Expired drugs may remain effective, safe to use in a pinch | Reuters
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Industry officials say patient safety is their highest priority. Olivia Shopshear, director of science and regulatory advocacy for the drug industry trade group Pharmaceutical Research and Manufacturers of America, says expiration dates are chosen "based on the period of time when any given lot will maintain its identity, potency and purity, which translates into safety for the patient.
That being said, it's an open secret among medical professionals that many drugs maintain their ability to combat ailments well after their labels say they don't. One pharmacist says he sometimes takes home expired over-the-counter medicine from his pharmacy so he and his family can use it.
The federal agencies that stockpile drugs — including the military, the Centers for Disease Control and Prevention and the U.
Department of Veterans Affairs — have long realized the savings in revisiting expiration dates. In , the Air Force, hoping to save on replacement costs, asked the FDA if certain drugs' expiration dates could be extended. Each year, drugs from the stockpiles are selected based on their value and pending expiration, and analyzed in batches to determine whether their end dates could be safely extended.
For several decades, the program has found that the actual shelf life of many drugs is well beyond the original expiration dates. A study of drugs tested by the program showed that two-thirds of the expired medications were stable every time a lot was tested. Each of them had their expiration dates extended, on average, by more than four years, according to research published in the Journal of Pharmaceutical Sciences.
Some that failed to hold their potency include the common asthma inhalant albuterol, the topical rash spray diphenhydramine, and a local anesthetic made from lidocaine and epinephrine, the study said. But neither Cantrell nor Dr. Cathleen Clancy, associate medical director of National Capital Poison Center, a nonprofit organization affiliated with the George Washington University Medical Center, had heard of anyone being harmed by any expired drugs.
Cantrell says there has been no recorded instance of such harm in medical literature. Marc Young, a pharmacist who helped run the extension program from to , says it has had a "ridiculous" return on investment. Hussain is now president of the National Institute for Pharmaceutical Technology and Education, an organization of 17 universities working to reduce the cost of pharmaceutical development.
He says the high price of drugs and shortages make it time to re-examine drug expiration dates in the commercial market.
The pharmacy at Newton-Wellesley Hospital. Some medical providers have pushed for a changed approach to drug expiration dates — with no success. In , the American Medical Association, foretelling the current prescription drug crisis, adopted a resolution urging action. The shelf life of many drugs, it wrote, seems to be "considerably longer" than their expiration dates, leading to "unnecessary waste, higher pharmaceutical costs, and possibly reduced access to necessary drugs for some patients.
Pharmacopeial Convention, which sets standards for drugs, and PhRMA asking for a re-examination of expiration dates. I think there's considerable waste. On a recent weekday, Berkowitz sorted through bins and boxes of medication in a back hallway of the hospital's pharmacy, peering at expiration dates.
As the pharmacy's assistant director, he carefully manages how the facility orders and dispenses drugs to patients. Running a pharmacy is like working in a restaurant because everything is perishable, he says, "but without the free food. David Berkowitz, assistant director of clinical pharmacy at Newton-Wellesley Hospital, says that the hospital has to throw out many drugs that are probably safe to use.
Federal and state laws prohibit pharmacists from dispensing expired drugs, and The Joint Commission, which accredits thousands of health care organizations, requires facilities to remove expired medication from their supply. So at Newton-Wellesley, outdated drugs are shunted to shelves in the back of the pharmacy and marked with a sign that says: "Do Not Dispense.
And then the bins fill again. One of the plastic boxes is piled with EpiPens — devices that automatically inject epinephrine to treat severe allergic reactions. These are from emergency kits that are rarely used, which means they often expire. This medication is used to treat a variety of skin conditions e.
Betamethasone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a medium-strength corticosteroid. Stinging, burning, itching, irritation, dryness, or redness of the skin may occur when this medication is first applied to the skin.
Skip to content Common questions. I mean, particularly if there are young children around then I would be concerned. Other issues included confusion and medicine duplication if multiple generic brands were stored; self-diagnosis and self-medication without medical advice; and sharing of medicines:. You might be more tempted to share. I've got this, I'm sure, they worked for me I'm sure they'll work for you.
