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Details: Published: 04 May 2022; Created: 04 May 2022

Rapid Alert Notification Form

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Rapid Alert Follow Up Form

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Details: Published: 25 March 2020; Created: 25 March 2020

Details: Published: 31 January 2022; Created: 31 January 2022

Operationalise a Fully Functional Regulatory System

BoMRA is targeting to be at WHO maturity level 3 (ML3) where 8 core regulatory functions will be operational and meet the criteria and standards set. The Authority will conduct annual WHO Global Benchmarking (GBT) self-assessments and final WHO assessments to reach ML3.

BoMRA develops and Implements the Institutional Development Plan (IDP), addressing identified gaps and interventions required as per the WHO Global Benchmarking Tool. The core functions are as follows:

Enhance its registration functions to ensure that medical and veterinary pharmaceutical products and related substances are registered and meet the efficacy, quality and safety standards
Enhance clinical trials controls to ensure good pharmaceutical processes are adhered to
Establish post-marketing surveillance to monitor and reduce unregistered, sub-standard and falsified medicines in the market
Strengthen Inspection and Licensing of pharmaceutical premises and Import/Export Controls
Establish Laboratory Services
Establish the Legal and Law Enforcement Function
Establish and implement a Quality Management System
Leverage ICT Services to enable efficiency

BoMRA will facilitate the review of the Medicines and Related Substance Act to strengthen its scope, definitions, structures, and instruments to enable its regulatory effectiveness.

Reduced incidences of substandard and falsified medicines and related substances.

The Botswana Medicines Regulatory Authority will establish a Pharmacovigilance system to track and report on Adverse Drug Reactions and take any remedial action to protect human and animal health.

Improved awareness and Public Trust in the Improved awareness and Public Trust in the Medical Products and Cosmetics regulatory system.

The Authority will:

Educate the public on effective, safe and quality human and animal medicines and their regulation
Facilitate stakeholder compliance
Establish strategic partnerships and collaborations
Establishing a robust Institutional Framework and Good Governance

BoMRA will scale up its current institutional capacity to deliver the full spectrum of regulatory services. In order to do this, the Authority will:

Enhance its HR Management System
Attract build and retain critical competencies to deliver on the regulatory requirements
Instil a High-Performance Culture underpinned by its core values, an enabling environment and workplace, with an accountable workforce and leaders who are effective
Improve sustainability to eventually become less reliant on government for its operations
Implement prudency in its Financial Management
Maintain institutional resources so they remain effective

Details: Published: 19 January 2021; Created: 19 January 2021

Details: Published: 09 December 2019; Created: 09 December 2019

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Details: Published: 16 December 2020; Created: 16 December 2020

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Details: Published: 09 December 2019; Created: 09 December 2019

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Details: Published: 08 October 2020; Created: 08 October 2020

SIGNAL COMMUNICATION

1. Methotrexate and Muscle spasm

Methotrexate (MTX) is a drug developed as a structural analogue to folic acid. As a folic acid antagonist, it blocks the synthesis of purines by inhibiting numerous regulatory enzymes. MTX produces an intense anti-inflammatory action and inhibits cell division. MTX is used in treatment of certain neoplastic conditions, rheumatoid arthritis and psoriasis. It is reported that muscle spasms could be associated with MTX, especially in those patients on chronic low doses.

Muscle spasms associated with MTX could impair the quality of life of patients, especially long-term users with chronic diseases. Prescribers need to be aware that muscle spasms could be present with the use of MTX and watch their patients for this possible adverse reaction. It is important to educate the patients about this adverse reaction and encourage them to report such experiences.

Methotrexate is a registered product in Botswana. Muscle spasms or muscle cramps are not currently mentioned in the product information leaflet (SmPC). Click the link below for further information.

Methotrexate and Muscle spasm

2. Clotrimazole and Vaginal Haemorrhage

Vaginal clotrimazole is indicated for vulvovaginal infections with Candida species, and available as creams and as vaginal tablets.
The imidazole clotrimazole has a broad spectrum of fungistatic activity against skin infections with yeasts and moulds by inhibiting ergosterol synthesis. About 3 to 10% of vaginally applied dose is systemically absorbed.

