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[Interministerial Order No. 232 MSPS/MEFCP of 16 September 1991 relating to the quality control of imported condoms distributed in Ivory Coast] Arrete interministerial No. 232 MSPS/MEFCP du 16 septembre 1991 relatif au controle qualitatif des preservatifs importes et distribues en Cote d'Ivoire.
JOURNAL OFFICIEL DE LA REPUBLIQUE DE COTE D'IVOIRE. 1991 Sep 26; (39):633.Interministerial decree number 232 of September 16, 1991, states that condoms or lots of condoms sold or distributed in the Ivory Coast must undergo preliminary quality control testing. The testing must be done in an independent laboratory approved by the World Health Organization or the Ministry of Public Health. The laboratory tests are to be interpreted according to the annexed specifications, conforming to Ivory Coast norms. The tests and controls concern packaging and labeling, the water and pneumatic inflation tests, tests of the integrity and watertightness of the packaging, and measures of length, diameter, and thickness. The exterior and interior packaging should meet World Health Organization specifications and must indicate the brand name, the lot number, the name and address of the manufacturer, country of origin, dates of manufacture and expiration, and the size of the product. Quality control tests are required every six months for stored lots of more than 10,000 condoms. The average sample for testing is 500 units for a lot of 35,000 to 150,000 condoms and 150 units for smaller lots. The National Public Health laboratory is the reference laboratory for quality control of condoms in the Ivory Coast. Other laboratories may be approved by the Minister of Public Health.
BOLETIN OFICIAL DEL ESTADO. 1991 Nov 29; (286):8102-13.Spain's royal decree 1688/1991 of November 22, 1991, establishes technical standards for condoms marketed in Spain and declares their approval obligatory. The technical specifications for characteristics and testing methods for condoms were defined in norm UNE 53-625-89, whose previously voluntary observation was declared obligatory by the 1991 decree. The specifications of UNE 53-625-89 are presented as an annex. The decree outlines the requirements and procedures for approval, to be granted by the General Office of Pharmacy and Health Products in accordance with the criteria spelled out in this decree. Packaging and product information requirements, regulations governing inspection, marketing, and advertising, and infractions and their sanctions are addressed as well. A form for requesting approval is included.
JOURNAL OF THE AMERICAN DENTAL ASSOCIATION. 1991 Dec; 122(13):79.Oral steroid contraceptives, a mixture of synthetic estrogen and progestagen, are the most widely used form of birth control in the US. Unfortunately, many antibiotics commonly used in dentistry interfere with the action of OSCs, resulting in unexpected pregnancies. Failure to inform a patient using OSCs during antibiotic therapy resulting in a birth could leave the dentist responsible for damages--including child support payments. The interaction between certain antibiotics and OCS has been known for the past 20 years. However, side effects such as hypertension and vascular diseases, have promoted the reduced dosages of OSC, triggering greater awareness of the interaction between these contraceptives and antibiotics. The ADA Council on Dental Therapeutics is concerned that this phenomenon of OSC inhibition by oral antibiotics has not become "common knowledge" in the profession. This report is intended to boost awareness when dentists prescribe antibiotics for women of childbearing age. Antibiotics that have been involved in OSC failure include penicillins, tetracyclines, sulfonamides, erythromycin, metronidazole, griseofulvin and cephalosporin. All inhibit or kill various microorganisms in the gut, where microflora help maintain plasma levels of estrogen and progestagen. However, not all antibiotics inhibit OSC efficacy. For instance, cotrimoxazole is a broad-spectrum antibiotic that also inhibits hepatitic metabolism of estrogen. In 1 study, a new antibiotic, roxithromycin, demonstrated no inhibition of OSC activity in 1 study. As with anticonvulsants, antibiotics may accelerate the metabolism of OSC. Reduced recycling of estrogen along with increased hepatitic metabolism of OSC may act in tandem to reduce plasma OSC levels below a