WHO Drug Information Vol. 24, No. 4, 2010 World Health Organization WHO Drug Information Contents WHO Prequalification Sitaxentan: worldwide withdrawal 307 Programmes Sibutramine: suspension of sales 307 Sibutramine-containing medicines: WHO Prequalification of Medicines withdrawal 308 Programme: survey of service Testosterone transdermal patch: quality provided to manufacturers 293 withdrawal of extension of WHO initiates pilot prequalification of indication application 308 active pharmaceutical ingredients 297 Aliskiren/valsartan: withdrawal of New on-line database for WHO marketing authorization application 308 prequalified vaccines 298 Mometasone furoate/formoterol fumarate: withdrawal of marketing Safety and Efficacy Issues authorization application 309 EMA and US FDA extend confidentiality H1N1 influenza vaccine: narcolepsy 299 arrangements indefinitely 309 Statins: interstitial lung disease 299 Tocilizumab: risk of fatal anaphylaxis 300 Recent Publications, Pioglitazone: potential bladder cancer 301 Information and Events Angiotensin receptor blockers and US Government to share patents with cancer: safety review 301 Medicines Patent Pool 310 GnRH agonists, diabetes and cardio- Clinical trials and global medicines vascular disease 301 development 310 Gadolinium-based contrast agents: Evaluation of future nanomedicines 311 kidney dysfunction 302 Reporting on opioid inaccessibility 311 Lamotrigine: aseptic meningitis Tinzaparin sodium: renal Impairment in elderly 303 Consultation Documents Tamoxifen: drug interactions involving The International Pharmacopoeia CYP2D6 genetic variants 303 Capreomycin sulfate 312 Zoledronic acid solution: renal Capreomycin for injection 316 dysfunction 304 Efavirenz tablets 319 Efavirenz, emtricitabine and tenofovir Regulatory Action and News tablets 323 Emtricitabine capsules 327 Influenza vaccines: 2011 southern Emtricitabine and tenofovir tablets 330 hemisphere 305 Levamisole tablets 334 Rosiglitazone-containing antidiabetes Levofloxacin 337 medicines: suspension of marketing Levofloxacin tablets 342 authorization 305 Levonorgestrel tablets 346 Modified-release oral opioids: suspension of marketing authorization 306 Human normal immunoglobulin: sus- Proposed International pension of marketing authorization 306 Nonproprietary Names Propoxyphene: recommendation List 104 351 against use 306 291 World Health Organization WHO Drug Information Vol. 24, No. 4, 2010 WHO Drug Information Digital Library, e-mail table of contents and subscriptions available at: http://www.who.int/druginformation 292 WHO Drug Information Vol. 24, No. 4, 2010 WHO Prequalification Programmes WHO Prequalification of Medicines Programme: survey of service quality provided to manufacturers Established in 2001, the Prequalification of Medicines Programme (PQP) is a service provided by the World Health Organization (WHO) to facilitate access to quality medi- cines for treating priority diseases. In order to be prequalified, medicines must meet WHO-specified standards for quality, safety and efficacy. PQP is supported by vari- ous United Nations agencies (e.g., UNAIDS, UNICEF, UNFPA) and the World Bank. WHO prequalification of medicines is a multi-step process whereby a manufacturer submits extensive information that is then evaluated by a WHO assessment team with respect to product quality, safety and efficacy, site(s) of manufacture and any clinical studies that may have been carried out during development. Products that successfully pass PQP evaluation are listed on the WHO List of Prequalified Medici- nal Products (see: http://www.who.int/prequal). This list provides UN agencies with a single source of reference for quality-assured priority medicines and is also used by a variety of entities, both country-specific and international, that purchase medicines in bulk quantities. The Prequalification of Medicines Programme has conducted a comprehensive sur- vey among pharmaceutical manufacturers to assess its level of service. PQP as- sessment and inspection activities reflect those carried out by national regulatory authorities before granting marketing authorization (registration) for a medicine. The assessment review was therefore designed to maximize the diagnostic capability of the survey: to measure both the level of service provided by PQP and the levels of service expected from regulatory authorities by manufacturers. The survey included items relevant to the assessment of product dossiers and on-site inspections of manu- facturing facilities in a way that separated service design (the service process) from service delivery (or the “people” aspects of service). The results of this survey pro- vide direction for improvements to the current Programme and have implications for future strategic development. The