You might hand them out to other people, your friends, relatives, family, whatever. A small number of participants highlighted the risk that medicines not for everyday use could be misused, re-sold or instigate break-ins. Many interview participants voiced an intention to return medicines to a pharmacy after finding out about The RUM Project at the end of the Stage Two general population survey:. Even so, 36 interview participants described a combination of disposal practices, which appeared to be influenced by the formulation or schedule of the medicine.
Participants discussed that they were more likely to return prescription tablets to the pharmacy and discard ointments, liquids, CAMs or general sale medicines, e. If they are other pills, I throw them in the garbage.
I wrap them up in a plastic bag and throw them. The other ones we obviously hoist in the rubbish bin. Participants applied individual risk assessments to guide disposal Additional file 1 : Table S1 , considering potential toxicity, perceived efficacy, inappropriate use, convenience and potential for diversion of medicines for manufacture of illicit drugs:. Disposal of medicines in the household rubbish was reported more frequently by younger participants 18 to 44 years , yet a greater proportion of people aged 45 years or older discarded medicines down the drain.
Return of medicines to the pharmacy was more prevalent amongst people living in rural locations, aged 45 years or older or those with recent healthcare work experience. What they do with them, I'm sure they do whatever needs to be done, the right thing. About a third of participants discussed recycling or resale of medicines to reduce wastage, provide access to medicines for people who cannot afford them, or to send to developing countries.
However, there was ambivalence over the reuse of medicines, particularly expired medicines:. We shouldn't just necessarily throw our rubbish at them.
We should sort of fund proper supplies…but I suppose on the other hand it's better to have something rather than nothing One participant stated that if medicines were to be re-used, they might as well just keep them themselves. A range of medicines not for everyday use are stored in multiple locations in Australian homes, and self-reported medicine storage, usage and disposal practices have direct implications for medicine quality, as well as environmental and health risks for individuals and other household members.
Whilst participants acknowledged accidental ingestion and reduced efficacy as key health risks of storing and using such medicines, this did not always translate to appropriate storage in the home. The majority of the medicines not in everyday use were found to be those purchased without a prescription. Overall, the propensity of participants to use individual and varied risk-benefit strategies to guide these behaviours was prominent. Multiple storage locations were used to support medicines adherence and provide easy access to commonly used medicines.
There were concerns that storing different generic versions of prescription medicines in multiple locations could create confusion and lead to medicine duplication.
These add to existing concerns over consumer confusion related to generic brands [ 43 ]. Additionally, if some of these storage locations are infrequently accessed, medicines are more likely to expire. However, the potential for decreased efficacy of medicines stored in bathrooms, and the risk of accidental ingestion by children when medicines are kept within easy access, such as dining room tables, was not always considered by participants.
Although the majority of participants in this study were over the age of 55 and unlikely to have children living at home, as potential grandparents, they may be placing visiting grandchildren at risk with current medicine storage practices.
While participants were aware that medicines not for everyday use could be hazardous to children, to what extent this translated to preventative action when grandchildren or others visited can only be speculated.
While some research into the impact of grandparent actions on the physical wellbeing of grandchildren is available [ 44 ], a focus on medication safety in terms of medicines not for everyday use is lacking and therefore, necessary. Participants demonstrated varying degrees of awareness about the volume of expired medicines in the home and the associated safety risks. Whilst keeping expired medicines is not new, insight into continued use is limited.
We know that financial burden can influence collection of prescribed medicines [ 45 ], but greater understanding of whether it contributes to continued use of expired medicines is warranted. Expired prescription medicines have previously been removed from the homes of consumers considered to be at-risk of medicine misadventure, i. Healthcare professionals cannot presume that high medicine users, as seen in our study population, are knowledgeable in terms of the quality use of medicine or medicine safety.
However, reduced effectiveness may have negative health implications if expired medicines with decreased efficacy are used to manage chronic health conditions. Our findings highlight the need for further health campaigns, regular review of household medicines and more routine reminders from health professionals than what currently occurs [ 22 ], specifically for consumers using multiple medicines.
A few participants mentioned the risk of sharing medicines not for everyday use; this builds on existing evidence of medicine sharing [ 46 , 47 ], but does not specifically explore sharing of expired medicines. Qualitative comparison of consumer views on, and decisions about sharing current medicines, those medicines not for everyday use, and expired medicines would provide additional insight.
