 2010
15. AVMA cautions DEA on plans to raise propofol to controlled status, American Veterinary Medical Association, December 22, 2010
16. Controlled Substances, US DOJ, July 24, 2012