drugs and drugs control

Pharmacies, such as the Svanen Pharmacy in Stockholm, provide a bond of unity between people.

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three-month stay in the U.S. taught me that the scientific programs of the pparmacy schools, the activities of the pharmaceutical industry and, above all, the control of drugs by the Federal Food and Drug Administration are all highly impressive. In Sweden all these things are done on a smaller scale and yet m y most persistent observation was the similarity of our basic problems. Some problems have not been solved satisfactorily in either country, some have been solved in different ways. The Swedish solutions in most cases are more radical than the American and our system might be considered a pilot plant experiment for your full scale operations. The drugs used in Sweden are generally the same as those used in the U.S. Many new products are developed in the U.S., and usually they soon after are mar keted in Sweden. We still use more of the old vegetable drugs and old-fashioned chemicals as medicines than you do in America, but instead the vitamin business has not reached the same height in our country as in y ours. In 1958 the total retail value of drugs sold to the Swedish public amounted to 68 million dollars or $9.25 per inhabitant. To a very large extent our pharmaceuticals are manufactured in Sweden. We have about 30 manufacturing companies, whose production in 1958 amounted to 33 million dollars (wholesale value). This part of the Swedish industry employs about 2,500 people, the biggest firm, Astra, having about 1,000 employees. Most well known discoveries by Swedes in the drug field are the local anesthetic lidocaine or X ylocaine (Lofgren) and the blood extender dextran (Gronvall and Ingelman). Also in the development of heparin important contributions have come from Sweden (J orpes and his school).

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We still do not export a large quantity of drugs but the amount is growing. I t should be possible for us to develop the field of fine chemicals to a greater extent. Our principal problem is to find sources of raw materials and in this respect there have been difficulties, especially with the aromatics, because we have no natural resources of coal or petroleum in our country . Swedish retail pharmacies manufacture finished, standardized pharmaceuticals. Their production is organized on a co-operative basis, a few of the larger pharmacies making the products and selling them to the others. In 1958 this production was 13 percent of their purchases of finished standardized pharmaceuticals. The Swedish pharmacies might be described as a big manufacturing firm operating many . small plants. Swedish manufacturers of pharmaceuticals-including the Swedish pharmacies- produce 80 percent of the total value of finished, standardized preparations sold in our country. The remaining 20 percent are imported, largely from the U.S. There are a few hundred American products on the Swedish market now, principally antibiotics and steroids. However, it is much more difficult to estimate how many of the basic drugs, used in the pharmaceutical dosage-forms, are really made in Sweden - probably a much lower percentage. We have practically no duties on drugs or pharmaceuticals and no administrative tricks to make marketing foreign products more difficuit than selling domestic ones. Both have the same potential possibilities. Drugs and pharmaceuticals in Sweden are distributed to the public only by private pharmacies. The hospital pharmacies belong at present to private pharmacies. Our pharmacies sell only pharmaceuticals and other health necessities, possibly a few cosmetics. Thus they resemble American professional pharmacies

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by Hans Hellberg

Hans Hellberg is head of the National Pharmaceutical Laboratory of Sweden. The work of NPL is comparable to the United States Food and Drug Administration in respect to drugs. After receiving his pharmaceutical and chemical education at the Royal Pharmaceutical Institute of Stockholm and at the University of Stockholm, Hellberg became a registered pharmacist in Sweden and practiced for several years in Swedish pharmacies. In 1945 he became connected with the state control of drugs and has devoted his time and efforts to that field for more than 15 years.

but have little in common with American drugstores. We have 530 pharmacies, all owned by registered pharmacistsone pharmacy per 14,000 people. The number of pharmacies is limited and the registered pharmacists are given the right to buy a pharmacy according to seniority and competence. The economic freedom of the pharmacy-owner, however, is restricted. He is, in a way, guaranteed a certain minimum income but, on the other hand , if his income exceeds certain limits, he has to pay increasingly high percentages of his net profit to a common pool. This pool is used to pay certain expenses for the pharmacies such as pensions , maintenance of central administration and central laboratories and a certain percentage of wages. The most important purpose of the pool, however,

The tableHing department of the Vasen Pharmacy at Linkoping is similar to that in many other Swedish retail pharmacies.

