Skip to main content

The importance of visual inspection in national quality assurance systems for medicines

Dear Editor,

In their short report, Schiavetti and colleagues presented a visual inspection checklist, designed to guide health workers at the point of care to rapidly identify suspect poor-quality medicines [1]. We would like to emphasize the importance of this tool, by discussing three cases reported at different time points in Sudan.

Since 1998, a simple checklist was implemented by the Revolving Drug Fund (RDF) in Khartoum State, Sudan, and later by the Sudanese National Medical Supplies Fund (NMSF), to monitor the quality of medicines at health facilities in Khartoum State and in Sudan respectively. In 1999, the national lay press widely publicized an incident of contaminated intravenous fluids purchased from an Indian manufacturer [2] and imported by the central medical public corporation (CMS), i.e., the national public procurement agency, which was further transformed into the non-profit NMSF in 2015 [3]. A fungal growth was clearly visible on different bottles from different batches, but those in charge of acting upon the non-conform product disagreed on actions to be undertaken. The “proponents,” mainly at the CMS, argued that findings of the visual inspection should not be generalized to other bottles or other batches that did not show (yet) fungal growth [2], while the “opponents,” mainly at the Chamber of Medicine’s Importers, argued that information from the lay press must be taken seriously, and that batch recalls were urgently needed, as not acting would cause health damage and perhaps claim lives [2]. Eventually, all intravenous fluids imported by CMS from this company were withdrawn from the market, regardless of contamination status, by a ministerial decree in 2001. Remarkably, findings from a simple visual inspection allowed to identify a non-reliable supplier and to prevent future harm.

A similar scenario was repeated in 2005 [3]. At that time, the General Directorate of Pharmacy (G-DOP) was acting as a secretariat of the National Medicines and Poisons Board (NMPB) that is the national medicine regulatory authority (an autonomous secretariat of NMPB, under direct supervision of the Minister of Health, was formally established in November 2007). The G-DOP revoked the marketing authorization of a cough syrup manufactured by a United Arab Emirates-based drug company, and imported by the CMS. The decision was taken because the visual inspection revealed leaked bottles from different batches. Again, decision-makers divided. “Proponents”complained that the G-DOP had not tested the product chemically and based its decision on visual inspection only. The G-DOP argued that when a defect that puts the integrity of a product at stake can be detected visually, there is no need to further test that product chemically.

A third case took place in 2009. According to the Medicines and Poisons Act 2009, the CMS must purchase and supply registered medicines only. Nonetheless, the Act was not fully implemented until 2011. Meanwhile, the CMS imported an unregistered Salbutamol inhaler from China [3], and as a common practice at that time, it sent samples of this unregistered product to NMPB for testing. The NMPB’s National Medicines Quality Control Laboratory (NMQCL) rejected the samples because the country of origin was not stated on both primary and secondary packaging. The CMS insisted that NMQCL should test the product chemically, while the Secretary General of NMPB decided not to do so, based on the definition of counterfeit medicines, as essential information to identify the medicine was missing on the packaging [4]. The discussion scaled up to the Federal Minister of Health, who directed the NMPB secretary general to do the chemical tests for Salbutamol inhaler of unknown source. The tests found that the product contained less than 70% of the stated active ingredient, while it should be at least 90%. In other words, the visual inspection had predicted chemical poor quality, and expensive confirmatory lab test could have been avoided by a less formalistic interpretation of the legislation [5]. In addition, even if the product had passed the chemical tests, an important problem of traceability would have remained.

The checklist of Schiavetti [1] requires to check the name of manufacturer and country of origin. These experiences from Sudan confirm that the availability and reliability of this information is crucial for acceptance of any pharmaceutical products. The level of risk for these parameters should be high (in case of Schiavetti’s checklist, “C” instead of “B” [1]), as lack of information on the origin of a medicine will make traceability impossible and may qualify it as a falsified product [6].

In summary, these real-life cases indicate that a careful visual inspection, i.e., a simple and inexpensive technology, is of paramount importance in monitoring the quality of medicines not only in the field, but also at central level. In a pharmaceutical scenario characterized by a situation of multiple quality standards [7,8,9,10], complex distribution networks [11, 12], and weaknesses of the pharmaceutical systems [13, 14], it can provide additional important guidance to timely recall suspicious batches, to revoke marketing authorizations of unreliable suppliers, and to protect public health [15]. Central medical stores and regulatory agencies need to consider the visual inspection as part of their prequalification and ongoing requalification system.

Availability of data and materials

Not applicable (this letter is based on publicly available information)

References

  1. 1.

    Schiavetti B, Wynendaele E, Melotte V, Van der Elst J, De Spiegeleer B, Ravinetto R. A simplified checklist for the visual inspection of finished pharmaceutical products: a way to empower frontline health workers in the fight against poor-quality medicines. J Pharm Policy Practice. 2020;13:9.

    CAS  Article  Google Scholar 

  2. 2.

    Mohamed Ali GK, Alfadl AA, Fathelrahman AI. Newspapers’ coverage of contaminated intravenous fluids from an Indian manufacturer distributed by Public Central Medical Supplies in Sudan: lessons to be learned. Health Policy. 2011;101:172–7.

