The prevention of medication errors within the pharmacy is an important issue in all health institutions and failure to comply with proper standards may lead to serious consequences
for Transplantation and
R F Simões
University of Lisbon
The prevention of medical errors has recently become an increasingly important issue in all health institutions. Of particular relevance are those errors regarding the overall medication management process. According to the literature, these errors cause significant morbidity and mortality rates in both the United States and Europe.
The medication management process includes manufacturing, packaging and labelling, as well as drug prescription, storage, monitoring, distribution to health operators and administration to patients. The failure to comply with proper standards may lead to the following errors:
- Errors related to drug deterioration (administration of expired drugs, or of chemically or physically deteriorated drugs, for example, improper storage).
- Errors related to improper drug preparation (due to incorrect formulation or improper manipulation prior to administration).
- Posology-related errors (administration of a drug at a different dosage than prescribed; mixing up of drugs because of similar labels).
- Errors related to the administration of unauthorised drugs (administration in the absence of a prescription).
Given the complex nature of health institutions, it is no longer sufficient to guarantee proper medication management and storage inside hospital pharmacies alone. Instead it is crucial to monitor carefully drug management within the individual units as well. The clinical pharmacist (CP) plays a key role in the implementation of safe and effective procedures for proper drug storage and use outside the pharmacy, where errors are most likely to occur to the detriment of the patient. Therefore, through his/her presence in the unit and constant monitoring efforts (such as regular inspections, see Table 1), the CP is able to monitor the proper management of medications.
ISMETT was recently accredited by the Joint Commission International (JCI), with a particular focus on patient safety and on the safe use of drugs inside the hospital. Based on our experience, the management of the medication room (MR) was regarded as a critical aspect.
The CP is responsible for checking the units, and particularly:
- Computerised medication cabinets (if present).
- Medication refrigerators.
- MR/carts and medication bins.
- Emergency drugs.
- High-risk medications.
- Medication samples.
- Patient’s own medications.
- Unit doses.
Computerised medication cabinets
These are increasingly becoming part of the hospital’s drug utilisation process. Safety is guaranteed by limited or controlled access, and use and retrieval criteria based on different security levels and on the inclusion of specific alerts for specific drugs: Look Alike-Sound Alike and High-Risk Medications. Many systems generate reports that enable the comparison of quantities assigned to the various users, while facilitating the regular rotation of supplies, inspections, the analysis of possible discrepancies and the removal of expired drugs. The CP must control and compare medications with similar packages or names, and implement proper corrective or preventative actions if necessary.
Refrigerators must contain a thermometer. The temperature must not exceed 2-8°C, and there must be a specific form where this information can be documented daily. It is also necessary to document any action taken when the measured temperature is out of this range. Medication refrigerators must have a label indicating: Drugs only; No food. Enteral nutrition requiring refrigeration must be stored in different refrigerators from those containing medications. All open vials must have a label indicating the first and last name of the respective patient, and the opening and expiration dates.
MR/carts and medication bins
Every MR must have a specific area for drug preparation, provided with the instructions and main devices required for preparation, and with the rules for good preparation. The pharmacy must hold regular training courses on drug preparation and management. Particular attention must be given to the 5 Rights (right patient, right drug, right time, right rate and right administration route). Every MR must provide bins for each room containing the patient’s own medications, the drugs dispensed on an individual basis/unit doses, and so on. All carts must be closed and locked. Multidose vials, if open, must indicate the dates of opening and expiration. Partially used single-dose vials must be discarded. Cancelled/transferred/expired/recalled drugs must be returned to the pharmacy. It is a good rule of thumb to ensure that no unusable medication (expired, defective or recalled) is present in the MRs or units so as to avoid any possible administration. Therefore the pharmacist must activate a notification, alert and collection process for such drugs.
Tables indicating units of measurement, conversion factors (for example gtt/ml/mg), drug stability after opening, lists of thermolabile/photolabile drugs and of drugs that cannot be crushed must be available at all times. Access to this area must be limited to clinical personnel only. The pharmacy must also regularly verify drug supplies based on their turnover.