The key benefit was to have medicines on hand for ease of use, which is appropriate for episodic conditions such as migraines, yet inappropriate if retaining antibiotics to self-treat future infections, particularly viral infections.
Inappropriate antibiotic use was reported in another survey of unused or expired medicines [ 48 ], and few people were concerned about resistance or treatment failure when sharing antibiotics with family or friends [ 46 ]. Microbial resistance is a significant public health concern and public health campaigns emphasise inappropriate antibiotic use in viral infections such as colds and influenza.
However, consumers may not translate this public health message to other infections. Another finding from our study was that the majority of unwanted or expired medicines found in homes were over the counter medicines.
It may be that consumers perceive over the counter medicines to be safe [ 49 ], or safer than prescription medicines [ 50 ], although we did not explore such perceptions.
As over the counter medicines traditionally involve less input from health care professionals, e. Such practice was guided by individual perceptions of health and safety rather than the risk to the environment. Indeed, how consumers dispose of other perishable goods could also influence medicine disposal; liquids were more likely to be poured down the drain similar to other fluids, and tablets placed in the bin like other solids such as food scraps.
On a positive note, increasing consumer awareness of pharmacy services for disposal of medicines not for everyday use can improve intended disposal practices [ 3 ]. This was identified in interviews, which perhaps reflects an educational effect of the Stage Two survey that could be extended to additional populations.
Furthermore, there was significant trust in pharmacists to safely dispose of returned medicines tempered by ambivalence over how this process actually occurs and whether medicines would be reused overseas.
Government funding of medicines disposal via The RUM Project supports appropriate disposal, unlike countries such as New Zealand where some pharmacists shoulder this financial burden [ 52 ]. Variability in disposal practices and views on the acceptability of medicine reuse further highlight different risk-benefit strategies and potential misconceptions. Health campaigns and grass-roots strategies, e. Study limitations include: interview data represents a snapshot in time and omits those medicines stored in other locations such as the workplace [ 5 ], or the potential for people to misread expiry dates [ 53 ].
We spoke to a single member of the household and there was potential under-reporting of medicines due to privacy concerns, and self-reported practices did not necessarily reflect those of other household members. We did not explore the influence of multiple prescribers or chronic illness morbidity on medicine management practices [ 35 ] and these limitations identify areas for more targeted exploration of medicine accumulation, use and disposal.
Interviews were conducted with consumers using multiple medicines, the majority of which were over the age of 55 years.
How these results differ from a generally healthy person, e. A key strength of this study was the nationwide sample of people self-reporting medicines storage, usage and disposal practices to reveal the individual risk-benefit assessments that guide these behaviours.
While other studies have used in-home visits to inventory consumer medicines [ 25 , 35 , 54 , 55 ] these have been restricted to discrete, often local, populations, unlike our nationwide representative sample. Additionally, an interview protocol was developed to ensure consistency between interviewers and limit potential for bias introduced by their pharmacy background; this enabled researchers to identify important insights into this subject area.
Australian consumers who could be considered experienced medicine users are storing medicines not for everyday use at home. The use of such medicines, including those which are expired, is not always appropriate and is guided by variable risk-benefit assessments and this has implications for individuals and households, the broader health system and the environment. Further research is needed to confirm these results with a younger, or healthier, population. Greater understanding of the underlying basis and significance of this is needed to identify and effectively address common misconceptions through consumer health campaigns or grass-roots strategies.
BMJ Qual Saf. Article PubMed Google Scholar. Int J Clin Pharm. Pharmaceuticals in wastewater: behavior, preferences, and willingness to pay for a disposal program. J Environ Manag. Article Google Scholar. Taking stock of medication wastage: unused medications in US households. Res Social Adm Pharm. Ruhoy I, Daughton C.
Beyond the medicine cabinet: an analysis of where and why medications accumulate. Environ Int. Vuong T, Marriott J. Unnecessary medicines stored in homes of patients at risk of medication misadventure. J Pharm Pract Res.