contraceptive level. It should be understood that there are conflicting data in the literature. As yet, there is not a definitive explanation for OSC failure during antibiotic therapy. All women of childbearing age should be informed of possible reduced efficacy of OSC during antibiotic therapy and advised to use additional forms of contraception during shortterm antibiotic use. During longterm antibiotic therapy, they should consult with their physicians about using higher dose OSC preparations. The OSC manufacturers and dental professionals should encourage pharmacists to place cautionary stickers on patients' OSC prescriptions warning of possible failure when used during antibiotic therapy. To receive a copy of the complete report, contact the ADA Health Foundation Research Institute, Dept. of Toxicology, 211 E. Chicago Ave., Chicago 60611, USA. (full text)
[Unpublished] 1991 Feb.  p.The summary minutes of the FDA Fertility and Maternal Health Drugs Advisory Committee (2/8/91) focused on improved instructions for taking oral contraceptives (OC). 6 speakers addressed the following items: topic introduction, open hearings with speakers, overview, analysis of current instruction, presentation of new draft OC instruction, justification for changes, manufacturer's instructions, and domestic and international implications. The Committee agreed unanimously with Family Health International (FHI) general recommendations that standardizing and simplifying the OC instructions might increase correct and continued use of this product. The Committee agreed unanimously with FHI's specific recommendation that the patient package insert 1) must be written at 5th and 6th grade reading level with easily understandable words and phrases, 2) must use large print, 3) must display the picture of the pill pack, and 4) must clearly indicate on the pill pack weeks of use: 3 weeks of active and 1 week of inactive pills, the 1st pill, and the directions for pill taking. The Committee unanimously agreed the FHI's specific recommendation for advice on using correct and effective OC as in: 1) taking the pill, 2) when to start the 1st pack of pills, 3) what to do during the month, and what to do if you miss pills, 4) what to do if you miss pills with a start day of Sunday, and 5), with a not on Sunday start day. Discussants represented FHI, International Planned Parenthood, the American College of Obstetrics and Gynecology, and the University Hospital of South Manchester, UK. In the public comments session the speakers who made a presentation represented the Association of Reproductive Health Professionals, Planned Parenthood Federation of America, the National Health Network, Emory School of Medicine, and NIH. A complete transcript is available. Future meeting dates were set.
Arlington, Virginia, Management Sciences for Health, Technologies for Primary Health Care [PRITECH], 1991. , 75 p. (USAID Contract No. DPE-5969-Z-00-7064-00)In 1991, a consultant conducted an evaluation of the need for alternative packaging for oral rehydration salts (ORS) in Pakistan. Specifically, the study needed to determine mothers knowledge of and proficiency with correct mixing of dry ORS with water and evidence of obstacles of correct ORS use that packaging design could overcome. He arranged interviews with low income mothers from rural areas around Islamabad, rural villages several miles away from the major highway between Islamabad and Lahore, and urban slums in Lahore. The mothers definitely understood how to prepare ORS and indeed demonstrated this knowledge. Thus the consultant deemed the expansion of ORS delivery (packaging) with features which aid in correct measurement or dispensing unnecessary. Nevertheless the women liked the prototypes. In fact, the prototypes would probably perform well, but the cost and lack of critical need did not justify further development. These results changed the focus from dry ORS to liquid ORS. Interviews in the Northwest Frontier Province and the Punjab provinces revealed that these mothers would accept a stable, liquid ORS (especially fruit flavored). Further they would not pay >2-3 Rs for an ORS packet. The consultant expressed concern that adding a prepared liquid ORS to the market would complicate purchasing decisions. Nevertheless he concluded that such an ORS would indeed have a place in Pakistan and would probably increase ORS use, but it would not replace dry ORS.
