1. Assess current situation
The planning process should begin with an assessment and overview of the current drug regulatory situation in the country, and an inventory of the market (see IV.C.2, page 32). Knowing whether the present system is manual or computerized and whether its data is reliable and usable is crucial to determining how to proceed with computerization. Through document review and a series of structured interviews with drug regulatory and MOH officials, obtain the following information:
Assessment Element |
Relevance and Remarks |
Presence of requirements to submit applications for:
New MAs,
Renewal of existing MAs
Variation of existing MA
Issuance of certificates
Other |
If requirements are not in place or are notoriously not complied with, it is necessary to delay the implementation of computer-assisted drug registration until requirements are effectively and reliably implemented. |
How many applications are received/expected every year for:
New MAs,
Renewal of existing MAs
Variation of existing MA
Issuance of certificates
Other |
If this information is not readily available or cannot be reliably obtained from existing files, there can be doubts about the reliability of the drug registration system in place. This does not imply that computerizing is not feasible, but it makes it difficult to estimate the amount of time required to reach routine functioning of the new system. The number of products to enter into the computerized system is obviously a major variable in determining length of time for entering backlog data. |
Presence of a validity term limit for MAs and length of validity |
If MAs are valid indefinitely, their number could be very high (in some developing countries it is above 30 000). In these cases, entry of backlog information from a manual system may entail an enormous amount of work. Although entering the backlog may be a legal requirement, the amount of work it would require cannot always be justified on public health grounds. It is necessary to identify mechanisms to minimize the DRA’s efforts to manage backlogs. |
How many pieces of information on each drug item are recorded in the current system, and how many are expected to be recorded into the new computer system |
Computer systems can accommodate and permit retrieval of much more information than most developing countries’ DRAs may need or want to use. Deciding the extent of information to be recorded in a computer system is a crucial decision that will influence the pace at which a new database can be reliably built. |
Presence of an efficient inspection system covering manufacturing and distribution channels |
The absence of regular inspections of the distribution channels poses a serious challenge to the credibility of the information on marketed drugs available at the DRA. |
Presence of written procedures and compliance with them |
This element is important when assessing the possibility of using existing information in order to computerize. If there is no assurance that standard procedures (especially regarding completeness of information) have been followed in the past, it is very likely that the existing information is incomplete or inconsistent and, therefore, unsuitable for direct transfer into the new computerized system. |
2. Estimate time required to enter existing information into the new computerized system
The amount of time required to enter data will vary from country to country, depending on a wide variety of factors. The assessment described above should enable the user to determine which of the following situations is most like his or her own. For the purpose of this guide, “usable data” means MA data that reflect the reality of the drug items actually being marketed, and that have sufficient consistency and completeness to permit their use to build the new computerized system. Therefore, a DRA has usable data if its files physically contain all the pieces of information that are required for entry into the new system, and these data are accurate and reflect the current situation of the marketed drugs.
Nothing in Place
This is the situation where no regulatory authority is in place. The market is usually regulated simply by means of import permits and sometimes positive and/or negative lists broadly indicating which drugs can be imported. There is either no assessment of technical documentation, or it is limited to ensuring that imported drugs are related to a WHO-type product certificate, or to other informal types of certificates called “free-sale certificates.” In these situations there is no way to know what is actually being marketed at the present time.
The obvious starting point in a situation like this is to seek political commitment to approving or reviewing, and/or enforcing proper drug legislation and regulations, thus establishing a drug regulatory authority capable of ensuring that the principles of the national drug policy are respected.
The second step is to identify and licence all persons and premises that are involved with pharmaceuticals. Such licensing should cover pharmacists, manufacturers, importers, wholesalers, and distributors. The third step necessary for any further operations is an inventory of the market situation, as described in the “Inventory of Market Situation” section in Chapter IV. During the time that is required to carry out the inventory of the market situation, a DRA can continue to receive applications for new marketing authorizations but should establish priority criteria to deal with them. These criteria should be published to ensure transparency and avoid conflict with applicants. In establishing such priority criteria, a balance needs to be struck between the need to review data on drugs marketed prior to the creation of the new regulations and the need to ensure that vital new drugs are made available.
Manual System with No Usable Information
This is probably the most common situation. A manual system has been in place for some time but information on the pharmaceutical products authorized for marketing is not properly organized, not consistent, and/or not current. After having ensured that proper legislation and regulations are in place and that the regulatory authority can reliably function, the only viable approach is to ask all concerned persons to resubmit applications to be licensed as companies/individuals. Then an inventory of the market must be carried out as described in Chapter IV.