The afterlife of drugs and the role of pharmacovigilance. Drug Saf. A survey of drug resistance bla genes originating from synthetic plasmid vectors in six Chinese rivers. Environ Sci Technol. They tested five types of drug, all one to four years past expiration, and compared these to fresh samples of the same medications to see if the expired versions were chemically stable and retained their active ingredient.
The drugs included atropine, which is used to treat certain types of pesticide or nerve agent poisonings; nifedipine, a calcium channel blocker that relaxes the heart and blood vessels in cases of high blood pressure and chest pain; flucloxacillin, an antibiotic in the penicillin family; bendroflumethiazide, a diuretic used to treat hypertension; and naproxen, a nonsteroidal anti-inflammatory NSAID painkiller.
By Carolyn Crist. In some parts of the world, doctors face the difficulty of getting medicine more than once a year. The study team tested the stability of five expired drugs that had been returned from the British Antarctic Survey, which operates five bases and two ships in the Antarctic region and has on-site medical and dental facilities.
Drugs for the Antarctic operation are ordered annually in May and shipped from the UK in September, arriving at the bases in December after spending several months at sea, the researchers note.
They tested five types of drug, all one to four years past expiration, and compared these to fresh samples of the same medications to see if the expired versions were chemically stable and retained their active ingredient. The drugs included atropine, which is used to treat certain types of pesticide or nerve agent poisonings; nifedipine, a calcium channel blocker that relaxes the heart and blood vessels in cases of high blood pressure and chest pain; flucloxacillin, an antibiotic in the penicillin family; bendroflumethiazide, a diuretic used to treat hypertension; and naproxen, a nonsteroidal anti-inflammatory NSAID painkiller.
Researchers found that all of the tested drugs were stable, and would, theoretically, have still been effective. The researchers caution that their results are limited by the fact that they did not know the exact temperature exposures the returned drugs had experienced.
If left in a car in hot summers in Arizona, California or other hot spots, some drugs could degrade more quickly, she noted. Health News Updated. By Carolyn Crist 5 Min Read.
A use-by date is shown on the tube and carton of Celestone M Cream. If you use this medicine after the expiry date has passed, it may not work as well. No: It probably would have very little effect on what you are treating. But somewhere should be an expiration date. Created for people with. Hospitals and pharmacies are required to toss expired drugs, no matter how expensive, vital or scarce. And that's even though the FDA has. The 'expiration' date is the last date that the Manufacturers will guarantee their product. In no way, does it mean it mysteriously stops. For topical dosage forms (cream, gel, lotion, and ointment). For redness, itching, and swelling of the skin: Adults and children That being said, it's an open secret among medical professionals that many drugs maintain their ability to combat ailments well after their labels say they don't. Additional file 1: Table S1.Metrics details. Consumers most commonly discard unwanted medicines in household rubbish or drains, however, there are global concerns over the extent, environmental impact and health risks.
When consumers procure or store medicines for future use, this can impact negatively on quality use of medicines and consumer safety. We sought greater insight into the extent of these practices by exploring the volume and types of medicines in Australian homes, and self-reported practices related to medicine accumulation, use and disposal. This qualitative study formed part of a larger project that included a general population survey on household medicine disposal practices.
Participants were eligible if they were experienced medicine users, i. Participants were asked to collect and name all medicines in their household; further detail was obtained about medicines used only when required or no longer used, such as expiry dates and quantity remaining.
The quantitative data on the number and type of medicines stored at home were analysed descriptively. All interviews were transcribed verbatim and thematically analysed. A total of medicines were identified as medicines not in everyday use unused, unwanted, expired or when required in households, and regularly used medicines by participants.
Medicines were often stored in multiple locations, particularly kitchens. Although accidental ingestion in children and pets and decreased efficacy were recognised health risks, this did not always translate to appropriate storage, usage or disposal practices.
Individual risk-benefit assessments were applied to decisions to retain, use or dispose of medicines, including expired medicines. Healthcare professionals must act to address consumer misconceptions around the quality use of medicines, including medicine retention, storage and disposal.
Future research is warranted to explore consumer practices in this context and confirm these findings in a younger, or healthier population. Peer Review reports. Medicine usage rates are increasing worldwide [ 1 ] and while timely access to medicines is important, there are global concerns over the extent of medicine waste from unused or unwanted medicines [ 2 ].
