Medication Safety: The Basics

FIP YPG
6 min readFeb 12, 2020

By BarbraKaryne Nchinda-Fobi

Photo Credit: World Health Organization (WHO)

The complexity of the medication management system continuously introduces factors that can compromise its safety and that of patients at large (ISMP, 2018). Adverse drug events are harms from the use of medications including allergic reactions, side effects, and medication errors (CDC, 2010). There has been a rise in global attention on safe medication practices, and the International Pharmaceutical Federation (FIP) has been on the forefront of promoting global patient safety. In fact, in March 2017, FIP worked closely with the the World Health Organization (WHO) in the development and launching of the “Medication without Harm” patient safety initiative aimed at reducing severe, avoidable medication-related harm by 50%, globally in the next 5 years (WHO, n.d. & FIP, 2019). This challenge intends to stimulate action and to create new policies at national and international levels in four areas: patients and the public, medicines, health care professionals, and systems and practices of medication (WHO, n.d.).

Drug-related problems result in substantial medical and economic burden (Nguyen et al., 2017). Medication errors — defined as medications administered at the incorrect time, frequency, strength, dose, by the incorrect route, or to the incorrect individual (Hines et al., 2018) — are extremely common, affecting millions of patients worldwide, sometimes leading to serious harm and death. The prevalence of medication error is higher in developing countries than developed nations (WHO, 2014). Globally, the cost associated with medication errors has been estimated at $42 billion annually (WHO, n.d.). Each year in the U.S., medication errors injure at least 1.5 million people, costing $3.5 billion (Shitu et al., 2020). The National Health Services (NHS) estimated that 237 million medication errors occur at some point in the medication use process per year, contributing to 1,708 deaths (Elliott et al., 2018). Adverse drug reactions are also costly. In fact, the NHS placed the estimated cost of avoidable adverse drug reactions at £98.5 million per year, consuming 181,626 bed-days (Elliott et al., 2018).

While the true global prevalence of medication error is unknown, medication errors occur when failures in medication systems and/or human factors affect prescribing, transcribing, dispensing, administration, and monitoring practices (WHO, n.d). Also, the presentation of the primary and secondary packaging of drugs can contribute to unsafe medication use. Aspects such as unclear, ambiguous drug label information, and similarities in appearance can lead to selection errors and inappropriate use including wrong drug, formulation, dose, or route of administration errors (IMSN, 2013).

The prevention of medication error is multifaceted with hospitals, pharmaceutical companies, healthcare organizations, and government officials having a role to play. Historically, pharmacists have safeguarded their community from substances that could cause harm such as poisons. Today, their role in ensuring safety from the use of medications is critical (FIP, 2019).

While multiple interventions addressing the frequency and impact of safe medication use have been developed, their implementation varies. As pharmaceutical companies try to improve product labelling and packaging, hospitals usually target specific sources of error such as drug identification, distraction, dispensing of incorrect drugs, or incorrect prescribing (Hines et al., 2018). Some hospital interventions include:

  • Technology based e.g., Electronic bar-coding scanning, Computerized Decision Support Systems (CDSS), and Computerized Physician Order Entry (CPOE): used to improve prescription and dispensing practices, drug titration, and patient monitoring;
  • Designated “quiet zones”: used to reduce the effect of distractions and interruptions;
  • Medication reconciliation: used to identify and rectify medication errors at transition of care; and
  • Education: used to improve awareness.

Interventions are not only directed to healthcare professionals. Education of patients and caregivers is also vital. To address the implementation of patient education as an intervention to medication errors, WHO developed the “5 moments for medication safety” which aims at engaging and empowering patients to be involved in their own care. This tool should be used in collaboration with health professionals but should always remain with the patient (WHO, n.d.).

Photo Credit: World Health Organization (WHO)

Another aspect of preventing medication errors and adverse drug reactions lies in the determination of the underlying causes. These can be achieved through an effective medication error (and adverse drug reactions) reporting system. Though error reporting is fundamental to error prevention, reporting systems can only operate when there is a high level of patient safety culture (WHO, 2014). Healthcare workers should be comfortable reporting suspected or observed errors in their workplace.

