Baseline Assessment of the Nigerian Pharmaceutical Sector: ANNEX 1: Forms for Level I Indicators

Forms for Level I Indicators

Questionnaire on structures and processes of country

Country

Date dd/mm/yyyy ..............

Name of respondent(s)

Position(s)

................................

2003

1. NATIONAL MEDICINES (DRUG POLICY (NMP)

1.1 Is there a National Medicines Policy (NMP) document? (See glossary for a definition of NMP.) If no, skip to 1.4.

Yes/No/Don’t Know

Is it an official or draft document?

Official/Draft/Don’t Know

What year was it last updated?

Year _____

1.2 Is there an NMP implementation plan that sets activities, responsibilities, budgets, and timeline?

Yes/No/Don’t Know

If yes, when was it last updated?

Year _____

1.3 Is the NMP integrated into a published/official national health policy/plan? If yes, when was it last updated?

Yes/No/Don’t Know

Year _____

1.4 Is there a national policy on traditional and complementary/ alternative medicine (TM/CAM) either as part of the medicine policy or health policy or as a separate document? (TM/CAM is defined in the glossary.)

Yes/No/Don’t Know

If yes, when was it last updated?

Year _____

1.5 Has a national assessment/indicator study been conducted? If yes, what areas have been studied and when was the most recent study covering each area conducted?

Yes/No/Don’t Know

Overall pharmaceutical situation:

Yes/No/Don’t Know

Year _____

Rational use/prescription audit:

Yes/No/Don’t Know

Year _____

Access

Yes/No/Don’t Know

Year _____

2. LEGISLATION/REGULATION

Is there a medicines law? If yes, when was it last updated? Which of the following areas are covered by medicines legislation and when was last updated?

Yes/No/Don’t Know

Year _____

Establishment of regulatory authority:

Yes/No/Don’t Know

Year _____

Marketing authorization of pharmaceuticals:

Yes/No/Don’t Know

Year _____

Manufacturing of medicines:

Yes/No/Don’t Know

Year _____

Distribution of medicines:

Yes/No/Don’t Know

Year _____

Promotion & advertising of medicines:

Yes/No/Don’t Know

Year _____

Importation of medicines:

Yes/No/Don’t Know

Year _____

Exportation of medicines:

Yes/No/Don’t Know

Year _____

Licensing & practice of prescribers:

Yes/No/Don’t Know

Year _____

Licensing & practice of pharmacy:

Yes/No/Don’t Know

Year _____

Herbal medicines (See glossary for definition):

Yes/No/Don’t Know

Year _____

Empowers inspectors to enter premises and collect samples and documentation:

Yes/No/Don’t Know

Year _____

Requires transparency, accountability and code of conduct in regulatory work:

Yes/No/Don’t Know

Year _____

2.2 System and operation of medicines registration:

a) Is marketing authorisation required for medicines to be sold? If yes, how many medicinal products have been approved to be marketed? (express as number of dosage forms & strengths)

Yes/No/Don’t Know
Total______

Is marketing authorisation required for herbal medicines to be sold? If yes, how many herbal medicinal products have been approved to be marketed? (express as number of dosage forms & strengths) (See glossary for a definition of herbal medicines)

Yes/No/Don’t Know
Total______

b) Are there detailed written guidelines, including reference guidelines and criteria, for submitting applications for the registration of medicinal products? Are there guidelines covering the registration of herbal medicines?

Yes/No/Don’t Know
Yes/No/Don’t Know

c) Is the WHO Certification Scheme certificate required as part of the marketing authorisation process?

Yes/No/Don’t Know

d) Is INN used in the registration of medicines?

Yes/No/Don’t Know

e) Is a list of all registered products publicly accessible? (Registered product is defined in the glossary.)

Yes/No/Don’t Know

2.3 Is there a computerised registration system that facilitates retrieval of information on registered products? (Registration system is defined in the glossary.)

Yes/No/Don’t Know

Is there a medicines regulatory authority website providing publicly accessible information on any of the following: legislation, regulatory procedures, prescribing information (such as indications, counter-indications, side effects, etc.), authorized companies, and/or approved medicines?

Yes/No/Don’t Know

2.4 Is licensing a requirement? (Licensing is defined in the glossary.) If yes, is it based on site inspection of:

Yes/No/Don’t Know

Manufacturers:

Yes/No/Don’t Know

Importers/wholesalers:

Yes/No/Don’t Know

Retail distributors/pharmacies:

Yes/No/Don’t Know

2.5 Are there written national guidelines/codes/checklists for the inspection of:

Manufacturers:

Yes/No/Don’t Know

Importers/wholesalers:

Yes/No/Don’t Know

Retail distributors/pharmacies:

Yes/No/Don’t Know

2.6 Is prescribing by generic name obligatory in the:

Public sector:

Yes/No/Don’t Know

Private sector:

Yes/No/Don’t Know

Is generic substitution permitted at: (Generic substitution is defined in the glossary.)