[Unpublished] 1991 Nov.  p.The sales of Sathi brand condoms in Pakistan remained low in November 1991. In fact, a warehouse in Karachi only sold 138,240 condoms. Nonavailability of packaging material and price stickers prevented higher sales at the wholesale level. Yet the percentage of retail outlets carrying Sathi condoms climbed from 47-53% between August-September 1991. Only 11-19% of retail outlets carried other condom brands. Further only 17% of stores that sell Sathi and Durex condoms did not have Sathi condoms in stock in September compared to 18-24% of stores did not have other condoms brands in stock. Moreover the market share for Sathi condoms climbed to 69%. At the same time, the market share for the public sector brand Sultan and Durex fell from 14-10% and to 7% respectively. Rough Rider condoms held 8% of the market share. Other brands claimed 6%. A new marketing plan for Sathi revealed that PSi would hold off introducing oral contraceptives (OCs) and a premium condom. PSI and other nongovernmental organizations conducted market research of married women with 2-4 years of education to test instructions for OCs. The study indicated that they better grasped instructions when they included a lifelike pointing hand instead of an arrowhead and all arrows pointed from left to right rather than zig zag. The test marketers also improved instructions in Urdu so the women could discern other aspects of OC use. A staff member from Family Health International evaluated storage conditions of condoms in karachi and lahore. He also obtained samples of USAID procured condoms for testing in the U.S. Family planning specialists observed distribution of Sathi condoms in several villages in the Punjab and in working class areas of Lahore.
Social Science and Medicine. 1991; 32(11):1201-18.The 3 drug distributing systems in Africa, private commercial, private non-profit, and public, are described, and issues involved in improving efficiency and rational use are exposed. The private pharmacy sector in Africa is largely located in cities, with retail prices multiples of those charged for name brands in the West. It includes pharmacies, drug shops, injection rooms, and drug peddlers, who obtain their supplies from wholesale and retail sources, and frequently pilferage from public supplies. The private non-profit system, largely missing health agencies, are often well-managed by regional drug procurement associations. The public sector consists of government and para-public enterprises and their distribution facilities. Supplies are limited, especially at the end of the transport chain, because of deficit financing and logistical obstacles. It is best to employ expatriate managers who are immune to local corruption. The most effective points to improve efficiency in drug supply are in procurement: to select generic drugs, take advantage of credit for certain brands, avoid non-essential, low priority, and expired drugs. Great savings could also be obtained by sound logistics, proper storage, and avoiding local purchase of emergency supplies. Rational use of drugs can be improved by consistent, conservative prescription, kits for managed care, and for AIDS especially, management protocols. Most African countries have their own pharmaceutical production facilities, but these have lost money because of the high cost of imported raw materials, technology and personnel. These facilities could best be used to formulate or re-package generics bought in bulk for local needs, to produce intravenous fluids, and to make simple products such as ointments at a profit. It might be efficient to produce essential drugs under regional agreement and quality control, avoiding duplication. Some concerns peculiar to Africa are self-medication, "cultural re-interpretation" of Western medications by users and traditional practitioners, sparse populations without transportation infrastructure, counterfeit drugs, and an entrenched informal system of private sales of non-essential and ineffective therapeutic agents. AIDS is an added burden to an already strained health system.
JAMA. 1991 Nov 6; 266(17):2373.We at Wyeth-Ayerst appreciate that Dr Reynolds has brought to our attention the fact that some healthcare providers are using the plastic tray in the Norplant system kit as a sterile field. As Dr Reynolds mentioned, an extra sterile drape is provided in the product kit for this purpose, and use of this drape as the sterile field is shown in all the audiovisual materials and in the package insert. As a result of this information, the instructors participating in the Norplant system instruction program have been notified of this unintended use of the plastic tray, and Wyeth-Ayerst has reemphasized the labeling recommendation to use the extra sterile drape provided as the sterile field. We have also contracted each healthcare provider who has participated in an instruction session where the plastic tray may have been incorrectly used as a sterile field. In addition, Wyeth-Ayerst is now placing high visibility stickers on the plastic tray, stating that the tray is not sterile. (full text)
JAMA. 1991 Nov 6; 266(17):2373.Evidence is presented of a potentially serious perception problem concerning the sterility of the Norplant packaging. The insertion kit consists of an outer cardboard box with an inner plastic tray that holds the individually wrapped, sterilized insertion materials. Also included is a sterile towel intended for use as a side table sterile field. At a physician training session conducted by Norplant's manufacturer, Wyeth-Ayerst Laboratories, the author observed the trainer to use the nonsterile plastic tray as a sterile field to lay out the insertion materials. The trainer reportedly had been taught this procedure at a seminar for trainers. The manufacturer's audiovisual materials and package insert outline the need to unwrap all insertion materials into a sterile field. All physicians, especially those who have attended trainings, should be aware of the nonsterile nature of the plastic tray. Both the Food and Drug Administration and the manufacturer have been informed of this perception problem.
