A closer look at the new national drug distribution guidelines

pharmacy

(By Dr. Lolu Ojo, FPSN)                                      

        The second edition of the National Drug Distribution Guidelines was published by the Federal Ministry of Health in 2012. The implementation of the guidelines is expected to take off in July, 2014 since all structures are expected to be in place on or before 30 June, 2014. Overall, the guidelines seek “to establish a well-ordered drug distribution system for Nigeria”.  This noble goal is a desirable end-point for which all pharmacists, young and old, have been clamouring.

The clamour is not without basis as the current system of drug distribution in Nigeria is anything but dignifying for the profession of Pharmacy. Drugs are peddled by all sorts of characters: sane, insane, learned, ignorant, etc. It is a rat race, the consequences of which are weighty and destructive for the health care delivery system in the nation, as well as its economy.

The most notable fallout of the chaotic and unorganised distribution system is the unrestricted circulation of fake, substandard and adulterated pharmaceutical products. Like most other issues, we do not have statistics that will adequately describe the extent of faking or the proportion of fake products in circulation. We have had figures from different sources that state that 70 per cent, 50 per cent or 15 per cent of total drugs circulating in Nigeria are fake. Our concern will not be the veracity or otherwise of these figures but the fact that we have a problem and it is our joint responsibility to solve it. The fake drug incidence or prevalence should be zero!

Responsibilities 

In summary, the guidelines have erected pillars and clearly delineated channels of distribution with roles and responsibilities:

1. The manufacturers and the importers are at the apex of the ladder and their role is to make the drugs available and sell ONLY to Mega Drug Distribution Centres (MDDC), State Drug Distribution Centres (SDDC) and National Health Programmes.
2. The next layer is occupied by the MDDC and the SDDC. While the MDDC is private sector-driven, the SDDC is for the public sector at the state level. The SDDC will cater for all public health facilities in the state and is also allowed to sell to National Health Programmes (where indicated) and wholesalers. The MDDC is allowed to sell to wholesalers ONLY.
3. The wholesalers occupy a pivotal role in the value chain. Purchases can be from MDDC or SDDC but NOT from the manufacturers or importers. The wholesaler is allowed to sell to community pharmacies, public/primary healthcare facilities and private health institutions. With this function clearly spelt out, there is really no need for a wholesaler to engage in retailing as it is now.
4. At the bottom of the distribution ladder, we have community pharmacists and public/private health institutions who sell directly to the consumers. The community pharmacy is also allowed to sell to private health institutions.
5. There other provisions which affect pharmacists directly:
   1. All drug retailing institutions, including private hospitals, local government clinics (a pharmacist is allowed to supervise four clinics) must be registered by the PCN. With this, more employment opportunities will open for pharmacists.
   2. Only pharmacists can register and operate a retail pharmacy. This is a clear departure from the current system.
   3. To be a superintendent pharmacist, you must have, at least, five years post qualification experience for retail and ten years for wholesale.
   4. The position and importance of pharmacists are well spelt-out in the structure and operation of the MDDC and the SDDC.
   5. The guidelines will be operated based on the existing PCN and NAFDAC laws.

It is important for everyone to have a copy of the guidelines and study it properly. Pharmacists must, working together, ensure that these guidelines are faithfully implemented.

Reservations

The PSN President, Pharm Olumide Akintayo FPSN, set up a committee headed by me early in March, 2013. The committee, made up of eminent and accomplished pharmacists, was to, among other things, fashion out what would be the appropriate response of Pharmacy House to the new guidelines. We have, since then, been working to get things moving.

From this vantage position, I have observed so many things:

1. The level of awareness among pharmacists is, unfortunately, still very low, considering that this document has been in circulation for more than one year.
2. People have some reservations on some of the provisions. The queries are:
   1. Why is the MDDC not restricted to pharmacist ownership?
   2. Some states already have a flawless drug supply system. Why do we want to rock the boat with this new system?
   3. What will happen to young pharmacists if the superintendent pharmacist’s position is reserved for experienced (5 years above) people?
   4. The PSN-promoted MDDC will suffer the same fate as CO-PHARM.  Why waste efforts on this venture??
   5. The drug market will still be operating. Why are we wasting time on these new guidelines?
   6. There are still many unresolved issues between the different cadres of pharmacists which may not augur well for the implementation of these guidelines.

