Every Government is committed to the objective of providing health care for its people. The health scenario in the country has undergone significant changes during the past few years. Even today, communicable diseases continue to be the leading cause towards health. Increase in life expectancy and the declining death rate and epidemiological transition is resulting in non-communicable diseases like cardiovascular ailments, cancer, diabetes etc.
Some of these diseases are mainly due to change in life styles in the urban population.
The National Healthcare policy was last formulated in the year 1983 and is under revision. The objective of any national health policy is to cater to the needs of the county's requirements, which include provision of primary and secondary healthcare, providing infrastructure for health care and creating qualified manpower to meet the demands of the health care.
The Governments continuous endeavour is to identify the disease patterns prevalent in the country and draw health programmes to overcome the diseases. The major health programmes that are being addressed by the Government are:
1. National Anti Malaria Programme
2. National Filaria Control Programme
3. Kala Azar Control Programme
4. Japanese Encephalitis Programme
5. Dengue Haemorrhage Fever Programme
6. Leprosy Eradication Programme
7. Tuberculosis Control Programme
8. AIDS Control Programme
9. Blindness Control Programme
10. Iodine Deficiency Control Programme
11. Mental Health Programme
12. Cancer Control Programme
13. Reproductive and Childcare Programme.
Medicines play a great role in the health care of the people. All the programmes mentioned above require various medicines for prevention as well as treatment. So the medicine management will start with identifying the required medicines for controlling the diseases. After identifying the medicines, it is essential to establish the required quantity for each of the category of the drugs.
It is also imperative that the Government makes a list of essential drugs for catering to the general needs of the public. There is also a need to define a national formulary based on the requirements, which should be a guiding factor for all the practicing Doctors. The Government has to evaluate as a part of its medicine management system, the pharmacoeconomics involved in treating each of the diseases. As a part of its evaluation, the Government should consider the options available for them in the range of products available for the management of disease, keeping in view the price at which they are available. As a part of health policy, the Government should also draw a policy for rational use of drugs. An effective policy will help stopping the indiscriminating use of the drugs, particularly antibiotics.
The major components of medicine management can be classified as:
1. Identifying manpower requirements for medicine management.
2. Identification of requirements including infrastructure.
3. Procurement Policy.
4. Evaluation of manufacturers.
5. Procurement of drugs.
6. Distribution and transport of drugs
7. Storage of drugs
8. Post purchase surveillance on quality of drugs.
1. Identifying Manpower Requirements for Medicine Management:
Management of medicines requires manpower that has basic understanding about the manufacture, stock and distribution and the quality parameters involved with these activities. Pharmacists are the key persons who have the basic knowledge and the number of pharmacists required depends upon the volume of drugs to be procured and distributed and the locations where these medicines will be stocked for further distribution either to dispensaries or to the patients. In addition to the pharmacists, people having adequate knowledge in inventory management should also be available to have an effective inventory control.
2. Identification of Requirements including Infrastructure:
It is essential to identify the drugs required to be procured for national health programmes, emergencies that may occur due to natural
calamities like floods, earthquake and war. The medicines require various different storage conditions.
Some medicines like vaccines are required to be stored between 2° to 8° C. Some of the antibiotics are required to be stored between 15° to 25° C and other can be stored at ambient temperature.
As the process of procurement and distribution will involve storage of drugs, the centres identified for storing such drugs should have requisite storage conditions as specified for each of the drugs being procured. These storage areas in addition should have temperature control and should also have proper pest control Programme in place. Otherwise some of the pests and rodents can damage the quality of the drugs stocked.
The infrastructure should also include proper stock maintenance through a computerized system and get inter linked with all the storage locations. This type of activity will help to cater to specific needs arising out of any outbreak of epidemic also to salvage stocks, which are nearing expiry. The data also helps to decide the purchase policy. The infrastructure should also include provisions for secondary packing in containers capable of protecting very high temperature during transit, particularly for thermo labile products. As a part of infrastructure requirements, qualified transporters having understanding and capabilities should be identified.
3. Procurement Policy:
The objective of procurement policy is to ensure that the drugs procured are of standard quality and are at competitive price. The procurement policy should also define the procedures to be adopted for procurement. The procurement policy should ensure that the drugs are procured directly from the manufacturers to the extent possible. The procurement policy should define the procedure for pre-qualification of suppliers based on the compliance to current good manufacturing practices requirements. It should also address primary testing of the drugs procured by notified agencies.
4. Evaluation of Manufacturers:
The quality of drugs produced by the manufacturers can be assured provided the firm is following principles of total quality management and adherence to current good manufacturing practice requirements. The evaluation of the installed capacity and financial capabilities to supply the drugs can be achieved through inspection of the facilities by a panel consisting of experts in the field. A proper grading system should be available which can be considered as one of the requirements for deciding the suppliers.
5. Procurement of Drugs:
A transparent mechanism should be created in procuring the drugs from the eligible manufacturers/ suppliers. A pre-inspection of the consignments at the manufacturers' level before supply should be made mandatory, as it will help proper evaluation of the supplies and will avoid rejections at the place of acceptance.
6. Distribution and Transfer of Drugs:
Based on the scientific estimation of requirements of each of the location in each State of the country, drugs need to be distributed through qualified transporters who understand the precautions to be taken during transportation. If the primary packing received from the supplier is not transport worthy, provision should be made to do a secondary packing in transport worthy packing.
7. Storage of Drugs:
Each of the locations where the drugs need to be stored should have proper storage conditions to store all categories of drugs which should include provision of deep freeze at minus 20° C, 2° to 8° C and air conditioned storage for storing below 25°C. Suitable racks/almirahs for storing the drugs at ambient temperature should be provided. The design of the warehouse should facilitate easy access and follow the principles of first in first out. The storage area should also have proper pest control and fire control to avoid any damage to the medicines procured.
8. Post Purchase Surveillance:
The quality of the drugs procured and distributed need to be evaluated through a well defined sampling procedure, post distribution, from hospitals.
There must be a focus approach in such programmes as it will enhance the quality programmes and help to achieve the objective of supplying standard drugs to the people. Compilation of data from such surveillance will help at the time of reevaluation of the manufacturers/suppliers for supply of drugs.
-- The author is Deputy Drugs Controller (India), CDSCO, West Zone, Mumbai