Preventing the preventable
The problem of medication errors is not new, although recently it has come under increasing scrutiny and public concern. Aashruti Kak discusses the use of labelling and packaging in Europe and the US in comparison with those in India
Medication errors are without doubt costly to patients, their families, their employers, hospitals, healthcare providers, and insurance companies.
They can occur anytime during the medication process—procuring the drug, prescribing, dispensing, admini-stering, and monitoring its impact—but they occur mostly during prescribing and administering stages. “Medication errors can be giving the wrong medicine and/or the wrong dose at the wrong time. They happen either because of improper information or human error—when patient takes the medicine or a doctor or a nurse administers medicine wrongly,” says Sandeep Goyal, CEO, Sanex Packaging Solutions.
Some of the most common causes include—miscommunication of drug orders, messy handwriting, incorrect abbreviations, similar drug name confusion, confusion of metric and other dosing units; performance and knowledge deficits due to improper training or education; unavailable drug information (lack of up-to-date warnings); inappropriate labelling as a drug is prepared and repackaged into smaller units.
Improving patient safety through medication error prevention requires a systems-based approach in order to modify the conditions that contribute to errors. Gautam Chakravarti, Global COO, Pharma Packaging and Research, Bilcare, says, “To my understanding, medication errors occur the maximum at the compliance level. The patient is supposed to look at the drug, tally it with his prescription and then buy it. In case of doubt or substitution of the brand name, the patient is supposed to confirm from his doctor regarding the safety of the medicine.”
Numbers don’t lie
The Institute of Medicine (IOM), US, in its 2006 report—Preventing medication errors—estimated that medical errors kill people in US hospitals every year more than auto accidents, workplace injuries, or AIDS. About 44,000 to 96,000 people die and around 1.5 million preventable errors occur in hospitals each year in the US. Medication errors, in particular, contribute annually to the deaths of more than 7000 patients in the US, which is a conservative number because many errors are never reported.
For years a lot of attention has been given to reducing medication errors by health care practitioners, i.e. prescrib-ing practices by physicians, dispensing practices by pharmacists, and medication administration procedures by nurses. Recently, the focus has moved to the pharma industry to reduce the risk of errors through clearer packaging and labelling.
“Distinctive packaging certainly has a role in identifying the right medicine and reducing medication errors, particularly in a country like India where there is a lot of illiteracy. Whatever literacy is there is mostly limited to non-English literacy and on most of the drugs the content on the packing material is printed in English,” says Chakravarti. Keeping this in mind, wouldn’t it be better if we had content printed in regional languages as well in the respective states? “It hasn’t currently been in use, but I don’t see any reason why this cannot happen. The FDA and our Drug Control authority require that everything should be written only in English. If the way it is going to be written is approved at the time of registration of the drug, then there should not be any problem,” says Chakravarti. Just as OTC and FMCG products have content written in other languages, prescription drugs can also incorporate this feature, as the risk involved is more in drugs.
There have been various collaborative efforts between government regulators and pharma manufacturers internationally for the cause. In the US, a task force under the Pharmaceutical Research and Manufacturers of America (PhRMA) was formed. Similar case was in the UK with the formation of the National Pharmaceutical Association, which in May 1999 published a guidance on packaging for manufacturers of pharma products. Also in Europe, the Federation Internationale Pharmaceutique had drafted a statement of professional standards in 2006, which, in addition to providing recommendations for medication prescribing, dispensing, and administration, also provides recommendations for regulatory authorities and manufacturers with regard to drug product naming, labelling, and packaging. “The government of India has spent a lot of money on AIDS awareness. Why not for this cause? Similar campaigns of less or similar scale are needed to spread awareness regarding the issue amongst the consumer population. It has to be a joint effort of the government and the industry,” says Chakravarti.
The naming game
Naming is an important part in the development of a new drug. And coming up with a snappy and memo-rable name that can distinguish one drug from another is not child’s play. What most drug companies want is a name that will heighten sales, while consumers are left craving for a name that indicates what the drug does. Medication errors can occur between brand, generic, and brand-to-generic names like Taxotere (docetaxel) and Taxol (paclitaxel), both meant for chemotherapy. But sometimes, its more than just name similarities. Abbreviations, acronyms, designated dose, and other symbols used in medication prescribing can also cause problems. Chakravarti says, “One way to curtail the confusion is through packaging. If one product is packed in aluminium strips, others can be blister foil or cold form aluminium, so that the options available are also in different packing, different colours of the material and the print. Patented packaging with different metals and unique colours can help various medicines in standing out.” He adds, “The company which has produced the drug needs to make a difference with distinguished packaging as it is much costlier than the generic versions, which imitate the packaging and ride on its brand equity.”
In the US, the FDA reviews about 400 brand names a year before they are marketed, rejecting about one-third in the process. The last time the FDA changed a drug name after its approval was in 2005, when the diabetes drug Amaryl was being confused with the Alzheimer’s medication Reminyl, and one person died. Now the Alzheimer’s medicine is called Razadyne.