 Recommendations

The committee, under my leadership, has made some recommendations to the President which have been accepted and endorsed at the last AGM of the PSN in Ilorin. One of the recommendations is the floating of a holding company which will belong to all of us and other investors, and will serve as Mega Drug Distribution Centre.

We have also made presentations at different fora on the need for pharmacists to know about and embrace the guidelines. We must all be involved. You must ask questions from your State PSN Chairman or the DPS on what is going on in your state. We must not be the ones to impede the progress of this new system. The document is already endorsed by the relevant authorities in government. Let us implement it as it is. There will be opportunities for amendment in future.

I am convinced that the implementation of these guidelines will move Pharmacy forward in Nigeria. It is our key to a more dignified practice. We can build on the momentum that will be generated in Pharmacy if drug distribution becomes well-organised.

Roles of the PCN

The PCN is the most important agency of government in the successful implementation of these guidelines. The value chain must be policed to ensure that there are no leakages and a parallel black market does not emerge. The existing drug markets must go, to allow for a smooth operation. The operators of the market can form their own MDDC. This should not be a problem to anybody. There is nowhere in the world where non-pharmacists do not play prominent roles in the business of Pharmacy. Our interest should remain that: the rules, as set up in the guidelines, must be followed.

The PCN registration must not be STATIC. PCN must feel the pulse of the organisations registered in order to curb the ‘register and go’ syndrome.  The chairman, registrar and other officials of the council must rise up to the challenge of creating a new Pharmacy. They must do more than what is expected of a government official. They must go the proverbial extra mile to deliver on commitments and expectations.

PCN will need our support in terms of resources to discharge her obligations under the guidelines. PSN must rise up to this challenge. No effort must be spared to get things moving. As pharmacists, we must be ready to make the necessary sacrifice when called upon to do so. I have created a question-and-answer package to throw more light on the implementation of the new guidelines particularly as it concerns the PSN-promoted MDDC. I urge the readers to go through carefully and make their contributions.

Dr. Lolu Ojo, FPSN, is the chairman/CEO, Merit Healthcare Limited and immediate past national chairman of AIPN.

NATIONAL DRUG DISTRIBUTION GUIDELINES

FREQUENTLY ASKED QUESTIONS

Q. WHAT ARE THE MAJOR OBJECTIVES OF THE NEW GUIDELINES?

A. i) To establish a well-ordered drug distribution system for Nigeria.

• ii) To ensure efficient and effective drug supply management in the public and private sector
• iii) To ensure availability of good quality, safe, efficacious and affordable drugs nationwide.

Q. WHAT ARE THE TARGET DATE(S) FOR IMPLEMENTATION?

A.  It is expected that by 30^th June, 2014:

1.                     i.            All state governments would have set up their STATE DRUG DISTRIBUTION CENTRES (SDDC)
2.                   ii.            The private sector would have established the MEGA DRUG DISTRIBUTION CENTRES (MDDC) with operation in all the states of the federation or at least in six geo-political zones of the country.
3.                 iii.            With the SDDC and MDDC in place, the guidelines become operational by 1^st July, 2014.

Q. IS THERE AN ENABLING LAW TO GUARANTEE THE OPERATION OF THE GUIDELINES?

A. The guidelines are to be operated based on the existing PCN and NAFDAC laws. No new law specifically enacted for the guidelines is available for now. However, the guideline is a federal government document which has been endorsed by the relevant authority.

Q. WHY WILL A STATE GOVERNMENT ABANDON THE CURRENT DRUG DISTRIBUTION SYSTEM AND ADOPT THE NEW GUIDELINES?

 A. Drugs and all issues relating to drugs are in the exclusive legislative list. It is, therefore, the exclusive prerogative of the Federal Government to issue guidelines as appropriate. Besides, the state governments were carried along at the drafting stages.

