On 20 January 2017, HSA issued a drug recall statement to local company Kerala Ayuveda Centre for their product Kottakkal Dasamulakatutrayadi Kashayam solution. The solution, manufactured in India, is known to treat asthma, bronchitis, cough and related chest pain due to its anti-inflammatory and broncho-dilatory effect. When it was tested and found to contain methoxybufotenine, a derivative of serotonin, which otherwise can cause psychoactive side effects, the product was removed from the market with immediate effect.

This was the first published class 2 drug recall in 2017.

When faced with drug recalls, some pharmacists sweat due to a lack of experience, while others frown due to complicated SOPs and the tedious work involved. Read on to find out what are the things pharmacists should know on drug recalls.

What should be reported?

Defects in therapeutic products may occur at any point in the supply chain. Product defects that compromises on safety, quality and efficacy may affect the health of its end users and therefore, under Health products (Therapeutic Products) Regulations 2016, these defects must be reported to HSA.

Who should report?

When the drug company (product registrants, manufacturers, importers and suppliers) are aware of potential/actual defect of their therapeutic products, they should gather information and review the extent of the defect and health risks posed to its end users.

The information must be submitted to HSA to assess if a product recall is needed with respect to a suitable timeline. Companies who intend to do a recall on therapeutic products should notify HSA no later than 24 hours before the start of the recall.

How to report?

In Singapore, companies can report defects in their therapeutic products to the Vigilance and Compliance Branch using the Product Defect Reporting Form and Product Recall Completion Form found on the HSA website if they deemed a therapeutic product recall necessary.

Different classes of drug recalls

Under HSA, there are two different classes of drug recalls.

1. Class 1 recall

This is initiated when the product defect poses a life-threatening situation to users, for example when sterile injections become contaminated with toxic substances.

2. Class 2 recall

This is less likely to cause serious harm to users, as compared to Class 1 recall. They can include minor labelling errors or TP failing to meet product specification or pharmacopoeia standards such as failing dissolution tests. Class 2 recall also includes detection of drugs/chemicals that are otherwise undeclared or unintended in the product.

Where can I get information on drug recalls?

To access up to date information, pharmacist can check out HSA website on product recalls. HSA periodically updates the list of TPs that were recalled in Singapore. This list is non-exhaustive because it serves only as a general guide to alert healthcare professionals and public consumers of the presence of these recalls in Singapore.

For past events, registered pharmacists of Singapore would also receive the dear healthcare professional letter and HSA bulletin which highlight significant TP recall in the local context.

What information will be provided for a drug recall?

The date and name of the product would be provided by HSA during a TP recall. The batch number, expiry date, pack size and product reference number will also be provided. The class of recall gives an idea of how dangerous the product can be if used by the consumer.

The level of recall, for example at retail level, gives evidence to who should act on these products during a recall event. HSA also provides details on the manufacturer, country of manufacture and its local supplier/retailer. The reason for the recall will be supplemented if not otherwise self-explanatory.

Legal duty of a pharmacist

We play multiple roles in the local healthcare scene to mitigate risks of use of defective therapeutic products.

1) We are gate keepers

As pharmacists, we have the legal duty to protect the public health of Singapore. When suspecting defects in therapeutic products, pharmacists should report to the company and provide details of the defects.

Pharmacists working in companies dealing with therapeutic products should also diligently report cases of defects to HSA. Collectively, this information can be assessed by pharmacists in HSA to determine the scale of danger and if recall is obligatory. We should be quick to act in the situation of an immediate drug recall.

2) We are ambassadors of health

We can educate our customers, patients as well as other healthcare professionals. We should keep ourselves abreast of news of TP recall and inform the end users of the danger of using a recalled product.

3) We are the spokesmen for our patients/customers

Who knows best how to report an event of defective TP to HSA other than the pharmacist? Pharmacists, especially those in the frontline, are the multiple minions on the ground to help speak out loud to raise an issue with TP use to the relevant government bodies for action.

4) We find alternatives

When a therapeutic product is being recalled, pharmacists have the best drug information knowledge to suggest alternatives and to bring in stocks for use. MIMS

Read more:
3 common drugs that should be tapered off and how to do it
4 strategies that pharmaceutical companies employ to protect drug patents
5 old drugs that are still gold

Sources:
http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/Safety_Information_and_Prod
uct_Recalls/Product_Recalls/2017/kottakkal-dasamulakatutrayadikashayam.html
http://www.hsa.gov.sg/content/hsa/en/Health_Products_Regulation/therapeutic-productsportover.html