NETWORK. 1991 Sep; 12(2):14-7, 27.Many unwanted births and pregnancies could be avoided by improving instructions for and comprehension of the use of oral contraceptives. Employed less than only the IUD, the oral contraceptive pill is the 2nd- most widely used reversible form of contraception, used by 8% of all married women of reproductive age. 6-20% of pill users, however, fall pregnant due to improper pill use. Improving instructions in the pill pack, ensuring that instructions are correct, and working to facilitate user understanding and motivation have been identified as priorities in maximizing the overall potential effectiveness of the pill against pregnancy. Since packets in developing countries may consist of pills in cycles of 21, 22, 28, or 35 days, providers must also be trained to instruct users in a manner consistent with the written instructions. Pictorial information should be available especially for semi-literate and illiterate audiences. The essay describes recommendation for instruction standardization and simplification put forth by Family Health International, and endorsed by the U.S. Food and Drug Administration. International Planned Parenthood Federation efforts to increase awareness of this issues are discussed.
Research Triangle Park, North Carolina, FHI, 1991 Feb 8.  p.A special notebook for use at a U.S. Food and Drug Administration meeting held February 8, 1991, for the Advisory Committee on Fertility and Maternal Health Drugs, contains draft instructions for oral contraceptive users to be included in the Patient's Package Insert (PPI). There are 9 manufacturers of 56 types of oral contraceptives in the U.S., as well as 26 family planning organizations, with many different sets of directions for use. Particular discrepancies exist in start date, what to do if 1, 2 or more pills are missed, and in related factors such as the design of the package. The suggested instructions are readable by a person with 5-6th grade reading level, are the same for all pills, and resemble those issued by the IPPF and WHO. THe only exception is the difference between 21- and 28-day pill packages. This draft has been pre-tested on a limited basis on 70 users. The rest of the notebook contains sections on advantages and disadvantages of the proposed instructions, a review of relevant biomedical and social literature on pill-taking with excerpted readings, list of manufacturers, types of instructions by manufacturer, bibliography, and contributors. With a 1st-year failure rate as high as 10%, leading to a 10-year failure rate of 40%, it is assumed that if compliance could be improved, the current estimated 250,000 pill failures annually in the U.S. would decrease.