Concerns include public health and environmental impacts from inappropriate medicine disposal, for example inappropriate self-medication; accidental consumption by children; accumulation of active pharmaceutical ingredients in waterways as environmental pollutants; risk of antibacterial resistance and accidental poisoning of wildlife [ 3 , 4 , 5 , 6 , 7 , 8 ].
Strategies recommended to address these issues include consumer general public education about medicine costs and appropriate disposal practices [ 4 ]. Alternatively, the redistribution of unwanted medicines has been proposed as another option to reduce medicine waste [ 9 , 10 ], a practice not yet sanctioned in countries such as the United Kingdom UK [ 11 ] and Australia [ 12 ].
Internationally, there is significant variability in how countries manage medicines disposal [ 13 , 14 ], particularly between developing and developed countries. Across Europe there is variation in returned medicines schemes and in how the public are informed about safe medicines disposal [ 15 ]. Pharmacies are legally required to participate in selected countries, e. Denmark, France; and it is voluntary in others, e. Austria, Italy [ 15 ].
Review of Canadian and American schemes reveals significant variability in timing, e. Pharmaceutical wholesalers and manufacturers have allegedly avoided their obligations towards managing medicine waste in Serbia [ 17 ]. There are well-established, fully resourced return of unwanted medicine programs in Sweden [ 18 ], the UK [ 19 ] and Australia [ 20 ], all of which involve community pharmacies. In Australia, returned medicines are deposited in Return Unwanted Medicine RUM bins situated within pharmacies, which are then collected by pharmaceutical wholesalers and transported to registered incineration sites.
The RUM Project is a national scheme established in and funded by the Australian Health Department as a quality use of medicines initiative.
Between July and May , Australian pharmacists have collected However, despite the availability of this free national scheme to return medicines, the most common form of medicine disposal reported by Australian consumers is the rubbish bin followed by the toilet or drain [ 21 , 22 ].
Consumer actions towards medicines use and storage are also influenced by socio-demographic and contextual factors, such as cultural beliefs and the availability and costs of medicines. For example, in Ethiopia, limited quantities of conventional medicine were found in participant homes, which did not account for the use of traditional medicines [ 26 ].
Ekedahl et al. Doctors and pharmacists have a significant role to inform the public on safe medicines disposal practices [ 14 , 22 ], yet the need to raise both public and health professional awareness of disposal schemes such as The RUM Project has been identified [ 28 ].
Given the plethora of studies that have explored the types of medicines returned to disposal collection points and why [ 29 , 30 , 31 ], or consumer opinions about disposal practices [ 16 , 18 , 24 , 32 , 33 ], it could be suggested that there is limited new information to be gained from this topic.
However, medicine wastage remains a considerable public health issue. Limited studies have identified or accounted for medicines currently stored in the home [ 17 , 23 , 34 ]; no data on the volume of unused or unwanted medicines, e. While concerns about poor medicine management practices have been identified for consumers with a range of chronic health conditions living at home in Uganda [ 35 ], overall, there has been limited focus on consumers using multiple medicines, a population that could be considered at greater risk of medicine mismanagement.
In this study, we sought to explore the volume and type of medicines in Australian homes, as well as self-reported practices related to medicine accumulation, storage, use and disposal for consumers who could be considered experienced medicine users. A two-stage mixed methods study into public awareness of The RUM Project and its effectiveness in reducing inappropriate medicine disposal was funded by the Australian Department of Health in [ 36 ].
Stage One involved a national audit of a representative sample of RUM pharmacy collection bins to describe the nature of the medicines returned to community pharmacies [ 36 ]. Most of the disposed items were considered appropriate and not high-cost medicines [ 37 ]. In Stage Two, a representative general population online survey of people was conducted to explore whether they had medicines not in everyday use in their home and why, disposal practices and awareness of The RUM Project [ 36 ].
Participants who were not aware of the scheme were provided with some information and asked about their intended future use of the scheme [ 36 ]. Survey results established that there was limited awareness and inappropriate disposal practices [ 22 ].
This paper presents findings from a sub-section of Stage Two; interviews were conducted with a sample of survey participants who were using five or more medicines. A purposeful and convenient sub-section of a representative survey sample of the Australian population by age, gender and geographical location were recruited by an external research panel company [ 22 , 38 ].