Q.   WHAT ARE THE MAJOR DIFFERENCES THAT THE NEW GUIDELINES WILL BRING INTO THE DRUG DISTRIBUTION SYSTEM?

A.

1.                       i.            The current distribution system is chaotic, lacks professionalism, breeds unethical practices, accommodates circulation of fake, substandard & adulterated drugs and is capable of undermining the total health care delivery system in the country.
2.                     ii.            The new guidelines recognises specific and established channels of distribution:
   1. The Manufacturers and Importers at the top of the ladder. Their job is to manufacture or import the drugs as the case may be. They are to sell directly to three major outlets or channels:
      1.                                                                             i.      The Mega Drug Distribution Centres (MDDC),
      2.                                                                           ii.      The State Drug Distribution Centres (SDDC), and
      3.                                                                         iii.      The National Health Programmes.
      4. Next on the ladder and at the lateral level are the:
         1.                                                                             i.      MDDC: A private sector initiative which can sell to WHOLESALERS only.
         2.                                                                           ii.      SDDC: A public sector organisation which caters primarily for the state drug needs (public and primary health care) but can also sell to the wholesalers.
         3. Next on the ladder are the WHOLESALERS who are already existing and the new ones that will come up. They are allowed to sell to community pharmacists, private health institutions, PPMV holders and public health facilities.
         4. Community pharmacies, hospitals (public and private), PPMV holders are at the bottom of the ladder. They are the retailers who will sell to the consumers. The community pharmacy is also allowed to sell to private hospitals.
         5.                   iii.            There is a clear role sort and responsibilities along the value chain. There is a clear distinction between the role of a retailer and that of the wholesaler. The manufacturer and importer can no longer sell to directly to the hospitals, wholesalers and community pharmacies.

 Q. WHAT ARE THE IMPLICATIONS FOR PHARMACISTS IF AND WHEN THESE GUIDELINES BECOME OPERATIONAL?

  A.

1.                       i.            The document is essentially a pro-Pharmacy document. Effective implementation will restore honour and dignity to the profession. The new system will promote professionalism.
2.                     ii.            The key management and operational staff of both the MDDC and SDDC are, by the provision of the guidelines, pharmacists. Therefore, there will be gainful employment and empowerment for pharmacists.
3.                   iii.            The guidelines clearly state that retail pharmacies are to be owned by pharmacists. There is no ambiguity in this provision.
4.                    iv.            All retail channels for drugs including the private hospitals must be registered by the PCN. This certainly will give more control about drug affairs to the pharmacists.
5.                      v.            A pharmacist is allowed to supervise drug use in up to four primary healthcare centres. Most states do not have pharmacists at this level right now.
6.                    vi.            To work as a superintendent pharmacist, you must have at least:
   1. five-year post qualification experience for retail pharmacy.
   2. ten-year post qualification experience for wholesale pharmacy.
   3. ten-year post qualification experience for MDDC and also to be on the board of the distribution channel companies.

Q.  IS THE MDDC GOING TO OPERATE LIKE A CORPORATE DRUG MARKET AS WE HAVE IN ONITSHA, IDUMOTA, ETC, CURRENTLY?

A.

1.           i.            NO. The MDDC is a limited liability company whose structure and operations are clearly spelt out in the guidelines. It is essentially drug distribution logistic organisation with mega warehouses, offices, distribution vans and personnel in all the states of the federation or, at least, nearly all. It is not a market!
2.         ii.            Drug procurement by wholesalers will be streamlined by appropriate technology which will make physical travel for drug purchase unnecessary.

Q.  HOW MANY MDDC ARE WE GOING TO HAVE AND IS IT GOING TO BE FOR OR OWNED BY PHARMACISTS ONLY?

A.