Pilot plants like this one of Astra, Swedish drug manufacturing company, are essential to the production of new drugs.

has been to give the authorities information on the overall economic outlook for the pharmaceutical retail business so the retail profit on pharmaceuticals for the next year can be established. Only a short time ago it was shown that the economic restrictions on pharmacyowners-peculiar in our country-have affected their interest in economic planning. I t is possible that a new policy will be inaugurated. The system, however, has had the advantage of promoting the reconstruction and modernization of old pharmacies. As high as 65 percent of the total sales of Swedish pharmacies comes from prescriptions. Only 13 percent of these prescriptions require extemporaneous compounding by the pharmacist, the rest are standardized products. The c1ermatologists' prescriptions require a

A Swedish researcher in the National Pharmaceutical Laboratory checks a drug to make sure it complies with the drug laws of Sweden.

lot of compounding as they do in the U.S. but in our country the ophthalmologists and the pediatricians also like to prescribe their own special formulas. In Sweden we have organized a social security system. Practically all hospitals are run by the state or by local communities. Our general and compulsory health insurance provides for the cost of hospitalization in a common ward or the cost of a private practicing physician up co certain maximum fees. If we want to consult a more expensive doctor or if we want care in a private room in the hospital, we have to pay the additional cost ourselves. Drugs prescribed by a physician are also in part paid for by health insurance. Thus certain preparations for certain chronic diseases are fully paid for, such as insulin in diabetes, digitalis in chronic heart weakness, epinephrine and ephedrine in asthma. On other prescribed drugs our insurance pays part of the cost. Because health insurance has reduced the cost of medicines to the individual, there may have been an unnecessary increase of drug consumption in Sweden. i think most people agree, however, that the benefits outweigh the disadvantages. Every manufacturer of any importance has his own drug control system. This control is organized in much the same way as in the drug companies in the U.S. However, the pharmacies in Sweden have created their own control system. Because the pharmacies in Sweden co-operatively manufacture standardized pharmaceuticals, they may be looked upon as a big manufacturing company. Their control system also follows the same pattern. There are

smaller analytical units assigned to the manufacturing pharmacies and there is a large central laboratory in Stockholm, the AKL (the Pharmacies' Control Laboratory). \ i \ ...••..............

a~.•k of AKl

is to analyze all

,}~. ~~f~~s, of',~.aw mate':j~fs, 'Hhich the wholel>~.~J~t.~;1 1nteri~. to sell tathe Swedish phar-

tn~~je~~ ,. T.~ese materials have to meet ; )~~r!.ai&" sp~cifications-in the first ploce th.?~.e ii\of the official Swedish compendia. \~~' batches, ore given certain code. num1:i~i'S which tell the buying pharmC;1cist with whot specificotion the drug has complied.

~ Secondly, AKl has to analyze those preparations which ore made by the manufacturihg pharmacies and call for special skill or special instrumentation. This applies, e.g., to certain spectrophotometric determinations, to microbiological ' and animal tests, etc. ~The third task for AKl is fo supply the local analytical units with methods suitable for the kind of control work they do.

The work performed in the laboratories of the manufacturers, including the pharmacies, is of course necessary and valuable. But by drug control in this article I refer principally to official state control. This control in our country is directed -as are most governmental activities in the health field-by the medical board, an agency under the Department of the Interior. The medical board enforces our drug laws and regulations , but the necessary investigations are made by the National Pharmaceutical Laboratory. * Biologicals with im-

*

I n Swedish: Statens farrnacevtiska laboratori urn. Thi s laboratory is directed by Hans Hell berg, !luth or of t his article.

VOl. 21, NO. 12, DECEMBER 1960/ PRACTICAL PHAR

ACY EDIT ON

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One of the first places a visitor to Sweden sees when he makes a tour of the city is the "stadshus" or town hall.

munological properties are handled by others. An industry-made pharmaceutical product can be sold in Sweden only after having been registered with the medical board. The first requisite for getting such a registration is proof by the manufacturer that the preparation is medically efficient and safe. A check is made by a special section of our laboratory, headed by an experienced specialist in internal medicine. The section also controls labeling and advertising, seeing that it only contains such claims as have been approved. Even the advertising to the medical professions is under our supervision. The standards, which our medical section set, are rather high. If possible, the manufacturer has to show the efficiency of every new drug and of many drug . combinations by tests ~f the double blind type, performed by well-known physicians in Sweden or abroad. I believe that it is principally this medical control that has kept down the number of pharmaceutical preparations on the Swedish market. We have no more than about 3,400 now. The preparations made by pharmacies on an industrial scale are mostly those described in the Swedish Pharmacopeia or in other official compendia. The few preparations which fall outside these books are examined in the same way as I have described for the industry-made products. The price of pharmaceuticals is controlled in Sweden. Rules for calculating retail profit are given by official authorities. But for wholesale prices control is only possible on old products made by different, independent firms. Price con-