CONTRACEPTION. 1991 Aug; 44(2):183-90.A small survey to assess the perception and experience of current family planning users and their husbands was carried out in a university family planning clinic. Women routinely visiting the clinic were asked to complete a short screening form. 56 women responded to the questionnaire concerning their attitude to the Femshield. 18 volunteers agreed to enter the study and were given verbal instruction on use of the device. Each volunteer was provided with 3-5 Femshields. Participants were asked to return to the clinic 1 month after admission. A Husband Form was then sent to the home of the volunteers to assess the attitude of their husbands. 13 volunteers returned for the followup visit. 50 Femshields were used. The results showed that the volunteers found the vaginal insertion of the device was acceptable, but the outer and inner rings of the device caused an uncomfortable feeling when having intercourse. The volunteers were more positive about the device than were their partners. Sexual satisfaction for both partners was reduced. A few couples suggested that the device be modified with the bag being smaller and thinner, the outer and inner rings reduced in size and softer, and the device itself being in a prelubricated packet. (author's)
[Unpublished] 1991 May. iii, 61 p.This WHO Specifications for Latex Rubber Condoms is appropriate for photocopy as an attachment to the Invitation to Bid and Purchase Order. Section 6 provides a place to indicate size or other specifications. The standard provided is the minimum for use and storage and delivery. Procurement needs to take into account 1) quality of design, and 2) conformance to specifications. Essential criteria are uniform high strength and elasticity and the absence of holes. Chapters include: 1) reason for specification and guidelines, 2) choice of design features, 3) alternative design specifications. The specifications include: 1) scope and definitions, 2) international standards and other publications, 3) requirements for materials, construction, lubrication, tensile properties, freedom from holes, bursting volume and pressure, colorfastness, individual packages, identification marking on individual packages, workmanship, 4) quality assurance provisions for compliance, objective evidence, inspection by purchaser, sampling procedures, examinations and tests for specific properties, inspection of packaging and marking, 5) packaging for delivery (inner boxes, consumer packs, exterior shipping cartons, markings for lot traceability) 6) ordering data. The WHO guidelines for condom procurement reports on 1) testing to insure conformance to specifications, 2) qualifying condom suppliers, 3) invitation to bid, 4) purchase order, 5) predelivery quality check. Additional support documents include: 1) essential performance criteria (limiting condoms that will break during use, that may leak during use, that may deteriorate on the shelf), 2) choosing from available design options (length, width, thickness, shape, lubrication, color, packaging), 3) manufacturers list, 4) invitation to bid, 5) WHO forms: Request for offer and request for sealed bids, 6) purchase order, 7) aggregate analysis criteria for shipments or orders. The recommended condom is parallel sided, reservoir end, 49 2 mm flat width or 53 2 mm flat width, 170 to 180 mm length, .05-.08 mm single wall thickness, smooth surface, no color, translucent, silicone fluid (plain) lubricant, and packaged in square plastic-aluminum foil laminate in 100 units per inner box.
NETWORK. 1991 Jun; 12(1):17-20.Social marketing of condoms in Zaire began in 1987 and sales rose to 8 million in 1990, a notable change from the previous situation where about half a million condoms were distributed by government health clinics only. Social marketing is the use of for-profit sales and marketing techniques for public health problem.s When the Zaire National AIDS Committee initiated social marketing of condoms, with the assistance of Population Services International, they had the experience of successful Asian programs of the 1970s, and the political sanction resulting from the AIDS threat to back them up. Efforts were made to find just the right product name, "Prudence," logo, package, color and slogan by consumer research. Prudence implies responsible behavior, capturing both the AIDS and STD prevention and the family planning markets. Consumers like the package and associate it with quality, since most condoms sold before in Zaire had no special packaging. Distribution outlets include 7000 retail shops, groceries, pharmacies, hotel, social clubs, 300 bars and even Congo River barges which sex workers frequent. The price was set close to that of a pack of gum for 3, or that of a bottle of beer for a dozen. Promotion is limited by a government ban of advertising in mass media, so point of purchase materials, special offers and promotional items are being used. Prudence condoms are now being marketed in Cameroon and Burundi.