    Article  Google Scholar 

  3. 3.

    Mohamed, G.K. and Ahmed, T.A. NMSF measures to assure the quality of medicines throughout the supply chain. Presented at the International Conference on “Medicine Quality and Public Health”; 23 to 28 September 2018. University of Oxford, Oxford, UK. 2018. Cited 23 July 2020: https://www.tropicalmedicine.ox.ac.uk/events/medicine-quality/mqph2018/speakers.

  4. 4.

    World Health Organization. Quality assurance of pharmaceuticals: a compendium of guidelines and related materials. Volume 1. 1997. World Health Organization. Geneva.

  5. 5.

    Borup R, Kaae S, Minssen T, et al. Fighting falsified medicines with paperwork – a historic review of Danish legislation governing distribution of medicines. J of Pharm Policy and Pract. 2016;9:30. https://doi.org/10.1186/s40545-016-0078-2.

    Article  Google Scholar 

  6. 6.

    World Health Organization. (22–31 May 2017). Seventieth World Health Assembly. Annex A70/23. Appendix 3. Geneva, Switzerland. Available: https://www.who.int/medicines/regulation/ssffc/A70_23-en1.pdf?ua=1. Accessed 20 July 2020.

  7. 7.

    Ravinetto R, Vandenbergh D, Macé C, et al. Fighting poor-quality medicines in low- and middle-income countries: the importance of advocacy and pedagogy. J of Pharm Policy and Pract. 2016;9:36.

    Article  Google Scholar 

  8. 8.

    Ravinetto R, Pinxten W, Rago L. Quality of medicines in resource-limited settings: need for ethical guidance. Global Bioethics. 2018;29(1):81–94.

    Article  Google Scholar 

  9. 9.

    Orubu ESF, Ching C, Zaman MH, et al. Tackling the blind spot of poor-quality medicines in Universal Health Coverage. J of Pharm Policy and Pract. 2020;13:40.

    CAS  Article  Google Scholar 

  10. 10.

    Paul N Newton, Katherine C Bond, on behalf of the Oxford Statement signatories. Global access to quality-assured medical products: the Oxford Statement and call to action. Lancet GH 2019: e1609-e1611.

  11. 11.

    NMSF, 2015. Value for money: proposed measures to improve health outcomes from expenditure on medicines and health technologies in Sudan. National Medical Supplies Fund, Khartoum Sudan. Cited 24 July 2020: https://www.researchgate.net/publication/283007568_Value_for_MoneyProposed_Measures_to_Improve_Health_Outcomes_from_Expenditure_on_Medicines_and_Health_Technologies_in_Sudan.

  12. 12.

    Gamal KM. Ali and Abdeen M. Omer. Pharmaceuticals in Sudan: development in regulations, governance and implementation of national drug policies. African J Pharmacy Pharmacol. 2012;6(1):1–12.

    Article  Google Scholar 

  13. 13.

    Hafner T, Walkowiak H, Lee D. et al. Defining pharmaceutical systems strengthening: concepts to enable measurement Health Policy and Planning. 2017;32:572–84.

    PubMed  Google Scholar 

  14. 14.

    Hafner T, Banda M, Kohler J, et al. Integrating pharmaceutical systems strengthening in the current global health scenario: three ‘uncomfortable truths’. J of Pharm Policy and Pract. 2020;13:38.

    Article  Google Scholar 

  15. 15.

    Ozawa S, Higgins CR, Yemeke TT, Nwokike JI, Evans L, Hajjou M, et al. Importance of medicine quality in achieving universal health coverage. PLoS ONE. 2020;15(7):e0232966.

    CAS  Article  Google Scholar 

Download references

Funding

There was no specific funding for writing this letter.

Author information

Affiliations

Authors

Contributions

GKMA was the manager of the Revolving Drug Fund in Khartoum state (1994–2002) and the director general of National Medical Supplies Fund (NMSF) (2010–2019), and this letter reports on activities he carried out when in these positions. He is also a former senior pharmacist at the Federal Ministry of Health (FMOH) and the former secretary general of the Sudanese National Medicines and Poisons Board (2007–2010). AAA was the Director of National Medicines Quality Control laboratory (2001–2011). RR is a researcher and policy advisor at the Institute of Tropical Medicine, Antwerp, Belgium. GKMA wrote the draft manuscript; AAA and RR reviewed the drafts. All authors approved the final submitted version.

Corresponding author

Correspondence to Raffaella Ravinetto.

Ethics declarations

Ethics approval and consent to participate

Not applicable

Consent for publication

Not applicable

Competing interests

RR is the last author of the paper of Schiavetti et al. (J Pharm Policy Practice 2020; 13:9) on which this letter is commenting.

Additional information

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Ali, G.K.M., Ravinetto, R. & Alfadl, A.A. The importance of visual inspection in national quality assurance systems for medicines. J of Pharm Policy and Pract 13, 52 (2020). https://doi.org/10.1186/s40545-020-00264-w

Download citation