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Patient Safety

Communicating safety information to patients and healthcare professionals is a public health responsibility and is essential to achieve the objectives of pharmacovigilance in terms of promoting the safe and rational use of medicines and preventing harm from adverse reactions.

As part of our commitment to transparent, accurate information sharing with our stakeholders, the Aspen Group is aligned to the South African Health Products Regulatory Authority’s (SAHPRA) “Guideline for Handling Dear Healthcare Professional Letters relating to Medicine Safety” that was published on 31 January 2020. This Guideline is intended to supplement the protocols relating to information sharing regarding the safety, quality and efficacy of medicines.

A Dear Healthcare Professional (DHCP) letter is a communiqué in the form of a letter intended to convey important medicine safety information, distributed by Marketing Authorisation Holders/Holders of Certificates of Registration, directly to individual healthcare professionals. The DHCP letter further advises healthcare professionals on the need to take certain action or adapt their practices in relation to the use of the implicated medicine. These letters may be complemented by other communication tools and channels while simultaneously ensuring that a principle of consistent information is applied.

All DHCP letters issued by Aspen Pharmacare to South African healthcare professionals with effect from 1 February 2020 are available below.

TitleVersionPublish Date
VALACICLOVIR/ACICLOVIR CONTAINING MEDICINES - RISK OF DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS)V116 Jan 2024
TOPICAL CORTICOSTEROIDS - RISK OF WITHDRAWAL REACTIONSV227 July 2022
SELECTIVE SEROTONIN REUPTAKE INHIBITORS (SSRIs) AND SEROTONIN–NOREPINEPHRINE REUPTAKE INHIBITORS (SNRIs) ASSOCIATED WITH THE RISK OF POSTPARTUM HAEMORRHAGEV121 June 2021
INCREASED RISK OF SUBCLINICAL ACUTE INTERSTITIAL NEPHRITIS
ASSOCIATED WITH THE USE OF PROTON PUMP INHIBITORS (PPIs) LEADING TO ACUTE KIDNEY INJURY AND/OR CHRONIC RENAL FAILURE		V111 February 2021
ELTROXIN NEW FORMULATION (25 mcg, 50 mcg, 75 mcg, 100 and 200 mcg TABLETS: INCREASED ADVERSE EVENTS REPORTS AND REQUIREMENT FOR PATIENT THERAPEUTIC MONITORING BY HEALTHCARE PROFESSIONALSV124 December 2020
DOPAMINERGIC MEDICINES USED IN THE TREATMENT OF PARKINSON’S DISEASE: RISK OF DOPAMINE DYSREGULATION SYNDROMEV115 October 2020

Please report any possible side effects to Aspen Pharmacare.

How to report a possible side effect?

To help us process your information quickly and effectively, please remember to report as much relevant information as possible. At a minimum you will need to provide the following:

1) The initials of the person who experienced the possible side effect and/or other identifiers, such as gender, date of birth.

2) The contact information of the reporter, namely the person who is reporting the issue.

3) A description of the possible side effect itself, such as the signs and symptoms experienced, date the possible side effect started and the result of the possible side effect.

4) The name of the Aspen product involved.

Contact details:

ASPEN PHARMACARE

  • Aspen South Africa Medical hotline: 0800 118 088.
    Alternatively, you can call the switchboard number +27 11 239 6100.

SOUTH AFRICAN HEALTH PRODUCTS REGULATORY AUTHORITY (SAHPRA)

  • Reports concerning all other Adverse Drug Reaction (ADR) or Adverse Event
    Following Immunisation (AEFI) can be emailed to: adr@sahpra.org.za
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