“But, in the US it is different because they do not get drugs in blister packs. They have adopted pharmacy based drugging over doctor’s prescription, through which the pharmacist does the dispensing, which is better than unit dose packaging,” explains Chakravarti. Which means that if at all there is an error, it is purely the pharmacist’s fault. But in India, since there is unit dose packaging, it helps in eliminating per dose error as well.
Another way is by using a mixture of uppercase and lowercase letters to highlight differences in similar generic names, such as vinBLAStine and vinCRIStine. This will encourage manufacturers to supplement their new drug applications with revised labels and labelling that visually differentiate their generic names with the “tall man” letters, as they are known. Also, doctors can be encouraged to write both brand and generic names on prescriptions, as per the recommendation of the National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP), an organisation of pharmacy and healthcare professional groups, including the US FDA, the US Pharmacopoeia and consumer organisations among others.
Reducing errors through labelling
Because many times errors go unreported, it is impossible to single out any one cause of the high medication error rate. According to an IOM report, in the period January 2000-March 2004, while 32,000 medication errors were linked to look-alike and sound-alike drugs, about 33 percent of errors and 30 percent of fatalities were due to label and packaging issues.
“Frankly speaking, there are no proper labelling solutions available in India to reduce medication errors. To achieve that, label suppliers have to be pharma focused and have to adopt the pharma culture. Currently label suppliers in India print labels for pharma, alonwith food, pesticides, chemicals, personal care, stationery etc. So the importance of pharma needs gets diluted,” says Goyal. “For pharma, huge investments are also required for inspection and R&D to ensure that every label is printed with right and complete text/colour etc,” he adds. Currently, hospitals use a variety of methods to label containers and syringes containing medications including stick-on labels, adhesive tape, commercial labels with gummed backs, steri-strips or most recently, a syringe with an integral write-on white stripe. “Currently, Indian companies have started using self-adhesive labels, which are better than the earlier glue labels, as these do not fall off easily, but no serious move has been seen in the selection of ‘functional labels’ for use in India, although, some companies have started enquiring for their export requirements.
Self-adhesive labels or those applied with wet glue for marking pharma products have always been there. It is only recently that labels have been equipped with additional features, going beyond the function of just marking products. These versatile features are useful for documentation (medical records, batch numbers, expiry dates) or to transfer warnings printed on detachable labels to identify unlabelled medication containers. These can come in handy for the end user, who will be handling the drug either to consume it or to administer it, with the assurance of safety. As medications are transferred from pre-labelled original containers to unlabelled syringes, medicine cups, basins, vials or ampoules; labels must be applied with the drug name, strength and amount (if not apparent from the container), the preparation date and time, diluents for all compounded IV admixtures, and initials of individual who has prepared the dose, because many times the drug is not administered immediately after being transferred. Until the drug is ready to be used, the container is left practically unmarked or is marked in crude ways. Another critical situation arises whenever the individual who has filled the syringe is not the same individual who will be administering the drug to the patient later on. This is where the removable labels come in, because, when raw material is received by hospitals, the first thing that they do is throw away the containing box or the packet label before using the material, resulting in a loss of a lot of basic information, which can be easily sidelined.
There is also scope for indicating the presence of medications that bear heightened risk of causing patient harm when they are used in error. Although errors may or may not be more common with these medications, their consequences are often more devastating. High risk/alert medications include neuro-muscular blockers, insulin, opiates, anticoagulants, chemotherapeutic agents and concentrated electrolytes. Ideally, the labels can contain 20 pieces of information, including product name, International Nonproprietary Name (INN), which may differ from the US adopted name, individual indication or intended use, batch identif-ication, “use before” date, list of inactive ingredients/carriers of medical relevance, and a machine-readable bar code. Goyal says, “We at Schreiner MediPharm are personally meeting companies and educating them with functional labels. We are trying to convey the message that labels are not a commodity but the critical part of the medicine and have a very important role to play. Labels should be selected as functional labels and not just as a naming device for a product.” The US and Europe have many regulations to ensure that proper labels are used, for example, vaccines in Europe always have detachable labels with batch number etc for vaccine records.
In order to reduce medication errors there is a dire need for the involvement of all healthcare professionals and of pharma firms in labelling issues. Labelling and packaging needs to be reviewed with respect to medication error risk prevention in internal labelling reviews at various points through product development and life cycle management, and bar-coding technology needs to be evaluated and assessed for container labels as a means of reducing dispensing and administration errors in hospitals and other health care institutions, which use such technology to identify and confirm product, dosage form, and potency at the time of medication dispensing. The issue of medication errors in India is extremely complex and goes much beyond brand names since generic brands offer the considerable advantage of quality combined with cost-effectiveness in the treatment of a variety of diseases.