Vaginal bleeding was reported with the use of clotrimazole vaginal preparations. The bleeding type and severity varied from bloody discharge-mild-menstrual like bleeding-worse than menstrual bleeding as mentioned by the reporter. The time taken for onset to bleeding with clotrimazole varied from immediately after administration to two days

Prescriber should inform women about the occurrence of vaginal haemorrhage with the use of clotrimazole in a similar way as with vaginal miconazole. Attention for this association is warranted, since vaginal bleeding may be indicative for additional vaginal or endometrial conditions. Patients should be encouraged to report such.

There are 5 Clotrimazole products registered in Botswana. For further information on the article click here.

Clotrimazole and Vaginal Haemorrhage

3. Blindness and Retinal disorder associated with Clomifene Citrate: Cases series assessment

Clomifene Citrate (clomiphene) citrate has both estrogenic and anti-estrogenic properties and used for induction of ovulation since 1962. Clomifene Citrate is reported to have been associated with visual problems, especially with increased dosage or duration of therapy. Visual Symptoms like blurring is mentioned in SmPC of Clomifene Citrate https://www.medicines.org.uk/emc/product/961. However, it is stated that the visual symptoms are mild and reversible. The visual disturbances may become irreversible with increased dosage or duration of therapy. If the patient complains of visual disturbances, treatment should be discontinued, and ophthalmologic evaluation performed. Clomifene Citrate is registered in Botswana and based on its wide use prescribers are urged to be cautious when prescribing Clomiphene citrate to patients.

A detailed Ophthalmic examination before the start of Clomifene citrate and regular ophthalmic examinations after starting the drug should be considered in all patients taking Clomifene citrate. For further information explore the link below.

Blindness and retinal disorder

4. Azathioprine and Erythema nodosum (EN)

Azathioprine (Azathioprine®, Imuran®) is an immunosuppressive antimetabolite that is indicated for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, polymyositis, autoimmune chronic active hepatitis, pemphigus vulgaris, polyarteritis nodosa, autoimmune haemolytic anaemia and chronic refractory idiopathic thrombocytopenic purpura.

Erythema nodosum (EN) is a cutaneous disorder that is characterized by tender red nodules, commonly on the shins of the lower legs, and without the formation of pus. The nodules disappear spontaneously within three to six weeks and resolve without residual scarring. However, the nodules can return after a period of time. EN can be triggered by exposure to medicines and micro-organisms but can also occur in combination with systemic diseases. EN is estimated to occur in up to 15% of patients with Crohn’s disease and is linked to an increased disease activity of inflammatory bowel disease. EN is more common in women than in men, and mostly arises in early adulthood.

Cases of EN are reported with use of Azathioprine. A total of 4 cases were reported in Netherlands, a further 70 cases on Eudravigilance and 94 on the WHO Global database. In majority of the cases patients recovered 3 weeks after withdrawal of the Azathioprine. Prescribers, while prescribing Azathioprine are therefore urged to inform patients and be on the lookout for EN. For further information please click here.

Azathioprine and erythema nodosum

5. Loperamide and acute pancreatitis in patients with history of cholecystectomy: Signal strengthening

Loperamide is an over-the counter (OTC) antidiarrheal with opioid receptor affinity. WHO global individual case safety reports database has received 35 case reports of loperamide and loperamide: simethicone and pancreatitis or acute pancreatitis. The recent safety signal communication from WHOI International drug monitoring program strengthens association between loperamide use and pancreatitis. Pancreatitis is not labelled in the European SmPC available at the Electronic Medicines Compendium https://www.medicines.org.uk/emc/product/188/smpc nor on the US FDA’s label.

Loperamide is a registered medicine in Botswana and it is available as OTC medicine. Therefore prescribers, pharmacists who dispense loperamide as OTC medicine are urged to be cautious with the use of loperamide. It is important to educate the patients to report any symptoms immediately. Click the link below for more details on Loperamide use and acute pancreatitis.

Loperamide and acute pancreatitis