Public pharmacies:

Yes/No/Don’t Know

Private pharmacies:

Yes/No/Don’t Know

2.7 Is promotion/advertisement of medicines reg

Company self-regulation:

Yes/No/Don’t Know

Government agency or medicines regulatory authority:

Yes/No/Don’t Know

Are civil society/non-governmental organisations involved in review, assessment, or surveillance of promotion/ advertisement of medicines?

Yes/No/Don’t Know

Do regulations on promotion/advertisement of medicines include: (See glossary for the distinction between promotion and advertisement.)

Published ethical criteria for medicines promotion:

Yes/No/Don’t Know

Pre-approval for promotional materials:

Yes/No/Don’t Know

Pre-approval for advertisement materials:

Yes/No/Don’t Know

Explicit prohibition on advertising prescription medicines:

Yes/No/Don’t Know

Detailed restrictions on advertising nonprescription medicines:

Yes/No/Don’t Know

2.8 Are adverse drug reactions (ADR) monitored? If yes, what is the total number of each of the following for the most recent year for which data is available?

Yes/No/Don’t Know

Total number of validated ADR reports received:

__(Year ___) DK

Total number of reporting physicians:

__(Year ___) DK

Total number of physicians in country:

__(Year ___) DK

Are ADR of herbal medicines monitored?

Yes/No/Don’t Know

3. QUALITY CONTROL OF PHARMACEUTICALS

3.1 Testing of medicines samples collected last year for regulatory purposes (i.e. including drug registration and post-marketing surveillance, but excluding testing done in conjunction with procurement activities):

Total number of samples

Total number of samples collected:

________

Don’t Know

Total number of samples tested:

________

Don’t Know

Total number of samples that failed identity or assay:

________

Don’t Know

3.2 Where have the above samples (see 3.1) been tested:

Percentage of total samples tested

Government quality control laboratory:

_______ %

Don’t Know

Local academic institutions:

_______ %

Don’t Know

Quality control laboratory in another country:

_______ %

Don’t Know

Private quality control laboratory:

_______ %

Don’t Know

4. ESSENTIAL MEDICINES LIST (EML)

4.1 Are there Essential Medicines Lists (EML)? (An Essential Medicines List is a government-approved selective list of medicines or national reimbursement list)

Total number of medicines

Year of last update

National EML:

Yes/No/DK

_______

State or provincial list:

Yes/No/DK

_______

List for primary health care:

Yes/No/DK

_______

4.2 Are EMLs being used in:

Public sector procurement:

Yes/No/Don’t Know

Public insurance reimbursement:

Yes/No/Don’t Know

Private insurance reimbursement:

Yes/No/Don’t Know

4.3 Are local herbal medicines included on the national EML?

Yes/No/Don’t Know

5. MEDICINES SUPPLY SYSTEM

5.1 Who is responsible for public sector drug procurement and distribution? What percentage of the total cost is each responsible for?

Procurement

Distribution

Ministry/Department of Health:

Yes/No/DK ___ %

Yes/No/DK __ %

Non-governmental organisation (NGO):

Yes/No/DK ___ %

Yes/No/DK __ %

Private institution contracted by the government:

Yes/No/DK ___ %

Yes/No/DK __ %

Individual health institutions:

Yes/No/DK ___ %

Yes/No/DK __ %

5.2 Is government procurement limited to medicines on the EML?

Yes/No/Don’t Know

If no, is a percentage of the budget set aside for non-EML items?

Yes/No/Don’t Know

What is the percentage?

_______ %

5.3 Type of tender and percentage of the total cost for each: (Tender is the process by which competing bids are entered for a particular contract.)

Percentage of total cost

National competitive tender:

Yes/No/DK

_______ %

International competitive tender:

Yes/No/DK

_______ %

Negotiation/direct purchasing:

Yes/No/DK

_______ %

5.4 Is drug registration a prerequisite for government purchases?

6. MEDICINES FINANCING

6.1 What is the total public or government budget for medicines in US$ for the most recent year for which data is available?

$ _____, Year ____

Public sector

Private sector

NGO

6.2 Are there guidelines on medicines donations that cover the public sector, the private sector, or non-governmental organisations (NGO)?

Yes/No/DK

6.3 Which medicines are free at primary public health facilities:

All medicines are free of charge:

Yes/No/Don’t Know

Malaria medicines are free:

Yes/No/Don’t Know

Tuberculosis medicines are free:

Yes/No/Don’t Know

Sexually transmitted diseases medicines are free:

Yes/No/Don’t Know

HIV/AIDS-related medicines are free:

Yes/No/Don’t Know

Medicines are free to those who cannot afford them:

Yes/No/Don’t Know

Medicines are free for children under 5 years of age:

Yes/No/Don’t Know

Medicines are free for pregnant women:

Yes/No/Don’t Know

Medicines are free for elderly persons:

Yes/No/Don’t Know

No medicines are free of charge:

(Don’t Know )

6.4 Which fees are charged in public health facilities:

Registration/Consultation fees:

Yes/No/Don’t Know

Dispensing fees:

Yes/No/Don’t Know

Flat fees for medicines:

Yes/No/Don’t Know

Flat rate copayments:

Yes/No/Don’t Know

Percentage copayments:
(Co-payments cover part of the cost of medicines, the other part being paid by an insurer or government.)

