Supplying licensed pharmacies, hospitals, clinics and laboratories

Docfan Academy

Short lessons and a daily game for pharmacies, hospitals, clinics and laboratories: pharmacy, laboratory, medical devices, clinic essentials, regulation and quality.

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✅ Regulation & quality · 7 min

Complaints, recalls and adverse reaction reporting

Things go wrong even in good pharmacies. What matters is how fast you notice and how well you respond. Three systems help: complaints, recalls and adverse reaction reporting.

Customer complaints

A complaint is free information about your quality. Handle it like this:

  1. Listen and thank the customer. Do not argue.
  2. Record the date, product name, batch number, the problem and the customer's contact details.
  3. Keep the product if you can, and check your remaining stock of the same batch.
  4. If the complaint may affect patient safety, tell the responsible pharmacist or manager immediately.
  5. Tell the supplier and, where required, the regulator. Tell the customer what you did.

Recalls

A recall means a product, or one batch of it, is being withdrawn because of a quality or safety problem. It may come from the manufacturer, the supplier or the regulator. When a notice arrives:

  • Read it the same day.
  • Find the batch in your stock using your batch records.
  • Stop sales and quarantine the stock.
  • Follow the instructions in the notice, and record what you found and what you did.
  • If you already supplied the batch to others, tell them quickly.

Speed matters. A recall acted on tomorrow may be too late today.

Reporting adverse reactions

Pharmacovigilance is the monitoring of medicine safety after sale. If a patient may have had an adverse reaction, advise them to seek medical care, then report it through the national reporting system. You do not need to be certain that the medicine caused it. A suspicion is enough. Follow the current EFDA directives on how to report.

Tip: Keep complaint, recall and reaction records in one place. You will be glad of them during an inspection.

Sources: WHO guidance on pharmacovigilance and adverse drug reaction reporting · WHO Technical Report Series: Good storage and distribution practices for medical products · EFDA directives (current)

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For licensed professionals and students. Educational information only: always follow current national guidelines (EFDA, Ministry of Health), the product label and your facility’s procedures.