From 9th February 2019, community pharmacies are expected to comply with the EU’s Falsified Medicines Directive (FMD), which requires all pharmacies to scan barcodes on medicine packaging at the point of dispensing. This should, in theory, help to prevent dispensing errors due to similar packaging and/or similar medicine names. However, this assumes that products will be scanned when they are dispensed, rather than when they are received into the pharmacy.
In October 2018, the National Pharmacy Association (NPA) published an information leaflet on look-alike and sound-alike (LASA) medicines. The NPA is also including common LASA combinations in its Medication Safety Officer (MSO)’s quarterly reports moving forwards. This followed Medicines and Healthcare products Regulatory Agency (MHRA) guidance in January 2018, warning healthcare professionals to be extra-vigilant when prescribing or dispensing medicines that could be confused with others due to similar-sounding or similar-looking names.
An estimated 237 million medication errors occur in England every year. Packaging similarities aren’t usually the sole reason for medication errors, but they can certainly be a contributing factor. Other reasons at the time of dispensing include distractions and tiredness. According to the PSNC, the top four LASA combinations leading to error, listed by NHS Improvement, are: propranolol and prednisolone; amlodipine and amitriptyline; carbamazepine and carbimazole; azathioprine and azithromycin; and atenolol and allopurinol.
So which steps are already in place within the generics industry to limit errors – and what can pharmacies do at the point of dispensing?
The packaging of medicines and other pharmaceutical products is more than just aesthetic. It has a purpose to inform and communicate vital information about its contents, including how to take (or use) the correct dose safely and effectively – to both healthcare professionals and patients. According to the European Medicines Agency (EMA)’s Good practice guide on risk minimisation and prevention of medical errors, published in November 2015, ‘the design of labelling and packaging may lead to mis-selection of a medicinal product.’
The MHRA published its own guidance on labelling and packaging in November 2015, stating: ‘Critical information … should be located more prominently than information of lesser importance. Prominence is influenced by text size and style but is also impacted by other factors, such as the colour used, the space on the pack and any other graphic elements included in the design.’
The pharmaceutical industry and MHRA regularly review the packaging of medicines that have been involved in a medication error, to see if changes can be made. “This is an important area for all of us, recognising that packaging is the public face of a medicinefor healthcare professionals and patients,” says Paul Fleming, technical director of the British Generic Manufacturers Association (BGMA). “It’s high on thelist of things that undergo continuous improvement. Over the last five or so years, we have had an openexchange with the MHRA, sharing examples of both complaints and best practice. To support improvement, BGMA membershave also been conducting user testing, working with pharmacists and technicians in community and hospital settings.”
It can take a few years to put substantial changes in place across a company’s whole portfolio.Many manufacturers have their own corporate theme, with particular graphics or colours to provide a visual marker. This helps to distinguish their products from other manufacturers’ products within the same therapeutic area and is important when multiple manufacturers’ products are stored together (on a shelf or in a fridge). However, this can be a problem if the manufacturer produces two or more similar products within the same therapeutic area, or if the same medicine is available in multiple strengths.
Kate Livesey, Policy and Programmes Manager at the Company Chemists’ Association (CCA), highlights a mix-up between chloramphenicol eye drops and ear drops (which are ten times stronger than the eye drops). Both products were stored in the fridge, in almost-identical packaging. After a review, the ear drops packaging was changed to blue instead of white and now features a large symbol of an ear. The eye drops packaging remained white and now features a large symbol of an eye.
To limit errors, many manufacturers emphasis drug name differences using different fonts or tall man lettering. Others may use different colours for different doses or high-risk medicines. However, this may require two potential LASA medicines to be side by side for a comparison and, even then, errors can still occur.
“Sometimes it’s less to do with the packaging, but more to do with how the human brain works,” says Ms Livesey. “How and why people read things in a certain way needs to be taken into account when packaging is designed. If the pharmacy team is noticing errors, they should report this to medication safety officer.”
To limit packaging errors, pharmacists may need to give some thought to how medicines are received into their pharmacy. “This involves more than just looking at a particular medicine in isolation,” says Paul Fleming. “Are the medicine boxes mixed up together with others? Is this in an open container, mixed up with other prescription medicines and other products, including medicines from multiple manufacturers. How are they put on the shelves, carousel or robotic system, and by whom? How are they stacked – front facing or end facing? What is the timing of deliveries and how many deliveries a day? What about staff changes and staff capacity?”
Ms Livesey says that making simple changes can limit the likelihood of errors. “Limit disruptions and improve checking procedures, making sure the entire team is involved,” she says. “Through root cause analysis, pharmacy teams generally find that it is often a combination of factors that has led to an incident actually reaching a patient and therefore re-visiting checking procedures, reducing distractions/disruptions especially at checking stage and looking at dispensary organisation/workflow can all be helpful in order to minimise risk. The MSOs have seen that seemingly small changes to practice can often have an impact.