Computerized System with No Usable Information
This situation is essentially the same as a manual system with no usable information, and the same strategy indicated above should be followed.
Manual System with Usable Information
If the existing manual system has been kept up to date and the information is reliably retrievable, computerization of information can start directly from the existing files by typing the information from the manual records into the computer software.
Computerized System with Usable Information
If the existing system has been kept up to date and the information is reliably retrievable, changing easily to the new system depends on whether data can be converted from the existing system to the new one. It is also necessary to determine whether additional information must be input into the new computer system, beyond the data contained in the old one. If the format of the existing data is not compatible with the new system, then the existing information must be re-entered into the new software.
The status of existing information systems will be the primary determinant of the time required to enter backlog data and achieve routine functioning of the new computerized system. Additional issues that need to be taken into account when estimating time requirements are:
• Entry of backlog information does not entail assessment of applications, but simply entering what is available or has been collected with future assessments in mind. Thus, when estimating time requirements, this is referred to as simple data entry. When all the necessary information is obtained and has been transferred to a data entry form (see section IV.B.), its entry into the computer system can be estimated at an average of 10 minutes per drug item if there is no need to re-type the full text of the product information sheet. This, in fact, can be avoided when using the WHO system because it has a feature to import this sheet from a diskette, leaving only the editing work to be done.
• The WHO system has a function to copy an application or MA already entered, and to edit it. This is particularly useful when entering several different strengths or dosage forms of the same product, or different brands of pharmaceutical equivalents. In these cases, data entry is limited to editing the few fields that require different information, and can be estimated to take up to four minutes per drug item.
3. Estimate computer use for routine operation
The chart shown on the next page provides a schematic description of a possible way to assess how much computer time will be necessary when the system has reached the phase of routine use. The first thing to look at is whether there has been - and for how long - a requirement for applications to be submitted. If requirements were in place and were complied with, DRAs should be able to calculate how many applications have been received in the last 24 months. Otherwise an estimate of the possible flow of applications can be made on the basis of the number of drug items that are currently on the market. If the latter figure is unknown and it is not possible to make a reliable guess, it is necessary to carry out an inventory of the market situation (see Chapter IV) to assess how much computer time will be needed.
When calculating the number of applications, specific figures for four different types of applications need to be obtained: applications for new MAs, applications for renewal of existing MAs, applications for variations to existing MAs, and applications for certificates. The number of renewal applications can be estimated on the basis of the length of validity of MAs established in law or regulations. After the number of applications has been calculated or estimated, this should be adjusted if any changes in requirements have been made that may have an impact on that number.
ASSESSING HOW MUCH COMPUTER TIME IS NEEDED
This refers to routine operation, i.e., after backlog data have been entered.
The chart shows average time estimates that can be used to calculate the total time of computer use. It should be noted that these time estimates are only for actual time spent using the computer; they do not include time for technical assessment, testing, etc. The box below presents an example of the reasoning behind those estimates.
Experienced users need 3 minutes when applications are received to record the application number and date, applicant, drug name, strength, dosage form, and primary container. In addition to this, for each application, 2 minutes are required to record when and to which assessment step(s) the application is assigned. Then, each assessor will require up to 15 minutes to complete drug item data (e.g., active substances, excipients, therapeutic classification, etc.) and record his or her report. Finally, another 10 minutes will be required to record the final decision and issue standard correspondence or certificates. In all, for an application with no more than two assessment reports and three printouts (i.e., letter confirming reception, letter informing of final decision, and MA certificate) the computer use will be about 45 minutes distributed over a period of several days or weeks. If the assessment faces problems that entail extensive correspondence with the applicant, computer use may reach 60 minutes or more. |
4. Estimate staff needed
It is impossible to estimate here how many staff will be needed for the computerization process, and for running the computer-assisted drug registration system. The amount of work, skills of staff, workload distribution, and other variables will be very different from case to case. Therefore this estimation is a matter of local judgement. It is mentioned here because it is a necessary part of the planning process.
A tip for finding staff to accomplish the work, that a number of countries has found successful, is to recruit pharmacy students on a temporary basis to carry out the bulk of the backlog data entry job. This has usually been a cheap and substantially positive experience. |
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