Pakistan’s drug watchdog has identified 104 “look-alike, sound-alike” medicines among around 70,000 registered in the country – prone to causing confusion – and directed their manufacturers to rename them and change their packaging.
Of these 104 medicines, 35 are a serious cause of concern as the confusion can have tremendous repercussions for the patients.
“Sometime ago, the Drug Regulatory Authority of Pakistan had started computerising all registered drugs in Pakistan and so far we have identified 104 ‘look-alike, sound-alike’ drugs. The manufacturers of most of these drugs have been issued notices to rename their products and modify their packaging to avoid medication errors,” the watchdog’s CEO Dr Muhammad Aslam said at a medical safety symposium on Saturday.
The symposium on “Medication Errors and ‘Look-Alike, Sound-Alike’ Drugs” was organised by the Aga Khan University and the DRAP provided technical support and advice for the event.
The DRAP CEO, who was the chief guest there, maintained that in addition to regulatory actions, the regulatory authority was also involved in creating awareness among pharmacists, doctors, paramedics, pharmaceutical industry and all other stakeholders.
“Pharmaceutical companies give an undertaking to the DRAP at the time of registration of a new drug but sometimes, look-alike, sound-alike drugs manage to reach the shelves at pharmacies and to patients, and result in the adverse affects,” he added.
Other speakers pointed out that confusing similarities in the brand name and packaging of drugs represent one of the most common reasons for medication errors and are of concern worldwide.
They noted that with thousands of drugs in the market, no drug name was without problems. But look-alike, sound-alike drugs increase the possibility of medication errors. From the World Health Organisation to the US Food and Drug Administration, the Institute for Safe Medication Practices to the Joint Commission International, world regulatory authorities and the global pharmaceutical industry are acting to tackle the risks associated with look-alike, sound-alike drugs and thereby reduce the chances of patients being given a medicine that is ineffective for the condition from which they suffer.
Commenting on the problem of look-alike, sound-alike medicines in Pakistan, Syed Shamim Raza, the pharmacy service line chief at the Aga Khan University’s teaching hospital, said the majority of ampules were of the same colour, shape and size even though they contained different chemical solutions.
“Many pharmaceutical companies also use identical colour schemes on packaging for different drug dosages which can also cause confusion in a busy pharmacy or hospital”, he added.
Raza explained that many medicines sold in Pakistan had common word stems such as Hydr, Met, Cef and Oxin which could result in mix-ups when reading cursive handwriting on prescriptions, and mistakes in recollecting drug names when pharmacists search for medicines in store.
Raza called on regulators to form comprehensive guidelines for retail outlets, healthcare providers and other stakeholders to address persistent challenges in the system.
Other experts highlighted how procurement teams in hospitals have noticed that different drugs had packages of a similar design, weight, material and size which increased the likelihood of mix-ups.
They recommended that companies could improve patient safety by adopting unique barcodes for every medicine, by using prominent fonts for important information about drug strength (50 mg versus 100 mg) and by using “tall man” (mixed case) lettering to emphasise drug name differences.
They also called on the DRAP to conduct a risk assessment about new brand names before approving new product names.
Jibran Yousuf, the pharmacy business manager at the AKUH, explained how advanced IT systems, pharmacy automation and barcoding could tackle the problem of look-alike and sound-alike drugs.
He added that the AKUH used a computerised physician order entry system that required pharmacists to type and then select drug names before dispensing them. Such systems enable an efficient medication usage process. Importantly, pharmacists can also review orders through the system which adds another safety check.
“A computer-based data entry system helps prevent many medication mix-ups since the software shows up all related medicines and drug strengths. IT systems can also contain dosage guidance which appear if pharmacists are about to recommend an adult dose to a child. Hospital and pharmacies should invest in such systems to address the problems found in manual systems and thereby improve patient safety,” Yousuf added.
Experts at the event shared instances of how the US FDA had been tackling the problem: in 2001 their Name Differentiation Project urged manufacturers to change the packaging of 16 drugs that looked alike. Speakers also drew attention to how the not-for-profit ISMP maintains a List of Confused Drug Names recording over 600 possible examples of mix-ups between medicines with similar names.
Sharing examples of effective action on LASA drugs, the speakers recalled that the FDA and ISMP acted on patient complaints about prescribers confusing a digestive drug Losec with a diuretic Lasix, and a thyroid medicine Levoxine with a cardiac drug Lanoxin.
By persuading the manufacturers of the drugs to change product names, US regulators succeeded in protecting patients from consuming the wrong medicine. They called on Pakistani regulators and companies to take similar steps.
In his speech, DRAP federal drug inspector Dr Obaid Ali urged healthcare institutions in Pakistan to learn from the successes of other countries. “Pakistan is far behind other countries when it comes to standards in drug quality and patient safety. We are aware of new approaches, standards and concerns but when designing regulations one also has to keep in mind that decisions remain grounded in science and that they are reached in an open and honest environment. It is also vital that decisions are applied consistently”, he added.
Representatives from the Pakistan Pharmaceuticals Manufacturing Association, information technology specialists, management from leading hospitals as well as leading physicians and nurses attended the one-day conference.
Source: The News
Byline: Waqar Bhatti
December 18, 2016