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Quality of family planning products the view of the pharma industry

Quality of family planning products the view of the pharma industry. Hans M Vemer. Responsibility for private and for public sector.

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Quality of family planning products the view of the pharma industry

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  1. Quality of family planning productsthe view of the pharma industry Hans M Vemer

  2. Responsibility for private and for public sector • Company A: “We have created numerous programs and public-private partnerships to help improve healthcare capacity and improve access to our products, so all can benefit, wherever they live.” • Company B: “...we support the cause of giving people access to methods of family planning, irrespective of their economic situation.” • Provide products, • and all product support, • of assured quality • for “cost-plus”.

  3. Good quality products. What do companies mean? • Products of assured quality, including the whole accompanying package, at cost-plus. • The package consists of: • The actual product • Education • Constant quality assurance • Follow-up • Sustainability • Choices

  4. Why is quality so important in family planning products? • Healthy consumers, not patients • so we need a very high benefit-risk ratio. • Quality is the same everywhere • a woman in Uganda is entitled to the same quality of care as a woman in the United States. • Quality can help registration • and act as a reference for authorities in less-resourced countries

  5. Quality = Quality Couples in Uganda are entitled to the same quality of product and product information as couples in the USA.

  6. Why is quality so important in family planning products? • Healthy consumers, not patients • so we need a very high benefit-risk ratio. • Quality is the same everywhere • a woman in Uganda is entitled to the same quality of care as a woman in the United States. • Quality can help registration • and act as a reference for authorities in less-resourced countries

  7. Education Either by the companies, or preferably with others: NGOs, MoHs, Med.Socs. • Awareness • Posters, media, etc • Teaching of users • What do products (not) do • Training of providers • Actual product training • Training in counseling • Helping with guidelines, etc

  8. Counseling postpartum increases decision to use, and actual use of, contraception Contraceptive use and decision about use after 20-minute informal counseling session with husband or close relative present plus educational leaflets, versus no formal counselingno formal counseling. Saeed GA, et al. Contraception 2008;77:377–381

  9. Counseling pre-abortion can substantially increase contraceptive use 2003: Targeted counseling in pre-abortion session 2000–2001: Poor counseling Yassin AS, et al. J Fam Plann Reprod Health Care 2005;31:115–116

  10. Education Either by the companies, or preferably with others: NGOs, MoHs, Med.Socs. • Awareness • Posters, media, etc • Teaching of users • What do products (not) do • Training of providers • Actual product training • Training in counseling • Helping with guidelines, etc

  11. Train-the-Trainer course Transfer of product knowledge and skills Training session artificial arm Trainer The trainees

  12. Train-the-Trainer course Practice counseling Live insertions Clinical practice

  13. The Four Gs • GCP: Good Clinical Practice • especially in clinical development: rights of subjects, reliability of data, adequate reporting • GMP: Good Manufacturing Practice • products are safe, pure and effective, guaranteed by record keeping, personnel qualifications, sanitation, cleanliness, equipment verification, process validation, complaint handling • GDP: Good Distribution Practice • controlled storage and distribution conditions • inventory control at central level and in-country • working capital vs. quick using of funds • GLP: Good Laboratory Practice • consistent and reliable data generation • during development • during quality testing

  14. Independent quality assurances ISO qualification • International Organization for Standardization: • voluntary adherence to strict quality standards WHO pre-qualification • WHO in cooperation with national regulatory agencies and partner organizations • unified standards of quality, safety and efficacy FDA and/or EMEA approval • Because people in all countries have a right to the same quality

  15. Follow up • Where do the products go? • Are the providers well trained? • Are the users well informed? • Where can users go with problems? • How is AE reporting organized?

  16. Sustainability Now • Reliability of supply • Reliability of supply date • Acceptable shelf life • Regulatory approvals Future • Will the company be there in three or five years • With the same range of products • Also for removal • Or in case of problems: long-term commitment

  17. Product range Choices • hormonal and non-hormonal • oral and non-oral • reversible and irreversible • short term and long term Innovation • newer, better, even safer molecules • alternative delivery systems • more efficient, cheaper, production methods • all with evidence based methods

  18. CONTRACEPTION Any contraceptive method is better than none, . . . . . . but choice of method makes a difference

  19. Long term partners based on trust

  20. Hormones and all that chickenwire thing It’s not that simple………

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