Taking the wrong prescription drug, too many of a prescribed drugs or missing the wrong prescription drugs can harmful. Regarding opioids, the U.S. Food and Drug Administration announced March 22, 2016 that it is requiring class-wide safety labeling changes for immediate-release (IR) opioid pain medications. The FDA is requiring a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death due to opioid medications. Here is what the FDA Commissioner, Robert Califf, M.D. said: “Opioid addiction and overdose have reached epidemic levels over the past decade, and the FDA remains steadfast in our commitment to do our part to help reverse the devastating impact of the misuse and abuse of prescription opioids.” Today’s actions are one of the largest undertakings for informing prescribers of risks across opioid products, and one of many steps the FDA intends to take this year as part of our comprehensive action plan to reverse this epidemic.”
This made me wonder how doctors learn to write prescriptions. And why does the FDA warn doctors? Don’t doctors and drug companies need to warn patients? And how do doctors do that? Is there a prescription writing class like English Composition 101? And what difference does it make to the patients how they write prescriptions? What difference does it make to the patients and how do we do something about it? Can it affect me?
Medication errors can be devastating. There are some powerful statistics primarily from the FDA:
- Medical errors of all kinds claim as many as 98,000 American lives each year and are the eighth leading cause of death in the United States.
- Up to 7,000 of these deaths are attributed to adverse drug events (ADEs) from medication errors (ibid).
- At least 1.5 million preventable ADEs happen in the United States each year (Source: “Preventing Medication Errors: Quality Chasm Series,” a July 2006 report from the IOM).
- The number of serious adverse drug events reported to the Food and Drug Administration totaled 89,842 in 2005, more than double the amount in 1998. Additionally, the number of fatal adverse drug events more than doubled over the same period to 15,107.
- There are approximately 1.25 million annual medication errors in the U.S. Approximately 39% of medication errors occur during the ordering process;
- Almost one in five medication doses administered in hospitals is given in error. Between 2.4% and 6.5% of patients admitted to U.S. hospitals experience an ADE according to data presented by the FDA in 2004. The mean rate is 4.3%.
- The average cost of an ADE is $2,257 (FDA 2004).
- Adverse drug events cost the United States $37.6 billion each year, and approximately $17 billion of these costs are associated with preventable errors
While a lot of these errors occur in the hospital, what happens when we pick up a prescription from the pharmacist? Do we know why we are taking the medicines? Do the labels on our prescriptions tell us?
When I receive prescriptions from the pharmacist, usually the drug manufacturer’s prescribing information is provided. I try to read it. I try to understand it. I try to remember it. But, what I see every day is the pill bottle with directions on it. What does it tell me? What should it tell me? If it does not tell us what the drug is for, then we should confirm with our doctors and write it down so we do not forget- or mix up drugs for the wrong reason.
The basic format of a prescription written by the doctor includes the patient’s name and usually the date of birth. It also has the medication and strength, the amount to be taken, the route by which it is to be taken and the frequency.. The prescriber also writes how often and much should be given, and how many refills. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) national patient safety goals list multiple criteria for prescribers to follow when writing prescriptions. They are there to provide the doctor with guidelines and to protect us.
Be sure the drug you get from the pharmacist it is what the doctor ordered. Then when you get your prescription, make sure everything is as you remember the doctor telling you and in accordance with what was written on the prescription. If not, first ask the pharmacist to double check or call the doctor. If you still do not think it is right, call the doctor’s office and clarify it. Or go see the doctor. Don’t be a statistic because you assume the doctor and the pharmacist got it right. They are human and make errors.