While medication errors are usually reported to Patient Safety Organizations (PSOs) such as the Institute for Safe Medication Practices (ISMP), adverse drug reactions are reported to national pharmacovigilance centers. Pharmacovigilance centers also collect medication error reports. For example, a study in the European Union (EU) showed a steady increase in the number and proportion of Individual Case Safety Reports (ICSRs) of medication errors in the EudraVigilance database between 2002 and 2015 (Newbould et al., 2017).

Reported errors should be analyzed and evaluated to help convert threats into opportunities to learn from our mistakes. Lessons learned from errors must be shared locally, nationally, and internationally. If not, the same mistake will occur many times in different settings and/or countries leading to continuous patient injury from preventable errors. Sharing lessons learned can be facilitated by patient safety organizations and pharmacovigilance centers.

Overall, to achieve a reduction of harm related to medication errors and adverse drug reactions, multiple interventions need to be put in place at the local, national, and international levels. Pharmacists and pharmaceutical scientists have a crucial role to play. Error reporting is vital in understanding the root cause of the error, and sharing of lessons learned can help increase awareness. Also, a close collaboration between patient safety organizations (national and international) and pharmacovigilance centers should be fostered to enable the sharing of data and prevention strategies.

In subsequent newsletter publications, we will be highlighting young pharmacists’ and scientists’ role in preventing medication errors. Stay tuned!

For more information about medication safety, please visit:

*“Medication Safety” by BarbraKaryne Nchinda-Fobi is a regular feature in the FIP YPG bimonthly newsletter for the year 2020.

References

CDC. (2010, September 28). Medication safety basics. Retrieved from: https://www.cdc.gov/medicationsafety/basics.html

Elliott R., Camacho E., Campbell F., Jankovic D., St James M.M., Kaltenthaler E., Wong R., Sculpher M., Faria R.(2018) . Prevalence and Economic Burden of Medication Errors in The NHS in England. Rapid evidence synthesis and economic analysis of the prevalence and burden of medication error in the UK. Retrieved from: http://www.eepru.org.uk/prevalence-and-economic-burden-of-medication-errors-in-the-nhs-in-england-2/

FIP. (2019, July 18). Patient safety is ensured by pharmacists. Retrieved from https://www.fip.org/patient-safety

Hines S., Kynoch K., Khalil H. (2018). Effectiveness of interventions to prevent medication errors: an umbrella systematic review protocol. JBI Database of Systematic Reviews and Implementation Reports, 16(2), 291–296. doi: 10.11124/JBISRIR-2017–003481

IMSN. (2013, October). Making Medicines Naming, Labelling and Packaging Safer. Retrieved from: https://www.intmedsafe.net/imsn-advocacy/imsn-papers/safer-packaging-and-labelling/

ISMP. (2018, August 1). The case for medication safety officer (MSO). Retrieved from: https://www.ismp.org/resources/white-paper-case-medication-safety-officers-mso

Newbould V., Le Meur S., Goedecke T., Kurz X. (2017). Medication Errors: A Characterisation of Spontaneously Reported Cases in EudraVigilance. Drug Saf, 40(12),1241–1248.

Nguyen, T. L., Leguelinel-Blache, G., Kinowski, J. M., Roux-Marson, C., Rougier, M., Spence, J., Le Manach Y., Landais, P. (2017). Improving medication safety: Development and impact of a multivariate model-based strategy to target high-risk patients. PloS one, 12(2), e0171995. doi: 10.1371/journal.pone.0171995

Shitu, Z., Aung, M.M.T., Tuan Kamauzaman, T.H., Rahman A.F. (2020). Prevalence and characteristics of medication errors at an emergency department of a teaching hospital in Malaysia. BMC Health Serv Res 20(56). doi.org/10.1186/s12913–020–4921–4

WHO. (n.d.) The third WHO global patient safety challenge: Medication without harm. Retrieved from: https://www.who.int/patientsafety/medication-safety/en/

WHO. (2014). Reporting and learning systems for medication errors: the role of pharmacovigilance centers. Retrieved from: https://www.who.int/medicines/areas/quality_safety/safety_efficacy/emp_mes/en/

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FIP YPG

The Young Pharmacists Group of FIP (International Pharmaceutical Federation)