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trol is something the medical board does itself. An important part of the official control system is the checking of the composition of the products and their pharmaceutical properties. We have in our laboratory a chemical department where the chemical and pharmaceutical tests are made and a biological department where all animal testing is performed. Microbiological work we send to specialists outside the laboratory. Both of our departmen ts are well equipped. We have the opportunity to work with infrared spectroscopy and with radio-isotopes on a tracer scale. Unfortunately we suffer from a shortage of qualified staff but we still try to do some research work. The Swedish laws do not give us the right to inspect plants where drugs are manufactured but we do inspect pharmacies. In a fourth section of our laboratory we have pharmacy inspectors and a special analytical branch for ·analyzing the pharmacy products. Biologicals with immunological properties-sera, vaccines, gamma-globulin fractions for human use-are with very few exceptions imported or manufactured only by a governmental institution, the National Bacteriological Laboratory. However an official control officer, appointed by the medical board, is responsible for the control of these products. Biologicals for veterinary use are not yet controlled in Sweden. To make the picture complete-cosmetics are not controlled at all in our country.

Nordic Pharmacopeia The backbone of all control is standards . As have most other countries, we have a Pharmacopeia, containing the official requirements on the most important drugs and preparations. The Pharmacopeia now in force was published in 1946, but a lot of corrections and amendments were issued in 1958. Unfortunately it is principally written with pharmacy conditions in mind and so its applicability to industry-made products might be questioned. The people now in charge of the Pharmacopeia revision plan to create standards covering drugs in general. Representatives of industry sometimes question this policy. In this respect you have a healthy system in the U.S. where drug manufacturers and academic people co-operate in the preparation of drug standards and the monographs are written to cover industrial products. There are many similarities in the drug field between Denmark, Finland, Norway and Sweden. Moreover our people are free to move between the countries without passports. So we have felt the need of a joint Nordic Pharmacopeia. Work on preparing such a book started in 1948 and the book

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itself may appear in 1963. The Danish Pharmacopeia Commission and the secretary general of the Scandinavian Pharmacopeia Council, Dr. Reimers, have done a great work on the basic outlines of the proposed Pharmacopeia. Unfortunately this has taken much time. The experimental work on the new Pharmacopeia is mostly done in special laboratories-one in Copenhagen, one in Oslo and one in Stockholm. We pay great attention to experimental testing of all parts of suggested monographs. There are more problems in the drug field to which the answer may be more control or new legislation.

increased use of drugs The use, or at least the purchase, of drugs has increased very much during recent years, a condition which may be attributed to higher wages, better social benefits, longer life expectancy, new and better remedies. Unfortunately the needless and sometimes harmful use of drugs has increased at the same time. In 1957 every Swede consumed on an average 20 normal sleeping doses of the two leading barbiturates. Other barbiturates, phenothiazine derivatives, etc. may contribute an equal amount of )doses. As to narcotics, Sweden holds one of the best positions, superseded in this respect only by Denmark. Until recently we did not see very much illicit narcotic trade in our country, but now, especially in Stockholm, this has become a serious problem. Many physicians are not suspicious enough when they write prescriptions for narcotics. The use of antibiotics in our country has also given rise to sensitivity and to resistant strains, in spite of the fact that antibiotics for human use always have been restricted to pharmaceuticals and, in fact, to prescription preparations. However, the difficulties have arisen from generous use of antibiotics without positive diagnosis. There has been a suggestion to reserve certain antibiotics for use only by qualified physicians in a limited number of hospitals, but this step has not yet been taken. We are trying to use the educational method first. The newest developments in the drug field have been as highly beneficial in our country as in any other. However, the new weapons are double-edged. There is, and will be, a struggle between promoting new drugs for the benefit of the sick and delaying new drugs for the benefit of public health. We on the control side have a rather thankless task, but we try to use the power we have so that all really important advances will be available to the public as soon as possible and the public in the long run also may benefit from the competition between different drugs and different firms. •