survey organization recommended that WHO undertake a process optimization review In administering the Prequalification of with respect to PQP – an exercise that Medicines Programme (PQP), WHO would include feedback from manufactur- interacts with a number of stakeholder ers with experience of WHO prequalifica- groups and organizations whose objec- tion of medicines. tives are dependent upon, or related to, WHO prequalification of medicines: To provide guidance in developing a manufacturers, government agencies survey of manufacturers, implementing (including national and regional medi- the survey and analysing the results, cines regulatory authorities) and donor PQP retained the services of a market organizations. In 2009, one such donor research consulting company, Interclarity 293 WHO Prequalification Programmes WHO Drug Information Vol. 24, No. 4, 2010 Research & Consulting, Inc. Interclarity (people) and (ii) including services Research created a survey development provided during both the assessment of process with both internal and external product dossiers and on-site inspections components that resulted in a survey of manufacturing facilities. whose contents were relevant to manu- facturers and, when assessed by those • Maximize the diagnostic ability of the manufacturers, actionable by PQP. The survey by incorporating questions that survey was undertaken with the clear use manufacturer experience with major understanding that PQP must operate in regulatory agencies (US FDA, EMA, accordance with respective WHO and etc.) to measure expectations of service other relevant international technical quality and prioritize areas for improve- standards. It was also understood that the ment. results of the survey should neither serve • Provide a unified framework for to “lower” PQP’s technical standards nor measurement. While the intent of the to “relax” the requirements for the sus- initial survey of pharmaceutical manu- tained quality, safety and efficacy of any facturers was to include only those medicine that WHO had prequalified. companies that have had at least one product prequalified, PQP was also Survey objectives interested in developing a survey format that could be extended to companies PQP identified three main objectives in involved for the first time (at some stage designing and conducting a survey of in the approval process or awaiting final pharmaceutical manufacturers: approval) and companies that are considering participation. • Implement a comprehensive ap- proach to assessing the level of service quality delivered to pharma- Survey development process ceutical manufacturers by PQP by Without the benefit of previous self- (i) incorporating aspects of both service assessment efforts, PQP had little to work design (process) and service delivery with in terms of survey content in January Figure 1. Survey development 294 WHO Drug Information Vol. 24, No. 4, 2010 WHO Prequalification Programmes 2010. The area of service delivery is rich qualitative research. Further analysis of in both academic research and practical the qualitative findings suggested that application [1]; the area of service design, service delivery aspects of PQP would be however, is specific to the organization, well-represented by items included in the application, and recipients of the service. SERVQUAL scale of service quality [4]. Figure 1 on page 294 illustrates the SERVQUAL is a widely-applied scale for process used by PQP to identify and measuring the quality of service delivery. codify important services related to the Developed in the 1980s, it has been prequalification of medicines. refined and applied over the past 25 years. A survey development process was designed to obtain input from within the Survey construction and deployment organization and from regulatory and The survey was divided into four main quality assurance professionals in phar- sections: maceutical companies. The overall aim of this process was to capture and include 1. Experience with PQP. the knowledge and experience of PQP so that, when combined with the “voice of 2. PQP Service Design (“process”). the customer”, survey contents would be both relevant and actionable. 3. PQP Service Delivery (“people”). 4. Other Aspects of PQP. Interclarity Research developed topic guides and facilitated discussions, inter- The first section includes an introduction views and working sessions for both to the survey and questions that provide internal and external phases of the indicators and measures of previous process. Internal working sessions, both experience with PQP. Section 2 (Service in conference call and in-person formats, Design) is “custom” to PQP – developed were conducted with key PQP members as a result of a process review with PQP and groups