1.                        i.            The guidelines do not state that only pharmacists can set up MDDC. It is a private sector initiative and any investor, entrepreneur or venture capitalists, including the so called traders, can set up MDDC either as an individual or group.
2.                      ii.            However, the guideline is very clear on the operation of the MDDC which must be run by pharmacists.
3.                    iii.            There is no limit to the number of MDDC that can be set up. As many applications as are considered worthy of registration by PCN can become MDDC.

Q. WHAT WILL HAPPEN TO THE EXISTING OPEN DRUG MARKETS?

      A.  The open drug markets have no role to play in the new drug distribution guidelines. They will eventually fizzle out.

       Q.  WHAT IS THE GUARANTEE THAT THE PROVISIONS OF THESE GUIDELINES WILL BE ENFORCED GIVEN OUR CURRENT EXPERIENCE?

       A.

1. The success of the new guidelines is a joint responsibility of all the stakeholders.
2. We must all join hands to police the system. We must give maximum support to PCN and NAFDAC in the discharge of their statutory duties.
3. The PSN and technical/interest groups must work in sync to ensure a seamless implementation of the guidelines.

Q. WHAT IS THE PSN DOING TO PROTECT THE INTEREST OF PHARMACY AND PHARMACISTS IN THE NEW DISPENSATION?

 A. PSN is doing a lot.

1. A committee, under the leadership of Dr. Lolu Ojo FPSN, was set up to formulate the appropriate response of PSN to the new guidelines.
2. The committee is working on:
   1. Generating more awareness about the guidelines among pharmacists through presentations, advocacy visits and other forms of communication.
   2. Liaising with state PSN chairmen and DPS on the setting up of SDDC in each state.
   3. Setting up of a MDDC which will belong to all Pharmacists.
   4. Doing everything possible to prevent a situation where the guidelines will be hijacked by a privileged few to the exclusion of the majority.

Q. HOW CAN I PARTICIPATE IN THE PSN-PROMOTED MDDC?                                                    

 A.

1. Participation will be open to all pharmacists. Other interest groups will be called upon to invest as well.
2. Minimum level of investment will be N100,000. Everyone will be encouraged to put in as much as he/she is capable of doing.
3. A register of members of the company will be opened and will close within a specified period. Details will be communicated in due course.
4. Our market research has shown that this is going to be a great business venture and everybody is encouraged to participate.

Q. WILL THE PSN-PROMOTED MDDC BE OPERATED LIKE THE CO-PHARM VENTURE?

A. NO. The PSN will not run the MDDC. The PSN is the promoter and will be a shareholder.

1.         i.            The company will be run by a competent management team under the supervision of a Board of Directors whose membership will reflect the shareholding structure.
2.       ii.            You can get a seat on the Board depending on your level of participation or shareholding.
3.     iii.            The company will be run based on the world’s best business practices, ensuring there is a commensurate return to the investors.
4.      iv.            It will also protect the interest of Pharmacy and the general public in the drug distribution system.
5.        v.            A dedicated account has been opened for the purpose of the proposed MDDC

Q.  IS THERE A POSSIBILITY OF A PARALLEL DISTRIBUTION SYSTEM (BLACK MARKET) DEVELOPING WHEN THESE GUIDELINES TAKE OFF?

A. There are no specific guarantees that Nigerians and others will not try to circumvent the system. There is no absolutism in issues like this. However, we all must remain very vigilant and police the value chain effectively. We must work with PCN and NAFDAC to ensure compliance.

Q. HOW DO I GET A COPY OF THE GUIDELINES?

A. You can get a copy:

1.           i.            Directly from the Food & Drug department of the Federal Ministry of Health. Mrs Joyce Ugwu is the project director.
2.         ii.            From PCN offices nationwide and the Pharmacy Department of the State Ministry of Health.
3.       iii.            From the PSN (national and state branches) and all the technical groups.
4.       iv.            From the websites of any or all of the organisations mentioned above.

Dr. Lolu Ojo FPSN

Chairman, Drug Distribution Committee