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Pharmaceutical Preparations
928
treated; indeed they may be overlooked, since the
severely depressed patient does not obtrude and his grief may be mistaken for physical discomfort and exhaustion.
HuGHEs,9 in his national survey of terminal care, has drawn attention to the inadequacy of present facilities.
Drugs Act to test any preparation in a retail pharmacy; but only one authority in the whole country, Birmingham Corporation, has used these powers to good purpose. Birmingham has developed an excellent local drugtesting scheme which aims at constructive control of all drugs dispensed in the area, both in retail pharmacies
patients’ needs in terms of security, and in hospitals. 22 On occasion this scheme has led a companionship, symptomatic treatment, and medical, manufacturer to withdraw an unsatisfactory product nursing, and domestic care. He estimates that half the from the Birmingham area without withdrawing it from deaths in England and Wales occur in the patient’s own other parts of the country. Since such work requires home. Many of the dying wish to spend the last days of highly trained staff and is costly, and has not been their lives at home; here the pattern of terminal illness encouraged by Whitehall, it is not surprising that may be very different from that shown by the hospital Birmingham still stands alone. How are we to deal with the present chaos ? Many investigations, and there is no doubt that a great contribution to our knowledge of more effective management sensible suggestions were made at a European technical of these patients could be made by systematic observa- meeting called by the World Health Organisation in 1961 tions of the problem in general practice. to discuss all aspects of pharmaceutical quality control.23 The meeting accepted the principle that manufacturers must take the main responsibility for the quality of all Pharmaceutical Preparations because they are best placed PRESCRIBERS commonly take the quality of drugs for preparations they produce, to do SO.2<1 But laboratory analyses and other forms of granted; for most manufacturers are people of integrity, control by Governments or their agencies are also necesand official standards are published which have the force to reveal any mistakes that may have occurred, and of law. But, while legal standards are one thing, efficient sary as an additional safeguard against unsatisfactory or supervision and enforcement are another. This has been dangerous products. Especially in the case of new drugs, made clear repeatedly in the past few years, notably by the control authorities depend on the manufacturer for studies published from the City of Birmingham analytical and analytical methods. The extent of this laboratories. Shortcomings of one kind or another have specifications is not generally realised, for a drug made by been found in standard official preparations supplied by dependence one manufacturer can hardly be included in a various manufacturers,1-0-13 imported drugs supplied to only or other official handbook unless the hospitals,14--16 and medicines dispensed extemporaneous- pharmacopoeia manufacturer provides the information for the monoly by pharmacists.17 These shortcomings ranged from graph. If an official specification departs in any way minor excess or deficiency to gross deficiency in drug from that of the manufacturer, then the official preparacontent, and tablets so badly formulated and manu- tion will exist only on paper. It is also most important factured that they completely failed to disintegrate and that national control authorities and manufacturers would have passed through the alimentary tract unshould use the same methods, and should changed. Enforcement of official standards would cooperate in improvinganalytical them. But effective quality improve matters; but even so none of the legion control cannot be achieved by only analysing samples of non-official proprietary products 18 19would be taken from the market; inspection of pharmaceutical adequately covered-and two-thirds of all the items factories is essential in order to ascertain whether each prescribed on Health Service prescriptions are pro- manufacturer can and does exercise adequate control prietary preparations. over every batch of all preparations he offers for sale. At present three agencies are empowered to sample and The report suggests that a drug control authority could test pharmaceutical preparations (but only in retail be part of a Ministry of Health, and should include both pharmacies, not in hospitals). The Pharmaceutical and services, possibly organised Society enforces the provisions of the Pharmacy and inspection Suchlaboratory an authority, whether or not it is to be Medicines Act, 1941, which is chiefly concerned with regionally. of the Ministry of Health,16 is needed here. There standards of labelling, packing, and composition of pre- part seems to be no satisfactory alternative to early legislation.25 packed household medicines. The Ministry of Health’s drug testing scheme is concerned with the pharmacist’s dispensing; its value as a method of quality control General-practitioner Maternity Beds has been questioned, and it is widely resented.2o 21 AT one time it was not unusual for doctors to combine Lastly, local authorities have powers under the Food and general practice with consulting work, and many 9. Hughes, H. L. G. Peace the Last. London, 1960. specialists established their reputations against a back10. Bagnall, H. H., Stock, F. G. Pharm. J. 1955, 174, 437. 11. Bagnall, H. H., Stock, F. G. ibid. 1956, 177, 441. ground of family practice. But circumstances have 12. Bagnall, H. H., Stock, F. G. ibid. 1957, 179, 336. 13. Stock, F. G. ibid. 1959, 183, 379. changed. The specialist is now entirely trained in 14. Rosenheim, M. L., Ross, E. J. Lancet, 1958, ii, 1371. 15. Stock, F. G. Pharm. J. 1961, 186, 13, 488. hospital, and on appointment to the staff he spends the the Scottish Department of the Pharmaceutical 16. Stock, F. G. Address He has defined the
at
to
17. 18. 19. 20. 21.
Society, March 1, 1963. Stock, F. G. Pharm. J. 1960, 184, 169. Stock, F. G. ibid. 1962, 188, 453. Medical Letter, British edition, 1963, 2, 9 (Feb. 8). Tees, J. G. Brit. med. J. 1962, i, suppl. 59. Whitney, J. D. W. ibid. suppl. 90.
22. Stock, F. G. Pharm. J. 1960, 185, 523. 23. Quality Control of Pharmaceutical Preparations. Tech. Rep. Wld Hlth Org. 1962, no. 249. Obtainable from H.M. Stationery Office, P.O. Box 569, London, S.E.1. 3s. 6d. 24. See Hartley, F. Practitioner, 1963, 190, 58. 25. See Lancet, April 20, 1963, p. 869.
treated; indeed they may be overlooked, since the
severely depressed patient does not obtrude and his grief may be mistaken for physical discomfort and exhaustion.
