National drug distribution guidelines and benefits
Medicines are meant to do good and the scripture recognized this fact when it stated that ‘A merry heart doeth good like Medicine’ (Prov 22:17). In our environment, we have so many instances where medicines no longer do good. In many of these cases, the conditions of the patients got worse and some even led to death. The cases of medicines ‘no longer doing good’ occur particularly when:
•It is not available at the point of need
•It is available but not at the right time and quantity
•It is available as adulterated or as outright fake.
•It is available and can be accessed in or at wrong places
•It is available in the wrong hands and not handled by the experts.
According to William Osler, a Canadian physician and one of the four founding Professors of the John Hopkins Hospital, ‘The desire to take medicine is perhaps the greatest feature which distinguishes man from animals’. In other words, the use of medicines is a veritable evidence of the wisdom of man. It is such a wonder, therefore, that we have not been able to handle medicines properly in this part of the world. Drugs are industrially manufactured and require distribution to reach the final consumer, the patient.
Distribution of drugs requires efficient supply chain systems and appropriate regulation to ensure that the medicines that reach the consumer are in their intended qualitative state, supported with the required infrastructure to ensure rational use. We have made some progress in drug production (despite the yearning gaps) but we have not done much in entrenching a distribution system that ensure that the medicine that gets to the consumers are effective, qualitative, safe and affordable. This is the challenge before all of us as professionals, policy formulators and other stakeholders. It is an attempt to face this challenge that the Federal Government released a New Drug Distribution Guidelines (NDDG) in 2012.
1.Drug distribution model:
The model describes the drug distribution model in developed countries. With most of the consumers of health products receiving their medicines through physician’s offices, pharmacies and dispensaries, there is a cohesive drug distribution and effective regulatory framework to assure the quality of the final product that reaches consumers.
In developing countries like Nigeria, the drug distribution infrastructure is fragmented and inefficient, resulting into a preponderance of fake, adulterated and substandard products infiltrating the market because of the activities of unscrupulous elements. The network is inept and complex, and due to technical inefficiencies, regulation is made ineffective. This leads to infiltration of fake, adulterated and substandard products getting to the final consumer
NATIONAL DRUG DISTRIBUTION GUIDELINES (NDDG):
The National drug distribution guidelines (NDDG) policy, which aimed at establishing a well-ordered drug distribution system in Nigeria, is a cumulative effort of stakeholders in the health sector from 2009 to 2012. It. The objectives outlined are very clear and altruistic:
•Reduction in the levels of adulterated and fake drugs in the market
•Elimination of the dominance of unregulated drug markets in major cities of the country
•Breaking of the stranglehold of the informal sector on drugs distribution
•Facilitation of the oversight role of relevant FGN agencies
•Ensuring that all drugs in the national drug distribution system are safe, efficacious, effective, affordable, and of good quality.
The NDDG framework was initially composed of Mega Drug Distribution Centers (MDDCs), States Drug Distribution Centers (SDDCs), Wholesalers and retail outlets in a hierarchical order to be operated by the private and public sectors. Regulatory agencies were recognized within the framework, including the Pharmacist Council of Nigeria (PCN) and the National Agency for Food and Drug Administration and Control (NAFDAC).
The guidelines also make provision for the set-up, organization and administration of each level of in the distribution chain. The administrative guidelines are more explicit at the State Drug Distribution Centre level because of the government involvement and the need to accommodate public governance process. Some stakeholders as described above criticized the original framework and the voice of the manufacturing group was more strident. They felt that their interest was not accommodated well enough and they called for amendment. In response to the criticisms, every stakeholder added the concept of Coordinated Wholesale Centers to pander to the entrenched interests and drive acceptability and adoption.
The addition was conceptualized as presenting better opportunity for improved drug distribution, as strategy to control illicit activities and ensure appropriate regulations in the country. The NDDG allowed for drug entry into the distribution cycle through the Importers and Manufacturers who must have been registered by the Pharmacists Council of Nigeria (PCN).
We are usually very good at formulating policies but remain consistently poor at implementation. The national ‘shelves’ are full of well of well-crafted policy documents that are gathering dusts and begging for implementation. A typical example is that of ‘National Drug Policy’, which prescribes that a certain percentage of drugs, purchases by government agencies should be reserved for local manufacturers. Till date, the policy is not better than the paper with which it was printed. This is a national malaise that requires urgent attention from all and sundry. Unfortunately, this malaise affected the implementation of the NDDG and the effective date of the implementation has been shifted three times already. The rhetoric is the same at each postponement announcement and the excuses can be extrapolated to the next one. Now, we are told that January 2019 is the new implementation year and we can just pray that this date will remain sacrosanct. The implementation challenge may be due to any (or all) of the following factors:
•Lack of knowledge: People have not taken time to study the guidelines deeply to understand and appreciate its provisions. This lack of knowledge gave room to fears and therefore, opposition.
•Lack of ownership: At the beginning, the ownership of the implementation was not clear and this made the NDDG an orphan. For seamless or effective execution, we need to have a clear ownership with passion to get things done.
•Selfish interest: As with most things in this clime, those who are benefiting from the current situation will do everything possible to prevent a change.
•Lack of vision: We are too fixated on today’s affairs that we fail to see the benefits that our current action can bring in the near and far future.
•Lack of affirmative action on the part of the Government: Government needs to be firm in taking some actions even if it is not so popular or its immediate benefits cannot be seen now. After all, it is stated that ‘you cannot eat omelette without breaking an egg’.
•Analysis that breed paralysis: There is a need to stop the cycle of ‘we are not ready yet’ as unending analysis will paralyze the system.
It is our fervent hope that the 2019 implementation date for the NDDG will not pushed forward any longer.
Benefits of NDDG implementation:
An effective drug distribution system has so many benefits not only for the consumers of the drugs but also for healthcare delivery system and the pharmaceutical industry.
•Conservation of scarce resources as the streamlining of drug distribution will promote the implementation of the essential drug project to satisfy most of the people.
•There will be quick audit to maintain the integrity of the system and respond to an intrusion once discovered.
•The circulation of fake and adulterated drugs will be curtailed.
•Drug procurement system will be simplified with reduced cost and improved efficiency.
•Generation of data for good health planning.
•Regulatory task will be facilitated and easier with organized system.
•The Pharmaceutical industry will be more robust.
•The practice of Pharmacy will be enhanced.
*Dr. Lolu Ojo is a consultant pharmacist and Fellow of the Pharmaceutical Society of Nigeria (PSN).
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