If emergency drugs are present in the MRs, it is important for them to be consistent, accessible, monitored and locked. Security and access must be sensible so that in the event of an emergency, drugs may be available even though they are secure. All emergency drugs in the MRs must be periodically checked, especially in order to verify stocks and expiration dates. The CP may support the use of these drugs by drafting tables indicating doses/kg, or by providing information on a case-by-case basis.
High-risk medications (HRMs)
These are drugs whose improper use may cause severe damage to patients. HRMs require particular attention with regard to their management and use due to their potential toxicity, low therapeutic index or high possibility of causing pharmacological interactions. The particular attention required does not depend on the frequency of errors associated with their use (in fact these errors are more or less common), but rather on the severity of the adverse effects caused by their improper use, which may cause potentially severe damage to patients.
The Institute for Safe Medication Practices (ISMP) has drafted a list of HRMs that includes 19 drug categories and 13 individual drugs (see Table 2). The ISMP recommends various preventative measures: limiting the use of these drugs; systemic verification of the indications for use, dosages, timetables and proper administration routes, to be performed by the CP (first dose order verification); and double-checking of medications prior to administration, to be performed by the nurses.
Particular attention must be given to concentrated electrolytes, which are preferably not to be stored in units in their concentrated form. Instead, they should be previously diluted by the pharmacy and distributed only in unit doses. Additionally, policies regulating their use should be freely available.
No medication samples should be stored in the MRs or units. Samples must be managed by the pharmacy, including the verification of expiration dates and proper storage. It is good practice for samples to be evaluated and approved by the hospital therapeutics committee.
Patient’s own medications
When a drug present in the formulary is unavailable, it is possible to resort to the patient’s own medications for the time required for drug procurement. These drugs must be previously authorised by the patient’s attending physician and administered by nurses. Specific substances such as medical herbs and homeopathic products, if approved by the physician, must be used similarly. The CP may provide support in terms of drug identification and evaluation of possible pharmacological
interactions and/or toxicity.
Unit dosing can reduce errors by eliminating the need for calculation, measurement, preparation and handling in the MR, and by providing a fully and secure labelled package.
The significant factors that affect proper clinical risk management include appropriate clinical staff training, enhanced use and development of computerised systems (electronic medical record, computerised medication cabinets), and the ability of workers to perceive medical errors not from a punitive perspective, but rather as a useful tool to improve quality levels.
Therefore, the CP is responsible for the monitoring of departments, units and MRs in order to classify medical errors, if any, and develop, in agreement with other clinical staff, corrective strategies aimed at improving patient safety.
On the basis of our experience as a clinical pharmacy and of the JCI accreditation process, we believe the following measures have proven to be very effective:
- Presence of a CP in the unit as a person of reference and support in the capacity of drug expert, and drug safety and quality controller. The regular presence of a CP creates an environment of trust and collaboration, which encourages requests for clarifications and/or information.
- Safety rounds. During these rounds, the group interviews patients and clinical employees to identify potential risks that may cause adverse events to the detriment of patients. This method allows the sharing of experiences, needs and opinions, and the receiving of feedback.
- Implementation of regular inspections and respective discussions with the clinical coordinators.
- Monitoring of therapeutic errors through the analysis of incident reports and the adoption of evaluation tools such as root case analysis, failure mode effects and criticality analysis.
1. Cohen MR. American Pharmacists Association. 2nd edition 2006;14:317-411.
2. Santell J, Camp S. US Pharm 2004;7:89-91.
3. The Handbook on Storing and Securing Medications 2006. Joint Commission on Accreditation of Healthcare Organizations.
4. Rich D. Am J Health Syst Pharm 2004;61:1349-58.
5. Feitelberg SF. The Permanente Journal 2006;10(2):29-36.
6. ISMP’s list of high-alert medications; http://www. ismp.org/Tools/highalertmedications.