"In one case, we found that staff weren’t checking the prescription against the medicine packaging – they were checking this with the applied printed dispensing label, which reflected the prescription, rather than the medicine itself. One way to counteract this is to place the medicine packs with label side face down in the basket when doing the final checks, so the pack has to be checked first. Pharmacies can also try different-sized baskets and different label positioning on the packs.”
The Centre for Pharmacy Postgraduate Education (CPPE) has done a substantial amount of work around patient safety in the last 12 months. This resulted in the development of an evidenced-based Risk Management Guide, which was sent to all registered pharmacy professionals with an address in England. The guide is linked to current research and supports pharmacy in understanding and minimising the risks linked to LASA medicines. It is included in the NHS England Community Pharmacy Quality Payments Scheme for February 2019 declarations. This has led to follow up work in collaboration with the RPS to deliver a series of joint workshops across the country. A new e-learning programme, Patient safety – LASA errors, has also been developed and is expected to be live on the CPPE website in the spring.
Stuart Gale, chief pharmacist and owner of www.oxfordonlinepharmacy.co.uk (online dispensing arm of the Frost Pharmacy Group in Oxfordshire), says that it’s important that manufacturers consult with pharmacists working on the frontline when developing packaging. “It isn’t surprising that similar packaging can lead to medication errors,” he says. “There is no doubt that advances in technology and scanning bar codes will help to solve the issue, but it shouldn’t exist in the first place.”
This is something that is now being addressed by everyone involved in the process, as the generics manufacturers take packaging design and its impact on patients very seriously. “Over the last 18 months, we have been engaging more directly with NHS England, participating in regional meetingswith prescribers, pharmacists and medical information specialists,” says Paul Fleming. “We have listened to discussions about specific therapeutic areas and how medicines are being practically used. Is it the patient self-administering the medicines or is it the relative or carer? Is this at home or in a residential setting? How can this then be improved further to reduce the number of medicine-related errors and medicine-related hospital admissions?”
Packaging design should take into account the needs of the widest-possible range of patients, especially older and partially sighted groups. MURs and providing written information about medicines is important, as well as discussing the differences in colour or shape betweeneach medicine prescribed. According to the EMA, eye drops are most likely to be used by patients with some level of visual impairment, so it’s critical that the font size used on eye drop packaging is carefully considered, given the small size of the container.
Gino Martini, chief scientist at Royal Pharmaceutical Society, says that it’s not just the packaging that can be a problem, as the actual tablets may look too similar as well. “Patients don’t always leave tablets in their packs, as instructed, preferring instead to put them into reminder systems,” he says. “If they’re taking 15 or 20 tablets a day for various diseases, at different times of the day, this doesn’t work if all of the tablets they’re taking are the same colour, usually white. Metformin, for example, is a large white tablet, standard shape, sometimes embossed with the strength. If someone has severe diabetes, their eyesight may be compromised or they may have diabetic retinopathy. They may not recognise what they’re taking or may take the wrong dose.”
When pharmacists choose generics suppliers, they may take the packaging into account to avoid look-alike packs where possible. “Customers are generally well informed about changing from one manufacturer’s product to another over time,” says Paul Fleming. “As long as the packaging is well designed, most patients are used to seeing changes between manufacturers of their generic medicines. However, there are some therapeutic areas where there can rightly be clinical concerns, such as in epilepsy, biological medicinesand with immunosuppressants. In these therapeutic categories, the medicines regulator MHRA often requires the product to have a brand name to ensure continuity.”
Here are some tips for pharmacists on limiting the risk of LASA errors.
1. Choose suppliers, liveries or brands carefully to avoid look-alike packs, when possible.
2. Be aware of the most common LASA combinations by checking the NPA’s new information leaflet and quarterly MSO reports. Keep this in mind when putting stock away, as well as when dispensing prescriptions.
3. Keep a list of common errors or near misses that have occurred. This may be different for each member of staff. Keep a note of these near the dispensary counter to check for mix-ups every time products are dispensed and before they are handed over to a customer.
4. Train staff to double-check at all stages of the process – when putting stock on the shelves (or in a robotics system) as well as at the point of dispensing.
5. Store LASA stock in separate locations in the dispensary and in the fridge. Some pharmacies create a ‘high risk’ medicines area within the dispensary or store LASA medicines in non-alphabetical order.
6. Use reminders and warning systems, such as brightly covered shelf stickers to highlight common culprits and programme pop-ups in the PMR system.
7. Using robotic pharmacy systems may provide another safety net to reduce picking errors, but make sure staff double check every medicine when filling these up. These can also lead to different types of errors, so it is important to remain vigilant.
8. With FMD, scan the barcode at the point of dispensing rather than when products arrive at the pharmacy. Don’t just use FMD to check for authenticity but use it as yet another safety check to ensure the correct medicines and doses are being dispensed.
9. Log and report all errors or near misses to medication safety officers and then discuss how to avoid them in the future.
10. Errors are more likely to occur when people are tired, hungry or thirsty, so it is important that pharmacy staff take regular breaks.