Yes/No/Don’t Know

6.5 Is revenue from fees or drug sales used to pay the salaries of public health personnel in the same facility?

Always/Frequently/Occasionally/Never/DK

6.6 Health insurance: (Health insurance is any prepayment scheme for health care costs additional to but excluding subsidies funded through the Ministry of Health budget.)

Public

Private

What percentage of the population has health insurance?

All/Some/None/DK

Are medicines covered by health insurance?

All/Some/None/DK

Of the covered medicines, what percentage of the cost is covered:

____ %

6.7 Is there a pricing policy on medicines that covers the public sector, the private sector, or non- governmental organisations?

Public sector

Private sector

NGO

If yes, does it apply to:

Yes/No/DK

All medicines, some or none:

All/Some/None/DK

Is maximum wholesale mark up established in laws/regulations:

Yes/No/DK

If yes, amount:

____ %

Maximum retail mark up established in laws/regulations:

Yes/No/DK

If yes, amount:

____ %

Duty on imported raw pharmaceutical materials:

Yes/No/DK

Duty on imported finished pharmaceutical products:

Yes/No/DK

7. ACCESS TO ESSENTIAL MEDICINES

7.1 In your opinion, what percentage of the population has regular access to essential medicines (i.e. minimum of 20 most essential medicines available and affordable at public and private facilities within a one-hour walking distance)?

____ %

7.2 What percentage of:

Public health facility

Private health facility

Public or private retail drug outlet

The population is within one-hour walking distance to:

____ %

Facilities have essential medicines available:

____ %

The population can afford essential medicines at:

____ %

8. PRODUCTION

8.1 What is the medicines production capability in the country?

Research and development of new active substances:

Yes/No/Don’t Know

Production of pharmaceutical active starting materials:

Yes/No/Don’t Know

Formulation from pharmaceutical starting materials:

Yes/No/Don’t Know

Repackaging of finished dosage forms:

Yes/No/Don’t Know

8.2 For each of the following types of local production, indicate number of factories and total annual sales in US$ for the most recent year for which data is available:

Number of factories

Sales in US$

Year

Don’t know

Starting materials:

$ _

Finished products:

$ _

Products containing active substances developed/marketed for the first time during the last 5 years:

$ _

8.3 What is the total volume and US$ value of the medicines market? Generic medicines compose what percentage of market volume and value?

Volume ____, Value $ ____
Volume ____%, Value ____%

9. RATIONAL USE OF MEDICINES

9.1 Are there standard treatment guidelines (STGs) produced by the health ministry/department for major conditions? (STGs are recommendations about how to treat a clinical condition.)

Number of condition s/ diseases

Year of publication or review

National STG:

Yes/No/DK

____

STG for hospital level:

Yes/No/DK

____

STG for primary health care level:

Yes/No/DK

____

9.2 Is there a National Medicines Formulary manual? (A formulary manual contains summary drug information.) If yes, does it cover only medicines on the Essential Medicines List?

Yes/No/Don’t Know
Yes/No/Don’t Know

What year was it last published/reviewed:

Year ___

9.3 Are any of the following aspects of the essential medicines concept generally part of the basic curricula in most health training institutions/universities for: (Essential medicines are those that satisfy the priority health care needs of the population. See glossary for a definition of problem-based pharmaco-therapy.)

Essential Medicines List

Standard Treatment Guidelines

Problem-based pharmaco-therapy

Rational prescribing

Doctors:

Yes/No/DK

Nurses:

Yes/No/DK

Pharmacists:

Yes/No/DK

Pharmacy assistants:

Yes/No/DK

Paramedical staff:

Yes/No/DK

9.4 Are there independent publicly or non- commercially funded obligatory continuing education programs which include use of medicines for:

Doctors:

Yes/No/Don’t Know

Nurses/midwives/paramedical staff:

Yes/No/Don’t Know

Pharmacists:

Yes/No/Don’t Know

Pharmacy aides/assistants:

Yes/No/Don’t Know

9.5 Is there a public or independently funded nationally accessible (e.g. by phone) medicines information centre or service co-ordinated by the Ministry of Health, academia, and/or a non-commercial non-governmental organisation that provides information on demand to:

Prescribers:

Yes/No/Don’t Know

Dispensers:

Yes/No/Don’t Know

Consumers:

Yes/No/Don’t Know

9.6 Has there been any public education campaign concerning rational medicines use in the previous two years conducted by Ministry of Health/non-governmental organisation/academia on the following topics:

Use of antibiotics:

Yes/No/Don’t Know

Use of injections:

Yes/No/Don’t Know