Participants needed to speak English without the use of an interpreter. Medicines used on a when-required basis, e. A semi-structured interview guide Table 1 was chosen to obtain specific medicine data, such as names, quantities and expiry dates of medicines not in everyday use, as well as participant views on medicine accumulation, storage, use, disposal and potential risks.
The interview guide was informed by research on returned medicines [ 39 , 40 ], the Stage Two survey [ 22 ] and feedback from the Project Advisory Panel.
The interview guide was piloted with six members of the general population who were known to the research team personally, and who were using five or more medicines; minor amendments were made. Eligible participants were invited to express interest in an interview at the completion of the Stage Two survey; their contact details were provided directly to the research panel company. The company provided a list of prospective interviewees to the research team separately to survey data to maintain confidentiality.
Research team members phoned participants to schedule interviews when they were at home with access to their medicines. Participants were excluded when contact details were incorrect, they could not be contacted or they declined to participate. To maximise opportunities for a full range of participant engagement, interviews occurred between 8 am and 8 pm on weekdays and weekends from September to October A research incentive was provided to participants by the research panel company, as per the terms of their engagement.
Telephone interviews were conducted by three researchers at one of two University sites in Queensland, audio-recorded and independently transcribed verbatim. Prior to each interview the researcher obtained verbal consent and permission to audio-record the conversation. Participants were asked to physically locate the medicines in their home and had either gathered their medicines near the telephone or physically moved between storage location s in the home during the interview.
Interviews were designed to be 15 min in duration and averaged Twice-daily debriefs to the entire research team were provided to facilitate discussions around data collection. Quality checking of a random sample of transcribed interviews, and all data entries of medicine information, was undertaken for reliability purposes.
Data saturation was established after interviews were completed and no new information was being offered. Analysis of qualitative open-ended data was exploratory and data were thematically analysed by two researchers FK, SM. Transcripts were read to assist with data familiarisation and frequent discussions were held between the two researchers due to the potential for bias; both were registered pharmacists.
Units of data were coded into themes and data were compared and contrasted between transcripts. The interview guide topics were used as over-arching themes; sub-themes for each of these were identified in the data. Quotes have been coded by individual participant numbers throughout the text as P and an ellipsis has been inserted to indicate omission of repetitive or unrelated text.
Medicines were classified by medicine schedule, e. The therapeutic category for each medicine was identified using the classification system within the Australian Medicines Handbook [ 42 ]. Of the Stage Two survey participants who responded to the question about using five or more medicines, This represented 3. Table 2 outlines the characteristics of interview participants and provides comparisons with the Stage Two general population survey sample [ 22 ].
Interview participants reflected an older sub-population of survey participants with About two-thirds of interview participants lived in urban areas and the majority A total number of medicines were identified, including medicines used on a regular basis for participants; on average, seven medicines were used regularly, with one participant reporting a maximum of 36 medicines. The kitchen was commonly used to store medicines, followed by the bedroom and bathroom.
Examples of storage spaces included, in or above the refrigerator, above the stove, in high cupboards, or on dining tables. Multiple locations were frequently mentioned, guided by storage requirements, e.
A minority of participants stated specifically that they used measures to restrict medicine access by children or pets. Additional quotes are provided in Additional file 1 : Table S1.
At the time of the interview, a total of medicines not in everyday use were stored at home. Although Some participants articulated concerns over the quantity of medicines stored, others used the interview as an opportunity to clean out their accumulated medicines:. Just looking at the expiry date on that one… See here I thought I was so good.
About two-thirds of the medicines not in everyday use The most common therapeutic medicine category was analgesics Over the counter medicines represented The majority of medicines not in everyday use I had new prescriptions with increased amounts. So these just got left in my bedside table. Factors that influenced accumulation included living or working away from home; ensuring adequate supply always on hand; impending travel and episodic illnesses such as migraines:.
The chemist basically issued a repeat and the first dose in one go because I wasn't too well at the time so it saves you coming back, there's your repeat, but I never used the repeat so that box [amoxicillin] is full. A small number of participants stated they were unlikely to discard medicines due to frequent prescribing changes, to limit wastage, or because they were forgotten, e.
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