By Felix Achanda
In a bid to ensure health technologies and medical products reach their final destination efficiently whilst retaining their initial good quality the Pharmacy and Poisons Board (PPB) has released new good distribution guidelines (GDP) replacing 2006 one.
“The Pharmacy and Poisons Board is committed to ensuring the availability of medical products and health technologies in Kenya which satisfy the needs of all citizens for the protection, diagnosis using safe, efficacious, high quality and cost-effective pharmaceutical products,” said PPB Chief Executive Officer Fred Siyoi.
The guidelines provide people involved or those willing to be involved in the business the way to successfully and lawfully run distribution outlets.
PPB emphasizes that various outlets at all levels from general distributors to wholesalers must have valid operating licenses, adding that those responsible for directly handling and prescription to clients are qualified personnel and with valid operating licenses from the Board.
Other personnel who aren’t pharmacist but are involved in the distribution process should undergo training to carry out assigned duties at acceptable levels. Records of all trainings should be well kept.
All care should be taken to ensure that unapproved people do not get access to drugs.
“Procedures and job descriptions for employees and other persons having access to products must be designed to minimize the possibility of drugs coming into unauthorized possession.
During operating hours, the business must at all times be conducted under the continuous supervision of a pharmacist or pharmaceutical technologists,” read the guidelines in part.
In addition, there should be enough personnel and equipment at all distribution points to ensure a streamlined flow of products.
Warehouses, wholesale and retail houses are to be permanent structure and offer protection from contamination and deterioration, excessive heat/humidity or undue exposure to direct sunlight. They should also be hygienic and be kept from the reach of rodents, vermin, birds, pests and rodents. Medical products and health technologies should be stored separately from all other products.
Medical products requiring controlled storage conditions should be regularly monitored.
“Medical products that need controlled storage environments like deep freeze, refrigeration, should be monitored using suitable temperature recording devices and records reviewed and filled. Refrigerated and freezing storage environments should be fitted with signals to indicate that refrigerated and freezing storage environments should be fitted with signals to indicate refrigeration has failed. The signal should permit resetting only by the authorized person,” says part of the guideline.
When handling medical products and health technologies particular attention should be given to maintain the integrity of seals on packs with thermos-labile products. Attention should also be paid to any special instructions from the manufacturer to handling or storage of the products.
Importers should take measures to ensure that medical products and health technologies are not mishandled or exposed to adverse storage conditions at entry points. All import/export consignments containing medical products and health technologies must be accompanied with authorization from PPB. The imports/exports should also be declared to Customs and Drug Regulatory Officials upon arrival or expected arrival of consignment of interest.
Receiving bays should protect products from the weather. They should also be designed and equipped to allow incoming containers of products to be cleaned if necessary before storage. Received stock should be examined for correctness against an order for expiry date and for absence of damage. Additionally, the registration/retention status of those products must be verified with PPB.
A system for the recognition and prompt handling of drugs of addiction, or those products requiring specific temperature storage, of products that have a short shell life and any other products that require special care.
Goods from suppliers rejected by the wholesaler because of error, breakage, leaking containers or other faults should be in quarantine until the matter is resolved with the supplier.
Stock which has been damaged or withheld from sale should be placed in quarantine until disposal so that it cannot be sold in error, in the case of liquid damage cause contamination to other goods. Stocks of products with broken seals, damaged packaging or suspected of possible contamination must not be sold or supplied.
Goods returned to the wholesalers should be returned to saleable stock if they have tapered with, not subjected to adverse conditions and were stored in special conditions if necessary they should be examined by a licensed by person to determine if they are fit for sale. Wholesalers should not recondition or repackage goods (including labelling) unless permitted by the manufacturer or PPB.
Written procedures should describe the different operations which may affect the quality of the products or of the distribution activity. Relevant documents must be issued at every stage. Periodic checks comparing physical counts and records. Any discrepancies should be investigated to ensure there have been no inadvertent mix-ups and misappropriation of goods. Any discrepancy must be referred to the responsible pharmacist.
Written procedure must be in place to ensure stock rotation. Medical products and health products due to expire first must be sold and/or first out (FEFO) principles.
Products suspected to be suspected spurious falsified and falsely labelled products and unregistered products should be stored in designated area and clearly labelled not for sale. PPB and holder of the products should be immediately informed. Complaints regarding the product or its packaging, as distinct from those relating solely to matters within the wholesalers’ control must be notified to the manufacturer or the sponsor of the goods.
Measures should be taken to ensure complaints arising from wholesalers’ actions don’t reoccur. Self-audit/inspections should be done in line the principles of good distribution and if necessary to trigger corrective and preventive measures.