POCT: opportunities and risks
August 1, 2019
Point-of-care testing (POCT) is diagnostic testing performed by a pharmacist or pharmacy technician within the practice of pharmacy, generally near to, or at the site of patient care. POCT is becoming increasingly prevalent in pharmacy practice, which prompted ACP to introduce its standards and guidance for laboratory and point-of-care testing in 2019.
As many technologies and types of tests continue to emerge, we asked two POCT experts some questions that may be on the minds of Alberta’s pharmacy professionals.
Christine Hughes (BSc Pharm, ACPR, Pharm D) is a professor with the Faculty of Pharmacy and Pharmaceutical Sciences at the University of Alberta. Her research areas and interests include perinatal transmission of HIV, drug interactions with antiretrovirals, and rapid HIV testing.
Deborah James (BSc Pharm, PhD, REPBC) is the executive director, Innovation, for the Faculty of Medicine & Dentistry at the University of Alberta. Her mandate is to support faculty members and trainees to translate research findings into new technologies and processes that solve health and societal problems.
What does a good point-of-care testing program look like?
“The first thing is meeting a need for the patient. There are a lot of tests out there. It might not be appropriate to do a test just because it’s available. There needs to be a comprehensive and well-thought-out program. This is everything from having written standard operating procedures to making sure the environment where the testing is done is appropriate, ensuring that the test is stored properly, managing waste materials, providing a detailed training program for staff and a quality assurance program to make sure the testing is reliable, establishing proper documentation, communicating the results to appropriate health providers if required, and ensuring proper follow up with the patient.”
“You also need trained personnel with knowledge of who to test and who not to test, based on a thorough understanding of the clinical guidelines for the condition being tested for. They also must know how to interpret and take appropriate actions with the test results. And, they need knowledge of the test platform itself and its advantages and limitations. Testing should be done in collaboration with other healthcare professionals and by taking an integrated approach with both information sharing and patient management.”
What can point-of-care tests be used for?
“There are quite a few tests on the market and advances in technology are really ramping up. The common ones are used to screen for diseases, which can be anything from HIV, Hepatitis C, cholesterol, or lipids. There are also tests for managing chronic conditions. There are some tests pharmacists have been involved with for a number of years now such as glucose, INR, and some that are used for diagnostic testing such as strep throat.”
“For pharmacists, there’s an important role in using point-of-care testing in chronic disease monitoring and management. It’s about managing someone’s disease, their treatment, and their drug dosages based partly on test results. It’s another tool to optimize patient care. That’s where I see great value for pharmacists and for patients. There’s also the pharmacogenetic piece and there’s been a lot of progress around that recently. That involves understanding how a patient handles drugs via the nature of their drug metabolizing enzymes. I think that’s an important role for pharmacists—to be able to tailor drug dosages based on the drug metabolizing abilities of an individual patient.”
What are the benefits of POCT?
“The goal is to optimize care. In cases such as infections, the sooner you can implement treatment, often the better the outcome. It’s also convenience. That can’t be overlooked. Patient-centred care is the new approach to health care and that’s important.”
“If a pharmacist is sitting down with a patient to go over their diabetes management, they can do an A1C test right there and discuss changes in therapy or lifestyle or any follow-up that’s needed with the patient. The alternative is giving the patient a requisition form for a laboratory test that they may or may not get done, and they may or may not come back to see the pharmacist or physician. POCT also, in some cases, reduces barriers and increases access to care. In the field that I work in, there are patients who don’t go for testing for HIV because of the stigma and the barriers to accessing care providers or even getting to a testing lab. POCT, for some people, can really reduce some of those barriers and provide another option for getting testing done.”
What are the risks and challenges associated with POCT?
“There are some of the same risks and challenges that go along with central laboratory testing. The actual parameters of the technology can be challenging—such as analytic validity which include, for instance, the accuracy and reproducibility of the technology. These parameters need to be understood by pharmacists. Also, the clinical validity—meaning, for instance, the sensitivity and specificity of the test needs to be taken into consideration when interpreting test results. There are also challenges working with biological samples in a pharmacy, such as workflow requirements, space issues, and the need to follow certain regulatory requirements. Data sharing can also be a challenge. When you’re garnering that kind of information, you want to share that data with other health providers, particularly physicians. It’s difficult to do that sometimes. We’re not all connected digitally.”
“There’s also potential for misinterpreting test results. For example, some of the tests are like a pregnancy test where you look for dots in the window, like the HIV point-of-care test. Sometimes that second dot can be quite faint, so it’s not always completely clear. That comes down to being aware of the training on how to use the test appropriately. Often patients have to pay for POCT, especially if it’s performed in a pharmacy setting. That could be a challenge for a patient.”
What should pharmacists be mindful of to ensure lab-quality results?
“Following the manufacturer’s instructions. Some manufacturers offer training programs as part of using their products, so take advantage of those. Sometimes there’s a defined window of when the test results should be read. If you wait too long or are interpreting the results too quickly, that could impact the results.”
“The technologies are easy to use, but you still have to pay attention to quality assurance and quality control. Assurance means you’re looking at the program as a whole and ensuring that it’s continually monitored and improved. In quality control, you’re looking at the components of the program, so the equipment itself. You need to understand the limitations of the test and what can interfere with test results.”
When would it be best to use a lab test versus a point-of-care test?
“The thinking used to be that POCT was only for when you needed immediate results, so it makes sense for example, for acute infections. But that thinking is changing. It’s also appropriate for other situations, such as screening or chronic disease management when you don’t really need the results immediately. I think a pharmacist also needs to consider if it makes economic sense for the patient as the patient may have to pay a fee for it in the pharmacy given that point-of-care testing is not currently reimbursed. In that case, it would be best to send the patient to a central lab.”
“One of the things that would impact the decision is whether those results are going to impact what you’re going to do for the patient at that point in time. If a patient is already going to get some other bloodwork, does it make sense to do that POCT today? Also, in some cases, even though the tests are approved on the market, the test may not have the same accuracy as a conventional lab test, so if they’re going to have to get additional testing done anyway to confirm or make decisions about disease management, there may not be value in doing the POCT for the patient. Another important aspect of decision making is the patient’s ability to afford the test, or their personal preferences about having the test done in the pharmacy versus through a central lab. So, for example, after counselling, would they would prefer to get it done in a lab versus having to pay for a test?”
What are your overall feelings about POCT?
“I think it’s exciting. It affords a lot of opportunities for the profession to provide expanded services and to reach people who may not otherwise be accessing care. Some patients may not have access to the lab. They may live hours from the closest lab. If you’re in a community where you’re one of the few health professionals, there can be a huge benefit in improving access.”
“I think it’s such an opportunity for pharmacists to provide a new model of managed care in the health system and deliver better outcomes for patients. Ultimately, that’s the goal. We’re shifting to earlier detection of disease and that’s something that can be done in the community setting and by using POCT.”