Specifications for the pharmacovigilance monitoring programme and telephonic medicines information service for the WCG DOH

Period: Aug 2014 to March 2017 [2 years and 8 months]

Enquiries: Neshaan Peton [021 483 6893; or Jannie Mouton [021 483 3116;

The Service Provider [SP] is requested to provide the compilation; technical analysis and reporting functionality for the DOH’s pharmacovigilance programme. The SP will need to provide a functioning electronic data base for collection of ADR details and submit quarterly reports to Pharmacy Services and the HAST directorate to the specifics required by the Department. The SP will be required to feedback to clinicians with respect to additional information that may be required to clarify causality and determine possible preventability strategies. The programme is required to be run by a pharmacist or doctor, with extensive clinical pharmacology experience working within the Clinical Pharmacology Department of a Medical Teaching University, with direct access to Clinical Pharmacologists support.

The same said Service Provider should provide an eight [8] hour, five [5] working day a week [Mon to Frid] telephonic medicine information service to the DOH services. This should be provided by pharmacist or doctor, with extensive clinical pharmacology.

A detailed budget broken down into the following line items is requested:

-HR salaries

-Administration

-Training and workshops

-Database management

Detailed operations:

  1. Capture ADR forms received from clinical staff working in the Western Cape Province DOH services until the Department has confirmed that this function has been decentralized and absorbed by the DOH at a district level.
  2. Support the training of personnel capturing data at a district / hospital level, once the standardized ADR database is developed and implemented.
  3. Conduct regular quality assurance audits of data captured and support improvement measures.
  4. Liaise with reporting DOH clinical staff with respect to submitted reports, to ensure accurate interpretation of ADR’s and possible improvement in the management of patients.
  5. Analyze submissions and feedback data and analyses to the Department’s Pharmacy Services and HAST directorate on a quarterly basis.
  6. Conduct real-time surveillance of reports and feedback via email andstandard reports, to the Department’s Pharmacy Services and HAST directorate as concerning trends emerge.
  7. Annually arrange and conduct training workshops of four [4] hours each in the following areas: George, Metro and Worcester. All training should be completed by the end of February 2014 and attendance registers submitted with quarterly invoices for payment. The training should target doctors; nurses; pharmacists and pharmacist’s assistants to support ADR identification; review the prevalence of ADR’s [both published and local data] and provide effective advice on the management of ADR’s.

Compiled by:

Lindsay Wilson

Pharmaceutical Policy Specialist

Date:

Approved by:

Ms Juanita Arendse

Director HAST

Date: