Pilot Study: The Role of the Hospitalized Patient in Medication Administration Safety

May / June 2009

Pilot Study:
The Role of the Hospitalized Patient in Medication Administration Safety

Talking about the hospitalized patient’s role in medication safety may suggest shifting responsibility away from the provider, but that is not my intent. This dialogue is intended to foster the development of approaches to care that lead to partnering with patients in care delivery and in sharing responsibility. A decade ago, a survey by the Canadian Institute for Health Information found that Canadians give high priority to enhanced information regarding health. Martin’s survey (2002) of patient views on the patient-provider relationship found that more than 50% of patients believe they have primary responsibility for decisions regarding their health; an additional 35.6% expect to share decision-making with their healthcare providers. In the past 5 years, patients and their families have formed organizations such as Consumers Advancing Patient Safety (www.patientsafety.org) and have assumed important roles with the World Health Organization’s Alliance for Patient Safety (www.who.int/patientsafety/en/). One way to foster patient involvement in patient safety is to examine and describe how providers can begin to share responsibility with patients and include them actively in safety improvement measures.

The first Canadian study of adverse events in hospitals reported that medication errors were second only to surgery-related events (Baker et al., 2004). Most adverse drug events happen at order entry (39%) and administration (38%) (Leape et al., 1995). Nurses know the medication administration process intimately, but there is no discussion in the nursing literature about the patient’s role in medication error. Little research exists on how patients perceive medication adverse events, and no studies have examined a role for the patient in medication administration safety.

The absence of any defined role for the patient in the medication administration process represents a gap in our knowledge and a unique opportunity to explore a potential aspect of safety. The objectives of this pilot study are stated below.

Research Objectives

  1. To explore patients and nurses perceptions and experiences of medication related safety.
  2. To explore patients and nurses perception of the patient’s role in medication administration safety and to arrive at a substantive explanation of the patient role.
  3. To determine what resources patients and nurses need to enhance medication safety while hospitalized.

Constructivist grounded theory methodology was used to conduct this study (Charmaz, 2000). Constructivist thinking recognizes that reality may be different across individuals, and that researchers and the participants contribute to study findings. The study method was interviews. Findings from the interviews are grounded in the data given by the participants, allowing the researcher to develop a theory about the patient role that was meaningful and understood by the participants. To insure trustworthiness in a qualitative study — what is known as “rigor” in a quantitative study — the researcher carefully explains each step of the data collection and analysis process leading to the development of the theory. After each interview, data were transcribed and analyzed. The analysis of the first interview produced a series of categories or concepts. As each subsequent interview was analyzed, findings were assigned to existing categories unless new categories were identified. The categories into which the data fit were retained. There was one category that more fully explained the existing role of the patient and was therefore called the core category. This core category and the three related categories formed the theory and are explained in the findings section.


Individual Interviews
A convenience sample of patients and nurses was used. For this study, we recruited six patients discharged from two units of a tertiary care center in Atlantic Canada and six nurses working on the units where the study participants had been patients. Because this was a pilot study, sample size was limited to 12 interviews to get a sense of the interest level of patients and nurses to participate in this research and to arrive at a tentative explanation of the role of the patient in medication administration safety.

Inclusion Criteria
Patient participants were 18 years of age or older, able to speak English, cognitively alert, and discharged from general medicine units 2 to 3 weeks prior to the interview. Nurse participants worked full-time or permanent part-time on the units from which the patient participants had been discharged. This pilot study received ethical approval by the Health Authority involved. Dalhousie University has a reciprocal agreement for ethical approval with the Health Authority.

The core category, which I call “knowing enough but not too much,” was generated from the data that met study objective number two and explained the present role of the hospitalized patient in medication administration safety. The concepts related to this core category were knowledgeable patients, system design, and patient teaching. Knowledgeable patients and system design represent the source of the problem or the reason for the present role. Patient teaching is a strategy supporting the present role.

Knowing Enough But Not Too Much
Being asked about a role for hospitalized patients in medication administration safety came as a bit of a surprise for study participants. Patients were surprised in two ways: (1) some believe they have no say and that medications are the domain of doctors, leaving the nurse and the patient to trust that the doctors would do the right thing, while (2) others wanted to be consulted directly about their medication orders and were pleasantly surprised at the prospect of this happening. Nurses in some cases had not thought about a patient role because they had learned that medication administration fell within the boundaries of the professional responsibility of the nurse, nevertheless they could see the potential for a patient role.