BMJ. British Medical Journal. 1991 Apr 27; 302(6783):1025.Dr R H B Meyboom (Netherlands Pharmacovigilance Centre, PO Box 5406, 2280 HK Rijswijk, The Netherlands) writes: 1 of the physiological effects of progesterone is a slight rise in body temperature, up to 0.5 degrees Celsius. Midcycle temperature rise may be used as evidence of ovulation and the formation of a corpus luteum. Although progestagens are a basic constituent of oral contraceptives (OCs), the possibility of an influence on temperature is not mentioned in the usual sources of information on side effects. A recent case report to The Netherlands Pharmacovigilance Centre described a 35 year old woman with longstanding rise in body temperature of about 0.5 degrees Celsius, which in the evening reached subfebrile values up to 38 degrees Celsius, in suspected association with Microgynon 30 (levonorgestrel 150 mcg, ethinyl estradiol 30 mcg). No medical cause was found and the course of the temperature after stopping and during rechallenge, as established by daily rectal assessment of morning temperature, was consistent with an effect of the contraceptive agent. Although the influence of progesterone on temperature is well known, there is a remarkable paucity of data in current physiology textbooks concerning this effect. With regard to OCs, only 1 reference was found in the medical literature, but without quantification and comment. A body temperature raised by 0.5 degrees Celsius may be mistaken for a subfebrile temperature and may be a cause of unnecessary concern and medical investigations. More information on the influence of progestagens on temperature is needed. The product information of all OCs containing a progestogen should mention the possibility of a slight rise in body temperature. (full text) (9 references cited in original document)
CONTRACEPTION. 1991 Mar; 43(3):263-71.From October 1987-May 1989, a total number of 527 women completed a total of 6291 treatment cycles in 6 centers in China for the study of a triphasic oral contraceptive (OC), Triquilar. The mean age of the subjects was 30.21 +or- 2.84 years. There were 7 pregnancies during the study period. Among them, 5 were patient failures due to a missed pill or incorrect dosage; 1 had taken barbiturates along with Triquilar. Only 1 woman became pregnancy in the 11th treatment cycle without any discernible reason. In most cases, menstrual flow decreased and dysmenorrhea improved as treatment continued. Of the total treatment cycles, the incidence of missed withdrawal bleeding was 0.25%, spotting 0.97%, and breakthrough bleeding 0.48%. Nausea and vomiting were the most common side effects and accounted for 6.4% of the total treatment cycles. This was followed by breast tenderness (3.7%), dizziness (2.4%), and headache (1.6%). Most of these occurred during the 1st few cycles and were alleviated later. By the end of 1 year, the total dropout was 64 cases. The reasons for discontinuation of treatment were: pregnancy 1.33/100 women, menstrual disturbances 0.76, side effects 3.80, other medical reasons 2.09, and personal reasons 4.18. Results confirm that Triquilar is an effective OC with good cycle control and low incidence of side effects. No serious reaction has been reported. It has been well accepted by the Chinese women. However, due to the low dosage of steroids, it is of utmost importance to avoid errors in its use. Not only should the package of the drug carry conspicuous warnings, but also detailed instructions should be given to the women in order to obtain the desired efficacy. (author's)
Interchangeability of low-dose oral contraceptives. Are current bioequivalent testing measures adequate to ensure therapeutic equivalency?
CONTRACEPTION. 1991 Feb; 43(2):139-47.Current Food and Drug Administration guidelines for assessing the differences in bioavailability between generic oral contraceptives (OCs) and brand name products are inadequate to ensure therapeutic equivalence. The guidelines do not take into account those women who may have blood levels of active ingredients well outside the range of acceptability. Due to the narrow therapeutic range of steroids, these women may become pregnant or experience an increased incidence of breakthrough bleeding. Furthermore, OC packaging is unique to each manufacturer, and any change in brands (and thus in packaging) can easily negate the sequential administration of the appropriate tablet. These are among the reasons suggested for placing OCs into the critical drug category, where generic substitution and interchangeability of products should not be allowed. (author's)
CONTRACEPTIVE TECHNOLOGY UPDATE. 1991 Mar; 12(3):33-6.There is a controversy over the effectiveness of the "Sunday-Start" oral contraceptive packaging. Some clinicians believe that the Sunday-start pills are dangerously ineffective because up to 6 days after menses can elapse before a new packet is started. This is particularly risky for women beginning orals, or switching from a combined pill to a new triphasic. These clinicians consider them merely a successful marketing strategy. Most physicians consider the Sunday-start pills more effective because of improved compliance. The reasons cited are that women are too confused to remember to start pill packets on odd days, and that they like having their menses occur on weekdays. Arguments on this side are studies showing that the length of the pill-free interval does not affect the efficacy of that cycle. There are not data to resolve this debate other than a report from Ortho Pharmaceuticals that women prefer Sunday-start 3:1.