HuGHEs,9 in his national survey of terminal care, has drawn attention to the inadequacy of present facilities.
Drugs Act to test any preparation in a retail pharmacy; but only one authority in the whole country, Birmingham Corporation, has used these powers to good purpose. Birmingham has developed an excellent local drugtesting scheme which aims at constructive control of all drugs dispensed in the area, both in retail pharmacies
patients’ needs in terms of security, and in hospitals. 22 On occasion this scheme has led a companionship, symptomatic treatment, and medical, manufacturer to withdraw an unsatisfactory product nursing, and domestic care. He estimates that half the from the Birmingham area without withdrawing it from deaths in England and Wales occur in the patient’s own other parts of the country. Since such work requires home. Many of the dying wish to spend the last days of highly trained staff and is costly, and has not been their lives at home; here the pattern of terminal illness encouraged by Whitehall, it is not surprising that may be very different from that shown by the hospital Birmingham still stands alone. How are we to deal with the present chaos ? Many investigations, and there is no doubt that a great contribution to our knowledge of more effective management sensible suggestions were made at a European technical of these patients could be made by systematic observa- meeting called by the World Health Organisation in 1961 tions of the problem in general practice. to discuss all aspects of pharmaceutical quality control.23 The meeting accepted the principle that manufacturers must take the main responsibility for the quality of all Pharmaceutical Preparations because they are best placed PRESCRIBERS commonly take the quality of drugs for preparations they produce, to do SO.2<1 But laboratory analyses and other forms of granted; for most manufacturers are people of integrity, control by Governments or their agencies are also necesand official standards are published which have the force to reveal any mistakes that may have occurred, and of law. But, while legal standards are one thing, efficient sary as an additional safeguard against unsatisfactory or supervision and enforcement are another. This has been dangerous products. Especially in the case of new drugs, made clear repeatedly in the past few years, notably by the control authorities depend on the manufacturer for studies published from the City of Birmingham analytical and analytical methods. The extent of this laboratories. Shortcomings of one kind or another have specifications is not generally realised, for a drug made by been found in standard official preparations supplied by dependence one manufacturer can hardly be included in a various manufacturers,1-0-13 imported drugs supplied to only or other official handbook unless the hospitals,14--16 and medicines dispensed extemporaneous- pharmacopoeia manufacturer provides the information for the monoly by pharmacists.17 These shortcomings ranged from graph. If an official specification departs in any way minor excess or deficiency to gross deficiency in drug from that of the manufacturer, then the official preparacontent, and tablets so badly formulated and manu- tion will exist only on paper. It is also most important factured that they completely failed to disintegrate and that national control authorities and manufacturers would have passed through the alimentary tract unshould use the same methods, and should changed. Enforcement of official standards would cooperate in improvinganalytical them. But effective quality improve matters; but even so none of the legion control cannot be achieved by only analysing samples of non-official proprietary products 18 19would be taken from the market; inspection of pharmaceutical adequately covered-and two-thirds of all the items factories is essential in order to ascertain whether each prescribed on Health Service prescriptions are pro- manufacturer can and does exercise adequate control prietary preparations. over every batch of all preparations he offers for sale. At present three agencies are empowered to sample and The report suggests that a drug control authority could test pharmaceutical preparations (but only in retail be part of a Ministry of Health, and should include both pharmacies, not in hospitals). The Pharmaceutical and services, possibly organised Society enforces the provisions of the Pharmacy and inspection Suchlaboratory an authority, whether or not it is to be Medicines Act, 1941, which is chiefly concerned with regionally. of the Ministry of Health,16 is needed here. There standards of labelling, packing, and composition of pre- part seems to be no satisfactory alternative to early legislation.25 packed household medicines. The Ministry of Health’s drug testing scheme is concerned with the pharmacist’s dispensing; its value as a method of quality control General-practitioner Maternity Beds has been questioned, and it is widely resented.2o 21 AT one time it was not unusual for doctors to combine Lastly, local authorities have powers under the Food and general practice with consulting work, and many 9. Hughes, H. L. G. Peace the Last. London, 1960. specialists established their reputations against a back10. Bagnall, H. H., Stock, F. G. Pharm. J. 1955, 174, 437. 11. Bagnall, H. H., Stock, F. G. ibid. 1956, 177, 441. ground of family practice. But circumstances have 12. Bagnall, H. H., Stock, F. G. ibid. 1957, 179, 336. 13. Stock, F. G. ibid. 1959, 183, 379. changed. The specialist is now entirely trained in 14. Rosenheim, M. L., Ross, E. J. Lancet, 1958, ii, 1371. 15. Stock, F. G. Pharm. J. 1961, 186, 13, 488. hospital, and on appointment to the staff he spends the the Scottish Department of the Pharmaceutical 16. Stock, F. G. Address He has defined the
at
to
17. 18. 19. 20. 21.
Society, March 1, 1963. Stock, F. G. Pharm. J. 1960, 184, 169. Stock, F. G. ibid. 1962, 188, 453. Medical Letter, British edition, 1963, 2, 9 (Feb. 8). Tees, J. G. Brit. med. J. 1962, i, suppl. 59. Whitney, J. D. W. ibid. suppl. 90.
22. Stock, F. G. Pharm. J. 1960, 185, 523. 23. Quality Control of Pharmaceutical Preparations. Tech. Rep. Wld Hlth Org. 1962, no. 249. Obtainable from H.M. Stationery Office, P.O. Box 569, London, S.E.1. 3s. 6d. 24. See Hartley, F. Practitioner, 1963, 190, 58. 25. See Lancet, April 20, 1963, p. 869.