“Knowing enough” means that patients recognize their pills; that is, they know how many to take and when, what they look like — size, shape, color — and what the pills are for. This means the patient knows if the pill, for example, is for controlling blood pressure, lowering cholesterol, or thinning blood. Patients and nurses accept this level of knowledge and find it very helpful. Patients generally want to know about their medications, and nurses find it helpful and an added measure of safety when they have patients who can look at the medications they are about to receive and confirm that the medications are what they usually take. If a patient looks at his or her medications and says, “Something has changed,” that is a flag for the nurse to double check that the medications are correct.

“Knowing enough but not too much” means there is a point at which the healthcare provider feels challenged by the patient/advocate about their medications. Some patients — those who “know too much” — want to be “insiders” with respect to their medications. This means they want to be consulted about their medication orders and adjustments to those orders. In one case, the patient was a health professional and, although the medications prescribed were consistent with the protocol for the disease of the patient, when the patient explained the medications were not working, the orders were changed. In another case the patient was very knowledgeable about the disease but the protocol was adhered to, and the patient believed the hospital stay was one day longer because of it. “Knowing enough but not too much” explains how patients and nurses in this study perceived the present role of the patient. The following factors contributed to the construction of this role.

Knowledgeable Patients
Nurses report that patients/advocates regularly use the Internet and generally trust what they read. Patients/advocates question the taking of certain medications, and at times this leads to frustration for both patients and nurses. When patients/advocates find out about the possible side effects of medications, they do not necessarily know how to weigh the risks and benefits and calculate the potential harm they might incur by altering how medications were taken. Nurses didn’t mind the questions; the point of difficulty is the patient’s or advocate’s insufficient knowledge about the condition and the risks involved in not taking medications as prescribed. Nurses explain that they have a set of competencies that allow them to understand the clinical condition of a patient and how each medication contributes to the management of that condition, knowledge that patients and families often do not have. Nurses believe that if patients were to be more fully involved with medication administration, they would need greater clinical understanding of their conditions.

System Design
The system for medication administration in hospitals is designed for use by healthcare providers, specifically nurses, pharmacists, and physicians, with both regulatory and structural elements. From a regulatory perspective, physicians order medications, nurses verify and transcribe these orders to a patient medication record, and the pharmacy dispenses the medication to the nursing unit. There was no evidence of a step that includes the participation of the patient, except to consume the medication. Nurses administer medications following the five rights of medication administration (right drug, dose, time, route, patient) and record this on the medication administration record (MAR) of each patient. Nurses believe that they are responsible for the administration of medications and that they can be held libel if they do not fulfill this responsibility. The MAR has no provision for a patient signature.

From a structural perspective, each hospital room is equipped with a medication cupboard. Pharmacy delivers all medications to these locked cupboards, and nurses hold the keys. Patients and nurses agree that the locked cupboard is a safety feature in the medication administration system and perceive the current system as safe in response to objective one. Patients know that sometimes they are incapable of managing their own medications while in hospital. Nurses like having a medication cupboard in each patient room because they are able to give their own medications reducing the likelihood of making a medication error. Nurses acknowledge that it is sometimes distracting if the patient wants to talk while nurses are preparing the medications. Patients know and accept that they cannot get at their medications with some exceptions, such as having medication for a headache on their person so they could take it when they wanted to rather than having to bother the nurse for it. This practice is neither allowed nor encouraged but points to the fact that patients want some control relative to their medications. Patients who are diabetic and accustomed to self-administering their insulin prefer to do so while in hospital. The structural design of the system is not meant to include the patient directly in medication administration. Nurses do not learn to have the patient participate in medication administration, yet when patients want to do so, and the nurse has a certain level of trust in the patient, then the nurse may permit the patient to self-medicate.

Model of Care
Part of system design was the model of patient care delivery on the units involved in the study. Nurses are responsible for administering all medications and the majority of treatments, as well as providing personal care and readying patients for discharge. The units involved are also staffed with licensed practical nurses who carry out certain treatments and personal care for patients. Nurses describe the amount of time they spend on each shift administering medications or obtaining missing medications from pharmacy. Pharmacy delivers the exact number of pills for each patient each day. If a pill is dropped, another has to be obtained. This is a source of frustration for nurses because it takes time to get another pill from pharmacy. Pharmacy on the other hand knows they dispense what is required and this is a source of tension between these two groups. Nurses express concern over the amount of time spent in medication administration and not having enough time to provide patient education.

Patient Teaching
Patient teaching means providing patients with information about their diseases, the medications necessary to manage those diseases, and how these medications work in the body. Nurses believe that patients will be better able to monitor and manage their disease when they have this information. Teaching is not simply preparing a list of pills with days and times attached. Some patients only want to know the basics — what is the pill for and when do I need to take it? — others want much greater detail including how the pill works in their body, how they can expect to feel while taking the pill, what to watch for to know if the pill was working or not, and if they can adjust their pills. Nurses unanimously describe the importance of having a comprehensive understanding of medications in order to teach patients. They also unanimously explain that they have very little time to teach patients and families about medications in the course of their shifts. Nurses go on to say that patients and families no longer carry on without explanations and will seek the information on their own, usually from the Internet. Nurses believe that knowledgeable patients add a measure of safety.

The present limited role for patients in medication administration has consequences for both patients and nurses. Patients expect to have some knowledge about their medications and to assume some responsibility for managing them. Patients are frustrated by the lack of information and experience with their own medications in the hospital, knowing that when they return home they are expected to know what to do.

Nurses know that many patients are readmitted to hospital because they do not completely understand their medications, which is disappointing and frustrating. Nurses recognize that there is no purposeful patient participation in the system at present, and realize their workflow must change in order to provide the patient education necessary to optimize the patient role.

Implications for Patients and Nurses
The third objective of this study was to determine what resources patients and nurses need to enhance medication safety while hospitalized. Patients report that, if able, they should verify the medications they are about to take. This is not one of the five rights of medication administration. Consideration might be given to revising the five rights to include a sixth right: re-verification of medications by the patient. Patients did not express the desire to self-medicate, however some patients believe they should be consulted as new medications are prescribed or when existing medications are altered. Writing patient consultation into existing standardized protocols is one strategy that could help. Increasing the level of patient/advocate involvement in the hospital will assist transitioning to self-care at home, and all patients remarked they are expected to safely manage their medications at home.

Nurses express the need for time to identify patients’ learning needs about diseases and medications. Nurses want access to electronic information (both the health record and the Internet) at their fingertips in order to respond to patient and family questions and to check out the web sites that patients use for information and to provide further explanation where necessary. Nurses recommend that the pharmacy generate medication lists for patients with pictures of the medications, brief descriptions of the actions, and the administration schedule. This will help patients and families understand their medications while in the hospital and participate more fully in the medication administration process. Nurses support having patients verify pills they are about to take. It is logical to assume nurses would support the idea of a sixth right in the medication administration process. RN regulatory agencies need to address nurses’ concerns about liability in transferring some responsibility to patients.

It must be noted that these findings come from a pilot study, a study from which I wanted to get a sense of the interest of patients and nurses in the patient role and what that role might look like. Clearly there is interest in this role from both perspectives, and a larger study is planned.

The main concerns of patients related to medication administration safety include knowing about their medications and having the opportunity to be more involved in decisions regarding orders or changes to existing medications. The main concerns of nurses are that patients should be knowledgeable about their medications, that they have limited time for providing patient education, and that sharing medication administration responsibility with patients could be a source of liability.

Both patients and nurses support the principle of a role for patients in medication administration safety. This role will vary based on the ability of the patient. When able, patients will verify the medications they are about to ingest are theirs. This role could potentially expand to include consulting the patient on medication orders and changes to orders.

Patients need to be recognized for the knowledge they have and to be provided with the knowledge they need in order to assume a role in medication administration safety. Nurses need time to provide patient and family education. Nurses need to know that the RN regulatory body sanctions sharing medication administration responsibility with patients. The model of care within which care is provided requires re-visioning in order for the healthcare team to partner with the patient in fashioning the patient role in care delivery.




Marilyn Macdonald is assistant professor at the School of Nursing, Dalhousie University in Halifax, Nova Scotia. Her program of research is safety focused in both hospital and home care. She is part of a Canadian team of researchers studying safety in home care, and participated in a national initiative to develop safety competencies for health care providers. Macdonald holds a baccalaureate degree in nursing from the University of New Brunswick, a masters degree in nursing from the University of Southern Maine, and a PhD from the University of San Diego. She has an extensive background in clinical nursing both in hospital and home care as well as 10 years of experience as a clinical nurse specialist). Macdonald may be contacted at marilyn.macdonald@dal.ca.